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BOARD OF PHARMACY MONTHLY MEETING UPDATES 11/18/2015Dien Vu12/2/2015

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Acronyms• FDA = Food and Drug Administration• CGMP = Current Good Manufacturing Practice • FDCA = Food, Drug, and Cosmetic Act• USP = United States Pharmacopeia• CE = Continuing Education• PCCA = Professional Compounding Centers of America• PDMP = Prescription Drug Monitoring Program• NH BOP = New Hampshire Board of Pharmacy• NABP = National Association of Boards of Pharmacy• MPJE = Multistate Pharmacy Jurisprudence Examination• CEAC = Continuing Education Advisory Council

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Summary of board meeting

1. Approval of Minutes from 10/15/2015 Public session. 2. PDMP monthly report. 3. Compliance monthly report – compounding Section 503A

versus 503B. 4. Change of ownership application for Colonial pharmacy.5. Renewal request as a provider of In-state CE. 6. Reinstatement application.7. Reciprocal pharmacist applicant with discipline. 8. Program approval request for PCCA vendor.

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Summary of board meeting9. Show Cause Hearing – Downing Lab, Non-resident

pharmacy applicant.10. Dispense Naloxone by standing order feedback. 11. Pharmacist workload survey. 12. Naturopathic board.13. 503A/503B discussion.14. Technician certification and CE. 15. CEAC committee update – Technician CE, board

member terms.16. Executive director report.

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(2) Prescription Drug Monitoring Program1

• Law passed in June 2012. New Hampshire became the 49 th states with PDMP. • Required NH BOP to keep track of schedule II – IV controlled substances.

• NH PDMP keeps track through a web-based data system. • Finding out drug diversion and abuse. • Identify patients who seek drug and “doctor shopping.” • Help board to see trend and patterns of prescribing and dispensing.

• Limitation: • Crossing state border to fill prescriptions. • Licensing and inspecting delivery companies for possessing drugs.

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(3,9,12,13,16) Compounding2,3

• Compounding is to combine and mix to create a medication that is specific to a patient.

• Triad of patient, provider, and pharmacist. • Two types of compounding:

• Non-sterile compounding: complies with USP 795.• Sterile compounding: complies with USP 797.

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Compounding4 • Who can compound?

• Licensed pharmacist, licensed physician, etc. • A person under the supervision of a licensed pharmacist

(pharmacy technician, pharmacy intern, etc.)

• Why are compounded drugs needed?• Drug with different formulation, different strength, etc that is:

• Specific to a patient’s need.• Not available commercially.• Example: morphine suppositories, estrogen hormone suppositories,

sildenafil troche, captopril suspension, etc.

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Risk of compounded drugs5,6

• Not regulated for safety and efficacy. • Contamination.

• Sterile compounding = low risk, medium risk, high risk. • Stability.

• Non-sterile compounding = simple, moderate, complex.• Potency change.• Purity.• Endotoxin-free.

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FDA regulation of compounded medications3

• Compounded medications are NOT FDA-approved. • No process to ensure drugs are safe and effective. • List of no-compounding drugs and unapproved ingredients. • Other regulations on packaging, storage, labeling, etc.

• State board of pharmacy has the primary responsibility to monitor pharmacies to makes sure Section 503A of the FDCA is followed.

• FDA has a responsibility to regulated outsourcing facility, who registered under Section 503B.

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Section 503A7

• Became law in November, 1997.• Compounded medications are exempted from 3 sections

of the FDCA:• Section 501(a)(2) = compliance with CGMP.• Section 502(f)(1) = labeling with adequate directions for use.• Section 505 = new drugs approval process.

• Regulated primarily by state board of pharmacy. • All pharmacies who compound will fall under 503A.

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Drug Quality and Security Act8

• Became law in November 27, 2013.

• Amends the FDCA regarding compounding drugs. • Create a uniform, national standard for tracking and tracing

pharmaceuticals in the supply chain. • Removing some provision of state laws.

• Add new section 503B Outsourcing Facilities.

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Section 503B2

• If a facility meets all conditions within Section 503B, 2 sections within FDCA are exempted:• Section 502(f)(1): labeling drugs with adequate directions for use.• Section 505 = new drug approval process.

• Pharmacies become outsourcing facilities.

• Regulated primarily by the FDA. • Facility must comply with CGMP requirement for compounding. • Facility will be inspected by FDA according to a risk-based

schedule.

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Outsourcing Facility2

• Outsourcing facility is a facility at one geographic location or

address that is engaged in the compounding of sterile drugs

and self-register as an outsourcing facility and comply with

503B.

• Voluntary registering.

• Not required to have a prescription prior compounding.

• Must comply with CGMP and subjected to FDA inspections.

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503A versus 503B practice9,10 503A 503B

All pharmacies that compound. Voluntary.

Regulated by State board of pharmacy. Regulated by FDA.

Compliance to USP 797, 795, etc. Compliance to USP 797, etc.

Require patient-specific prescriptions. Prescriptions are optional.

Patient-specific needs.Triad (doctor-patient-pharmacist)

Standardized dosing.

Limit on bulk compounding. Restriction on compounding copies.

If shortage, can compound extra. Manufacturers of sterile compounding.

No “office use” Can compound for office use.

Not yet to be resolved. No limit on distribution to interstates.

No difficult compounding. Can compound some difficult compounds if able to resolve “difficulties”.

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(4) Change of ownership application11

• Require new application submitted to the Board.

• Require a cover letter with company letterhead.

• Noting the current owner’s BOP licensing number and

effective date of ownership change.

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(6) Reinstatement application12

• For individuals who want to reinstate their pharmacy

license or who have not held a valid license for 12 months

prior their applications.

• Reinstatement fee of $200.

• 15 CE credits (5 didactic).

• Completion of MPJE after the Board approved the application.

• Additional documents may be requested.

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(7) Pharmacist Reciprocal application13

• For pharmacist licensed in another state to obtain pharmacist license in New Hampshire by license transfer (reciprocity.)

• License transfer through NABP website. • Official NABP license transfer application and instruction.• Fee of $265.• Copy of birth certificate.• Passport photo 3x5 inches.• Official finalized transcript. • Apply for NH MPJE.

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(10) Naloxone Standing Order14

• Authorizes pharmacists to dispense naloxone rescue kits.• Can be dispensed without a prescription under this standing

order.

• Must be signed by a licensed physician.

• Naloxone can neither be abused nor cause overdose. • Rare hypersensitivity (rash, difficulty breathing, etc.)

• Too much naloxone can cause withdrawals (anxiety, N/V/D, disorientation, etc.)

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Naloxone rescue kits

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(14,15) Technician training and CE15

• All pharmacy technicians in New Hampshire pharmacies must be registered with the NH BOP.

• Pharmacy Technician certification is optional in NH currently.

Pharmacy technician CE - 10 CE credits (2 didactic) every 2 years. - Technician programs and schooling information online.

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(15) Board member at BOP16

• BOP consists of 7 members appointed by the governor and approval of the council.• 6 members are licensed pharmacists for at least 10 years.

• 5 years practice in New Hampshire. • 1 public member.

• Never have been a member of pharmaceutical profession.• Never have been a spouse of such person.• Never have had a financial interest in provision of pharmaceutical services.

• Members can serve maximum 2 consecutive terms, each term for 5 years.

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Reference1. NH Prescription Drug Monitoring Program Fact Sheet. New Hampshire Board of Pharmacy.

http://www.nh.gov/pharmacy/prescription-monitoring/documents/pdmp_fact_sheet.pdf. Accessed 12/1/2015.

2. Compounding and the FDA: Questions and Answers. Food and drug Administration. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm. Accessed 12/1/2015.

3. Guidelines for Compounding Practices. The Art, Science, and Technology of Pharmaceutical Compounding. http://www.pharmacist.com/sites/default/files/files/Allen_%20Chap_%201_Art,%20Science%20and%20Technology%20of%20Pharmaceutical%20Compounding,%204e.pdf. Accessed 12/1/2015.

4. What is Compounding? Professional Compounding Centers of America. http://www.pccarx.com/what-is-compounding. Accessed 12/1/2015.

5. Gudeman J, Jozwiakowski M, Chollet J, et al. Potential Risks Of Pharmacy Compounding. Drug R D. 2013 Mar;13(1):1-8.

6. Proper Identification of Compounding risk Levels and Notification to The Board of Pharmacy. http://www.ncbop.org/PDF/CompoundingRiskLevelsandCategoriesMar2015.pdf. Accessed 12/1/2015.

7. Compounding. Food and Drug Administration. http://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/. Accessed 12/1/2015.

8. The Drug Quality and Security Act Summary: November 2013. Health Industry Distributors Association. https://www.hida.org/App_Themes/Member/docs/GA/Industry-Issues/Pedigree/HIDA-Summary-Flowchart-Nov14.pdf . Accessed 12/1/2015.

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Reference9. Topoleski CJ. The Drug Quality and Security Act: What’s Next for Sterile Compounding and

Outsourcing. American Society of Heath-System Pharmacists. http://www.ashp.org/DocLibrary/Policy/Compounding/Webinar-Handout-Drug-Quality-Security-Act.pdf. Accessed 12/1/2015.

10. Campbell Jay. North Carolina Board of Pharmacy. https://www.nabp.net/system/rich/rich_files/rich_files/000/000/335/original/campbell.pdf. Accessed 12/1/2015.

11. Reporting Changes In Information To The Board. State of New Hampshire Board of Pharmacy. http://www.nh.gov/pharmacy/technicians/reporting_changes.htm. Accessed 12/1/2015.

12. Pharmacist License Reinstatement. State of New Hampshire Board of Pharmacy. http://www.nh.gov/pharmacy/pharmacists/reinstatement.htm. Accessed 12/1/2015.

13. Reciprocity (License Transfer) Information. http://www.nh.gov/pharmacy/pharmacists/reciprocity.htm. Accessed 12/1/2015.

14. Naloxone Example Standing Order. Massachusetts Department of Public Health. http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy/example-naloxone-standing-order-4-18-14.pdf. Accessed 12/1/2015.

15. Pharmacy Tech Information. State of New Hampshire Board of Pharmacy. http://www.nh.gov/pharmacy/technicians/index.htm. Accessed 12/1/2015.

16. Board Members. State of New Hampshire Board of Pharmacy. http://www.nh.gov/pharmacy/aboutus/members.htm. Accessed 12/1/2015.

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Question?• Thank you