Ensuring Robust Compounding Management


October 2015 - Vol. 12 No. 10 - Page #8

Given recent concerns related to the practices of certain compounding companies, many organizations have reexamined their strategies for providing compounded sterile preparations (CSPs) to patients. Some institutions have decided to compound in-house products that historically were outsourced. Whether an institution continues to outsource or reassigns CSP production to its in-house pharmacy, ensuring that the infrastructure is in place to provide safe CSPs to patients is crucial.

CSPs may be purchased directly from the manufacturer, activated at the point of care (POC), compounded externally by an outsourced compounding company or in-house by pharmacy, or compounded at the POC by non-pharmacy health care providers. In late 2008, a consensus panel rated manufacturer-prepared CSPs highest in terms of safety, and those compounded at the POC by non-pharmacy health care providers the least safe (see Table 1).1 CSPs prepared by a compounding company ranked slightly higher than those prepared in-house by pharmacy. However, the consensus conference was held in late 2008, before the New England Compounding Center incident that caused the deaths of 64 people and sickened 751.

The University of Illinois Hospital & Health Sciences System (UI Health) utilizes all of these CSP types, some more frequently than others. Key benefits and challenges for each CSP type are listed in Table 2.1 Because manufacturers must adhere to current Good Manufacturing Practices (cGMPs), as a general rule, UI Health purchases manufacturer-prepared CSPs whenever feasible. However, these products are not always available in the correct concentration or volume desired, may be on shortage, or may be cost-prohibitive. Clearly, providing safe CSPs to patients is an organization’s primary objective, but today’s complex health care environment mandates assessment of
multiple factors.



Developing a CSP Strategy
To help guide the assessment, UI Health utilizes its Pharmacy Value Analysis Committee (PVAC), comprising physicians and representatives from pharmacy, materials management, and administration. The committee’s charge is to reduce medication expenditures and/or expenses associated with medication use without negatively affecting patient outcomes. The committee works closely with the pharmacy department on medication-related initiatives. Two recent initiatives related to CSPs that the PVAC participated in were the decision to return nicar-dipine infusion compounding to the institution’s cleanroom, rather than purchase the commercially available product, and evaluation of a ready-to-use, POC-activated system for select CSPs. The nicardipine change resulted in a yearly cost savings of almost $300,000.

Minimizing compounding of CSPs at the POC by non-pharmacy health care providers is a priority at UI Health. Per The Joint Commission’s medication management standard MM.05.01.07, sterile preparations are to be prepared by pharmacy except in emergent situations, but this can be challenging in the perioperative setting. The OR pharmacy is open 12 hours per day and prepares a high percentage of the CSPs needed in this setting. After hours, requests for CSPs are handled by our cleanroom.  

Most CSPs are prepared in our cleanroom by pharmacy technicians under a pharmacist’s direction. As such, all pharmacists and technicians who work in this area undergo extensive training, with a variety of competencies assessed on a yearly basis (see Table 3). Initial training is conducted in the college of pharmacy’s compounding laboratory, which is located next to the hospital. Once a baseline skill set is attained, additional training is provided in the cleanroom under the direction of a pharmacist and/or technician.

To help ensure compliance with USP <797> requirements, UI Health uses a sterile compounding quality management system. This Web-based program streamlines cleanroom documentation, facilitates performance of quality assurance activities, and helps identify risks related to CSP preparation.



Reasons for Outsourcing CSPs
Organizations that outsource CSPs do so for a variety of reasons (see Table 4). Our primary motivations for outsourcing select products (see Table 5) are to streamline workflow, reduce workload, simplify record keeping, reduce waste, meet regulatory requirements (see Table 6), and eliminate difficult-to-prepare preparations. Our list of outsourced CSPs is consistent with those reported in Pharmacy Purchasing & Products’ 2015 State of Pharmacy Compounding Survey in which 59% of respondents outsourced patient-controlled analgesia (PCA), 53% outsourced oxytocin/pitocin, 50% outsourced epidurals, and 37% outsourced OR syringes.2

Outsourced CSPs constitute a small percentage of the overall drug expenditures in our organization; in FY14, this number was 1.7%. Potential products to outsource are identified by pharmacy operations managers, clinical staff pharmacists, or other health care providers (eg, anesthesiologist). A financial analysis is performed on all suggested products to determine the impact of outsourcing those items. Outsourced products have higher acquisition costs, but to make a direct comparison to in-house prepared CSPs, one needs to consider not only the cost of the drug, but other related expenses, such as quality assurance, labor, equipment, testing, and waste.



Selecting an Outsourcing Facility
Numerous factors must be considered when selecting an outsourcing facility (see Table 7). Some of the primary considerations at UI Health include:

  • FDA Registration: Former FDA Commissioner, Margaret Hamburg, MD, urged hospitals to purchase from only FDA-registered outsourcing facilities, calling it “A critical step they can take to better ensure the health and safety of their patients.”3 FDA registration indicates that the facility is willing to comply with all the requirements necessary for this designation. Currently, there are 55 registered facilities.4

  • 483 Forms: Assess any FDA 483 forms issued to outsourcing facilities upon FDA inspection, as well as the facility’s response to the FDA, to determine the significance of the issue(s) identified and the outsourcer’s responsiveness. For example, was the 483 the result of an oversight, such as the lack of a signature on a policy? Or did the 483 derive from a more serious concern, such as a problem with product stability?

  • GPO Contracting: Evaluate whether the outsourcing facility has contracted with the organization’s group purchasing organization (GPO). Contracting with the GPO is an indication that the facility has met the criteria set forth by the GPO; this also may simplify the internal contracting process with the outsourcing facility.

  • Reputation: The reputation of the outsourcing facility can be an important determinant in the selection process. If your peers have had negative experiences with an outsourcing facility, it may be prudent to remove this facility from consideration. Conversely, positive feedback from other hospitals may help narrow the field.

  • Site Visit: If at all possible, conduct a site visit prior to choosing a vendor. Looking at the facility on the company’s Web site and reviewing documents sent by the company are not substitutes for actually seeing the facility and having the opportunity to ask questions of the staff working there. A group from your organization with the necessary expertise to evaluate the outsourcing facility (eg, pharmacy director, infection control specialist, USP <797> expert) should conduct the visit.

Often, organizations will utilize both a primary and secondary outsourcing facility. UI Health purchases the majority of its outsourced CSPs from its primary facility, while cardioplegia solution is purchased from a secondary facility (the primary facility does not compound it). Keep in mind that using more than two outsourcing facilities may result in additional work for your staff (eg, purchaser, business manager), introduce a variety of labels into the institution, and may limit your ability to obtain drugs that are in short supply. Utilizing primary and secondary facilities has been an effective strategy at UI Health.

Once the outsourcing facilities are selected, you must continue to ensure that they provide the level of service required. This can be accomplished by reviewing the facilities’ quality assurance data on a quarterly basis, determining whether any issues have arisen with the outsourced products used at your institution, and reviewing any disciplinary actions taken against the facility.


Addressing Drug Shortages
Although the number of drugs on shortage has decreased in recent years, shortages still occur and can be disruptive to patient care. For CSPs compounded in-house, UI Health conserves medications in short supply by putting criteria in place for their use, changing administration schedules, and/or switching to different medications when appropriate. The institution also has been successful at acquiring difficult-to-obtain medications from our compounding facility; this includes medications that were not outsourced routinely. Often, the compounding facility still has drug even when we are not able to obtain it elsewhere. However, if the shortage is severe, the outsourcing facility may need to ration the allotment until availability of the drug improves. This pertains to both CSPs that are routinely obtained from an outsourcing facility, as well as those that are not.


Conclusion
When it comes to CSPs, an institution’s primary objective is to provide a safe product for administration to patients. Whether the CSP is premade by the manufacturer, is POC activated, prepared in-house, or outsourced, it is incumbent upon pharmacy to make certain that the appropriate infrastructure is in place to ensure that all CSPs are safe and effective.


Andrew J. Donnelly, PharmD, MBA, FASHP, is director of pharmacy services at University of Illinois Hospital & Health Sciences System, and clinical professor and assistant dean for clinical affairs at the University of Illinois Chicago College of Pharmacy.


References

  1. Sanborn MD, Moody ML, Harder KA, et al. Second consensus development conference on the safety of intravenous drug delivery systems—2008. Am J Health-Syst Pharm. 2009;66(2):185-192.

  2. State of Pharmacy Compounding. Outsourced Compounding. Pharm Purch Prod. 2015;12(4):S38-S40.

  3. Dear Hospital/Purchaser Letter (January 8, 2014). US Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM380599.pdf. Accessed July 30, 2015.

  4. Registered Outsourcing Facilities. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm. Accessed July 30, 2015.

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