by Hank Rahe
Some of you out there need to try harder. I have spent the last week reviewing MSDS (Material Safety Data Sheets) for cytotoxic drugs and give most of the pharmaceutical industry a failing grade on the quality of information contained in their MSDS documents. Section 8, which is supposed to provide information on personnel protection measures, reads like it has been sanitized by the famous three monkeys who see no, hear no, or speak no evil.
The Chemical Manufacturers Association in the early 1990s developed the Material Safety Data Sheet format called ANSI Z400 for use by individuals responsible for developing and reviewing the MSDS information within their companies. The standard describes recommended content for each of the sixteen sections of the MSDS. This work was an effort by manufacturers of the materials to provide consistency to the preparation of the MSDS documents required by OSHA.
Section 8 of the MSDS should describe exposure controls and personnel protection measures to be used in the routine handling of the compound. The purpose of the section is to discuss the engineering controls needed to minimize chemical and physical hazards. The scope on the information must mention applicable control measures including engineering controls and should contain recommendations for containment. Personal Protective Equipment (PPE) guidance should also be provided for emergency situations. The control measures should protect the route of potential exposures to the compound including both inhalation and absorption. OSHA requireswhere economically feasibleengineered solutions be used for routine handling of hazardous materials.
For those manufacturers who provided little if no data in Section 8, does this mean that they have no data on the potency of these compounds or its effect on people?
If not then how did they determine the effective dosage for the individuals taking the medication? If they do have the data then why are they not communicating the information? Not communicating the information will only increase their liability.
The responsibility of protecting not only the individuals manufacturing, filling and packaging the potent compounds as well as the people who handle it in the delivery system to the patient is that of the manufacturer. The manufacturer must also accept that they alone have the responsibility of informing any individual coming in contact with the drug substance on the potential effects of exposure. Failure to do so will result in OSHA enforcing fines and possible criminal penalties.
The majority of MSDS documents lacking information were from companies manufacturing off patient drugs or generics. We are lead to believe that these are equivalent to the “brand names” in all aspects but can that be true if these companies are not providing full disclosure for containment of their drugs. “NA” seems a poor answer to what protective measures an individual should take when handling their product.
Continued cost pressure on health care providers causes them to seek the low cost solution sometimes without consideration of what may be missing in terms of information, which is critical to the protection of their employees. Risk management may want to take a look at potential liability created by the “NA” in the MSDS sheet of a known carcinogen being prepared in your pharmacy.
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.