P716 Final Exam

Automatic reinstatement if _____ or less versus petitioned reinstatement of license if greater than ____ suspension was given

6 months

C3 and 4 script validity and allowed refills

6 months/5 refills

stare decisis

meaning to abide by decided cases

how long should cancer drug repository forms be maintained?

5 years

MI board of pharmacy composition

(a) Six pharmacists. (b) One pharmacy technician. (c) Four public members.

A pharmacy dispensing an opioid antagonist under the standing order shall submit all of the following information, without individual identifiers, to the department on a quarterly basis, in a manner established by the department...

(a) The total number of doses of opioid antagonists dispensed under the standing order. (b)The total number of doses of opioid antagonists dispensed under any type of prescription, including the standing order. (c) The number of each type of formulation dispensed. (d) Any other relevant information specified by the department.

compounded drug label requirements

-"this is a compounded drug" -Name, address, and phone number of outsourcing facility -Lot or batch number, established name of the drug, dosage form and strength, volume or quantity, date of compound, expiration date, storage and handling instruction, NDC if available, "not for resale" statement

minimum requirements for MI pharmacist

-Age 18 or older -Have good moral character -Specific education, training equivalent, or experience in pharmacy so as to be able to promote safe and competent practice and informed consumer choice -Working knowledge of the English language -Payment of license and application fees -Successfully pass examinations -No disciplinary actions pending in another state

tech CE requirements

-20 accredited hours during a two-year license period 1 hour: pain and symptom management 1 hour: patient safety 1 hour: pharmacy law Human Trafficking -No more than 12 hours in one 24 hour period -A least 5 hours "live"

CE requirements

-30 hours of approved continuing education (CE) credits during a 2 year period that the RPh license is in effect -At least 1 CE hour must address pain management -A minimum of 10 hours (of 30) must be obtained from attending live presentations, as opposed to paper or on-line CE programs -No more than 12 hours of CE credit per 24 hour period

medicare provides federal health insure for the following...

-65 years and older -permanent disability -end-stage renal disease (ESRD) -health related issues from living in a declared emergency area

CMEA exclusions

-A person who possesses ephedrine or pseudoephedrine pursuant to a license issued by US to manufacture, deliver, dispense -A person who possesses drug pursuant to a prescription -A person who possesses the drugs for retail sale pursuant to a license issued under the general sales tax act. -Possesses drug in the course of business (legitimate) -Possession of product formulated to prevent conversion to methamphetamine -Possession of any pediatric product intended for administration to children under 12 years of age

Exception to dispensing of Schedule 2 controlled substances in LTC Partial dispensing is permitted where:

-Admitted to facility or outpatient and -Documented terminal illness

if a pharmacist objects to filling plan b, what are their options?

-Another pharmacist on duty could dispense -Pharmacist/staff identify another pharmacy patient can go to nearby -Cannot obstruct patient access through refusal to transfer, etc

What can be added or changed on a noncontrolled substance prescription?

-Any information can be added or changed after consulting with the prescriber. -If signatures are missing, verbal confirmation can serve as the signature and must be documented on the prescription face.

Exemption of Federal Government Practitioners from DEA Registration

-Armed Services (U.S. Army, -Navy, Marine Corps, Air Force, Coast Guard) -Public Health Service Bureau of Prisons

verbal rx

-Between prescriber (or agent) and pharmacy personnel -Original rx is the transcribed version written by pharmacy personnel

Health Professional Recovery Program (1994)

-Ccreated under majority regulatory reform legislation -Endorsed by Michigan's licensing boards, professional societies and associations -Confidential (not subject to discovery, subpoena, FOIA) depending on referral source -Includes both Non-Regulatory and Regulatory participants

first time licensed pharmacist requirements

-Completed a degree from a program of pharmacy education approved by the Board. Must be accredited by the ACPE. Certificate of Pharmacy -Education from school to board --> Completed a program of internship -Use the form provided by LARA and pay the fee. -Pass a criminal background check -Completion of 1600 hours intern/externship --> If from other states, must be reported directly to MI Board

Proper records for partial filling in LTC Dispensing pharmacist must record:

-Date of partial fill -Quantity dispensed at time of fill -Remaining quantity authorized -Name, initials, or other identification of dispensing pharmacist -Total quantity cannot exceed total prescribed -Valid in this manner no longer than 60 days from data of issue (not partial fill date)

Dietary Supplement Health and Education Act of 1994

-Defined dietary supplements -Permit manufacturers to make certain claims that would not have been permitted under FDCA -Supplements treated more like food than drug

Prescription Drug Marketing Act of 1987

-Established sales restrictions and recordkeeping requirements for samples -Prohibits hospitals and other healthcare entities from reselling their medications to other businesses

Durham-Humphrey Amendment of 1951

-Established two classes of drugs: Prescription & Over the Counter (OTC) -Authorizes oral prescriptions and refills -Removed the requirement for 'adequate directions for use' from prescription medications *if* the label stated, "Caution: Federal law prohibits dispensing without prescription"

Robinson-Patman Act (1936)

-Makes it unlawful for sellers to discriminate in price between purchasers of like products -When the effect of discrimination may injure competition

Relicensure

-Every 2 years a pharmacist must renew their pharmacist license *Renewal date is original Issue Date (this is new) *And controlled substance license if working with controlled substances *Renewal date determination *Randomized to 1 year or 2 years from date of initial licensure -Must have all CE completed prior to relicensure date -Submit relicensure application, pay fee, submit affidavit of completion of CE -60 day grace period -Good to check on other information on file such as address, name, place of work

MAPS exceptions

-Exceptions: administered directly to a patient -Dispensed by health facility for up to a 48 hour supply -Dispensed from a Veteran's Affairs facility -Dispensed in emergency for hospice care -Methadone from methadone treatment program

Secure and Responsible Drug Disposal Act of 2010

-Focused on controlled substances -Does not stop previous methods of disposal -Provides additional options for disposal -Non-Retrievable

Expedited Partner Therapy (EPT)

-For chlamydia and gonorrhea diagnoses -EPT for chlamydia: azithromycin 1 gram oral x 1 dose -EPT for gonorrhea: cefixime 400mg oral x 1 dose and azithromycin 1 gram oral x 1 dose -Dispense in name of partner if known --> If patient not known, then use "expedited partner therapy" -Allowed for any partner in the previous 60 days of diagnosis -No requirement to third party payers to pay

C2 phone script exceptions

-Immediate administration necessary for proper treatment -Alternative not available -Not reasonably possible to provide written Rx -Quantity prescribed and dispensed limited to amount adequate to treat patient during emergency period *Only the prescriber may phone in the emergency prescription *Prescriber must write the phoned order on a prescription form and forward to the dispensing pharmacy within 7 days of oral transmission

MI prescribing authority for NPs or NMs

-In Michigan, must be given delegated authority by an MD or DO for CS (no quantities greater than 30 day supply) -Cannot delegate prescriptions intended to cause miscarriage or fetal death

MI prescribing authority for PAs

-In Michigan, must work under a collaborative agreement with an MD or DO -In Michigan, if prescribing CS, need a CS License -Cannot delegate prescriptions intended to cause miscarriage or fetal death

written rx

-Includes both handwritten and printed from a computer -Commonly known as a "hard copy" -Original rx is the hard copy

Personal Disqualification

-Incompetence -Substance abuse -Mental or physical inability, reasonably related to the ability to practice safe and competent manner --> Mental incompetence -Conviction of a misdemeanor punishable by imprisonment for a maximum of 2 years, conviction of a misdemeanor involving illegal delivery, possession, or use of CS, or a felony -Lack of good moral character Conviction of specified criminal offenses -Destroying medical records/creating false records -Conviction of misdemeanor or felony involving fraud -Adverse licensure action by Board of Pharmacy -Conviction of misdemeanor related to ability to practice in safe and competent manner

outsourcing pharmacy drug reporting

-June and December, must submit report -for each drug, provide active ingredient per unit, dosage form and route of admin, package description, number of individual units produced, NDC code if assigned

false claims act prohibits

-Knowingly presenting or causing to be presented a false or fraudulent claim for payment or approval -Knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim Examples: -billing a different drug than dispensed or not dispensed at all -splitting rx to receive additional fees -refilling medications without patient authorization

Granting a license to a person whose license lapsed for failure to renew within 60 days after expiration date and not more than 3 years

-License is considered null and void, cannot practice (RPh, Intern). -Must provide evidence of completion of 30 hours of approved CE within the 2 year period immediately preceding the application for renewal -Complete application and fee -Be in good moral character

verbal rx CS requirements

-Limited to Schedule 3-5 prescriptions (only pharmacist or delegated intern may perform this interaction) -Prescription must be immediately reduced to writing and follow the same requirements as for controlled substance written prescriptions except for the signature -Name of pharmacist or intern receiving the prescription is also required

How long to keep original Rxs for?

-MI state law: 5 years -Hard copies can be saved as electronic records after the first three years. -Health plans may require longer (i.e.; Medicaid: 7 years)

additional overdose risk indicators

-Multiple provides - received CS prescriptions from more than 5 providers in any 365-day period -Multiple pharmacies - used more than 4 pharmacies in 90 day period -High dose, average daily opiate dose over 40 morphine milligram equivalents (MME) and more than 100 MME total in any time in the previous two years

Opioid Antagonist Public Acts 311, 312, 313

-Naloxone hydrochloride or any other similarly acting and equally safe drug approved by the FDA for treatment of drug overdose -Prescription may be issued to and the pharmacist can dispense opioid antagonist to a person or individual other than the patient - (recently updated) -Civil immunity for certain acts - such as dispensing under these rules -Naloxone access: the Chief Medical Executive for MI write a standing order for naloxone. RPh can dispense without a prescription from physicians. -Individual at risk, family member, friend, any person willing to assist another individual at risk can pick up naloxone

Prescribers under collaborative practice must have...

-Name of dependent prescriber -Signature of dependent prescriber -If able to write for controlled substance, must have dependent prescriber DEA number

Pharmacists under delegated authority must have...

-Name of dependent prescriber -Signature of dependent prescriber -Name of delegating physician on prescription

Prescribers with delegated authority (NPs, NMs) must have...

-Name of dependent prescriber -Signature of dependent prescriber -Name of delegating physician on prescription If a controlled substance, must have *Dependent prescriber (NPs, NMs) DEA number *Delegating physician's name & DEA number.

DATA waiver requirements

-Open to independent and dependent (Mid-level) practitioners (2017) -Must obtain a special DEA number that begins with "X" --> In addition to regularly assigned DEA number -Cannot treat more than thirty (30) patients in first year, then up to two hundred seventy-five (275) --> Mid-level practitioners can treat up to thirty (30) patients

Health Professional Recovery Committee (HPRC)

-Oversees the HPRP -Statewide committee -Comprised of members representing the healthcare professions regulated under the public health code -2 public members appointed by the Director of the Department of Community Health -Authority to develop policies and procedures for the program contractor to follow -Oversees the performance of the contractor who operates the program

pharmacist in charge (PIC)

-PIC to be licensed in Michigan -PIC and pharmacy will be jointly responsible for compliance -May be the PIC for more than 1 pharmacy -Work an average of 8 hours per week at the pharmacy for which they are PIC -PIC shall maintain appropriate records and demonstrate compliance upon request of the board -Notify the board of pharmacy of change in PIC no later than 30 days after change

What can be added or changed on a controlled substance prescription?

-Patient address, drug strength and quantity, directions for use, refills, or issue date may all be added/changed after consultation with prescriber. -Things that CANNOT be changed include patient's name, prescriber signature, "do not fill until" dates, or the drug prescribed.

Auto-injectable Epinephrine Public Acts 186 and 187

-Pharmacist can dispense to a school board on a prescription from prescriber -School board is the patient name. My be expanded to other entities such as restaurants.

Remote Supervision

-Pharmacists may supervise pharmacy technicians and other pharmacy staff remotely. -Supervision must be conducted through a real-time, continuous audiovisual camera system, capable of allowing the pharmacist to visually identify the markings on tablets and capsules. -The pharmacist must have access to all relevant patient information to accomplish the remote supervision and must be available at all times during the supervision to provide real-time patient consultation. -A pharmacy technician may not perform sterile or nonsterile compounding without a pharmacist on the premises.

3 circumstances that a C2 can be faxed

-Practitioners prescribing C2 for long term care residents -Practitioners prescribing C2 for hospice patient (this must be documented on prescription face) -Practitioners prescribing C2 to be compounded for direct patient administration via parenteral, IV, IM, subcutaneous, or intraspinal infusion

electronic rx

-Prescription communication via electronic means -Includes computer-to-computer and computer-to-fax prescription -Original rx is the electronic record

USP<797> Sterile Preparations

-Procedures and requirements for compounding sterile preparations. -Describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations

Exempt Schedule V Sales

-Product that is limited to no more than 240 ml (8 ounces) or 48 solid doses of a substance containing opium -No more than 120 ml (4 ounces) or 24 solid doses of any other controlled substance exempt schedule 5. Not dispensed any more often than every 48 hours Purchaser 18 years or older

medicaid provides healthcare costs for the following groups...

-blind -disabled -aged -members of families with dependent children -eligibility determined by income and assets

CMEA store restrictions

-Products must be placed behind the counter or in a locked cabinet -Within a locked case so that a customer wanting access must ask a store employee for assistance -Within 20 feet of a counter that allows the attendant to view the products in an unobstructed manner or utilize an antitheft device on those products that use special package tags and detection alarms along with constant video surveillance

DEA registration designation of Narcotic Treatment Program (NTP)

-Provider must be separately registered with DEA as NTP -Cannot provide treatment for addiction as part as usual course of regular practice -Later changed to Opioid Treatment Programs (OTP) -Administered directly to patient at OTP location

Resource Conservation and Recovery Act

-Provides a mechanism for tracking hazardous waste from its generation to disposal -Lists of agents that are to be considered hazardous waste when they are discarded -Requires handling of RCRA as hazardous

Compounding of Alcohol-Based Hand Sanitizers

-Public Health Emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020 -FDA issued guidance for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists -Remain in effect for duration of the state of emergency declared on March 10, 2020

faxed rx

-Rx is faxed from prescriber's office to the pharmacy -Original rx is the printed copy

Combat Methamphetamine Epidemic Act of 2005, Methamphetamine Prevention Act of 2008

-Sale limited to 3.6 grams alone or in mixture/person/day -9 grams alone or in mixture/person/ 30 days *7.5 g/person/30 days via mail order *7.5 g/person/30 days via mobile retailer A person may not possess more than 12 grams of ephedrine or pseudoephedrine alone or in a mixture

If more than 8 years for relicensure

-Submit proof of completion of 30 hours CE in 2 years prior -Take and pass MPJE -Take and pass NAPLEX -Complete, within 6 months of apply for relicensure, a program of at least 400 hours of practical pharmacy experience under licensed pharmacist -Application and fee -Good moral character -Fingerprints

USP<800> Hazardous Preparations

-USP800: Hazardous Drugs - Handling in Healthcare Settings: -This General Chapter provides guidelines and recommendations to protect healthcare personnel and the environment when handling hazardous drugs. Staff handling hazardous drugs can experience adverse health effects when exposed to such drugs if appropriate precautions are not taken

Preparation, mixing, assembling, packaging, and labeling of a drug or device by a pharmacist under the following circumstances:

-Upon receipt of a prescription for a specific patient -Upon receipt of a medical or dental order from a prescriber or agent for use in the treatment of patients within the course of the prescribers professional practice -In anticipation of the receipt of a prescription or medical or dental order based on routine, regularly observed prescription or medical or dental order patterns -For the purpose of or incidental to research, teaching, or chemical analysis and not for purpose of sale or dispensing

If patient not currently enrolled in an NTP in an LTCF that is not registered with DEA as a hospital/clinic or an NTP...

-a practitioner may administer narcotic drugs to the individual for relieving acute withdrawal symptoms -No more than one day's medication may be administered to the individual or for the individual's use at one time (i.e. can't dispense) -No more than three days and may not be renewed or extended.

transferring a non-controlled prescription requires what information?

-all required info from the original rx -rx number from original phramacy -name of pharmacy issuing the copy -date copy was issued -number of refills remaining

regulatory referral process

-boards or disciplinary subcommittees require involvement as a condition of being allowed to continue or resume practicing their profession -monitoring agreements typically contain the same elements as for non-regulatory participants -regulatory participation is subject to FOIA and federal reporting requirements

verbal rx for noncontrolled substances

-communication should occur between the prescribed and the pharmacist -verbal order needs to be immediately reduced to writing and dated -prescriber signature is not needed

penalties

-community service is no longer an option for a BOP sanction -for an offense committed within 2 years after a pervious offense of the same kind, a disciplinary subcommittee shall suspend the license/registration for a period of at least 180 days or revoke the license/registration

drug for cancer drug repository is eligible for donation if...

-completed donor form stating drug properly stored, never opening, used, tampered with, adulterated, or misbranded -drugs expiration date is at least 6 months later than the date donated -in original, tamper-evident packaging that includes the drug's lot number and expiration date

If not engaged in practice of pharmacy for more than 3 but less than 8 consecutive years, may relicense upon application and...

-completion of a program of practical pharmacy experience of at least 200 hours within 6 months of applying for relicensure - licensed pharmacist, practical pharmacy experience; -Submit proof of completed 30 hours CE in 2 years prior -Take and pass MJPE -Application and fee -Establish good moral character -Submit fingerprints

non-regulatory referral process

-confidential in nature -records expunged after 5 years for voluntary participants who have fulfilled monitoring agreement and have shown no indication of relapse

CMEA log requirements

-date of sale -time of purchase -name, address, and date of birth of buyer -the amount and description of product sold -description of the identification used to make the purchase (state or federal ID required that includes name and DOB) -purchaser to sign the log at the time of scale -information (in MI) entered into NPLEx

unused prescription drug program does not permit

-expired prescription drugs -controlled substances -drugs that have been held outside of the health professionals control where sanitation and security cannot be assured -drugs that can only be dispensed to a patient registered with the drug's manufacturer

medicaid covers all or part of

-inpatient and outpatient stays -lab/xray -SNF and home healthcare -MD, DDS, RN, OD -outpatient rx meds

Anti-Kickback Statute prohibits anyone from

-knowingly and willfully soliciting, receiving, offering, or paying any remuneration in exchange for referrals or for furnishing any goods or services paid for by medicare/medicaid -violations of AKS also constitute violations of FCA Examples: -free services in exchange for a contract -any renumeration to a prescriber for referral to a pharmacy -cash for rx transfers

written rx for CS requirements

-must include prescriber phone number and quantity denoted in both number and written terms -If more than one prescription for a controlled substance are issued with "do not fill until" dates, separate forms must be used

written or fixed non controlled prescriptions must also include what?

-must include provider's professional designation -up to 4 orders can be on a handwritten rx, a printed/typed list can contain up to 6 --> there is not a limit for rxs created in medical institutions for inpatient use -CMS requires that written rxs have at least 3 tamper resistant characteristics

Elements required in the C-V OTC record

-name and address of patient -name and address of the purchaser if different -name and quantity of substance -date of purchase -full name or initials of pharmacist/intern -medical purpose as determined by pharmacist

central fill recording requirements

-need to maintain a copy of the rx -needs to keep record of the date of the order received, date filled, date and method of delivery to the originating pharmacy, and pharmacist name who filled the prescription

transferring C3-5 rx requirements

-original required rx data -date copy was issued -original date of dispensing -original number of refills and refills remaining -pharmacy name, address, DEA, and rx number from original pharmacy -name of pharmacist transferring the rx

institutional CS rx requirements

-patient name -prescriber name, address, DEA number or supervising DEA number if the provider does not have independent prescriptive authority, and signature -drug name, dose, frequency -date ordered -prescriptions written for animals need to include owner's name and address and the species

hospice emergency drug box exchange log documenting...

-receipt of the boxes from the pharmacy (that provides them) -assignment of the boxes to registered nurses or physicians' assistants -return of the boxes to the pharmacy for restocking

requirements for outpatient controlled rxs

-same as noncontrolled -additional items include patient address, drug dosage form, prescriber DEA, provider professional designation

electronically transmitted rx

-security measures must be in place to ensure technical nonrepudiation, confidentiality, and authentication of the prescriber/dispenser -additional requirements include prescriber telephone number and provider professional designation

each CPMP must be labeled with what?

-serial number for the CPMP itself and a separate identifying serial number for each of the rx orders for each drug contained in the CPMP -drug name, strength, physical description, and total quantity of each drug product -the name of the prescriber for each drug product -directions for use and cautionary statements -date of preparation -expiration date shall not be later than the earliest manufacturer's expiration date or 60 days after dispensing -name, address, telephone number of dispenser

disciplinary subcommittee

-subcommittee of the BOP -conducts hearings, investigations, and promulgates consent agreements -consists of pharmacist and community board members

for a pharmacy to participate in cancer drug respository

-submit to the board the name, street address, and telephone number of the pharmacy -the name and telephone number of a pharmacist employed by or under contract with the pharmacy, who is familiar with the program -statement indicating that the pharmacy is licensed in the state and in compliance with all laws, and is voluntarily participating

disciplinary subcommittee procedure

-the attorney general office rep or member for the DCH along with a member of the BOP meet with the person with the allegation and in many cases they develop a consent agreement -the agreements then come to the disciplinary subcommittee for approval, they DO NOT go to the full board -the subcommittee votes on the consent agreement with the requirement of a majority approval

compounding does not include...

-the compounding of a drug product that is essentially a copy of a commercially available product (if documented drug shortage, federal law allows limited compounding of the product) -the reconstitution, mixing, or other similar act that is performed pursuant to the directions contained in approved labeling provided by the manufacturer of a commercially available product -the compounding of allergenic extracts or biologic products

Order of priority in who to dispense to for cancer drug repository

-uninsured or do not have coverage for cancer drugs or supplies -individuals who are enrolled in Medicaid, medicare, or any other public assistance health care program -all other individuals who are state residents with cancer

The patient presenting to CDR to obtain medication must provide

-verification of current diagnosis of cancer -proof of insurance if any -sign of cancer drug repository recipient form

dispensing records can be documented one of three ways, what are the three ways?

-written manual system: refills, dates, pharmacist initials, manufacturer, and generic substitutions are documented on the prescription itself -uniform system: essentially a logbook for dispensing rxs -automated uniform system: electronic systems used to maintain dispensing records

Each box must have a label attached to the drug box so that it is visible from the outside of the box:

1. The name and address of the pharmacy 2. The name and address of the hospice 3. The name of the pharmacist who last inspected and restocked the drug box 4. The date the drug box was last restocked 5. The date on which the drug box must be returned to the pharmacy for the replacement of expired drugs 6. The number of the drug box

hospice emergency drug box log must contain

1. The number of the box 2. The name of the hospice to which the box is released 3. The date the box is released to the hospice 4. The name and signature of the pharmacist who releases the box to the hospice 5. The expiration date assigned 6. The date the box is returned to the pharmacy for restocking 7. The name and signature of the pharmacist who received the box for restocking

If the total number of dosage units of all prescription drugs prepared or compounded by a pharmacy for resale, compounding, or dispensing by another person, during any consecutive 12 month period is more than ___% of the total number of dosage units prepared during the 12 month period, the pharmacy is a manufacturer.

5

mandatory reporting requirements

1. requires licensed/registered health care professionals to make good faith reports of any suspected violations to the DCH 2. requires a licensee or registrant to notify the department of a criminal convictions or a sister-state sanction within 30 days after the date of the conviction/action 3. allows a report of suspected substance use or mental health disorders to be made to the HPRP in lieu of the DCH

non-controlled script validity and allowed refills

12 months/unlimited

how long are controlled substance licenses good for in MI?

2 years

what controlled substance rxs can be faxed?

3-5

DATA waived practitioners may treat __ or __ patients at any one time, dependent on individual authorization.

30 in the first year, 100 after that, if approved

how long do those sit on the MI BOP?

4 years

Collection of CS - DEA form __ used when shipping container to reverse distributor

41

Compliance with USP ___ for nonsterile compounding is/should not be a burden for community pharmacies

795

Compounding under section 503A for sterile products must be done in accordance with U.S. Pharmacopeia (USP) chapters ___ and ___.

797, 800

An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a __-day supply of a Schedule II controlled substance

90 must meet following criteria: -issued for legitimate medical purpose -earliest date on each rx -does not create an undue risk

C2 script validity and allowed refills

90 days/none

3 day rule

ADMINISTER (not prescribe) to relieve acute withdrawal while arranging for pts referral for treatment No more than 1 day administered at one time Max of 3 days CAN NOT be renewed or extended past 72 hours

Public Health Service Act Section 319

Authorizes the Department of Health and Human Services (HHS) secretary to determine that a public health emergency exists Triggers emergency powers that permit the federal government to: -assist state and local governments -suspend or modify certain legal requirements -expend available funds to address public health emergencies

HD drugs include

Carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low dose, genotoxicity

CMEA

Combat Methamphetamine Epidemic Act

partial filling on C2s

DEA law states that Schedule 2 controlled substances can be incrementally partially filled, but the prescription will only remain valid 30 days from the original written date

MAPS: information collected

Drug name, NDC number, quantity, days supply, prescription number, date prescription issued, date dispensed, DEA reg of prescriber, DEA reg of dispenser, MI license number of pharmacy

Food and Drug Administration Amendments Act (2007)

Expanded FDA responsibility and authority to -Mandate safety labeling changes -Require clinical trial data reporting and registries -Require post-marketing surveillance -Require Risk Evaluation and Mitigation Strategies (REMS)

Manufacturers, distributors, re-packagers, and dispensers may only purchase compounded drugs from facilities registered with the ___

FDA

Misbranding

False or misleading labeling Lack of warning for habit forming drugs (PI only) Lack of listing of active and inactive ingredients Lack of adequate directions for use Lack of adequate information for use Imitation drugs Dispensing a prescription medication without a valid prescription

Form 106

For loss or theft of significant amount of controlled substance Must notify MI BOP within 10 days of discovery

Form 41

Form to request permission to destroy damaged, outdated, or unwanted controlled substances Keep original form for 2 years

Form 222

Form used to order C-II controlled substances Purchaser submits copy 1 and copy 2 to the supplier, retaining copy 3. Supplier fills out copies 1 and 2, keeps copy 1, sends copy 2 back with order to purchaser. Kept for 2 years

Insulins available without a prescription

Humulin N, Novolin N, Humulin R (100 u/ml), Novolin R, Humulin 70/30, Novolin 70/30, Humulin 50/50

Some medications are both prescription and OTC...

Ibuprofen: 200mg OTC; 400, 600, and 800 mg Rx Famotidine: 10, 20mg OTC; 20, 40 mg Rx Omeprazole: 20mg OTC, 10, 20, 40 mg Rx

What are the rules pertaining to "returning to stock" medications that have not been picked up?

If the pharmacy "returns to stock" in an open bottle of the medication with the same lot number and expiration date from which the drug was originally filled from, it is not misbranding. If the lot number and expiration dates are different, or it is left in the vial without an expiration date or lot number, then it would be considered misbranding. It would also violate the rule of ensuring the strength, purity and quality of the medication dispensed.

pharmacist prescribing authority in MI

In Michigan, pharmacists can write non-controlled prescriptions under delegated authority. Another pharmacist may fill.

Anabolic Steroid Control Act of 2004

Includes anabolic steroids in CIII and provides automatic schedule without need to prove they promote muscle growth.

Who Can Write for Controlled Substances?

Independent practitioners (MD, DS, DO, DP, DVM) Dependent practitioners (Mid-levels; NP, PA, RPh)

what amendment stated compounded drugs do not require FDA pre-marketing approval?

Kefauver-Harris Amendment - 1962

A statewide drug repository and distribution program overseen by ___

LARA

common law

Law made by the courts: judicial opinion has the power of law in which both law and science experts assist the court in making sound decisions. e.g. drug therapy issues

Nutrition Labeling and Education Act of 1990

Mandated nutritional labeling on food products and authorized health claims on labeling as long as in compliance with FDA regulations

The Chemical Diversion and Trafficking Act of 1988

Manufacturers and suppliers of chemicals and machines used in manufacturing selected chemicals must verify the legitimacy of customers before concluding transactions and must keep records

what should the records for each CPMP contain?

Must contain pt name and address, serial number for each drug product, info identifying the design of the CPMP, date prepared, expiration date, special labeling, name or initials of RPh

violation of general duty

Negligence or failure to exercise due care, including negligent delegation to, or supervision of , employees or other individuals, whether or not injury results, or any conduct, practice, or condition which impairs, or may impair, the ability to safely and skillfully practice the health profession

DAW 0

No product selection indicated

Dispensing schedule 5 substances without prescriptions maximum quantities

Not more than 240 cc (8 ounces) or 48 solid doses of a substance containing opium or more than 120 cc (4 ounces) or 24 solid doses of any other substance listed in schedule 5 are distributed at retail to the same purchaser in any single 48-hour period.

delegation authority

Only MDs and DOs are allowed to delegate prescribing authority

minimum requirements for noncontrolled prescriptions

Patient name Prescriber name and address --> If written under delegated authority, the delegating AND delegated prescriber's names must be on the prescription. Prescriber signature Drug name, strength, quantity, and directions for use Refills authorized Date written

Adulteration

Prepared, packed, or held in conditions where it may have been contaminated Exposed to a container that may have been contaminated Manufacturer under conditions that do not meet GMP Strength, quality, or purity differ from compendia standards or that stated on label Contains unsafe coloring agent Does not meet tamper-proof packaging requirements

Medicare part D

Prescription drug coverage Includes: medically accepted indications, biologics, insulin Excludes: OTCs, weight loss or gain, fertility, ED, cosmetic purposes or hair growth, cough and cold, vitamins (except prenatal, fluoride, vit D analogs), outpatient medications requiring testing or monitoring

Physician Anti-Self- Referral Law (Stark)

Prevent overuse of healthcare services & reduce costs to Medicare and Medicaid Directed at physicians with intent to avoid direction of patients to services where a financial relationship existed

Drug Quality and Security Act of 2013

Regulates compounding pharmacies and establishes framework for track and trace system (Drug Supply Chain Security Act)

Drug Listing Act of 1972

Required drug establishments engaged in manufacturing, preparation, propagation, compounding, or processing of a drug to register their establishment and products with the FDA

Section 340B of the Public Health Service Act (1992)

Required manufacturers provide outpatient drugs at special reduced prices to designated entities serving uninsured and underinsured

Prescription Drug User Fee Act (1992)

Required manufacturers seeking new drug applications (NDAs) to pay fees for applications and supplements when FDA must review clinical studies

Color Additive Amendments of 1960

Required manufacturers to establish the safety of color additives in food drugs and cosmetics

Food Additives Amendment of 1958

Requires additives found to cause or induce cancer in humans or animals as indicated by testing are banned

Food, Drug, and Cosmetic Act of 1938

Requires new drugs must be proven safe before marketing

Fair Packaging and Labeling Act of 1967

Requires the label to state: The identity of the product; The name and place of business of the manufacturer, packer, or distributor; and The net quantity of contents

Poison Prevention Packaging Act of 1970

Requires use of child-resistant containers for prescription and nonprescription drugs Must be manufactured such that 80% of children less than 5 cannot open them and 90% of adults can Allows manufacturers to market one size specifically for patients who may experience trouble opening --> caution warning needs to be included

Sherman Antitrust Act

Section I: makes unlawful every contract, combination, and conspiracy in restraint of trade, prohibits monopolies, attempt to monopolize, or conspiracies to monopolize Section II: limitations in individual businesses that constitute monopolies

OTC labeling requirements

Statement of identity of the product: -must include the established name -accurate statement of general pharmacological category/action -name and address of manufacturer, packer, or distributer -net quantity in package -cautions and warnings -adequate directions -drug facts panel

Drug Price Competition and Patent Term Restoration Act of 1984 or Hatch-Waxman Amendment

Streamline generic drug approval process and grant patent extensions

Kefauver-Harris Amendment of 1962

Strengthened new drug approval process by: -Requiring drugs be proved safe AND effective Administrative impact: -Transferred jurisdiction of prescription drugs from Federal Trade Commission (FTC) to FDA -Established Good Manufacturing Practices (GMP) -Required 'informed consent' of research subjects and reporting of adverse drug reactions (ADRs)

Permission to Destroy on Site

Submit written request in advance to local DEA office -Name, address, DEA number; proposed date; who destroying and witness; method; DEA Form 41

DAW 1

Substitution not allowed by provider

Orphan Drug Act of 1983

Tax and licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of 'rare diseases or conditions

The Controlled Substances Registrant Protection Act of 1984

Theft of Controlled Substances became a Federal offense (if any of these conditions are met): -Replacement value of $500.00 or greater -Registrant or other person killed or injured -Interstate or foreign commerce is involved in the planning or execution of the crime

Relationship of common law to statutory law

They merge when courts are required to interpret the meaning of statutes. e.g. intentionally vague laws to prevent selling and use of illicit drugs that even items like household teaspoons could have been considered illegal.

2014 OIG Special Advisory Bulletin

Warned manufacturers that coupons reducing or eliminating copayments for branded drugs for Part D patients might violate AKS

what is required on a rx for opioid use disorder?

X-DEA numbers

the federal register

a daily publication of the US federal government that issues proposed and final administrative regulations of federal agencies

MAT qualifying physician

a physician who is board certified in addiction psychiatry or addiction medicine OR at least eight (8) hours of authorized training in treatment and management of opioid-dependent patients

what is compounding?

a practice in which a licensed pharmacist, physician, or, in the case of an outsourcing facility, a person under supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient

Immunity from Civil or Criminal Liability

acting in good faith who makes a report; assists in originating, investigating, or preparing a report; or assists a board or task force, a disciplinary subcommittee, a hearings examiner, the committee, or the department in carrying out its duties under this article is immune from civil or criminal liability including, but not limited to, liability in a civil action for damages that might otherwise be incurred thereby and is protected under the whistleblowers' protection act

The Drug Enforcement Administration (DEA)

administers the federal controlled substances act

The Food and Drug Administration (FDA)

administers the food, drug, and cosmetic act (FDCA)

Emergency kit medications shall be approved and reviewed periodically as deemed necessary, but not less than ______

annually

the code of federal regulations (CFR)

annually revised compilation of final regulations divided & indexed by subject matter

category 2 CSP

are prepared in an ISO 5 primary engineering control located in a classified clean room environment are considered category 2 CSPs multiple BUDs, depends on aseptic vs terminally sterilized, sterilized testing, and storage conditions

Form 224

authority to dispense or handle CS

Pharmacies that compound for patients can/cannot also manufacture compounded medication at the same physical site

cannot

what is compounding not?

compounding does not include mixing, reconstituting, or other acts performed with directions in approved labels

administrative agencies

contribute to law making: statutes are created by the legislature, administrative agencies create more detailed regulations through rulemaking. Example: Boards of Pharmacy

The Federal Trade Commission (FTC)

deals with unfair business practices and antitrust violations

maintenance treatment

dispense narcotic for purpose of maintenance treatment, in excess of 21 days.

Legislative function

e.g. FDCA enacted by Congress requires compliance with "current good manufacturing practices" promulgated by the FDA; CE credits promulgated by Boards of Pharmacy. Most follow: "Notice and Comment Rule Making" Regulations are not statutes but have the same legal force. They must meet three tests: 1. Must be within the scope of the agencies' authority 2. Must be based on a statute that authorizes the promulgation of regulations 3. Must bear a relationship to public health, safety and welfare

how often does the MI BOP meet?

every other month

Judicial function

exercised through enforcement activities agency decisions are subject to judicial review only after "exhaustion of remedies"

comprehensive addiction and recovery act (CARA)

expands access to substance use treatment services and overdose reversal medications Increased the maximum number of patients that a practitioner may treat to 275.

how long to keep CS rxs

federal: 2 years MI: 5 years

CS inventory time of count

federal: no specification MI: AM or PM of business day

CS inventory frequency

federal: once every 2 years MI: annual

4 main sections of MAPS report

header, scores and indicators, graphs, and full prescription details

Medicare part A

hospital insurance include LTCF, home health, hospice

he Centers for Medicare and Medicaid Services (CMS)

housed in the Department of Health and Human Services (DHHS): Reimbursement policies and procedures for pharmacies and other health professionals participating in the program

Form 225

manufacturers, reverse distributors, researchers, and other supply chain & ancillary categories

Legal Definition of "Impaired" or "Impairment"

means the inability or immediately impending inability of a health professional to practice his or her profession in a manner that conforms to the minimal standards of acceptable and prevailing practice for the health professional due to the health professional's substance abuse, chemical dependency, or mental illness or the health professional's use of drugs or alcohol that does not constitute substance abuse or chemical dependency

Limited treatment options for Opioid Treatment Programs (OTP)

methadone Levo-alpha-acetyl-methadol (LAAM) buprenorphine sublingual buprenorphine-naloxone

transaction information (TI)

name of product, strength and dosage form, NDC, container size, number containers, lot number, date of shipment, business name and address of person from whom and to whom ownership of product being transferred

detoxification treatment

narcotic drug dispensed in decreasing doses, not exceeding 180 days, in decreasing doses, to alleviate adverse physiological or psychological effects incident to withdrawal from continuous or sustained narcotic use

civil action

one private party sues another alleging an injury can be based on common of statutory law eg. pharmacist dispenses drug when patient has allergy to it

Medicare part C

optional managed care plan

If an LTCF is registered with DEA as a hospital/clinic can administer or dispense as adjunct to medical or surgical treatment of conditions...

other than addiction

Medicare part B

outpatient medical services -Prescription drugs that the patient cannot self-administer, furnished by MD or Hospital Outpatient Department (HOPD) 'incident to' -Durable Medical Equipment (DME) -Some vaccines (flu, pneumococcal) -Diabetic Supplies (NOT syringes)

state legislations

permissible except those prohibited by constitutions or given to congress: broad powers to pass laws that will protect health, safety, and welfare of public

FDA Modernization Act Section 503A

regulates compounding and generally exempts individual compounding from the adulteration, misbranding, and new drug rules for manufacturers

category 1 CSP

preparations that are compounded in a segregated compounding area, which consists of an ISO 5 primary engineering control—such as a laminar-airflow workbench—that is located outside of an ISO 7 clean room only allowed a BUD of 12 hours at controlled room temp or 24 hrs if refrigerated

NARX score

quick evaluation of CS use. Calculated for narcotic, sedative, and stimulant use. 000 - discuss risks benefit of using CS. Consider obtaining informed consent 010-200 - review patterns for unsafe conditions. Discuss any with patient. If previously high usage with recent abstinence, consider risks/benefits of new prescriptions. 201-650 - review patterns for unsafe conditions. Discuss concerns with patient > 650 - Review use patterns; if multiple providers, discuss concern with patient and consider contacting other providers directly. If multiple pharmacies, discuss with patient and consider pharmacy lock-in program. If evidence of SUD, consider inpatient admit or referral for outpatient evaluation and treatment

Form 223

requesting duplicate certificate of registrations

ordinances

state authorities create subdivisions: municipalities and counties may enact ordinances that are enforceable as laws

medicaid is administered by

state government with partial federal funding

state constitutions

state supreme law

state level agencies include...

the board of pharmacy and state medicaid agencies

LTCF not registered with DEA as a hospital/clinic & has a patient who is also currently enrolled in a licensed NTP may...

transfer medication to the LTCF with the approval of the State

federal statues

vested in congress: senate and house of representatives

administrative action (hearings)

violation of a statue or regulation, or an action that warrants investigation may lead to sanctions such as warnings, fines, license revocations or suspension, probation

criminal action

violation of statute eg. selling controlled substances without rx

Each hospice emergency drug box under the control of the pharmacy must be examined at least ___

weekly Examination must ensure: -the seal which designates that the box has not been opened is still intact -the expiration date has not been exceeded