Pharmacy Compliance with Hazardous Drugs

Pharmacies play an important role in our healthcare system. Pharmacies procure and dispense needed medications. In serving this essential role, pharmacies must take adequate precautionary measures to ensure their storage, handling and dispensement of these medications is done safely and in accordance with state and federal law. Mishandling of medications can have severe consequences, both for patients and pharmacy employees.

Pharmacies are overseen by state-specific pharmacy boards. Although pharmacies are regulated by state specific laws, all states have provisions dealing with a pharmacy’s handling of certain medications – or more commonly named “hazardous drugs.” Hazardous drugs are defined as any substance that can cause a toxic effect within the body. Depending on the type of drug, toxicity can be caused by physical ingestion, inhalation, or through skin absorption. Pharmacies must make sure that all hazardous drugs are properly identified and labeled within the pharmacy. Proper identification mitigates the risk of a pharmacy employee accidentally mixing up medications. Unfortunately, a patient receiving the incorrect drug at a pharmacy is a common, yet preventable form of inadequate pharmacy operation. A pharmacy should designate an individual as a compliance officer to oversee the proper storage and labeling of hazardous drugs. Having a single individual act as a compliance officer allows this person to solely focus on hazardous drug safety and does not divert the attention of other pharmacy employees. This compliance officer should also be responsible for keeping up to date on all changes on the state and federal level regarding the proper protocols for hazardous drugs. When there are changes with regard to hazardous drug compliance, the designated compliance officer needs to ensure the pharmacy’s internal policies and procedures reflect these changes and pharmacy employees need to be timely trained on these new procedures as well.

Although the designated compliance officer should be in charge of monitoring the pharmacy’s due diligence with respect to hazardous drugs, a pharmacy owner or operator needs to ensure written compliance polices and procedures are enacted in the first place. No pharmacy should operate simply by verbal conveyances. Not having a sound written compliance policy opens a pharmacy up to increased scrutiny should a mistake in handling hazardous drugs occur. Written policies allow for pharmacy employees to be properly trained and also provide guidance should an employee have a question about hazardous drug protocol. Written policies should detail activities occurring within the pharmacy that could create a potential toxic exposure to employees. The policies should also detail which drugs kept at the pharmacy have a potential for toxic exposure so employees can take proper precautionary measures when handling these certain drugs.

If your pharmacy is a compounding pharmacy, extra precautionary measures need to be undertaken to ensure safety when working with and handling hazardous drugs. Since compounding pharmacies actually engineer unique medications, possible exposure to toxicity is greater. If your compounding pharmacy creates unique medications, additional compliance measures need to be undertaken to promote safe handling of hazardous drugs. Whoever is doing the compounding needs to be aware of how certain drugs interact if they are mixed and how drugs react when they are taken out of their original form. For example, if a compounding pharmacy is creating a topical version of a mediation for a patient who cannot take drugs orally, the compounder needs to be educated about and aware of any toxicity warnings of the drug in the altered topical state. Personal protective equipment (PPE) needs should be evaluated for any individual creating compounded medications. Personal protective equipment can include gowns, masks and goggles. This protective equipment can protect compounders from potential toxic exposure during the compounding process. Whether or not personal protective equipment is needed should be evaluated on a case by case basis depending on whether the compounding creation process has any potential toxic side effects. The hazardous drug compliance officer for the pharmacy should ensure protective equipment is available if needed and that all pharmacy employees are wearing protective equipment in required situations.

Pharmacies are also required to dispose of hazardous drugs properly. Hazardous drugs that are improperly disposed of can negatively affect the environment and human health. In the past, the improper disposal of hazardous drugs by pharmacies led to contamination of drinking water in certain areas. Now, both state and federal law dictate how pharmacies must dispose of their hazardous drugs. Pharmacies must create a detailed inventory of all hazardous drugs it is planning on disposing. This inventory must include the name of the drug(s) and the weight of the drug(s). After this inventory is created, the pharmacy must contact its local waste management facility and have the noted drugs taken to this facility. The waste management facility will ensure (or is supposed to ensure) that all hazardous drugs are destroyed in accordance with state and federal guidelines.

Pharmacy compliance with hazardous drugs is just one of many compliance measures pharmacies must abide by. Owners and operators of pharmacies should check with their local state pharmacy boards to ensure they are up to date on all respective compliance guidelines.

Contact Oberheiden, P.C. for Your Pharmacy’s Hazardous Drugs Compliance

The experienced hazardous drugs compliance attorneys of Oberheiden, P.C. can offer help for your pharmacy compliance. Contact us today online, or give us a call at 888-680-1745.

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