Assuring Process Control and Extending CSP Beyond-Use Dating by Pharmacy in Accordance with USP <797> and <71>
Many of our hospital and clinical pharmacies need to achieve better control of the sterile products they dispense.1, 2, 3, 6 Thorough inspection of regional aftermarket CSP producers (claiming to be pharmacies) in Massachusetts (the state in which the indicted New England Compounding Center [NECC] operated) revealed unacceptable operating conditions and compounding processes resulting in the unconditional closure of more than one-third of these businesses (11 of 29). Furthermore, extensive violations of proper aseptic technique, product storage, and handling techniques by more than half of these businesses (15 of 29), resulted in immediate cease and desist all compounding orders until numerous product safety violations were corrected. Only 4 of 29 of these businesses were allowed to continue operating with no adverse findings by the inspecting authorities. From this in-depth study of aftermarket CSP-compounding businesses, it is clear the risk of receiving quality-compromised CSPs from a majority of these aftermarket producers is increased, and an unreasonable threat to the patient, the dispensing pharmacist, and the hospital. These findings indicate the pressing need for far-reaching quality-improvement of such operations.
The pharmacist is perceived as one of the most trusted individuals in our modern community. The vast majority of dedicated practitioners take CSP compounding very seriously. On occasion, the horrendous consequences of perverted CSPs provided by pharmacists to trusting and unsuspecting patients have led to the kind of extreme measures taken by a pharmacy owner in the case of Walnut Creek in 2002. Simply unable to live with the deaths and injuries he had allowed to happen to his patients, Jamie Phillip Sheets applied six Fentanyl patches to his neck, leaving behind a wife and two children.
Every time pharmacists dispense an IV CSP, a medication produced by a complex array of demanding steps and calculations, they assume a life-and-death responsibility for the patient. Any error in the prescribed medication, or compromise in the manner in which it was admixed, could result in irretrievable damage to a trusting patient who never gives a thought to the risks associated with this kind of therapy.
There is no Federal regulatory authority, such as the FDA, to assure the mandatory quality of CSPs. This grave responsibility is entrusted to the pharmacist in charge of dispensing these products to patients. When outside vendors are used in lieu of in-house personnel and facilities, the pharmacist's primary responsibility for quality remains undiminished by the fact that compounding was accomplished elsewhere.
Whenever an outside vendor is used to supply needed CSPs, due diligence requires that thorough and regular ongoing outside vendor audits be carried out by the pharmacist to assure that all necessary facilities, training, and practices are in effect and ongoing.4 Allowing individuals who may not be properly educated, experienced, or motivated to assume responsibility for these critical admixtures may ultimately lead to the kind of painful tragedy caused by the New England Compounding Center, the distress from which any involved pharmacist of conscience will share for a lifetime.
Lab Safety Corporation will effectively assist practitioners in returning the responsibility for the batch compounding of sterile products, and extending the expiration dating of these CSPs, to their effective control (See: ExtenDATETM Product Information). This control is accomplished by one of two methods:
- Training in, and a complete understanding of, the products, procedures, facilities, and supporting educational materials that assure safe and accurate batch compounding
- A formalized plan and complete documentation necessary to assure the effective conduct of regular, thorough, comprehensive Vendor Audits of any such supplier5 to assure the necessary continuity of quality.
To do less would be a failure to assist the practice with the very much-needed quality improvements to assure that, above all, we do no patient harm.
1. Hellums, M., et al. Instruction On Compounded Sterile Preparations at U.S. Schools of Pharmacy. Am J Health Syst Pharm., 2007 Nov 1;64(21):2267-74.
2. "Moving Forward For Safer Sterile Compounding." Medication Safety Alert! Jour. of the Institute for Safe Medication Practices. Nov. 12, 2012.
3. Frandzel, S. "Hand and Glove Hygiene Keys to Safe Compounding." Pharmacy Practice News. March, 2012. Accessed on 1/15/13.
4. "Instructional Design and Assessment: Parenterals Laboratory Course to Reduce Microbial Contamination Rates in Media Fill Tests Performed by Pharmacy Students." Christine M. Isanhart, PharmD, et al., American Journal of Pharmaceutical Education. 72(2), 1-4, Article 27 2008.
5. McAteer, F., and Churchill, W. "Develop an Approved Vendor Program for Outsourced Compounding." Pharmacy Purchasing and Products. www.PPPMag.com, Sunnyvale, CA. May, 2009.
6. American Society of Health-System Pharmacists. (Mar. 19, 2013) New Jersey Compounder Issues Recall Over Contaminated IV Product. ASHP Daily Briefing.