The process of outsourcing to compounding pharmacies plays a vital role in the medical community because compounding pharmacies:
- Can help alleviate drug shortages, which have increased in number and duration;
- Can provide specialized, tailored medications for individual patients;
- Can resolve operational inefficiencies for health systems in areas such as batch compounding, and ease consolidation of pharmaceutical services during high-demand periods;
- Can minimize the cost of facility remodeling to meet USP <797> requirements; and
- Can reduce and/or control labor costs of health systems by shifting responsibility for employees, benefits, and liabilities to a compounding pharmacy.
In light of the recent meningitis outbreak, health systems are rightfully re-investigating their contracted compounding pharmacies to verify adherence to quality and safety standards. In doing so, many of these health systems are utilizing the American Society of Health System Pharmacists’ (ASHP) Outsourcing Sterile Products Preparation: Contractor Assessment Tool. Hartley Medical fully supports the distribution of resources to help educate the medical world on what to look for when selecting a sterile compounding pharmacy; however, we can only support those resources that provide unbiased information promoting industry standards. ASHP’s Outsourcing Tool, in our opinion, is not an unbiased resource.
It is common knowledge within the compounding pharmacy industry that ASHP’s Outsourcing Tool was developed with funding from PharMEDium; this is confirmed at the bottom of the Tool’s cover page where it states, “Developed with support from PharMEDium Services, LLC.” However, it is in the assessment itself where it is evident that the Tool is tailored to PharMEDium’s business model and not to the standards of the industry. Many of the questions are written – and scored – to eliminate smaller, specialty compounding pharmacies (those that do not operate as manufacturers) as qualified candidates.
For example, ASHP’s assessment deducts points if a compounding pharmacy does not offer certain services, such as the compounding of anesthesia syringes or TPN products, etc. However, a more focused product line could be an advantage to a hospital since it may mean that a higher-quality product is being compounded.
That said, Hartley Medical does support ASHP’s attempt to establish tools to assist physicians and health systems in analyzing compounding pharmacies. As we have stated many times, not all compounding pharmacies are the same, and the decision of which compounding pharmacy to work with should be made only after thorough due diligence is performed.
Hartley Medical recommends that you utilize the International Academy of Compounding Pharmacists’ (IACP) Compounding Pharmacy Assessment Questionnaire (CPAQ™) along with ASHP’s Outsourcing Sterile Products Preparation: Contractor Assessment Tool when researching compounding pharmacies.
Or, click here to access Hartley Medical’s list of FAQs that compounding pharmacies should be asked regarding USP and Board of Pharmacy compliance and internal policies and procedures that align with industry best practices.
For more information, visit Hartley Medical’s Knowledge Center by clicking here