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Guidance to ISIS Members Who Use Compounding Pharmacies

Posted By Administration, Tuesday, October 16, 2012

In the wake of this terrible outbreak, ISIS understands the conundrum of our members who utilize compounding pharmacy products to balance providing the best care for our patients while simultaneously ensuring reasonable steps are taken for the safety of the preparations being used. Given the recent outbreak, which has revealed significant shortcomings in oversight processes regulating compounding pharmacies between the jurisdictions of the FDA and State Pharmacy Boards, we recommend caution when using compounding pharmacy products, especially with injectable agents. Until gaps in regulatory oversight are rectified, it appears that we cannot be certain whether compounding pharmacies are on par with the uniform quality and sterility standards that we - as physicians - have become accustomed to from major pharmaceutical manufacturers.

If using products from a compounding pharmacy, we suggest the compounding pharmacy provide your purchasing agent with documentation meeting minimum compliance standards compiled by the American Society of Health-System Pharmacists (ASHP). The ASHP has developed a tool to assist in evaluating compounding pharmacies. The assessment tool helps you evaluate each of these areas:

  • Regulatory compliance
  • Quality and patient safety measures
  • Medication administration safety features
  • Service excellence

ASHP Outsourcing Sterile Products Preparation: Contractor Assessment Tool:

Other questions, suggested bythe Professional Compounding Centers of America,that should be directed towards a potential compounding pharmacy vendor:

1. Does the pharmacy use PCCA-tested Formulas and Pharmaceutical Ingredients?

2. What initial training is required for the pharmacy staff members when they begin working there?

3. What ongoing education do staff members receive? Do they participate in formal continuing compounding education programs?

4. Does the pharmacy have a quality assurance and continuous quality improvement program? Does the pharmacy have its compounded preparations tested for potency to ensure you are getting the right amount of medication? Do they test their sterile preparations to ensure sterility? Ask for details.

5. How are patients educated on the appropriate use of their compounded prescriptions? Does the pharmacy conduct a review of all the patients' current medications along with any compounded preparations?

6. If the pharmacy is in a different state than the one you reside in, and you are considering having them ship a compounded prescription to you, first verify that they are appropriately licensed to dispense prescriptions in your state as well.

Tags:  Patient Safety 

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