Pharmacy Law Review 2015 Eric Roath, Pharm.D.

Transcription

1 Pharmacy Law Review 2015 Eric Roath, Pharm.D. Director of Professional Practice Michigan Pharmacists Association

2 Learning Objectives 1. Identify general competencies used to prepare for the Multistate Pharmacy Jurisprudence Examination (MPJE); 2. Discuss how laws imposed by federal and state governments, the Drug Enforcement Agency (DEA), and state boards of pharmacy shape the pharmacy regulatory environment; and 3. Explain the statutes and regulations impacting the practice of pharmacy in the state of Michigan.

3 MPJE Structure Computer Adaptive Test Can t go back to prior questions 90 Questions 60 questions counted

4 What is on the MPJE Area 1 Pharmacy Practice (84%) Area 2 Licensure, Registration, Certification and Operational Requirements (13%) Area 3 Regulatory Structure and Terms (3%)

5 AREA 1.01 PHARMACY PRACTICE Identify the legal responsibilities of the pharmacist and other pharmacy personnel. The practice of pharmacy Roles and responsibilities of pharmacy personnel Pharmacy security, theft/loss procedures Disposal and destruction of medications

6 What is Scope of Practice? Scope of practice is essentially the list (or scope ) of privileges that is granted to an individual by a license All healthcare providers in the state of Michigan have scope that is defined by their licensure status In Michigan, being given a license by the bureau of health professions = being a healthcare provider.

7 Practice of Pharmacy MCL (5) Practice of pharmacy means a health service, the clinical application of which includes the encouragement of safety and efficacy in the prescribing, dispensing, administering, and use of drugs and related articles for the prevention of illness, and the maintenance and management of health. Professional functions associated with the practice of pharmacy include: (a) The interpretation and evaluation of the prescription. (b) Drug product selection. (c) The compounding, dispensing, safe storage, and distribution of drugs and devices. (d) The maintenance of legally required records. (e) Advising the prescriber and the patient as required as to contents, therapeutic action, utilization, and possible adverse reactions or interactions of drugs.

8 Roles and Responsibilities MCL (2) Pharmacist means an individual licensed under this article to engage in the practice of pharmacy. (4) Pharmacist intern or intern means an individual who satisfactorily completes the requirements set forth in rules promulgated by the board and is licensed by the board for the purpose of obtaining instruction in the practice of pharmacy from a preceptor approved by the board.

9 Roles and Responsibilities MCL (3) Pharmacist in charge or PIC means the pharmacist who is designated by a pharmacy, manufacturer, or wholesale distributor as its pharmacist in charge MCL (5) A pharmacist in charge shall supervise the practice of pharmacy for the pharmacy in which he or she has been designated the PIC. The duties of the PIC include, but are not limited to, the following: (a) Supervision of all activities of pharmacy employees as they relate to the practice of pharmacy including the purchasing, storage, compounding, repackaging, dispensing, and distribution of drugs and devices to ensure that those activities are performed in compliance with this part and the rules promulgated under this part.

10 Roles and Responsibilities MCL (5) (b) Enforcement and oversight of policies and procedures applicable to the employees of the pharmacy for the procurement, storage, compounding, and dispensing of drugs and the communication of information to the patient in relation to drug therapy. (c) Establishment and supervision of the method and manner for storage and safekeeping of pharmaceuticals, including maintenance of security provisions to be used when the pharmacy is closed. (d) Establishment and supervision of the record-keeping system for the purchase, sale, delivery, possession, storage, and safekeeping of drugs and devices. (e) Establishment of policies and procedures for individuals who are delegated responsibilities for any of the tasks described in this subsection by the PIC.

11 Roles and Responsibilities MCL (6) Pharmacy technician means an individual who is required to hold a health profession subfield license under this part to serve as a pharmacy technician. MCL (1) An individual who performs any of the following functions is considered to be serving as a pharmacy technician and, except as otherwise provided in this part, is required to be licensed under this part as a pharmacy technician: (a) Assisting in the dispensing process. (b) Handling transfer of prescriptions, except controlled substances prescriptions.

12 Roles and Responsibilities MCL (1) (c) Compounding drugs. (d) Preparing or mixing intravenous drugs for injection into a human patient. (e) Contacting prescribers concerning prescription drug order clarification, which does not include drug regimen review or clinical or therapeutic interpretation. (f) Receiving verbal orders for prescription drugs, except orders for controlled substances. (g) Subject to section 16215, performing any other functions authorized under rules promulgated by the department in consultation with the board.

13 Pharmacy Security Requirements Controlled Substances (21 CFR ): Kept in a locked substantially constructed cabinet Dispersed throughout the pharmacy (with noncontrols) Michigan law (R ) is consistent with federal law. Employment Controls (21 CFR ): Cannot employ someone with a felony conviction related controlled substances OR someone denied a DEA registration (with cause)

14 Theft/Loss of Prescription Drugs File a police report Any signs of a break in, physical entry or armed robbery should be reported Controlled Substances (21 CFR ): Notify DEA Field Division Office within 1 business day for significant loss Fill out DEA Form 106 (available online within 10 business days) for any loss. (R (3)) Significant Loss open to the judgement of a registrant Quantity, Regular disappearance/patterns, what C.S. has gone missing.

15 Disposal of Medications Legal for pharmacies to conduct medication take back programs Medications are considered diverted waste NOT medical waste Pharmacies must register with the Department of Environmental Quality as a producer medical waste only if they administer vaccines or perform some other task that generates medical waste. If a pharmacy is collecting used medications, they must be kept in a separate area from other inventory. Collection of C.S. s requires an enhanced DEA registration.

16 Disposal of Controlled Substances 21 CFR (a) Practitioner inventory. Any registered practitioner in lawful possession of a controlled substance in its inventory that desires to dispose of that substance shall do so in one of the following ways: (1) Promptly destroy that controlled substance in accordance with subpart C of this part using an on-site method of destruction; (2) Promptly deliver that controlled substance to a reverse distributor's registered location (3) For the purpose of return or recall, promptly deliver that controlled substance to: The registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf; or (4) Request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located.

17 Destruction of Controlled Substances 21 CFR (c) (iv) Practitioner methods of destruction. Collectors that are practitioners (i.e., retail pharmacies and hospitals/clinics) shall dispose of sealed inner liners and their contents by delivering sealed inner liners and their contents to a distributor's registered location by common or contract carrier pick-up or by distributor pick-up at the collector's authorized collection location.

18 Medication Returns in an Institution R (7) A pharmacist shall personally supervise the destruction of unused portions of prescription medication, other than controlled substances under part 71 of the code, dispensed to patients. However, medications in single-unit packages and intravenous solutions which are designed to be tamper-evident and which show no evidence that tampering has occurred may be returned to stock. Medications that leave the medical institution or its legal affiliates may not be returned to stock for redispensing.

19 AREA 1.02 PHARMACY PRACTICE Identify the requirements for the acquisition and distribution of pharmaceutical products, including samples. Maintenance of Prescriptions and Records Customized Medication Packaging Repackaging Compounding

20 What Records Must Be Maintained? DEA Registration Certificate DEA 222-Forms (and Power of Attorney to sign) Controlled Substance Ordering System (CSOS) Digital certificate to sign a CSOS order Controlled substance receipts and invoices Controlled substance transfer, distribution or loss forms including: DEA Form-106 (Theft/loss) DEA Form-41 (Surrender for Disposal) Records dispensed controlled substances Prescriptions/Prescription Records Inventories (initial and yearly) Signature Logs

21 Prescription Records R (1) A prescription shall be numbered, dated, and initialed or electronically initialed by the pharmacist who performs the final verification prior to dispensing at the time of the first filling at the pharmacy. (2) If the drug that is dispensed is other than the brand prescribed or if the prescription is written generically, the name of the manufacturer or supplier of the drug dispensed shall be indicated on the prescription. (3) This rule does not apply to inpatient medical institution service.

22 What is maintained in the record? R a (4) A pharmacy may utilize a uniform automated data processing system of recording refills if the system is in compliance with all of the following criteria: (a) All information that is pertinent to a prescription shall be entered on the record, including all of the following information: (i) The prescription number. (ii) The patient s name and address. (iii) The prescriber s name. (iv) The prescriber s federal drug enforcement administration number, if appropriate.

23 What is maintained in the record? R a (4) (a) (v) The number of refills authorized. (vi) Whether the drug must be dispensed as written. (vii) The name, strength, dosage form, and quantity of the drug prescribed and the drug dispensed originally and upon each refill. If the drug dispensed is other than the brand prescribed or if the prescription is written generically, then the name of the manufacturer or supplier of the drug dispensed shall be indicated. (viii) The date of issuance of the prescription. (ix) The date and identifying designation of the dispensing pharmacist for the original filling and for each refill.

24 Document Retention Time Period Document Type All records for controlled substances (inventories, acquisition records, etc.) Schedule 2 Prescriptions Schedule 3-5 Prescriptions Non-controlled Prescriptions Storage Requirement 2 years (Federal) 5 years (Michigan) 5 years (Michigan) 5 years (Michigan) *** In Michigan, it is required that 3 separate files be maintained: one for CII prescriptions, one for CIII-CV prescriptions, and one for all other prescriptions Note: This is commonly understood to mean retained from the last date of fill, so effectively, most prescriptions must be retained for a total of 6 years. Prescriptions filled under Medicare plans must be retained for as long as 10 years after service. This is a requirement for plan participants, however, not a legal requirement.

25 Track & Trace ( Pedigree ) Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically. Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market. Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.

26 Track & Trace ( Pedigree ) Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous. Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found. Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database. Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

27 Repackaging d(5)(c) Repackage means a process by which the pharmacy prepares a unit dose package, unit of issue package, or customized patient medication package for immediate dispensing pursuant to a current prescription.

28 Customized Patient Medication Packages R c (1) In place of dispensing 2 or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient s caregiver, or a prescriber, provide a customized patient medication package (CPMP) The package label must contain: Serial numbers for each prescription The name, strength, physical description, and total quantity of each drug product The directions for use & cautionary statements The date of preparation & expiration date Name of the prescriber for each drug product Name address and telephone number of the dispenser

29 Compounding Compounding of pharmaceutical products by pharmacies is permitted under FDA 503A Must be done by a licensed pharmacist or dispensing physician (21 USC 353a) upon Receipt of a valid, patient-specific prescription order In anticipation of receipt of a prescription based upon commonly observed prescribing patterns. Under new Michigan laws, pharmacies that compound sterile products must be certified as being compliant with USP <797>

30 Sales to Practitioners Also called dispensing for office-use. Pharmacies in Michigan may dispense FDA approved products to prescribers to use in their professional practice. Sales to practitioners cannot constitute >5% of the pharmacy s prescription volume (in dosage units). Note: Compounding for office use is currently prohibited federally unless a pharmacy is registered as an Outsourcing facility under 503B

31 AREA 1.03 PHARMACY PRACTICE Identify the legal requirements that must be observed in the issuance of a prescription/drug order. Writing and transmitting prescriptions Delegation Controlled Substances Modifying Prescriptions

32 Prescriptions MCL (3) "Prescription" means an order by a prescriber to fill, compound, or dispense a drug or device written and signed; written or created in an electronic format, signed, and transmitted by facsimile; or transmitted electronically or by other means of communication Prescription includes, but is not limited to, an order for a drug, not including a controlled substance as defined in section 7104 except under circumstances described in section 17763(e), written and signed; written or created in an electronic format, signed, and transmitted by facsimile; or transmitted electronically or by other means of communication by a prescriber

33 Prescription Form MCL (5) Prescription form means a printed form, that is authorized and intended for use by a prescribing practitioner to prescribe controlled substances or other prescription drugs. and all of the following requirements: Bears the preprinted, stamped, typed, or manually printed name, address, and telephone number or pager number of the prescribing practitioner. Includes the manually printed name of the patient, the address of the patient, the prescribing practitioner s signature, and the prescribing practitioner s drug enforcement administration registration number. The quantity of the prescription drug prescribed, in both written and numerical terms. (for controlled substances) Includes the date the prescription drug was prescribed.

34 What can be changed on a Rx? Upon verbal consultation with the prescriber, a pharmacist may add or change: A patient's address Dosage form Drug strength Drug quantity Directions for use Issue date A pharmacist shall note the details of the consultation and shall maintain that documentation with the prescription.

35 What can t be changed? Patient Name Prescriber Name Drug (Chemical Entity) NOTE: switches such as Adderall to Adderall XR are considered changes in the chemical entity, not the dosage form.

36 Mode of Transmission Written: Hand written prescription Can be prepared electronically, must be signed manually Phone Transmitted by phone Facsimile Essentially a written prescription transmitted via fax Electronic

37 Electronic Prescription Legally in Michigan, this refers to prescriptions transmitted: From Computer-to-Computer From Computer-to-Facsimile HOWEVER: Medicare policy (as well as those of some commercial insurers) does not recognize computerized facsimile prescriptions as valid.

38 Signature Requirements Prescription Type Written Prescription Phone Prescriptions Facsimile Prescriptions Electronic Prescriptions Signature Requirement Manual or Wet signature No signature necessary* Manual or Wet signature Electronic signature** * Pharmacy personnel are responsible for properly identifying the prescriber ** Prescriptions are only electronic if they REMAIN electronic. Once a prescription is printed, it is now considered a written prescription.

39 Prescriptive Authority MCL (2) "Prescriber" means a licensed dentist, a licensed doctor of medicine, a licensed doctor of osteopathic medicine and surgery, a licensed doctor of podiatric medicine and surgery, a licensed optometrist certified under part 174 to administer and prescribe therapeutic pharmaceutical agents, a licensed veterinarian, or another licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery.

40 Who is a Prescriber? Dentist Doctor of medicine Doctor of osteopathic medicine and surgery Doctor of podiatric medicine and surgery [Certified] Optometrist Veterinarian Another licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery.

41 Licenses MCL (2) License, except as otherwise provided in this subsection, means an authorization issued under this article to practice where practice would otherwise be unlawful... For purposes of the definition of prescriber contained in section 17708(2) only, license includes an authorization issued under the laws of another state, or the country of Canada to practice in that state or in the country of Canada, where practice would otherwise be unlawful, and is limited to a licensed doctor of medicine, a licensed doctor of osteopathic medicine and surgery, or another licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery. License does not include a health profession specialty field license.

42 Delegation MCL (1) Delegation means an authorization granted by a licensee to a licensed or unlicensed individual to perform selected acts, tasks, or functions that fall within the scope of practice of the delegator and that are not within the scope of practice of the delegate and that, in the absence of the authorization, would constitute illegal practice of a licensed profession.

43 The Rules of Delegation Prescribers writing prescriptions under delegation MUST list: Their name Their DEA (if writing for a controlled substance) The name of the delegating prescriber Delegating prescriber s DEA (controlled substances) Their signature (wet or electronic)

44 Controlled Substance Schedules Schedule Prescriptive Authority Physician P.A. (Delegated) N.P. (Delegated) Schedule I VERY limited No No Schedule II Yes Yes Limited Schedule III Yes Yes Yes Schedule IV Yes Yes Yes Schedule V Yes Yes Yes Legend (Unscheduled) Yes Yes Yes

45 Classifications of Medications Classification Valid For Refills Allowed Schedule II 90 Days 0 Schedule III 6 Months 5 Schedule IV 6 Months 5 Schedule V 1 Year PRN Legend Drugs 1 Year PRN Over-the-Counter 1 Year (If written as RX) PRN

46 Issuing Multiple CII Prescriptions Prescribers may issue multiple prescriptions for the same CII medication under the following conditions: 1. Up to 90 day supply 2. Legitimate medical purpose 3. Indicates earliest day may be filled Do not fill until..:

47 Detoxification Programs Regulations for Methadone Treatment: R Methadone treatment and pharmacists: Cannot dispense methadone on an outpatient basis unless working for a methadone treatment program Typically may only dispense methadone if being used for pain Suboxone/subutex may be dispensed for detoxification purposes Prescriber must have an X DEA number

48 Controlled Substances & Medicaid For controlled substance prescriptions written for Michigan Medicaid beneficiaries, it is required that the prescription be issued on a tamper-resistant (tamper evident) prescription form.

49 AREA 1.04 PHARMACY PRACTICE Identify the procedures necessary to properly dispense a pharmaceutical product, including controlled substances, pursuant to a prescription/drug order Prescription Transfers Controlled Substance Situations Generic Substitution Labeling Requirements Adulteration & Misbranding Automated Dispensing Systems Centralized Prescription Processing Hospice Emergency Drug Box

50 Prescription Transfers Also called Prescription Copies A pharmacist or technician may transfer a prescription between pharmacies Controlled substances may: Only be transferred by a pharmacist Only be transferred 1 time Using a real time data transfer to transmit between pharmacies in the same company

51 Partial Fills and Controlled Substances A pharmacist may dispense partial fills for a controlled substance in schedules 3-5 any number of times as long as it is within the quantity limits specified on the prescription and the prescription is within its window of validity (i.e. not expired). Note: A partial fill does not constitute a refill. A partial fill for a controlled substance schedule 2 may be issued as long as the remainder of the prescription is dispensed within 72 hours of the first fill.

52 Transmitting C2s Via Fax (a) A paper prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. (e) A prescription for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription (f) A prescription for a Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription (g) A prescription for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription

53 Emergency C2 Prescriptions (d) In the case of an emergency situation a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (2) The prescription shall be immediately reduced to writing by the pharmacist (3) If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and (4) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. the prescription shall have written on its face Authorization for Emergency Dispensing, and the date of the oral order Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that had earlier been reduced to writing

54 Generic Substitution (1) When a pharmacist receives a prescription for a brand name drug product, the pharmacist may, or when a purchaser requests a lower cost generically equivalent drug product, the pharmacist shall dispense a lower cost but not higher cost generically equivalent drug product if available in the pharmacy, except as provided in subsection (3). If a drug is dispensed which is not the prescribed brand, the purchaser shall be notified and the prescription label shall indicate both the name of the brand prescribed and the name of the brand dispensed and designate each respectively. If the dispensed drug does not have a brand name, the prescription label shall indicate the generic name of the drug dispensed, except as otherwise provided in section

55 Labeling Requirements MCL (1) A prescription dispensed by a pharmacist shall bear upon the label the name of the medication in the container, unless the prescriber writes do not label on the prescription. The prescription shall also bear upon the label the following statement: Discard this medication 1 year after the date it is dispensed, unless the medication expires on another date under applicable state or federal law or rules or regulations or other state or federal standards. If the medication expires on another date, the pharmacist dispensing the prescription shall strike or omit the statement required under this subsection and shall specify on the label the actual expiration date of the medication.

56 Labeling Requirements (cont..) R (6) A pharmacy shall ensure that every medication dispensed is identified with its name and strength labeled on the container in which it is dispensed or on each single unit package. A pharmacy that is engaged in drug distribution to medical institutions which use unit-of-use packaging shall place identification on the label of its package to allow the package to be readily traced. The name of the patient, and or a unique identifier shall be labeled on the medication container. The container may be the individual patients' assigned medication drawer. The directions for use shall be on the label of the container if the directions are not communicated in another effective manner. If the medication is to be selfadministered, then directions for use shall be on the container. The preceding provisions of this subrule are minimum labeling standards only and do not supersede other applicable laws or rules.

57 Adulteration Any alteration that may effect the purity or quality of a product Includes: Violation of packaging stability Contamination, Product appearance Variations in strength, quality or purity vs. official compendium Violation of Current Good Manufacturing Practice (CGMP) MCL (2) A person shall not knowingly or recklessly do either of the following: (a) Adulterate, misbrand, remove, or substitute a drug or device knowing or intending that the drug or device shall be used. (b) Sell, offer for sale, possess for sale, cause to be sold, or manufacture for sale an adulterated or misbranded drug.

58 Misbranding Labeling or advertising is wrong/misleading Dispensing errors, among other things, are an example of misbranding Applies to prescriptions as well as manufacture label MCL manufacturer s label states name & place of business of the manufacturer

59 Adulteration vs. Misbranding Misbranded if: Incorrect or misleading labeling, directions, or advertising Adulterated if: Quality or strength impairments Purity impairments Manufacturing deficiencies Prescriptions can be both misbranded and adulterated at the same time.

60 Automated Dispensing Cabinets R (7) Policy and procedures for the use of the automated device shall include a requirement for pharmacist review of the prescription or medication order before system profiling or removal of any medication from the system for immediate patient administration. This subrule does not apply to the following situations: (a) The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as provided in R (4)(i). (b) The system is being used in place of an emergency kit as provided in R (4)(c). (c) The system is being accessed to remove medication required to treat the emergent needs of a patient as provided in R (4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to review the medication order. (d) In each of the situations specified in subdivisions (a) to (c) of this subrule, a pharmacist shall review the orders and authorize any further dispensing within 48 hours. (e) The device is located in a dispensing prescriber s office.

61 Automated Dispensing Systems (ADS) (2) An automated device may be used only in the following locations: (a) A pharmacy. (b) A hospital. (c) A county medical care facility. (d) A hospice. (e) A nursing home. (f) Other skilled nursing facility... (g) An office of a dispensing prescriber. (3) An automated device designed for the specific purpose of selling, dispensing, or otherwise disposing of any drug or device ordered by a prescription, as defined in the code, and located within a licensed pharmacy shall be used only by a pharmacist, or other pharmacy personnel under the personal charge of a pharmacist.

62 ADS Machines R (4) The pharmacist who directs the pharmacy services shall develop, implement, supervise, and coordinate all of the services provided, including, at a minimum, all of the following: (a) Dispensing medications in a form that minimizes additional preparation before administration to the patient, including the admixture of parenterals. (b) Obtaining the prescriber's original medication order, a direct carbonized copy, an electromechanical facsimile, or other electronic order transmission. Security measures shall be in place to ensure that system access by unauthorized individuals is not allowed

63 ADS as Emergency Kits R (4) (c) Interpreting and reviewing the prescriber's medication orders and communicating problems with these orders to the physician or nurse before administration of first doses. If the interpretation and review will cause a medically unacceptable delay, then a limited number of medications may be stocked at the patient care areas for the administration of first doses. These medications shall be provided in a manner that ensures security and immediate availability, such as sealed or secured medication kits, carts, or treatment trays. A pharmacist shall routinely inspect the medications and, after use, shall verify the contents and replace the medications as necessary.

64 After Hours Dispensing (4)(i) Providing a method by which medications can be obtained during the absence of a pharmacist in a medical institution where a pharmacist is not available 24 hours a day During the absence of a pharmacist, the services of a pharmacist shall be available on an on-call basis. Only a limited number of medications that are packaged in units of use shall be available. The medications shall be approved and reviewed periodically as deemed necessary, but not less than once a year, by an appropriate interdisciplinary practitioner committee of the medical institution The order and document shall be reviewed by the pharmacist within 48 hours of removing medication from the cabinet or its equivalent. The pharmacist who directs pharmacy services in the medical institution shall designate the practitioners who are permitted to remove the medication. A pharmacist shall audit the storage

65 Centralized Prescription Processing R (1) (a) Centralized prescription processing center means a pharmacy operated under the direction of a pharmacist that processes information related to the practice of pharmacy and engages in centralized prescription processing. MCL (3) As used in this section, centralized prescription processing means the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions such as dispensing, performing drug utilization review, completing claims adjudication, obtaining refill authorizations, initiating therapeutic interventions, and other functions related to the practice of pharmacy.

66 Central Fill Pharmacies Must be licensed in the state of Michigan Share patient and drug information with the delivering pharmacy Delivering pharmacist is responsible for counseling Controlled substances must have CENTRAL FILL on the face of the original prescription record.

67 Hospice Emergency Drug Box R (1) A pharmacy that establishes a medication box exchange program for hospice emergency care services rendered in patients homes shall establish drug boxes that are in compliance with this rule. Before providing drug boxes for a hospice emergency care system, the pharmacist in charge shall assure that the hospice has developed policies and procedures that require all of the following: (a) Maintenance by the hospice of a drug box exchange log that accounts for the hospice s receipt of the boxes from the pharmacy, assignment of the boxes to registered nurses or physicians assistants, and return of the boxes to the pharmacy for restocking. (b) A procedure to assure that the drug boxes are inspected at least weekly to determine if they have expired or have been opened. (c) Procedures for the storage and control of a drug box while it is assigned to, and being used by, a registered nurse or physician s assistant. (d) A procedure for implementing the hospice medical director s responsibility for assuring that prescriptions for drugs removed from the drug boxes are obtained from the attending physicians.

68 Hospice Emergency Drug Box R (5) A label that contains all of the following information shall be attached to the drug box so that it is visible from the outside of the box: (a) The name and address of the pharmacy. (b) The name and address of the hospice. (c) The name of the pharmacist who last inspected and restocked the drug box. (d) The date the drug box was last restocked. (e) The date on which the drug box must be returned to the pharmacy for the replacement of expired drugs. (f) The number of the drug box.

69 Hospice Emergency Drug Box R (10) The pharmacy shall maintain a permanent record of drug box exchanges on a drug box exchange log. The record shall contain all of the following information: (a) The number of the box. (b) The name of the hospice to which the box is released. (c) The date the box is released to the hospice. (d) The name and signature of the pharmacist who releases the box to the hospice. (e) The expiration date assigned. (f) The date the box is returned to the pharmacy for restocking. (g) The name and signature of the pharmacist who received the box for restocking.

70 AREA 1.05 PHARMACY PRACTICE Identify the conditions for making an offer to counsel or counseling appropriate patients, including the requirements for documentation.

71 Counseling Requirements OBRA '90 also states to establish standards governing patient counseling. Such discussions must include matters that are significant, (in the professional judgment of the pharmacist) which include, but are not limited to, the following: name and description of the medication, route of administration, dose, dosage form, and duration of drug therapy. OBRA '90 also mandates pharmacists discuss special directions and precautions for preparation of drugs, administration and use by the patient; common severe side effects or adverse effects interactions and therapeutic contraindications techniques for self-monitoring drug therapy; proper storage; refill information; and appropriate action in case of a missed dose.

72 AREA 1.06 PHARMACY PRACTICE Identify the requirements for the distribution and/or dispensing of nonprescription pharmaceutical products, including controlled substances. Behind the counter products Schedule V exemptions NPLEX

73 Behind the Counter Drugs Emergency Contraceptives Plan B for women over 17 y/o Plan B One-step indicated for women over 15 y/o Pseudoephedrine OTC Schedule V Cough Syrups Anti-diarrheals

74 Ephedrine/PSE Containing Products MCL c (1) A person shall not do any of the following: (a) Purchase more than 3.6 grams of ephedrine or pseudoephedrine alone or in a mixture within a single calendar day. (b) Purchase more than 9 grams of ephedrine or pseudoephedrine alone or in a mixture within a 30-day period. (c) Possess more than 12 grams of ephedrine or pseudoephedrine alone or in a mixture.

75 National Precursor Log Exchange (NPLEX) Pharmacy s are required to maintain a log of pseudoephedrine purchases, maintained for a minimum of 6 months (R e). NPLEX meets this requirement. Any purchase of pseudoephedrine from a pharmacy must be reported to NPLEX within the next business day (MCL a)

76 Schedule V Exemption The following schedule V naroctics are considered to be exempt Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit Not more than 100 milligrams of opium per 100 milliliters or per 100 grams Not more than 0.5 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit Functionally, loperamide operates this way in MI.

77 AREA 1.07 PHARMACY PRACTICE Identify the proper procedures for keeping records of information related to pharmacy practice, pharmaceutical products and patients, including requirements for protecting patient confidentiality. Controlled Substance Inventories Michigan Automated Prescription System Health Insurance Portability and Accountability Act

78 Controlled Substance Inventories R (2) Beginning May 1, 1989, and annually thereafter, each person licensed under this article to manufacture, distribute, prescribe, or dispense controlled substances shall inventory and report to the administrator all schedule 2 to 5 controlled substances possessed by the person at the time of the inventory. The annual report required under this subsection may be conducted and submitted to the administrator not more than 30 days before May 1, but shall be conducted and submitted to the administrator not later than 60 days after May 1. A person who violates this subsection may be punished by a civil fine of not more than $25, in a proceeding in the circuit court.

79 Michigan Automated Prescription System (MAPS) Prescription Drug Monitoring Program (PDMP) for Michigan Logs all controlled substances dispensed to Michigan patients Many states, like New York, have already implemented laws mandating MAPS screening prior to writing a prescription MICHIGAN IS NOT ONE OF THESE

80 Data upload to MAPS Report daily (electronically) or twice monthly (R b) The patient identifier: Driver s License or State ID If the patient is under 16 years of age, zeroes shall be entered as the identification number. If the patient is an animal, positive identification of the animal s owner The name of the controlled substance dispensed. The metric quantity of the controlled substance dispensed. The NDC of the controlled substance dispensed. The date of issue of the prescription. The date of dispensing. The estimated days of supply of the controlled substance dispensed. The prescription number assigned by the dispenser. The DEA registration number of the prescriber and the dispensing pharmacy. The Michigan license number of the dispensing pharmacy.

81 MAPS Exemptions Medications administered directly to patients Dispensing of up to a 48 hour supply upon discharge Controlled substance samples Veteran s Affairs prescriptions Methadone treatment centers

82 HIPAA & Confidentiality HIPAA prohibits the dissemination of Personal Health Information (PHI) to any parties: Without patient permission Not involved in the direct care of the patient All healthcare entities are bound by HIPAA requirements, as well as companies contracted with those entities. Requires a signed court order (or similar documentation) to disclose any information related to HIPAA.

83 AREA 2 LICENSE & OPERATION REQ. Licensure for facilities Drug control licenses for dispensing practitioners DEA registration validation Renewal of pharmacist licenses Out of state practices Pharmacy space and signage requirements

84 Licensure for Facilities MCL (1) "Health facility or agency", except as provided in section 20115, means: (a) An ambulance operation, aircraft transport operation, nontransport prehospital life support operation, or medical first response service. (b) A clinical laboratory. (c) A county medical care facility. (d) A freestanding surgical outpatient facility. (e) A health maintenance organization. (f) A home for the aged. (g) A hospital. (h) A nursing home. (i) A hospice. (j) A hospice residence

85 Drug Control License MCL (1) Except as otherwise provided in this subsection, a prescriber who wishes to dispense prescription drugs shall obtain from the board a drug control license for each location in which the storage and dispensing of prescription drugs occur. A drug control license is not necessary if the dispensing occurs in the emergency department, emergency room, or trauma center of a hospital licensed under article 17 or if the dispensing involves only the issuance of complimentary starter dose drugs. See MCL for additional details on the drug control license. Each physician prescribes under their personal DEA. No additional DEA for the facility is needed. A prescriber only needs separate DEA numbers when practicing in multiple states (as it is tied to their state license), or if they are working with substance abuse detoxification. 21 USC 823:

86 DEA Numbers and Verification Required for any practitioner prescribing, dispensing or otherwise handling controlled substances. Source:

87 Renewal of Licenses Pharmacist Fees: Application Fee - $20.00 (initial) Pharmacist License - $30.00 (per year) Controlled Substance License - $85.00 (per year) CE requirements: 30 hours of CE total 10 hours of live CE 1 hour of pain & symptom management

88 Out of State Practices Any practice dispensing medications to patients residing in MI at the time of delivery must be licensed as a MI pharmacy If you are shipping to other states, you may be subject to similar laws in those state (e.g. mailorder) Compounding pharmacies are subject to riskbased inspections from the MI Board and they are responsible for the costs

89 Housing of a Pharmacy R (1) All professional and technical equipment and supplies and prescription drugs shall be housed in a suitable, welllighted and well-ventilated room or department with clean and sanitary surroundings. (2) All pharmacies shall have a prescription department which is devoted primarily to the practice of pharmacy which occupies not less than 150 square feet of space, and which includes a prescription counter that provides not less than 10 square feet of free working surface. For each additional pharmacist who is on duty at any one time, the free working space shall be increased by not less than 4 square feet. The prescription counter shall be kept clean and orderly. The space behind the prescription counter shall be sufficient to allow free movement within the area and shall be free of obstructions.

90 Housing of a Pharmacy R (3) All pharmacies that occupy less than the entire area of the premises owned, leased, used, or controlled by the licensee shall be permanently enclosed by partitions from the floor to the ceiling. All partitions shall be of substantial construction and shall be securely lockable so that drugs and devices that can only be sold by a pharmacist are unobtainable during the absence of the pharmacist. Identification of this department by the use of the words "drug, medicines," or "pharmacy" or by the use of a similar term or combination of terms shall be restricted to the area that is licensed by the board. The pharmacy department shall be locked when the pharmacist is not in the on the premises

91 Signage Requirements MCL (2) A pharmacist engaged in the business of selling drugs at retail shall conspicuously display the [following] notice described in subsection (3) at each counter over which prescription drugs are dispense: 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 that 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.

92 Pharmacist Supervision The pharmacy must operate under the personal charge of a pharmacist. Personal charge means the immediate physical presence of a pharmacist or dispensing prescriber. MCL (2) Supervision the overseeing of or participation in the work of another individual by a health professional in circumstances where at least all of the following conditions exist: (a) The continuous availability of direct communication in person or by radio, telephone, or telecommunication between the supervised individual and a licensed health professional. (b) The availability of a licensed health professional on a regularly scheduled basis to review the practice of the supervised individual, to provide consultation to the supervised individual, to review records, and to further educate the supervised individual in the performance of the individual's functions. (c) The provision by the licensed supervising health professional of predetermined procedures and drug protocol.

93 AREA 3 REGULATORY STRUCTURE Overview of federal legislative action

94 Pure Food and Drug Act Enacted in 1906 Prohibited selling adulterated and misbranded drugs. No requirements for ingredients or approval Did not apply to medical devices or cosmetics

95 Food, Drug & Cosmetic Act Enacted in 1938 Established the New Drug Application/Approval Process (NDA) Required medications to have adequate directions for use. Required labeling: Prescriptions Pharmacy Label Patient Information Label Manufactured Products Habit-forming drugs

96 Food, Drug & Cosmetic Act Grandfather Clause: Drugs marketed before 1938 were not subject to review or NDA requirements No prescription-only stipulations Safe only when used under medical supervision. Did not necessarily require drugs to be effective for intended use. Recognized USP-NF and Homeopathic Pharmacopoeia of the US as official compendia.

97 Durham-Humphrey Act Amended the FDCA in 1951 Created Prescription-Only and OTC Drugs Rx Only Indication for prescription use only must appear on manufacturer labeling OTC Safe to use without medical supervision when accompanied by adequate directions for use. Authorized verbal prescription orders and permitted prescription refills.

98 Kefauver-Harris Act Amended the FDCA in 1962 NOW drugs must be proven effective for intended purposes Retro-active back to drugs approved between 1938 and 1962 Drug Efficacy Study Implementation (DESI) for pre drugs [over 1000 products found to be ineffective!] Required Informed Consent for Human Research Subjects Implemented CGMPs

99 Poison Prevention Packaging Act Enacted in 1970 Prevention of accidental poisoning of children under age 5 Requires Hazardous Household Products (including MOST drugs) to be marketed in childresistant packaging. Patient or Physician may ask for non-childresistant packaging.

100 Poison Prevention Packaging Act Exemptions: Powdered unflavored aspirin Effervescent aspirin Sublingual nitroglycerin Oral contraceptives Hormone replacement therapy Powdered iron preparations Effervescent acetaminophen Hydrocarbon-containing products where the liquid cannot flow freely

101 Federal Anti-Tampering Act Enacted in 1982 Requires most oral OTC drug products (including some dietary supplements) to have tamper-proof indicators or barriers. Enacted after intentional cyanide contamination of Tylenol in Chicago.

102 Medical Device Act Enacted in 1976 Requires pre-market approval of medical devices Required implementation of: CGMP manufacturing standards Classification by intended use Record keeping and reporting requirements

103 Orphan Drug Act Enacted in 1983 Provides incentives for manufacturers to produce medications to treat rare diseases. Rare diseases effects <20,000 persons in the United States.

104 Hatch-Waxman Act Amended FDCA in 1984 Established standards for marketing generic drugs Abbreviated New Drug Application/Approval (ANDA) 5 years of patent exclusivity to innovator products (in general) Generic products must prove to be therapeutically equivalent Established the FDA Orange Book Michigan is not an Orange Book State

105 Prescription Drug Marketing Act Enacted in 1987 Prohibits re-importation of drugs that have left the United States. Requires licensure of wholesalers under state law. Bans the sale of drugs samples (complimentary starter doses) Dispensed only at the behest of a physician Class of trade prohibitions keeping hospitals from selling drugs to community pharmacies

106 Omnibus Budget Reconciliation Act OBRA 90 Enacted in 1990 Requires necessary and appropriate prospective drug utilization review Mandates offer to counsel Document it, or it didn t happen

107 FDA Modernization Act Amended FDCA in 1997 Fast track NDA process for treatments for lifethreatening diseases Guidelines for pharmacy compounding Eliminated habit-forming warning labels (from back in 1938) Mandated that drugs with pediatric indications be tested in children

108 Biologic Price Competition & Innovation Act Amended the FDCA in 2009 Provided an abbreviated application pathway for follow-on biologic (biosimilar) products Allows for substitution of biosimilar products that the FDA deems as interchangeable at the point of sale without intervention or notification of the prescriber.

109 Drug Quality and Security Act Amended the FDCA in 2013 Introduced by Rep. Upton (R, MI-6) in response to New England Compounding Center incident. Created a new 503(B) classification for compounding for office use Implemented Track & Trace provisions.

110 United States Pharmacopeia & National Formulary (USP-NF) The official compendium of the United States If something is included in the official compendium, it is considered a drug Also sets standards for dietary supplements and food ingredients General chapters elaborate on compounding and manufacturing standards (among other things)

111 Preparing for the MPJE Michigan Pharmacy Law: A Guide to the Statutes and Regulations (7 th edition) ASHP s PharmPrep 4 th edition, Federal Pharmacy Law Reiss and Hall, Guide to Federal Pharmacy Law, 8 th edition Links to free online resources: ance

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114 Eric Roath, Pharm.D. Director of Professional Practice Michigan Pharmacists Association Office: (517) Fax: (517)