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Greg Baran, RPh, MA, FMPA Baran Consulting LLC Objectives Review the changes to the pharmacy practice act related to sterile compounding. Understand the role of the Pharmacist-‐in-‐Charge (PIC) and the potential impact upon the PICs license. Review the federal act, Drug Quality and Security Act and understand the impact upon pharmacy. Understanding the differences between the state and federal regulations. Review other changes to the pharmacy practice act. Law Additions and Changes Affecting Institutional Practice 1. Pilot Projects – Public Act 267 of 20131 a. Effective March 30, 2014 b. Maximum of 10 pilot projects c. Possible fee charged d. Department establish a process e. Possible restrictions on pilots f. Department may grant a waiver to a rule g. Pilot period for 18 months with one extension h. May be required to notify patients affected by the pilot project i. Directions at: https://www.michigan.gov/documents/lara/lara_Pharm_Pilot_project_pr
ocedures2014_448962_7.pdf 2. Dispensing to Other than the Patient (No patient-‐physician relationship required) a. Auto-‐injectable Epinephrine Public Acts 186 & 187 of 20132 i.
Effective March 14, 2014 ii.
Pharmacist can dispense to a school board on a prescription from prescriber. iii.
School board is the patient name. b. Opioid Antagonist Public Acts 311, 312 and 313 of 20143 i.
Effective October 14, 2014 ii.
Naloxone hydrochloride or any other similarly active and equally safe drug approved by FDA for treatment of drug overdose. Law Update 2015 Baran Consulting LLC 1 iii.
RPh can dispense opioid antagonist to a person or individual other than the patient. c. Expedited Partner Therapy Public Act 525 of 20144 i.
Authorizes a health professional, under specific circumstances to provide expedited partner therapy (EPT), prescribe a drug or treatment or dispense a drug or treatment for the partner of a patient diagnosed with a SDT without examining the partner. ii.
Department of Community Health (DCH) to maintain a list of STDs for which EPT is appropriate. iii.
Require the health professional to dispense the prescribed therapy in the name of “expedited partner therapy” if the partner’s name were unknown. iv.
DCH to develop and distribute an information sheet that includes information regarding EPT, antibiotic treatment for STIs and other information. v.
Effective January 1, 2015 3. Public Act 95 of 2014 a. Effective July 1. 2014 b. Approval of investigation of licensee now a 3-‐member panel, chair and 2 members. c. Permits an investigation of an allegation made more than 4 years after alleged violation. 4. Regulatory Boards and Commissions Ethics Act, Public Act 96 0f 2014 • New law effective July 1, 2014 • Establish conflict of interest disclosure requirements for members of regulatory boards in the Department of Licensing and Regulator Affairs (LARA). • Require a board member to abstain from voting on, and refrain from discussing with the board, a matter in which he or she has a conflict of interest. 6. Public Act 97 of 2014 • Effective July 1, 2014 • Removes community service as an option for a Board sanction. • Investigate an allegation that there are grounds for action against a health professional by a disciplinary subcommittee. • Sexual conduct with a patient in a category of unprofessional conduct that is grounds for disciplinary action and prescribe sanctions • Practice-‐related services in exchange for sexual favors as unprofessional conduct. Law Update 2015 Baran Consulting LLC 2 •
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Require the disciplinary subcommittee to impose sanctions if a licensee or registrant fails to notify LARA of a criminal conviction or disciplinary action by another state. Require the disciplinary subcommittee to impose of fine of at least $25K if a violation of a general duty or a personal disqualification results in a patient’s death, and otherwise modify the sanctions that a DSC may impose. 7. Public Act 98 of 2014 • Effective July 1, 2014 • Permit LARA to review a final decision of a disciplinary subcommittee and, under certain circumstances, to set aside the decision. • Provide that the final action of LARA will serve as the final action on the matter and be subject to judicial review. • Require LARA to post on its website each final decision in which disciplinary action is taken. Adds in MCL 333.16227(1) “For an offense 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.” 5 8. Pharmacist in Charge (PIC), Public Act 280 of 20146,7 a. Effective September 30, 2014 b. Pharmacist in Charge (PIC) i. PIC to be licensed in Michigan for a pharmacy. ii. PIC and Pharmacy will be jointly responsible for compliance. iii. May be PIC for more than 1 pharmacy. iv. Work at least 8 hours per week at pharmacy for which she/he is PIC. v. PIC shall maintain appropriate records and demonstrate compliance upon request of Board. c. Notify of change in PIC no later than 30 days. d. Supervise the practice of pharmacy for all locations and duties include: i. Supervision of all activities of pharmacy employees as they relate to practice of pharmacy. ii. Enforcement and oversight of policies and procedures. iii. Establishment and supervision of method and manner fro storage and safekeeping of drugs. iv. Establishment and maintenance of security for individual who are delegated responsibilities for any of the tasks described in this subsection by the PIC. Law Update 2015 Baran Consulting LLC 3 9.
Compounding Laws •
Federal o Drug Quality and Security Act o Title I “Compounding Quality Act”8 • 503A Traditional Compounding • 503B Outsourcing Facility o Title II Drug Supply Chain Security Act • “Outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States”9 • Development of they system will be phased in over 10-‐years • State o Compounding Pharmacy, Public Act 280 of 2014 Definitions •
Federal: o “In general, compounding is a practice in which a licensed pharmacist, as licensed physician, or, in the case of an outsourcing facility, a person under the 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.”10 • State: o “Compounding” means the preparation, mixing, assembling, packaging, and labeling of a drug or device by a pharmacist under the following circumstances: (a) Upon the receipt of a prescription for a specific patient. (b) Upon the receipt of a medical or dental order from a prescriber or agent for use in the treatment of patients within the course of the prescriber’s professional practice. (c) In anticipation of the receipt of a prescription or medical or dental order patterns. (d) For the purpose of or incidental to research, teaching, or chemical analysis and not for the purpose of sale or dispensing. Compounding dose not include any of the following: (a) Except as provided in section 17748c, the compounding of a drug product that is essentially a copy of a commercially available product. (b) The reconstitution, mixing, or other similar act that is performed pursuant to the directions contained in approved labeling provided by the manufacturer of a commercially available product. Law Update 2015 Baran Consulting LLC 4 (c) The compound of allergenic extracts or biologic products.11 o Mixing of two or more drugs is compounding. 10 o Compounding does not include mixing, reconstituting, or other acts performed with directions in approved labeling. 10. Compounding (f) = federal (s) = state • Traditional Pharmacy • Outsourcing Facility • Manufacturer •
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Traditional Compounding 8, 10, 12-‐15 Compounding by licensed pharmacist in state licensed pharmacy (federal (f), State (s)) Limited quantities before receipt of prescription based on history (f, s) Compounded in compliance with USP chapters on pharmacy compounding (f) Compound sterile pharmaceuticals to be accredited or show compliance with USP standards by September, 30, 2015 (s) Drug substances used in compounding use bulk drug substances with USP/NF monograph or a component of a FDA approved drug until final rules (f) Cannot be compounded using bulk drug substances: (f) o Withdrawn or removed from market for safety or not effective o On “demonstrably difficult” list Cannot compound regularly or inordinate amounts “copies” of commercially available products (f) Adds extensive record keeping for sterile products (exempts distribution within hospital) (s) Shall not off excess compounded pharmaceuticals to other pharmacies for resale (f, s) Shall not distribute samples of a compounded pharmaceutical to a health professional (s) May advertise or otherwise promote the fact that they provide compounding services (f, s) Cannot compound and manufacture drug products at same location (s) Department may promulgate rules (f, s) If provides compounding services must be licensed as pharmacy or manufacturer (s) If ships more than 5% across state lines, the state located in has signed a memorandum of understanding (MOU) with FDA (f) State Boards to continue oversight and regulations (f) State Boards to report to FDA compounding and other violations (f) Law Update 2015 Baran Consulting LLC 5 11. Outsourcing Facility 8, 13-‐14 • FDA registration “voluntary” (FDA may require registration as manufacturer) • Comply with current good manufacturing practices (CGMP) • Comply with all FDA requirements (f, s) • Licensed as a pharmacy in Michigan (no separate license category for outsourcing facility) • Not required to be licensed as a pharmacy by the FDA • Compound drugs not commercially available (s) • Can’t compound copies of drugs unless they are on FDA shortage list (f) • Compound without a prescription apply to the Department (s) • May compound sterile products (f) • Report adverse events regarding compounded products (f, s within 10 days) • Provide FDA with certain information about the products they compound (f) • Will be inspected by FDA according to a risk-‐based schedule • Labeling requirements and must have statement “This is a compounded drug” (f) 12. Public Act 280 of 2014 14-‐16 • Requires a pharmacy to notify within 30 days o Of a complaint filed by another state o An investigation by federal authorities o An investigation of an agency into compounding accreditation standards 12. Pharmacy Technician Licensure, Public Act 285 of 2014 • Effective December 22, 2014 • Requires licensure if performing any of the following functions: 16 o Assisting in the dispensing process o Handling transfer of prescriptions, except controlled substance prescriptions o Compounding drugs o Preparing or mixing intravenous drugs for injection into a human patient o Contacting prescribers concerning prescription drug order clarification, which does not include drug regimen review or clinical or therapeutic interpretation o Receiving verbal orders for prescription drugs, except orders for controlled substances o Subject to section 333.16215, performing any other functions authorized under rules promulgated by the Department in consultation with the Board. Law Update 2015 Baran Consulting LLC 6 •
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Pharmacy, PIC, pharmacist responsible that technician is licensed or otherwise authorized to serve as a technician Under supervision and personal charge of pharmacist or dispensing prescriber 20 hours of continuing education for renewal of licensure Types of licensure 17-‐19 o Full license – Board approved certified technician o Temporary license – valid 210 days while preparing for examination o Limited license – only valid while working for that distinct pharmacy 13. Revocation of Licenses, Public Act 413 of 2014 20 • Once license revoked, permanent – ineligible to relicense • Delayed licensure requirement for pharmacy technicians until June 30, 2015. 14. Human Trafficking Training, Public Act 343 of 2014 21 • Effective January 1, 2015 • By January 14, 2017 rules for training standards to identify victims of human trafficking 15. “Right to Try”, Public Act 345 and 346 of 2014 22 • Effective October 17, 2014 • Using a drug that completed Phase I (experimental treatments) • Third parties no required to pay 16. Board of Pharmacy Rules • Program for Utilization of Unused Prescription Drugs – Effective Sept. 24, 2014 • Pharmacy Technicians – Proposed Revision o PTCB –ASHP, APHA, ICHP, MPA o ExCPT – NACDS, NCPA v Continuing Education o
Human Trafficking o
Patient Safety o
Pain Management o
Law Update • Compounding – Required accreditation for all pharmacies (hospitals included) that provide sterile compounding services by Sept. 30, 2015 o PCAB – Pharmacy Compounding Accreditation Board o NABP – Verified Pharmacy Program (VPP) • Human Trafficking Training for all healthcare licensees Law Update 2015 Baran Consulting LLC 7 Law Update 2015 Baran Consulting LLC 8 References: 1. 1978 PA 368, as amended by 2013 PA 267, MCL 333.17723 2. 1978 PA 368, as amended by 2013 PA 186 & 187 3. 1978 PA 368, as amended by 2014 PA 311, 312 and 313 4. 1978 PA 368, as amended by 2014 PA 525 5. 1978 PA 368, as amended by 2014 PA 97, MCL 333.16227 6. 1978 PA 368, as amended by 2014 PA 280, MCL 333.17707 7. 1978 PA 368, as amended by 2014 PA 280, MCL 333.17748 8. Compounding [Internet]. Silver Spring (MD): U.S. Food and Drug Administration: 2014 [updated 2014 July 1; cited 2014 July 2]. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Ph
armacyCompounding/defaulty.htm. 9. Drug Supply Chain Security Act (DSCSA) [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2014 [updated 2014 June 10; cited 2014 July 4]. Available from: http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity
/drugsupplychainsecurityact/default.htm 10. Compounding and the FDA: Questions and Answers [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2013 Dec [updated 2013 Dec 2; cited 2014 Oc 22]. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforamtion/Pha
rmacyCompounding/ucm339764.htm 11. 1978 PA 368 as amended by 2014 PA 280, MCL 333.17702 12. Guidance Pharmacy Compounding of Human Drug products Under Section 503A of the Federal Food, Drug, and Cosmetic Ace [Internet]. Silver Spring (MD): U.S. Food and Drug Administration: 2014 July [updated 2014 July 1; cited 2014 July 2]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInfor
mation/Guideaces/UCM377052.pdf. 13. 1978 PA 368, as amended by 2014 PA 280, MCL 333.17748A 14. 1978 PA 368, as amended by 2014 PA 280, MCL 333.17748B 15. 1978 PA 368, as amended by 2014 PA 280, MCL 333.17748C 16. 1978 PA 368, as amended by 2014 PA 285, MCL 333.17739 17. 1978 PA 368, as amended by 2014 PA 285, MCL 333.17739a. 18. 1978 PA 368, as amended by 2014 PA 285, MCL 333.17739b 19. 1978 PA 368, as amended by 2014 PA 285, MCL 333.17739c 20. 1978 PA 368, as amended by 2014 PA 413 21. 1978 PA 368, as amended by 2014 PA 343 22. 1978 PA 368, as amended by 2014 PA 345 and 346 Law Update 2015 Baran Consulting LLC 9 Finding Rules and the Public Health Code (PHC) on the Internet Rules: Go to www.michigan.gov/lara, select “Licensing & Regulation” found on the left hand side from the middle of the page, “Bureau of Health Care Services,” towards the bottom of the page “Administrative Rule for Health Boards.” Selecting this will bring up all the rules. Scroll down to Board of Pharmacy and all of the Pharmacy rules are listed underneath. This is also where you will find the Board of Medicine rules and the Board of Osteopathic Medicine & Surgery rules. Selecting those rules, you will find the rules for delegation of the prescribing to physicians assistants, nurse practitioners and nurse midwifes. Public Health Code: Go to www.michigan.gov/lara and select “Licensing & Regulation” then “Bureau of Health Care Services,” then towards the bottom of the page, “Public Health Code for Health Professions.” Caution as this part of the PHC only covers Article 15, Occupations. For Article 7, the controlled substance section of the PHC, or other articles, you will need to follow these steps. Starting with www.michigan.gov, select “State Web Site Index” then “Legislature.” Under the Legislative Branch, then “Chapter Index” on the left hand side; then select “Chapter 333” (scroll down) ten “Act 368 of 1978.” This will bring up the complete PHC. Here again is Article 15 Occupations, Article 7 Controlled Substances and the remaining articles in the PCH. If you are looking for a single section in the PHC such as 333.17708, go to www.michigan.gov, select “State Web Site Index” under Featured Links, then “Legislature”. Under “Legislative Branch” then type in 333.17708 in the box under MCL Section and select search. Law Update 2015 Baran Consulting LLC 10 Post Test Questions 1. Which of the following are true regarding pharmacist in charge (PIC)?
a. Can be the PIC for more than 1 pharmacy.
b. A change in PIC must be reported to the department within 30 days.
c. The PIC must work an average of 8 hours per week at each pharmacy for
which they are a PIC.
d. PIC and pharmacy are jointly responsible for the pharmacy’s compliance with
public health code and rules.
e. All of the above are true. 2. Which of the following is true?
a. Compounding pharmacies must follow CGMP.
b. Pharmacies can compound drugs withdrawn from the market.
c. Pharmacies that compound non-sterile topical must be accredited.
d. Outsourcing facilities are required by Michigan to be a state licensed
pharmacy.
3. Which of the following is true?
a. A pharmacy may advertise that it compounds.
b. A pharmacy may compound anything in anticipation of a prescription.
c. A pharmacy may sell compounded drugs to another pharmacy for resale.
d. It is considered compounding when a pharmacy reconstitutes a drug according
to manufacturers directions and labeling.
4. According to the USP, which of the following are compounded sterile products? a. Small volume parenteral b. Irrigations c. Ophthalmic d. Inhalations e. All of the Above 5. Which of the following are acceptable accrediting bodies for facilities that compound? a. TJC b. PCAB c. MPA d. ASHP e. APHA 1. e, 2. d, 3. a, 4 e, 5 b Law Update 2015 Baran Consulting LLC 11