4 Up Front
Pharmacy Practice News • July 2020
Letters
Have We Conflated Low- and High-Risk Compounding? To the Editor: Re: “Lessons Learned From a Once Not-So-Sterile CR” (bit.ly/3cqg7jD): [It seems] to me that there is far too much energy and resources devoted to surrogate end points in sterile compounding. Have we entered an era where we “can’t see the forest for the trees”? The legitimate end point is product contamination. Where are the studies showing that the USP’s [U.S. Pharmacopeial Convention’s] surrogate end points make a difference in the end product? This is especially true for low-risk compounding (which is mostly what hospitals do) involving the simple transfer of a sterile drug solution to a sterile diluent (IV piggybacks). Risk for contamination is minimal because the sterile
Before recent USP updates, compounding practices showed a lack of understanding of proper aseptic technique.
ingredients are sequestered within sterile syringes, needles and closed system drug-transfer devices. Indeed, the only study I could find comparing traditional and sterile room influences concluded: “The most important variable affecting microbial contamination of admixtures was the aseptic technique of personnel, not the environment in which the drugs were compounded” (Am J Health Syst Pharm 2005;62[22]:2386-2392). Have we conflated low-risk compounding with the problems of high-risk compounding? Should we be asking who profits from perpetuating a culture of regulatory extremism? How much has it cost us? Does anybody care? —Ray Vella, PharmD Central Coast, Calif.
Jerry Siegel, PharmD, one of the sources interviewed in the story, responds: I can’t speak for USP on the issue of surrogate end points, but I can speak to the main question underlying Dr. Vella’s letter: whether fully outfitted and USPcompliant cleanrooms are necessary or overkill. As both a microbiologist and pharmacist, I, too, often have questioned the need for the increasing requirements of USP <797> for compounding sterile products. Certainly, these requirements are a far stretch from the practices of the 1970s, when I first started working as a
hospital pharmacist. We didn’t use key personal protective equipment, such as gloves, and we just started employing laminar airflow in cleanrooms, but typically not in any type of buffer room— so basically, compounding in street clothes, with no guidelines on hand hygiene. I participated in studies to wear scrubs and move our “hoods” to separate rooms but not with measured air pressures. Morever, validation testing to document changes in nosocomial infections were not done. The wake-up call was the New England Compounding Center disaster in 2012, when nearly 800 people were sickened and more than 100 died from fungal contamination in compounded sterile products. The lawsuits that followed, along with CDC and FDA investigations, prompted a stern look at the in-hospital and outsourced pharmacy compounding state of affairs. In my own work with cleanrooms, I saw many deplorable conditions in hospital compounding facilities. Practices and facilities were inconsistent across every state as well as any level of enforcement. Although USP was and is still trying to set standards that are enforceable, not all states have or will accept this standard. As a result, I have seen not only poor facilities but very poor practices as well. I have so many examples of sinks in compounding areas leaking water contaminated with Pseudomonas spp, with compounded IVs stacked up right next to them, that the chance of not infecting the patient is relatively small in that situation. As for the financial burden that cleanroom renovations can pose—and the pushback that often results—I understand those concerns. Still, I am in favor of risk reduction for patient care; it’s hard to put a price on that! Jerry Siegel, PharmD Vice President of Safe Medication Management Associates Inc. East Greenwich, R.I.
Promised Safety Solutions Fall Short To the Editor: Re: “Preventing Medication Errors At Small and Rural Hospitals” (bit.ly/3cqmcwt) Humans make mistakes, but computers should catch them. Despite the fact that insulin dosages change and new orders are generated, the “chain of custody” referring to the original order should always be maintained back to the first patient-specific order for that medication. This might have been problematic
in 1985, but not today. The workaround that was cited in the article—creating a “dummy order with the patient’s ID but no dose information, which generated a patient-specific barcode that stayed with that patient, even if dosing information changed”— is a solution that embarrasses the software vendor, the hospital and the pharmacist, and is dangerous for the patient. Pharmacy Practice News does everyone a disfavor by not identifying the electronic health record (EHR) vendor and following up with them as to why such an important safety net is unavailable in their system. I'll even give the EHR vendor the benefit of the doubt because this may be a configuration issue that the people who bought this system are unaware of, but critically need to know how to fix. If not, it behooves the vendor to fix the problem as soon as possible and provide the promised safety solution that the customer thought they were purchasing in the first place. —Bruce Kiacz, BSPharm Toledo, Ohio
ISMP Responds: Thank you for your interest in our work. Health care practitioners working in smaller hospitals with fewer resources are often compelled to be creative with the tools that are available to ensure the safest care for our patients. The function identified as a contributing factor in the case described is not unique to one EHR vendor. This issue and potential solutions were in fact discussed with the EHR vendor. ISMP's advocacy efforts include regular discussions with EHR (and other medication-related technology) vendors when medication safety risks for which they should be aware are identified. ISMP offers vendors safe practice recommendations based on our experience investigating and analyzing medication errors, that can be used in a plan of action to prevent further events. We disagree, however, that any disfavor was done by not providing the name of the EHR vendor in the article. In fact, one might argue that if the vendor name were included, those who do not use that vendor may have dismissed the importance of the message being conveyed. It is important to learn and use information about medication safety risks and errors that have occurred outside one’s organization. Establishing a process for learning from external risks helps to
assess an organization’s vulnerability to similar events and can trigger them to take preventative action. It is our hope that through sharing this event and the challenges that are specific to those practicing in small and/or rural hospitals, not only practitioners, but also vendors will be motivated to investigate their insulin use in the hospital setting and take action to implement processes that will make it harder for us to err. Christina Michalek, BS, RPh, FASHP Medication Safety Specialist Institute for Safe Medication Practices Horsham, Pa.
Deborah Sadowski, RPh, MHA Director of Pharmacy Services Deborah Heart and Lung Center Browns Mills, N.J.
Vendor Offers More Information On Telepharmacy To the Editor: Re: “Trying Telepharmacy? Here’s What You Need to Know” (bit.ly/3gI9oop) As a representative of TelePharm, the proprietary HIPAA-compliant software used by the Medicap telepharmacy provider described in this article, I thought it might be worth mentioning that the main barrier listed in the article—that all communications have to be conducted via HIPAA-compliant software—can be addressed by using available software. Additionally, as noted correctly in the article, regulations governing telepharmacy vary state to state. So it may be worth mentioning that we at TelePharm have comprehensive resources fully briefing pharmacists from every state as to the regulatory landscape for telepharmacy. We also have a full-time regulatory affairs staff available to help efforts in both states where the practice is and is not allowed. As noted in the article, reimbursement is a critical component of a successful telepharmacy operation. As far as the standard practice of remote dispensing using telepharmacy goes, the scope of practice is exactly the same as in a traditional pharmacy, and thus reimbursement works the same way. Pharmacists are not reimbursed for their consultations in a traditional setting, and that remains the same in telepharmacy. Indeed, the issue of reimbursement is not unique in the telepharmacy versus traditional fields of pharmacy operation. —Mitch Larson Senior Marketing Specialist, TelePharm Iowa City, Iowa
