Quality. Guaranteeing High Quality. Outsourced Pharmacy Services. Disclosure 3/18/2013

Transcription

1 Disclosure Outsourced Pharmacy Services By: Eddie Bostic, RPh For: South Carolina Society of Health System Pharmacist Annual Meeting, March 24 th 2013 Charleston, SC The views and opinions expressed in this presentation are my own and do not reflect the position of the Medical University of South Carolina I have no other interest to disclose Objectives for Pharmacists: 1. Build confidence in assessing purchases from outsource pharmacies 2. Discuss practical activities that contribute toward the accurate perception of quality of outsourced items 3. Understand the role and practice of the outsource pharmacy to health care systems Objectives for Technicians: 1. Understand the liability and risk associated with the use of outsourced items 2. Recognize the roll technicians can assume monitoring quality concerns of outsourced items 3. Understand the relationship outsource pharmacies have with healthcare systems Quality Barriers to an Accurate Perception of Quality Marketing Unclear Standards Impractical Standards Poor Compliance Ineffective Accountability Dynamics Perception Art yehuegnbjd49gtt5ogwba&ved=0cdgqsaq&biw=1920&bih=955 1

2 Compounding s History of Quality New Take on an Old Theme A Brief History of the FDA c Mark W. Mugler United States Pharmacopeia est The Bureau of Chemistry est National Formulary est Pure Food and Drug Act passed Food and Drug Administration est The US Food, Drug, and Cosmetic Act of 1938 National Coordinating Committee on Large Volume Parenterals developed standards of practice in the 60 s and 70 s 1975 USP purchases NF continued Compounding s History of Quality (cont.) USP adopts 1074 and it becomes USP 1206 Sterile Drug Products for Home Use 1992 USP releases Chpt 1161 Pharmacy Compounding Practices 1993 Food and Drug Administration Modernization Act 1997 Sections 503A Pharmacy Compounding passed 1998 USP argues the constitutionality of FDAMA January 2000 USP made 795 official and enforceable by the FDA January 2004 USP made 797 official and enforceable by the FDA Pharmacist Pharmacy Practice Iron Triad Patient Physician Outsourced Medications: How Can You Know They are Safe? A presentation by Eric Kastango, Clinical IQ, LLC Nov. 7, Meds.pdf Compounding vs. Manufacturing Attribute Compounding Manufacturing Direct distribution To patients and prescribers To pharmacies, wholesalers, and prescribers Therapeutic paradigm Match drug to patient Match patient to drug Public health risk from exposed gross contamination or ingredient error History Main legal regulation Small: Few people exposed concurrently Thousands of years BC. It dominated first USP in USP renewed activity in 1993 by appointing an advisory panel to create what initially became Chapter <1161> State pharmacy boards and practice acts Large: Many people exposed concurrently Since the late 1700s industrial revolution, USP standards increased markedly during and after WW II e.g., 1942 Injections chapter, and 1974,solid oral dosage test US Food and Drug Administration Exceptions for Compounded Preparations according to 503A 1. Adulteration provision of section 501(a)(2)(21 U.S.C. 51(a)(2)(B)) (current good manufacturing practice [CGMP] requirements); 2. Misbranding provision of section 502(f)(1) (21 U.S.C. 352(f)(1)) (labeling of drugs with adequate directions for use); and 3. New drug provision of section 505 (21 U.S.C. 355) ( use of drugs under INDs NDAs...ANDAs). drug products that present demonstrable difficulties for compounding that reasonably demonstrate adverse effect on the safety or effectiveness of that drug product (section 503A(b)(3) of the Act) {include} All sterile products that are compounded under procedures other than those described in Chapter 1206 [ Sterile Drug Products for Home Use ] of the United States Pharmacopeia (USP). US Food and Drug Administration Food and Drug Administration Modernization Act Section 503A Tribble D., Kastango E. Key Considerations in Pharmacy Outsourcing: Understanding Risk and Managing Liability Hospital Pharmacy Vol 47, Feb 2012 pg

3 cgmp s vs pharmacy practice standards FDA NABP January 3, 2013 Commissioner Margaret Hamburg, MD US Food and Drug Administration New Hampshire Avenue Silver Spring, MD Dear Dr Hamburg: It was a pleasure seeing you at Food and Drug Administration s (FDA) Intergovernmental Working Meeting on Compounding on December 19, Thank you for hosting and allowing me to participate in this important meeting. As the representative of the state of Utah, I thought, as did other state representatives with whom I spoke, that the dialogue between the representatives of FDA and the states was most beneficial. It is our hope that the meeting and resulting actions could prove to be even more beneficial if the feedback from the states is incorporated into future positions, legislative proposals, or Congressional testimony provided by FDA in regard to pharmacy compounding and manufacturing. The discussions at the Intergovernmental Meeting identified a number of issues of concern and interest to the state boards of pharmacy and FDA. On behalf of the majority of states present at the meeting, and on behalf of states not in attendance that have been in close communication with the National Association of Boards of Pharmacy (NABP) on this issue, we respectfully submit the following items for your consideration. NABP also requests, on behalf of the states, that the input provided be incorporated into FDA actions and policy decisions and, as has been the case in our past interactions with FDA, that if FDA determines it necessary to submit a proposal to Congress as a result of the information gathered from the Intergovernmental Meeting, that FDA share that proposal with the states and NABP prior to submitting it to Congress. 1. Distinguishing Between Compounding and Manufacturing: Compounding, as defined by the states, is a patient specific activity based on a valid patient prescriber pharmacist relationship that forms the basis for a legitimate prescription. Compounding is an element of the practice of pharmacy, and as such, should be regulated and overseen by the state boards of pharmacy. We respectfully request that FDA not pursue legislation establishing this third-tier of activity within the context of compounding. Manufacturing is outside the regulatory scope of the boards of pharmacy and more directly within the purview of FDA; therefore, standards and regulatory oversight should be set and implemented by FDA. Definitions for compounding and manufacturing must be established in federal statutes and regulations, consistent with state statutes and regulations, and written in such a way so as to provide concise and uniform distinctions between the two activities. Patient specific activities should be the basis for the definition of compounding, while nonpatientspecific activities should be the basis for the definition of manufacturing with the following critical considerations: Who Guarantees Quality? FDA Boards of Pharmacy Outsourcers Description of an Outsourcing Pharmacy Facility Staff Services Preparations Operations Quality Assessing quality of an outsource pharmacy Research Visit web site Other customers State Board Registrations FDA audits, medwatch, 483 s, recalls 3

4 Inquire by Phone Preparing for a Site Visit 1. Phone interview 2. Quality Assurance Reports 3. Request current internal audit or gap analysis QA processes Sterility Review the QA report What processes do I want to see? Environmental concerns Legal dept. Ask, What if the worst happens? TQKaicQ The Site Visit Get a visual but look behind the scenes 1. Process SOPs 2. Validation batch records, release test, etc. 3. Quality CAPA, measure and report staff compliance, training, etc. 4. Documentation QA, liability, contracts, indemnify kykwspqu5cd met0pp56wpslcru738tpacutq Preparing our Pharmacies 1. Become familiar with USP, state guidelines, and potential weaknesses of outsourced items 2. Implement quality assurance activities with your pharmacy staff: a. alert staff of all outsourced items and how they are different from manufacturer items b. review your recall procedures and make sure policies address outsourced items c. implement release processes of outsourced items d. quarantine all receivables till inspected e. inspect packaging list for accuracy and dating f. package condition g. storage plans h. labeling i. visual inspection j. assume the worst and establish a plan of action k. keep documentation relative to services mwfco_zy_ivmyjp0zvjv6gvg1oj4kgq OUb5AWba9BQ YzA Preparing the next generation How can pharmacist embrace the responsibility for the future? What standards should be expected of the pharmacy compounding training for new pharmacist and technicians? To what standard of competency should candidates be tested? Should national standards include some type of wet board or practical test? Outsourced Pharmacy Services I am not concerned that you have fallen I am concerned that you arise. Abraham Lincoln 4

5 References 1. Allen Jr. LV. USP Chapter <795> Pharmaceutical Compounding Non Sterile Preparations Sacundum Artem. 2008; 13:4 Available fro Paddock Laboratories, Inc Accessed Feb. 8, ASHP Foundation. Outsourcing Sterile Products Preparation: Contractor Assessment Tool org/mainmenucategories/practicetools/sterileproductstool.aspx. Feb. 4, Erickson, A, Unraveling the complexity of compounding and drug shortage Pharmacy Today, Feb. 1, Food and Drug Administration Compliance Policy Guidance for FDA Staff and Industry Sec Pharmacy Compounding, 5. Food and Drug Administration Warning Letters, olationletterstopharmaceuticalcompanies/ucm htm. 6. Kastango, E. The ASHP Discussion Guide for Compounding Sterile Preparations Available from American Society of Health System Pharmacist. Accessed Feb. 9, Kastango, E. Outsourced Medications: How Can You Know They are Safe? presentation, Clinical IQ, LLC Nov. 7, Meds.pdf. 8. Newton D., Trissel, L. A Primer on USP Chapter <797> Pharmaceutical Compounding Sterile Preparations, and USP Process for Drug and Practice Standards. Accessed Feb. 7, Thank you! My contact information: Eddie Bostic, RPh 615 Chimney Bluff Drive Mount Pleasant, SC eddiebostic@bellsouth.net 9. South Carolina Pharmacy Practice Act Chapter Tribble D., Kastango E. Key Considerations in Pharmacy Outsourcing: Understanding Risk and Managing Liability Hospital Pharmacy Vol 47, Feb 2012 pg