Law Summary

Practitioners register with DEA using Form 363 Approval and certification by the Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services Administration (SAMHSA) of the US Department of Health and Human Services If a practitioner wants to prescribe suboxone, subtext what do they need?

1.request a waiver from CSAT -DEA notified by CSAT of all waiver requests. Called DATA waived practitioners. -DATA waived practitioners may treat 30 or 100 patients at any one time, dependent on individual authorization The practitioner required to include the identification number on all records when dispensing and on all prescriptions when prescribing controlled drugs used for maintenance or detoxification treatment:unique identification number (X number) required in addition to all other controlled substance information on the prescription

Michigan Board of Pharmacy

11 voting members all with 4 year terms - staggered, 2 term limit 6 pharmacists, four public members, and one pharmacy technician. RPh - minimum of 2 years as licensed pharmacist, but do not have to be actively practicing. Meetings once every 2 months (6 meetings total per year) Quorum of at least 6 of 11 board members to hold an open meeting Meeting cannot be cancelled if disciplinary cases to be discussed Board meeting structure: same for all boards In accordance with internal practice, the Open Meetings act, and the Public Health Code and Robert's Rules of Order Little intersection between other health professional boards Unless overlapping disciplinary issues regarding controlled substances and drug control licenses to physicians MPB meetings are open to the public A request to attend the meeting must be made to the executive secretary to the Board or its chairperson before the meeting Public member may not address the board about pending disciplinary action Advance notice must be given if a group of 5 or more will be attending Michigan Board of Pharmacy Periodicals Published bimonthly Include approved minutes from the open meeting Annual report of the Bureau of Health Professions Published by the BHP and pertains to all licenses Information on each professional board reports, licensing statistics, disciplinary actions, fiscal year budget HealthLink - newsletter sent to all licenses

CE Requirements

30 accredited hours during two year license period (Not 15o/yr) Theory only: "proficiency exam" One CE: pain and symptom management 10 hours "live" Human trafficking one time Must receive Date Earned Certification before Renewal Date Waivers Board may exempt person if Disability, military service, absence from US or other circumstances beyond control. Exempted time and hours waived are proportional New pharmacist If licensed less than one year on date that license has to be renewed, CE requirement waived If licensed more than 1 year but less than 2 years by renewal date, only 15 hours of CE needed (1 must be a pain CE) Renewal date determination Randomized to 1 year or 2 years from date of initial licensure Non-ACPE accredited programs - provider can apply for approval by Board 12 hours of CE may be earned for each academic quarter hour of postgraduate study of a course approved for CE credit given by an academic institution approved by the Board - pharmacy related 18 hours may be earned for each academic semester of postgraduate study or course approved by the Board - pharmacy related If licensed and practice in another state, but also licensed in MI: if other state similar in renewal requirements to MI, then accept other state's renewal. If not equivalent, must obtain MI equivalent CE for MI renewal

How long are hospital Automated Dispensing Machine records retained? How long does a pharmacist have to review the order removed after hours, in place of an emergency kit, or used to treat emergent needs?

5 years All events involving access to the machine are recorded electronically: Identity of the device; individual accessing device; type of transaction; name, strength, dosage form, quantity of drug accessed, name of patient; ID of RPh responsible for machine A PHARMACIST MUST REVIEW THE ORDER WITHIN 48 HOURS

How long do you keep paper copies?

5 years from date last filled under Michigan law

How long are Institutional CS order records kept? How long do you have to present a printed copy to a an authorized agent of the board?

5 years from the date of patient discharge After 3 years, an electronic duplicate of the original order may be made which shall become the original order a printed copy shall be immediately available for a current inpatient and within 48 hours upon request of an authorized agent of the board for any patient of the previous 5 years.

How long is a CPMP good for after dispensing?

60days

Hatch-Waxman Act Whats the orange book?

A guide to drug product substitution: "Approved Drug Products with Therapeutic Equivalence and Evaluations": Drug products approved by FDA (bio-equivalency) Provides formulary guidance only (not law) in Michigan Michigan is NOT an Orange Book State

Emergency Drug Boxes

A pharmacist shall routinely inspect the medications and, after use, verify the contents and replace the medications as necessary-name RPh last inspected/restocked the box Medications shall be approved and reviewed periodically as deemed necessary, but not less than once a year Can be stored in an area of limited access in a centralized area outside of the pharmacy (not a hallway!) Each medication shall be labeled to include the name of the medication, strength, expiration date, and lot number. Pharmacist in charge of participating pharmacy must work with the medical director of the hospice program to develop policies and procedures. -how prescriptions will be obtained from the medial directors when and if drugs are removed and used. Also procedures for drug box exchange, assignment of boxes to registered RN, and take back policy. Inspection at least weekly to determine if expired or opened Storage and control while in assigned area. Inspected weekly to see if opened or expired

If an Automated Dispensing Machine is operated in a dispensing prescriber's office, used only to dispense medications to patients and only under control of the dispensing prescriber. Can a pharmacy own it?

A pharmacy shall NOT own, control, or operate a device in a dispensing prescriber's office

CII Multiple prescription rule

A prescriber may issue multiple prescriptions for a total of up to 90 day supply - Post date rule

Mandatory Reporting Requirements

A violation of general duty, consisting of 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 that impairs, or may impair, the ability to safely and skillfully practice the health profession. Requires a licensee or registrant to notify the department of a criminal conviction or a sister-state sanction within 30 days after the date of the conviction or action Disciplinary action results in change of employment status. b. Disciplinary action is based on conduct that adversely affects clinical privileges for 15 days or more. c. Restriction or acceptance of the surrender of clinical privileges if: 1) the licensee or registrant is under investigation, or 2) there is an agreement in which the facility or agency agrees not to conduct an investigation into alleged professional incompetence or improper professional conduct. d. The health professional resigns or terminates a contract or whose contract is not renewed instead of the health facility taking disciplinary action against the health professional

A pharmacy needs to dispose of 100 outdated alprazolam. Which of the following must the pharmacy do?

A. Send them to a reverse distributor using an invoice

You have compounded fixamab at your pharmacy, an FDA unapproved drug. You are shipping this directly to patients per prescription all over the US. What act have you violated?

A. Violated Food, Drug and Cosmetic Act

What type of law is the Board of Pharmacy usually enforcing?

Administrative

A person shall not knowingly or recklessly do:

Adulterate, misbrand, remove, or substitute a drug or device knowing or intending that the drug be used Sell, offer for sale, possess for sale, cause to be sold, manufacture for sale adulterated or misbranded drug Penalties vary from misdemeanor (misleading information) to felony and life in prison for knowingly committing violation with intent to kill or cause serious impairment of 2 or more individuals.

Advertising compounding

Advertising Cannot advertise a specific compounded product Can advertise that the pharmacy compounds

What changes can be made to a controlled substance Rx?

After consultation and agreement from the prescriber, may add or changed Patient's address Dosage form Drug strength Drug quantity Directions for use Issue date Make notation on prescription

What must be included on every CII- CIV prescription NOT CV's

"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

Legal Definition of "Impaired" or "Impairment"

"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.

Personal Charge

"Personal charge" means the immediate physical presence of a pharmacist or dispensing prescriber.

When is a stamped signature allowed?

NEVER

Are these in compliance with HIPAA? A chain pharmacy computers containing health related information sold to the public with intact database A manufacturer obtained patients contact numbers and mailed letters to patients urging them to have their physicians to switch them to their companies drugs (with incentives) Supervisors/employers accessing applicants' medical information for hiring or firing purposes A daughter of a hospital employee obtains patients names and telephone numbers from the hospital and calls patient to tell them they have HIV (intended to be a joke)

NO

Death of the prescriber - is the prescription still legal? Can it be filled?

NO

Prescriptions from dependent prescribers (NPs, NMs, PAs) must have:

Name of dependent prescriber (NPs, NMs, PAs) Signature of dependent prescriber (NPs, NMs, PAs) Name of delegating physician on prescription If a controlled substance, also must have dependent prescriber (NPs, NMs, PAs) DEA number, as well as the delegating physician's DEA number.

Prescription Drug Receipt What is on it? How long to do you retain copy?

Name of drug, strength, quantity dispensed, name and address of the pharmacy, serial number of the Rx, date dispensed, name of prescriber, name of patient (Label) Price sold to the purchaser Retain copy of receipt for 90 days. (electronically stored)

Federal and State Law on Labeling

Name of medication, strength, quantity dispensed -Unless "do not label" Discard date information -Discard this medication 1 year after the date it is dispensed (or sooner depending upon expiration) Generic substitution/drug product selection Refill information: good practice - NOT LAW Filling Pharmacist: good practice - NOT LAW

Label for OTC products dispensed by a pharmacist

Name of product Name and address of manufacturer, packer, or distributor Net contents of the package Active ingredients and quantity of ingredients Name of any habit-forming drug Cautions and warnings needed for protection of the user Adequate directions for safe and effective use

What is identifiable health information?

Names & addresses Dates: birth, admission, discharge, death, age Tel. and fax numbers Medical record, social security, & health plan numbers Vehicle identifiers Device identifiers and serial numbers E-mail; relevant URLs Finger and voice prints Photographic images Other unique identifiers

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

Drug Approval Process

New Drug Application (Investigational New Drug and New Drug Development): Generic Drug Application (Abbreviated New Drug Application) Supplemental New Drug Application - aka now Prior Approval Supplement (Changes to an existing NDA or ANDA)

NAPB Number

Newer requirement for all CE Pharmacist must register with NAPB Provided a unique number When take CE, provide NAPB number and birthday CE recorded to NABP

Computer generated prescription with one computer generated medication but 4 handwritten medications added. Is this legal? How would you handle it in the pharmacy?

No Make a copy of one of those, then file two separate copies

Can Federal Legend Drugs be Returned to the Pharmacy?

No But............ If dispensed in error, can take back wrong Rx. Must dispose (or stored separately), not restocked. Unit dose or unit of use products can, as long as not tampered.

Cancer Drug Repository What cannot be donated and further regulations?

No controlled substances Separate inventories in the pharmacy No drop box for donations Donated drugs may be dispensed by a pharmacist pursuant to a prescription, or dispensed by a dispensing prescriber in a repository facility Inspected by a pharmacist before dispensing

How many insulin syringes may be sold at one time without a prescription?

No limit

Limitations to how many PAs and NPs that MD or DO are permitted to supervise?

No more than 4 PAs at one time -multiple sites: no more than 2 PAs at each site No limitation to NPs

IF A PHYSICIAN'S ASSISTANT WRITE AN RX FOR C2, DOES THE SCRIPT NEED BOTH DOCTOR AND PA SIGNATURES?

No, just names (no signatures) Need the signature of the PA though

How should the pharmacist handle a prescription that was emailed from a delegated employee of a physician to the email of the pharmacy?

No, you would not accept it

Duration of life of a prescription refills?

Noncontrolled: lives for 1 year from date written C3-4 lives for 6 months C2 lives for 90 days C 5 lives for 1 year, just like noncontrolled Refills: Controlled Substance C III and CIV, 6 months from date written Allowed up to 5 refills during the timeframe -Prescriber can indicate fewer refills if desired CII none

The discipline record of a licensee is:

Not a public record But Board of Pharmacy meeting minutes are public Available by petitioning the Governor (LARA) Available under a Freedom of Information Act request

What is the Consumer Information Notice?

Notifies patients they can obtain the prescription drug price before it is dispensed. (Under Michigan law, you have the right to find out the price of a prescription drug before the pharmacist fills the prescription. You are under no obligation to have the prescription filled here and may use this price information to shop around at other pharmacies. You may request price information in person or by telephone. Every pharmacy has the current selling prices of both generic and brand name drugs dispensed by the pharmacy. Ask your pharmacist if a lower-cost generic drug is available to fill your prescription. A generic drug contains the same medicine as a brand name drug and is a suitable substitute in most instances. A generic drug may not be dispensed by your pharmacist if your doctor has written "dispense as written" or the initials "d.a.w." on the prescription. If you have questions about the drugs which have been prescribed for you, ask your doctor or pharmacist for more information. To avoid dangerous drug interactions, let your doctor and pharmacist know about any other medications you are taking. This is especially important if you have more than 1 doctor or have prescriptions filled at more than 1 pharmacy. (4) The notice required under subsection (2) shall also contain the address and phone number of the board and the department. The text of the notice shall be in at least 32-point bold type and shall be printed on paper at least 11 inches by 17 inches in size. The notice may be printed on multiple pages. )

Nurse anesthetist

Nurse anesthetist (CRNA) CANNOT be dependent prescribers

Federal Anti-Tampering Act of 1982 (Not FDCA- related to PPPA but independent) What does this do to prove something hasn't been tampered with?

ORAL OTC drug products and many dietary supplements must have tamper-proof indicator or barrier that shows if package has been opened or tampered with

What can an Agent do that has been Designated by a Prescriber?

Only a prescriber may issue a prescription. An agent may prepare and transmit a prescription Must be signed by the prescriber

Acceptance of drugs by Unused Medication Repository

Only prescription drugs in original sealed, tamper evident, and unopened unit dose packaging may be accepted for dispensing Prescription drugs packaged in single unit dose packaging may be accepted for dispensing even if the outside packaging is opened

Pharmacist in Charge

PIC to be licensed in Michigan PIC and pharmacy will be jointly responsible for compliance May be 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

Which of the following does not require a safety cap- or child proof tamper resistant cap? Aspirin Packages <8 g erythromycin SL nitroglycerin <105 mg prednisone Controlled substances Most Prescription drugs Oral contraceptives

Packages <8 g erythromycin SL nitroglycerin <105 mg prednisone Oral contraceptives

Who can donate and what can be donated?

People 18 years and older can donate legally obtained cancer drugs or supplies to a repository. If not previously dispensed, a pharmacy, manufacturer, wholesaler may donate drugs Drug eligible for donation if Completed donor form stating drug properly stored, never opened, used, tampered with, adulterated, or misbranded. Drugs expiration date is at least 6 months later than the date donated In original, unopened, tamper-evident packaging that includes drug's lot number and expiration date

Fine, reprimand, or place pharmacist licensee on probation or deny, limit, suspend, revoke license

Permitting dispensing by individual not a pharmacist, intern, or dispensing prescriber Permitting dispensing of prescriptions by intern without supervision Selling at auction drugs in bulk or open packages unless authorized by board Promoting a prescription drug to the public in any manner

WHO, IN THE PHARMACY, CAN ACCEPT A VERBAL PRESCRIPTION FOR A C III TO V?

Pharmacists or interns

If an Automated Dispensing Machine is for a hospital, county clinic, RN home, hospice or off site surgical center who manages it?

Pharmacy ADM may be under control of a hospital pharmacy if the ADM is located in a hospital owned building separate from the hospital itself.

Customized Patient Medication Packages (CPMP) What can go into these? Whose consent is needed? How is it labeled?

Pharmacy can package drugs together for doses given at the same time of the day. Each container shall be either not reclosable or designed to show evidence of having been opened (tamper evidence) If a prescription for any drug is changed, a new appropriately labeled CPMP must be prepared for the patient Solid dosage forms only; cannot have PHYSICAL interactions -Cannot use CPMP if any product must be dispensed by itself Cannot restock if unused Must have patient package insert for any meds that it is required Consent of the patient & caregiver & prescriber needed. Designed and labeled to indicate day and time each dose taken Serial number for the CPMP itself and a separate identifying serial number for each of the prescription 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 (so may be multiple Drs) Directions for use and cautionary statements, if any, for each drug Date of preparation of the CPMP Expiration date for the CPMP. -Shall not be later than the earliest manufacturer's expiration date or 60 days after dispensing Name, address, telephone number of dispenser Any other info or warnings required for the drug by law

Out of state and Canada prescriptions, what kinds can be filled in michigan?

Physicians (MD, DO) and Dentists non-controlled and controlled in the states Non-controlled medications only: Veterinarians (other states) and Delegation allowed - PA, NP from other states or Canada Only non-controlled for Physicians (MD, DO) and Dentists from Canada

Which of the following mandates child resistant packaging for prescription drugs?

Poison Prevention Packaging Act

Which step in the drug review process is the drug studied in animals?

Pre clinical phase

Tell me what the phases of the trials are:

Preclinical:Testing of drug in non-human subjects, to gather efficacy, toxicityand pharmacokinetic information Phase I: limited number of patients. Pharmacokinetics particularly oral bioavailability and half-life of the drug Testing of drug on healthy volunteers for dose-ranging Phase II: dosages at which efficacy occurs Testing of drug on patients to assess efficacy and side effects Phase III: expansion of experimentation to a population to prove safety and efficacy Testing of drug on patients to assess efficacy, effectiveness and safety Phase IV: post marketing clinical studies- watching drug use in public

Drug Control License

Prescribers (other than vets) that dispense drugs directly to own patients must apply for license from Board of Pharmacy. Each site where meds are dispensed Not required for emergency hospital/trauma center Not required for "complimentary starter dose" (samples-PDMA) Labeling, recordkeeping, storage

MAPS- Michigan Automated Prescription System Who has access? How often do you submit data? What is required from the patient?

Prescription Monitoring Program used to identify and prevent drug diversion at the prescriber, pharmacy, and patient level for C2-5. Pharmacist, dispensing prescriber, and veterinarian Daily -If a dispenser or practitioner does not have online capabilities, prescription data may be recorded on a CD in the ASAP 4.1 format and mailed to MAPS for submission into the MAPS database Requires patient identification: A Michigan driver's license number State-issued identification number The number "0" if the positive ID presented is not a license number of ID card. Minors, pets.

Drug Samples Can pharmacies have them?

Prohibits retail pharmacies from stocking, handling, or possessing EXCEPT: Institutional pharmacies may handle, only at request of physician who asks the distributor for samples

Poison Prevention Packaging Act of 1970 (PPPA) (Not Part of FDCA) (Kiddos get into everything)

Purpose to prevent accidental poisoning of children under age five Requires "Hazardous Household Products" to be marketed in child-resistant packaging

What professional responsibility to ensure for all drugs and devices dispensed under a prescription?

Quality, Purity and Labeling

By law, which of the following must be on the prescription label?

Quantity, Name of Drug, Name of Prescriber

Form 41

RPh can destroy meds and report with Form 41 OR Reverse distributor will report the destruction of CS to the DEA via Form 41 Practitioners, pharmacies can request permission once a year Submit written request in advance to local DEA office -Name, address, DEA number; proposed date; who destroying and witness; method; DEA Form 41 Approval in writing After destruction, send copy Form 41 to DEA, keep original for 2 years Manufacturers, distributors, hospitals can be granted blanket approval -Same requirements

Licensing in MI if already licensed in another state

Reciprocation or Licensure by Endorsement Not all states reciprocate with MI Pharmacists from the reciprocating state would fill out a form from Board, pay fee, take MPJE (a) Pass the jurisprudence examination under R 338.473b, which measures an applicant's knowledge of the rules and regulations governing the practice of pharmacy. (b) Establish that the applicant is currently licensed in another state and was initially licensed by examination in another state.

What is a Device?

Recognized in USP, NF,HP Used for diagnosis, cure, mitigation, treatment or prevention of disease Intended to affect the structure or any function of the body Not dependent upon being metabolized

What is a Drug

Recognized in USP/NF, HP (CANNOT buy drugs found only in other countries and not US) Used for diagnosis, cure, mitigation, treatment or prevention of disease Intended to affect the structure or any function of the body (other than food) Intended for use as a component of A,B,& C Therapeutic claims is key in these definitions

C V OTC Products

Record can be kept in a bound notebook, or in the same manner as CV prescriptions Name and address of patient Name and address of the purchaser if different Name and quantity of substance Date of purchase Full name of pharmacist or intern Medical purpose as determined by the RPh Record kept for same duration as Rx CV

Transferring control

Record name, address, and DEA registration of the pharmacy to which it is transferred, along with the name of the RPh who took the transfer as well as the RPh who transferred the Rx, date of transfer receiving pharmacist must write the word TRANSFER on the face of the transferred Rx; record all information normally associated with controlled substance, indicate date of the original Rx, the number of original refills, the number of remaining refills, the date of the last prior refill (if any), the name, address, and DEA number of the pharmacy where the original Rx was dispensed, and the name of the RPh who transferred the Rx.

When selling a schedule 5 exempt CS, the pharmacist must do what?

Record the medical purpose for which the med is used

Central Fill Pharmacies Who keeps records? Who is responsible for checking medical purpose? How do you transmit a prescription? What must the retail Rx have written on it? How long does the retail pharmacy retain original rx? What does the central fill pharmacy have on file? Does the prescription label have to indicate both pharmacies?

Records must be kept by both the retail pharmacy and the central fill pharmacy Both retail and central fill RPh have a corresponding responsibility to ensure that the Rx was issued for a legitimate medical purpose by a legitimate prescriber Transmit electronically, including via fax retail Rx must write the words CENTRAL FILL (for CS) on the face of original prescription record the name, address, and DEA registration (for CS) of the central fill Rx to which the prescription was transmitted and the name of the retail pharmacy pharmacist transmitting the prescription, and date of transmittal 5 years copy of the prescription, record of date of receipt- pharmacist filled and dates of filling, date of delivery and method of delivery Yes, The prescription label must indicate each pharmacy involved - can be a unique identifier

Outsourcing Facilities

Register with FDA Subject to mandatory adverse event reporting Risk-based inspections User fees New labeling requirements as required by good manufacturing practices Secretary of Health and Human Services (HHS) will have delegated authority over them Coordinate law between federal government and state boards Outsourcing facilities register under section 503B and are regulated by FDA and must comply with cGMP requirements and will be inspected by FDA based on risk-based schedule. June and December, submit a report Identifying drugs compounded during the previous 6 months For each drug, provide active ingredient, source, NDC of source/bulk active ingredient, strength of active ingredient per unit, dosage form and route of administration, package description, number of individual units produced, NDC code if assigned

Preceptor License What are the requirements?

Required for training/supervising interns Must have Michigan pharmacist license for 1 year

DEA Termination and Transfer of Business

Return: Pharmacy's DEA registration certificate Unused Form 222 Information provided to the DEA Location of inventory storage Controlled substance records Must be done 14 days BEFORE the date of transfer/termination

FDAC Color Additive Amendment of 1960

Safety for color additives in foods, drugs, and cosmetics (with a Delaney clause)

Form 222 What is it and how many copies do you have? Do CIII-V have this? How long do you keep it on record? Partial filling by supplier must be completed in how many days? When do you report lost or stolen CIIs? If lost prior to receipt by the pharmacy, who is responsible?

Schedule I and II, used for distribution, purchase, and transfer of C II. Copy 1 to pharmaceutical supplier Copy 2 to nearest DEA office Copy 3 to ordering pharmacy (document items and amounts received) No special forms for ordering III-V drugs Must be kept for 2 years at the same address printed on the form Partial filling by supplier Must be completed within 60 days of order request Must report Lost or stolen CIIs to the local DEA office IMMEDIATELY -Must provide serial numbers of each lost/stolen form, or the approximate date of issue If prior to receipt by the pharmacy, loss is the responsibility of the supplier -If loss after receipt, loss is responsibility of the pharmacy, and must be reported to the DEA Return to : Supplier: Document to show transfer; DEA Form 222 for Schedule 2 drugs Reverse Distributor: Firms registered by DEA to acquire and dispose; Documented on DEA form 222 for Schedule 2 drugs; Cost money; has own system of inventory, documenting

Refills/Partial fills for controlled substance RX

Schedules 3 and 4: Up to 5 times in 6 months from the date written C5 - refill as authorized (same as noncontrolled drugs) No refills for C2 Partial fills (hospice), post-dating exceptions For C-2, partial fills for out of stock cannot be made if you can't get the remainder from wholesaler within 72 hours A prescription for C2 for terminally ill patient whose terminal illness the pharmacist documents may be partially filled in increments for not more than 60 days after the date on which the prescription was issued -On each partial fill, RPh must document quantity dispensed, date, and remaining quantity of the Rx Fax transmission of C2 is allowed for: Compounded product for direct administration to patient (for example, injectable morphine drip infusion). Fax serves as written Rx. Long term care, Fax serves as written Rx.

Omnibus Budget Reconciliation Act of 1990 (OBRA) What must be done under this act? What must a pharmacist counsel on?

Screening prescriptions: "Pharmacists must detect "potential" problems" Counseling patients: to remove all inherent risks in medication use not detected during the screening process -A verbal offer to counsel the patient (Medicaid) Documenting information: Pharmacists to make reasonable efforts to document information related drug therapy To obtain/update patient profiles for Michigan: all new prescriptions for all patients; at the discretion of the pharmacist for refills -OBRA90: Federal law that focused on Medicaid new prescriptions (Pharmacists must offer to discuss): Name and use of the drug product Route of administration Duration of therapy Action to be taken if necessary for a missed dose Contraindications, precautions, and warnings Common adverse side effects Drug-drug interactions Food-drug interactions Storage of medications Refill information Anything listed under pharmaceutical care as pharmacist determines

Controlled Substance Medication Storage (3 options)

Securely locked in cabinet Dispersed throughout the stock of non-controlled substances Combination of the above Schedule 1 must be stored in a cabinet anchored to the wall/floor

Which of the following must be noted on the original prescription (either paper or electronic) when filled?

Serial number, date filled, drug dispensed, initials of RPh

What are Physical Requirements to Start a Pharmacy?

Sink with hot and cold water Refrigerator If occupy less than the entire premises: -Partitioned from floor to ceiling -Securely lockable -Premises is inaccessible during absence of pharmacist Work Space >= 150 sq ft floor space >= 10 sq ft counter space >=4 sq ft additional counter space for each additional pharmacist Necessary technical equipment to compound and dispense References -Current MI law -2 or more reference texts ->Pharmacology ->Drug interactions ->Drug composition =>Electronic medium OK (internet)

Controlled substance for Animals

Species of the animal and full name and address of owner must be indicated on the prescription.

If there is a conflict between federal and Michigan law, which law should you follow?

Stricter law

Disciplinary Subcommittee

Subcommittee of the Board of Pharmacy Conducts hearings, investigations, and consent agreements Pharmacist and community members The Attorney General Office representative or member of the Department of Community Health, along with a member of the Board (pharmacist) meet with the individual with the allegation and in many cases they develop a consent agreement. These consent agreements then come to the Disciplinary Subcommittee for approval. They do not go to the full Board. The Disciplinary Subcommittee votes on them and there needs to be a majority approval (not unanimous approval).

The Department (BOP) will review your licensing file if what occurs?

The Board receives a written notice of a felony The Board receives a notice that you failed to notify the Board of a change in employment The Board receives a notice from a hospital you were discharged for stealing Vicodin

What are the two publications of federal laws?

The Federal Register The Code of Federal Regulations (CFR):

Who is determining the final decision of a sanction on a pharmacist?

The disciplinary subcommittee of the Board votes with a majority vote in favor of the discipline with at least one public member voting with the majority (4/7/2017 - after discussion with Dr. Stevenson this morning, this is the correct answer. The slide set changed to reflect the updated procedures).

Prescription Transfers or Copies

The original Rx has authorized refills remaining a the time of transfer The prescription must still be "alive" or valid -Time from date written The pharmacist issuing the copy must cancel the original Rx and document as transferred or cancelled, recording the date, name of pharmacy getting the copy, name of RPh who issued the copy. Must also include: prescription number of the original Rx, the name of the pharmacy issued the copy, the date the copy was issued, the number of refills remaining available to the patient Good practice to include the person who gave the copy and the person who recorded the copy. Only RPh or intern under direct supervision of RPh can transfer controlled substance Rx Original must have the word VOID written on it when transferred

Improper prescription examples

The prescription appears to be improperly written. The prescription is susceptible to more than one interpretation. The pharmacist has reason to believe that the prescription could cause harm to the patient. The pharmacist has reason to believe that the prescription will be used for other than legitimate medical purposes.

CS loss or theft needs to be reported to the DEA:

True theft or significant loss Within one business day of discovery Report must be signed by DEA registrant and kept in the pharmacy, sent to the local DEA diversion office Michigan BOP: requires form 106 (or equivalent) to document any controlled substances not accounted for, notifying state within 10 days

Durham-Humphrey Amendment of 1951

Two classes of drugs established: legend and OTC

Loss, Theft, Transfer Scheduled Listed Chemical Products (SLCP)

Verbal report to local DEA office Written report filed within 15 days Report includes: Registrant DEA number Name and address of business Date/type of loss Description of circumstances

You inadvertently disclosed a patient' profile to the wrong patient. What did you violate?

Violation of HIPPA

Methadone

When used for addiction, may only be dispensed in accordance to guidelines Substance Abuse and mental health services administration (SAMHSA) center for substance abuse treatment (CSAT). Further regulations vary by state. During inpatient care, when the patient admitted for any condition other than concurrent opioid addiction, to facilitate treatment of the primary diagnosis. During emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility. extend the treatment options of methadone-maintained opioid-dependent patients from specialized clinics to office-based opioid therapy (OBOT). Methadone may only be used to maintain narcotic addiction or to detoxify a patient when the prescriber is registered by Drug Enforcement Administration (DEA) as a narcotic treatment facility (NTF). In such cases, the drug may only be administered by the NTF. Max of 1 day supply given at a time for a max of 3 days = to administer only 3 day rule does not exist in MI law MI->In an inpatient setting, any practicing physician may prescribe and dispense methadone to recovering addicts for drug dependent maintenance therapy The drug may only be administered by the NTF. Delegation to dispense to LPN, RN, PA, or NP in this setting If a practitioner chooses to dispense controlled substances, the practitioner must maintain all required records of receipt, storage, and distribution. Records kept for 2 years

Controlled Substance Prescriptions Must:

Written in ink or indelible pencil, or printer prepared Preprinted, stamped, typed, or manually printed name, address, and telephone number or pager number of the prescribing practitioner Printed name and address of the patient Prescribing practitioner's signature Prescribing practitioner's DEA number The quantity of the prescription drug prescribed, in both writing and numbers (only number of E-scripts) The date the prescription was written Any information otherwise required

If an Rx for a C2 is presented to a pharmacy without a prescriber DEA number, can the DEA number be added to the Rx by the pharmacist after consultation with and approval by the prescriber?

Yes, but document that you write it in there

Can Chiropractors prescribe?

Yes, legend and nonprescription drugs. But not in Michigan.

OBRA 90 Can you wave the right of counseling?

Yes, must be in writing

Manufacturer did not conform to GMP: adulteration or misbranding?

adulteration

You didn't clean the tray or you used an bottle the patient brought back to you: adulteration or misbranding?

adulteration

coloring agents are unsafe: adulteration or misbranding?

adulteration

the bottle wasn't closed all the way and it got some toxic fumes and moisture in there: adulteration or misbranding?

adulteration

Cancer Drug Repository Program

allowing a person to donate a cancer drug or supply for use by an individual who meets the eligibility criteria To participate, a pharmacy must: 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 he pharmacy is licensed in the state and in compliance with all laws, and is voluntarily participating

How long does a HIPAA notice must be kept?

at least 6 years once requested by a patient you have 60 days to provide them with an accounting of their disclosure

PA's ability to prescribe

can write for non-controlled federal legend drugs with no restrictions Permitted to prescribe both non-controlled substances and controlled substances federal legend drugs No longer required to list the delegating physician on non-controlled prescriptions Delegating provider and their DEA number must be listed on controlled substance prescriptions

Expedited Partner Therapy (EPT) What two disease states? -drugs Do you have to dispense in name of partner? How long do you have to fill a prescription for a partner? Do third party payers pay?

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 No, If patient not known, then use "expedited partner therapy" : there doesn't need to be a physician-patient relationship Allowed for any partner in the previous 60 days No, third party payers don't pay

Duty to Counsel

communicated orally and in person. -Printed material designed to help the patient use the medication safely and effectively satisfies the requirements The information provided for a drug not previously prescribed for the patient. (new drug) If the pharmacists deems it necessary, provide information on refills. The information provided if requested by the patient, caregiver, or agent .

Neutraceuticals: am I food? am i a drug? (who knows maybe I'm a lion)

dietary supplements, herbal products, and processed foods such as cereal) Provides health or medical benefits, including the prevention or treatment of disease

What are the 4 drugs pre-1938 that got grandfathered in so that it did not need a NDA?

digoxin, nitroglycerin, levothyroxine (thyroid products), phenobarbital

Do you counsel patients who don't speak english?

do everything in your power to communicate with that patient -> translator

Non-24 Hour Institutional Pharmacies

establish a method by which medications can be obtained during the absence of a pharmacist that minimizes the potential for medication errors. the services of a pharmacist are available on an on-call basis a limited number of medications that are packaged in "unit of use" (or unit-dose packaging) may be made available in a securely locked, substantially constructed cabinet in an area of limited access in a centralized area outside the pharmacy list of medications kept in this "after hours" lock box has to be approved and reviewed at least quarterly by the P&T Committee each medication kept in the after hours box has to be labeled to include the name of the medication, the strength, the expiration date (if dated) and the lot number a written order and a proof of removal and use document have to be obtained for each medication unit removed. order has to be reviewed by a pharmacist within 48 hours of the removal of the medication from the cabinet. director is required to designate which practitioners will be permitted to remove the medications from the box. an audit of the box as often as needed to guarantee control, but not less than once every 30 days.

How often is renewal of a pharmacy license?

every two years on July 1

Comprehensive Addiction and Recovery Act (CARA)

expands access to substance use treatment services and overdose reversal medications—including the full spectrum of services from prevention to medication-assisted treatment (MAT) and recovery support—by extending the privilege of prescribing buprenorphine in office-based settings to qualifying nurse practitioners (NPs) and physician assistants (PAs) until Oct. 1, 2021.

Automated Machine Dispensing Who can use this?

hospital, pharmacy, county medical care facility, hospice, nursing home, other skilled nursing facility, office of a dispensing prescriber

What's a class II device? (I'll hold up to your standards don't worry)

infusion pumps, insulin syringes, tampons, diagnostic reagents meet specific performance standards

Who can Use of a Hospital's DEA Registration Number?

intern, resident, staff physician, mid-level practitioner

How many prescriptions can be written on a 1. manual 2. printed prescription? Can you mix non-controlled with CII-CV prescriptions?

manual- 4 printed- 6 HECK YES FILL THEM ALL

Refill documentation What are the 3 types When do you have to have refill information put by if the computer crashes?

manually refill log computer- if crashes all rx info must be entered w/in 48 hours

Drug Recall who does it? What are the class levels?

manufacturers and FDA Class 1 through 3

Who has a DEA number that starts with an M?

mid-level practitioners (NP/PA/OD/ET, etc.)

label is unclear and you don't know if it says infliximab or icantreadumab: adulteration or misbranding?

misbranding

take as directed on package label is put onto a prescription but the patient never received any direction on the package label because it was tore off: adulteration or misbranding?

misbranding

this blue pill sure looks a lot like my viagra but it sure crumbles a lot easier than it normally does... I think it is trying to be something its not and imitating viagra: adulteration or misbranding?

misbranding

you choose not to counsel on a new prescription: adulteration or misbranding?

misbranding

you compound a medication and leave out one of the ingredients : adulteration or misbranding?

misbranding

you give a label that says only the brand, but you dispensed the generic: adulteration or misbranding?

misbranding

Institution prescription can contain how many prescriptions on one paper? when does the prescriber sign the order?

more than 6 and may contain schedule 3 through 5 C.S. and noncontrolled substances on the same form. The prescriber signs the original order at the time of next visit or within 7 days.

What's a class I device? (you don't need to regulate me, I'm not pointy or anything)

needles, scissors, gloves, toothbrushes and stethoscopes least regulation; least potential harm to users

MI Law Requirements Closing a Pharmacy

notify the Michigan Board of Pharmacy of the effective closing date must return the current pharmacy license and controlled substance license to the Board office The Board of Pharmacy must be notified about the disposition of the prescription files and prescription drugs for both controlled substances and non-controlled substances. -When transferring CS to another pharmacy, a complete inventory should be completed and a Form 222 used. -All previous CS records need to be transferred to the new owner (if selling your pharmacy) -Transferred inventory records must be kept for 2 years by the seller and the purchaser of the pharmacy.

What's a class III device? (did I get pre-market approval, or can I just not see it without my contacts)

pacemakers, soft contact lenses, replacement heart valves Must have pre-market approval for its life supporting or sustaining feature

who owns the prescription?

patient "owns" the prescription up until the medication is dispensed then its the pharmacy's

What can't you change on a controlled substance rx?

patient's name the controlled substance prescribed (unless authorized to dispense a lower cost, generically equivalent drug product) prescriber's signature. "do not fill until date"

Who has a DEA number that starts with an A, B, F or G?

physicians, dentists, veterinarians, and other practitioners Hospital/ Clinic/ Practitioner/ Teaching Institution/ Pharmacy

Federal Definition - FDA of compounding

practice in which a licensed pharmacists, a licensed 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

Drug Advertising and Promotion by Pharmacies

price information without reference to safety or efficacy; inclusive of all services; names and strengths of advertised drug

Federal Food, Drug and Cosmetic Act (FDCA) 1951

proven 'safe' for labeled indication. Established New Drug Application/Approval Process (NDA) Not all drugs on US market have an NDA Pre-1938 drugs grandfathered Examples: digoxin, nitroglycerin, levothyroxine (thyroid products), phenobarbital (been around long enough to rely on their safety profile)

How to get drugs from Cancer Drug Repository?

provide verification of current diagnosis of cancer, provide proof of insurance if any, and sign a cancer drug repository recipient form. Form includes information that the drug dispensed was donated; that visual inspection was conducted; and that the program or participants cannot guarantee the safety of the drug or supply being dispensed or administered, and the drug is safe based on inspection and donation form Any resident of Michigan diagnosed with cancer is eligible Donated drugs or supplies cannot be resold - only dispensed or administered Pharmacy will not bill a public or private third party payer for drugs or supplies Order of priority in who to dispense to 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 All forms maintained for 5 years For drugs destroyed, record shall include Date of destruction Name, strength, and quantity of cancer drug destroyed Name of person or firm destroying drug Source of destroyed drugs

Federal Food, Drug and Cosmetic Act (FDCA) 1906

regulation of all drugs introduced into interstate commerce. protect consumers from adulterated or misbranded foods, drugs, cosmetics, or devices.

For an offence committed within 2 years after a previous offense of the same kind, a disciplinary subcommittee shall:

suspend the license or registration for a period of at least 180 days or revoke the license or registration. The BOP can permanently revoke a pharmacist license

A pharmacy can compound a limited amount ahead of time in anticipation of prescriptions. t/f

true

If reprimanded by BOP, it is permanently on your record. No expunging. t/f

true

Only the patient may sign the acknowledgement of the privacy notice t/f At least 90% of each pharmacy's patients must have signed the acknowledgement t/f Patients may not be called by name to pick up their prescriptions t/f The pharmacist may not counsel anyone other than the patient unless there is a written authorization t/f No counseling may occur unless assured that others will not hear t/f No confidential information can be shared with the physician without a written authorization t/f Information cannot be shared with relatives or friends without the patient's written authorization t/f No refill reminder information can be sent to the patient without the patient's authorization t/f No marketing information can be sent to patients on new and improved diabetic control devices t/f Patients name and demographic information can be given to firms intending to offer the patient with a free newsletter that may help them manage their disease t/f Social worker should not be in attendance when nurses give report on patient management at the end of the shift t/f DEA agents cannot request the drug profile records of patients they are investigating t/f

true true false false true false true false true, can't advertise med mngt but can be targeted for DM control management true false false

Preprinted Controlled Substance prescription with checkbox next to preprinted quantity. OK?

yes

AN EMPLOYEE (DELEGATED AGENT) OF A PRESCRIBER MAY TRANSMIT VERBALLY TO A PHARMACIST WHAT SCHEDULE OF CONTROLLED SUBSTANCE?

Anything but CIIs

Applications for Licensure

Applications are valid for 2 years Applicants for licensure by examination Applicants for licensure by score transfer (NAPLEX but not MPJE) Applicants by endorsement (licensed in another state) If cannot fulfill requirements within 2 years of application, then must reapply

Who is Eligible for HPRP?

Audiologist Allopathic Physician (MD) Chiropractor Dentist, Dental Hygienist and Dental Assistant Marriage & Family Therapist Nursing Home Administrator Occupational Therapist and Occupational Therapy Assistant Optometrist Osteopathic Physician & Surgeon (DO) Physician's Assistant Podiatric Physician Professional Counselor Registered Nurse (RN), Licensed Practical Nurse (LPN) Pharmacist Physical Therapist Psychologist Respiratory Therapist Sanitarian Social Worker, Social Worker Technician Veterinarian and Veterinary Technician

What can you dispense if there is no physician-patient relationship? describe the circumstance

Auto-injectable Epinephrine -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. 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

What is the Difference between suspension of 6 months or less versus 6 months and a day or more?

Automatic versus petitioned reinstatement of license

Regulatory Referral Process

Boards or disciplinary subcommittees require involvement as a condition of being allowed to continue or resume practicing their profession

Emergency Hospice Drug Boxes

Boxes under control of the pharmacy shall be inspected weekly to assure the seal intact and not expired If expired or used, return to pharmacy with written prescriptions for drugs used by attending MD or hospice med director. Prescriptions filed as usual.

Transfer of controlled substances

CIII-CV only once b/w non-linked pharmacies CII never

C 2 through C5 can be transmitted ?

CIII-CV via electronic means written telephone faxed CII via electronic means written Fax CII: only if original Rx must be presented at pick up, If it needs to be compounded for direct IM/IV/IS administration, If prescribed to residents of Long Term Care Facilities, If prescribed to a patient in a State certified Hospice care program oral: CII Rx for emergencies only. Prescriber must write the phoned order on a prescription form and forward to the dispensing pharmacy within 7 days of oral transmission Must record on the face of the Rx "Authorization for Emergency Dispensing" and date of oral order

Prescription for a Compound

Calculations Ingredients (quantity, name/manufacturer, lot number, expiration date) Liquid vehicle or topical base (name/manufacturer, lot number, expiration date) Stability (expiration date) Special storage information, auxiliary labels References as appropriate

Federal Food, Drug and Cosmetic Act (FDCA) Food Additives Amendments of 1958

Can't put cancer causing agents into food products

reasonable probability will cause serious adverse health consequences or death: what recall class am I? (How classy am I?) eg. Glass shards may be problematic

Class I Recall

product may cause temporary or medically reversible health consequences : what recall class am I? (How classy am I?)

Class II Recall

product not likely to cause adverse health consequences : what recall class am I? (How classy am I?) Eg. Darn paperwork issues

Class III Recall

NP's ability to prescribe:

Clinical Nurse Specialists (CNS), along with Nurse Practitioners and Nurse Midwives are able to prescribe controlled and non-controlled prescriptions. NP no longer required to list their delegating physician on non-controlled substances. Delegating provider name and DEA number must be listed on controlled substance prescriptions NP can prescribe non-controlled federal legend drugs and controlled substances CIII-CV. NP can prescribe C II controlled legend drugs, but no quantities greater than a 30-day supply

So, what happens when an allegation or complaint is filed?

Complaint or allegation goes to the Michigan Department of Licensing and Regulatory Affairs, Bureau of Health Care Services Referred to the BOP Disciplinary Subcommittee Investigation LARA presents formal allegation once investigation completed

Guidelines for Reinstatement - Depends on the Violation

Completed 1 or more substance abuse treatment programs Participated in inpatient or outpatient treatment for mental, psychological, emotional, or physical disorder Complied with all terms of discipline, including payment of fines and costs Completed 1 or more CE programs concerning the practice of their profession Participated in didactic or clinical training, remedial education, refresher course Submitted assessment or evaluation of applicant's professional skills and knowledge by trained or qualified person or entity The applicant desires in good faith to be restored to the privilege of practicing his or her profession in Michigan

Becoming a licensed pharmacist - First Timer

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 the LARA department 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 120 multiple choice questions (20 questions are separate assessment questions not used for score), 2.5 hours, passing score is 75. Pass the MPJE with a score of not less than 75 If fail, must wait 30 days before another attempt Pass the NAPLEX with a score of not less than 75 If fail, must wait 91 days before another attempt For the MPJE, if after 5 times do not pass, must take a pharmacy law class before reapplying for exam Some states are more restrictive Arkansas, California, Guam, Puerto Rico, Virginia, and the Virgin Islands do not participate in the MPJE.

Compounds

Compounded drugs are not FDA approved. Lack FDA finding of manufacturing quality. State boards of pharmacy oversee in accordance to the FDCA section 503A for traditional compounding. Compounding under section 503A for sterile products must be done in accordance with U.S. Pharmacopeia (USP) chapters 795 and 797. May be costly and a burden to establish Compliance with USP 795 for nonsterile compounding is/should not be a burden for community pharmacies Nonsterile products Drug product made for an identified individual patient based on an unsolicited prescription Limited quantities before the receipt of a valid prescription based on a history of receiving orders for compounded product Generated solely within an established relationship between pharmacists, physician, patient

Multistate Pharmacy Jurisprudence Examination

Computer Adaptive Test Answer question Can't go back to prior questions 2.5 hours 120 Questions Most questions counted, but some are pretest questions No way to know which questions don't count Assume every question counts 100 OF THEM COUNT

What Type of Signature is Required?

Computer to computer DEA Electronic Signature -non-controlled can be MI electronic sig Computer to Fax: only non-controlled can have MI electronic signature Fax to Fax: Manual -only 3 situations where CII can be faxed Paper- patient presents: manual signature

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

What is Adulteration?

Contaminated (manufacturing - marketing) Exposed to contaminated containers Manufacturer does not conform to GMP Contains unsafe coloring agents If not appropriately tamper proof

What did DATA 2000 do?

DATA 2000 expanded the clinical context of medication assisted opioid addiction treatment Allows qualified physicians to dispense or prescribed specifically approved C III, IV and V narcotic medications for treatment of opioid addiction in treatment settings other than traditional Opioid Treatment Programs (methadone clinics).

DATA-waivers

DATA-waived providers can prescribe C3-5 -open to NPs and PAs as of 2017 Michigan requires a separate controlled substance license for treatment programs

Starting a pharmacy- controlled substance requirements

DEA Registration Form 224 - authority to dispense or handle CS -Separate registration is required for each site -Renewal in 3 years -->Form 224a for retail pharmacy -->Form 224b for chain pharmacy -Must be renewed within 60 days of expiration of certificate -Form 223 - requesting duplicate certificate of registrations -State licenses must be issued PRIOR to DEA Registration

Nursing homes have blanket drug destruction approval and not DEA registrants - requests approval by submitting written protocol to DEA; permission granted in writing; approved protocol must be followed. What form is used to document? How many people have to witness it has been destroyed? How long do you maintain documents?

DEA form 41 2 people 2 YEARS

Nonprescription Schedule 5 controlled substance What does this label have to include? How old do you need to be? How many oz per 48h? do you have to record sale in narcotic book?

Date sold, name of pharmacist, name and address of pharmacy Purchaser must be 18 years or older No more than 4 oz every 48 hrs Record sale in exempt narcotic book

Noncontrolled Drug Prescription

Date the prescription was issued Name of patient Prescriber's printed name and address Drug name and strength Quantity prescribed Directions for use Number of refills, if any, that are authorized. Life of the prescription is for a year from the date written

Pharmacist

Delegated prescriptive authority given under collaborative practice agreements (CPAs) In Michigan, pharmacists can write non-controlled prescriptions under delegated authority. Another pharmacist may fill. Cannot write for a controlled substance Cannot obtain DEA number Not in public health code, but does specifically indicate PA and NP can prescribe CS

Who Can Prescribe in Michigan?

Dentist (DDS, DMD) Doctor of medicine (MD) Doctor of osteopathic medicine and surgery (DO) Doctor of podiatric medicine and surgery (DPM) Optometrist (OD) certified under part 174 to administer and prescribe therapeutic pharmaceutical agents Veterinarian (DVM)

Who can write for controlled medications?

Dentist (DDS, DMD)- affecting the oral structures of the mouth Doctor of medicine (MD) Doctor of osteopathic medicine and surgery (DO) Doctor of podiatric medicine and surgery (DPM)- related to hands, feet and ankles Optometrist (OD) (Certain optometrists who are certified by the Michigan Board of Optometry can write for therapeutic pharmaceutical agents for patient use, as well as controlled substances CIII-V. MUST have a certification of qualification.- DPA and TPA ) Veterinarian (DVM)- limited to animals

what 4 nutraceutical that is regulated by the fda? (and rhythms with fietary fluffament)

Dietary supplements vitamins minerals amino acids =increase total dietary intake (FDA restricted from premarket authority except when an unapproved health claim is made. Limited claims, however, are permitted Health or disease claims Dietary supplements containing drugs)

Dispensing from Unused Medication Repository

Dispense to eligible participants Medicare or Medicaid eligible, uninsured or do not have prescription insurance, MI resident Can charge a handling fee for the service Comply with federal and state laws on storage and distribution Inspect all accepted drugs before dispensing Dispense only pursuant to a prescription The pharmacy cannot resell the medications

Who has the ability to delegate authority? What kind of prescription can they not delegate?

Doctors of Medicine; Doctors of Osteopathic Medicine and Surgery; Cannot delegate prescriptions intended to cause miscarriage or fetal death

Need this according to CMS:

Doctors-NPI Pharmacies- Fraud, Waste and Abuse Training (new hire, annual, records kept) Medicare and Your Rights Notice- Part D enrollees when prescription not covered (rejected) a the point of sale

Naltrexone Does it require special waiver?

Does not need special certification. Any licensed prescriber can prescribe for addiction

Which of the following can be sold without a prescription? A. Insulin aspart B. Insulin lispro C. Insulin detemir D. Insulin glargine E. Insulin regular

E. Insulin regular

Michigan License Application Self-Inspection Form What is included?

Equipment Work space Rx bottle labeling Rx documentation Rx file storage Reference material Licenses displayed Controlled substance storage and records Inventory records Refill records

Relicensure

Every 2 years a pharmacist must renew their pharmacist license And controlled substance license if working with controlled substances Must have all CE completed prior to relicensure date Submit relicensure application, pay fee, submit affidavit of completion of CE Have 60 day grace period Good to check on other information on file such as address, name, place of work 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 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 - licensed pharmacist, practical pharmacy experience; Submit proof of completed 30 hours CE in 2 years prior Take and pass MJPE If more than 8 years Submit proof of completion of 30 hours CE in 2 years prior Take and pass MPJE Complete, within 6 months of apply for relicensure, a program of at least 400 hours of practical pharmacy experience under licensed pharmacist Take and pass the NAPLEX If engaged as pharmacist in another state, but let MI license lapse (>3 years), then just take MPJE, proof of CE of 30 hours in the previous 2 years, and application plus fee No disciplinary action or pending action

Unacceptable drugs at Unused Medication Repository

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 drug's manufacturer

Drug Advertising and Promotion Who regulates prescriptions? Who regulates nonprescription?

FDA regulates prescription drug advertisement (under FDCA) FTC regulates non prescription drugs (under Federal Trade Commission Act)

Simple but often problematic problems

Failure to report a change of name or mailing address within 30 days Violation or aiding/abetting in a violation Failure to comply with subpoena issued by MPHC Failure to respond to a complaint issued under MPHC Failure to appear in administrative hearing or conference Failure to report knowledge that another licensee is impaired or violated the MPHC

Optometrists can write prescriptions for hypertension medications T/F?

False

Unethical Business Behavior and Unprofessional Conduct

False or misleading advertising Dividing fees for referral or accepting kickbacks Fraud or deceit obtaining 3rd party reimbursement Misrepresentation Betrayal of professional confidence Promotion for personal gain unnecessary drug or service Directing or requiring purchase from affiliated financial interest

Misbranding

False or misleading labeling Missing active and inactive ingredients list Not stating warnings, e.g. habit forming drugs (in package insert only) Not having adequate directions for use Not having information for use Imitation drugs e.g. shape, size, color, claimed effect

Exemption of who from DEA Registration?

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

Which of the following sanctions could be imposed on a pharmacist license?

Fine Suspension Restitution Take the MPJE exam

What does the second letter in the DEA mean?

First letter of the Last Name of the person

Controlled Substance Inventory Frequency of count Count submission Time of Count Exact count required How long Records kept Authentication Do records have to be kept separate? How long do you have to access files during inspection?

Frequency of count Federal-Once / 2 years State- Yearly: 30d<May1st>60d Count submission Federal- No; "readily available" State- To MI Board yearly/will change to not required to submit to board Time of Count Federal: No specification State: AM or PM of business day Exact count required Federal and state: CS I&II; CS III-V: Bottles >1000 tab; noncontrolled: not required How long Records kept Federal and state: 2 years Authentication Federal and state: Pharmacy Rx Information, Signature & date Inventory records for Schedule 2 must be separated from Schedule 3-5. Both must be accessible within 48 hours for inspection.

FDAC Kefauver-Harris Amendment of 1962

Good Manufacturing Practices (GMP) established Control over clinical investigations and patient consent (informed consent)

Who oversees Health Professional Recovery Program (HPRP)?

Health Professional Recovery Program (HPRP) oversees the Health Professional Recovery Committee (HPRC)

A pharmacy may supply and control an automated dispensing device at which of the following locations? Select all that apply.

Hospital Nursing home Skilled nursing facility free standing surgical care facility is not explicitly mentioned in the administrative rules. This facility is usually owned by a hospital or health system, and as such most likely qualifies. If owned independently by a physician, then the rule seems to be able to be interpreted as a pharmacy cannot own or operate the device.

What are the rules pertaining to "returning to stock" medications that have not been picked up by the patient? Can medication be added back into the open bottle, or must it remain in the prescription vial that was prepared for dispensing?

If the same lot number and expiration date from which the drug was originally filled, it is not misbranding and can be done. If the lot number and expiration dates are different, or it I left in the vial without an expiration date or lot number, it would be considered misbranding.

Michigan - Manufacturing/Distribution

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 5% of the total number of dosage units prepared during the 12 month period, the pharmacy is a manufacturer. If manufacturer or wholesale distributor distributes in MI only from location outside of MI, obtain one license. If located in MI, then license for each location manufacturer compounds. If manufacturer, must follow cGMP. License application Includes, among other things, description of the building owned by the applicant where manufacturing activity occurs Compounding, packaging, repackaging, quality control, recordkeeping and storage, sales office, warehouse Furnish information as to the formula and name or names of each prescription drug supplied or distributed under the manufacturer's label. Licensed every 2 years Inspection by board inspector at any reasonable time Cannot extend to financial data, sales data, pricing, personnel data, research data For manufactured prescription drugs, can distribute (sell) only to persons licensed by the board or licensed to prescribe drugs in this state.

Health Insurance Portability and Accountability Act of 1996 (HIPAA) What is the goal? ***what must pharmacy provide?

Improve transaction and code sets; National Provider Identifier (for claims) Improve portability and continuity of health insurance Prohibit discrimination in health coverage Regulates the privacy & security of health information Protected Health Information Includes all records not just computerized ***Pharmacy must provide a notice of privacy practices to each patient, and posted in pharmacy. A patient acknowledgement is required once after first dispensing unless refused by patient

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 Fraud or deceit in obtaining or renewing a license Permitting a license to be used by unauthorized person Practice outside of the scope of a license Obtaining CS without lawful authority, selling, giving away drugs for other than lawful purposes

Medication Guides Who makes and approves them? What do they include?

Information for higher risk medications in a format that people will understand Manufacturer produced after FDA approval of language Includes approved uses, when not to use, serious adverse reactions, proper use, cautions. Each dispensing must have the MedGuide included. Other pharmacy generated educational material is not a replacement

CS loss or theft should not be reported to the DEA if

Insignificant loss (determined by the RPh) Discrepancies due to clerical errors Document in a record if possible

Inspection

Inspector from MI Board of Pharmacy May enter at any reasonable time Concern only with matters relevant to the distribution of prescription drugs Not interested (or should not be) in finances or personnel.

What is a cosmetic?

Intended to rubbed, poured, sprinkled, sprayed, introduced into human body...for cleansing, beautifying... Intended for use as a component of any such articles (soap excluded) FDA will not intervene not unless a therapeutic claim is made

Professional Functions of the Practice of Pharmacy

Interpreting and evaluating a prescription Selecting drug products Compounding, dispensing, storing & distributing drugs & devices Maintaining legal records Advising prescribers and patients on content, therapeutic actions, utilization, drug reactions and interactions

Consent Agreement

Investigation findings and penalty/reprimand Representatives of the Attorney General Office, Board of Pharmacy, Disciplinary subcommittee, pharmacist + lawyer Negotiation between parties Pharmacist may accept or not, but in the end may agree to accept the penalty If penalty not accepted by pharmacist, then case sent to administrative law judge for hearing

How long are Prescription Records in Medical Institutions - Controlled Substances kept?

Kept 5 years from date of discharge

The Federal Drug and Cosmetic Act (FDCA) is an example of what type of administrative law?

Legislative

Manufacturer/Wholesaler License What is the 5% Rule?

License is required if wholesale distribution or compounding accounts for over 5% of prepared and dispensed units.

When compounding-

Licensed pharmacist or licensed physician Product using bulk drug substances comply with standards of USP/NF or approved list by the Secretary of HHS Not for a drug product that was withdrawn or removed from the market Does not compound regularly or in inordinate amounts, essentially copies of commercially available products Does not compound products deemed demonstrable difficulties for compounding Label "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 Maintain a record of compounded sterile products - 5 years Name, strength, quantity, and dosage form Formula including mixing directions, ingredients Prescription number or assigned internal ID number Date of preparation Manufacturer and lot number of each ingredient Expiration or beyond use date Name of person who prepared Name of pharmacist who approved Upon application by a pharmacist or compounding pharmacy, the department may authorize the pharmacist or compounding pharmacy to compound nonsterile or sterile products for a prescriber of health facility to administer to the prescribers or facilities' patients in limited quantities without a prescription. The pharmacy must maintain complete records on a monthly basis of requests

Intern License

Limited pharmacist license Eligible to apply at the beginning of the first professional year (or 3rd year of college in a standard 4 year PharmD program - hmmm, not so fast!) Application and pay fee to the Board Must prove admitted to and enrolled in a professional program within a college or school of pharmacy Good for up to 1 year after graduation Must pay annual fee to keep active. Will expire on June 30 of each year if not renewed Supervision of a preceptor Under personal charge of a pharmacist Must complete no fewer than 1600 internship hours, 500 of which are completed within 18 months immediately preceding MPJE/NAPLEX Job, school Must be licensed to earn credit, both student and preceptor Maximum of 40 hrs per calendar week; max of 16 hrs when full time student Can earn up to 400 hrs in unconventional internship Can earn hrs in another state with similar standards to MI Must be reported through the other states' board

Who has a DEA number that starts with an P/R?

Manufacturer/ Distributor/ Researcher /Analytical Lab/ Importer/ Exporter/ Reverse Distributor/ Narcotic Treatment Program

Some of your controlled substance records are stored at a central record keeping site, off site from your pharmacy. The pharmacy Board inspector has requested on May 1 to see these records. What is the latest date you must provide the records on site at your pharmacy?

May 3

Federal Reporting programs

Medwatch (adverse drug event reporting) Medmarx (USP's collection of medication error and adverse event data from hospitals and health systems) safety programs: iPLEDGE (isotretinoin), STEPS (Thalidomide)

how many buckets for storing prescriptions -Mi -Federal

Michigan there are 3 "buckets" or categories C II C III- C V All noncontrolled => kept for 5 years 2 for federal controlled and non-controlled => kept for 2 years

Other licensed health practitioners prescribe under delegated authority as dependent prescribers?

Mid-level providers: Nurse Practitioners, Nurse Midwives, Physician Assistants, Pharmacists (under collaborative practice agreements)

How do you become a licensed pharmacist?

Minimum requirements in Michigan 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

Pseudoephedrine, ephedrine, or phenylpropanolamine Where and how stored? Self-Certification (required by the CMEA) how often? How do you document sales? how long do you keep in michigan vs. federal?

Must be stored "behind the counter, or if in an area where the public has access, in a locked cabinet." annual Self-Certification (required by the CMEA) -Disclosure of employee training and proper placement of products and full compliance to sale limits -Acknowledgement of employee training must be kept Log book or NPLEx (electronic tracking of sales) Not applicable to products < 60 mg of pseudoephedrine or valid prescriptions Michigan: keep 6 months; federal keep 2 years 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

What must be included in a record of a dispensed CPMP?

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