District of ColumbiaDepartment of Health

Patricia M. D’Antonio, RPh, MS, MBA,CGPExecutive Director, Board of Pharmacy

Program Manager, Pharmaceutical ControlSeptember 28, 2013

Health Regulation and Licensing AdministrationBoard of Pharmacy and Pharmaceutical Control

Organization

• Health Professions Licensing Administration – Board of Pharmacy

• Pharmacists– Authority to Immunize

• Pharmaceutical Detailers• Pharmacy Interns • Pharmacy Technicians (Bill passed; regulations

pending)

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

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

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

Liaison RoleBetween 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

Pharmacy Law and Regulations

• DC Code Title 47, Section 2885.01 Pharmacy

• DC Code Title 48, Section 701-901Pharmacy related laws

• Federal Law– Code of Federal Regulations (CFR) 21, Part 1

• Section 1300 - Drugs

Pharmacy Law and Regulations• DCMR Title 22 Public Health & Medicine

Chapter 4 – Distribution, Manufacturer, or Wholesaler of Drugs

Chapter 5 – Safe Disposal of MedicationsChapter 10 – Controlled Substance Registration for

Manufacturers, Distributors, and DispensersChapter 12 – Controlled SubstancesChapter 13 – Prescription and DistributionChapter 15 – InspectionsChapter 19 – Pharmacies

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

Other Regulations of InterestTitle 22 DCMR

Chapter 20 – Hospital and Clinics, Pharmacy ServicesChapter 31 – Health Care and Community Residence

FacilitiesChapter 32 – Nursing Facilities, Pharmaceutical

ServicesChapter 35 – Group Homes

Where can I find this?

• DC Municipal Regulations and DC Register www.dcregs.dc.gov– Subscribe– My favorites

• DC Board of Pharmacy webpage– http://doh.dc.gov/bop

• DC Pharmaceutical Control webpage– http://doh.dc.gov/pcd

What’s New?

• Criminal Background Check• Immunization Updates • Safe Disposal of Unused Pharmaceuticals• Collaborative Practice• Pharmacy Technician • Prescription Drug Monitoring Program

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

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

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

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

Immunization

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

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

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

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

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

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.

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

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:

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 training program 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.

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

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

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

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

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

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

AccessRxPrescription 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)

Future• Clarification of Student Intern

requirements

• Prescription Drug Monitoring Program

• Manufacturer/Distributor Regulations

• Compounding Regulations

Board of Pharmacy Meeting

First Thursday of every month9:30am899 North Capitol Street, NE2nd Floor Conference RoomOpen to the Public

Health Regulation and Licensing AdministrationBoard of Pharmacy and Pharmaceutical Control

899 North Capitol Street, NE2nd FloorWashington DC 20002

Phone Number:202-727-9856patricia.dantonio@dc.gov