Federal
Which Act required more extensive controls for clinical investigators (informed consent / reporting of ADRs)?
Kefauver-Harris Amendment 1961
What is stare decisis?
to stand by what has been decided in court cases
How long must copies of DEA form 222 be retained
2 years
What resource should be utilized to determine bioequivalence between drugs
"Approved Drug Products with Therapeutic Equivalence Evaluations" AKA The Orange Book
What is the Drug Price Competition and Patent Term Restoration Act of 1984?
(Also calles Hatch-Waxman Amendment) streamlined the generic drug approval process (created ANDA, abbreviated NDA, allowed generics to be more readily available to the public). Only requires proof of bioequivalence with brand name(research may begin before patent expiration). Also extended patent extensions to innovator drugs - the manufacturer of the innovator drug has 5 years of patent restoration or at least 5 years of exclusive marketing once the drug has been approved by the FDA to keep incentive of new drug development (previously 17 years)
How does HIPPA affect pharmacies
- A "Notice if Privacy Practices" must be given to each patient when first service provided. Ideally pharmacy should retain acknowledgement of notice given. If pt refuses to sign, may still provide service but RPh should document good faith efforts to obtain acknowledgment from patient. Acknowledgment only needed the first time service is provided. A parent or guardian may sign off as well. - Pharmacy must post an entire "Notice of Privacy Practices" in a prominent location and its website if applicable.
What are the various methods an Rx drug may be granted OTC status
- A full NDA requesting OTC status may be submitted to FDA for evaluation if previously approved - FDA may grant exemption if Rx-only status deemed unnecessary for protection of public health - A supplement to NDA may be filed, FDA then review relative safety of the drug based on previous marketing experiences and lack of a history of adverse effects - The Nonprescription Drug Advisory Committee may recommend that a particular ingredient be converted to nonprescription status
Which medications are required to have a patient package insert dispensed along with the drug
- Accutane - Statins - Estrogen or progestin containing products
What legally must be contained in the OTC "Drug Facts" section
- Active ingredient (and amount) - Uses - Warning (may include when to not use product, conditions requiring advice from doctor before using the product, interactions, when to stop taking and call doctor. **Must include statement: "As with any drug, if you are pregnant or nursing a baby, seek advice of a healthcare professional before using this product", UNLESS the product contains drug intended to benefit the fetus or nursing infant and those products intended exclusively for pediatric use) - Inactive ingredients - Purpose - Directions (how to take, age categories) - Other information (can include how to store, information on minerals contained in product, etc.) - If any of above missing, product considered to be misbranded
What medications are exempt from Tamper resistent packaging regulations
- Aerosol products - Non-Rx products not accessible to general public (i.e. those used in hospitals/other institutions) - Lozenges, and drugs in first aid kits
What medications are required to have child proof packaging by the PPA
- All PO ASA - Methyl salicylate liquids greater than 5% unless packaged in pressurized spray - All PO dosage forms of Rx and controlled substances - Iron containing supplements containing 250mg or more per package - APAP PO packages with 1g or more - Diphenhydramine PO packages with 66mg base or more - Ibuprofen PO packages with 1g of more - Loperamide PO packages with 0.045mg or more - Mouthwash packages with 3g ethanol or more - Lidocaine products with 5mg per single package or more - Dibucaine products with 0.5mg per single package or more - Naproxen PO packages with 250mg or more - Ketoprofen PO packages with 50mg or more - Fluoride PO packages with 50mg AND 0.5% fluoride or more - Minoxidil products with 14mg or more in single package - All PO non-Rx medications with any active ingredient previously available by Rx only
What labeling is required on customized patient Med Paks
- All information required for unit dose packages - Serial number for the patients Med Pak - Prescription serial numbers for each drug product - Expiration dating, should not exceed 60 days from date of Med Pak preparation
What are CMS requirements for Part D sponsers for providing MTM
- All sponsers must automatically enroll qualified beneficiaries unless they opt out - Beneficiaries must be targeted for enrollment at least quarterly, targeting those with: multiple chronic disease states, taking many Part D medications, or are predicted to incur a predetermined annual cost from Part D medications - Sponsors must target 4 of the following disease states: HTN, HF, DM, dyslipidemia, respiratory disease, bone disease (Osteoporosis, RA, OA), mental health - Offer interventions for beneficiaries and prescribers - Report specific outcomes data to CMS, including: # of CMRs, # of targeted medication reviews, # of prescriber interventions, changes in therapy directly resulting from MTM interventions - Minimum interventions must include: Comprehensive medication review (CMR), targeted medication review (person-to-person or by computer), reviews quarterly for each participant, interventions to prescribers that may be passive (fax, mail) or interactive - Sponsers can include passive interventions such as educational newsletters, DUR edits, refill reminders, medication lists
What should be done if significant breakage, damage, or spillage of controlled substance occurs
- Any recoverable substance must be disposed of according to DEA regulations - DEA Form 41 should be filled
Who must sign the DEA registration application form
- Applicant, if an individual OR - Partner of the applicant, if in a partnership, OR - An officer of the applicant, if a corporation, corporate division, association, trust or other entity - Note: applicant not required to be a pharmacist
Which group of drugs are generally not covered under Medicare part D
- Barbiturates - Benzodiazepines - Weight loss or gain drugs - Hair growth drugs - Fertility drugs - Prescriptivists vitamins (except prenatal and fluoride products) - Outpatient drugs which manufacturers require monitoring
What are the special label warning requirements of Ipecac Syrup
- Boxed statement in red type that states "For emergency use to cause vomiting in poisoning. Before using, call physician, poison prevention center, or hospital emergency room immediately for advice" - The statement "Warning: Keep out of the reach of children. Do not use in unconscious persons or for poisonings involving corrosives (lye, strong acids), petroleum distillates such as kerosene, gasoline, cleaning fluids, or for strychnine" - The dosage, usual dose one tablespoonful (15mL) in individuals over one year May only be sold in 1 oz containers
What are examples of C-I substances
- Bufotenine - Gamma-Hydrocybutyric acid (GHB) - Heroin - Lysergic Acid (LSD) - Mescaline - Marijuana - Methaqualone - Methcathinone (CAT) - Peyote
What are the limits of controlled substance compounding that may be performed by a pharmacist without having to register as a manufacturer
- CS compounded as an aqueous, oleaginous, or solid dosage form - Does not contain more than 20% controlled substance - Is only distributed to a practitioner who is authorized to dispense
What are laws regarding refills of CS III-V substances
- CS-III&IV may be refilled no more than 5 times in a 6 month period from the date the Rx was issued - CS-V may be refilled as outlined by prescriber (some states limit to same as above) - Refills must be entered on the back of the Rx or other appropriate document
When must OTC labeling specify the level of various minerals within each dosage unit of a drug product
- Calcium if over 20mg - Magnesium if over 8mg - Potassium if over 5mg - Label warnings for patients on electrolyte restricted diets required if maximum daily intake may exceed: - 140mg Sodium - 3.2g Calcium - 600mg Magnesium - 975mg Potassium
Which medications are considered Narrow Therapeutic Drugs by the FDA
- Carbamazepine - Cyclosporine - Digoxin - Ethosuximide - Levothyroxine - Lithium - Phenytoin - Procainamide - Tacrolimus - Theophylline - Warfarin
When is a product considered to be adulterated
- Contains in whole or in part any filthy, putrid, decomposed substance - Has been prepared, packaged, or held under unsanitary conditions where it may be contaminated - Manufactured under conditions not meeting GMP - Contains an unapproved color additive - Strength, purity or quality is lower than official standards - Container is composed of deleterious substance that may leach into product contents - Contains drug not recognized in official compendia, but strength, quality or purity lower than listed on label - Contains any ingredient as substitute for active ingredient
What is done with each copy of the DEA form 222 given to the supplier
- Copy 1 retained by supplier - Copy 2 is kept until the close of the month then sent to the Special Agent in Charge of the DEA office in the area in which the supplier is located, or at the end of the 60 day period if a partial fill was required
What information is required on the prescription label of a CS-II substance
- Date of fill - Pharmacy name/address - Serial # of Rx - Name of pt - Name of prescriber - Directions for use - "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" (not required in blinded study use)
When are dispensing of CS-V substances allowed without an Rx
- Dispensed only by an RPh, and not by another employee even under the supervision of a pharmacist - No more than 120 mL (or 240 mL of opium containing product) or 24 dosage units (or 48 for opium containing products) is dispensed to the same purchaser in any given 48 hour period - Purchaser over 18 years of age - Patient furnishes ID if unknown to RPh - Bound record book maintained by RPh, contains name and address of purchaser, name and quantity of CS purchased, date, name/initials of RPh who dispensed the substance. SHOULD MAINTAIN FOR 2 YEARS
Which substances may only be ordered on the DEA Form 222 if they are ordered alone
- Etorphine HCl - Carfentanil - Diprenorphine
What is considered an adequate emergency for an oral Rx of a CS-II substance
- Immediate administration is necessary for proper treatment of the user - No appropriate alternative treatment is available with non CS-II substance - Not reasonably possible for the prescriber to provide a written Rx to be presented to the person dispensing the substance prior to dispensing
What are the goals of the FDA MedWatch program
- Increase awareness of drug and device induced disease - Clarify what should and should not be reported to the agency - Simplify problem reporting by operating a single system for health professionals to report adverse events and product problems to the agency - To provide regular feedback to the healthcare community about safety issues involving medical products
What specific drugs and adjuvants must have special warning labels added to any product containing them
- FD&C Yellow no. 5 (tartrazine): susceptible to allergic reactions - Aspartame: Phenylketonurics: Contains phenylalanine x mg per x dosage units - Sulfites: Allergy warning - Mineral Oil: Only be used at bedtime and avoid use in infants unless specified by physician. Also discouraged use in pregnancy - Wintergreen Oil (methyl salicylate): If greater than 5%, may be dangerous and kept out of the reach of children - Sodium Phosphate: Use as saline laxative should not exceed 90ml per OTC container - Isoproterenol inhalation products: User should not exceed prescribed dose, contact physician if breathing difficulties persist - Ipecac Syrup: long instructions, separate card - Acetophenetidin (phenacetin): Warning about possible kidney damage when taken in large amounts for long period of time - Salicylates: Must include Reye's syndrome warning - Alcohol warning: Internal analgesics and antipyretics (APAP, ibuprofen, etc.) must have label warning to consult physicians if they consume 3 or more drinks a day
How is the NDC number of drug products structured
- First 4 numbers indicate manufacturer (given to manufacturers by FDA, also known as labelers code) - Next 4 numbers ID specific drug (established by individual manufacturers, ie Warfarin 5mg at one company may have different numbers than at another) - Last 2-3 number ID specific packaging - Required on ALL Rx drugs
How are DEA numbers constructed
- First letter of A, B, or F (or M for midlevels) - Second letter is the first letter of registrants last name or business name - Followed by computer generated 7 digit number - To verify validity, add 1st, 3rd, and 5th digit, then the 2nd, 4th, and 6th digit and multiplying this sum by 2. Add the first sum and doubled second sum and the last digit should match the last digit of the DEA number. If it does not match, the DEA number is invalid
When may a pharmacist dispense a controlled substance
- For CS-II, only pursuant to a written Rx or an electronic order signed by a practitioner - For others, written Rx signed by practitioner, fax of a written & signed Rx transmitted by the prescriber or agent, an electronic Rx meeting CSA requirments, or an oral Rx made by individual practitioner and promptly reduced to writting by the RPh with all necessary information minus prescriber signature
When must an OTC product specify the products sodium content per unit dose
- For PO or PR products containing over 5mg Sodium per single dose. - **If amount of sodium in the maximum daily dose exceeds 140 mg, a warning must be included stating "Ask a doctor before use if you have a sodium restricted diet" - "Very low sodium" indicates 35mg or less, "low sodium" considered 140mg or less
When should a DEA form 222 order not be filled by the supplier
- Form is not complete, legible, or properly prepared, executed, or endorsed - Form shows any alteration, erasure, or change of any description - If cannot be filled, supplier must return Copies 1 and 2 to the purchaser with a statement as to the reason
What is federally required on the Rx of a controlled substance
- Full name and address of the patient - Drug name, strength, and dosage form - Quantity prescribed - Directions for use - Name, address, and DEA number of practitioner - Rx for a CS III-V narcotic drug approved specifically for "detoxification treatment" must include identification number issued to the practitioner by the DEA administrator - Practitioner must sign the RC in same manner as legal document - Where oral order not permitted, paper Rx must be written with ink or indelible pencil, typewritter, or printed on a computer and must be manually signed by practitioner. A computer generated Rx that is printed out or faxed by the practitioner must be manually signed - An agent of the practitioner (secretary, nurse, etc.) may prepare Rxs for the practitioners signature, but prescriber is responsible for ensuring prescription conforms to all essential laws. - If prescriber is exempt from registration under CSA, must instead include the registration number of the hospital/institution on all prescriptions
What information must be included on unit dose packages
- Generic name and trade name, if appropriate - Quantity of active drug (and number of dosage units, if more than 1) - Name of manufacturer, packer, or distributor - Repackagers lot number - Expiration date - Any other appropriate information concerning the specific drug (ie special storage requirements) - If used in hospitals, barcodes must be used for scanning, that encode the drugs NDC
When is the faxing of CS-II substances permitted
- Home infusion pharmacies receiving Rx intended for parental administration - A resident of a LTC facility - For patients enrolled in hospice, certified or licensed by state. Practitioner must note on the Rx that the patient is a hospice patient - Otherwise, faxes only serve for information purposes and cannot serve as the original Rx - Fax serves as the original Rx and must be filed accordingly
When is a medication required to have a MedGuide prepared by drug manufacturer and dispensed for one of their drug products
- If patient labeling could prevent serious adverse effects - The product has serious risks relative to benefit - Patient adherence to directions is crucial
What are the laws regarding take home doses for opioid withdrawal treatment
- If the Medical Director determines the patient is fit for take home doses (regular clinic visits, absence of problems, stable life), may start with single weekly take home dose in first 90 days - In next 90 days, may take home 2 doses per week - In 3rd 90 days, may take home 3 doses per week - In the remaining months of first year, may be given a maximum of 6 day supply to take home - After one year continuous treatment, may be given 2 week supply - After 2 years, may be give a maximum one month supply with weekly visits
Who in the Controlled substance manufacturer, distribution, and dispenser chain must be registered with the DEA
- Individual researchers - Manufacturers - Distributors - Laboratories - Exporters - Narcotic treatment programs - Dispensing locations (ie pharmacies, hospital) Individual pharmacists generally do not need to register if they are working in a registered establishment
What records must pharmacists maintain with regards to controlled substances
- Inventories and records of all CS listed in I and II maintained separately from other records, in separate Rx files - Same as above for CS III-V, or in such form that they are readily retrievable - Considered readily retrievable if at time of initial filing, the face of Rx is stamped with red "C" on lower right - If computer system used, the requirement for a red "C" is waived if identificaton by Rx number easily. (for CS III-V)
When is a drug product considered to be misbranded
- Labeling is false or misleading - Is missing either name or location of manufacturer, packager or distributor - Does not contain a word, statement or other information required by law to be displayed in a prominent, readable manner - Does not include name of active drug, or each active drug ingredient identified - Does not contain precautionary statement for a drug product subject to deterioration - Missing the quantity of container ingredients - Has inadequate directions for use of non-Rx drugs or appropriate warnings required to protect those using the medication or packaging - Not in accordance to USP/NF specifications - Offers the sale of a drug under the name of another drug Considered misbranding if pharmacy dispenses Rx only drug without legal prescription or authorized refill
When may the DEA deny registration of an applicant
- Materially falsified information on the application - Been convicted of a drug related felony - Committed acts which would make registration inconsistent with the public interest - Had its state license suspended, revoked, or denied
How may a purchaser cancel part or all of an order on a DEA form 222 order form
- May notify the supplier in writing of such cancellation. - Supplier must indicate cancellation on copies 1 and 2 by drawing a line through the canceled items and printing "Cancelled" in the space provided for number of items shipped
Which medications are legally allowed to be used by Opioid Treatment Programs
- Methadone - Buprenorphine - Naltrexone - May use investigational drugs if OTP in compliance with protocal of application under IND
What must be done with Copies 1 and 2 of DEA form 222 if they are sent back to the purchaser by the supplier
- Must be attached to copy 3 and retained in the files of the purchaser - May NOT correct an order form that is incorrect. Must use a new order form
What must be done if an unused DEA Form 222 is lost or stolen
- Must immediately report the loss to the Special Agent in Charge of the DEA Divisional Office responsible for the area in which the registrant is located. Must state serial numbers of forms lost, or if unable to report serial numbers, date or approximate date of receipt of thereof. - If any form is recovered, must subsequently notify the agent immediately
What is required of prescribers when they send electronic Rxs for controlled substances
- Must obtain two-factor authentication credential OR digital certificates from federally approved credential service providers (CSPs) or certification authorities (CAs). - For two factor authentication, DEA allows 2 of the following: something you know (knowledge factor), something you have (a hard token stored separately from the computer being accessed), and something you are (biometric information)
What is required of a purchaser to be able to use the CSOS
- Must sign an electronic order with a digital signature issued to the purchaser by the DEA - Must fill out data fields on electronic order indicating: Unique 9-character number to track order (first 2 digits indicate year, followed by X, followed by 6 charaters selected by purchaser, i.e. 19X123456), the purchasers DEA registration number, the name of supplier, complete address of the supplier (either filled by purchaser or supplier), suppliers DEA registration number (also filled by either), date order is signed, name/strength of CS product or NDC number, quantity in a single package, number of packages or containers of each item
What resources may be used to look up the NDC numbers and their identity
- NDC Directory - Red Book - Blue Book (All on FDA website)
What are acceptable reasons to exercise a pharmacists right to refuse filling a Rx
- Rx is a suspected forgery or fictitious - RPh would be violating the law if filled the R - The drug product is not in stock - RPh believes product may be harmful to the patient
What are the labeling requirements for manufacturers containers of drug products
- Name and address of manufacturer, packer, or distributor - Established name of drug or drug product - Net quantity in package - Weight if each active ingredient contained in each dosing unit. Electrolytes must additionally contain concentration in terms of mEq - The federal legend: Caution: Federal law prohibits dispensing without a prescription" or the more recent version "Rx only" (if applicable) - If not given orally, specific routes of administration must be stated - Special storage directions, if appropriate - Manufactures control or lot number - Expiration date established by manufacturer Any label non-adherent may be considered misbranded
When are the typical labeling requirements for CS III-V products not necessary for institutionalized patients
- No more than 34 day supply or 100 dosages, whichever is less, is dispensed at once - Substance is not in the possession of the ultimate user prior to administration - Institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of substances - System employed by RPh in filling a Rx is adequate to identify the supplier, the product and the patient, and to include directions for use and cautionary statements
When may reregistration with the DEA take place
- No more than 60 days before expiration of current registration - Bulk manufacturers or importers of Schedule I or II substances may apply no more than 120 days before expiration
What records does the DEA require of registrants be kept
- Official order forms (DEA Form 222) - Power of Attorney authorization to sign order forms - Receipts and invoices for CS III-V substances - All inventory records of CS, including the initial and biennial inventories - Records of CS distributed and dispensed (i.e. Rxs) - Report of Theft or Loss (DEA Form 106) - Inventory of Drugs Surrendered for Disposal (Form 41) - Records of transfers of controlled substances between pharmacies - DEA registration certificate
What suggestions does the FDA give to prevent the accidental purchase of counterfeit drugs
- Oppose purchase of drugs from abroad - Warn against purchase from domestic websites UNLESS they display the VIPPS (Verified Internet Pharmacy Practice Sites) seal. Hyperlink seal developed by NABP where verified info about pharmacy is available
May Rx for CS III-V be transferred between pharmacies
- Original Rx information only on a one time basis for the purpose of refill dispensing - May share electronically real time online database for a maximum amount of refills permitted by law - Must write "VOID" on the face of an invalidated prescription, record on the back the name, address, and DEA number of the pharmacy to which it was transferred and the name of the RPh receiving the information. Record the date and RPh transferring this information - For paper and oral Rxs, RPh receiving the transferred Rx mist write "Transfer" on the face of the transferred Rx and reduce to writing all information required by CSA to be on the Rx - Original and transferred Rx must be kept for period of 2 years from the date of last refill
Who may fill orders written on DEA form 222
- Persons registered as a manufacturer or distributor of CS-I or II substances - A pharmacist discontinuing a pharmacy - Registrants who are about to have a registration expire without plans to re-register - Registrants returning CS-I or II substances to the supplier from which it was obtained - A person registered or authorized to conduct chemical analysis or research with controlled substances may distribute CS-I or II to another person registered or authorized to do the same - A person registered as a compounder of narcotic substances for use at offsite locations in conjunction with a narcotic treatment program at the compounding location. Such persons may fill orders for narcotic drugs for off-site narcotic treatment programs only
What are the specific forms for applying for registration and reregistration with the DEA
- Pharmacies: Form 224 - Manufacturers, distributors, importers, or researchers: Form 225 - Narcotic treatment programs: Form 363 - Registrations renewals generally same number with "a" at end, ie. form 224a for pharmacies
What must be done in the case that theft or significant loss of a controlled substance is discovered
- Pharmacy must contact nearest DEA diversion office by telephone or brief written message explaining the circumstances. May also need to contact local police as may be required by state law - DEA Form 106 (Report of Theft or Loss of Controlled Substances) should be completed by pharmacy, formally documents the circumstances of theft or loss and the quantities involved. Should send the original and a copy to the DEA Diversion Field office and keep a record - If lost in transit from the supplier, the supplier is responsible for reporting, unless an RPh has signed for a shipment and later discovers the loss, and must fill Form 106
What information is required on the label of a CS-III-V dispensed product
- Pharmacy name and address - Serial number - Date of initial filling - Name of the patient - Name of practitioner issuing Rx - Directions for use - Cautionary statements mandated by law "Caution: Federal law prohibits the transfer of this drug to any person other than the patient whom it was prescribed"
What is the Dietary Supplement Health Education Act
- Placed health foods, food supplements, and herbal products into class differing from Rx and non-Rx drugs. Can include herbals, amino acids, vitamins, minerals, related supplements - Allowed products to be marketed without efficacy proven. FDA or FTC can only challenge products if evidence surfaced they are ineffective for advertised use - Products available at the time of passage do not have to be proven safe, FDA has responsibility to prove product is unsafe. However, manufacturer must provide reasonable assurances that no product presents significant risk for injury
What must be done if a purchaser determines that an unfilled DEA form 222 order form has been lost
- Prepare another form, along with a statement containing the serial number and date of the lost form. Should indicate the goods covered by first order were not received because that order form was lost - Copy 3 of new form must be kept with copy 3 of the last form - If the supplier subsequently receives the first order form, supplier must write "Not Accepted" on the face of the form and return copies 1 and 2 to the purchaser, who must then attach it to copy 3 and the statement.
What is in the FDA Modernization Act of 1997?
- Provision for fast track review of some NDA submissions, intended to expedite drug approval for serious/life threatening conditions - Clarified conditions under which pharmacies can perform extemporaneous compounding. Individual states should regulate compounding. Pharmacies are exempt from strict federal GMP standards and requirements of NDAs - Replaced need for "Caution: federal law prohibits dispensing without a prescription" label with "Rx only" - Removed requirement to label certain substances with "Warning — May be habit forming" - Encouraged manufactures to conduct research for new uses of drugs and to submit supplemental NDAs for these new uses. Manufacturers could disseminate limited info about unapproved uses provided statement specifying use hasn't been approved by FDA - Encouraged manufactures to perform pediatric studies of drugs by providing an additional 6 months of marketing exclusivity
What should be done if a CSOS order is determined to have been lost
- Purchaser must provide to the supplier a signed statement containing the unique tracking number and date of the lost order and stating that the goods covered by the first order were not received through loss of that order - If purchaser executes an order to replace last order, must electronically link the second order and a copy of the statement with the record of the first order and retain them - If the supplier subsequently receives the first order, must indicate "Not Accepted" and return it to the purchaser. Purchaser must link the returned order to the record of that orde and the statement - Purchaser must retain the original and all linked orders for 2 years - Supplier must retain each original order for 2 years as well
What are the laws regarding oral prescription and orders of CS-II substances for emergencies
- Quantity prescribed must be limited to the amount adequate to treat the patient during the emergency period - Prescription must be immediately reduced to writing by RPh, with all necessary information minus the prescribers signature - If the RPh doesnt know the prescriber, must make a good faith effort to ensure the order is legitimate - Within 7 days, prescriber must have delivered (in person or by mail within 7 days) to the dispensing pharmacist a written prescription for the emergency quantity prescribed. This cover Rx must have all needed info as a normal CS-II Rx, and in addition must write on the face "Authorization for Emergency Dispensing" and the date of the oral order. - RPh must attach this Rx to the oral Rx. If not received in 7 days, should notify nearest DEA office
What is the Prescription Drug Marketing Act of 1987?
- Required Rx Drug wholesalers be licensed by states under federal guidelines - Banned re-importation of Rx drugs produced in US - Banned sale, trade, or purchase of Rx Drug samples. Practitioner may not deliver samples to retail pharmacy, any possession of drug samples in pharmacy considered diversion. - Specified precise storage, handling and recordkeeping requirements of drug samples - Prohibited resale of Rx drugs purchased by hospitals or healthcare facilities (some exception) -Requires proper storage of drugs and maintenance of appropriate distribution records - Prohibited companies shipping drugs between states without registering in the state being shipped to - Prohibited reimported drugs into US except by manufacturers of said drugs - Allows use of starter packs containing small quantities of drug product, not to be considered samples. - Also allows use of vouchers or coupons. Nah be filled from pharmacy stock at manufacturer expense - Allows pharmacies in healthcare facilities to receive samples if licensed prescriber has requested them and precise records are maintained of their disposition. Must be stored separately - Prohibition reselling drug products by healthcare facilities if purchased at special prices. - Restricted resale of drug products by healthcare facilities - Permits practitioners licensed to receive samples provided written request with name, address, medical specialty, signature, drug name, quantity, manufacturer and date of request. Manufacturer and distributor must keep copies of request for 3 years - Requires sales representatives to be responsible for all samples and take annual inventory - Establishes stiff penalties for violation of law Bill intended to place stringent controls on distribution of Rx Drug products and samples
When should a CSOS order not be filled by a supplier
- Required data fields have not been completed - The order is not signed using a digital certificate issued by DEA - Digital certificate used has expired or has beeen revoked prior to signature - Purchasers public key will not validate the digital signiture - The validation of the order shows that the order is invalid for any reason - The supplier may also refuse to fill and should provide a statement as to the reason (if improperly prepared, if not available in stock, etc.) - Note: if defective order sent, cannot be corrected, must send new form
What is the Patient Protection and Affordable Care Act of 2010?
- Requires all individuals have health insurance (fine for not carrying). Health insurance exchange will be created allowing families to purchase coverage based upon Federal Poverty Level (FPL). Also provides small businesses with credits if the provide employee health coverage - Requires standards for financial and administrative transactions including timely and transparent claims using standard electronic transactions (14 days) - Stop agreements between brand and generic drug manufacturers that limit or delay competition from generic drugs - Phases elimination of catastrophic threshold (donut hole or coverage gap) during which patient pays all costs of prescriptions - No longer may deny children (or anyone else) with preexisting illness coverage, and may stay on parents plan until age 26 - Those without insurance for 6 months can receive subsidy to enroll in high risk insurance pool run by individual states - Plans must exempt preventative care and screenings from deductibles - Businesses under 25 employees receive 35% tax credit for providing health insurance - Senior citizens in donut hole receive 50% discount on drugs - Employers include cost of healthcare in W-2 forms - Includes new Medicare tax on individuals earning over $200,000 a year - Requires insurance industry to pay annual fee to help pay for exchanges to cover all citizens who may not otherwise receive insurance - Establishment or independent Medicare board to curb Medicare costs if costs rise more quickly than inflation
What is considered appropriate for a prospective DUR by OBRA 90
- Review of patients written medical record and/or medication profile before dispensing Rx. - RPh must make effort to create/update medication profile each time an Rx is filled, and should have the following: Patient name address and phone #, age or DOB, sex, disease states information provided by patient or physician, any known allergies, list of meds previously dispensed, and pharmacist comments concerning patients drug therapy when appropriate. - Prospective DUR should consist of review of Rx and patient records for over or underutilization of drugs, checking for therapeutic duplications, checking for incorrect dosing or regimens, extending a verbal offer to the client or to their representative to personally discuss matters that will enhance or optimize their drug therapy (ie MUST OFFER COUNSELING)
What medications are exempt from PPPA packaging requirements
- SL NTG - SL or chewable isosorbide dinitrate if strength 10mg or less - Erythromycin ethylsuccinate granules for PO suspension and oral suspensions containing no more than 8g or equivalent of erythromycin - Erythromycin ethylsuccinate tablets in packages containing no more than 16g Erythromycin - Anhydrous cholestyramine in powder form - Potassium supplements in unit dose form (individually wrapped effervescent tabs, unit dose liquid vials, unit powder packs) not exceeding 50mEq per dose - NaF drug preparations, including liquid and tablet form containing no more than 264mg of NaF a package - Betamethasone tablets in manufacturers dispenser packages of no more than 12.6mg - Mebenazole tablet packages with no more than 600mg drug - Methylprednisolone in tablet form packages of no more than 84mg drug - Colestipol powder in packages less than 5g - Pancrelipase in tablet, capsule, or powder form - Cyclically administered PO contraceptives in dispensed packs - Prednisone tablets if dispensed in container of no more than 105mg - Conjugated estrogen tablets in dispenser packs of no more than 32mg of the drug - Norethindrone acetate tabs in dispenser packs no more than 50mg of the drug - Medroxyprogesterone acetate tablets - Sacrosidase (sucrose) preparations in solution of glycerol and water - Hormont Replacement Therapy productos relying solely on activity of one or more progestogen or estrogen substances
What is the difference between short term detoxification treatment and long term detoxification treatment
- Short term is for a period not to exceed 30 days - Long term for a period of greater than 30 days but not in excess of 180 days
What is the expiration dating for compounded prescriptions
- Should base on stability information if available - Nonaqueous liquids and solids from commercially manufactured products, no more than 25% of time remaining on commercial product or 6 months, whichever is less - Aqueous solutions made from solids obtained in commercially manufactured drug products: 14 days when stored at cold temperature - All others: Duration of therapy, but no more than 30 days
What is "therapeutic substitution" and when is it legally allowed
- Substitution of one drug with a different drug than is written for on the Rx or medical order without contacting the prescriber - Generally limited to institutions that utilize a drug formulary/P&T committee, prescribers must agree to therapeutic substitution policies
What data is most critical to determining bioequivalence
- Time to peak - Peak concentrations - AUC
What references can be used to identify nonactive ingredients of drug products
- USP Dictionary of ISAN and International Drug Names - CFTA International Cosmetic Ingredient Dictionary and Handbook - Food Chemicals Codex
When must unused DEA form 222s be returned to the DEA
- Upon termination of the registration of a purchaser (i.e. death, discontinued business, revoked/suspended registration) - Change in name or address of a registrant
What is required of the supplier before filling a CSOS order
- Verify the integrity of the signature and the order by using software that complies with CSOS regulations - Verify that the digital certificate has not expired - Check the validity of the certificate holders certificate by checking the Certificate Revocation List - Must retain E-record of each order, as well as record of number of commercial or bulk containers furnished on each item and the date shipped. Forward electronic order filled to DEA within 2 business days - Again, order valid for no more than 60 days, may partial fill and reimburse within time frame - Endorsements NOT allowed for CSOS
What locations involved in manufacture, distribution, or dispensing of controlled substances are exempt from requiring registration with the DEA
- Warehouses used by registrants to store controlled substances - A practitioners office where drugs are prescribed, but not administered or dispensed - Common carriers (ie. delivery companies) - An office where sales of controlled substances are solicited, made or supervised, but the location does NOT contain controlled substances
When must a patient be provided with a MedGuide for a REMS drug
- When the pt requests one - When the drug is dispensed in outpatient setting and then used by patient without direct supervision by healthcare professional - The first time the drug is dispensed to a healthcare professional for administration to a patient in an outpatient setting (i.e in clinic, dialysis or infusion center) - The first time a drug is dispensed in an outpatient setting of any kind - After a MedGuide has been materially changed - When the drug is subject to a REMS that specifically includes requirement for reviewing and providing MedGuide as part of an element to assure safe use
When will forms for reregistry with DEA be mailed to a registered DEA entity
- Will be mailed 60 days before expiration of current registration - Registrant must notify DEA if not received within 45 days of expiry and request such forms in writing
Is partial filling of CS-II substances permissable
- Yes, must make notation of quantity supplied on the face of written Rx - Remaining portion may be filled within 72 hours. If unable to, must notify prescriber. Cannot dispense more after 72 hours without a new Rx - May NOT perform partial fill at the request of a patient, only if temporarily out of stock - May perform partial quantity fills for terminal patients at LTC facilities. RPh must record this on the Rx, and record partial fills on the back with the date of fill, quantity dispensed, remaining quantity, and identification of the dispensing RPh. Validity of Rx should NOT exceed 60 days
What is the Poison Prevention Packaging Act
-passed to protect children from accidental poisonings -enforced by the consumer product safety commission (CPSC) since 1973 - Requires child resistant closures on all Rx and non-Rx drugs, as well as hazardous household products, and other substances (liquid methyl salicylate, iron, lidocaine, mouthwash, fluoride) - If OTC product available in several sizes, one size is not required to have safety closure, but must be labeled "This package for households without children - All new and refilled Rxs must be child proof unless the prescriber specifies the none is to be used on each individual prescription, or the patient indicates they do not want such a closure. Patient may use a "blanket waiver" that directs pharmacists to never use child proof caps for this individual. - Plastic vials and caps may not be reused upon refill, due to wear and tear of child proof cap. May reuse glass vial if used, but not cap
Provisions of Medicare programs
1. All Rx benefit programs must accept participation from any pharmacy that agrees to terms of drug plan. ("Any willing provider clause") 2. Sponsors cannot require beneficiaries to obtain Rxs through mail order 3. Larger quantities (ie 90 day supplies) May be obtained at participating local pharmacies 4. If brand name dispensed, patient must be informed of available lower cost generics 5. Pharmacies eligible to receive payment from Medicare for providing MTM if enrolled in Medicare Part D 6. Each drug plan sponsor much establish MTM programs for enrolled pts having high drug costs from multiple chronic conditions 7. Importation of drugs from Canada or other countries may be permitted if HHS certifies importation poses no public health risk 8. Explicitly blocking Medicare's purchasing power to negotiate prices with Pharm manufacturers to obtain lower cost drugs for elderly and disabled 9. Bringing higher reimbursement prices paid by Medicare into a lower range. Reported AWP will be phased out in favor of ASP. Value to be between AAP and present AWP 10. Preventing drug company from filing multiple 30 month stays to prevent competing companies from marketing generic versions of drug product 11. Allowing multiple manufacturers of generic product to obtain 180 day exclusivity period if they file their applications on first day of eligibility
What information is required to place on package inserts
1. Description of drug (solubility, chemical characteristics, etc) 2. Clinical pharmacology 3. Indications and usage 4. Contraindications 5. Warnings 6. Precautions 7. Adverse reactions 8. Potential for abuse of patient dependence 9. Symptoms and treatment of oberdose 10. Dosage and administration 11. Available dosage form of the product 12. Date of the most recent revision of the labeling 13. Recommended or usual dosage Newer labels include sections: - Highlights: summary of boxed warnings, indications and usages, dosage and administration - Table of contents - Inclusion of day of initial product review - A roll free number and internet reporting options to encourage reporting of suspected side effects - All substantive changes made to insert in last year
What are the 5 levels of mitigation risk for REMS drugs
1. Professional Label and Package Insert 2. REMS - mediation guide (MedGuide) 3. REMS - communication plan (May include training videos, protocols, informed consent agreements, etc.) 4. Elements to Assure Safe use (ETASU): Elements may include restrictions on accessing drug based on the following: training or experience of prescriber, type of setting that dispenses the drug must demonstrate sufficient training, site of care may be specified (ie can only be given in hospital, or first dose in hospital), patient must show evidence or documentation of safe use conditions (ie normal labs, negative preg test), patient must agree to be properly monitored, enrolled in registry 5. Implementation system: Used for drugs with severe adverse effect profiles, usually implementation of limited distribution and/or access program for drug, can include: open distribution (PO drugs typically), managed distribution (usually drugs used in specialized care sites), controlled distribution (drugs used by specific physicians, ie oncologists, in specific practice site), or restricted access (usually for drugs requiring patient registry or being used for treating rare diseases) All REMS drugs use at least one of the above
When may an individual practitioner administer or dispense directly a CS-II without an Rx to a narcotic dependent person for the purposes of maintenance or detox treatment
1. The practitioner is separately registered with DEA as a narcotic treatment program 2. The practitioner is in compliance with DEA regulations regarding treatment qualifications, security, records, and unsupervised use of the drugs pursuant to the CSA - If the above 2 are not met, prescriber may only administer, but not prescribe medications to treat acute withdrawal when necessary while arrangement for referral are made
What are USP 36-NF 31 standards for prescription container labeling
1. Top of label should have pts name, Rx #, drug name (generic/brand), strength, and clear directions of use 2. Less critical info (Rx #, exp date, quantity, etc) should not supersede critical patient information. Place in less prominent area such as the bottom of the label 3. Should use familiar fonts (ie 12 point Times New Roman, 11 point Arial) 4. Drug names should be spelled out and not abbreviated (no APAP or ASA) 5. Explicit instructions must be clarified (use number 2 instead of "two", use "take 2 tablets in morning and 2 tablets in evening" instead of "Take 2 tablets twice daily", use specific hour designations (take at 8AM and 8PM, or in the morning or after breakfast) instead of "every 12 hours" 6. Purpose for medication should appear on label, unless patient prefers it not to 7. Label directions should be in patients preferred language, but drug name should be in English to aid emergency personnel 8. Pharmacy name, address, tele #, etc should not supersede critical information, should be placed away from dosing instructions 9. Label should include prescribers name 10. Date on label should indicate when Rx was either written of dispensed. Some states require date of refill upon refills 11. Inclusion of exp date, lot #, and/or name of manufacturer left to discretion of individual states
According to federal law (Medicare Modernization Act of 2003) how long must prescriptions be kept on record at pharmacies?
10 years (in practice, typically kept indefinitely)
ADA regulations in employment only apply to organizations with _____ employees
15 or more full time
How long is a DEA registration valid for?
36 months
How long after a drug has been discontinued may an NDC number be recycled for use of a new drug product
5 years
How long is the DEA form 222 valid for
60 days (from the day it was signed). If an order cannot be filled, may be partially filled and the balance supplied within this time frame
How many DEA form 222s are in each book?
7. Number of booklets sent to business limited based on activity, unless additional forms specifically requested on Form 222a
What is the Supplemental New Drug Application
Abbreviated application used after drug product has been marketed by manufacturer when the manufacturer desires to change drug synthesis, production procedures, or manufacturing locations, packaging, labeling, etc, rather than submitting new NDA (can be used for new dosage form, tablet strength, or alternative therapeutic use by same sponser as original NDA)
What is the law regarding exportation of drug products from the US to a foreign country
Action generally acceptable if performed by original manufacturer, if there is no intention to bring product back to the US
What is the Methamphetamine Anti-Proliferation Act of 2000
Addressed issues ranging from the diversion of drug products containing pseudoephedrine and phenylpropanolamine from retail and mail order sources for illicit methamphetamine production
What is the main difference between adulteration and misbranding
Adulteration refers to composition of product, misbranding refers to labeling
What is the NDA process?
After drug efficacy, toxicity, stability, production methods, packaging and data from clinical trials collected, NDA is submitted to review Phase 1, 2, 3 data. If approved by FDA, NDA kept on file and manufacturers may now market new drug product, and phase 4 post marketing surveillance may begin.
Who must dispense patient package inserts with Rx medications that legally require them to be dispensed with PPIs
All physicians, community pharmacists, and hospital pharmacists that dispense drugs. Also applies to nursing homes. Must be given every 30 days even in hospitalized patients
What is the Comprehensive Drug Abuse Prevention and Control Act of 1970
Allow the use of Methadone to wean narcotic dependent individuals from opiates
What are the regulations regarding mailing of controlled substances
Allowed provided package not outwardly dangerous or will cause injury to a persons life or health if the following packaging standards are met: - Inner package containing controlled substance is packaged and labeled as required by the Controlled Substances Act - Controlled substance is placed in a plain outer container or securely wrapped in plain paper - Inner container also labeled to show name and address of pharmacy, practitioner or other person dispensing the Rx - The outer wrapper is free of markings that would indicate the nature of the contents All regulations for USPS, UPS and FedEx May establish their own rules
What is the Women's Preventative Healtg Care Amendment?
Amendment to ACA. Provides services to women including well women visits, gestational DM screenings, HPV screenings, STD counseling, HIV counseling and screening, contraceptive counseling. Provided periodically without patient cost
What is the Medical Device Amendment of 1976
Amendment to FDCA ensured medical devices were safe and effective. Provides for better classification of medical devices, establishment of performance standards, pre-market approval, conformity with GMP
What is the Durham-Humphrey Amendment?
Amendment to FDCA that differentiated prescription drugs from nonprescription drugs. Meds that's required medical supervision no longer needed "adequate directions for use", but must include "Caution: Federal law prohibits dispensing without a prescription". Adequate directions are provided by RPh placing directions provided by prescriber on label of dispensed product. These are known as prescription, or "legend" drugs. Also provided for oral prescriptions and prescription refills
What is the Kefauver-Harris Amendment of 1962?
Amendment to FDCA that requires pharm companies to prove drugs are safe AND effective before approval. Became needed for all drugs approved between 1938 and 1962. Also placed Rx drug advertising regulation under FDA control (but not OTC, goes to FTC jurisdiction). Also requires consent from research subjects in drug trials, reporting of adverse drug effects, and creation of clearly defined GMP requirements
Which drug product is generally exempt from substitution regulations due to lack of significant differences in effect
Amino acid solutions used in TPN
What may be done by a supplier if they are not able to fill an order on the DEA form 222 within the specified time limitation of 60 days
An order form may be endorsed to another supplier for filing. Must include the name and address of the second supplier, as well as the signature of a person authorized to obtain and execute order forms on behalf of the supplier (spaces available on the reverse sides of copies 1 and 2) - Original supplier may NOT fill any part of the endorsed form, second supplier must fill the order, if possible, and send all substances to the original suppliers
Is a pharmacy allowed to fill a foreign prescription to directly export to that country
Appears to be legitimate if the prescription is for a reasonable quantity of drug and pt is determined to be monitored properly. (Should not do for CS though, only US prescribers may write CS Rxs)
What is the Combat Methamphetamine Epidemic Act of 2005?
Applies to all cough/cold products containing ephedrine, pseudoephedrine or phenylpropanolamine. Restrictions include: - Retail sales may not exceed 3.6 g PSE per day per purchaser - Prohibited from purchasing more than 9 g PSE per 30 day period - All non-liquid forms must be sold in blister packs with no more than two dosages or in unit dose packets or pouches - Mail order companies may not sell more than 7.5g to a customer in a 30 day period - Must place PSE behind the counter, or in a locked display case located on the selling floor (does not have to be behind a pharmacy counter) - Retailer must have log book on transaction, either in written or electronic form. Must log purchasers signature, name, address, date and time of sale. Retailer must check against a photo ID. DOES NOT APPLY to single sales packages that contain no more than 60mg PSE - Must maintain logbook for 2 years from the date of entry - Retailers must train applicable personnel to ensure understanding of PSE product sales and submit self-certifications to the attorney general in this regard
What is the Controlled Substance Export Reform Act
Authorizes the Attorney General or the DEA to permit re-export of controlled substances in categories I-IV to other countries as long as they are being shipped to DEA permit or license holders in those countries as long as DEA is notifies of the re-export within 30 days.
When may a prescriber authorize additional refills for CS-III/IV substances
Can be done on original Rx through an oral refill authorization transmitted to the pharmacist provided that: - Total quantity authorized, including the original Rx, does not exceed 5 refills within a 6 month period from the date of issue of the original prescription - RPh obtaining the oral authorization must record on the reverse of the original paper Rx or annotates the e-Rx record: the date of authorization, the quantity of medication per refill, the number of additional refills authorized, their initials showing who received authorization from the prescribing practitioner who issued the original Rx - The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original Rx - The prescriber must issue a new and separate Rx for any additional quantities beyond the 5 refill, 6 month limitation
For which recall classes must manufacturers have the responsibility of sending written recall notices to all wholesalers and pharmacies
Class I and II
What are the classes of drug recalls
Class I: Drug product may cause serious adverse health outcomes including death. Recall should include stocks located in pharmacies and notification of patients to whom drug has been dispensed. Class II: Drug product may cause temporary or reversible effects but the probability of serious adverse effects is remote. Recall includes stock located in pharmacies Class III: The drug product is unlikely to cause any serious health consequence
Which copies of DEA form 222 are required to be kept by the purchaser and what is to be done with it
Copy 3 (Blue), send 1 (Brown) and 2 (Green) to the supplier. Upon reception of shipment, must record the number of commercial or bulk containers received on each item and the dates on which the 60-day validity period expires
How may a purchaser allow other individuals to obtain and execute DEA form 222 order forms on their behalf
Creation of Power of Attorney for each such individual
Which form must be used in the sale and transfer of a schedule I or II substance
DEA form 222
Which act required that Dietary supplements be proven unsafe by the FDA before it can be removed from the market?
DSHEA (Dietary Supplement Health and Education Act)
Where may patients report perceived HIPPA violations
Department of Heath and Human Services Office for Civil Rights (HHS/OCR)
What is the MedMARx reporting system
Developed by USP to allow hospitals to anonymously report medication error data, allowing users to learn from adverse experiences of others and share successful solutions
What is the law regarding importation of drug products to the US from a foreign country
Drug product must meet all standards established by FDA including GMP and labeling standards, as well as approval by FDA
What are "pharmaceutical alternatives" in respect to substitution laws
Drugs containing same therapeutic moiety, but can contain different sets of salts, esters or complexes, dosage forms and strengths. Generally not allowed for substitution
Which medications are not required to be listed in the Orange Book
Drugs marketed before 1938, include: - ASA with codeine - Codeine - Digoxin - Ephedrine - Epinephrine - Levothyroxine - Morphine - NTG - Phenobarbital - PO KCl preparations - Pseudoephedrine - Thyroid - Quinine - Some generic forms of NTG transdermal marketed prior to 1962 - Despite exemption, some manufacturers have began producing bioequivalence data for inclusion in orange book
What is the Controlled Substance Ordering System (CSOS)
Electronic equivalent of DEA form 222. Allows electronic ordering of not only CS-I and II, but all CS categories. Also allows for ordering more than 10 items at once, faster transactions, reduction of ordering errors, and decreased paper work
What is the Medicare Prescription Drug Improvement and Modernization Act of 2003?
Encompasses 4 programs: - Part A: Provides hospital insurance - Part B: Provides medical insurance for physician services - Part C: Medicare managed care (Medicare advantage) - Part D: Medicare prescription drug program
How does Medicare enrollment functuon
Enrollment period begins first day of 3rd month before eligibility, lasts 7 months. After enrolled, clients are locked into plan until next enrollment period. Failure to enroll can result in late enrollment penalty
What is the Medicaid Prudent Pharmaceutical Purchasing Provisions of OBRA 90
Established conditions for federal government to reimburse states for outpatient Medicaid services. Required establishment of a Drug Utilization Review (DUR) program including a prospective and retrospective component in order to receive that money.
How often will the FDA inspect drug manufacturer facilities to ensure GMP
Every 2 years, unless deemed more frequently necessary
What is the vaccines for children program (VFC)
Federally funded program to ensure 16 vaccines at no cost to children. CDC buys vaccines at discount to distribute to state health depts and local health agencies, to distribute to private physician offices and public health clinics registered as VFC providers
What are the laws regarding initial dosing of methadone
First dose may not exceed 30mg, and total first day dose cannot exceed 40mg unless the physician documents that 40mg could not suppress symptoms
What form must be filled for organizations who wish to receive shipments of narcotic drugs for the treatment of narcotic addiction
Form FDA 2632
What is the Food and Drug Administration Amendments Act
Gave FDA authority to require REMS from manufacturer to ensure benefits of drug outweigh risks.
What is the Health Insurance Portability & Accountability Act
HIPAA: Federal law to protect privacy of health information without diminishing client access to care. Responsibilities of health institutions under HIPAA include 1) reasonable steps taken to limit use or disclosure of health information 2) Various steps taken by health care providers - Medical groups (clinics, hospitals, physician offices, etc.) must provide written privacy notice to patients, describing how the patients medical information may be used and disclosed, as well as where to access this information. Most will require patient to sign off as acknowledgment. Form must be kept for 6 years from that date of last Rx, no requirement for future signatures.
What is the Pure Food and Drug Act?
Halted the sale of contaminated foods and medicines and called for truth in labeling. Prohibited food and drugs distribution through interstate commerce to be adulterated or misbranded. Did NOT require manufacturers to list ingredients or directions for use. One of the first drug regularion laws (1906)
How is child resistant packaging tested
If a package may be opened by more than 20% of children aged 5 years and under within 10 minutes, OR less than 90% of adults aged 50-70 are unable to open and close the package in 5 minutes and again within 1 minute, upon testing, packaging is said to be insufficient
What is the FDA Therapeutic Classification for New Drugs
Important to know: Type P: Drug represents major therapeutic gain, no other effective drugs available for particular illness. These drugs given priority review Type S: Drug similar to other available drugs. Undergo standard review Less common classifications: Type AA: Drug with potential use for HIV/AIDS related disease, often given fast track Type E: Drug for life threatening/severely debilitating disease. Given priority review and may be used in patients in imminent danger of death Type F: Indicates drug placed in hold until submitted data is further evaluated Type N: Indicates drug considered for non-Rx status Type V: Drug considered for orphan drug status
What is the Medicaid Tamper-Resistant Prescription Requirement
In 2008 CMS issued requirement that all written, non-electronic Rxs for medicaid outpatient drugs must contain 3 tamper resistant features: - Prevent unauthorized copying of completed or blank prescription form - Prevent the erasure or modification of information written on the Rx by the provider - Prevent the use of counterfeit Rx forms - Does not apply to medical equipment,, prosthetics, orthotics, and diabetic testing strips. (Differ by states, review)
What is the expiration date requirement for repackaged unit dose packages
In absence of stability data, recommended to not exceed 25% of remaining time between date of repackage or 12 months from the date of repackaging, whichever is shorter
What additional regulations are required of drugs the FDA deems as narrow therapeutic index drugs
Instead of allowing the usual variability limit of 90-110% of label claim, variability limits kept to 95-105%, with some states having tighter limits
What may be done in the case of an electronic prescription for a controlled substance fails to be transmitted.
Intermediary must notify the practitioner. If the Rx is for CS III-V, practitioner may print the prescription, manually sign it, and fax the Rx directly to the pharmacy
What is the IND application
Investigational New Drug application, first step in bringing a drug to market. Sponsors (manufacturers, researchers, academics, orgs, etc) must complete extensive testing to assure safety and efficacy for its claimed use. Once submitter FDA must decide in 30 days whether investigational drug is suitable for testing, before clinical trial may be conducted.
Orphan diseases are said to affect how many people
Less than 200,000
What products are considered low risk CSPs
Manufactured in closed system, include: - Transfer of a solution from a commercial vial or ampules with needle and syringe - Compounding TPN solutions using commercially available sterile solutions - Transfer of sterile solutions into elastomeric devices
What are regulations regarding pharmacist refill for written non-Rx drugs
May refill without prescriber authorization unless: - Dose requested greater than recommended dose on OTC labeling - Prescriber has limited the number of refills on the original prescription - Drug is CS V where the number of refills must be designated by the prescriber - Individual state has set a time period limit for refills
What is Medigap?
Medicare Supplemental Insurance-to pay for medical services and items not covered by Medicare and Medicare's coinsurance and deductible. Medigap is a private insurance designed to help pay for those amounts that are typically the pt's responsibility under Medicare. there are several standard Medigap policies established by the federal gov w/ the ins industry
What products are considered high risk CSPs
More complex compounds, include: Class I — involves pooling sterile drug products for subsequent transfers, complex compounding involving numerous aseptic processes, or preparing an infusion intended for multi-day use in a portable pump or reservoir system (ie TPN compounded with automated compound devices) Class II — involve greatest contamination risk, most which will have to be sterilized by compounder. Include using non sterile drug substances in preparing product, using "open systems" such as compounding morphine solutions for injection using morphine powder, or compounding sterile nutritional solutions using nonsterile ingredients during which the initial mixing is performed in an unsealed or nonsterile reservoir
What is the USP guideline for beyond use dating of dispensed multidose solid oral dosage forms
Must be the shorter of either manufacturers expiration or not more than one year from date dispensed
Are drugs that have been marketed prior to 1962 listed in the orange book
No
Are refills of CS-II substances allowed
No
May notice of inspection form 482 be refused
No
May one substitute an AB1 product for an AB2 product
No
Must cosmetics obtain premarket approval or conformance with cGMP?
No, however they must manufacturer products under sanitary conditions, otherwise may be considered adulterated, or if they are deemed unsafe may be misbranded
May a pharmacy hire anyone with a past felony related to controlled substance
No, unless a specific exemption is requested from the DEA through which a waiver must be sent into the DEA by the employer before the individual may be hired
Are prescribers required to maintain records of CS prescribed
No, unless prescribed as part of a maintenance and detox program - If they dispense such medication, MUST keep records
What are FDA regulations regarding patients who obtain Rx drugs from outside the US via mail or visiting
Not sanctioned, but appears acceptable provided that: 1. Intended use of drug unapproved and for serious condition which effective treatment may not be available domestically through commercial or clinical means 2. Drug will not be distributed to others 3. Product considered not to represent unreasonable risk 4. Individual seeking to import product affirms in writing that it's for the patients own use (no more than 3 month supply) and provides name and address of doctor licensed in US responsible for treatment, or provides evidence that product is for continuation of treatment begun in foreign country 5. Drug may be shipped to patient or their physician or pharmacy FDA may still decide that drugs can be refused entry as they are technically illegal
Who is the legal owner of a prescription
Once handed to the pharmacy, and filled/dispensed, it is legally owned by the pharmacy and shall not be removed from the files unless by court order. RPh may refuse to gives the patient or prescriber the prescription back if they request, but may offer a copy
How must CS be stored?
One of two ways: 1) Securely locked (only method if used in research) 2) Dispersed throughout stock to prevent theft - Electronic alarm system also recommended - Carfentanil, etorphine HCl, and diphrenorphine must be stored in a safe or steel cabinet equivalent to a US Government Class V security container
When may oral prescriptions be used for Controlled substances
Only for CS III-V
Who may obtain DEA order forms (DEA form 222)
Only persons registered to handle controlled substances listed in schedules I and II, and persons registered to export such substances
What is a treatment IND
Permits the use of an investigational drug in the treatment of patients not enrolled in the clinical study. Pertains to the treatment of serious or immediately life-threatening diseases, with which there is no known cure or currently available drugs are ineffective (common with Alzheimer's, Parkinson's). Drug must be in stage 2 or 3 development
Who must sign the DEA form 222
Person authorized to sign an application for registration, AND the purchasers name in the signature space, if different than the signer
What are the Phases of clinical drug trials
Phase 1: Small group of healthy subject given drug to evaluate toxicological, PK/PD properties and safety to humans Phase 2: Larger group (>100) with target condition to be treated are given drug. Determines effectiveness of drug to obtain information about dosage, relative safety, and adverse effects Phase 3: Large groups (can be thousands) in several geographic area are part of controlled clinical study. Purpose to obtain data concerning effectiveness compared to placebo. Most double blinded. Usually conducted by independent investigators instead of sponser
When are the typical CS-II prescription labeling requirements not needed
Prescribed to patients in an institution, provided that: - No more than 7 day supply dispensed at once - Substance is not in the possession of the ultimate user prior to administration - Institution maintains appropriate safeguards and records regarding proper administration, control, dispensing, and storage of the substance - System employed by RPh in filling is able to identify the supplier, product, and the patient, and to set for directions of use and cautionary statements required by law
What is allowed regarding off label uses
Prescribers may prescribe meds for off label uses, despite discouragement from FDA. Manufacturers may NOT advertise these uses or allow sales representatives to detail unofficial uses, but may distribute peer-reviewed research papers describing off label uses
What is Medicare Part D?
Prescription drug coverage program available to all Medicare beneficiaries. Private companies contracted by Medicare provide the coverage. Cost to patient depends on beneficiaries income, if not low income, pays monthly premium, annual deductible, and copayment responsibilities. Copays based of tiers (Tier 1 least expensive generics, Tier 2 preferred brand name, Tier 3 non preferred brand name, Tier 4 rarer high cost drugs)
What is the law regarding reimportation of drug products to the US
Procedure is legal only if performed by original manufacturers
What is the FDA's "Bad Ad Program"?
Program by FDAs Office of Prescription Drug Promotion (OPDP) that asks health care professionals to assist in recognizing misleading promotional activities and reporting them as they cannot be at all promotional launchings etc. Also aids in educating HCPs about misleading promotions
What is the Drug Addiction Treatment Act of 2000
Provided a waiver for Narcotic Addict Treatment Act (NATA) requirements and permits qualified office based physicians to prescribe and pharmacists to dispense CS III-V narcotic drugs for treatment of opioid addiction. These prescribers must also not have more than 30 patients on such addiction treatments at any one time (use of buprenorphine)
What is the Narcotic Addict Treatment Act (NATA)
Provided more stringent control for use of methadone in narcotic dependence treatment. Restricted its dispensing to practitioners registered with the DEA
What is the Biologics Price Competition and Innovations Act of 2009
Provides abbreviated approval pathway for biological products classified as "biosimilar" to an FDA approved reference product (vaccine, blood/blood component, gene therapy, tissues, or proteins). Should have same mechanism of action, route of administration, dosage form and strength of reference product; that is, no clinically meaningful difference. NOT considered interchangeable
What is the Controlled Substances Registrant Protection Act of 1984
Provides for the federal investigation of pharmaceutical thefts and robberies if: - Replacement cost of CS taken is $500 or more - A registrant or other person is killed or suffers significant bodily injury during the commission
What is the Federal Anti-Tampering Act of 1982
Required tamper evident packaging be used on select OTC products and cosmetics, particularly PO products. Package must indicate how the consumer can determine if package was tampered
How may a purchaser register for CSOS
Required to acquire a CSOS digital certificate through a technology called Public Key Infrastructure (PKI)
What are fast track products
Sponsor of experimental new drug can have review accelerated by requesting secretary of HHS grant drug "fast track" status. Intended for drugs that treat disease with no known alternative therapies. Permits sponsor to begin clinical development phases before adequate and well controlled studies to establish efficacy. Also allows "rolling submission", allows sponsor to submit data in sections rather than when the entire application is complete. FDA will review and respond within six months rather than the 10 month required for standard review
What are drug formulary requirements for Medicare part D
Standard plans MUST include drugs within all therapeutic drug categories/classes developed by USP. 6 drug categories (anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, immunosuppressants) require MOST drug products be included. Changes are made yearly, must inform pharmacies/beneficiaries before changes made
What is the FDA Compliance Policy Guide of 1992
States pharmacies may compound drugs extemporaneously, without being deemed manufacturing if: - Quantity prepared is reasonable for filling existing or anticipated prescriptions based off habits of local prescribers or Rxs on file - Dosage forms are not being compounded, provided, or sold to other pharmacies or third parties such as physicians offices - Drug products are not ones already commercially available - Ingredients included meet official standards of USP/NF. If no official monograph available, may be used if it is a component of an approved drug product, or on a list of approved substances developed by HHS - The pharmacy does not actively solicit business for specific compounded drug products by advertising of by otherwise promoting compounding capabilities. BUT may advertise to the public and health professionals that is specializes in Rx compounding. - Pharmacy does not attempt to compound product on the list of products withdrawn from market - Pharmacy limits interstate distribution of compounded products to no more than 5% of total prescriptions filled by said pharmacy
What is a premarket notification, or 510(k)
Submitted to FDA before a manufacturer proposes to market a medical device. If FDA agrees the new device is substantially equivalent to a legally marketed device for which premarket approval is not required, the manufacturer may market it immediately. FDA does not require clinical data in most 510(k)s
What happens if a drug product does not have an expiration date
The product is considered to be misbranded
What is the Orphan Drug Act of 1983?
This act fosters orphan drug development for diseases so rare that the usual approval process would take decades to complete. Provides various tax and licensing incentives to manufacturers to make development of drugs appealing
What is the FDA Chemical Classification of new drugs
Type 1: Indicates new molecular structure, different from existing drugs, but may be used for similar therapeutic purposes to available drugs. Drug cannot be marketed at present in US (important to know) Type 2: Indicates drug is derivative of molecular structure already approved in US (ie new salt or ester of existing drug) Type 3: Indicates drug is a new formulation of drug already previously approved Type 4: Indicates product is combination of two or more drugs Type 5: Indicates drug has been manufactured by new company Type 6: Indicates new therapeutic indication for previously approved drug (important to know)
Who is responsible for designating nonproprietary (generic) name for new drugs
United States Adopted Names Council (USAN, sponsored by AMA, APhA, and USPC), BUT must be granted final approval by secretary of HHS, who can require a name change if confusion with other drugs is plausible.
What is the Abbreviated New Drug Application
Used for generics of drugs previously approved under the brand name. Rather than submitting complete NDAs, ANDAs can be submitted, only requiring drug PK, bioavailability and clinical activity data similar to innovator drug. First applicant to complete formal review showing equivalence is awarded 6 month generic exclusivity
Is the mailing of prescription/narcotic drugs permitted by USPS
Yes, including Controlled substances if mailed by drug manufacturers or their agents, pharmacies or other authorized handlers if lawful under DEA regulations (mailer is registered with DEA)
May an individual practitioner who is an agent of a hospital of institution prescribe a CS under the registration of a hospital
Yes, provided it is in the usual course of that practitioners professional practice, and the institution assigns a specific internal code number for each prescriber authorized to do so (i.e. DEA # of AB1234567-012, last 3 digits the internal code)
Is the transfer of CS between pharmacies permitted
Yes, provided that the practitioner to whom the CS is to be distributed to is registered under the CSA to dispense that CS, the distribution is recorded by both sides, a DEA Form 222 is used if needed, the dosage units of all CS distributed does not exceed 5% of yearly CS dispensed (if they do, must register as distributor - May also be done in case of pharmacy closing down
Are partial fills of CS III-V substances legally allowed
Yes, provided that: - Each partial fill is recorded in the same manner as a refill - The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed - No dispensing occurs beyond 6 months after the date on which the prescription was issues
At what intervals may a patient with Medicare PDP or MA-PD card change their provider
once a year
What is the Food, Drug, and Cosmetic Act of 1938?
required that new drugs cannot be marketed until proven SAFE for use under the conditions described on the label. Labels must now contain adequate directions for use. Warnings included about medications that may be habit forming. Also first law regulating cosmetics and medical devices. Drugs marketed before 1938 exempt from labeling and safety proof.
