116th Annual Convention

Transcription

1 116th Annual Convention Date: Saturday, October 18, 2014 Time: 10:30 am 12:00 pm Location: Austin Convention Center, Room 16A, Level 4 Title: Activity Type: Speaker: Impetus for Change and Standards of Practice for Compounding: A New Era Sponsored by MEDISCA, Inc. ACPE # L04-P 0.15 CEUs Application-based Mark Badria, PharmD, BSc, Hon. Pharm., Southern California Compounding Pharmacy Pharmacist Learning Objectives: Upon completion of this activity, participants will be able to: 1. Analyze the implications of H.R. 3204, Drug Quality and Security Act, and 503A and 503B of the FD&C Act. 2. Contrast similarities and differences in standards of practice requirements under 503A and 503B of the FD&C Act. 3. Summarize the health and safety requirements under NIOSH and the proposed USP Chapter <800>. 4. Recognize a unique framework for a comprehensive compounding-related Quality First Management System. 5. Illustrate new opportunities under a revised business practice infrastructure for pharmacy compounding. 6. Construct the benefits of establishing a compounding practice infrastructure based on Quality, Risk and Validation Management. 7. List new and innovative opportunities for the small and large compounding practice. Disclosures: Mark Badria is receiving an honorarium from Medisca Network, Inc for this program. The conflict of interest was resolved by peer review of the slide content. NCPA s education staff declares no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. NCPA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is accredited by NCPA for 0.15 CEUs (1.5 contact hours) of continuing education credit.

2 NCPA Disclosure Statement The National Community Pharmacists Association (NCPA) Office of Continuing Education makes every effort to develop continuing education activities that are scientifically based, accurate, current, and objectively presented. In accordance with the Accreditation Council for Pharmacy Education Standards for Commercial Support NCPA has implemented a mechanism requiring everyone in a position to control the content of an educational activity to disclose any relevant financial relationships with any proprietary entities producing health care goods or services and mange/resolve any conflicts of interest prior to the activity. Individuals must disclose to participants the existence or non-existence of financial relationships. NCPA does not view the existence of interests or relationships with commercial entities as implying bias or decreasing the value of a presentation. It is up to the participants to determine whether the interest or relationships influence the presenter with regard to exposition or conclusions. If at any time during this activity you feel that there has been commercial or promotional bias, please inform us by reflecting the information on the session evaluation form.

3 IMPETUS FOR CHANGE AND STANDARDS OF PRACTICE FOR COMPOUNDING; A NEW ERA SPONSORED BY MEDISCA, INC Mark Badria B.Sc. Pharm., B.Sc. Pharmacology ACTIVITY CONTENTCOPYRIGHTMEDISCA NETWORK, INC ACCREDITATION This Activity has been afforded 1.5 contact hours of continuing pharmacy education (0.15 credits). 2 SPEAKER DISCLOSURES Mark Badria, B.Sc. Pharm., B.Sc. Pharmacology IMPETUS FOR CHANGE AND STANDARDS OF PRACTICE FOR COMPOUNDING; A NEW ERA I have the following financial relationship: Consultant/Facilitator for MEDISCA NETWORK Inc. The conflict of interest was resolved by peer review of the slide content. 3 1

4 LEARNING OBJECTIVES 1. Analyze the implications of H.R. 3204, Drug Quality and Security Act. 2. Contrast practice requirements under 503A and 503B of the FD&C Act. 3. Summarize the health and safety requirements under NIOSH and the proposed USP Chapter <800>. 4. Recognize a unique framework for a comprehensive compoundingrelated Quality First Management System. 5. Illustrate new opportunities under a revised business practice infrastructure for pharmacy compounding. 6. List new and innovative opportunities for the small and large compounding practice. 4 COMPARE AND CONTRAST UNDER 503A AND 503B 503A and USP Traditional Compounding Defining Parameters of 503A Defining Standards under 503A Implications under 503A Requirements under USP 503B and cgmp Outsourcing facility Defining Parameters of 503B Defining Standards under 503B Implications under 503B Requirements under cgmp Implications of USP 800 Hazardous Risk Management (ICH Q9) Visualization of Facility under 503A Visualization of Facility under 503AB 5 IMPETUS FOR CHANGE A DRIVING FORCE TO IMPROVE AND PROTECT THE COMPOUNDING INDUSTRY. 6 2

5 A QUESTION TO PONDER In the year 2016, what will be the difference between the USP for Compounding (503A) and the FDA s Guidance Documents on cgmp for Outsourcing Facilities (503B)? 7 DEFINING PRACTICE PARAMETERS (503A) TRADITIONAL COMPOUNDING PHARMACY GENERAL RULES No commercial medications Licensed pharmacist; technician; physician Receipt of prescription Anticipatory compounding specific requirements Office use and hospital preparations patient specific The 5% rule for inter state compounding 8 DEFINING PRACTICE PARAMETERS (503A) TRADITIONAL COMPOUNDING PHARMACY INGREDIENT REQUIREMENTS USP NF Monographs Prohibited: Drugs with demonstrative difficulty Prohibited: Drugs withdrawn or removed from the market 9 3

6 DEFINING PRACTICE PARAMETERS (503A) TRADITIONAL COMPOUNDING PHARMACY JURISDICATION The State Board of Pharmacy USP standards or practice 10 GENERAL RULES No copies of commercial medications Engaged in compounding of sterile preparations Direct supervision of licensed pharmacist With/Without prescription FDA drug shortage list 11 GENERAL RULES Selling to health care facilities Selling for office use and hospitals Inter state commerce; no volume limitation 12 4

7 INGREDIENT REQUIREMENTS USP NF Monograph Components of FDA drug list FDA Approved drug list 13 INGREDIENT REQUIREMENTS Prohibited: Drugs with demonstrative difficulty Prohibited: Drugs withdrawn or removed from market Drugs subject to Risk Evaluation and Mitigation Strategy (REMS) 14 JURISDICTION FDA Registration FDA Reporting requirements Adverse event reporting cgmp Interim guidance 15 5

8 SUMMARY Similarities Prohibited: Copies of commercially available drugs. Prohibited: Drugs with demonstrative difficulty Prohibited: Drugs withdrawn or removed from market USP NF monograph or FDA approved list of bulk drug substances Licensed pharmacist, pharmacy technician or physician Differences Office use and hospital outsourcing Interstate Shipping Pharmacy facility licensing Reporting requirements Governing authority and standards of practice 16 TRADITIONAL PHARMACY OR Pharmacy A: Compounds chemotherapeutic preparations for the local hospital. 17 TRADITIONAL PHARMACY OR Pharmacy A: Compounds chemotherapeutic preparations for the local hospital. IS IT PATIENT SPECIFIC? 18 6

9 TRADITIONAL PHARMACY OR Pharmacy B: Provides intrathecal preparations in Texas and Oklahoma. 19 TRADITIONAL PHARMACY OR Pharmacy B: Provides intrathecal preparations in Texas and Oklahoma. INTERSTATE SHIPPING: HOW MUCH? 20 THE DEFINING QUESTION Why would you want to be regulated by the FDA? 21 7

10 DIFFERENTIATING STANDARDS OF PRACTICE 22 GENERAL IMPLICATIONS OF CHANGE Track and Trace Prohibits reselling of NOTE FOR RESALE drugs Prohibits intentional falsification 23 GENERAL IMPLICATIONS OF CHANGE Waivers Exemptions Ten (10) year historical record Preemptive action 24 8

11 IMPLICATIONS FOR INFORMATION COMMUNICATION Disciplinary action reporting Demonstrably difficult drug list publication Advertising revisions Reporting on adequacy of Federal and State efforts Transaction exchange requirements Public meetings to enhance safety and security 25 IMPLICATIONS FOR MANUFACTURER, WHOLESALE DISTRIBUTOR, DISPENSER, AND RE PACKAGER Prior transactions and transfer of ownership Release of transaction documentation Standardized numerical identifiers Authorized trading partners only Suspect or illegitimate investigational system Standards for licensing wholesale distributors 26 IMPLICATIONS FOR TRACK AND TRACE JANUARY 1, 2015 Transaction history Quarantine suspicious drugs Electronic system Curb counterfeit drugs 27 9

12 IMPLICATIONS FOR TRADITIONAL COMPOUNDING PHARMACIES May only effect a few pharmacies Track and Trace effects all pharmacies Pharmacy compounding advisory committee Exceptional FDA enforcement action FDA Guidance document; recommendations Citing of regulatory or statutory requirements 28 IMPLICATIONS FOR Meets applicable outsourcing facility requirements Establish annual registration requirements 29 PRODUCTION UNDER SECTION 503B Hygiene Controlled environment Clearly defined processes Change control required Validation required Good documentation practices apply 30 10

13 THE FUTURE OF USP FOR COMPOUNDING USP 795 USP 797 USP 800 NIOSH referenced 31 USP 797 AND THE COMPOUNDING OF STERILE PREPARATIONS USP 797 RISK Low Medium High 32 ENVIRONMENTAL MAINTENANCE AND MANAGEMENT Facility design parameters Testing for non viable and viable particulate Air and surface testing ISO Environmental standards ISO Room classifications 33 11

14 USP 800 AND THE MANAGEMENT OF HAZARDOUS DRUGS Focus on containment OSHA standards apply Focus on protection THERE IS NO ACCEPTABLE LEVEL OF EXPOSURE TO HAZARDOUS DRUGS 34 USP 800 AND THE MANAGEMENT OF HAZARDOUS DRUGS Imposes personnel competency Medical surveillance program Prevents worker exposure Protects the environment 35 USP 800 AND THE MANAGEMENT OF HAZARDOUS DRUGS Requires a compounding supervisor Demands the use of Personal Protective Equipment Demands containment type engineering controls 36 12

15 USP 800 AND THE MANAGEMENT OF HAZARDOUS DRUGS FACILITY DESIGN Negative pressure room LAFW or glove box cannot be used Designated areas and restricted access required C PEC for non sterile compounding required Class II Biological Safety Cabinet or Compounding Aseptic Containment Isolator (CACI) 37 USP 800 AND THE MANAGEMENT OF HAZARDOUS DRUGS FUNCTION C PEC C SEC ACPH (AIRFLOW) BUD Compounding sterile HD in a cleanroom BSC or CACI ISO 7 Cleanroom 30 ACPH HEPA filtered As per <797> Compounding sterile HD in a CACI meeting requirements listed in <797> CACI C SCA 12 ACPH exhausted outside As per <797> Compounding lowor medium risk sterile HDs in a BSC BSC C SCA 12 ACPH exhausted outside As per <797> 38 CLOSED SYSTEM DRUG TRANSFER DEVICES (CSTD S) CLOSED SYSTEM TRANSFER DEVICES 39 13

16 USP 800 AND THE MANAGEMENT OF HAZARDOUS DRUGS PPE for HD Personnel training HD Unit dose or unit of use packaging Cleaning and deactivation Spill control Monitoring NIOSH and CDC 40 A QUESTION TO PONDER In the year 2016, what will be the difference between the USP for Compounding (503A) and the FDA s Guidance Documents on cgmp for Outsourcing Facilities (503B)? 41 THE FUTURE OF CGMP FOR OUTSOURCING FACILITIES Implementation, oversight and control Interim guidance and 21 CFR 210 & 211 New guidance for the future 42 14

17 NEWLY REALIZED PHILOSOPHICAL AND FUNDAMENTAL BUSINESS PRACTICES PHILOSOPHY OF BUSINESS AND BUSINESS PHILOSOPHY 43 OPPORTUNITIES FOR 503A PHARMACIES Maintaining traditional pharmacy practice with the patient, physician and pharmacy triad. Maintaining a smaller traditional scale of patient specific prescription compounding to fit a smaller facility design. Financial impact: A smaller facility allows for pharmacist to continue their practice without paying larger registration fees as with the outsourcing facilities. Custom compounding and maintaining a more personal relationship with patient and physician. Traditional pharmacist consultation and education of the public is very important. Critical role in public health. OPPORTUNITIES UNDER 503A AND 503B OPPORTUNITIES FOR 503B OUTSOURCING FACILITIES Working with physicians and hospitals to identify those types of drugs that are critical to have on hand in office settings or hospitals. The compounding of sterile products in unlimited quantities in regards to the drugs on the FDA drug shortage list without a pre existing prescription and avoid new drug approval requirements under the FD&C Act. Drugs must be compounded under the direct supervision of a licensed pharmacist, hence still maintaining pharmacist job opportunities. Not required to be a licensed pharmacy. The ability to compound on a larger scale and have more guidelines or parameters to do so legally. The distribution of compounds out of state without limitations. 44 QUALITY MANAGEMENT IN THE NEW ERA OF CHANGE P6 PATIENT P1 PERSONNEL P5 PREPARATION P2 PROPERTY P4 PROCESS P3 PROCEDURE 45 15

18 QUALITY MANAGEMENT IN THE NEW ERA OF CHANGE QUALITY RISK VALIDATION 46 QUALITY MANAGEMENT IN THE NEW ERA OF CHANGE P1 PERSONNEL P2 PROPERTY P3 PROCEDURE P4 PROCESS P5 PREPARATION P6 PATIENT 47 A QUESTION TO PONDER In the year 2016, what will be the difference between the USP for Compounding (503A) and the FDA s Guidance Documents on cgmp for Outsourcing Facilities (503B)? 48 16

19 Q & A