Pharmacy practice, even while afforded much autonomy, is highly regulated given the types of information, drug products, and other substances that are handled routinely. Compliance with state board of pharmacy regulations is obviously paramount. Additionally, there are a number of other government agencies with rules and regulations to which we must abide, and these agencies take more prominence in certain settings. A very prominent Federal agency in many pharmacy practice settings is the Occupational Health and Safety Administration (OSHA). OSHA is concerned with workplace safety. Their reach spans widely, from assurance of proper ergonomic design of chairs and the manner in which employees type on keyboards to prevent carpel tunnel syndrome and back injuries, to the handling of potentially toxic medicinal agents and chemicals common throughout hospitals and other settings.
Mixon and Nain provide an in-depth discussion of compliance with OSHA for compounding pharmacists.1 The article was written from a managerial perspective to help those in the business protect themselves and their employees. They describe categories of violations ranging from those that are “serious” which can incur a fine close to $10,000, to “willful”, “repeat”, and “egregious” violations whose fines can run from $75,000 to $100,000. They describe steps taken by a compounding pharmacy to help minimize the likelihood of OSHA violations such as: a chemical inventory of supplies, a chemical hygiene plan, a respiratory protection plan, a chemical labeling system, fire prevention and emergency action plans, and a safety and health/loss prevention audit checklist. They further discuss: development of an effective occupational safety program, assessing environmental risks, and training employees, along with the possibility of other needs such as written plans for blood-borne pathogen exposure. The authors state that being proactive can minimize the likelihood of fines, protect the business against loss, increase profits, and improve employee morale.
Taking preventive measures to ensure compliance with OSHA and other regulators can result in a highly positive return on investment. Pharmacy managers must take a broad view of compliance and should speak with other industry representatives and attorneys to make sure they cover all the bases.
Additional information about Compliance with Regulations and Regulatory Bodies can be found in Pharmacy Management: Essentials for All Practice Settings, 4e. If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to Pharmacy Management: Essentials for All Practice Settings, 4e. If your institution does not provide access, ask your medical librarian about subscribing.
1Mixon B, Nain J. Complying with Occupational Health and Safety Administration regulations: A guide for compounding pharmacists. Int J Pharm Compd. 2013;17:182-190.