What Do IACP Members Think?

Transcription

1 What Do IACP Members Think? Results of a National Survey of Compounding Practitioners February 27, 2013 Final Summary Results

2 What Do Compounders Think? National Survey of 2,857 pharmacists and technicians Electronic survey of IACP membership February notification, reminder, FAX reminder Survey design 40 questions 5 point Likert scale with open comment sections 227 responses (7.9%)

3 Strong Support for Quality Compounders support state regulatory requirements for: Compliance with USP <795> for non-sterile preparations 95.2% Compliance with USP <797> for sterile preparations 96.4% Additional CE requirements for compounders 79.4% QI/QA program in place for non-sterile compounding 83.9% QI/QA program in place for sterile compounding 95.2%

4 Strong Support for Oversight Compounders support state regulatory requirements for: Assuring adequate funding for Boards of Pharmacy 90.8% Pharmacy inspections should be done by pharmacists 94.5% Inspectors should be adequately/regularly trained 96.8% Inspectors should be trained in USP <797> standards 98.6% Sterile compounding sites must be inspected annually 84.1%

5 Strong Support for Compliance Compounders support consistent following of state laws: Non-pharmacy sterile compounders should be inspected and expected to follow the same laws and regulations 86.1% Non-pharmacy non-sterile compounders should be inspected and expected to follow the same laws and regulations 79.7% Non-resident pharmacies must know/follow state laws 88.3% Wholesalers/suppliers must be registered with states 79.8% States must clearly define office-use regulations 94.4%

6 Definitions - Anticipatory Compounding Compounders support clear and consistent definitions: Anticipatory Compounding is the preparation of compounded medications based upon historical prescriptions received by the pharmacy. Anticipatory Compounding is a form of inventory management which enables the pharmacy and pharmacist to prepare compounded preparations in amounts sufficient to meet the needs of patients and prescribers. 99.5% Distinctly different from manufacturing 99.0% Should be defined in state, not federal law 82.4%

7 Definitions Office-Use Dispensing Compounders support clear and consistent definitions: Office-Use Dispensing is the preparation, labeling, and dispensing of a non-controlled medication by a pharmacist and pharmacy upon the receipt of a prescription or medical order from an identified authorized prescriber (e.g., physician, nurse practitioner, dentist, veterinarians, etc.) for that prescriber s use in the treatment of or administration to a patient during their normal course of medical practice. Office-use dispensing includes both manufactured finished drug products and compounded preparations. 89.4% Should be defined in state, not federal law 61.5% Permitted for sterile and non-sterile products 85.1% Should not have arbitrary quantity limits 80.2%

8 Jurisdictional Authority Compounders believe states regulate pharmacy and the FDA regulates manufacturing Compounding on prescription or medical order is a pharmacy practice activity and should be governed by state Boards of Pharmacy 96.5% There is no such thing as a non-traditional compounding pharmacy 82.3% The FDA is responsible for oversight of businesses engaged in manufacturing 94.4% A pharmacy that wishes to become a manufacturer should be able to do so. 76.9% A clear delineation between compounding and manufacturing must be established. 86.2%

9 Non-Traditional Manufacturers The FDA should be empowered to create a new category of non-traditional manufacturers who produce and sell compounded preparations in the absence of a prescription or medical order. Strongly Agree 18.7% Agree 23.3% Neutral 19.7% Disagree 13.5% Strongly Disagree 24.8%

10 Non-Traditional Manufacturers IACP should support a clear delineation between businesses that manufacture and sell compounded preparations when no prescription or medical order from an authorized prescriber exists and the traditional practice of pharmacy where pharmacists receive and dispensed based upon such prescriptions or medical orders. Strongly Agree 64.4% Agree 31.8% Neutral 7.2% Disagree 2.6% Strongly Disagree 4.1%