Pharmacy management facing pressures to improve, update sterile facilities
06/01/2002
Hospital environments have been identified as a major source of secondary infections
by Hank Rahe
Hospital and homecare pharmacies in the United States number in the thousands and range in size from facilities servicing a patient load of less than 20 beds to those servicing hundreds.
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This diversity of size and internal technical support makes it difficult to introduce contamination-control technologies into the pharmacy parenteral products preparation area.
Pharmacy management, however, is under increasing regulatory pressures from state and federal levels to improve the quality of facilities in which sterile products are prepared. The pressure is to improve the quality of the clean environments and upgrade their facilities from the basic technologies introduced more than 20 years ago to current cleanroom and barrier-isolation technology. The state boards of pharmacy, made up of hard-working volunteer's with no formal training or experience in contamination-control technologies, develop the guidance or regulations. The combination of inexperienced users and, in many cases, less than complete guidance creates an opportunity for vendors to provide less than quality solutions.
Pharmacy professionals had turned to typical professional societies and publications for support to understand and implement changes but have found that they do not have the technical expertise to support the facility changes required. The membership typically includes pharmacists and few have formal training in the engineering skills needed to design and implement the proper technologies.
Terms like directional airflow and particle filtration are used but the understanding of applications of these technologies is limited. If they exist, engineering and contamination-control staff in the hospital are focused on other issues and in many cases are not trained in the installation and maintenance of cleanrooms and barrier-isolation technologies.
The problem is compounded by hospital management's expectation that the pharmacy director and their staff can add the regulatory change requirements to their normal duties without the correct information or expanded skill sets.
Changes are seen as overkill and unnecessary and hospital staffs ask for proof that a problem exists. The truth is, little data exist directly linking secondary infections to a particular area in the hospital. The fact remains, however, that the hospital environment has been identified as a major source of secondary infections. These infections result in the loss of thousands of lives each year. The "mystery" of where and how the secondary infections occur within the hospital will remain a "mystery" until active programs are developed to identify the sources. If we continue on the path of not looking, we won't find anything.
Trained individuals observing the facility and work practices in almost any facility preparing parenteral products can see the potential for contamination. The environments in which parenteral products are prepared and the handling practices used in preparation are prime examples of why the potential for contamination exists in most pharmacies.
People coming and going from the "clean" areas without changing their scrubs, or visiting the cafeteria and observing the working attire in public places, indicates that the work practices are a major contributor to the spread of contamination.
The term cleanroom can be loosely applied to many of the facilities. The basic elements of a clean environment such as hard cleanable surfaces for the walls and ceiling, proper pressurization and anti rooms for transition are many times missing. Suppliers of cleanrooms, in some cases, add to the confusion by reducing the standards to provide "cost effective" solutions. These less than proper solutions add to the problem and could put lives at risk.
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He is a member of the CleanRooms Editorial Advisory Board.