Regulating for good reason

by Hank Rahe

Regulations, regulations. Why so many regulations? The answer may be that in many cases we simply do not do a very good job of protecting people in the workplace.

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OSHA has recently indicated it is concerned about the handling of cytotoxics compounds in hospitals, clinics and oncology infusion centers, where these pharmaceuticals are prepared for delivery to patients.

Many of the products used to treat cancers are, themselves, suspected carcinogens and require protection for the caregivers. Without the proper level of protection these individuals can exceed exposure level limits, in terms of airborne concentrations, of the product. In many cases, the quantity of product required to exceed the exposure limit is less than 10 micrograms.

How does the contamination happen during the preparation of these products? Several times during the routine manipulations the pharmacist is required to withdraw the product from a vial and place it, along with other products into a “piggyback,” which then is infused into the patient. This operation requires the person preparing the product to draw the product into a syringe and then use the syringe to transfer to another container. During this transfer, the liquid is placed under pressure and can aerosolize, drip or leak and become airborne.

Employee protection needed

Class II biological safety cabinets were adopted in the early 1980s as a standard containment device in which to transfer cytotoxics in the hospital setting. However, today some oncology infusion centers still do not use any type of protection for the employee preparing these drugs.

Information gathered during the 1990s has shown that, in many cases, the level of containment protection provided by these devices is inadequate for products having exposure limits of less than 10 micrograms. (The use of closed systems, which are not dependent on airflow, is the only way of consistently providing adequate protection levels.)

The combination of this total lack of protection for some employees and data indicating less-than-adequate protection levels using the standard containment devices has caused OSHA to refocus on employee protection in the area of cytotoxic preparation. The impact of this focus will most likely be stricter enforcement of the current regulations and more stringent future requirements.

How can industry relieve itself of the burden from all these regulations? We need to do a better job of policing ourselves.

We must provide our employees a safe environment where they can come and go without being impacted by the materials with which they come into contact while doing their jobs. If industry doesn't do a good job of providing safety in the workplace, we will have an agency, such as OSHA, step in and do it for us.

It is true that the suggested changes will have an economic impact, but this impact will be less than facing possible fines, legal expenses and, in the end, having to implement the proper technology to provide the safer workplace anyway. Doing the responsible and correct thing is the most cost-effective solution in the long run.

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.


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