Darryl S. Rich, PharmD, MBA, FASHP,
Medication Safety Specialist, ISMP
Pharmacy Purchasing & Products: What elements should be included in a hospital pharmacy strategy to ensure patients receive safe, effective compounded sterile preparations (CSPs)?
Darryl S. Rich: First, hospital pharmacies must develop a comprehensive strategy for obtaining medications that addresses whether medications will be produced in-house, purchased from the manufacturer or a 503B compounding facility, or obtained through a combination of methods. Compounding in-house provides expedient access to medications and greater control over costs. However, because 503B facilities are required to follow cGMPs, hospitals can, in most cases, be assured that the quality of CSPs from these facilities is higher than those produced under USP <797>. In addition, extended dating is often available for products from 503B facilities, which reduces the likelihood of waste.
If it is determined that some medications will be produced in-house, identify these products and the circumstances under which in-house compounding will be permitted (eg, during drug shortages). Also, consider those medications required for specific departments, such as procedural areas where drugs ordered on an emergent basis may not require extended dating as typically they are used immediately.
Clearly, medication safety must be the driving force behind determining whether to obtain sterile drugs from an outsourcing provider or to prepare them in-house. It is imperative to evaluate the environment in which medications will be compounded to determine if those performing the task have the necessary expertise and resources to ensure safety. If compounding in-house, full compliance with USP <797> and the ISMP Guidelines for SAFE Preparation of Sterile Compounds1 to ensure sterility and prevent errors is required. Does the hospital have a compliant cleanroom for medication compounding? In addition, consider whether the pharmacy is staffed appropriately to compound CSPs without taking staff away from other important clinical tasks, such as patient safety programs, anti-coagulation management, pharmacist participation in rounds, etc.
On January 8, 2014, Margaret Hamburg, Commissioner of Food and Drugs for the FDA, sent a letter to hospital purchasers encouraging them to purchase their outsourced compounds from 503B outsourcing facilities.2 Outsourcing facilities, under section 503B3:
Whenever possible, hospitals should purchase drugs from 503B facilities rather than from non-503B providers. However, there are times when this may not be possible—for example, when a patient-specific medication, such as a TPN, is required, and no 503B pharmacy is nearby.
PP&P: How should a pharmacy director vet the quality of a potential outsourcing vendor?
Rich: A number of steps are required to evaluate the quality of an outsourcing vendor. The ASHP guidelines on outsourcing sterile compounding services provide a comprehensive overview of the primary considerations.4 Moreover, a great deal of information is freely available in the public domain.
Ask the vendor to provide some basic information, such as their hours, licenses and quality control documentation, liability insurance, and 503B registration (a list of registered 503B facilities is available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm). In addition, determine if they have had any outside review or accreditation. Identify and review any disciplinary actions taken by the board of pharmacy, product recalls affecting their products, and customer complaints. Finally, conduct a primary source verification of their license, paying close attention to any actions involving the director of pharmacy.
If the vendor is not willing to forward the requested documents, they should allow a site visit. The goal of a site visit is to evaluate compliance with guidelines and ensure the facility is following required practices, so be sure that whomever visits is familiar with USP <797> requirements or cGMPs. Moreover, visit with a specific checklist in hand that includes documents to view and staff to interview; do not simply tour the facility.
After the visit, review the findings with a multidisciplinary group of decision makers to determine if the vendor meets your hospital’s requirements. Visiting multiple potential vendors will improve your understanding of how facilities are meeting or not meeting cGMPs or USP <797>. When comparing vendors, it may be wise to create a file that includes each company’s disciplinary procedures, complaints, company ownership changes, etc, for internal comparison purposes. After a vendor is chosen, revisit these files periodically (eg, every 3 or 4 years) to ensure continued compliance.
PP&P: What staff training procedures should be in place?
Rich: A comprehensive compounding training program is critical to ensuring staff members have the skills and knowledge required to properly prepare CSPs. USP <797> has clear training and competency guidelines that can be used to develop an internal training program, and several vendors provide compounding training (see Where To Find—USP <797> Training Programs). Training policies and procedures (P&Ps) should be easy to understand and detailed; including a checklist of steps for the compounder can be especially useful. It is important to note that many pharmacy students do not receive any training in sterile compounding, making a comprehensive compounding training program all the more vital.
In addition, hospitals should have a method for certifying which staff members are authorized to compound medications. The qualifications should include: 1) Pharmacy technicians who have completed the training program; and 2) Pharmacy technicians who prepare CSPs on a regular basis. Just as heart patients prefer the cardiologist who has performed the greatest number of open-heart surgeries, so should compounding be performed by technicians with the most training and experience.
If your hospital compounds medications in-house, it is important to be cognizant of practice drift, which tends to occur over time. Continuous vigilance is necessary to ensure continued adherence to P&Ps when compounding in-house. To avoid practice drift, it may be prudent to assign one staff member the responsibility of monitoring staff adherence to compounding P&Ps. Conducting self-audits also can be particularly useful.
PP&P: What trends do you anticipate in outsourced compounding?
Rich: Looking to the future, there likely will be an increased emphasis on outsourced compounding. CMS is currently developing new requirements, and several states are increasing or considering increasing their requirements. For example, California is drafting legislation for compounding CSPs that exceeds the requirements of USP <797>. Also, some states are now training their inspectors in USP <797>. This will increase pressure on hospitals to ensure compliance, which may lead more organizations to outsourcing and make it all the more important that hospitals choose quality vendors.
Darryl S. Rich, PharmD, MBA, FASHP, is a medication safety specialist for ISMP. Previously, he was a surveyor for TJC in the hospital, home care, and ambulatory accreditation programs. In addition, Darryl worked for the Standards Interpretation Group, serving as an internal resource for TJC on issues related to pharmacy and medication management. Darryl also served as associate director for surveyor management and development at TJC for 11 years. Prior to that, he was director of pharmacy for Boston University Medical Center. Darryl received his BS from the University of California at Davis, his Doctor of Pharmacy degree from the University of California at San Francisco, and his MBA in Health Care Management from Bryant University in Rhode Island.