1. District of Columbia Department of Health Patricia M. D’Antonio, RPh, MS, MBA,CGP Executive Director, Board of Pharmacy Program Manager, Pharmaceutical Control September 28, 2013 Health Regulation and Licensing Administration Board of Pharmacy and Pharmaceutical Control

2. Organization Health Professions Licensing Administration – Board of Pharmacy Pharmacists –Authority to Immunize Pharmaceutical Detailers Pharmacy Interns Pharmacy Technicians (Bill passed; regulations pending)

3. Board of Pharmacy The mission of Board of Pharmacy is to protect and improve the public health through the efficient and effective regulation of the practice of Pharmacy and Pharmaceutical Detailing; through the licensure of Pharmacist, Pharmaceutical Detailers and Pharmacy Interns. 7 Members –5 pharmacists –2 consumers (1 space vacant) –Daphne Bernard, PharmD Chairperson

4. Pharmaceutical Control Division Health Regulation and Licensing Administration – Division of Food, Drug, Radiation and Community Hygiene –Conduct routine and complaint driven inspections of pharmacy operations of health facilities –Investigate reports of contaminated or suspect drugs or improper distribution of controlled substances –Investigate unusual or suspicious reports in drug supply or in the handling of the drug by the professional

5. Regulated Facilities Include: Pharmacies –Resident –Non-Resident Researchers/Teaching Institutions Wholesalers/Distributors/ Manufacturers Fire/EMS Medical Examiner Substance Abuse Treatment Programs Animal Clinics Dialysis Centers Ambulatory Surgical Centers Controlled Substance Registration for Professionals

6. Liaison Role Between District and Federal entities: Food and Drug (FDA) Drug Enforcement Administration (DEA) Health Human Service (HHS) Consumer Protection Agency And others involving regulatory control matters related to medications

7. Pharmacy Law and Regulations DC Code Title 47, Section 2885.01 Pharmacy DC Code Title 48, Section 701-901 Pharmacy related laws Federal Law –Code of Federal Regulations (CFR) 21, Part 1 Section 1300 - Drugs

8. Pharmacy Law and Regulations DCMR Title 22 Public Health & Medicine Chapter 4 – Distribution, Manufacturer, or Wholesaler of Drugs Chapter 5 – Safe Disposal of Medications Chapter 10 – Controlled Substance Registration for Manufacturers, Distributors, and Dispensers Chapter 12 – Controlled Substances Chapter 13 – Prescription and Distribution Chapter 15 – Inspections Chapter 19 – Pharmacies

9. Laws/Regulations DCMR Title 17 Business, Industry Professions –Chapter 40 – Health Occupations, General Rules –Chapter 41 – Health Occupations, Administrative Procedures –Chapter 65 – Pharmacists, Pharmacy Interns –Chapter 83 – Pharmaceutical Detailers –Chapter 85 – Criminal Background Check

10. Other Regulations of Interest Title 22 DCMR Chapter 20 – Hospital and Clinics, Pharmacy Services Chapter 31 – Health Care and Community Residence Facilities Chapter 32 – Nursing Facilities, Pharmaceutical Services Chapter 35 – Group Homes

11. Where can I find this? DC Municipal Regulations and DC Register www.dcregs.dc.govwww.dcregs.dc.gov –Subscribe –My favorites DC Board of Pharmacy webpage –http://doh.dc.gov/bophttp://doh.dc.gov/bop DC Pharmaceutical Control webpage –http://doh.dc.gov/pcdhttp://doh.dc.gov/pcd

12. What’s New? Criminal Background Check Immunization Updates Safe Disposal of Unused Pharmaceuticals Collaborative Practice Pharmacy Technician Prescription Drug Monitoring Program

13. Criminal Background Check As of January 3, 2011 Initial, renewal or reinstatement license All health care professionals FBI and Local Repeat every 4 years Through Morpho Trust Services In District/Out of District Process http://doh.dc.gov/cbc

14. Immunization 17 DCMR Section 6512 Effective, June 8, 2012 immunize patients twelve (12) years and older with parental consent or patients eighteen (18) years and older that present valid identification for specific vaccinations by protocol

15. Immunization Obtain written protocol for the vaccinations from a physician Report vaccine administration to the physician listed on the Vaccination Protocol and to the patient’s primary care physician. Adverse events reporting requirements –Pharmaceutical Control Division –Director of the Department of Health –within 48 hours of the discovery of occurrence

16. Immunization Hepatitis Shingles Human Papillomavirus Tetanus Tdap Meningococcal Heamophilus Influenzae Pneumococcal Influenza including but not limited to H1N1 and other epidemic vaccinations specified by the World Health Organization or the Center for Disease Control at the time of vaccination

17. Immunization Registration with the Board required –not new but seems to cause confusion –FAQs on Board of Pharmacy website –Pharmacist License not Facility License

18. Safe Disposal of Unused Pharmaceuticals Unused Pharmaceutical Safe Disposal Act of 2009 (legislation) Applies to Health Care Facilities Facilities shall not disposed of unused pharmaceuticals by flushing the product down a drain or any method that uses the public sewer system

19. Safe Disposal of Unused Pharmaceuticals Subject to a civil fine of up to one thousand dollars ($1,000) per occurrence; and Required to submit to the Board of Pharmacy, or its designee, a mitigation plan designed to prevent further such occurrences within thirty (30) days of receipt of a request for the mitigation plan

20. Collaborative Practice Collaborative Care Expansion Amendment Act of 2012 passed in May 31, 2013 Regulations pending from Board of Pharmacy and Board of Medicine Voluntary written agreement Between a licensed pharmacist and a licensed physician or another health practitioner with independent prescriptive authority

21. Collaborative Practice Defines the scope of practice between the licensed pharmacist and licensed physician, or other health practitioner, –Licensed by a District health occupation board Initiation, modification, or discontinuation of a drug therapy regimen

22. Collaborative Practice Agreements Specification of the drug therapy to be provided and any tests that may be necessarily incident to its provision; Conditions for initiating, modifying, or discontinuing a drug therapy; and Directions concerning the monitoring of a drug therapy and the conditions that would warrant a modification Establish policies and procedures for approving, disapproving, and revoking collaborative practice agreements.

23. Pharmacy Technician Pharmacy Technician Amendment Act –Passed July 19, 2013 17 years of age A high school diploma or its equivalent, or has passed a Board-approved examination that proves that he or she has achieved competency in the educational skills required to perform the function of a pharmacy technician; and

24. Pharmacy Technician A current certification from the Pharmacy Technician Certification Board, the National Health Career Association, or another national or state certifying organization approved by the Board; or Successfully completed one of the following types of pharmacy training programs, which shall include a Board-approved exam:

25. Technician Training Programs (i) A national, regional, or state accredited pharmacy technician training program recognized by the Board; (ii) A pharmacy technician program at a college or university that is accredited by an accrediting body recognized by the Secretary of the United States Department of Education or the Council on Postsecondary Accreditation (iii) An employer-based pharmacy technician trainingprogram recognized by the Board that includes within a one-year period a minimum of 160 hours of training, including theoretical and practical instruction; or (iv) A pharmacy technician program that meets the guidelines of the American Society of Health-System Pharmacists, is licensed by the District of Columbia Educational Licensure Commission, and has certified to the Board its intent to pursue accreditation upon becoming eligible to do so.

26. Pharmacy Technician Grandfather Clause Defines the roles of ancillary personnel Addresses supervision responsibilities of a pharmacist Regulations pending Board of Pharmacy –Legislation provides one year –Monitor communications and DC Register for Proposed Regulations

27. Prescription Drug Monitoring Program Tool for practitioners to review prior to writing controlled substance prescription Legislation introduced in 2012 Hearing held in July 2013 Expected passage by end of 2013

28. Findings on Inspection Failure to document administration and/or wasting of CSII substances Failure to obtain drugs from an approved supplier Failure to conduct CSII audit as indicated Medication Administration Records (MARs) not consistently reflecting current date and time Physician signature log missing DC Controlled Substance and DEA numbers and respective expiration dates

29. Compounding preparation, mixing, assembling, packaging, or labeling of a drug or device result of a practitioner’s prescription drug order or for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns

30. Manufacturing prepare, produce, propagate, compound, convert, process, or package a drug, either directly or indirectly, by extraction from a substance of natural origin, or independently by means of chemical synthesis

31. Manufacturing any packaging or repackaging of the substance or drug; labeling or relabeling of any drug package or container to further distribution from the original place of manufacture to the person who makes final delivery, distribution, or sale to the ultimate consumer or user

32. AccessRx Prescription Drug Marketing Costs manufacturers and labelers of prescription drugs who engage in marketing in District report their costs for pharmaceutical drug marketing in the District 2011 report $83.7M (158 companies) Impact Reports –Antipsychotic Use in Children (2012) –Antipsychotic Use in the Elderly (2013)

33. Future Clarification of Student Intern requirements Prescription Drug Monitoring Program Manufacturer/Distributor Regulations Compounding Regulations

34. Board of Pharmacy Meeting First Thursday of every month 9:30am 899 North Capitol Street, NE 2 nd Floor Conference Room Open to the Public

35. Health Regulation and Licensing Administration Board of Pharmacy and Pharmaceutical Control 899 North Capitol Street, NE 2 nd Floor Washington DC 20002 Phone Number:202-727-9856 patricia.dantonio@dc.gov