As consultants and practitioners of pharmacy quality management, much of our professional focus is centered on cleanroom operations and production processes for compounded sterile preparations (CSPs). As such, we always take notice of any news involving procedural mistakes and medication errors that occur in everyday practice, and so should you. Much can be gained by incorporating the lessons drawn from the unfortunate experiences of other pharmacy professionals into our daily practices. Mistakes are inherently unintentional and as there are no perfect systems, mistakes will continue to happen. Therefore the most productive goal is to mitigate the severity of inevitable mistakes, and the best way to do that is to ensure productive staff training and education measures are in place consistently.
Automated Compounding Devices
Driven by factors such as patient population variations, daily census, specialties offered, and bed size, many hospitals choose to modernize their cleanroom services by installing or upgrading automated compounding devices for TPN compounding and other specialty preparations. As with most automation implementations, the processes of working through organizational budgeting, return on investment analyses, and logistical obstacles can be exhausting. So, once the device is implemented and operational, the idea of then creating a policy and procedure (P&P) document to ensure proper training and usage going forward can be overwhelming.
From the onset, many people assume the chosen device manufacturer will provide templates for such documents and that those templates will ensure USP <797> compliance. In actuality, even if the device manufacturer provides template documents and on-site instruction for use and setup, safety gaps and technical compliance gaps still remain.
If implemented and used properly, automated compounding devices make sterile compounding practices safer and more efficient when compared to manual processes; however, if such devices are used without proper forethought and training, significant errors resulting in patient injury and death can occur rapidly and with little recourse.1,2
Practically all automated compounding device manufacturers provide on-site assistance with device setup, P&P templates, and likely some one-on-one staff training on proper use. However, as with any perpetual process, these steps are not sufficient to guarantee continual safe practices. Taking time to properly establish a secure password and log-in schema is the first step to properly engaging these devices, as this will ensure security for devices that are often accessible by anyone working in the pharmacy. Also, limit the number of administrative users who can effect global changes to the drug library, calculations tables, and other vital data tables. Taking these initial steps will keep less experienced users from inadvertently making dangerous changes to orders when otherwise tasked to make simple changes to a preparation. By limiting the issuance and security levels of user accounts and passwords—and insisting that authorized users are the only ones using those accounts and passwords—pharmacy leadership can more easily track what changes were made, and by whom.
In the last year, drug shortages have caused almost daily interruptions in supplies of both macro and micro TPN additives. To help navigate these disruptions, it is important that P&Ps clearly delineate action steps to handle shortages of products and that the individual shortages are accounted for in critical data tables. Any staff members tasked with managing shortage data must review all the implications of any changes made to normal processes, and ensure that alerts are set up to inform all users of these changes before attempting to compound.
Keep in mind, continuity is key to any effective training program. If your automated compounding device vendor provides P&P templates, remember that they are templates only, and must be reviewed for compatibility with your existing pharmacy practice guidelines, as well as with the actual practices employed in your cleanroom. Editing, augmenting, and tailoring these documents up front will avoid confusion and the need to re-educate later. Two items that are commonly omitted from most policy manuals that we review are an attachment of the device owner’s manual (as a PDF) and a training competency review checklist that allows documentation of each user’s initial and ongoing proficiency with the specific automated compounding device.
A sample Competency Assessment Form is available online at www.pppmag.com/AssessmentForm
Environmental Monitoring and Documentation
It is likely your organization has invested much time and effort into both the cleanroom complex and its most expensive and important resource—compounding personnel. Without a doubt, robust initial training and periodic reinforcement of P&Ps will yield consistent, competent, and efficient compounding personnel. Each compounding staff member should be able to demonstrate a solid understanding of hand hygiene, aseptic technique, and environmental monitoring tenets, which form the cornerstone of all compounding programs and enable the provision of safe CSPs to patients.
Fortunately, most quality audits we conduct are uneventful and while occasional gaps in simple documentation, such as missing cleaning logs, can be quickly addressed, we sometimes see a more disturbing phenomenon: completed log forms that include the repeated use of out-of-range conditions without any mention of having notified supervisory personnel or taken corrective actions to remedy the problem. Most compounding supervisors create easy-to-read recording documents which include areas to fill in reference data and normal values or ranges directly on the form. These should not be optional entries. Furthermore, several operations have implemented automated documentation systems to both improve their practices and comply with regulations. Regardless, none of these tools automatically deter personnel from simply checking boxes and moving on to the next task.
To address the need for thorough staff documentation, it is necessary to reinforce to staff that the most sensitive and important tool in sterile compounding is the cleanroom complex itself. Accordingly, treating all out-of-range conditions with care should be a top priority for supervisory personnel so that control of the compounding environment can be maintained consistently. The most common out-of-range documentation pertains to the following:
All these situations warrant quick and thorough investigation and if unresolved, also warrant the possible suspension of compounding activities until repairs or remedies can be made. Ignoring these details creates the potential for catastrophic downstream consequences.
Hazardous Drug Compounding
Unfortunately, we still routinely find compounding conditions and practices involving hazardous drugs that are noncompliant with prevailing OSHA, NIOSH, and USP <797> statutes, rules, and guidance. In November 2004 (and with a recent update in September 2010) OSHA published the NIOSH Alert—Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings.3 The recommendations in this document focus on work practices and controls designed to protect all parties involved in the life cycle (receiving, storage, handling, compounding, transporting, and disposal) of hazardous drugs administered to patients.
In a recent Pharmacy Purchasing & Products article (Proposed Changes to USP Chapter <797>; April 2011), Clyde Buchanan discusses the current committee’s activities surrounding hazardous drugs as CSPs. The proposed language he reported is intended to clarify any confusion over how secondary engineering controls (BSCs/CACIs) should be vented. To augment this concept, focus should be placed not only on the equipment, but also on the behaviors of compounding personnel handling these agents.
It is evident that hazardous drugs are not being handled with care at all times throughout the process, beginning with receiving. We routinely discover a lack of proper personal protective equipment (PPE) as specified by OSHA and NIOSH. Requiring the use of cytotoxic-rated gloves while unpacking hazardous agents can reduce your employees’ casual exposure and is a simple and cost-effective preventative measure. Furthermore, segregating these drugs for storage is not always a consistent practice. NIOSH requires that these agents be segregated and handled appropriately.3 Supervisory personnel often struggle to realize that the ideal negative pressure containment storage area (with proper ventilation) in which these chemicals are housed should almost mirror the negative pressure cleanroom they are employing to compound hazardous CSPs.
It is interesting to note that some compounding operations limit hazardous drug compounding training to a small group of pharmacists and technicians only. This, in our opinion, is a shortsighted strategy fraught with risks. These limitations become evident, for example, when hazardous compounding operations are decentralized and assigning appropriately trained staff to those satellites becomes difficult.
From a risk management and operational point of view, investment in additional training would give compounding supervisory personnel much more flexibility and add an extra measure of protection to staff should they be asked to compound hazardous agents because of unforeseen staffing issues.
Beyond pharmacy, all too often nursing staff receive inadequate training in proper handling procedures. Cooperative efforts between nursing and pharmacy can yield positive results, decrease the risk of mishandling and spills during transport and administration of hazardous CSPs, and better protect the housekeeping staff handling the waste produced by these agents. This last point can be particularly pernicious. Compounding training must extend to housekeeping/waste management personnel who often encounter these drugs in their regular duties, whether in specific compounding areas or in treatment areas. These staff cannot be overlooked, and must be provided the same educational resources to protect themselves as would be extended to your own staff.
Personnel training and relevant, up-to-date policies and procedures are essential for safe CSP operations. As mistakes will always occur, take advantage of the lessons learned by others so as to avoid them in your own practice. Remaining abreast of gaps that have occurred in other operations and incorporating this knowledge into your operation is an indispensable safety tool.
The importance of staff vigilance in compounding operations cannot be overemphasized. Staff experience and confidence are vital to stop processes when things are not right or when a process has not been thoroughly thought through, and this will only occur if strong, continuous training programs are in place. Staff also must recognize that changing processes on the fly is not acceptable. CSP preparation is complex, and all parties that engage in compounding must acknowledge the attendant risks. Patients and employees need to be protected from inadvertent exposure and contamination, and this protection begins and ends with proper training and continuing education on cleanroom operations.
Lou Diorio, RPh, is a principal of LDT Health Solutions, Inc, a quality management consulting company, and a graduate of Long Island University’s Schwartz College of Pharmacy. Lou has practiced in and managed pharmacies in hospital, home care, and retail settings and can be reached at LSDiorio@ldtrx.com.
Dave Thomas, RPh, MBA, is a principal of LDT Health Solutions, Inc. He previously served as the director of information technology operations for SoluNet, LLC. Dave is a graduate of St. Louis College of Pharmacy, and can be reached at DThomas@ldtrx.com.
Enter our Sweepstakes now for your chance to win the following prizes:
Just answer the following quick question for your chance to win:
Entries are limited to one entry per person in any active sweepstakes.
Thank you for your entry.