Protect those who handle pharmaceuticals
02/01/2001
by Hank Rahe
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The United States scientific advisory panel has recommended by an 8-to-1 margin that estrogen be added to the growing list of chemicals having cancer-causing properties. This information appeared recently in several newspapers and highlights estrogen as yet another example of the fact that all drugs are hazardous. Pharmaceuticals by definition cause an effect on people exposed to a single dose of the drug and can cause adverse effects at much lower dosage levels.
The advisory panel stresses that the listing should not frighten the more than 16 million women taking hormone therapy, but act as a warning for them to discuss with their physicians how the drug can be given safely.
Pharmaceutical products have an impact on the gamut of individuals coming in contact with the compounds. From the people who manufacture the drug substance to the pharmacist, nurses, physicians and healthcare workers, each of these individuals has the potential of being over exposed if proper engineering controls are not in place.
All drugs are hazardous. The difference between the individual compounds is the amount of the material to which an individual can be exposed without suffering an adverse effect. That the long-term effects are not understood until large numbers of people have been exposed is the major problem in several cases. Because of the risk of repeated exposures, inadequate engineering controls and less-than-complete information about the drug substance, individuals involved during the delivery process many times represent the highest potential for exposure.
Pharmacy and nursing staffs do not have technical engineering support at their disposal. Even in the largest hospitals, engineering support for contamination control is limited. This means the staff must rely on outside resources for information that helps define the dangers and determine the correct technologies to implement for personnel protection.
One information source, the MSDS (Material Safety Data Sheet), is generally lacking in the detailed information required to create changes. Other sources, such as technical journals, focus on areas of professional development within their professional area and rarely contain articles concerning contamination control techniques for drugs. The lack of proper support combined with no clear avenue to obtain information has put a great number of healthcare workers at risk.
Risk comes from continued exposure to the drug substances. Exposure of individuals occurs when the drug substance enters the body whether by breathing, absorption through the skin or soft membranes and ingestion. To prevent exposures, the drug must be separated from people during preparation and given to patients using proper technique.
It is important to understand how we can build contamination control interfaces, which will allow the necessary feel or touch while offering the proper protection. A determination must be made that the activities required during the preparation and administration of drugs are safe. Individual technologies need to be reviewed and tested to determine their capabilities, because without this information we cannot be assured it will provide adequate protection to the workers.
Healthcare workers need to be informed, provided the proper contamination control technologies and trained in the proper use of these tools. I have overheard nurses saying that they are willing to put themselves at risk to serve the patient. I cannot help but wonder if the loss of such a valuable and scarce resource is truly a service to the patient.
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He has over 30 years' experience in the healthcare industry, as well as four years in academia. He is an expert in the areas of conventional and advanced aseptic processing. He is the past chairman of the board of the International Society of Pharmaceutical Engineers, and is a member of the CleanRooms Editorial Advisory Board.