Combo with All Federal MPJE Study Sets
What cautionary statement must be on every controlled substance label?
"Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
Prescription Drug Marketing Act of 1987 Establishes ------------- which is a paper or electronic trail of a drug as it moves from the manufacturer through drug wholesalers
"PEDIGREE"
What is the prescription drug legend?
"Rx Only" which was recently amended from "Caution: Federal Law prohibits dispensing without a prescription"
Failure to provide PPI is considered
"misbranding"
What is the penalty for inadequate CS record keeping?
$10,000 PER OFFENSE or 1 year in prison
What conditions must be met for the FDA to authorize a patient to obtain an investigational new drug or device, prior to FDA approval, to be used for diagnosis, monitoring, or treatment of a serious disease/condition in emergency situations?
(1) A licensed physician must determine no comparable/satisfactory alternative available and that probably risk from investigational drug/device is not greater than probable risk from disease/condition. (2) FDA determines sufficient evidence of safety and effectiveness to support use. (3) FDA determines provision will not interfere with initiation, conduct, or completion of clinical investigations to support marketing approval. (4) Sponsor or clinical investigator submits to Secretary of HHS a clinical protocol describing use of drug/device in single patient or small group of patients.
recordkeeping and reporting requirements for medical devices
(1) Device user facility must report deaths and serious injuries, establish and maintain ADE files, submit summary annual reports. (2) Manufacturer/importer must report deaths and serious injuries, report malfunctions, establish and maintain ADE files, submit specified follow-up reports. (3) Distributor must maintain records of incidents but required to report.
Unless the owner, operator, or agent in charge gives consent, FDA inspections do not include ____.
(1) Financial data. (2) Sales data other than shipment data. (3) Pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to the FDCA). (4) Research data (other than relating to new drugs, antibiotics, devices, tobacco products subject to reporting and inspection regulations under FDCA).
DEA registration number
(1) First letter: "A" for practitioners before October 1, 1985. "B" for practitioners after October 1, 1985. "M" for midlevel practitioners. "X" for practitioners approved to treat opioid dependency. (2) Second letter: First letter of registrant's last name. If registrant's name begins with a number, may be a number rather than a letter. (3) 7-digit sequential number following the 2 letters. The sum of digits 1,3,5 and 2 times the sum of digits 2,4,6 are added together. The last digit of the sum is the 7th digit.
requirements for distributing drug samples
(1) Manufacturer/distributor must receive written request signed by licensed practitioner. (2) Manufacturer/distributor must verify with state authority that requesting practitioner is licensed or authorized under state law to prescribe drug product. (3) Receipt signed by recipient when drug sample is delivered and returned to manufacturer/distributor.
labeling requirements for prescription drugs dispensed by a pharmacist
(1) Name and address of dispenser. (2) Serial number and date of the prescription or fill. (3) Name or prescriber. (4) Name of patient, directions for use, cautionary statements.
labeling requirements for unit-dose packaging
(1) Name of manufacturer/packer/distributor. (2) Quantity of active drug(s). (3) Generic and trade name. (4) Repackager's lot number. (5) Expiration. (6) Any other appropriate information.
labeling requirements for manufacturer
(1) Name or address of manufacturer/packer/distributor. (2) Established name of drug or drug product (3) Ingredient quantity and proportion of each active ingredient. (4) Inactive ingredients if not for oral use with some exceptions. (5) Generic and proprietary names. (6) Quantity by weight. (7) Net quantity of container. (8) Recommended/usual dosage or reference to package insert. (9) Lot or control number. (10) Legend "Rx only". (11) Route. (12) Storage instructions. (13) Expiration. --Every commercial container of a controlled substance except for nonnarcotics exempt by application must have printed on the label a symbol designating the schedule. If the container is too small, the symbol is not required as long as the symbol is printed on the box/package from which the container is removed when dispensing to ultimate user. The symbol is not required on commercial container or its labeling if the controlled substance is being used in clinical research involving blind or double-blind studies.
labeling requirements for OTC drugs
(1) Product identity. (2) Name or address of manufacturer/packer/distributor. (3) Net quantity of contents. (4) Cautions and warnings. (5) Adequate directions for use. --Conditions, uses, purposes. --Quantity/dosage for each intended use and for persons of different ages and physical conditions. --Frequency, duration, time, route/method of administration/application. --Preparation necessary for use. (6) Drug facts panel. --Active ingredients. --Purpose. --Uses. --Warnings. --Directions. --Other information are required. --Inactive ingredients in alphabetical order. --Section for "Questions?" and "Comments?" with telephone number.
What are the appropriate methods for a pharmacist to distribute "side effects" statement?
(1) Sticker attached to the unit package, vial, or container of the drug product (2) On a preprinted pharmacy prescription vial cap (3) On a separate sheet of paper (4) In consumer medication information (5) FDA approved Medication Guide that contains the side effects statement
The Official Compendia in the federal FDCA includes ____.
(1) United States Pharmacopeia (2) Homeopathic Pharmacopeia of the United States (3) National Formulary
No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug which was purchased by a public or private hospital or other health care entity, or which was donated or supplied at a reduced price to a charitable organization. This does not apply to ____.
(i) acquisition by a health care entity that is a member of a group-purchasing organization of a drug for its own use from the group-purchasing organization or from other health care entities that are members of such an organization (ii) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization to a nonprofit affiliate of the organization (iii) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among health care entities under common control (iv) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons (v) a sale, purchase, or trade of a drug; an offer to sell, purchase, or trade a drug; or the dispensing of a drug pursuant to a prescription
Pregnancy Categories
- A: human studies show NO risk - B: animal studies show NO risk; NO human studies - C: animal studies show risk; NO human studies - D: human studies show risk, but benefit may outweigh risk - X: human studies show fetal abnormality/risk
Compounding Cytotoxic Drugs: Pressure of Compounding vs. Ante Room
- Compounding room hast negative pressure - Ante room has positive pressure
DEA Form 222: Who Can Sign?
- Individual who signed the DEA registration - Individual w/ power of attorney for signer of DEA registration
Inventory Requirements: Records for Schedule II - V Controlled Substances
- Keep records for 2 years - Take inventory every 2 years
Pseudoephedrine Laws: Quantity Limits
- Max 3.6g per day per purchaser - Max 7.5g per 30 day period per purchaser at a mobile retail vendor *Keep logbook of sales for at least 2 years from date of sale
Who most often uses hospital DEA with internal code to prescribe controlled substances?
- Medical residents -Foreign MD's at the hospital
Rules for Dispensing NON-Prescription Schedule II - V Controlled Substances
- No more than 240ml (8oz) or 48 dosage units of opium-containing controlled substance - No more than 120ml (4oz) or 24 dosage units of any other controlled substance *Purchaser must be 18 years or older
DEA Registration Rules
- Register every 3 years - DEA sends renewal notice 60 days before expiration date - MUST notify DEA in writing if not received renewal form 45 days before expiration date
Inventory Requirements: Counting Schedule II - V Controlled Substances
- Schedule II: actual count - Schedule II - V if Bottle < 1,000: estimate count - Schedule II - V if Bottle > 1,000: actual count
Order of Personal Hygiene Before Sterile Compounding
- Shoe covers - Head/facial hair covers - Face mask - Wash hands to elbows for a min. 30 seconds - Gown - Gloves - Disinfect gloves (e.g. 70% IPA)
2 Examples of Low-Risk Compounding
- Single volume transfers - Manually measuring/mixing maximum of 3 manufactured products
Plan B Rules
- Sold OTC to ages 17 and older (males and females) - Sold by PRESCRIPTION to ages 16 and younger - Must be kept BEHIND pharmacy counter
DEA Form 222: Ordering Drugs
- Supplier takes Copy 1 & 2; Supplier sends Copy 2 to DEA - Pharmacy keeps Copy 3 *Order form valid for 60 days ONLY
2 Examples of Medium-Risk Compounding
- Techniques more complicated than single volume transfers (e.g. compounding TPN w/ multiple injections, detachments and attachments of nutrient sources) - Product will be administered over several days without bacteriostatic substance
DEA Form 222: Rules for Completing
- Use ink, indelible pencil or typewritten - 1 item per numbered line - Number of lines completed must be filled in at bottom of form - Name and address of drug supplier must be filled in
2 Examples of High-Risk Compounding
- Uses non-sterile ingredients - Exposes sterile ingredients to room air quality worse than ISO Class 5
What criteria constitute misbranding?
- label is false or misleading - drug is imitation but labeled as real drug - insulin or abx not properly batch certified under the FDCA - deteriorating (expiring) drug and label doesn't bear proper precautions such as exp'n date, etc. - dispensed in non-child resistant container when one is required. - If manufacturer doesn't state certain things on label - If pharmacist fails to place certain things on label - certain drugs dispensed w/o required PPI - Rx drug refilled w/o authorization from MD (bc MD's name on label)
What is required of the pharmacist to place on a label or else it's misbranding?
- name and address of pharmacy - # dispensed - date of filling - Name of prescriber - name of patient - direction for use - cautionary statements
What info required in log?
- product name - qty sold - name and address of purchaser - date and time of sale
What is required of the manufacturer to place on label or else it's misbranding?
- that it's habit forming (if it is) - ingredients - name and place of business or manufacturer, packer or distributor
What did the Kefauver-Harris Act do?
-"drug efficacy act": all new drugs after 1962 must be proven effective for intended purposes -Established Drug Efficacy Study Initiative (DESI) class of drugs -Established informed consent for human research subjects -Implemented Good manufacturing processes (GMPs) -Gave regulation of labeling of dietary supplements to the FTC -Gave regulation of labeling of Rx-only and OTC to FDA
Regulated seller may not in a single calendar day sell any purchaser more than ____ of what drugs?
--3.6 grams of ephedrine base. --3.6 grams of pseudoephedrine base. --3.6 grams of phenylpropanolamine base.
exceptions to DEA registration requirements regarding controlled substances
--Agent or employee of any registered manufacturer, distributor, dispenser of any controlled substance or list I chemical if acting in usual course of business/employment. Registered facility must assign identification numbers for each agent/employee who handles or prescribes controlled substances using the facility's DEA number. --Common or contract carrier or warehouseman, or employee thereof, whose possession of the controlled substance or list I chemical is in usual course of business/employment.
Ryan Haight Online Pharmacy Consumer Protection Act of 2008
--Amends CSA by adding new regulatory requirements and criminal provisions to curtail proliferation fo rogue Internet sites that unlawfully dispense controlled substances. --Online pharmacy must be first registered with DEA as pharmacy. After registered as pharmacy, must apply for modification of registration to operate as online pharmacy.
Computers on which records are maintained may be located ____. Electronic application must be capable of _____.
--At another location but records must be readily retrievable at registered location. --Electronic application must be capable of printing out or transferring records ina format readily understandable at registered location.
readily retrievable prescription requirements
--At the time initially filed, face of prescription is stamped in red ink in lower right corner with "C" no less than 1 inch high and filed in appropriate prescription file. --Requirement to mark hard copy prescription with red "C" waived if pharmacy uses computer application for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber name, patient's name, drug dispensed, and date filled.
conditions for off-label use of approved drugs
--Authorized prescribers may legally prescribe off-label uses of FDA-approved drugs. --Manufacturers cannot advertise off-label uses to consumers but may distribute peer-reviewed research papers that describe off-label uses.
requirements for taking inventory of open containers of controlled substances
--CI-II: must make exact count/measure of contents. --CIII-V: may make estimate count/measure of contents unless container holds >1000 tablets/capsules, in which case, must make exact count.
physical security controls for controlled substances for practitioners and nonpractitioners authorized to conduct research or chemical analysis under another registration
--CI: must be stored in securely locked, substantially constructed cabinet. --CII-V: must be stored in securely locked, substantially constructed cabinet; pharmacies and institutional practitioners may disperse throughout stock of noncontrolled substances in such a manner as to obstruct theft/diversion. --Carfentanil, etorphine hydrochloride, diprenorphine must be stored in safe or steel cabinet equivalent to US government Class V security container.
Faxed prescriptions for CII may be used as the original prescription without follow-up written prescription when ____.
--Compounded for direct administration to patient by parenteral, IV, IM, SC, or intraspinal infusion. --For resident of LTC facility. --For patient in hospice care program certified and/or paid for by Medicare or in hospice program licensed by state.
The personal use exemption under the Controlled Substances Act allows an individual with a CII-V lawfully obtained for his/her personal medical use or for administration to an animal accompanying him/her to enter/depart the US under what conditions?
--Controlled substance is in original container it was dispensed. --Declaration made to appropriate official of Bureau of Customs and Border protection stating that controlled substance possessed for personal use or animal accompanying him/her, trade/chemical name and symbol designating schedule if it appears on the container label or (if such name does not appear on the label) name and address of pharmacy or practitioner who dispensed and prescription number. --US resident may import no more than 50 dosage units combined of all controlled substances obtained abroad for personal medical use. Limit does not apply to controlled substances obtained in US pursuant to prescription issued by DEA registrant.
DEA Form 222
--DEA Form 222 or CSOS required for distribution of CI-II. --Available through Attorney General. --Registrant obtains by submitting order form requisition with application for DEA registration (DEA Form 222a). To obtain forms, registrant must request in writing from local DEA office. --Executed form must be kept at least 2 years. --May authorize individual whether or not located at registered location to issue orders on registrant's behalf by power of attorney. --Purchaser prepares and executes all three copies of each DEA Form 222 simultaneously using typewriter, pen, or indelible pencil. --Purchaser retains copy 3 and sends copies 1 and 2 to supplier. Supplier retains copy 1 and sends copy 2 to DEA. --When purchaser receives order, must record # of containers received of each item and date received on copy 3.
labeling requirements for CII-V prescription
--Date of filling. --Pharmacy name and address. --Serial number of prescription. --Name of patient. --Name of prescribing practitioner. --Directions and cautionary statements.
What information must a transferring pharmacist provide a receiving pharmacist for electronic prescriptions transferred electronically, in addition to original electronic prescription data?
--Date of original dispensing. --# of refills remaining. --Dates and locations of previous refills. --Pharmacy name, address, DEA registration number, and prescription number from which it was originally filled. --Transferring pharmacy name, address, DEA registration number, and prescription number for each dispensing. --Name of pharmacist transferring.
prescription requirements for controlled substances
--Dated and signed on day issued. --Full name and address of patient. --Drug name. --Strength. --Dosage form. --Quantity. --Directions. --Name, address, registration number of practitioner.
Pharmacy registered to dispense controlled substance may distribute to another practitioner for the purpose of general dispensing by the practitioner to patients without registering to distribute under what conditions?
--Distribution recorded by distributing practitioner and receiving practitioner. --If CI-II, DEA Form 222 or CSOS is used. --Total # of dosage units of all controlled substances distributed by the pharmacy during each calendar year does not exceed 5% of total # of dosage units of all controlled substances distributed and dispensed during same calendar year.
Partial filling of CIII-V prescription permissible under what conditions?
--Each partial filling is recorded in same manner as refill. --No dispensing occurs after 6 months after date prescription was issued.
Controlled Substance Ordering System (CSOS)
--Electronic equivalent to DEA Form 222. DEA Form 222 or CSOS required for distribution of CI-II. --May use to purchase CI-V and noncontrolled substances. --Purchaser must retain each original signed order filled and all linked records for 2 years. --Purchaser must retain all copies of each unaccepted/defective order and each linked statement. --Supplier must retain each original order filled and linked records for 2 years. --Supplier must forward copy of electronic order or electronic report of order to DEA within 2 business days for each electronic order filled.
registration requirements for manufacturing/distributing/dispensing controlled substance
--Every person who manufactures/distributes or proposes to engage in the manufacture/distribution of any controlled substance or list I chemical must register annually with the Attorney General. --Every person who dispenses or proposes to dispense any controlled substance must register with the Attorney General every 3 years. This includes the act of prescribing. --Separate registration for each group of activities required for each principal place of business or professional practice where controlled substances are manufactured, distributed, imported, exported, dispensed by a person with exclusion of warehouses for storage of controlled substances but not distribution, office used by agents for sales but not storage/distribution of controlled substances, office used by practitioner to prescribe but not storage/administration/dispensing controlled substances, freight-forwarding facilities.
"Notice of Privacy Practices" must include ____.
--How pharmacy intends to use and disclose PHI. --Legal duties of pharmacy to protect confidentiality. --Patient rights and how to exercise those rights. --How to complain of violations and file complaint. --Contact person for privacy concerns.
emergency situation
--Immediate administration necessary for proper treatment of intended ultimate user. --No appropriate alternative, including drug in different schedule. --Not reasonably possible for prescribing practitioner to provide written prescription prior to dispensing.
What situations do not require AIW?
--Informed and voluntary consent of owner, operator, or agent in charge of controlled premises. --Presentation of administrative subpoena issued under CSA. --Situations presenting imminent danger to health/safety. --Situations involving inspections of conveyances where there is reasonable cause to believe that mobility of conveyance makes it impracticable to obtain a warrant. --Exceptional/emergency circumstance where time or opportunity to apply for a warrant is lacking. --Situation where warrant is not constitutionally required.
Attorney General may require periodic reports of sales, deliveries, disposal of controlled substances from ____.
--Manufacturers of any controlled substance. --Distributors of narcotic controlled substances: must include registration number of person/entity to whom sale, delivery, disposal was made. --Pharmacists that dispense controlled substances by means of Internet must report total quantity of each controlled substance dispensed each month. No reporting required unless pharmacy has met 1 of following thresholds in the month for which reporting is required: 100+ prescriptions dispensed or 5000+ dosage units of all controlled substances combined dispensed.
responsibility of prescriber and dispenser over prescription
--May be prepared by secretary or agent for signature of prescriber but prescribing practitioner is responsible if prescription does not conform in all essential respects to law and regulations. --Corresponding liability upon pharmacist who fills prescription not prepared in conformance with DEA regulations.
How to dispose of controlled substance?
--May request assistance from Special Agent in Charge of local DEA office. --If registrant, must list controlled substances that he/she desires to dispose of on DEA Form 41 and submit 3 copies of that form to the local DEA office. --If not registrant, must submit letter stating name and address of the person; name and quantity of each controlled substance to be disposed; how the applicant obtained the substance if known; name, address, registration number of person who possessed prior to applicant if known.
FDA-approved drugs for purpose of maintenance or detoxification treatment in OTP are ____.
--Methadone and levo-alpha-acetyl-methadol (LAAM). --May not be dispensed by a pharmacist or prescribed for purpose of maintenance or detoxification treatment.
Electronic Prescriptions for Controlled Substances (EPCS)
--Modified regulations to give practitioners option of electronically writing prescriptions for controlled substances. --State law may restrict use of electronic prescriptions for controlled substances. --Practitioner may issue electronic prescription for CII-V if electronic prescription application used found to be consistent with regulations by third-party auditor or certification organization, two-factor authentication credential obtained from approved credential service provider of certified certification authority.
requirements for written authorization for use/disclosure of PHI
--Must be detailed and customized for particular use/disclosure. --Blanket authorizations not permitted. --Must contain expiration. "None" or until "end of research study" is acceptable. --Must be signed by patient. --Patient must receive copy of signed authorization.
When does each regulated person required to report mail-order sales of scheduled listed chemical products submit a report?
--Must submit written report containing details of sale on or before the 15th day of each month following the month in which distributions took place. --Upon request of and approval by DEA, submit electronic form via computer disk or direct electronic data transmission.
Pharmacist transferring a prescription must ____.
--Must write "Void" on face of invalidated prescription or add transfer information to prescription record for electronic prescriptions. --Must record on reverse of invalidated prescription the name, address, DEA registration number of pharmacy to which it was transferred, and name of pharmacist receiving information, or add this information to prescription record for electronic prescriptions. --Must record date of transfer and name of pharmacist transferring.
Pharmacist receiving a prescription transfer must ____.
--Must write "transfer" on face of transferred prescription, reduce to writing all information required to be on a prescription. --Must include date of issuance of original prescription, original number of refills authorized, date of original dispensing, # of valid refills remaining, dates and locations of previous refills; pharmacy name, address, DEA registration number, prescription number from which it was originally filled; pharmacy name, address, DEA registration number, prescription number from which it was transferred; and name of pharmacist transferring.
information that must be retrievable by prescription number
--Name and address of person to whom it was dispensed. --Name and dosage form of controlled substance. --Date filled or refilled. --Quantity dispensed. --Name or initials of dispensing pharmacist for each refill. --Total number of refills.
Records of receipt must contain ____.
--Name of substance. --Dosage form. --Strength. --# of dosage units or volume in container. --# of commercial containers received. --Date of receipt. --Name, address, registration number of supplier.
When is the symbol designating the schedule for a controlled substance not required on a label?
--Nonnarcotics exempt by application. --If the commercial container is too small and as long as symbol is printed on box/package from which the container is removed when dispensing to ultimate user. --If the controlled substance is being used in clinical research involving blind or double-blind studies.
Labeling requirements for CIII-V prescriptions do not apply if ultimate user is institutionalized and what conditions are met?
--Not more than 34-day supply or 100 dosage units of controlled substance dispensed at 1 time. --Controlled substance not in possession of ultimate user prior to administration. --Institution maintains safeguards and records regarding administration, control, dispensing, storage of controlled substance. --System used by filling pharmacist adequate to identify supplier, product, patient and to provide directions and cautionary statements.
Except for purchase by individual of a single sales package containing not more than ____ of ____, regulated seller must maintain written or electronic list (logbook) of each scheduled listed chemical product sale that ____.
--Not more than 60 milligrams of pseudoephedrine. --Identifies products by name, quantity sold, names and addresses of purchasers, dates and times of sales. Must include notice: "WARNING: Section 1001 of Title 18, United States Code, states that whoever, with respect to the logbook, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device a material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or $500,000 if an organization, imprisoned not more than five years, or both".
Labeling requirements for CII prescriptions do not apply if ultimate user is institutionalized and what conditions are met?
--Not more than 7-day supply of controlled substance dispensed at 1 time. --Controlled substance not in possession of ultimate user prior to administration. --Institution maintains safeguards and records regarding administration, control, dispensing, storage of controlled substance. --System used by filling pharmacist adequate to identify supplier, product, patient and to provide directions and cautionary statements.
Medications may be mailed via USPS if ____.
--Outside packaging does not have any markings indicating nature of contents. --Only pharmacist or medical practitioner who dispenses the medicine mails to patients under their care. --Poisonous drugs and medicines are sent only from the manufacturer/dealer to licensed physicians, surgeons, dentists, pharmacists, druggists, cosmetologists, barbers, veterinarians. --For mailable controlled substances, mailer and addressee are registered with DEA or exempt from DEA registration.
Pharmacist may dispense CIII-V prescriptions that are ____.
--Paper prescription signed by practitioner. --Fax of signed paper prescription transmitted by practitioner or practitioner's agent to the pharmacy. --Electronic prescription. --Oral prescription promptly reduced to writing by pharmacist containing required information except for signature of practitioner.
Pharmacies may transfer refill information under what conditions?
--Permitted by state law. --1 time basis unless pharmacies share real-time, online database. If so, may transfer refill information up to maximum number of refills permitted by prescription or by law. --Transfer may take place only by direct communication between 2 licensed pharmacists. --Transferring pharmacist: Must write "Void" on face of invalidated prescription or add transfer information to prescription record for electronic prescriptions. Must record on reverse of invalidated prescription the name, address, DEA registration number of pharmacy to which it was transferred, and name of pharmacist receiving information, or add this information to prescription record for electronic prescriptions. Must record date of transfer and name of pharmacist transferring. --Receiving pharmacist: Must write "transfer" on face of transferred prescription, reduce to writing all information required to be on a prescription. Must include date of issuance of original prescription, original number of refills authorized, date of original dispensing, # of valid refills remaining, dates and locations of previous refills; pharmacy name, address, DEA registration number from which it was originally filled; pharmacy name, address, DEA registration number from which it was transferred; and name of pharmacist transferring.
Requirements for distribution of Notice of Privacy Practices include ____.
--Pharmacies must provide to each patient on day pharmacy first provides service. In emergency, provide as soon as reasonably practicable after emergency treatment situation. Pharmacist may email notice to patient if patient agrees to electronic notice. --If pharmacy has Web site, notice must be posted prominently on Web site.
Under what conditions can a pharmacist dispense a CII-V that is not a prescription drug to a purchaser at retail without a prescription?
--Pharmacist dispenses. Transaction/delivery may be completed by nonpharmacist. --Not more than 240 cc (8 oz) of opium-containing controlled substance and not more than 120 cc (4 oz) of other such controlled substance dispensed to same purchaser in any given 48-hour period. --Not more than 48 dosage units of opium-containing controlled substance and not more than 24 units of other such controlled substance dispensed to same purchaser in any given 48-hour period. --Purchaser at least 18 years old. --Pharmacist requires every purchaser not known to him/her to furnish suitable identification, including proof of age where appropriate. --Bound record book for dispensing nonprescription controlled substances containing name and address of purchaser, name and quantity of controlled substance purchased, date of each purchase, name or initials of dispensing pharmacist. --Prescription not required for distribution/dispensing of the controlled substance pursuant to any other federal, state, or local law. --Central fill pharmacies may not dispense.
Partial filling of CII prescription permissible under what conditions?
--Pharmacist unable to supply full quantity. --Pharmacist makes notation of quantity supplied on face of written prescription or in electronic prescription record. --Date, quantity dispensed, remaining quantity to be dispensed, dispensing pharmacist should be noted in record for each partial refill. --Remaining portion of prescription may be filled within 72 hours of 1st partial filling. If remaining not filled within 72-hour period, pharmacist must notify the prescriber. --No further quantity may be supplied beyond the 72 hours without a new prescription. --To permit dispensing of individual dosage units to patients in LTC facilities and to patients who are terminally ill. Pharmacist must record on prescription whether patient is "terminally ill" or "LTCF patient".
recordkeeping requirements of controlled substances
--Pharmacy must keep records of inventory, drugs received, drugs dispensed. --Kept for at least 2 years at place of registration. --Financial and shipping records may be kept at a central location rather than registered location if registrant has notified DEA.
PPI distribution requirements
--Potentially dangerous drugs required to be dispensed with patient package insert include Accutane, statins, OCP, estrogen-containing products. --All dispensers are required to distribute PPIs. --Manufacturers are required to provide dispensers with sufficient number of PPIs. --In hospitals and LTC facilities, pharmacists must distribute PPIs to both outpatients and inpatients. For inpatients, PPIs must be distributed before initial dose and then every 30 days as long as therapy continues. --Pharmacists do not meet legal obligations by distributing PPIs to the prescriber. Dispensers must give PPIs to the patient.
requirements for executing power of attorney for individual to issue orders for CI-II on registrant's behalf
--Power of attorney must be retained in files with executed DEA Form 222 bearing signature of attorney. --Power of attorney must be available for inspection together with other order records. --Registrant may revoke power of attorney at any time by executing notice of revocation. --Registrant that grants power of attorney must report to DEA Certification Authority within 6 hours if person with power of attorney has left employ of institution or has had privileges revoked. --Registrant must maintain record that lists each person granted power of attorney to sign controlled substances orders.
Opioid Treatment Programs (OTP)
--Practitioner may administer or dispense directly, but not prescribe, a narcotic listed in any schedule to narcotic-dependent person for purpose of maintenance or detoxification treatment if practitioner separately registers annually with DEA as an OTP. --Registration is in addition to DEA registration as a dispenser. Additional registration requirement waived for practitioners who qualify under Drug Addiction Treatment Act. --Only drugs FDA-approved for this purpose may be administered/dispensed.
Drug Addiction Treatment Act (DATA) (Office-Based Treatment)
--Practitioners who dispense narcotic drugs for maintenance treatment or detoxification treatment must obtain annually a separate registration for that purpose in addition to DEA registration as a dispenser. Additional registration requirement waived for practitioners who qualify under DATA to treat addiction in office-based practice. --Registered practitioner who qualifies under DATA may dispense and prescribe FDA-approved CIII-V narcotics for use in maintenance or detoxification treatment without obtaining separate registration as OTP. Before initial dispensing, must submit to Secretary of HHS notification of intent to begin dispensing drugs for such purpose. Notification of intent must state that practitioner is a qualifying physician, has capacity to refer patients to counseling and other ancillary services, total # of patients at any 1 time NTE 30 for the 1st year. After 1st year, practitioner may submit 2nd application to treat up to 100 patients with approval of Secretary. --Secretary determines within 45 days of receiving notification. Attorney General assigns identification to practitioner that is included in registration as dispenser. --Practitioner may begin to prescribe or dispense during 45-day period if it facilitates treatment of individual patient and practitioner notifies Secretary and Attorney General of intent to begin prescribing/dispensing.
conditions for waiving dispensing prescription without child safety closure
--Prescriber may waive safety closure for that prescription and any refills but may not request blanket waiver for all future prescriptions for that patient. --Patient may request blanket waiver for all prescriptions. Pharmacist should obtain written waiver and periodically check with patient.
Exceptions for dispensing prescriptions with child-resistant safety closures include ____.
--Prescriber specifies that safety closures should not be used. --Patient indicates he/she does not want safety closure. --Container used in facility in which drugs remain under control of health care professionals.
exceptions to controlled substance inventory requirements
--Prescribing of CII-V by practitioners acting in course of practice unless in course of maintenance/detoxification treatment. --Administering of CII-V unless practitioner regularly engages in dispensing/administering controlled substances and charges patients or unless administered in course of maintenance/detoxification treatment. --Use of controlled substances at registered establishments that qualify for drug research exemption. --Use of controlled substances at registered establishments that keep records with respect to such substances in preclinical research or teaching. --Exemption granted by Attorney General.
Records of drugs dispersed include what types of records?
--Prescription orders. --Nonprescription CV sales. --Distributions from a pharmacy to another practitioner. --Institutional medication orders. --Reports of disposal or destruction of controlled substances (DEA Form 41). --Reports of theft or loss (DEA Form 106).
Poison Prevention Packaging Act of 1970
--Protect children under 5 years. US Consumer Product Safety Commission (CPSC) has responsibility of overseeing enforcement). --Requires child-resistant closures to almost all prescription drugs dispensed direct to consumers, nonprescription drugs, hazardous household products.
Computer application may be used as alternative for storage and retrieval of refill information for original paper prescription orders for CIII-IV if what conditions are met?
--Provides online retrieval (via computer monitor or hard-copy printout) of original prescription order information for those prescription orders currently authorized for refilling. --Provides online retrieval of current refill history for prescription orders authorized for refill during past 6 months. --Pharmacist must document that refill information entered into computer is correct. --Provides hard-copy printout of each day's controlled substance prescription order refill data that must be verified, dated, and signed by individual pharmacist who refilled prescription order. Must be maintained in separate file at that pharmacy for 2 years from dispensing date. --In lieu of printout, pharmacy must maintain bound logbook or separate file in which individual pharmacist involved in dispensing must sign a statement each day, attesting to the fact that refill information entered into computer that day has been reviewed by him/her and is correct as shown. Must be maintained for 2 years after date of dispensing. In event of system downtime, pharmacy must have auxiliary procedure for documentation or CIII-IV prescription order refills.
Before completing retail sale of scheduled listed chemical product, ____.
--Purchaser must present identification card that provides photograph and is issued by state or federal government or document considered acceptable for purposes of employment. --Purchaser must sign logbook. --If purchaser enters information, seller must determine that the name entered corresponds to that provided on identification and that date and time entered are correct. --If seller enters information, prospective purchaser must verify that the information is correct. --Regulated seller must enter into logbook the name of the product and quantity sold.
Prior to shipping scheduled listed chemical product for mail-order sale at retail, regulated person must ____.
--Receive from purchaser a copy of identification card that provides photograph and is issued by state or federal government or document considered acceptable for purposes of employment. --Determine that name and address on identification correspond to that provided by purchaser as part of sales transaction. --If being shipped to a third party, verify that purchaser and person to whom product is being shipped live at addresses provided.
activities allowed coincident to registration as controlled substance dispenser
--Registered dispenser may conduct research and instructional activities with those substances except that midlevel practitioner may conduct such research only to extent authorized under state statute. --Pharmacist may manufacturer narcotic controlled substance in CII-V in proportion NTE 20% of complete solution/compound/mixture. Pharmacy may need to register as manufacturer under FDCA. --Retail pharmacy may perform central fill pharmacy activities.
components of prospective review
--Screening (of prescriptions): To identify potential drug therapy problems. Pharmacist must conduct review of drug therapy before each prescription is filled or delivered. --Patient counseling: Pharmacist must offer to counsel each patient or caregiver in person or via telephone service toll-free for long-distance calls. Pharmacist not required to verify offer to provide counseling or refusal of offer. --Patient profile: Pharmacist documentation of relevant patient information. Must make reasonable effort to obtain, record, maintain at minimum name, address, telephone number, DOB or age, gender, history (including disease states, allergies, drug reactions), comprehensive list of medications and relevant devices, comments relevant to drug therapy.
controlled substance inventory requirements
--Separate inventory must be taken initially and then every 2 years for each registered location and each independent activity registered. Biennial inventory may be prepared on general inventory date as long as within 6 months of biennial inventory date that would otherwise apply. --Inventory for newly scheduled drug must be taken on effective date of regulation. --Inventories must be kept at least 2 years.
When may or may not a supplier endorse an order to another supplier to fill?
--Supplier may not endorse electronic order to another supplier to fill. --Written DEA Form 222 may be endorsed to another supplier if original supplier cannot fill order.
Prescribing practitioner may authorize addition refills of CIII-IV on original prescription via oral refill authorization transmitted to the pharmacist under what conditions?
--Total quantity authorized does not exceed 5 refills nor extend beyond 6 months from date of issue of original prescription. --Pharmacist obtaining oral authorization must record on reverse of original paper prescription or annotate electronic prescription record with date, quantity of refill, and number of additional refills authorized. --Pharmacist must initial paper prescription or annotate electronic prescription record showing who received refill authorization from prescribing practitioner who issued the original prescription. --Quantity of each additional refill authorized is equal to or less than quantity authorized for initial filling of original prescription.
Authorized hospital staff may administer/dispense narcotic in hospital to maintain or detoxify a patient under what conditions?
--Treatment is incidental to other medical or surgical treatment of conditions other than addiction. --Treatment is to relieve intractable pain for which no relief or cure is possible or none has been found after reasonable efforts.
Parent or guardian has access access to PHI of minor unless ____.
--Under state law, minor has right to consent to health care service. --Court or person authorized by law consents to health care service. --Parent or guardian agrees to confidentiality.
Before filling an order submitted via CSOS, supplier must ____.
--Verify integrity of signature and order using software that complies to validate the order. --Verify digital certificate has not expired. --Check validity of certificate holder's certificate by checking Certificate Revocation List. Supplier may cache Certificate Revocation List until it expires. --Verify registrants eligibility to order controlled substances by checking certificate extension data.
If a practitioner is treating patients in the outpatient setting for narcotic addiction, how many patients are they legally allowed to treat?
-30 patients during the first year -Up to 100 patients in the subsequent years
What testing must a packaging system undergo in order to be determined "child resistant"?
-80% of children (under 5 yo) cannot open it -90% of adults can open it
How does the DQSA of 2013 define an "outsourcing facility"?
-A facility at one geographic location/address that is engaged in the compounding of sterile drugs -Has elected to register as an outsourcing facility -Complies with all the requirements of section 503B
How can you verify if a prescriber or pharmacy has a DEA approved system to transmit CS rx's electronically?
-A list is posted in Federal Register -NABP has announcements
What options do participants have in offering to collect pharmaceutical CS from ultimate users?
-Administering a mail-back program -Maintain collection receptacles
Who is exempt from registering with the DEA?
-Agents/employees of the manufacturer, distributor, or dispense (pharmacists) when acting in the usual course of business -Common or contract carriers, warehouse men (i.e. FedEx) -Officials of armed forces, public health system, bureau or prisons (the organization is registered)
What are the new (2010) warnings for OTC APAP and NSAID products?
-All OTC APAP: risk of liver injury -All NSAIDS: risk of stomach bleeding -Peds: Caution parents against use of APAP and cough/cold products for children < 2 yo
What is "drug repackaging"?
-An FDA-registered facility that repackages drugs from manufacturers and places them into new packaging -Often unit-of-use packaging or more convenient types
What is OBRA '90?
-Applied originally only to medicaid prescriptions -Requires a Drug Utilization Review: pharmacy must ensure the drug is both necessary and appropriate and offer to counsel -Requires record keeping of the DUR and offer to counsel
Labeling (as opposed to advertising) includes:
-Brochures, booklets, mailing pieces, price lists, references, provided by the manufacturer for use by healthcare professionals -Information must include everything required by labeling
During a CS inventory, when must exact counts be taken?
-CI drugs -CII drugs -CIII-CV if bottle is > 1000 units
What are the manufacturer labeling and packing requirements for controlled substances?
-Commercial containers must be labeled with designated schedule -Symbol must be prominently located on label and must be clear and large enough to provide easy identification
What requirements must a registered outsourcing facility for compounding meet?
-Comply with CGMP -Inspected by FDA according to a risk-based schedule -Reporting AE -Provide FDA with information about the products that they compound
What did the Durham-Humphrey Act do?
-Created 2 classes of drugs: Rx only (503b1) and OTC -Allowed oral transmission of prescriptions -Allowed prescription refills
What special labeling requirements do CIII drugs contain?
-Date of initial filling -Date of refill
When distributing controlled substances among DEA registrants, what must be contained on the written record of transfer?
-Date of transaction -Name, form, quantity of substance -Name, address, registration number of the person making the distribution -Name, address, registration number of the supplier or manufacturer
Definition of "dispensing" by the CSA/DEA
-Delivering a controlled substance to an ultimate user or research subject by order of a practitioner -Includes prescribing and administration in compliance with packaging and labeling requirements
What does pharmacist have to record on refills of a CS rx?
-Dispensing pharmacist initial -Date refill -Amt of drugs dispensed on the refill (if different than the full amt of the rx)
How would a local pharmacy qualify for "traditional compounding" and therefore exemption from DQSA under 503A?
-Drug is compounded for an individual patient based on receipt of a valid rx order -Compounding is performed by a licensed pharmacist in a licensed pharmacy, or by a licensed physician -Anticipatory compounding is permitted only in limited quantities, based on the history of receiving valid orders -Complies with USP chapters -Compounded using bulk drugs that are manufactured by a registered establishment -Cannot use drugs that have been removed from the market -Cannot compound regularly or in inordinate amounts of products that are commercially available -May not distribute more than 5% of the total prescriptions dispensed or distributed by that pharmacy without a memorandum of understanding between their state and FDA
Who must receive monthly retrospective medication regimen reviews (MRR) by a pharmacist in LTC facilities?
-Each individual resident in a Medicare or Medicaid certified nursing home
A CII rx must be an original, written prescription or electronic, and signed by the prescriber EXCEPT:
-Emergency situations -Fax for home infusion/LTC/hospice patients -Partial fills when a pharmacy cannot supply the entire rx amount
What did the Drug Price Competition and Patent Term Restoration Act do?
-Established standards for marketing of generic drugs without necessity of NDA process -Replaced with Abbreviated New Drug Application (ANDA) -Generics have to be therapeutically equivalent to pioneer drugs
What information is required for the pharmacy RECEIVING a transferred CS rx?
-Face: write "transfer" -Date of original rx -Original number of refills authorized -Date of original dispensing -Number of refills remaining -Dates and locations of previous refills -Transferring pharmacy's name, address, DEA #, rx # -Name of both pharmacists
What is the difference between generic substitution and therapeutic substitution?
-Generic substitution: dispense generic when brand is written -Therapeutic substitution: dispense different drug in same therapeutic class (i.e. prevacid vs prilosec)
What did the HITECH Act make changes to and help clarify?
-HIPAA privacy and security rules -Business associates
Criteria for Schedule II drugs
-High potential for abuse -Currently accepted medical treatment in the US or currently accepted medical use with severe restrictions -Abuse can lead to severe physical or psychological dependence
Criteria for Schedule I drugs
-High potential for abuse -No currently accepted medical use in the US -Lack of accepted information on safety even under medical supervision
Criteria for Schedule III drugs
-High potential for abuse, but less than CI and CII drugs -Currently accepted medical use in the US -Abuse may lead to moderate or low physical dependence or high psychological dependence
When might a prescriber prescribe controlled substances under the hospital's DEA number?
-In a hospital setting -If dispensing, administering, and prescribing is in the usual course of professional practice -If the practitioner is authorized by jurisdiction -Hospital where he is employed assures that the individual can -Acting within the scope of employment at the hospital -Hospital maintains a list of internal codes, accessible upon request
If a pharmacy is partially filling controlled substance rx's for a terminally ill patient to reduce waste associated with unused meds, what must be recorded ON THE FACE of the rx by the pharmacist?
-Information regarding the patient's residence in LTC facility -Information regarding the patient's terminally ill condition -For each fill: date, quantity dispensed, remaining quantity authorized, name of dispensing pharmacist
Definition of a "prescription drug"
-Intended for use by man -Not safe for use except under the supervision of a practitioner licensed by law to administer such a drug, because of toxicity, harmful effect, method of use, or collateral measures necessary for its use
What are the federal CS record keeping requirements?
-Inventory -Drugs received -Drugs dispersed -CII records must be kept separately from other records
If the DEA newly schedules a drug, what must a pharmacy do?
-Inventory those drugs on the date that new scheduling becomes effective
Advertising (as opposed to labeling) includes information in these 3 areas:
-Journals and periodicals -Broadcast media -Telephone communications
What is the "closed distribution system" for regulating controlled drugs in the US?
-Laws apply to entities and persons registered with the DEA may dispense, administer, manufacturer, purchase, sell, or otherwise acquire controlled substances -Laws and regulations for every step in the system, from "cradle to grave"
Criteria for Schedule IV drugs
-Low potential for abuse (relative to CIII drugs) -Current accepted medical use in the US -Abuse may lead to limited physical dependence or psychological dependence (relative to CIII drugs)
Criteria for Schedule V drugs
-Low potential for abuse (relative to CIV drugs) -Current accepted medical use in the US -Abuse may lead to limited physical dependence or psychological dependence (relative to CIV drugs)
What are the requirements of an E-rx system under the DEA E-Rx rule?
-Main prescriber's registration is clearly identified (in the case of mid-level practioners working under a provider) -Accommodate suffixes for institutional prescribers under the institution's DEA # -Must accommodate "do not fill before" instructions -Must accommodate notes that allow for dispensing methadone outside of narcotic treatment programs
What must the pharmacist due when receiving an oral CII prescription for an emergency situation?
-Make reasonable efforts to determine that the rx is valid -Reduce the rx immediately to writing -Use judgement regarding whether the rx is for emergency purposes
As of 10/2014, who is allowed to collect pharmaceutical CS from ultimate users?
-Manufacturers -Distributors -Reverse distributors -Narcotic treatment programs -Hospitals/clinics with an on-site pharmacy -Retail pharmacies
How must a package be properly prepared if a pharmacist is mailing a controlled substance to a patient, at the patient's request?
-Marked and sealed -Labeled properly -Plain outer container -Nothing to indicate controlled substances inside the package
Exceptions to the schedule II fax prescription
-Meds to be directly administered as IV, SQ, IM, intraspinal -Pts in long term care facility -Pts in hospice
What are federally mandated requirements for LTC facilities in regards to medication distribution systems and clinical services?
-Multiple daily deliveries of medications to facility -Around-the-clock (stat) deliver of emergency medications -Consultant pharmacists interventions to optimize medication therapy and reduce medication related problems -Pharmacists available 24/7 -Special packaging systems -Organized record keeping -Dispensing errors < 5%
Legally, who can purchase a prescription for a CV (i.e. cough syrup) without an rx?
-Must be 18 yo -Must present proof of age
Compounding non-prescription products
-Must be labeled according to FDA provisions of an OTC agent -Cannot be prepared with any prescription ingredients -FDA might intervene if significant health hazards occur in a pharmacy compounding on a regular basis
What are the stricter requirements for prescribes who work with internet websites to provide consults?
-Must conduct at least one in-person evaluation for patients
What are the requirements for packaging Rx and OTC drugs under the PPPA of 1970?
-Must have child resistant containers -New bottle and cap with each prescription filled
What are the stricter requirements for online pharmacies?
-Must submit a separate registration to the DEA -Must maintain records of online dispensing of controlled substances
What must be contained in a protocol for dispensers conducting research that is submitted to the DEA?
-Name and qualifications of the investigator -Institutional affiliation -Description of the project -Copies of the IND -Description of the security procedures used
When requesting DEA 222 Forms, what information must be included in the written request?
-Name of each registrant -Address of each registrant -DEA Registration number of each registrant -Number of envelopes requested -Signed and dated by the same person who signed the DEA registration application
What must be contained on the log book for CV controlled substances dispensed without an rx?
-Name of patient -Address of patient -Quantity sold -Date of sale -Initials of pharmacist
What information is required to be documented during CS inventory?
-Name of substance -Dosage form and strength -Number of units or volume in each container -Number of containers -Date of receipt -Name, address, and registration number of supplier
What must be written on the back of the rx when transferring a CS rx?
-Name, address, and DEA# of the pharmacy where the rx is being transferred -Name of pharmacist receiving the info -Date of transfer -Your name (transferring pharmacist)
What does OBRA 90 require a pharmacist to have documented and kept in a written record for each patient?
-Name, address, telephone number, birth date, gender -Significant pt history (i.e. allergies, diseases) -Pharmacist comments relevant to drug therapy
In what situations may a retail pharmacy use a faxed CII rx as the original, and fill accordingly without ever receiving a hard copy original?
-Narcotic substance compounded by pharmacy for direct administration to patient by IV, IM, Q or intraspinal infusion -LTC residents -Hospice patients that have been certified by the Medicare program
Which products must have an NCD?
-OTC drugs -Rx drugs
Where does a pharmacy obtain DEA 222 Forms from?
-Originally: DEA headquarters office in Washington, DC -Subsequent orders: DEA field office
What is "waste" in fraud, waste, and abuse laws?
-Over-use of services -Practices that result in unnecessary costs
What is the third segment of the NDC number?
-Package code -Identifies package sizes and types
What items on a controlled substance rx is a pharmacist NEVER permitted to change?
-Patient's name -Drug -Prescriber's signature
If a pharmacist fills an rx that is knowingly not in the course of professional treatment, who can be held responsible under the CSA?
-Pharmacist -Prescriber/person issuing the rx
What extra requirements for information must CII-IV drugs have on their labeling?
-Pharmacy name and address -Serial number/rx number -Name of patient -Name of prescriber -Directions for use -Cautionary statements -Caution related to transfer
Who are authorized witnesses on DEA Form 41 for the disposal or destruction of CS?
-Physicians -Pharmacists -Mid-level practitioners -Nurses -Law enforcement officers
What is "abuse" in fraud, waste, and abuse laws?
-Practices that are inconsistent with sound fiscal, business or medical practices -Result in an unnecessary cost to the state/federal government or health plan
Who may communicate information to the pharmacy regarding dispensing of a controlled substance under CSA?
-Prescriber -Employee or agent of the prescriber, who is under the direct control or supervision of the prescriber -Nurse at an offsite location (i.e. LTC) IF they have an agreement with prescriber
What criteria may indicate that a rx was not issued for a legitimate medical purpose?
-Prescriber write significantly more rx's or larger quantities compared to other prescribers -Patient appears to be returning too frequently -Prescriber writes rx's for antagonistic drugs (i.e. depressants and stimulants) -Patient presents with rx's written in the names of other people -A number of people appear within a short period of time, all bearing similar rx's from the same prescriber -Numerous "strangers" suddenly show up with similar rx's from the same prescriber
If a prescriber's electronic system has not been approved by the DEA, and they send a CIII rx to your pharmacy, what must you do with the rx?
-Print it out -Call and verify -Take as an oral rx
What is the second segment of the NDC number?
-Product code -Strength -Dosage form
What is the purpose of CGMP inspections by the FDA?
-Production and control procedures to ensure proper identity, strength, quality, and purity of drugs -Identify deficiencies and provide follow-up for correction
Federal Food, Drug and Cosmetic Act What did it require?
-Proof of safety of a drug - Labels to give adequate directions for use - Had to get approval for drugs except for drugs already on market
What is the PPPA designed to protect the public against?
-Protect children from accidental poisonings with household substances (including rx drugs)
Who is exempt from DEA registration under CSA and can prescribe controlled substances?
-Public Health Service practitioners -Federal Bureau of Prisons practitioners -Military practitioners
What must happen if a DEA Form 222 is lost or stolen in transmission?
-Purchaser must execute a new 222 form -Record on new order form the serial number of the lost form, date of loss, and fact that the CS were not recieved -Purchaser maintains copy #3 of both new and lost forms together -Serial numbers of stolen 222 forms must be reported to the DEA
What did the Poison Prevention Packaging Act do?
-Purpose is to prevent accidental poisoning of children under 5. -Requires "Hazardous household products" to be marketed in child-resistant packaging.
What incentives exist for a compounding facility to register as an outsourcing facility under DQSA of 2013?
-Qualifies the facility for exemptions of the rigorous requirements of a manufacturer
What is a Class I recall?
-REASONABLE PROBABILITY that the product WILL CAUSE serious, adverse health consequences or death
Why are controlled substances highly regulated in the US?
-Reduces the potential for diversion -Regulates the manufacture, distribution, and dispensing of drugs that are identified as having a high potential for addiction and abuse
What are the requirements for dispensers conducting research in regards to DEA numbers?
-Registered dispensers may conduct research without a separate registration for CII-CV -Applicant must submit a protocol to DEA
What must the applicant provide to the FDA legally for a new drug to be approved?
-Reports of drug safety and efficacy -Drug components and composition -Methods, facilities, and controls used in manufacturing, processing, and packaging -Samples of drugs -Proposed labeling
What new requirements for pharmacies was established in OBRA 90?
-Required complete prospective drug utilization reviews -Offer counseling -Maintain comprehensive databases of prescription records
What must occur with a DEA number when a business closes/discontinues?
-Return the certificate of registration to DEA office in Washington, DC -Return 222 Forms to DEA office in Washington, DC -Notify state board
If a prescriber's electronic system has not been approved by the DEA, and they send a CII rx to your pharmacy, what must you do with the rx?
-Rx is not valid because there is no "wet" signature -Rx must be signed manually until systems are approved
Define prescription only drug
-Rx only legend must appear on manufacturer label -Safe only when used under medical supervision -"adequate directions for use" not required if dispensed pursuant to a prescription using a pharmacy label in its place
Who (besides the prescriber himself) may prepare a prescription for a controlled substance under CSA?
-Secretary or agent of the prescriber who is under direct control or supervision of the prescriber -Prescriber must sign after rx has been prepared
How must schedule I controlled substances be stored?
-Securely locked in a substantially constructed cabinet
What must happen if a supplier receives a DEA Form 222 that had thought to be lost or stolen in transmission, and a subsequent 222 has also been received?
-Supplier must mark original as "not accepted" -Supplier must return original copy #1 and #2 to the purchaser -Purchaser must retain all three copies together in their records
What happens to a DEA Form 222 if the order is illegible, incomplete, altered or erased, upon receipt by the supplier?
-Supplier must return copy #1 and copy #2 to the purchaser -Supplier must provide the rationale for not filling the order -Purchaser must maintain all 3 copies in its files
What happens to a DEA Form 222 if the supplier cannot fulfill the order?
-Supplier must return copy #1 and copy #2 to the purchaser -Supplier must provide the rationale for not filling the order -Purchaser must maintain all 3 copies in its files
Who must be notified after a breach of PHI under HIPAA 96?
-The affected individuals -HHS Secretary -Media (if > 500 residents are affected)
Who may request non-child-resistant packaging for the patient?
-The physician -The patient
How are NDC's used?
-To identify drugs -To process claims by insurance companies
What are the primary goals of fraud, waste, and abuse laws?
-To prevent false claims -To protect consumers -To protect government health care programs
What are some varieties of proper disposal/destruction procedures of CS via DEA Form 41?
-Transfer to registrant authorized to possess the substance -Delivery to DEA agent or nearest field officer -Destroy in presence of DEA agent or other authorized person -Transfer to registered distributor -Other methods authorized by DEA
What factors should be considered when determining whether a loss of controlled substances was significant?
-Types and amounts of controlled substances lost or stolen -Activities and individuals involved in the loss/theft -Pattern of loss/stealing -Local trends in the area of loss/stolen controlled substances
What is a Class II recall?
-When a product MAY cause temporary or medically reversible adverse health consequences -Probability of serious adverse consequence is remote
What is a Class III recall?
-When a product is NOT LIKELY to cause adverse health consequences
How must CS inventory records be maintained?
-Written OR typewritten OR printed -Taken using a recording device, if promptly reduced to writing
What information is required on a controlled substance prescription?
-Written in ink, indelible pencil or typed -Dated and must be signed on the date when issued -Patient's full name and address -Prescriber's full name, address, DEA # -Drug name, strength, dosage form, quantity, directions, refills authorized -Manual signature of practitioner
Definition of "drug"
-articles recognized in the USP, Homeopathic Pharmacopoeia of the US, or National Formulary -articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals -articles (other than food) intended to affect the structure or any function of the body of man or other animals.
What did the FDA Modernization Act of 1997 do?
-established "fast track" NDA process for drugs intended to treat life-threatening diseases -established guidelines to allow pharmacy compounding of drugs without adhering to GMPs or NDAs -Changed "prescription legend" to "Rx-only" -Eliminated habit forming warning labeling -provides incentives for SNDAs -mandates pediatric testing of pediatric drugs
What did the Food Drug and Cosmetic Act do?
-established the NDA: no new drug could be introduced without first being proven safe -required adequate directions for use -required labeling for habit-forming drugs -established FDA
How might a chain pharmacy maintain some records of CS inventory at a central location?
-must notify the board of types of records, exact location -can send packing records, invoices, and shipping records -must maintain individual rx records on site at pharmacy
What did the Prescription Drug Marketing Act do?
-prohibits re-importation of drugs into the US after they have left the US -wholesalers must be licensed under state law according to federal standards -bans the sale, trade, or purchase of drug samples -institutions (hospitals) cannot sell drugs to community pharmacies unless there is a bone fide emergency
Schedule V drug difenoxin may not contain more than ______ per __________
0.5 mg per dosage unit
When was the new format for professional package insert requirements adopted?
06/2006
Registrant must notify local DEA in writing of theft or significant loss of any controlled substances within ____ of discovery of such loss or theft.
1 business day.
How many times can C3-5 prescriptions be transferred? What is the exception?
1 time only, unless transferred by pharmacies sharing real time online databases (then as many as they want)
If unit dose was repackaged, which date should be used for the "beyond use" date on the repackaging label?
1 year OR expiration date on manufacturer's container (whichever is earlier)
Pure Food and Drug Act - 1906 What are the two main parts?
1) Adulteration: food/drugs should not be contaminated. 2) Misbranding: labels on food/drugs should accurately state what they contain.
What did the 1984 Drug Price Competition and Patent-term Restoration Act do?
1) Created abbreviated new drug application for multisource generic drugs 2) Allowed mkt'g of generics without clinical studies 3) Required CGMP and bioequivalence
Durham-Humphrey Amendment 3 things it did??
1) Established legend (Rx) and non-legend (OTC) categories 2) Prohibited refills of rx w/out MD consent 3) Outlined minimum info requred on label
How does the manufacturer have to package meds so it's safe?
1) MUST be in child resistant packaging if intended to be dispensed directly to patient and not repackaged by pharmacy 2) Bulk packaging inteded to be repackaged by pharmacy does not need resistant packaging. 3) Unit packaging from manufacturer must, unless it meets exceptions above.
Who can request a non-child resistant container?
1) Prescriber in writting on the rx but CAN'T make a blanket statement that all meds from him/her be dispensed in this way. 2) Patient, verbally or in writting. CAN make a blanket statement.
Kefauver-Harris Ammendment Required what?
1) Required that drugs be SAFE and EFFECTVE 2) Established current good manufacturing practices (CGMP) 3) Provided for testing in humans **Pre 1938 drugs grandfathered in
What does OBRA '90 say that counseling must cover?
1) administration 2) common AE 3) Severe SE 4) self-monitoring techniques 5) proper storage
What does 1994's Drug Supplement Health and education Act (DSHEA) require?
1) supplements not regulated by FDA but the manufacturer can't make health claims.
Requirements of packaging to be considered tamper resistant?
1)Must have one or more indicators that will provide visible evidence in the case of breach. 2) package must be distinctive in design so it can't be duplicated easily
DSHEA Definition of "dietary supplement"
1. A product that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following: vitamin; mineral; herb/botanical; amino acid; dietary substance for use by humans to supplement the diet by increasing the total dietary intake; concentrate/metabolite/constituent/extract
What are the 3 components of a prospective drug use review under OBRA 90?
1. A screen of rx before dispensing 2. Pt counseling by the pharmacist 3. Pharmacist documentation of relevant information
What 8 pieces of information must be contained on an OTC "drug facts" panel?
1. Active ingredient 2. Purpose 3. Uses and indications 4. Warnings 5. Directions 6. Other information 7. Inactive ingredients 8. Phone number to call with questions or comments
What items does the term "Labeling" include (3 items):
1. Actual label 2. Any written, printed or graphic material upon the container 3. Any wrapper, package insert, drug ad, promotional material, information in publication
FDCA Definition of "Cosmetic"
1. Articles intended to be rubbed, poured, sprinkled, sprayed, or applied to body 2. For cleansing, promoting attractiveness
FDCA Definition of "Drug"
1. Articles recognized by official compendia in the US (USP/NF) 2. And used for the diagnosis, cure, mitigation, treatment, or prevention of disease 3. And intended to affect the structure or any function of the body 4. In man or other animals
What are the two options for controlled substance prescription filing?
1. C2 separate from all other Rxs 2. C2 separate from C2-5, separate from all other Rxs
Prescription drugs are drugs which (3 items): Can also be worded, drugs must be prescription (not OTC) if they satisfy one of the following
1. Cannot be made safe with directions and warningson the label 2. Experts agree that adequate directions cannot be provided on label 3. Drugs that are habit forming, toxic, harm potential, or in NDA
What must be done if a 222 form is lost or stolen? (4 things)
1. Complete a second order from so the supplier can fill the original order 2. Pharmacist must prepare a statement with the order form serial numbers and date 3. Must verify that the DEA form was lost 4. Must IMMEDIATELY report the form loss to the DEA
What are the label requirements for dispensing (7 items)?
1. Date of filling 2. Pharmacy name/address 3. Rx number 4. Name of patient 5. Name of prescriber 6. Directions 7. Cautionary statements
Which types of OTC products are exempt from being placed in tamper resistant packaging (4 items):
1. Dermatological 2. Dentifrice 3. Insulin 4. Lozenge product
Valid Rx Requirements (8 items):
1. Drug 2. Strength 3. Dosage form 4. Quantity prescribed 5. Directions 6. Number of refills 7. Date 8. Prescribers signature
Definition of "Rx Drug"
1. Drug intended for use by man 2. Because of toxicity or other harmful effect, or the method of use, or the collateral measures necessary for its use is not safe except under the supervision of a practitioner licensed by law to administer such a drug 3. Must be dispensed via a written or oral Rx, promptly reduced to writing or a refill authorized by the practitioner 4. Drugs required to be dispensed by a pharmacy via a prescription is misbranded if it fails to bear the legend "Rx only"
What two things must be present for a treatment IND?
1. Drug must be in phase 2 or 3 and show safety and effectiveness, physician completes application 2. The patient must not be in the original controlled trial, must have a life threatening illness with no cure, or must have failed what is commercially available
C3-C5 transfer from pharmacy to pharmacy documentation requirements (5 items):
1. Drug name 2. Dosage form 3. Strength 4. Quantity 5. Date transferred
Definition of a "new drug"
1. Drugs NOT generally recognized by qualified experts as safe and effective for use under the conditions recommended in the labeling 2. Must be used for a "material" amount of time for indications in the labeling 3. FDA determination on new drugs considered final authority (not court decision) 4. Sometimes applies to existing drugs with different/new indications, formulations, etc. 5. Not allowed in interstate commerce unless approved by FDA
The FDA requires a patient package insert ("PPI") to accompany which 4 classes of medications?
1. Estrogens 2. DES (Diethylstilbestrol) 3. Oral contraceptives 4. Intrauterine contraceptive devices
Required Records (11 items):
1. Executed AND unexecuted DEA 222 forms 2. Power of attorney authorization to sign forms 3. Receipts for C3-5 drugs 4. All inventory records 5. Records of controlled substances distributed 6. Records of controlled substances dispensed 7. Reports of theft or loss (Form 106) 8. Inventory of drugs surrendered for disposal (41) 9. Records of controlled substance transfers between pharmacies 10. DEA registration certificate 11. Self-certification certificate for the Combat Methamphetamine Act of 2005
Reasons for denying/suspending/revoking registrations (5 items)
1. Falsified application 2. Registrant has a felony relating to controlled substance or list 1 chemical 3. Registrant has had state license or registration suspended by a different state 4. Registrant committed an act which would make it inconsistent with public interest 5. Registrant excluded from Medicare/Medicaid
What order form is used for controlled substance ordering? Where must they be stored? What must be documented on the purchaser's copy when the packages are received (2 things documented)?
1. Form 222 2. Stored separately from other business records 3. The actual number of packages received and date received
How must tamper-evident packaging be labeled (3 features):
1. Identifies the tamper evident feature 2. Is prominently placed on the package 3. Is placed so that it will be unaffected if the tamper resistant feature is breached or missing
What are the requirements for C2 emergency prescriptions (5 items)?
1. Immediate administration is necessary for proper treatment 2. No alternative is available 3. It is not possible to get a written script 4. Must provide a written script within 7 DAYS 5. Drug quantity must only the necessary amount during the emergency period
A tamper-evident package may involve which types of closure systems (2 items):
1. Immediate container 2. Secondary container These are designed to provide a visual indication of package integrity
What are the 4 steps of the drug approval process?
1. In vivo animal studies 2. Submission of IND 3. Clinical trials (three phases) 4. Submission of NDA
Definition of adulteration (key points)
1. Includes drugs that consist in whole or in part of filthy, putrid, or decomposed substances 2. Drugs prepared, packed or held in unsanitary conditions 3. Drug's container is composed of any substance which may contaminate the drug 4. Drugs prepared, packaged, processed or held under conditions that violate CGMPs 5. Drugs containing an unsafe color additive 6. Drugs that purport to be those recognized in official compendia but strength, quality or purity falls below the standards 7. Drugs mixed or packed to reduce quality or strengths
FDCA Definition of "Device"
1. Instrument, implant, machine, or similar article 2. Intended to affect the structure or function of body 3. And which does not achieve principal intended purposes through chemical action (i.e. drug)
When must a pharmacy register as a distributor? (2 items)
1. It participates in joint buying activities, and is a storage/shipping location 2. Annual distribution of controlled substances to other pharmacies >5% of total DOSAGE UNITS dispensed
Definition of misbranding (key points)
1. Label/labeling must not be false or misleading 2. Package must contain information on manufacturer, packer, or distributor 3. Must contain all statements required or approved by FDA 4. Prescription drugs must have established name ingredient prominently displayed 5. Can't be imitation of another drug or offered for sale under the name of another drug 6. Information regarding dosages that might be dangerous to health or unsafe 7. Information related to dangers of use in children 8. Special packaging requirements to prevent deterioration, etc. 9. Must meet conditions of the Poison Prevention Packaging Act and/or other laws regarding packaging 10. Pharmacist cannot dispense a Rx drug without a prescription
Pharmacy activities for registration (11 items)
1. Manufacturer 2. Distributor 3. Dispenser 4. Research 5. Instructional activities 6. Narcotic treatment programs 7. Research with C-1 products 8. Chemical Analysis 9. Importer 10. Exporter 11. Compounding for a narcotic treatment program
What stipulations are required by the FDA regarding patient package insert ("PPI")?
1. Manufacturer must notify pharmacist to insert leaflet in each prescription dispensed 2. Leaflet must provide general information regarding the risks associated with use and potential adverse effects
Who is exempt from prescriber registration (3 items)? What can they not do as practitioners?
1. Military 2. Public Health 3. Prisons They can't procure or purchase controlled substances
Practitioners with DEA numbers starting with M: (6 practitioners)
1. NP 2. PA 3. Optometrists 4. Pharmacists 5. Chiropractors 6. Naturopaths
What are the 5 MINIMAL requirements under FDCA for a dispensed Rx label?
1. Name and address of pharmacy 2. Serial number and date of the Rx/fill 3. Name of prescriber 4. Name of patient 5. Directions for use and cautionary statements ***States may require more***
What must be contained on a unit dose labeling of a Rx drug?
1. Name of drug 2. Quantity of active ingredient in each dosage unit 3. Expiration date 4. Lot or control number 5. Name of manufacturer 6. Any statements regarding special characteristics if required by a compendia
What records must be kept for pseudoephedrine purchases (or other SLCPs) (4 items)?
1. Name of purchaser 2. Address of purchaser 3. Date and time of sale 4. Amount of product sold
Requirements for transfer of business (4 items)
1. Name, Address, Registration #, business activity of transferer 2. Same as above for transferee 3. If they will keep the same location or move 4. Date of controlled substance transfer
Procedures for lost/theft of any controlled substance (4 steps):
1. Notify the DEA and local police within 1 business day 2. Complete DEA form 106 3. If no theft or loss found, notify the DEA in writing 4. Registrant must identify significant loss
How can C3-5 prescriptions be written (4 items)?
1. Paper 2. Fax (signed) 3. Electronic 4. Call in
How can patients receive non-child resistant caps (2 items):
1. Patients can provide a blanket statement to get only non-child resistant caps 2. Physicians can request each drug to have a non-child resistant cap (must request each individually)
REMS must include at least one of the following elements designed to ensure safety of use
1. Practitioners must be certified or have training to prescribe medication 2. Pharmacies and other dispensers or those who administer must have special certification 3. Drug distribution is limited to only certain settings such as clinics or hospitals 4. Patients who receive the medication must receive special information regarding safe use, including required lab testing 5. Patients must be monitored when using medication 6. Patients must be enrolled in a registry to use drug
A drug is defined as a substance that (4 items):
1. Recognized by USP/NF or homeopathic pharmacopeia 2. Intended for diagnosis, cure, mitigation, treatment, or prevention of disease 3. A non food article intended to affect structure or function of the body 4. Intended as a component of the above
Considerations for determining if pharmacy registration is in the public interest (5 items)
1. Recommended to not register by another state 2. Applicants experience dispensing/researching 3. Conviction record relating to controlled substances 4. Compliance w/law relating to controlled substances 5. Other acts relating to public safety
C3-C5 records must be readily retrievable. This means that (2 items):
1. Records kept by computers can be separated in a reasonable amount of time 2. Records kept by hardcopy must be marked in a way that certain items are visually identifiable for easy access
What 3 pieces of CS recordkeeping MUST be kept on site at the pharmacy, while all other records can be stored at a central location (after notifying the board).
1. Rx 2. Executed 222 forms 3. Inventory records
Which products are exempt from the Poison Prevention Packaging Act (7 items):
1. SL nitroglycerine 2. SL or chewable isosorbide dinitrate 3. Effervescent aspirin or acetaminophen tablets 4. OC in dial packs 5. Unit dose potassium 6. Cheloestyramine or cholestipol powder 7. Aerosol inhalation products
What are the requirements for C2 partial dispensing (2 items)?
1. The FULL quantity must be dispensed within 72 hours of the partial fill 2. In a LTCF or terminally ill patient, valid for no more than 60 days
Who can can mail and be mailed controlled substances (2 items)?
1. The mailer and addressee must either be registered with the DEA, 2. Or must be exempt from DEA registration
Why are labeling provisions included in the FDCA?
1. To ensure that drugs are not misbranded 2. The label property indicates the content
Why are interstate commerce provisions included in the FDCA?
1. To ensure that drugs are safe and clinically effective for purposes indicated in label 2. To ensure that only approved drugs can enter interstate commerce
What 4 areas of health information are targeted in HIPAA 1996?
1. Transaction and code sets 2. National provider identities 3. Security 4. Privacy
When can C2 prescriptions be faxed (3 items)?
1. When it is to be given by direct administration and is parenteral 2. To residents of LTC facilities 3. Patient enrolled in hospice programs, must be noted that it is a hospice patient on the fax
What are the 3 exceptions to HIPAA breach notifications
1. When the acquisition, access, or disclosure is unintentional and in good faith, and does not result in further use or disclosure 2. When the unauthorized person to who the PHI has been disclosed would not reasonably have been able to retain it 3. When the disclosure is inadvertent between two authorized individuals at the same facility if the information is not further used or disclosed
When must a pharmacy register as a manufacturer? (2 items)
1. When the pharmacy purchases controlled substances for the purpose of repackaging them for sale 2. Compounds drugs which contain >20% (either weight or volume) controlled substance, compounds IV
The Durham Humphrey Amendment states that prescription drugs can only be dispensed if (4 items):
1. Written by practitioner 2. Orally given by practitioner 3. Refilling 4. Administration directly be prescriber Act established Rx drugs by prescriber only
Can you order controlled substances online? C2s?
1. Yes 2. Yes Must maintain records for 2 years
Name 5 examples of drugs not required to be in child-resistant packaging.
1. packages of less than 8g of erythromycin ethylsuccinate 2. sublingual nitroglycerin tablets 3. Oral contraceptives dispensed in manufacturer's mnemonic packaging 4. Packages of less than 105mg of prednisone tablets 5. One size of OTC line with label indicating package is not child resistant
Schedule III drug codeine or dihydrocodeine may not contain more than ______ per __________
1.8 grams per 100 mL ; 90 mg per dosage unit
How many digits are in the new NDC system?
10
How many total lines are on the DEA Form 222?
10 lines
Schedule V drug dihydrocodeine may not contain more than ______ per __________
100 mg per 100 mL or 100 grams
Schedule V drug ethylmorphine may not contain more than ______ per __________
100 mg per 100 mL or 100 grams
Schedule V drug opium may not contain more than ______ per __________
100 mg per 100 mL or 100 grams
how many digit in NDC ?
11
How many days to report lost/theft of scheduled listed chemical products?
15 days
What year was the Pure Food and Drug Act?
1906
What year was the Food Drug and Cosmetic Act?
1938
When was the Durham-Humphrey Act?
1951
When was the Kefauver-HArris Act?
1962
When was the Poison Prevention Packaging Act?
1970
When was the Medical Device Act and what did it do?
1976. -GMP manufacturing standards, performance standards, records and reporting requirements, etc
When was the federal anti-tampering act?
1982
When and what was the orphan drug act?
1983. tax incentives to manufacturers of drugs that treat diseases that affect <20,000 persons in the US
When was the Drug Price Competition and Patent Term Restoration Act?
1984
When did the FDA publish the Orange Book and what is it?
1984. "approved drug products with therapeutic equivalence evaluations"
When was the Prescription Drug Marketing Act?
1987
When was the FDA Modernization Act?
1997
The initial enrollment period for Medicare begins on the ___ day of the ___ month and lasts for ___ months.
1st 3rd 7 (3 months before and 4 months after their birthday)
What does the second letter of a DEA number indicate?
1st letter of prescriber's last name (may be different if they've gotten married, etc) or company name
Supplier must forward copy of electronic order or electronic report of order to DEA within ____ for each electronic order filled.
2 business days.
What is the format of a DEA number?
2 letters - 7 numbers i.e. AB1234567
Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006
2 parallel, mandatory reporting systems for serious ADEs: OTC and dietary supplements.
When must the DEA Form 41 be submitted?
2 weeks in advance
A pharmacy must make a controlled substance inventory every _____ year(s).
2 years
Electronic records must be maintained electronically for ______ year(s).
2 years
How long must records of transferred CS rx's be kept?
2 years
How long must required records concerning controlled substances be stored according to the DEA:
2 years
In general, how long must CS inventory records be kept at the place of registration?
2 years
Each entry in the written or electronic logbook of scheduled listed chemical product sales must be maintained for not fewer than ____.
2 years after the date on which the entry is made.
Electronic records regarding controlled substance prescriptions must be maintained electronically for ____.
2 years from date of creation or receipt (unless federal or state law requires longer period).
How long must the long book for CV controlled substances dispensed without an rx be maintained?
2 years from date of last transaction
Original and transferred prescriptions must be maintained for a period of ____.
2 years from the date of last refill.
How long must electronic records be maintained electronically?
2 years from the date of their creation or receipt
Schedule V drug codeine may not contain more than ______ per __________
200 mg per 100 mL ; 200 mg per 100 grams
Schedule V drug atropine sulfate may not contain LESS than ______ per __________
25 mcg per dosage unit
PPPA applies to packages of drugs with more than _____mg of non-injectable iron.
250
Maximum number of chronic diseases a plan sponsor can require:
3
How many carbon copies are on a DEA Form 222?
3 copies, triplicate form
A pharmacy registration must be renewed every ______ year(s) utilizing the DEA Form 224a.
3 years
Every person who dispenses or proposes to dispense any controlled substance must register with the Attorney General every ____.
3 years
Prescription Drug Marketing Act drug companies must keep the drug samples request records for how many years
3 years
If an innovator drug is on the market for an approved use, and it is then approved for a NEW USE, the innovator is granted ---------years of exclusive marketing for the new use
3 years of exclusive marketing , BUT a generic manufacturer may still sell/promote the drug for the prior approved use.
What is the federal limit on sales of sudafed per day?
3.6 grams
hospitalized patients must be given PPI prior to first dose, and every ------ there after
30 days
the clinical trials of IND can start ig the FDA didn't reject the INDA within ------ days
30 days
Schedule III drug dihydrocodeinone and ethylmorphine may not contain more than ______ per __________
300 mg per 100 mL ; 15 mg per dosage unit
How are NDC's configured?
4-4-2 OR 5-3-2 OR 5-4-1
How many times may a CIII rx be refilled?
5 times within 6 months
How many times may a CIV rx be refilled?
5 times within 6 months
Prescription for CIII-IV cannot be refilled more than ____ times within ____ period. After this, ____.
5 times within 6-month period. After this, prescriber must issue new prescription.
Drug Price Competition and Patent Term Restoration Act of 1984 gave drug innovators how many years of drug exclusivity ?
5 years of exclusive marketing or the remainder of the patent life which ever is longer
Schedule III drug morphine may not contain more than ______ per __________
50 mg per 100 mL ; 50 mg per 100 grams
Schedule III drug opium may not contain more than ______ per __________
500 mg per 100 mL ; 500 mg per 100 grams ; 25 mg per dosage unit
What provision on DQSA of 2013 provides an exemption for "traditional compounding" on a small scale at a local pharmacy?
503A
PPPA applies to packages of drugs with more than ____ mg of elemental fluoride or _____ fluoride.
50mg, 0.5%
No prescription for CIII-IV can be filled or refilled more than ____ after date of issue.
6 months.
Copies of notices, written acknowledgements of receipt of "Notice of Privacy Practices", or documentations of good faith efforts to obtain written acknowledgements must be retained for ____.
6 years.
How many days notice must be provided to Medicare patients, CMS, state prescription plans, and pharmacies before a formulary change may be made?
60
A registrant can renew online no more than ______ days prior to the current expiration date. (pharmacy registration)
60 days
The DEA issues renewal notices ____ days prior to expiration
60 days
CII prescriptions for patients in LTC facility or with terminal illness are valid for period not to exceed ____ unless ____.
60 days from issue date unless terminated sooner by discontinuation of medication.
Prescribing individual practitioner must deliver written prescription for emergency quantity of CII orally prescribed of via oral prescription within ____.
7 days.
Orphan Drug Act gave manufactures what incentives
7 years of exclusive marketing, waiver of NDA filing fee, tax credits
What is the maximum allowable limit of sudafed sales if purchased via mail?
7.5 grams per 30 days
At least how many days before introducing/delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must the manufacturer/distributor submit to the FDA information on which basis the manufacturer/distributor has concluded that the dietary supplement can reasonably be expected to be safe?
75
How many digits are in the original NDC system?
9
How many digits is a DEA number?
9 digits with 2 letters and 7 numbers
Limit quantity for ephedrine, pseudoephedrine and phenylpropylamine
9 gm per every 30 days (<7.5gm from carrier or postal mails) and 3.6gm a day
What is the federal limit on sales of sudafed per 30 days?
9 grams
Regulated seller may not sell to the same person more than ____ of listed chemical product within ____ period except for sales through ____ which are limited to no more than ____ per ____ period.
9 grams within 30-day period except for sales through mobile retail vendors and mail-order sales which are limited to no more than 7.5 grams per 30-day period.
What is the max total number of day supply for multiple CII rx?
90 days
Individual practitioner may issue multiple prescriptions authorizing patient to receive total of up to ____ of CII under what conditions?
90-day supply under following conditions: --Written instructions on each prescription indicating earliest date on which a pharmacy may fill each prescription. --Individual practitioner concludes that providing patient with multiple prescriptions does not create undue risk of diversion/abuse. --Permissible under applicable state laws.
Alcohol is -------- % ethyl alcohol
95 %
Which Medicare Act provides hospitalization insurance?
A
What does the first letter in the orange book rating describe?
A = therapeutically equivalent B = not equivalent
DEA numbers starting with A/B/F/G indicate ___________.
A hospital, clinic, practitioner, teaching institution, or pharmacy
Describe "adequate directions for use" on OTC labeling
A layperson can safely use for purposes intended; conditions, purposes, uses, quantity to use, frequency of administration, duration of administration, time of administration in relation to meals or symptoms, route of administration, preparation if necessary for use, etc.
What are the only 2 letters that an orange book rating with start with?
A or B
What is the first letter of a DEA number for a physician?
A or B or F or G
What is the first letter of a DEA number for a certified practitioner prescribing suboxone for pain?
A or B or F or G (see: indication)
What are the letters of a physician DEA typically?
A, B, F then the first letter of last name
drug product substitution ratings
A: bioequivalent and therapeutically equivalent to brand-anme; substitutions of same strength and dosage forms permitted. B: not bioequivalent; substitutions not permitted. AB: have had problems with bioequivalence but have been resolved; substitutions of same strength and dosage forms permitted.
Examples of products that FDA says must be packaged in tamper resistant packaging?
ALL OTC products contact lens solution opthalmic solutions Oral hygiene products cosmetic vaginal products (?)
ANDA or SNDA: new generic
ANDA
Generic mrf. need not do all the safety and efficacy testing the innovator company did, but can use that data to support an ANDA Must establish that generic version is bioequivalent to the innovator drug
Abbreviated New Drug Application (ANDA)
What is the purpose of an ANDA?
Abbreviated new drug application: For the approval of generic products to prove equal bioavailability, pharmacokinetics, and clinical activity
Accepting reimbursement for services that are not medically necessary is an example of ______ (fraud/waste/abuse)?
Abuse
Accepting reimbursements that are a result of billing mistakes is an example of ________(fraud/waste/abuse)?
Abuse
Schedule III Controlled Substances
Abuse potential leading to: - MODERATE or LOW physical dependence - HIGH psychological dependence
AAC
Actual acquisition cost (the actual price a pharmacist pays when purchasing a drug)
DEA number calculations:
Add digits 1, 3, 5 Add digits 2, 4, 6 (multiply sum by 2) Add the first two lines ^ The "ones" unit in the sum should be equal to the last digit in the DEA number
FDA Amendments Act of 2007
Additional FDA authority over premarketing and postmarketing safety. Postmarketing studies and clinical trials, safety labeling changes, REMS. Required "side effects" statement that notifies patients to report ADEs. FDA pre-review direct to-consumer ads. FDA only makes recommendations about ad and may require change only if change addresses serious risks associated with drug use.
deals with a drug's strength, purity, quality, manufacturing (CGMP) or storage conditions
Adulteration
The Food, Drug and Cosmetics act deals with what issues? (2 items)
Adulteration and Misbranding
When does retrospective review occur?
After drugs have been dispensed.
Are there any special security requirements a practitioner should follow if a stock of controlled substances is maintained in their office for dispensing and administering?
All controlled substances should be stored in a locked cabinet or other secure storage container with limited access by the office staff.
What is protected health information (PHI) in HIPAA 1996?
All forms of health information that -Relate to past, present, or future physical or mental health -Provision of care -Payment for care -Identify that patient or could reasonably be expected to identify the patient
Definition of "labeling"
All labels AND other written/printed/graphic material upon any article or any of its containers or wrappers, or accompanying such article (i.e. package insert, box, etc)
Dispensers required to distribute side effects statement with ____.
All new and refill prescriptions. Must read: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088".
Is a practitioner required to keep records?
All records related to controlled substances must be maintained and be available for inspection for a minimum of two years. C2: Must maintain inventories and records separately from all other records maintained by the registrant. C3-5: inventories and records must be maintained separately or in such a form that they are readily retrievable from the ordinary business records of the practitioner. A registered practitioner is required to keep records of controlled substances that are DISPENSED to the patient, other than by prescribing or administering, in the lawful course of professional practice. A registered practitioner is NOT required to keep records of controlled substances that are: - prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment. - administered in the lawful course of professional practice unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered.
Schedule III - V Controlled Substances: Partial Refills
Allowed
OTC Rules: Pharmacist Selling OTC Drugs
Allowed if pharmacist feels it is in best interest of patient
How often must sellers of pseudoephedrine be re-self-certified?
Annually
Practitioner must register with DEA ____ to treat addicts in an OTP.
Annually.
What criteria consitute adulteration?
Any of the following: - filthy, putrid, decomposed - prep'd, packed or held in unsanitary conditions - In a container that's nasty or poisonous - strength, quality or purity deviates from what's stated (it got diluted or is too strong) - mixed in a way that reduced quality or strength - substituted whole or in part with something else - OTC not in tamper-resistant package - OTC not labeled in accordance with tamper resistant labeling - Non-sterile opthalmic
Flunitrazepam
Any person convicted of possession shall be imprisoned and/or fined.
What is "fraud" in fraud, waste, and abuse laws?
Any type of intentional deception or misrepresentation made with the knowledge that it could result in some unauthorized benefit
DEA Form 224
Application for new DEA Certificate of Registration.
Obtain guarantee from suppliers for "safe harbor"
Applies strict liability/liability without fault Food, Drug, & Cosmetic Act of 1938
If a registrant must change their name or address of DEA registration, what process must they undergo?
Apply to DEA in writing to request changes
When was the REMS system enacted by Congress/implemented?
Approved by Congress in 2007, implemented in 2008
cosmetic
Articles intended to be rubbed, poured, sprinkled, sprayed to the body for cleansing, beautifying, promoting attractiveness, altering appearance. Does not include soap. Does not require premarket approval. Manufacturers not required to register with FDA or follow GMPs. Must list ingredients in descending order or predominance. Must conform to PPPA. Warnings, if applicable, required: (1) inhaling contents under pressure may be harmful or fatal; (2) the safety of the product has not been determined; (3) the presence of coal tar in hair dye.
FDCA Definition of "Food"
Articles used for food or drink for man or other animals
How does the FDA classify an activity where a pharmacist compounds an OTC item without a prescription for a patient?
As manufacturing (not dispensing)
If a pharmacy shares electronic information in real-time online databases, how many times may it transfer refill information for controlled substances?
As many times as law permits
When does prospective review occur?
At point of dispensing before prescription is dispensed.
____ may ____ a registration or limit to particular schedule(s).
Attorney General may deny, revoke, or suspend a registration. Suspension or revocation may be limited to particular schedule(s).
Secure and Responsible Drug Disposal Act (Disposal Act)
Authorized DEA to develop methods for disposal of controlled substances that have been dispensed to an ultimate user. 3 additional voluntary disposal options available to ultimate users: take-back events, mail-back programs, collection receptacle programs.
What does "ADS" stand for in regards to dispensing in LTC facilities?
Automated dispensing systems
AMP
Average manufacturer price (avg price paid by wholesalers to a manufacturer)
AWP
Average wholesale price (published wholesale price for a drug product that can be used as the basis for pricing drugs)
Which Medicare Act provides coverage for physician services?
B
If the drug poses special risks, the FDA may require the package insert to contain a -----
BBW (part of REMS)
Prescription Drug Marketing Act (1987) What did it mandate?
Bans the sale, trade or purchase of samples Mandates storage and records of drug samples Bans re-importation of Rx drugs except by wholesaler Prohibits resale of Rx drugs by hospital for drugs purchased at special prices.
Why is it important to remember that not all drugs have an NDA?
Because then not all drugs will have an orange book rating event though there may be equivalents available
Registrant shall not employ any person who has access to controlled substances, and who has ____.
Been convicted of a felony offense relating to controlled substances or at any time had application for DEA registration denied or had registration revoked/surrendered for cause.
Regulated seller must place listed chemical products ____ and delivery product ____.
Behind-the-counter and delivery product directly into custody of the purchaser.
What is the "beyond use" date in comparison to "expiration date"?
Beyond use: drug should not be used after this date, cannot exceed expiration date, date used on repackaged unit dose containers. Expiration date: manufacturer's date that is expected to meet the requirements of USP
What color is copy #3 of DEA Form 222?
Blue
When refilling a prescription which parts of a plastic container must be replaced?
Both parts (cap and bottle)
Legally, which pharmacy must maintain records of CS filled by a central fill pharmacy?
Both pharmacies are responsible for the validity of the rx and both must maintain records - central fill pharmacy maintains a faxed copy of the original
How does a DEA registrant report breakage or spillage of controlled substances?
Breakage of controlled substances does not constitute a "loss" of controlled substances. When there is breakage, damage, spillage, or some other form of destruction, any recoverable controlled substances must be disposed of according to DEA requirements. Damaged goods may be disposed of through shipment to a "reverse distributor" or by a DEA approved process. The DEA recommends that any registrant seeking to dispose of controlled substances first contact the nearest DEA Diversion Field Office for disposal instructions. In no case should drugs be forwarded to the DEA unless the registrant has received prior approval from the DEA. If the breakage or spillage is not recoverable, the registrant must document the circumstances of the breakage in the inventory records. Two individuals who witnessed the breakage must sign the inventory records indicating what they witnessed. The submission of a DEA Form 41, Registrant Record of Controlled Substances Destroyed, is not required for non-recoverable controlled substances. The DEA procedures established for the destruction of controlled substances shall not be construed as altering in any way the state laws or regulations for the disposal of controlled substances. When this disposal occurs, it must be reported to the DEA on a DEA Form 41.
What color is copy #1 of DEA Form 222?
Brown
FDA-approved drugs for purpose of maintenance or detoxification treatment under DATA qualification are ____.
Buprenorphine sublingual tablets (Subutex) and buprenorphine/naloxone tablets (Suboxone).
Which Medicare Act provides managed care?
C
DEA form 222
C-II order
When can you estimate controlled substance inventory?
C3-5, when NOT an initial inventory or a biennial inventory
Authorized Agent & Controlled Substances: 1 Limitation
CANNOT orally authorize EMERGENCY Schedule II controlled substance
Who produces the Drugs@FDA drug information resource?
CDER
Amobarbital is a C____.
CII
Cocaine is a C____.
CII
Glutethimide is a C____.
CII
Pentobarbital is a C____.
CII
Dexedrine is a C____.
CII (Amphetamine)
Sublimaze is a C____.
CII (Fentanyl)
Desoxyn is a C____.
CII (Methamphetamine)
Dolophine is a C____.
CII (methadone)
Which controlled substances can be transmitted electronically (as long as the DEA system requirements are met)?
CII - CV
Ketamine is a C____.
CIII
Phendimetrazine is a C____.
CIII
Oxandrin is a C____.
CIII (Oxandrolone)
Didrex is a C____.
CIII (benzphetamine)
Suboxone and Subutex are C____.
CIII (buprenorphine products)
gamma-hydroxybutyric acid (GHB)
CIII for FDA-approved uses. Available only through single centralized pharmacy as part of restricted distribution program.
Clonazepam, temazepam, midazolam, diazempam are C_____.
CIV
Triazolam is a C____.
CIV (Halcion)
Clorazepate is a C____.
CIV (Tranxene)
Xanax is a C____.
CIV (alprazolam)
Who must approve Medicare formulary changes of Part D plans?
CMS
What is the name of the electronic equivalent to DEA Form 222?
CSOS
Phenergan with codeine is a C____.
CV
Robitussin AC is a C____.
CV
What is the statement that must be included with all dispensed Rx drugs in regards to side effects?
Call your doctor for medical advice about side effects. You may also report side effects to 800-FDA-1088.
3 standards to be considered DME
Can stand repeated use Primarily for a medical purpose Appropriate to use in the home
Which drugs of their own separate order forms?
Carfentanil, etorphine hydrochloride, diprenorphine.
pregnancy warning categories
Category A: clear evidence of no risk to fetus. Category B: animal studies fail to show risk to fetus. Category C: risk to fetus undetermined. Category D: positive evidence of risk to fetus. Category E: risk to fetus outweighs any possible benefit.
What caution related to transfer must be on the labeling of all CII-IV drug labels?
Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed
When central fill pharmacies contract with private, common, or contract carriers to transport filled prescriptions to retail pharmacy, ____ is responsible for reporting in-transit losses upon discovery of such loss.
Central fill pharmacy is responsible for reporting by use of DEA Form 106.
Before a business can begin, what is required from the DEA?
Certificate of Registration
what class of recall reasonable probability that the product will cause serious adverse health consequence
Class I
What are the 3 types of Drug Recalls?
Class I, Class II, Class III
classes of medical devices
Class I: least potential harm to users. Class II Class III: life-sustaining; require premarket approval.
classes of drug recalls
Class I: serious adverse health consequences. Class II: temporary/reversible. Class III: unlikely to cause.
what class of recall the product may cause temporary or reversible adverse health consequences, but probability of serious adverse consequences is remote
Class II
what class of recall the product is not likely to cause adverse health consequences (technical violations)
Class III
CFR
Code of federal regulations
Can use IND drugs in Phases I- III through what program for Condition must be serious/life-threatening and No other effective treatment options are available
Compassionate use/Treatment INDA
Pharmacies that compound in the regular course of business may advertise/promote ____.
Compounding service, not a particular drug that it compounds.
When dispensed to/for a patient, CII-IV prescription label shall contain concise warning that ____.
Concise warning that it is a crime to transfer the drug to any person other than the patient.
covering practitioner
Conducts medical evaluation at request of a practitioner who has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through telemedicine within previous 24 months and is temporarily unavailable to conduct evaluation of the patient.
medical food
Consumed or administered enterally under supervision of physician and intended for specific dietary management of disease or condition for which distinctive nutritional requirements are established by medical evaluation.
What does CMI stand for in regards to drug labeling?
Consumer Medication Information
CPSC
Consumer Product Safety Commission
Poison Prevention Packaging Act of 1970 is enforced by --------
Consumer Product Safety Commission
Who enforces the Poison Prevention Packaging Act?
Consumer Product Safety Commission NOT the FDA
What government agency has the authority to regulate, enforce and ensure compliance with the Poison Prevention Packaging Act of 1970?
Consumer Products Safety Commission (CPSC)
Contents of package inserts include ____. The format requires ____.
Contents include the following: (1) Description of the drug. (2) Clinical pharmacology. (3) Indications and usage. (4) Contraindications. (5) Warnings. (6) Precautions. (7) ADRs. (8) Potential for abuse or dependence. (9) Symptoms and treatment of overdose. (10) Dosage and administration. (11) Available dosage forms. (12) Date of most recent revision of labeling. (13) Recommended/usual dosage. The format requires the following: (1) Highlights section. --Immediate access to information about benefits and risks. --Boxed warnings. --Indications. --Dosage and administration. (2) Table of contents. (3) Date of initial product approval. (4) Toll-free number and Internet reporting information to encourage reporting of side effects. (5) Section on "patient counseling information" to encourage communication between health professionals and patients.
What does CMEA stand for?
Control Methamphetamine Epidemic Act
What does "CSA" stand for?
Controlled Substances Act
If a pharmacy wants to RETURN a CI or CII using DEA Form 222, who retains which copy?
Copy 1 (brown): pharmacy is considered supplier Copy 2 (green): DEA office in Greensboro Copy 3 (blue): distributor
Where do the DEA 222 triplicates go?
Copy 1: Transferring entity Copy 2: DEA Copy 3: Requesting entity
Which clause in the CSA is the main focus for disciplinary and criminal proceedings against practitioners?
Corresponding responsibility - To be valid, a rx for a CS must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of CS. In addition, a corresponding responsibility rests with the pharmacist who fills the prescription.
What is the pharmacist's responsibility under the Controlled Substances Act?
Corresponding responsibility - holds the pharmacist responsible for knowingly dispensing a prescription that was not issued in the usual course of professional treatment
Intended to be applied to the body for cleansing, beautifying, promoting attractiveness (Example: Deodorants)
Cosmetics
disclosure of PHI to business associations
Covered entity may disclose PHI to business associate and may allow business associate to create or receive PHI on its behalf if satisfactory assurance that business associate appropriately safeguards information.
Pharmacist receiving a transferred electronic prescription must ____.
Create an electronic record for the prescription that includes the receiving pharmacist's name and all information transferred with the prescription.
Department of Homeland Security Appropriations Act of 2007
Created Canadian Personal Use Exemption for individual patients transporting FDA-approved prescription drugs from Canada into US.
1951 Durham-Humphrey Amendments
Created OTC and prescription drug categories
What penalties are associated with online pharmacists knowingly filling rx's for controlled substances from prescribers associated with online pharmacies?
Criminal and monetary penalties for both the pharmacist and the pharmacy
What does CGMP stand for?
Current good manufacturing practices
Practitioners who treat narcotic addiction in the outpatient setting must have what type of DEA number to prescribe Subutex and Suboxone?
DATA-waived DEA # that begins with an "X"
What form a pharmacy should use to apply for DEA registration
DEA 224 either online or request paper app *if pharmacy wants a copy, request it online
What form a pharmacy should use to renew pharmacy DEA registration?
DEA 224a *can start renew 60 days prior to exp date
What form can a chain retail pharmacy use to renew DEA registration?
DEA 224b
What form to use for DEA chemical distributor registration?
DEA 510
What form use used to document significant losses and thefts of controlled substances to the DEA?
DEA Form 106
What form pharmacy use to notify the DEA of theft, loss?
DEA Form 106 Report of Theft or Loss of Controlled Substances
To order or transfer a CI CS, what form must DEA registrants utilize?
DEA Form 222
To order or transfer a CII CS, what form must DEA registrants utilize?
DEA Form 222
Which form must central fill pharmacies use to register with the DEA?
DEA Form 224
What DEA form is required for physicians to register for authorization to prescribe Subutex and Suboxone to treat narcotic addiction in the outpatient setting?
DEA Form 363
What form is used for opioid treatment programs to become re-accredited and re-certified?
DEA Form 363
Which DEA form is used in the disposal and destruction of CS?
DEA Form 41
What form pharmacy use to notify the DEA of breakage and spillage of CS?
DEA Form 41 (Registrants Inventory of Drugs Surrendered)
reverse distributor
DEA registrant to whom pharmacy can return unwanted, unusable, or outdated controlled substances.
DEA form 224a
DEA renewal every 3 years
Which form to use to prescribe and dispense methadone?
DEA-363
Combat Meth Act Daily and monthly purchase limits?
Daily: 3.6 g 30 Day: 9.0 g Mail service has 7.5 g 30 day limit
What special labeling requirements do CII drugs contain?
Date of filling
What information is required on a prescription for a controlled substance?
Date of issue; Patient's name and address; Practitioner's name, address, and DEA registration number; Drug name; Drug strength; Dosage form; Quantity prescribed; Directions for use; Number of refills (if any) authorized; and Manual signature of prescriber. - must be written in ink or indelible pencil or typewritten (except for e-Rx) - must be manually signed by the practitioner. (e-signature OK for e-Rx) - An individual may be designated by the practitioner to prepare the prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation. - Rx for C2 must be written and be signed by the practitioner. (or use approved/certified e-Rx system) - Emergency: oral Rx OK for C2, must follow up with a written Rx w/in 7 days. (72 hrs in NY) - Rx for CIII-V: written, oral or fax
No controlled substance that is a prescription drug may be ____ by means of the Internet without ____.
Delivered, distributed, dispensed without valid prescription. Valid prescription is issued for legitimate medical purpose in usual course of professional practice by practitioner who has conducted at least 1 in-person medical evaluation.
Products exempt from tamper-evident packaging are ____.
Dermatological, dentifrice, insulin, lozenge.
Who develops and approves REMS programs?
Developed by manufacturer, approved by FDA
Intended to affect the structure or function of the body of man or other animals (Example: Antiperspirants
Devices
DRG
Diagnosis Related Groups (classification system for hospital inpatients based on the principal diagnosis)
Amended the Food, Drug and Cosmetic Act by creating a new type of product called Dietary Supplements
Dietary Supplement Health and Education Act of 1994
What does DSHEA stand for and what year was this law enacted?
Dietary Supplement Health and Education Act of 1994
DI
Dietary ingredient (vitamin, mineral, herb, AA, or other dietary substance that supplements the diet)
DS
Dietary supplement
Abbreviated New Drug Application (ANDA)
Different company submits to market generic drug after innovator company patent expires. New drug requires proof of similar pharmacokinetic properties, bioavailability, clinical activity.
Who is OTC labeling directed towards? What must be contained in the labeling of OTC drugs?
Directed towards consumer/patients; Must contain 1. Adequate directions for use (warnings to stop use, dosages, intended patient populations, route of administration, time of administration, etc) 2. Statement of identity of the product (established name of drug and category) 3. Name and address of manufacturer, packer, distributor 4. Net quantity of contents 5. Cautions and warnings needed to protect consumer 6. Drug facts panel (active ingredient, purpose, indications, warnings, directions, other information, inactive ingredients, phone number to call with questions/comments)
Who is Rx labeling directed towards? What must be contained in the package insert of Rx drugs?
Directed towards healthcare professionals; must contain adequate information for use in its labeling including: 1. legend 2. recommended and usual dosage 3. type of container used to dispense 4. name and address of manufacturer, packer, distributor 5. established name of drug 6. ingredients 7. inactive ingredients (IF not for PO use) 8. quantity (i.e. 100 mg and 100 tablets) 9. statement of usual dosage or reference to PI 10. lot number 11. expiration date
What does "anti-kickback" laws prohibit people or corporations from doing?
Directly or indirectly: -Intentionally soliciting -Receiving remuneration (bribes, rebates, case) -In order to get patient referrals or additional business that is reimbursed under state and federal health care programs
Written prescription for CII not required when ____.
Dispensed directly to ultimate user by practitioner other than pharmacist.
maintenance treatment
Dispensing for a period in excess of 21 days of narcotic in treatment of an individual for dependence upon morphine-like drugs.
detoxification treatment
Dispensing for a specified period of time of narcotic in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from continuous or sustained use of narcotic. Method of bringing individual to narcotic drug-free state within such period of time.
Reimportation of drug products is legal when ____.
Done by the original manufacturer for emergency use. Otherwise, reimportation of drug products is illegal.
Exportation of drug products is legal when ____.
Done by the original manufacturer or licensed wholesaler and no intention to reimport.
What is the definition of "maintenance treatment" in an opioid treatment program?
Dosage levels in excess of 21 days
What does "DEA" stand for?
Drug Enforcement Administration
Innovator of drug given at least 5 years of exclusive marketing or remainder of patent life, whichever was longer
Drug Price Competition and Patent Term Restoration Act of 1984
Sometimes called Waxman-Hatch Amendment
Drug Price Competition and Patent Term Restoration Act of 1984
AKA the Hatch-Waxman Amendment. Streamlined the drug approval process for generics through the abbreviated new drug application (ANDA), which only required bioequivalence testing with its brand-name counterpart. Brand name manufacturers were provided with incentives to develop new drug products by being awarded up to 5 additional years of patent protection.
Drug Price Competition and Patent-Term Restoration Act
After 2014 pharmacies may register as HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES under the ------- act
Drug Quality and Security Act
What does "DQSA" law of 2013 stand for?
Drug Quality and Security Act
Pharmacies may register with the FDA as HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES
Drug Quality and Security Act of 2013
Which law contains important provisions relating to the oversight of compounding human drugs?
Drug Quality and Security Act of 2013
Intended for use in the diagnosis, treatment or prevention of disease in man or other animals (Example: Vitamin C for scurvy)
Drugs
Phase 3 clinical trials primarily assess what? How many patients are tested?
Drugs effectiveness compared to placebo Up to thousands
What types of drugs are class 1 recalled drugs?
Drugs with a reasonable probability of causing serious adverse health consequences or death
This drug information resource has: -labels -generics of a brand name -regulatory history of a drug -consumer information for drugs approved after '98 -therapeutic equivalent drug products for a brand name or generic
Drugs@FDA
Established Prescription vs. OTC drugs
Durham-Humphrey Amendment of 1951
Required a prescription before a pharmacist could sell/dispense a Rx drug
Durham-Humphrey Amendment of 1951
This law established two classes of drugs--legend drugs and OTCs. Also required the "Caution: Federal law prohibts dispensing without a prescription" on the manufacturer's label. Also created oral prescriptions and prescription refills.
Durham-Humphrey Amendment of 1951
Which legislation distinguished legend from non-prescription drugs?
Durham-Humphrey Amendment of 1951
Which legislation provided for verbal orders and refills on prescriptions?
Durham-Humphrey Amendment of 1951
prescriptions for multiple CII
Each prescription for CII must be a separate prescription.
What is the retrospective review requirement of OBRA '90?
Each state must establish a DUR board consisting of physicians, pharmacists, and other health care professionals to review the use of drugs over a specified period of time to identify patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care among physicians, pharmacists, and individuals receiving Medicaid benefits, or associated with specific drugs or groups of drugs. The committee may suggest changes to prescribing habits and may initiate educational programs for prescribers and pharmacists.
How often must manufacturers and distributors (wholesalers) register with the DEA?
Each year, at the end of the month assigned by DEA for that year
Phase 2 clinical trials primarily assess what (4 items)? How many patients are tested?
Effectiveness, dosing info, safety, SEs 100 or more patients
How must CII-CV controlled substances be stored?
Either: -Dispersed throughout inventory to prevention diversion or theft -Stored in a securely locked and substantially constructed cabinet
Practitioner may issue electronic prescription for CII-V if ____.
Electronic prescription application used found to be consistent with regulations by third-party auditor or certification organization, two-factor authentication credential obtained from approved credential service provider of certified certification authority.
Electronic Signatures in Global and National Commerce Act of 2000 (E-Sign)
Electronic records, signatures, contracts in interstate commerce recognized as legally valid.
Oral prescriptions for CII not permitted unless ____. Conditions include ____.
Emergency situation. Conditions include: --Quantity prescribed and dispensed limited to amount adequate to treat during emergency period. Dispensing beyond must be pursuant to paper/electronic prescription signed by prescribing individual practitioner. --Prescription must be immediately reduced to writing by pharmacist and contain all required information except for signature of prescribing individual practitioner. --If prescribing individual practitioner not known to pharmacist, must make reasonable effort to determine that oral authorization came from registered individual practitioner. --Dispensing pharmacist must receive from prescribing individual practitioner a written prescription for emergency quantity prescribed within 7 days. Prescription must have "Authorization for Emergency Dispensing" written on its face. Paper prescription may be delivered in person or by mail, but if by mail, must be postmarked within 7-day period. Upon receipt, dispensing pharmacist must attach this paper prescription to the oral emergency prescription earlier reduced to writing. For electronic prescriptions, pharmacist must annotate record of electronic prescription with original authorization and date of oral order. --Pharmacist must notify nearest DEA office if prescribing individual practitioner fails to deliver written prescription.
When was FDCA initially enacted, and what was the catalyst for it's creation?
Enacted in 1938; Prompted by the sulfanilamide elixir tradegy of 1937
Medicaid Maximum Allowable Cost Program
Encourage generic substitution for more expensive brand-name drugs. Set upper limit on what Medicaid would reimburse for certain multisource drugs. Drug product selection laws vary from state to state: mandatory substitution states and permissive substitution states.
What is the goal of the Secure and Responsible Drug Disposal Act of 2010 (aka Disposal Act)?
Encourage public and private entities to develop a variety of methods of collection and disposal in a secure, convenient, and responsible manner
Methamphetamine Production Prevention Act of 2008
Encourages and facilitates use of electronic logbooks to discourage smurfing. Federal grants provided to states to develop electronic logbook systems to prevent smurfing across state lines.
HIPPA is enforced by
Enforced by the Office Of Civil Rights in HHS
FDA Food Safety Modernization Act of 2011
Ensure US food supply is safe. Shift focus from responding to contamination to preventing it.
For CIII-V prescription refills, pharmacist must ____.
Enter each refill on the back of the prescription or appropriate document or electronic prescription record.
Scheduled listed chemical products include ____ which are precursors to ____.
Ephedrine, pseudoephedrine, phenylpropanolamine which are precursors to methamphetamine.
Durham-Humphrey Amendment of 1951 (Prescription Drug Amendment)
Established 2 classes of drugs: Rx and OTC. Legend: "Caution: Federal law prohibits dispensing without a prescription". Authorized oral prescriptions and refills.
Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act) (CSA)
Establishes closed system for distribution of controlled substances. Only persons/entities registered with DEA may legally engage in manufacturing, distributing, dispensing controlled substances.
How often must a pharmacy renew it's DEA registration? With which form?
Every 3 years, form 224a
Omnibus Reconciliation Act of 1990 (OBRA '90)
Expanded standards of practice for pharmacists to save federal government money. Theory that improving quality of drug therapy would reduce costs of health care. One of primary mechanisms to accomplish goal is DUR.
What types of drugs are class 2 recalled drugs?
Exposure may cause temporary or reversible adverse health consequences, probability of serious health issues is remote
What agency approved medication guides or "MedGuide"?
FDA
What agency determines if the information contained on the label and labeling of drugs is false or misleading, and ultimately approves the information?
FDA
What government agency controls prescription drug advertising?
FDA
Which entity regulates legend drug advertising?
FDA
Who regulates legend drug advertising?
FDA
advertising of RX drugs is regulated by ?
FDA
compounding pharmacies registered through HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES Must be inspected by what agency?
FDA
what agency enforce the FDCA
FDA
Risk Evaluation and Mitigation Strategy (REMS)
FDA Amendments Act of 2007 authorized FDA to require sponsors to include REMS in pending NDA if necessary to ensure that benefits outweigh risks.
Created a fast-track review of select NDAs Created exemptions from GMPs for compounding pharmacies. Allowed individual states to regulate compounding. "Caution: Federal law prohibits dispensing without a prescription" can now just be "Rx only." "Warning--May be habit forming" no longer required Allows manufacturers to publicly disseminate limited information about unapproved uses in order to encourage supplemental NDAs Encouraged pediatric studies of drugs by providing an additional six months of marketing exclusivity
FDA Modernization Act of 1997
Which legislation abbreviated the required "Caution: Federal law prohibits dispensing without a prescription" to "Rx only"?
FDA Modernization Act of 1997
Which legislation draws the distinction between compounding (to be regulated by states) and manufacturing (federally regulated)?
FDA Modernization Act of 1997
Which legislation eliminated the need for certain substances to be labeled "Warning - May be habit forming"
FDA Modernization Act of 1997
Which legislation expedites the approval of an Amended New Drug Application for serious or life-threatening conditions?
FDA Modernization Act of 1997
Which legislation specifically prohibits manufacturers from disseminating information about unapproved uses for drugs?
FDA Modernization Act of 1997
Safe Medical Devices Act of 1990
FDA additional authority over medical devices. Postmarketing approval. Require health care facilities to report problems to FDA. FDA new authority to recall.
Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act)
FDA authority to regulate manufacturing, distribution, marketing of tobacco.
medical device tracking
FDA issues tracking order to manufacturer of Class II or III device that meets 1 of 3 criteria: (1) Failure of device likely to have serious adverse health consequences. (2) Intended to be implanted in body for >1 year. (3) Life-sustaining or life-supporting device used outside device user facility.
expedited approval (fast track)
FDA may grant if new drug intended to treat serious or life-threatening condition and addresses unmet medical need. Sponsor must agree to conduct postapproval studies to validate use.
Compassionate Use Policy
FDA permits personal importation of small amounts of drugs under following conditions: --Drug is not approved for use in this country. --Drug treats serious condition for which no satisfactory treatment is available in the US. --Drug does not pose unreasonable risk. --Patient seeking to import drug provides name of US physician treating patient with unapproved drug.
Orange Book
FDA publishes to help determine bioequivalence of generic drugs.
Dietary Supplement Health and Education Act (DSHEA)
FDA regulates dietary supplements more as foods than drugs FDA must prove it is unsafe before removing it from the market
What agency decides whether a drug is Rx or OTC?
FDA, based on panel review
The provision that allows pharma manufacturers to provide off-label information to healthcare entities (i.e. pharmacists, prescribers, hospitals, third party payers) is contained in which law?
FDCA
The provision that restricts pharmacies from receiving or distributing drug samples from manufacturers is contained in which law, and prohibits the sale of drug samples by hospitals or other heathcare entities?
FDCA
This law arose from 107 deaths caused by the mistaken use of diethylene glycol. This law required that any new drug could not be marketed unless it had first been proven to be safe when used according to the directions on the label. It also required labels that include adequate directions for use and warnings about habit-forming drugs. Also the first law to apply to cosmetics and medical devices.
FDCA of 1938
Advertising of OTC is regulated by
FTC
Who regulates OTC advertising?
FTC
T/F: CSOS can be used to order CII's.
False
T/F: DEA is allowed to examine and copy any records relating to controlled substances, including financial records
False
T/F: Legally, any pharmacy can dispense methadone for opioid addiction use.
False
T/F: Paper DEA Form 222's can be used to order CIII-V's
False
T/F: Paper DEA Form 222's can only be used to order non-controlled substances
False
T/F: Pharmacies may administer a one-day supply of methadone outside of the opioid treatment program
False
T/F: Under DEA, prescribers are allowed to issue multiple rx's in one visit, up to a 120 day supply
False - 90 day supply
T/F: Significant losses and all thefts of controlled substances must be reported in writing to the FDA.
False - DEA requires reporting in writing to the Field Office of the DEA
T/F: On the face of all Suboxone rx's must contain the prescribers DEA #, starting with an "X"
False - Suboxone can be used to treat pain and in this setting, prescriber would not need DEA "X"
T/F: The PPPA requires products to have a tamper resistant seal
False - Tamper Resistant Packaging Act
T/F: Drugs that purport to be those recognized in official compendia but strength, quality or purity falls below the standards is considered misbranding
False - adulteration
T/F: Only the pharmacy must have a DEA approved system to transmit CS rx's electronically
False - both the prescriber and the pharmacy
T/F: CS inventory records must be stored in manual form.
False - can be computer
T/F: Recalls are only by FDA order under statutory authority
False - can be conducted on a firm's own initiative, upon FDA request, or upon FDA order under statutory authority
T/F: An oral refill authorized by a practitioner must be written
False - can be oral and immediately reduced to writing by the pharmacist
T/F: Legally, a central fill pharmacy can receive and fill an rx for a controlled substance, and then sends the rx directly to the patient.
False - cannot provide directly to patient or practitioner - must send it back to the originating pharmacy
T/F: Physicians that inject or provide medications in their office is considered dispensing
False - considered administration - some states allow MD's to dispense drugs as well
T/F: Under HIPAA 96, a pharmacy can fully disclose a patients medical record to another healthcare provider, if it is for treatment, payment, or operations for that patient.
False - disclose the minimum amount of PHI necessary to accomplish the objective
T/F: A pharmacy must separately register an automated dispensing system with the DEA and has to pay additional fees
False - does have to register separately, but does not have to pay any additional fees
T/F: If a pharmacist makes an error on the DEA Form 222, they can cross it off and correct the error, as long as then initial the change.
False - errors may not be corrected - must fill out a new 222 Form
T/F: Every individual healthcare practitioner must be registered with the DEA in order to prescribe controlled substances
False - every employer or affiliated health care setting must be registered
T/F: During a CS inventory, exact counts of each agent are necessary
False - exact counts for CI and CII - estimates for CIII-CV
T/F: As of 10/2014, it is mandatory that retail pharmacies have an option to collect pharmaceutical CS from ultimate users.
False - it is optional
T/F: If a supplier cannot provide the entire quantity of CS requested on DEA Form 222, they can provide a partial shipment and supply the balance within 90 days.
False - must supply within 60 days
T/F: The quantity of drugs prescribed and frequency of rx filled are indications for fraud or improper prescribing.
False - not alone - patient could be being treated with opioids for pain management - patient could have drug tolerance/physical dependence as a result of chronic pain management
T/F: The DQSA of 2013 requires a compounder of sterile products to register as an "outsourcing facility"
False - not required
T/F: requests for non-child-resistant packaging by the physician or patient must be in writing
False - not required to be in writing, but encouraged
T/F: Each DEA form is numbered by the pharmacist when they receive the forms
False - numbered by the DEA
T/F: Practitioners need multiple DEA registration numbers if they practice and write prescriptions at more than once site
False - only need one DEA number in each state
T/F: The OBRA 87 federal requirements apply to all LTC facilities
False - only those that are certified and receive money from Medicare or Medicaid programs
T/F: A pharmacist can perform MRR's for a LTC facility from a central location, as long as they have access to all records electronically.
False - the pharmacist must physically visit the nursing home to conduct the review
T/F: In the retail setting, a pharmacy cannot fill a CII rx received via fax
False - they can fill via fax - cannot dispense until they receive the original rx
T/F: Medication orders for inpatients are considered prescriptions under CSA
False - they do not need to conform to all recordkeeping requirements
T/F: A drug may be considered misbranding if it contains an unsafe color additive.
False - this is adulteration
T/F: After a breach of unsecured PHI, the covered entity must provide notification to the affected individuals within 30 days of discovery
False - within 60 days
T/F: A drug is not adulterated if the container was exposed to something putrid, so long as the container was sealed and the drug itself was not contaminated.
False! It would still be considered adulterated
T/F: If a drug has a REMS program associated, a MedGuide is necessary.
False, many medications already approed for REMS have MedGuides as well
T/F: The breakage or spillage of controlled substances constitutes a "loss" of controlled substances
False. It does not constitute a loss of controlled substances and does not require the DEA form 106. It requires a DEA form 41 (surrendered drug).
OBRA '90!! What does it require?
Fed attached certain conditions for reimbursement to medications dispensed through Medicaid: 1) Make a good faith effort to obtain and maintain a pt and medication hx. 2) Prospective DUR for every script to review for drug therapy problems 3) Must make an offer to counsel each patient
What does FDCA stand for?
Federal Food, Drug and Cosmetic Act
Where does the DEA publish information related to newly scheduled drugs?
Federal Register
Advertising for dietary supplements is regulated by the
Federal Trade Commission (FTC)
What government agency controls OTC drug advertising?
Federal Trade Commission (FTC)
Which entity regulates OTC advertising?
Federal Trade Commission (FTC)
Federal Anti-Tampering Act of 1982
Federal crime to tamper with OTC. Required tamper-resistant packaging on selected OTC drug products and cosmetics accessible to the public while held for sale. Barrier that provides visible evidence of entry if disturbed and directions to consumer on how to determine if tampering has occurred.
When must the prescriber provide the pharmacy with the original, signed, written rx for an emergency CII, after authorizing the emergency rx?
Federal law: within 7 days (postmarked)
How long must executed DEA Form 222 records's be maintained by each entity?
Federal: For at least 2 years (Check NC for longer) (Check Medicaid/Medicare for longer)
What is the general difference in perview between federal and state legislation in pharmacy practice?
Federal: Regulates manufacturing, labeling, promotion and distribution of drugs. State: Regulates the PRACTICE of the profession
How many times can a pharmacy transfer a CIII rx for refill purposes?
Federal: once
How many times can a pharmacy transfer a CIV rx for refill purposes?
Federal: once
Generic Drug Enforcement Act of 1992
Felony to make false statement, bribe, fail to disclose material-related facts, etc.
What do the three portions of an NDC code stand for?
First 4: Manufacturer Middle 4: ID of drug Last 2: Package size
What changes may a pharmacist make to a prescription written for a C II?
Follow state rule. "the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)...may not be modified orally." The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber. (Policy Letter) Therefore, when information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.
Permitted FDA to order Phase IV (post-marketing surveillance) on Rx drugs
Food & Drug Administration Amendments Act of 2007
Permitted FDA to require Risk Evaluation & Mitigation Strategies (REMS) for drugs which may pose an increased risk to patients
Food & Drug Administration Amendments Act of 2007
Permitted the FDA to order a drug recall
Food & Drug Administration Amendments Act of 2007
Renewed the Prescription Drug User Fee Act for another 5 years. (Had been renewed in 2002) Increased the fee manufactures paid by about 30%
Food & Drug Administration Amendments Act of 2007
Allowed manufacturers to provide prescribers with scientific peer-reviewed articles on UNAPPROVED uses for approved drugs
Food & Drug Administration Modernization Act of 1997
Changed the "legend" on Rx drug container to allow "RX ONLY" in addition to "CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION"
Food & Drug Administration Modernization Act of 1997
Clarified that pharmacists were permitted to COMPOUND a drug for a specific patient pursuant to a prescription, and to compound limited quantities of a drug in anticipation of receiving a prescription.
Food & Drug Administration Modernization Act of 1997
Created "fast-track" approval process for drugs intended for serious conditions. If approved, the manufacturer must do post-marketing surveillance.
Food & Drug Administration Modernization Act of 1997
Encouraged Rx drug manufacturers to perform pediatric clinical trials on drugs that might be used/beneficial for pediatric patients
Food & Drug Administration Modernization Act of 1997
Permitted Rx drug manufacturers to provide prescribers with economic data on drug therapy
Food & Drug Administration Modernization Act of 1997
Which legislation requires new drugs to be proven safe when used according to labeled directions?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation requires that labels include warnings about habit-forming risk?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation requires that medications include labels with adequate directions for use?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation was urged by 107 accidental deaths caused by anti-freeze (diethylene glycol) poisoning?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation was urged by 107 accidental deaths caused by anti-freeze diethylene glycol poisoning?
Food Drug and Cosmetic Act (FDCA) of 1938
Food Additives Amendment of 1958
Food additives require premarket approval for safety.
Required drugs to be proven SAFE before shipment or marketing in interstate commerce Uses "adulteration" and "misbranding" as basis for enforcement actions
Food, Drug, & Cosmetic Act of 1938
Result of sulfanilamide elixir tragedy in 1937
Food, Drug, & Cosmetic Act of 1938
what act gave the FDA the authority to inspect facilities where drugs are manufactured or stored
Food, Drug, & Cosmetic Act of 1938
Are dietary supplements regulated more like foods or drugs under DSHEA?
Foods
Intended for use as a food or drink (Example: Orange Juice)
Foods
When are MedGuides required by the FDA?
For certain products posing a "serious and significant concern" other than estrogen-containing products if FDA founds a. Pt labeling could help prevent serious adverse effects b. Product has serious risks that patient could benefit from knowing c. Pt adherence must be approved by FDA
DEA Form 41
For disposal/destruction of controlled substances; need 2 witnesses
What must be listed on DEA Form 41 for disposal and destruction of CS?
For each drug that will be disposed/destroyed: -Name of drug -Content of container -Date and method of destruction -List of witnesses
DEA Form 106
For reporting theft/loss of controlled substances; need to notify DEA within 1 BUSINESS day
DEA Form _____ is used to report theft or loss of controlled substances.
Form 106
Controlled substance theft or significant loss at a pharmacy shall notify DEA and local police and Complete DEA Form _____ in ______ day(s).
Form 106 1 business day of the discovery
DEA Form _____ is the offical order form.
Form 222
New Pharmacy Registration Form
Form 224
DEA Form ______ must be completed to register as a new pharmacy.
Form 224 (this form is also for practitioners and teaching institutions)
Manufacturer/Wholesaler/Importer/Exporter/Researcher Registration Form
Form 225 (225a renewal)
DEA form ______ is used for controlled substances surrendered for destroying
Form 41
Form for lost/destroyed C2s
Form 41
Billing for services that has a higher reimbursement rate than the service provided is an example of _______ (fraud/waste/abuse)?
Fraud = false claims
Billing for services that were never given is an example of ________ (fraud/waste/abuse)?
Fraud = false claims
What color is copy #2 of DEA Form 222?
Green
was passed in 2009 to strengthen disclosure issues Required that any disclosures of PHI be limited to the minimum amount necessary Notification to patient if unsecured PHI is breached
HITECH
First act to control CS?
Harrison Narcotic Act in 1914 Controlled sale of opium, morphine, codeine
What is another name for the Drug Price Competition and Patent-Term Restoration Act?
Hatch-Waxman Amendment
Which legislation provided a streamline approval process for generic drugs with the creation of the Abbreviated New Drug Application (ANDA)?
Hatch-Waxman Amendment or Drug Price Competition and Patent-Term Restoration Act
Which legislation provided a streamline approval process for generic drugs with the creation of the Amended New Drug Application (ANDA)?
Hatch-Waxman Amendment or Drug Price Competition and Patent-Term Restoration Act
What does HITECH stand for?
Health Information Technology for Economic and Clinical Health Act
What does HIPAA stand for? When was it established?
Health Insurance Portability and Accountability Act of 1996
Schedule II Controlled Substances
High abuse potential leading to: - SEVERE physical dependence - SEVERE psychological dependence
Schedule I Controlled Substances
High abuse potential; No accepted medical use *Peyote use by Native American Church is allowed, but manufacturers/distributors must be registered
Schedule 3 Dependence Potential
High psychological, moderate-low physical (steroids, Suboxone)
What is a pharmacists corresponding responsibility under the CSA?
Holds the pharmacist responsible for knowingly dispensing a prescription that was not issued in the usual course of professional treatment
What might an internal DEA code at a hospital look like?
Hospital DEA # - internal code XXXXXXXXX - XXXX
What does Medicare part A cover?
Hospitalization
What is the "Own Use Doctrine"?
Hospitals can sells drugs to its patients and employees at its cost but not to other community places
What are level I, II, and III drug recalls?
I: causes death or serious injury II: could cause illness but is reversed when drug is stopped III: usually some type of labeling thing
before testing a drug on humans what type of application need to be filed with the FDA ?
INDA
Can a patient in an LTCF receive methadone for maintenance purposes?
If the LTCF is registered with DEA as a hospital/clinic, it need not be separately registered as a Narcotic Treatment Program (NTP) to administer or dispense methadone as an adjunct to medical treatment of conditions other than addiction. [21 CFR 1306.07(c)] IF NOT DEA registered: - Pt currently enrolled in an NTP: The NTP may transfer medication to the LTCF with the approval of the State Methadone Authority - If pt NOT enrolled in an NTP: can administer one day's dose at a time for up to 3 days (no extensions or exceptions) for acute withdrawal symptoms only while arrangements are being made for referral for treatment. [21 CFR 1306.07(b)]
At what point would a "cosmetic" become a "drug"?
If the manufacturing promotes the product for a therapeutic purpose (structure/function claims, treatment, diagnosis, mitigation, cure claims), despite product chemistry
When might a pharmacy be deemed a manufacturer?
If the pharmacy repackages or compounds medications for sale under certain conditions
When is a sale of sudafed exempt from the maximum daily and monthly limits?
If the purchase is less than 60 mg of sudafed
When must significant losses and thefts of controlled substances be reported in writing to the Field Office of the DEA?
Immediately upon discovery
Under which circumstance may an IND be used to treat a disease?
Imminent life threatening stage of an illness for which there is presently no cure, or current drugs are inneffective
What is the overall goal of HIPAA 1996?
Improve the efficiency and effectiveness of the health care system
Anabolic Steroid Control Act of 2004
Includes anabolic steroids in CIII and provides automatic schedule without need to prove they promote muscle growth.
Investigational New Drug Application (INDA)
Includes animal studies and proposed clinical protocols for humans. FDA has 30 days to determine whether drug is suitable for testing.
Dispensing controlled substances includes ____.
Includes prescribing and administering controlled substance and packaging, labeling, compounding necessary to prepare substance for delivery to ultimate user.
requesting PHI amendment
Individual has right to have covered entity amend PHI. Covered entity may deny request for amendment if it determines that PHI was not created by covered entity or if PHI is accurate and complete.
Pharmacy Website exempt from definition of online pharmacy if ____.
Internet-related activity regarding controlled substances is limited to filling new prescriptions in CIII-V and/or refilling those prescriptions. Filling new prescriptions means that pharmacy previously dispensed the controlled substance to the patient by means other than the Internet pursuant to valid prescription, and pharmacy has contacted the prescriber who issued the original prescription at the request of the patient to determine if the prescriber will authorize issuance of a new prescription after determining there is legitimate medical purpose.
A drug that has been tested on animals, and has shown it is safe and effective for the intended treatment
Investigational New Drug
____ are appropriate records of receipt for CIII-V.
Invoices.
Reconsititution
Involves mixing drug products for use by a patient pursuant to manufacturer's instructions
what drugs required to have PPI ?
Isoproterenol inhalation/birth control pills/estrogens
Administrative Inspection Warrant (AIW)
Issued by federal judge upon showing probably cause. Must be served during normal business hours. Requirements for obtaining AIW are much less than requirements for obtaining search warrant under Fourth Amendment.
prescribing or dispensing a narcotic for the purpose of maintenance or detoxification treatment
It is illegal to prescribe or dispense narcotic drugs for the purpose of maintaining an addiction or detoxifying an addict.
What happens if a schedule III drug codeine (NMT 1.8 grams/100mL) exceeds the drug concentration allowed?
It will fall into schedule II
What happens if a schedule V drug opium (NMT 100 mg/100mL) exceeds the drug concentration allowed?
It will fall into schedule III
Required drugs to be proven BOTH safe and effective before marketing in interstate commerce
Kefauver-Harris Amendment of 1963
Required informed consent from patients participating in clinical trials of drugs
Kefauver-Harris Amendment of 1963
thalidomide induced birth defects led to what amendment ?
Kefauver-Harris Amendment of 1963
what amendment Established CGMP requirements
Kefauver-Harris Amendment of 1963
what amendment transferred the Rx drug advertising control to FDA
Kefauver-Harris Amendment of 1963
Which legislation created Good Manufacturing Practice (GMP) requirements?
Kefauver-Harris Amendment of 1962
Which legislation gave the FDA authority to regulate prescription drug advertisements?
Kefauver-Harris Amendment of 1962
Which legislation is also referred to as the Drug Efficacy Amendment?
Kefauver-Harris Amendment of 1962
Which legislation required new drugs must be EFFECTIVE in addition to being safe?
Kefauver-Harris Amendment of 1962
Which legislation was adopted as a result of public concern about thalidomide?
Kefauver-Harris Amendment of 1962
Adopted as a result of the thalidomide debacle. Also referred to as the Drug Efficacy Amendment, this law required that all new marketed drugs had to be shown to be not only safe, but also effective. Placed the authority for regulating prescription drug advertising into the hands of the FDA. Required informed consent for research patients, reporting of adverse drug reactions, and created GMPs.
Kevauver-Harris Amendment of 1962
A pharmacy offering a rebate to a prescriber to refer patients to their pharmacy is an example of _______ violation?
Kick-back
A pharmacy offering cash to a prescriber for referring patients to their part D plans is an example of _______ violation?
Kick-back
A pharmacy offering coupons for prescription transfers is violating __________?
Kick-back
Which facilities are exempt from the PPPA of 1970?
LTC facilities, institutional settings - if the facility personnel will administer the medications to the patients
Medicare sponsors are not required to provide interactive consults to this group:
LTC residents
Actual written/printed information placed upon the container
Label
What is the first segment of the NDC number?
Labeler (manufacturer/repacker/distributor)
National Drug Code (NDC) components
Labeler's code identifies manufacturer or distributor. Second segment identifies specific strength, dosage form, formulation. Last component identifies trade package size and characteristics. FDA has standard 10-digit number while HIPAA has 11-digit standard.
Written/printed information placed upon the container PLUS any other written/printed information packaged with the container
Labeling
What does the first letter of a DEA number indicate?
Level of prescribing ability
REMS was initially created because of this class of agents
Long acting opioid medications
1983 Orphan Drug Act
Longer patent life as incentive to create drugs for rare diseases
Schedule 4 Dependence Potential
Low potential for abuse, dependence not listed (benzos, soma, barbiturates)
Schedule IV Controlled Substances
Lower abuse potential than previous Schedules
Schedule V Controlled Substances
Lower abuse potential than previous Schedules
What are the letters a mid-level DEA typically?
M
What is the first letter of a DEA number for a midlevel prescriber?
M
what prohibits insurance plans from unsolicited direct contact of prospective enrollee in medicare
MIPAA
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendment)
Make generics more readily available. Incentives to develop new drugs.
What does Medicare part C cover?
Managed care
Nutrition Labeling and Education Act of 1990
Mandated nutrition labeling on food productions. Authorized health claims on product labeling. Standardized labeling terms with health implications.
How does an Rx drug become OTC?
Manufacturer must submit an application or petition for review
DEA numbers starting with P/R indicate ___________.
Manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, or narcotic treatment program
To whom do most adulteration provisions apply?
Manufacturers
To whom does the FDCA usually apply to most often?
Manufacturers and wholesalers (CGMPs)
PPPA exemptions
Manufacturers or packers may apply for exemption.
Phase 4 - Postmarketing Surveillance
Manufacturers submit yearly reports on new information about drug.
Uses/disclosures requiring patient's written authorization include ____.
Marketing. Research. Employment applications. Insurance coverage applications.
Refills for Schedule III - V Drugs
Max 5 refills in the 6 months from the date written
How do refills for C3-5 work?
May be refilled 5 times within 6 months after the date of issue
Recall Rules: Class II Recall
May cause temporary or reversible health effects
Pharmacist may dispense CII only after receiving ____ unless ____.
May dispense after receiving written prescription unless in emergency situation.
Registrant presented with AIW by DEA inspector may ____.
May not refuse to consent to inspection.
Why might an NDC contain 11 digits?
May see asterisk as a place holder for HIPAA
HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES can sell to
May sell the products to physicians, hospitals, other pharmacies, ----
Best Pharmaceuticals for Children Act of 2002
Mechanisms for studying on- and off-patent drugs in children. Extended provision from 1997 FDA Modernization Act that offered additional 6 months patent exclusivity for on-patent drugs being tested for pediatric use.
Medical Device Amendment Act of 1976
Medical device classification according to function and requires premarket approval. Established performance standards, GMP, recordkeeping, reporting requirements.
Federal program to provide health insurance to those at least 65 years of age and those who are disabled
Medicare
What are the four programs of the Medicare Prescription Drug Improvement and Modernization Act of 2003?
Medicare Parts A, B, C, and D
1998: FDA announced a "new" program called --------for drugs that posed a "serious and significant" concern to health.
Medication Guides
What does MRR stand for?
Medication Regimen review
A _____ policy is health insurance sold by private insurance companies to fill the "gaps" in the original Medicare Plan coverage. Can also be referred to as Medicare Supplemental Insurance.
Medigap
DEA number starting with M indicates ___________.
Mid-level practitioner (NP, PA, OD, ET...)
What is being violated if a prescription medication fails to bear the legend "Rx only"?
Misbranding
What law is broken if a pharmacist fails to provide a patient package insert ("PPI") to a patient with her oral contraceptive?
Misbranding
deals with a drug's label or labeling (dispensing Rx drug w/o Rx authorization=
Misbranding
If a company forgets or fails to print all statements required or approved by the FDA, what law is being violated?
Misbranding under FDCA
If a drug is an imitation of another drug or offered for sale under the name of another drug, what law is being violated?
Misbranding under FDCA
If a pharmacist dispenses an Rx drug without a prescription, what law is being violated?
Misbranding under FDCA
If an OTC package insert fails to contain adequate directions for use, what law is being violated?
Misbranding under FDCA
If a drug package insert fails to meet conditions regarding packaging, which 2 laws are being violated?
Misbranding under FDCA; Poison Prevention Packaging Act
If a drug package does not contain information about the manufacturer, packer, or distributor, what law is being violated?
Misbranding under the FDCA
Prescription Drug Marketing Act of 1987
More stringent controls on distribution to address diversion. Limit distribution beyond conventional retail. Specify storage, handling, recordkeeping for prescription drug samples. Ban sale, trade, purchase or prescription drug samples. Illegal for pharmacy to possess prescription drug samples. Prohibit health care entities from reselling pharmaceuticals to other businesses with some exceptions. Require state licensing of prescription drug wholesalers. Ban reimportation of prescription drugs produced in the US.
What did the Federal Anti-Tampering Act do?
Most oral OTC drug products and many dietary supplements must have tamper-proof indicator that shows if package has been opened or tampered with
Logbook of scheduled listed chemical product sales must be kept ____ except ____.
Must be kept at regulated seller's place of business where transaction occurred except may be kept at single, central location of regulated seller if regulated seller has notified DEA.
pharmacy paper prescriptions for CIII-V
Must be maintained at registered location in separate prescription file or in such form readily retrievable from other prescription records of the pharmacy.
pharmacy paper prescriptions for CII
Must be maintained at registered location in separate prescription file.
pharmacy inventories and records of CIII-V
Must be maintained separately from all other records of the pharmacy or in such form that information is readily retrievable from ordinary business records of the pharmacy.
pharmacy inventories and records of CI-II
Must be maintained separately from all other records of the pharmacy.
oral prescription requirements
Must be promptly reduced to writing by pharmacist and filed. Limitations for CII.
What are the requirements for C3-5 partial dispensing?
Must be recorded in the same manner as refilling
OTC Rules: Dose Higher Than OTC Limit
Must be written and filled as a prescription
What legal restrictions apply to advertising by manufacturers to health care professionals?
Must be: -True statements -Provide information related to the drug name, active ingredients -Summary of information regarding side effects, contraindications, clinical effectiveness -Can't be false or misleading -Must present "fair balance" -Must reveal material facts
If online pharmacy does not meet reporting thresholds for reporting period ____.
Must file report stating that it did not meet reporting thresholds.
DEA inspector is authorized to enter a pharmacy to conduct administrative inspection under what circumstances?
Must state purpose and present to owner, operator, or agent in charge or premises appropriate credentials and written notice of inspection authority (administrative inspection warrant).
If CS labeling requirements have been exempt (i.e. administration to an institutionalized patient), what are the NMT limitations on CIII drugs?
NMT (the lesser of) 34 day supply OR 100 dosage units
If CS labeling requirements have been exempt (i.e. administration to an institutionalized patient), what are the NMT limitations on CII drugs?
NMT 7 day supply of CII dispensed at one time
Can an individual return his/her controlled substance prescription medication to a pharmacy?
NO (unless there's drug recall or dispensing error). An individual may dispose of his/her own controlled substance medication without approval from DEA. Federal laws and regulations make no provisions for an individual to return the controlled substance prescription medication to a pharmacy for further dispensing or for disposal. There are no provisions in the Controlled Substances Act or Code of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., individual patient). In situations where an individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications.
Legally, can a manufacturer promote a medication for an off-label use?
NO - only approved indications
Is it appropriate to provide a DEA registration number when purchasing items other than controlled substances such as prescription drugs, over-the-counter drugs, or medical supplies from a distributor?
NO. Use NPI instead.
What does the orange book rating of "BA" mean?
NOT therapeutically equivalent
Under HIPPA pharmacist must provide patient with one -----
NOTICE OF PRIVACY PRACTICES (plus any later changes or amendments)
What does NDC stand for?
National Drug Code
How many times may a CII be refilled?
Never
How many times can a pharmacy transfer a CII rx for refill purposes?
Never! No refills allowed
A drug that is not generally accepted by experts as safe & effective for the intended use
New Drug
Submitted to FDA after Phase III trials completed Includes proposed label, package insert and manufacturing process If FDA finds the drug to be safe & effective for the purpose intended, the drug is approved for sale
New Drug Application (NDA)
Food, Drug, and Cosmetic Act of 1938
New drug could not be marketed until proven safe.
Kefauver-Harris Amendment of 1962 (Drug Efficacy Amendment)
New drugs to be proved effective as well as safe. Transferred prescription advertising jurisdiction from FTC to FDA. Required all advertising carry labeling on possible side effects. Established GMP requirement, registration with FDA by manufacturers, recordkeeping requirements, regular inspections, animal testing before human testing, informed consent of research subjects before participating in clinical trial, reporting of ADEs.
Can Medigap policies that are produced now provide drug coverage?
No
Is reconstitution considered compounding?
No
Under DQSA exemption 503A, can certified technicians and pharmacy interns compound prescriptions?
No
Is there a deadline to refill a CS from the day of issuance per fed law?
No - it's only specific to state
Legally, can a pharmacy student intern transfer a CS rx to another pharmacist?
No - must be two pharmacists
Should pharmacy submit initial and biennial inventory to DEA?
No - not required
Are USP <795> and <797> "law"?
No - unless a state has incorporated it into their laws
How many timese may a CV rx be refilled?
No limits
Dietary Supplement Health and Education Act of 1994
No premarket approval required if manufacturers of dietary supplements follow GMPs and do not make structure or function claims that indicate the dietary supplement is intended to diagnose, treat, cure, prevent any disease; otherwise, would require FDA approval.
CII prescription refills
No refills permitted for CII.
Can a chain pharmacy, after notifying the board, maintain CS inventory records and executed 222 forms at a central location?
No!
Is it legal for a pharmacist to provide a limited quantity of a drug without a valid prescription or authorized refill?
No, although it is often done anyway as an emergency supply. ect.
Can prescribers forward date prescriptions to prevent them from being filled early?
No, the written date must be on the prescription. They can write "do not dispense until XXX" and this is valid
Does the following statement violate dietary supplement structure/function claims under DSHEA: "Vitamins in orange juice have been determined by the American Heart Association to help prevent heart disease"
No, this statement does not violate the DSHEA because it is validated by science
Can an LTCF return a resident's unused controlled substance medication to a pharmacy?
No. There are no provisions in the Controlled Substances Act for a DEA registrant (i.e., retail pharmacy) to acquire CS from a non-registrant (i.e., resident of an LTCF). Most LTFCs are not licensed by their respective state to handle CS and, therefore, are not registered with DEA. LTCFs act in a custodial capacity, holding CS that, pursuant to a prescription, have been dispensed to and belong to the resident of the LTCF. Federal laws and regulations make no provisions for CS that have already been dispensed to patients, regardless of the packaging method, to be returned to a pharmacy for further dispensing or disposal.
Do all drugs on the US market have an NDA?
No. Pre-1938 drugs were grandfathered.
Pseudoephedrine Laws: Packaging
Non-liquid forms (including gelcaps) MUST be in unit dose packaging
Rules for employing a person has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for DEA registration denied, revoked, or surrendered for cause
Not allowed to hire them unless applying for a waiver
Central fill pharmacies are ____ to prepare CII upon oral authorization from retail pharmacist or individual practitioner.
Not authorized.
Prescriptions that exceed a practitioner's prescribing authority are ____.
Not legal prescriptions.
Recall Rules: Class III Recall
Not likely to cause adverse health effects
Are pharmacies required to be registered with the FDA for CGMP compliance?
Not required, but could be inspected in some cases
use/disclosure of de-identified information
Not subject to HIPAA and may be used/disclosed without patient authorization.
Under HIPAA 1996, what is required to be given to the patient on the day services are first provided or upon request?
Notice of Privacy Practices - contains how pharmacy intends to use their information, describes legal duties of provider, a statement of the patient's rights and how to exercise them, how to file a complaint, and a contact within the company to contact with concerns
What must occur with a DEA number when the death of a person, corporation or discontinuation of business occurs?
Notify the DEA and terminate the registration
DEA Form 223
Number of the DEA Certificate of Registration that is displayed at the registrant's location.
What law established federal requirements for medication reviews in nursing homes that receive money from Medicare or Medicaid?
OBRA 87
What bill was passed by Congress in 1990 to include Medicaid pharmacy reimbursement reforms?
OBRA 90
Required manufacturers to pay a rebate to the states based on volume of a drug sold
OMNIBUS Budget Reconciliation Act of 1990
Required pharmacists to Prospective drug use review on each new prescription Offer to counsel patients on each new prescription Obtain and maintain patient information (patient profile/patient history)
OMNIBUS Budget Reconciliation Act of 1990
what law changes how the pharmacist practice
OMNIBUS Budget Reconciliation Act of 1990
what requires manufacturing to provide pharmacuticals to medicaid at thier best price ( the lowest price at which they sell the product to any consumer)
OMNIBUS Budget Reconciliation Act of 1990
How many package sizes is a manufacturer allowed to make in non-PPPA/child resistant packages?
ONE
Recall Rules: FDA Authority
ONLY authority to recall devices, NOT drugs
Drug Facts Panel is part of what drug information
OTC drug information
Requirements of tamper resistant labeling?
OTCs must be labeled with a prominantly placed statement alerting consumers to the spfc tamper resistant feature of the package. Statement must be placed so it will not be affected if the tamper resistant feature is breached or missing
What does OBRA 90 stand for?
Omnibus Budget Reconciliation Act of 1990
How often must hospitals and clinics register with the DEA?
Once every 3 years, in the month assigned
How often must pharmacies register with the DEA?
Once every 3 years, in the month assigned
How often must teaching institutions register with the DEA?
Once every 3 years, in the month assigned
How many times can CIII-V be transferred?
Once unless it's chain stores
Online pharmacy must ____ and afterward, ____ to operate as online pharmacy.
Online pharmacy must be first registered with DEA as pharmacy. After registered as pharmacy, must apply for modification of registration to operate as online pharmacy.
Legally, a pharmacy can transfer CS rx information for refill purposes.
Only for CIII, CIV, and CV - can only transfer once
Can compounding be preformed in advance?
Only if it is based on previous prescription orders for the compounded drug
Behind-the-counter drugs may be sold by ____.
Only pharmacists.
What are the 2 options for CS paper recordkeeping?
Option #1: 3 separate files (CII, CIII-CV, non-C) Option #2: 2 separate files (CII, CII-CV with 1" red C stamp on bottom R corner + non-C together)
What devices/meds need to be dispensed with a patient package insert (ppi) EVERY TIME or else it's misbranding?
Oral Contraceptives intrauterine devices estrogen products progestrin-containing products
Dietary Supplements under Dietary Supplement Health and Education Act of 1994 must be used for what route
Oral ingestion
requirements for faxed prescriptions for CII
Original written (paper or electronic) signed prescription must be presented to pharmacist for review prior to actual dispensing of controlled substance. Faxed prescriptions for CII may be used as the original prescription without follow-up written prescription if: --Compounded for direct administration to patient by parenteral, IV, IM, SC, or intraspinal infusion. --For resident of LTC facility. --For patient in hospice care program certified and/or paid for by Medicare or in hospice program licensed by state.
Designed to encourage drug manufacturers to develop and market Rx drugs for conditions affecting fewer than 200,000 patients in the United States
Orphan Drug Act of 1983
Which legislation provides tax and licensing incentives to manufacturers to develop drugs used to treat rare diseases?
Orphan Drug Act of 1983
What event triggered the passage of DQSA of 2013?
Outbreak of fungal meningitis from products compounded and distributed by the New England Compounding Center (NECC) in 2012
What is the first letter of a DEA number for a distributor?
P or R
What is the maximum allowable amount of an opium CV that can be dispensed without an rx?
PER 48 HOURS: -NMT 240 mL -NMT 48 dosage units
What is the maximum allowable amount of a CV (i.e. cough syrup) that can be dispensed without an rx?
PER 48 HOURS: -NMT 120 mL -NMT 24 solid dosage units
What qualifications must a mediation meet in order to be OTC?
Panel review as safe and effective for use by consumers without a prescription
Written prescriptions include ____.
Paper and electronic.
Covers a portion of hospital charges including inpatient drug therapy Provided at no cost to the patient/beneficiary
Part A
Covers a portion of physician charges and some outpatient diagnostic/ treatment services and some drugs that a patient can not self-administer Voluntary program that costs patients about $115/month
Part B
An alternative to Parts A & B & D provided by managed care plans (HMOs) The plans are called "Medicare Advantage"
Part C
Provides coverage for outpatient prescription drug therapy Voluntary program administered through private insurance companies with various monthly premiums based on co-payments/deductibles and drugs covered
Part D
Requires insurance companies to provide coverage for Medication Therapy Management (MTM) services to patients taking multiple drugs that will exceed an annual cost determined by HHS
Part D
prescription of the dual eligible ( medicare and Medicaid) are covered through----
Part D
What does "PPI" stand for in regards to package labeling?
Patient Package Insert
Required by FDA to warn/educate patients of risks with certain drugs
Patient Package Inserts (PPI)
Canadian Personal Use Exemption
Patients transporting FDA-approved prescription drugs from Canada into US in quantity NTE 90-day supply. Not a controlled substance or biological product.
What must a pharmaceutical manufacturer do to obtain an additional six months of market exclusivity? According to which legislation?
Pediatric studies. FDA Modernization Act of 1997
What is the overall goal of HIPAA 1996 with regards to accountability?
Penalties provided for those that do not meet the law's requirements
long-term detoxification treatment
Period more than 30 days but not in excess of 180 days.
short-term detoxification treatment
Period not in excess of 30 days.
HIPAA policies and procedures in the pharmacy
Pharmacies must identify privacy officer to oversee pharmacy's compliance programs. Must train personnel. Must provide and enforce sanctions against employee who violates.
Prescription that is noncompliant with Tamper-Resistant Prescription Law can be filled if ____.
Pharmacist fills on emergency basis provided that the pharmacy obtains compliant prescription within 72 hours of fill date. Compliant prescription may be in the form of written prescription on tamper-resistant paper or may be obtained by verbal communication with prescriber by fax or e-prescription.
permissive substitution
Pharmacist may choose to substitute less expensive generic for brand-name drug only if prescriber writes prescription in a way that permits substitution.
Requirements for acknowledgement of receipt of "Notice of Privacy Practices" include ____.
Pharmacist must make good faith effort to obtain written acknowledgement of receipt of "Notice of Privacy Practices" from patient. If cannot be obtained, must document efforts to obtain and reason acknowledgement was not obtained. Pharmacist may not refuse to treat a patient who refuses to sign the acknowledgement.
If prescribing individual practitioner fails to deliver written prescription for emergency quantity of CII orally prescribed, ____.
Pharmacist must notify nearest DEA office.
What must the pharmacist do if a prescriber fails to deliver a written prescription within 7 days, after authorizing an oral emergency CII rx?
Pharmacist must notify the nearest DEA office
mandatory substitution
Pharmacist required to substitute less expensive generic for brand-name drug unless prescriber indicated to "Dispense as written" or similar notation.
refill requirements
Pharmacists should note refills on back of written prescription or by other recording method, such as computer system. Pharmacist May not refill prescription unless specific authorization oral or written from authorized prescriber. Secretary can communicate refill or new prescription authorization but pharmacist should confirm that someone who has prescribing authority has actually authorized. Prescribers may limit number of refills.
What is the purpose of pharmacists screening rx's before dispensing, mandated by OBRA 90?
Pharmacists will detect potential problems i.e. -Therapeutic duplication -Drug-disease contraindications -Drug-drug interactions -Incorrect doses and durations -Allergy interactions -Abuse and misuse
What government agency/law controls pharmacy and pharmacist advertising?
Pharmacy Practice Acts
Pharmacy may dispense controlled substances pursuant to electronic prescription if ____.
Pharmacy application approved by third-party auditor or certification organization that has found it to conform to regulations.
How does a pharmacy obtain a DEA Form 222 if they wish to return a CI or CII item to the manufacturer or distributor?
Pharmacy must notify the manufacturer/distributor and they will send the 222 form with the quantity and amounts recorded
central fill pharmacy
Pharmacy permitted by law in the state in which it is located to prepare valid prescription orders for controlled substances transmitted from registered retail pharmacy and to return labeled, filled prescriptions to retail pharmacy for delivery to ultimate user. Authorized to fill on behalf of retail pharmacy only if contractual relationship.
Requirement to mark hard copy prescription with red "C" waived if ____.
Pharmacy uses computer application for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber name, patient's name, drug dispensed, and date filled.
Drug is tested on a small number of healthy people to establish safety what phase ?
Phase I
Which phase during clinical trials is intended to evaluate pharmacokinetics and toxicology of a new drug?
Phase I
Drug is tested on a limited number of sick people to test its efficacy and safety what phase ?
Phase II
Which phase during clinical trials evaluate efficacy, but also to help determine appropriate dosing, risk of ADRs, etc?
Phase II
Drug is tested on a large number of sick people to establish safety and efficacy what phase ?
Phase III
Participants in clinical trials must give informed consent Oral consent is permissible in Phase -------``
Phase III
Which phase during clinical trials are likely to be randomized double-blinded, placebo controlled trials?
Phase III
After drug is approved manufacturer will do post-marketing surveillance what phase ?
Phase IV
What does Medicare part B cover?
Physician services
Compounding REQUIRES relationships between which 3 persons?
Physician, patient, pharmacist
safety closure under what act
Poison Prevention Packaging Act of 1970
What is the PPPA? When was it enacted?
Poison Prevention Packaging Act of 1970
To obtain a supply of controlled substances for general dispensing to patients, practitioner may not ____ but may ____.
Practitioner may not obtain supply of controlled substances by issuing prescription for general dispensing to patients. Practitioner may purchase from pharmacy, manufacturer, or wholesaler using invoice and receipt.
prescription requirements for gamma-hydroxybutyric acid (GHB)
Practitioner must note on face of prescription the medical need of the patient for the prescription.
Registered practitioner may dispense and prescribe FDA-approved CIII-V narcotics for use in maintenance or detoxification treatment without obtaining separate registration as OTP if ____.
Practitioner qualifies under DATA.
Chemical Diversion and Trafficking Act of 1988
Precursor chemicals, essential chemicals, tableting and encapsulating machines commonly used in illegal manufacture of controlled substances placed under federal control by imposing recordkeeping and import/export reporting requirements on transactions involving these materials.
What is the difference between repackaging and prepackaging?
Prepackaging is when a pharmacy packages drugs from manufacturer's container to a customized unit dose or other type of unique dispensing systems for direct patient use
Prescribing Methadone: Prescriber Requirement for Maintenance or Detoxification
Prescriber MUST be registered with DEA as a Narcotic Treatment Program (NTP) *If indicated for pain, Federal law does not restrict methadone prescribing
Schedule III - V Controlled Substances: Refill Authorization
Prescriber allowed to orally authorize refill, BUT cannot exceed 5 refills in a 6 month time period from the date of the ORIGINAL prescription
Only ppl authorized to receive samples? How?
Prescribers They must make written request
Bans the reimportation of Rx drugs manufactured in the U.S. once the drugs are exported
Prescription Drug Marketing Act of 1987
Requires states to license drug wholesalers Bans the sale of Rx drug SAMPLES
Prescription Drug Marketing Act of 1987
Prohibits pharmacies in the U.S. from purchasing Rx drugs from Canadian wholesalers, even if drugs were manufactured in U.S. (A pharmacy is never permitted to purchase non-FDA approved drugs from another country)
Prescription Drug Marketing Act of 1987
Prohibits the resale of Rx drugs purchased by hospitals or HMOs
Prescription Drug Marketing Act of 1987
Which legislation regulated prescription drug sample distribution?
Prescription Drug Marketing Act of 1987
Which legislation required federal licensing of wholesalers and prohibited resale of prescription drugs purchased by hospitals?
Prescription Drug Marketing Act of 1987
What does PDMP stand for?
Prescription Drug Monitoring Program
A fee was required with every New Drug Application (NDA) or Supplemental NDA filed with the FDA.
Prescription Drug User Fee Act of 1992
Medicare Prescription Drug Improvement and Modernization Act of 2003 (Medicare Part D)
Prescription drug and preventive health care benefits added to Medicare. Donut hole limits benefits: seniors had to pay 100% of drug costs above $2250 until they reached $3600 out-of-pocket and then Medicare would pay 95% of drug costs. Affordable Care Act minimized impact of donut hole. Electronic prescriptions authorized. Allow wholesale importation of drugs from Canada only if Secretary of HHS certifies that program would pose no additional risk to public health and safety and would significantly reduce prescription drug costs.
What does Medicare part D cover?
Prescription drugs
When may or may not a prescription be issued for maintenance or detoxification treatment?
Prescription may not be issued unless by qualifying prescriber under DATA for FDA-approved drug for that purpose.
Products that can not be taken safely without medical supervision regardless of how much information or labeling the patient is given
Prescription/Legend/Non-Proprietary Drugs
Federal Antitrust Laws
Prevents individual competitors from entering agreements that reduce competition and affect consumer interest in cost containment.
Which area of health information targeted by HIPAA 1996 is the greatest concern for pharmacists?
Privacy regulations
What's required on the label of OTC products?
Product name Manufacturer or distributer name and address List (not amount) of all active and inactivei ingredients Amount of contents (#) Adequate warnings Adequate directions for use
Behind-the-counter placement includes _____.
Product stored in locked cabinet in area of facility where customers do not have direct access. Mobile retail vendors must store products in locked cabinet.
Other requirements of Combat Meth Act?
Products must be placed behind counter or in locked cabinet Log book must be maintained by seller Purchaser must present photo ID All non-liquid forms must be blister packed Must train staff about requirements and tell AG
What does "PI" stand for in regards to package labeling?
Professional Package Insert
Pure Food and Drug Act of 1906
Prohibit manufacture, sale, delivery, holding, or offering for sale of misbranded and adulterated food, drug, device, tobacco, or cosmetic. Prohibit false efficacy claims.
Returning Controlled Substances to Pharmacy
Prohibited; patient must dispose of the drug
Delaney Clause (Anticancer Clause)
Prohibits approval of food additives that might cause cancer.
Anti-Kickback Statute
Prohibits from knowingly and willfully solicity, receiving, offering, paying any remuneration in exchange for inducing referrals or furnishing any goods or services paid for by Medicare or Medicaid.
False Claims Act
Prohibits from knowingly presenting false/fraudulent claim to federal government for payment. Prohibits making/using false record or statement to get false claim submitted to federal government paid or approved.
What is the overall goal of HIPAA 1996 with regards to administrative simplification?
Promotion of electronic health care transactions
Information such as advertising that does not accompany the container. Must give "fair balance" of risks vs. benefits
Promotional Labeling
The Med-Guide must provide information on:
Proper use and when product should not be used Serious adverse reactions that may occur
What is a PDR?
Prospective drug review
components of DUR under OPRA 90
Prospective drug use review on each new prescription Offer to counsel patients on each new prescription Obtain and maintain patient information (patient profile/patient history)
Federal Food, Drug & Cosmetic Act: Purpose
Protect public health by requiring SAFE, EFFECTIVE and PROPERLY LABELED drugs and devices
What does PHI stand for in HIPAA 1996?
Protected Health Information
Health Insurance Portability and Accountability Act (HIPAA)
Protects PHI and imposes penalties on covered entities that make unauthorized disclosures of PHI.
To issue a prescription for maintenance or detoxification treatment, a qualifying practitioner under DATA must ____.
Provide identification number issued by Attorney General after certification by Secretary of HHS. If within 45-day application period, written statement that prescriber is acting under good faith belief that practitioner qualifies under DATA, that practitioner has applied for number, that the Secretary will certify practitioner, and identification number will be issued.
How must institutions comply with the FDA requirements for patient package insert ("PPI")?
Provide leaflet to patient upon administration of first dose, and then once every 30 days
smurfing
Purchasing products containing ephedrine, pseudophedrine, phenylpropanolamine from many different pharmacies that maintain only written logbooks.
What act Prohibited adulteration and misbranding of foods and drugs in interstate commerce
Pure Food & Drug Act of 1906
This law prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded.
Pure Food and Drug Act of 1906
Which legislation prohibits adulteration or misbranding of foods and drugs?
Pure Food and Drug Act of 1906
How often must a pharmacy take inventory of it's CS?
Q2 years
How often must opioid treatment programs become re-accredited and re-certified?
Q3 years
Companies that provide patients with educational materials, including a Medication Guide, that use consumer friendly language to explain both safe usage and disposal is a provision of what act?
REMS program
Educating prescribers about proper pain management, patient selection, and improving patient awareness about how to use the agents safely is contained in what information?
REMS program for long acting and extended release opioid medications
Recall Rules: Class I Recall
Reasonable probability to cause serious adverse health effects or death
Incidental disclosure of PHI to permitted use or disclosure is not a violation of HIPAA if ____.
Reasonable safeguards have been taken to protect PHI.
adulteration
Referring to composition/purity. (1) Contains filthy/putrid/decomposed substance, unapproved color additive, ingredient as substitute for active drug. (2) Prepared/packaged/held under unsanitary conditions. (3) Manufactured under conditions that do not meet GMP standards. (4) Contains drug recognized in official compendia but strength/purity/quality lower than official standards unless plainly stated on label. (5) Contains drug not recognized in official compendia but strength/purity/quality lower than listed on label. (6) Container composed of poisonous/deleterious substance that may leach into product contents.
misbranding
Referring to labeling. (1) False, misleading. (2) Missing name or location of manufacturer/packer/distributor. (3) Does not contain a word, statement, information required by law displayed in prominent, readable manner. (4) Does not include established name of active drug. (5) Does not have each active ingredient and its quantity identified (unless prescription not for human use). (6) Does not have each inactive ingredient listed in alphabetical order (unless prescription not for human use or nonprescription cosmetic). (7) Does not state "Rx only" if drug available only by prescription (unless prescription dispensed to consumers). (8) Does not contain precautionary statement concerning drug subject to deterioration. (9) Missing accurate statement of quantity of contents in terms of weight, measure, numerical count (reasonable variations permitted and exemptions for small packages). (10) Inadequate directions for use of nonprescription drugs or does not include appropriate warnings required to protect those using medication or packaging. (11) Inadequate information for use (prescription drugs). (12) Does not conform to requirements as prescribed in official compendium if listed. (13) Offers sale of drug under name of another drug. (14) Offers sale of imitation of another drug. (15) Prescribes, recommends, suggests dosage dangerous to health. (16) Does not conform to requirements for packaging and labeling of color additives. (17) Does not include all advertisements and other descriptive material required for prescription drugs (information for use). (18) Container misbranded. (19) Manufactured, prepared, propagated, compounded, processed in establishment not duly registered under applicable law. (20) Not manufactured using tamper-evident or tamper-resistant packaging as required by law. (21) Does not conform to PPPA of 1970. (22) Pharmacy dispenses prescription-only drug without legal prescription or authorized refill.
Adultered
Refers to actual makeup or composition of drug
Misbranded
Refers to drug labeling
A pharmacy that repackages OTC products or changes the container/wrapper/labeling in any way for resale must ____.
Register as a manufacturer.
DEA Form 106
Registrant must complete and submit to report theft or loss of controlled substances.
Advertising Regulation: Prescription Drugs
Regulated by FDA
Advertising Regulation: OTC Drugs
Regulated by Federal Trade Commission
Combat Methamphetamine Epidemic Act of 2005
Regulates OTC sale of any product containing precursors to methamphetamine by placing them into new category of CSA known as "scheduled listed chemical products". Precursors include ephedrine, pseudophedrine, phenylpropanolamine.
FDA Modernization Act of 1997
Regulatory procedures to ensure expedited availability of safe and effective drugs and devices. Increased FDA public accountability. Compliance plan in consultation with industry representatives, scientific experts, health care professionals, consumers. Fast-track approval for drugs for serious or life-threatening diseases. Replaced legend "Caution: Federal law prohibits dispensing without a prescription" with "Rx only". Clarified conditions under which pharmacists may perform extemporaneous compounding of prescriptions. Pharmacists exempt from GMP standards and NDA requirements. Data bank for clinical trial information. Authorized scientific panels to review clinical investigations. Rights of manufacturers to disseminate unlabeled use information and require specification that such use is not FDA approved. Encourage manufacturers to conduct research for new uses of approved drugs and submit SNDAs for these uses. Eliminated manufacturer requirement that certain substances carry label "Warning--May be habit forming". OTC ingredient labeling requirements for inactive ingredients and preempted states from establishing labeling requirements for OTC drugs and cosmetics when federal requirements exist. Mandated priority review for breakthrough technologies for medical devices. Allow FDA to contract with outside scientific experts for review of medical device applications. Allowed investigational new drug to be accessible outside clinical trial to treat patients with immediate or life-threatening diseases for which no satisfactory alternative is available if reasonable basis to conclude that drug may be effective and would not expose patients to unreasonable and significant risk.
A physician who is not specifically registered to conduct a narcotic treatment program may administer, but not prescribe, narcotic for purpose of ____. Not more than ____ may be administered for maximum of ____.
Relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. Not more than 1 day's medication administered at 1 time for maximum of 3 days.
DEA Form 224a
Renewal application that DEA mails to registrants approximately 60 days before expiration of DEA Certificate of Registration.
What other activities (besides compounding) could place a pharmacy into the realm of being considered a manufacturer, wholesaler, repackager, distributor, outsourcing facility, etc.?
Repackaging of drugs, resale or distribution of products, etc.
Pharmacist must report to DEA any unusual or excessive loss or disappearance of scheduled listed chemical product. Report must be ____ and ____ must be filed within ____.
Report must be made orally, if possible, as soon as possible, and written report must be filed within 15 days after pharmacist becomes aware of loss.
Prescription Drug User Fee Act of 1992
Require manufacturers to pay fees for applications and supplements when FDA reviews clinical studies. Provide revenues to hire additional reviewers to speed up NDA reviews.
DEA Form 222
Required for sale or transfer of Schedule I or II controlled substances
What provision was established in OBRA 90 as a requirement for Medicaid programs?
Required states that participate in Medicaid to establish a mandatory counseling program for prescriptions provded Medicaid eligible beneficiaries at the point of sale
Drug Supply Chain Security Act
Requirements for tracing prescription drug products through pharmaceutical supply distribution chain.
Color Additives Amendment of 1960
Requires manufacturers to establish safety of color additives. Contains anticancer clause prohibiting approval of any color additive that might cause cancer.
Poison Prevention Packaging Act What did it require?
Requires that ORAL drugs for use in humans be dispensed in child resistant/safety packaging.
What is the term to describe the switching of hydrocodone products from CIII to CII?
Rescheduling
When retail pharmacies contract with private, common, or contract carriers to retrieve filled prescriptions from central fill pharmacy, ____ is responsible for reporting in-transit losses upon discovery of such loss.
Retail pharmacy is responsible for reporting by use of DEA Form 106.
If prescription for controlled substance is filled at a central fill pharmacy, central fill pharmacy must affix to the package a label showing ____.
Retail pharmacy name and address and unique identifier (central fill pharmacy's DEA registration number) to indicate that prescription was filled at central fill pharmacy.
Drug Use Review (DUR) components include ____.
Retrospective review. Educational programs. Prospective review.
What does REMS stand for?
Risk Evaluation and Mitigation System/Strategies
What are exceptions to the anti-tampering act?
SL NTG SL/chew Isosorbide dinitrate < 10 mg Erythromycin granules < 8 g Oral contraceptives in manufacturer's package K supplements < 50 mEq Sodium Fluoride < 264 mg Prednisone in packs w/ < 105 mg total some others
ANDA or SNDA: new indication
SNDA
Define OTC drug
Safe to use without medical supervision and when accompanied by "adequate directions for use"
Phase 1 clinical trials primarily assess what? How many patients are tested?
Safety, small group
Supplemental New Drug Application (SNDA)
Same company submits change to approved drug.
Substances in this schedule have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision.
Schedule I Controlled Substances (Some examples of substances listed in schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine ("ecstasy").)
What are the classes of controlled drugs?
Schedule I-V
Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.
Schedule II Controlled Substance (Examples of single entity schedule II narcotics include hydrocodone, morphine and opium, hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®), and fentanyl (Sublimaze® or Duragesic®). Examples of schedule II stimulants include: amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®). Other schedule II substances include: cocaine, amobarbital, glutethimide, and pentobarbital.)
Substances in this schedule have a potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.
Schedule III Controlled Substance (Examples of schedule III narcotics include combination products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with codeine®). Also included are buprenorphine products (Suboxone® and Subutex®) used to treat opioid addiction. Examples of schedule III non-narcotics include benzphetamine (Didrex®), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin®).)
Substances in this schedule have a low potential for abuse relative to substances in schedule III.
Schedule IV Controlled Substance (Other schedule IV substances include: alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).)
Substances in this schedule have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. These are generally used for antitussive, antidiarrheal, and analgesic purposes.
Schedule V Controlled Substance (Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC® and Phenergan with Codeine®).)
What is the law that regulated CS disposal by the patient/ultimate user?
Secure and Responsible Drug Disposal Act of 2010 (aka Disposal Act)
What must be written on the original, signed, written rx for an emergency CII, in addition to meeting all CII requirements?
"Authorization for Emergency Dispensing" and date of oral order
What does the orange book rating of "AB" mean?
Therapeutically equivalent
Importation of drug products is legal when ____.
There are personal use exceptions. Otherwise, importation is illegal.
What is the time limit to fill a controlled substance according to the DEA?
There is no federal time limit
Prescription drug labeling must contain "adequate information for use" designed for ____ which must include ____. Prescription drugs dispensed by a pharmacist are exempt if they bear a label containing ____.
This information is designed for the health care provide. It includes the following: (1) Indications. (2) Side effects. (3) Dosages. (4) Routes, methods, frequency, duration of administration. (5) Contraindications. (6) Warnings and precautions that enable practitioner to administer/prescribe/dispense safely. Prescription drugs dispensed by a pharmacist are exempt from these requirements if they bear a label containing the following: (1) Name and address of dispenser. (2) Serial number and date of the prescription or fill. (3) Name or prescriber. (4) Name of patient, directions for use, cautionary statements.
Which drugs available at pharmacies today have not been evaluated for their safety?
Those in use before the FDCA of 1938, which have been "grandfathered" in
Prescription records can be filed in by 2 options:
Three separate files File for CIIs, File for CIII,IV, an V, and File for noncontrolled drugs. OR Two separate files File for CIIs, file for all other drugs (controlls must have red "C" stamp not less than 1 inch high or if electronic recordkeeping, then may permit prescription number differences)
Controlled Substance Registrant Protection Act of 1984
To combat threat of robberies, burglarries, violent crimes, mandates federal investigation under following circumstances: --Replacement cost of controlled substances $500+. --Person killed or suffers significant injury as result of crime. --Interstate/foreign commerce involved in planning/execution of crime.
What is the overall goal of HIPAA 1996 with regards to insurance portability?
To eliminate job lock
Why were adulteration laws put in place?
To ensure that drugs are manufactured under conditions that are not PUTRID, FILTHY, OR IMPURE
Why are adulteration provisions included in the FDCA?
To ensure the drugs are manufactured under conditions that are not putrid, filthy, or impure
Why was the REMS program initiated?
To establish formal protocols to communicate information about safety and efficacy concerns with certain medications
What does "marketing" mean, under HIPAA 96?
To make a communication to an individual about a product or service that encourages the individual to purchase or use that product or service
What is the purpose of an SNDA?
To make changes to the information reviewed and approved by the FDA (could be anything really)
child-resistant test panel requirement
To pass child-resistant test, 80% of children under 5 years should not be able to open package within 10 minutes and 90% of adults between 50-70 years should be able to open package within 5 minutes and 2nd time within 1 minute.
What is the primary purpose of the Investigational New Drug Application (IND)?
To prove a new drug is safe for human trials
Where should all DEA Form 41 be sent?
To the DEA
Each regulated seller must ensure that all individuals responsible for delivering products into the custody of purchasers or who deal directly with purchasers by obtaining payments for products are ____. Regulated seller must submit to the DEA ____ and maintain a copy and all records demonstrating.
Trained in regulations governing the sale of schedule listed chemical products. Must submit to DEA self-certification that all such individuals have undergone training.
Under HIPPA Pharmacists may only disclose PHI for
Treatment, Payment, or Health Care Operations (TPO)
Permissible uses and disclosures of PHI without written patient authorization include ____.
Treatment. Payment. Health care operations.
T/F: A company can add any additional information on their prescription labeling to go above and beyond the minimum standards.
True
T/F: A drug can be rendered BOTH misbranded and adulterated
True
T/F: A drug recall is an action taken by a firm to remove a product from the market
True
T/F: A drug that is mixed or packed to reduce quality or strength is adulterated
True
T/F: A manufacturer must be registered with the DEA for each class of controlled substance.
True
T/F: A new NDC is issued to a drug that has been repackaged.
True
T/F: A pharmacist can be found for adulteration of a product if it is not stored properly in the pharmacy (i.e. shelf instead of fridge)
True
T/F: A pharmacist can be found for misbranding of a product if they forgot to include PPI/MedGuide
True
T/F: A pharmacist can be punished criminally if they fail to uphold their responsibilities under CSA
True
T/F: A pharmacist must be aware of potentially improperly prescribed medications and take measures to clarify or correct the problem under CSA
True
T/F: A pharmacist should contact the hospital for verification of DEA # and internal code, if they have any doubts in dispensing such a prescription.
True
T/F: A pharmacist that fills a CS prescription that is knowingly not in the course of professional treatment or legitimate research shall be subject to the penalties provided for violations of the CSA
True
T/F: A prescription issued NOT in the usual course of professional treatment is not a valid prescription within the meaning and intent of the CSA.
True
T/F: A pure drug may be considered adulterated due to how it was prepared, packaged, or stored if it MAY HAVE been contaminated.
True
T/F: A pure drug may be considered adulterated if it was manufactured under conditions not conforming with GMP
True
T/F: An oral prescription must be promptly reduced to writing
True
T/F: CS inventory must be taken either at the beginning of the day or at the close of business
True
T/F: CSOS can be used to order CIII's
True
T/F: CSOS can be used to order CIV's
True
T/F: CSOS can be used to order CV's
True
T/F: CSOS can be used to order non-controlled substances
True
T/F: Central fill pharmacies are recognized by the DEA to package and deliver patient specific prescriptions to another pharmacy to help manage pharmacy's volume
True
T/F: DEA inspector must state the purpose for the inspection with a written notice to which the owner/PIC must consent
True
T/F: DEA is allowed to enter premises of registrants where controlled substances and records are maintained
True
T/F: DEA is allowed to examine and copy any records relating to controlled substance distribution, prescribing, or dispensing
True
T/F: DEA is allowed to inspect the premises of any registrants where controlled substances are maintained
True
T/F: DEA is allowed to inventory controlled substances at the site of registrants
True
T/F: Dispensing generally relates to providing medications through a pharmacy for the person to take away with them for personal use
True
T/F: Electronic transmission of CS Rx information from originating pharmacy to central fill pharmacy is permitted
True
T/F: Every employer or affiliated healthcare setting must be registered with the DEA in order to prescribe controlled substances
True
T/F: Federal funding is available to states to help with statewide electronic databases containing prescription drug monitoring programs.
True
T/F: If a person owns and operates more than one pharmacy, each place of business must be registered.
True
T/F: If a pharmacy uses ADS in a LTC facility, it must follow all provisions for pharmacies, including e-prescribing
True
T/F: If a practitioner practices in more than once state, they will need DEA registration numbers in both states
True
T/F: If an rx is created, signed, transmitted, and received electronically, all records related to that rx must be retained electronically.
True
T/F: Legally, a hospital pharmacy can maintain a CS collection receptacle at a LTC facility.
True
T/F: Legally, a retail pharmacy can maintain a CS collection receptacle at a LTC facility.
True
T/F: Legally, any pharmacy can dispense methadone for analgesic use.
True
T/F: Legally, central fill pharmacies can fill both new and refill rx's.
True
T/F: Midlevel prescribers are registered and authorized by the DEA and state to administer, dispense, and prescribe controlled substances.
True
T/F: Only pharmacies involved with opioid treatment programs can dispense methadone for detoxification or maintenance of addiction
True
T/F: PHI in HIPAA 1996 includes written, oral, and electronic health information
True
T/F: Paper DEA Form 222's can only be used to order CII's
True
T/F: Pharmacies are exempt from registering as manufacturers under DQSA 503A if they do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail
True
T/F: Pharmacies that use ADS are exempt from the 5% restriction on transfer of CS inventory
True
T/F: Pharmacists share a responsibility for solving the rx drug abuse and diversion problem
True
T/F: Physicians may administer a one-day supply of methadone outside of the opioid treatment program
True
T/F: Prior to opening a new pharmacy, an inventory of ALL CS must be taken.
True
T/F: Professional Package Inserts must accompany every prescription drug product and include essential scientific and medical information needed for safe and effective use of the drug by healthcare professionals.
True
T/F: Recalls may be conducted on a firm's own initiative
True
T/F: Restrictions on controlled substances do not apply to CV drugs under DEA requirements.
True
T/F: Sudafed log book recording sales must be kept separate from all other log books.
True
T/F: Sudafed must be sold in blister packs?
True
T/F: The DEA must approve transfers or assignments of DEA numbers per a written request.
True
T/F: The DEA pre-prints DEA Form 222's with the name, address, DEA number, and schedules of CS that may be ordered or handled
True
T/F: The FDA can ask manufacturer's to recall drugs from the market if found to be misbranded or adulterated
True
T/F: The FDA can seize all adulterated drugs during a CGMP inspection.
True
T/F: The FDA permits certain health claims for supplements, as long as certain scientific agreement exists for claim.
True
T/F: To reduce waste associated with unused meds for terminally ill patients, a pharmacy legally can partially fill controlled substance rx's
True
T/F: Under DEA, no quantity or time limit exists for dispensing CII's.
True
T/F: Under DEA, prescriber must determine that there is no undue risk of diversion or abuse, before prescribing up to a 90 day supply of a CII.
True
T/F: a prescription drug is considered misbranded if it is dispensed without the legend "Rx only"
True
T/F: a prescription drug must be dispensed via a written or oral prescription
True
T/F: an individual can bring actions against a manufacturer for false/misleading advertisements.
True
T/F: drugs provided to residents of nursing homes and LTC facilities are considered dispensed to a patient
True
T/F: each entity must provide separate DEA for each site where it conducts business with controlled substances
True
T/F: A DEA registrant may deliver CI or CII substances to other DEA registrants (i.e. "can I buy it from you?").
True -IF the registrant is permitted to dispense, < 5% units/year -Must use DEA Form 222
T/F: The DEA permits emergency dispensing of oral CII prescriptions in retail pharmacies. What stipulations exist?
True -Quantity prescribed is limited to the amount necessary to treat the patient for the emergency period -Rx must be reduced to writing immediately by a pharmacist -Rx must contain all necessary information (except signature)
T/F: A pharmacy can use and disclose PHI for "TPO" under HIPAA 96
True - T: treatment P: payment O: operations
T/F: During a CS inventory, estimate counts of CIII are acceptable.
True - EXCEPT if container > 1000 tablets
T/F: Dispensing pharmacists/pharmacies can be exempt from extensive labeling requirements
True - IF labeling.... -Meets requirements of the state -Is not false or misleading -Packaging and labeling conform to official compendia standards -Drugs packaged and labeled appropriately -Drug is packaged in conformance with the Poison Prevention Packaging Act (when required)
T/F: Pharmacies must include an FDA mandated side effects statement for all dispensed Rx drugs, and it must be provided on the vial.
True - Must contain the statement: Call your doctor for medical advice about side effects. You may also report side effects to 800-FDA-1088. False - can be on vial cap, CMI leaflet, or MedGuide also
T/F: Pharmacies can manufacture and distribute narcotic substances to other practitioners without providing registration.
True - ONLY IF preparation is aqueous, oleaginous solution, or solid dosage form - and ONLY IF narcotic preparation does not exceed 20% of the complete product
T/F: Under the PPPA of 1970, a new vial must be used for each prescription filled
True - can reuse glass containers
T/F: A new class of controlled substances was created to control methamphetamine.
True - class of drugs is called "schedule listed chemical product"
T/F: Some specific drug products have specific labeling requirements for their labeling.
True - examples: ipecac, isporoterenol
T/F: Legally, a pharmacy can dispense 40mg strength of methadone for purposes of pain management
True - however the healthcare team has a voluntary agreement not to use this dosage strength for pain (40 mg not approved for pain)
T/F: States have their own authority to place drugs into stricter categories that what the Attorney General recommends.
True - i.e. numerous states place Sudafed as CIII
T/F: Even if a state passes a low to approve medical use of Schedule I drugs (i.e. Marijuana), the DEA could charge with violation of federal law.
True - if not recognized by CSA
T/F: An OTC product marketed specifically for the elderly/disabled is exempt from PPPA requirements.
True - if there is proper notation that the packaging is not child-resistant
T/F: Researchers may legally conduct experiments with Schedule I drugs
True - if they register with the DEA
T/F: Pharmacies not registered with the DEA as on-line pharmacies cannot fill prescriptions for controlled substances from prescribers associated with online pharmacies.
True - not knowingly
T/F: A digital certificate is required to use CSOS for EACH location
True - required for each location with a DEA registration - each pharmacy will need their own
T/F: Legally, pharmacies can dispense CIII, IV and V opioids for the outpatient treatment of narcotic addiction
True - suboxone and subutex
T/F: Legally, prescribers can prescribe CIII, IV and V opioids for the outpatient treatment of narcotic addiction
True - suboxone and subutex
T/F: Controlled substance E-Rx's from systems that do not comply with DEA rule are considered paper rx's
True - therefore doesn't contain a signature and not valid
T/F: CS labeling requirements do not apply if drug is prescribed for administration to an institutionalized ultimate user
True - this is considered a medication order
T/F: If the department of HHS finds that a drug should not be controlled, the Attorney General must comply.
True - unless there is a finding of imminent hazard to the public safety
T/F: A DEA registrant may deliver controlled substances to other DEA registrants (i.e. "can I buy it from you?").
True -IF the registrant is permitted to dispense and dosage units < 5% of total units of controlled substances dispensed/year
T/F: Under HIPAA, refill reminders from pharmacies are considered marketing.
True however HIPAA has made this an exception to the marketing clause
T/F: solid oral drugs must be marketed with an imprint that permits identification
True: this applies to both Rx and OTC drugs, there are exceptions where this is impractical (ex: sublingual nitrogen)
Which end of the chemical classification of drugs (type 1 to 6) refers to the most difference from existing drugs?
Type 1
approval process - chemical classifications
Type 1: new molecular structure from existing drugs used for therapeutic purpose; new and unique. Type 2: new derivative of molecular structure already approved in US. Type 3: new formation of drug already marketed in US. Type 4: new combination. Type 5: new company manufactured drug. Type 6: new indication for already approved drug. Type 7: already marketed without approved NDA. Type 8: OTC switch. Type 10: new indication submitted as distinct NDA, not consolidated. No type 9.
approval process - review classifications
Type P: priority; no other effective drugs available for particular illness or significant advantage over currently marketed drugs. Type S: standard; similar to others currently on the market. Type O: treats rare disease.
____ has the authority to add drugs to, transfer drugs between, remove drugs from schedules by ____ from ____. What is the exception to this?
US Attorney General has the authority but must request scientific and medical evaluation from the Secretary of HHS. The exception is when the Attorney General finds scheduling a substance in schedule I is necessary to avoid imminent hazard to public safety and may do so temporarily without obtaining recommendation from the Secretary of HHS.
This compendia contains mongraphs of recognized drugs that include the chemical characteristics and standards of quality.
USP/NF
If a drug is in both the USP/NF and HPUS, which standards must it meet?
USP/NF (unless distinctly marketed as a homeopathic drug)
Who publishes the United States Pharmacopoeia/National Formulary (USP/NF)?
USPC (US Pharmacopoeia Convention)
In the "closed loop" distribution process of controlled substances, every entity must register with the DEA except:
Ultimate consumer
The drug/dosage form/strength has not been approved by the FDA. Illegal to ship in interstate commerce
Unapproved Drug
The responsibility of designating generic names is held by ____ and approved by ____.
United States Adopted Names Council (USANC) and Secretary of HHS gives final approval.
How long must new and old DEA certificates be maintained?
Until expiration. Never throw away an old one; keep it or return it.
What is the maximum days supply that a prescriber can prescribe of C2s?
Up to a 90 days supply, can write multiple prescriptions
What types of drugs are class 3 recalled drugs?
Use or exposure is unlikely to cause serious adverse health consequences
DEA Form 222a
Used to obtain DEA Form 222 to order CI-II. To obtain forms, registrant must request in writing from local DEA office.
DEA Form 363
Used to register for narcotic treatment programs.
DEA Form 225
Used to register under CSA for manufacturers, wholesalers, distributors, importers/exporters, research.
DEA Form 41
Used to return, dispose, or destroy drugs per DEA approval. 3 copies of the form must be submitted to the local DEA office.
DEA Form 104
Used to surrender controlled substances/permit on a voluntary basis. Usually used to close a pharmacy.
Schedule 5 Description
Usually preparations containing limited quantities of narcotics (cough/cold products w/codeine)
What must be written on the face of the rx when transferring a CS rx?
VOID
Drug Quality and Security Act of 2013 (DQSA)
Voluntary registration with FDA for facilities that compound drugs outside traditional pharmacy practice as outsourcing facility exempt from registering as manufacturer and other FDA requirements. Registered outsourcing facilities are subject to risk-based inspection schedule.
Another name for the Drug Price and Competition Patent Term Restoration Act
Waxman-Hatch
MedGuide requirement
When mandated for a specific drug by FDA, required to be dispensed to outpatients for new and refill prescriptions. Manufacturer is responsible for providing MedGuides to dispensers.
If a pharmacy is partially filling controlled substance rx's for a terminally ill patient to reduce waste associated with unused meds, when must all of the medication be dispense / when does the prescription become terminated/expire?
Within 60 days
When must a pharmacy provide the balance of a partial filled CII rx?
Within 72 hours
What is required of an individual under HIPAA, before PHI can be sold or used for marketing?
Written authorization by the individual
Unlawful to distribute CI-II except pursuant to ____ or ____. Exceptions include ____.
Written order on DEA Form 222 or Controlled Substance Ordering System. Exceptions include lawful exportation and delivery to common carrier in lawful and usual course of business or delivery to/by warehouseman for storage in lawful and usual course of business.
Tamper-Resistant Prescription Law
Written prescriptions (excluding electronic, oral, faxed) for Medicaid-covered outpatient drugs must be issued on tamper-resistant paper. Prescription form must be designed to prevent unauthorized copying of completed or blank prescription pad, erasure or modifications of information written on prescription pad by prescriber, and use of counterfeit prescription forms. If prescription form does not comply, pharmacist may fill on emergency basis provided that the pharmacy obtains compliant prescription within 72 hours of fill date. Compliant prescription may be in the form of written prescription on tamper-resistant paper or may be obtained by verbal communication with prescriber by fax or e-prescription.
Definition of a "label"
Written, printed, or graphic material upon the immediate container of any article (includes container or wrapper)
What is the first letter of a DEA number for a certified practitioner prescribing suboxone for opioid addiction?
X
can compounding pharmacies make small/reasonable quantity in anticipation of receiving a prescription ?
YES
Does the patient have to request a non-child resistant container?
YES! Can't dispense in non-resistant container unless they actually ask for it.
Who determines if a loss of controlled substances is significant?
YOU! The pharmacist!
Are manufacturer's required to be registered with the FDA for CGMP compliance?
Yes
Can a drug also be a cosmetic?
Yes
Legally, are automated dispensing systems permitted in LTC facilities?
Yes
Are postmarking studies required? How is new information gathered (2 ways)?
Yes 1. Manufacturer collects data 2. FDA MedWatch program
Legally, can a pharmacist dispense a controlled substance without a prescription?
Yes - Only CV's
Legally, can a CIII rx be partially filled?
Yes - as long as it meets requirements of refilling - as long as total quantity dispensed does not exceed total quantity prescribed
Legally, can a manufacturer distribute peer-reviewed articles with information about unlabeled uses to PBMs/healthcare practitioners/govt agencies?
Yes - as long as the information is not influenced by the company
Legally, can a technician sell a prescription for a CV without a rx (i.e. cough syrup)?
Yes - but the pharmacist must prepare it and dispense it
Legally, can a pharmacy contract with a central fill pharmacy in a different state?
Yes - if both states allow central filling
Legally, can a pharmacy mail controlled substances to the patient, at the patient's request?
Yes - if not outwardly dangerous - must be prepared and packaged properly
Legally, can pharmacy technicians assist the pharmacist in dispensing prescriptions for controlled substances?
Yes - if the state ph ermits
Legally, can a pharmacy provide a partial quantity of a CII rx?
Yes - if they are unable to provide the entire quantity - must note on the face of the rx and fill the balance within 72 hours
Legally, can a pharmacy provide a partial quantity of a CII rx if the patient cannot pay for the entire quantity of the CS?
Yes - must provide balance within 72 hours after the partial fill
Legally, can a pharmacist fill an Rx for an off-label use?
Yes - use professional judgement
Legally, can a pharmacist give a professional package insert to a patient?
Yes! It's available online! However, it is designed for the healthcare professional, and the pharmacist should help the patient navigate and interpret the information that the patient is looking for.
Legally, can a pharmacist fill a prescription for a controlled substance that is written by a foreign MD who uses a hospital DEA # with internal code?
Yes, as long as he has this agreement with the hospital and is authorized by jurisdiction
Is "off-label" prescribing and marketing okay?
Yes, as long as it's supported by scientific literature
Legally, can pharmacists recommend dietary supplements?
Yes, based on scientific and clinical information about the product
Can pharmacies maintain shipping and financial records at a central location?
Yes, but they must submit written notification to the DEA
Is CS disposal by the patient/ultimate user legal?
Yes, under the Secure and Responsible Drug Disposal Act of 2010 (aka Disposal Act)
Can controlled substance (CS) prescriptions for a resident of an LTCF be faxed to a pharmacy?
Yes. Schedules II-V controlled substance prescriptions may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription.
Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in a greater number of dispensations than the number of refills indicated on the prescription?
Yes. Partial refills of C III and IV are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after six months past the date of issue.
What form should the registered reverse distributor who will destroy the controlled substances is responsible for submitting?
a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the controlled substances have been destroyed
compounding pharmacies can't compound what?
a commercially available product a drug that was withdrawn from the market for safety reasons
In medicare and Medicaid Fraud and abuse statute each illegally prescription count as -----
a separate false claim--- multiply by 25,000 per false claim
How do you verify a DEA number?
add 1st, 3rd, 5th and get sum add 2nd, 4th, 6th and get sum then times 2 add both together and the right most digit should be the same as the 9th digit of the DEA number
The Rx label provides the patient with ?
adequate directions for use
Manufacturers provide what information to prescribes and dispensers ?
adequate information for use
If a drug is not made using good manufacturing practice it is said to be _______.
adulterated
If a drug's strength, quality, or purity is different from official compendium (USP), it is said to be _______.
adulterated
Advertising or labeling: a telephone communication to consumers
advertising
What did the Robinson-Patman Act of 1936 do?
aka "anti-price discrimination act" prohibits institutions that buy drugs at discounted rates from selling drugs at cost to others.
Prescription Drug Marketing Act of 1987
allows drug samples but prohibits the sale, purchase, or trade of samples from pharmacies
The PPPA applies to all oral dosage forms of _____, ______, and _____.
aspirin, controlled substances, prescription drugs
Generic companies could use the innovator's data on safety and efficacy, and only needed to prove ----------------------to innovator drug(ANDA)
bioeqivalence
What are USP/NF monographs?
chemical characteristics and quality standards of listed drugs
DEA form 106
control loss
Who gets copies of DEA form 222
copy 1 to supplier copy 2 to DEA copy 3 stays with pharmacy
Durham-Humphrey Amendment
created distinction between OTC and Rx authorized oral Rx's and refills
Give examples of drugs that do not have an NDA/
digoxin, nitroglycerin, levothyroxine, phenobarbital
DEA form 41
disposal or destruction of controls
Exception of the log book requirement for ephedrine, pseudoephedrine and phenylpropylamine
does not apply to purchase of any individual of a single sale package that contain not more than 60 mg of pseudoephedrine
prescription drug coverage through Medicaid is optional service and depend on---
each state coverage
What is the Medicare Prescription Drug Improvement and Modernization Act of 2003?
established Medicare Part D: introduces an entitlement benefit for prescription drugs through tax breaks and subsidies
What is the DESI class of drugs?
established by the Kefauver-Harris Act of 1962, applied to drugs marketed between 1938 and 1962. This put the burden on the FDA to prove any of these drugs was not effective.
How often are manufacturer's inspected for CGMP compliance?
every 2 years
Food and Drug Administration Modernization Act
exempts form pharmacies from requirements for compliance with new drug applications and current good manufacturing requirements when compounding drugs for an individual patient
T/F: s solid oral drug without an imprint for identification is adulterated
false: it is misbranded
What are the five "articles" included in the food drug and cosmetic act?
food, drug, cosmetic, dietary supplement, soap (whatever the manufacturer claims that the drug does, that's what determines what type of article it is)
How long should record for CS should be kept for?
for at least two years for inspection and copying by duly authorized DEA officials
If generic is chemically/pharmaceutically equivalent to Brand name prescribed ______ _______ is permitted.
generic interchange
Poison Prevention Packaging Act of 1970
human oral Rx drugs dispensed in safety packaging
Exemption of the Ryan Haight Act for online pharmacies
if the pharmacy is limited to dispensing new and and refilling rx of CIII-V
Food, Drug, & Cosmetic Act of 1938 required what to provide adequate directions for use
label
The term ______ means a display of written , printed, or graphic material upon the immediate container of any article.
label
Advertising or labeling: a booklet provided in the mail for use by a healthcare professional
labeling
The term ______ means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers or accompanying such article
labeling
what topical rx covered under Poison Prevention Packaging Act of 1970
lidocaine (over 5 mg), dibucaine (over 0.5 mg) & minoxidil (over 14 mg)
If a drug is mislabeled, it is ______.
misbranded
Failure to comply to PPPA is an act of ______.
misbranding
Selling a prescription drug without a prescription or refilling a prescription without the prescriber's authorization is considered
misbranding
Food Drug and Cosmetic Act
no drug marketed until proven safe described by label due to sulfanilamide tragedy
What does NMT stand for?
not contain more than
What does the second letter in the orange book rating describe?
other information...
Requirement by the DEA on a rx for CS?
patient's full name and address, and the practitioner's full name, address, and DEA registration number, drug name, strength, dosage form, quantity prescribed, directions for use, # of refills
compounding pharmacies must only provide compounded medication to -------
patients with prescription
What did the Pure Food and Drug Act do?
prohibited the introduction of adulterated or misbranded drugs and foods into interstate commerce
Pure Food and Drug Act
prohibits adulteration/misbranding of food and drugs in interstate commerce
Two times the % of ethyl alcohol
proof 100---> 50 %
Exceptions to the Poison Prevention Packaging Act
pt request dr request SL nitro oral contraceptives Medrol dosepak Hospital administration
DEA form 224
register as a new pharmacy with DEA to dispense controls
Registration requirement regarding the sale of SCLP?
retails store just have to self-certify, don't need registration wholesale distributor have to get a chemical distributor registration
When do logbook and ID requirements not apply?
sales of 60 mg or less
the primary goal of OPRA 90 is
save money
Drug Price and Competition Patent Term Restoration Act of 1984
streamlined generic drug approval patents given to innovators
Kefauver-Harris Amendment
strengthen drug approval process requiring drugs not only be safe but also effective due to thalidomide tragedy
what oral drugs are except from Poison Prevention Packaging Act of 1970 child proof closure
sublingual nitroglycerin or isosorbide, steroid and birth control dosepacks
What disaster lead to the passage of the Federal Food, Drug and Cosmetic Act?
sulfanilamide elixer tragedy: antifreeze used as a solvent in preparations. 107 patients died.
After submitting a DEA Form 41, who will inform the registrant of proper disposal/destruction procedures?
the DEA
Who assigns the first segment of the NDC number that identifies the manufacturer?
the FDA
Who initiates a drug recall?
the manufacturer!
the first five digit indicate ?
the mfr. or distributor
the last 2 digit of NDC identifies ?
the package size
the Next 4 digits of NDC identifies ?
the strength, dosage form, and formulation
"Closed door" pharmacies?
those pharmacies that sell quantities of SLCPs to institutions, including long term care facilities, jails, and other institutional-type settings for non-patient specific use.
HIPPA Covers 4 aspects or healthcare information
transactions and code sets National provider Identification Security Privacy
T/F: Some states require following the Orange Book. Michigan is not one of these states.
true
T/F: With exceptions, ALL drugs are hazardous household products subject to special packaging requirements.
true
T/F: a physician's request that a medication not be in child-resistant packaging does not have to be in writing
true
T/F: anything published in the official compendia is a drug
true
T/F: hospital pharmacies may "hold" samples and "dispense" them at the request of a staff physician
true
T/F: generic substitution is illegal in michigan
true: "substitution" means to dispense a drug other than the drug that is prescribed i.e. a different chemical entity
T/F: "Adequate directions for use" applies to ALL drugs
true: but can remove and replace by prescription labeling on pharmacy label
it is illegal for a manufacturer to promote or market an approved drug for an ---------------------
unapproved use (Except providing a peer-reviewed scientific article on the unapproved use)
when should pharmacist provide med.guides ?
with each new and refilled prescription for any covered drug
Electronic copies of prescription records must be _____.
Sortable by prescriber, patient, drug dispensed, date filled.
____ will authorize and instruct applicant to dispose of controlled substance in what possible ways?
Special Agent in Charge will authorize and instruct to dispose in 1 of following ways: --Transfer to person registered under the act and authorized to possess the controlled substance. --Delivery to DEA agent or nearest DEA office. --Destruction in presence of DEA agent or other authorized person. --Other means as Special Agent in Charge may determine to ensure that controlled substance does not become available to unauthorized persons. --If registrant is required to dispose of controlled substances on regular basis, may authorize to dispose without prior DEA approval. Registrant must keep records of each disposal and file periodic reports with Special Agent in Charge summarizing disposals. Special Agent in Charge may place conditions on disposal.
1999 OTC Labeling Requirements
Standardized OTC labeling
What is the educational program requirement of OBRA '90?
State DUR boards must provide active and ongoing educational outreach programs to educate practitioners on common drug therapy problems with the aim of improving prescribing or dispensing practices.
Who may access records for "schedule listed chemical products" (i.e. sudafed) under CMEA?
State and local law enforcement officials
Can schedule V drugs be sold by a pharmacist without a prescription?
State laws - in NC? Yes
What must be stated on the label of dietary supplements?
Statements have not been evaluated by the FDA and the product is not intended to diagnose, treat, cure, or prevent any disease.
T/F: Misbranding and adulteration laws are at the federal level
States ALSO have misbranding and adulteration laws
Calculating Valid DEA Number
Step 1: Add 1st, 3rd and 5th digits in DEA number Step 2: Add 2nd, 4th and 6th digits in DEA number AND multiply by 2 Step 3: Add the results from the two calculations *Last digit in the sum of the first 2 steps should be the same as the 7th digit in the DEA number
When types of compounds can outsourcing facilities make without a patient specific prescription?
Sterile compounded products, basically anything
What is an example of a specific drug that is exempt from PPPA packaging requirements?
Sublingual nitroglycerine
New Drug Application (NDA)
Submitted after phases 1,2,3 of clinical trails. FDA has at least 6 months to review.
Which two drugs have been approved for the treatment of narcotic addiction in the outpatient setting?
Suboxone, Subutex
What is an SNDA?
Supplemental new drug application. This is what a manufacturer gets when they want to change the label for indicated uses of a drug
Who records the date of shipment on DEA Form 222?
Supplier
special dietary food
Supply special dietary need that exists by reason of physical, physiological, pathological, or other condition.
The tylenol incident of 1982 (cyanide) led to the passage of what law?
Tamper Resistant packaging act
Federal Anti-Tampering Act Two types of requirements?
Tamper Resistant packaging for OTCs Tamper Resistant labeling for OTCs
Orphan Drug Act of 1983
Tax and exclusive licensing incentives to develop and market drugs or biological products for treatment of rare diseases/conditions that affecting <20,000 Americans.
what type of alcohol is used in Laboratory testing for inpatients and outpatients Scientific and mechanical purposes Educational and research purposes Governmental purposes In-patient medications
Tax-Free ethyl alcohol
what type of alcohol is used in Laboratory testing for private outpatients of physicians Any beverage use
Taxed ethyl alcohol
Who maintains ultimate records of copy #3 of DEA Form 222?
The "purchaser" = pharmacy usually
Who maintains ultimate records of copy #1 of DEA Form 222?
The "supplier"
Who classifies a drug as controlled?
The Attorney General of the United States, after consulting with the Department of HHS for a clinical and medical evaluation of the drug
Who maintains ultimate records of copy #2 of DEA Form 222?
The DEA in Greensboro (field office)
Who is able to enact regulations under HIPAA 1996?
The Department of Health and Human Services (HHS)
What government agency takes complaints, investigates, and enforces penalties of HIPAA 1996?
The HHS Office of Civil Rights (OCR)
What aren't states/people being prosecuted for violating the CSA with Marijuana?
The Obama administration does not want to use resources to investigate this, however illegal activity
Medicare and Medicaid Fraud and Abuse Statute
The Part D program requires pharmacies to have a comprehensive program to prevent and correct waste, fraud, and abuse. Illigal to make false statement/representation of material fact in any application for benefit or payment.
Every person who owns or operates any establishment in any state engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs must register with ____ every ____ and include ____. Those exempt are ____.
The Secretary of Health and Human Services (HHS) every year and include name and places of business. Separate registration must be made for each establishment. Pharmacists compounding in the regular course of business, pursuant to a prescription or in anticipation of a prescription are exempt.
____ certifies qualifying practitioners under DATA rather than the DEA.
The Substance Abuse and Mental Health Services Administration.
A pharmacy must report breaches of unsecured PHI occurring on or after September 23, 2009. Depending on the seriousness, notifications must be made to ____.
The individual, media, and Secretary of HHS.
When an expiration date only contains a month and year (i.e. 8/2016), what is the actual expiration date?
The last day of the month - i.e. 8/31/2016
Who enters the name and address of the supplier on the DEA Form 222?
The pharmacist
If pharmacist merely initials and dates back of prescription or annotates electronic prescription record, it is deemed that ____.
The pharmacist has dispensed the full face amount of the prescription.
What changes may a pharmacist make to a prescription written for a C III-V?
The pharmacist may add or change: - the patient's address upon verification - the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions. The pharmacist is NEVER permitted to make changes to the patient's name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber's signature.
When refilling a prescription which parts of a glass container must be replaced?
The plastic cap, but not the glass bottle
Who is ultimately responsible for ensuring that the CS rx conforms to all state and federal requirements?
The practitioner is responsible, the pharmacist should always check before you file it
What reports must be filed if a practitioner experiences a theft or significant loss of controlled substances?
The practitioner shall notify the local DEA office, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The practitioner shall also complete and submit DEA Form 106 which may be found at www.DEAdiversion.usdoj.gov.
Who must sign and date the DEA Form 222 order?
The purchaser = the pharmacist
Who completes all 3 copies of the DEA Form 222 simultaneously?
The purchaser = the pharmacy
Who submits copies 1 and 2 of DEA Form 222, and retains copy 3?
The purchaser = the pharmacy
Who must pay the fees associated with a CS drug take-back program?
The registrant (i.e. the pharmacy)
Who provides Copy #2 of DEA Form 222 to the DEA?
The supplier
Who MUST enter the NDC of a CS ordered using DEA Form 222?
The wholesaler/supplier. Pharmacist may, but wholesaler MUST.
