USP General Chapter <800> applies to all healthcare personnel who handle hazardous drug (HD) preparations and all entities that store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians’ practice facilities, or veterinarians’ offices). Personnel who may potentially be exposed to HDs include pharmacists, pharmacy technicians, and other personnel who work in a pharmacy.
Community pharmacies handle HDs in their normal course of business. Some examples of common HDs include:
• Estradiol tablets
• Methotrexate tablets
• Azathioprine tablets
• Cyclophosphamide tablets
• Cyclosporine capsules
• Risperidone tablets
• Paroxetine tablets
The risks involved in handling these drugs depend on many factors including the actual toxicity of the drug, how the drugs may enter the body (dermal, inhalation, ingestion, etc.), how they may be manipulated, how often they are handled, and availability and use of primary and secondary engineering controls and personal protective equipment. Non-compounding pharmacies often don’t think about primary and secondary engineering controls or personal protective equipment. The emergence of USP <800> forcibly changes that unawareness.
At a minimum, community pharmacies should be doing the following:
• Review USP <800> (download for free after registering at the USP website).
• Download and review a copy of the NIOSH 2016 List of Hazardous Drugs
• Create a list of NIOSH listed HDs in your inventory.
• Conduct assessments of risk for handling those HDs in you inventory.
An assessment of risk may be used only for counting and packaging HD finished dosage forms in preparation for dispensing. An assessment of risk may NOT be used to avoid the requirements of USP 800 if any manipulation (crushing, breaking, or compounding) of the finished dosage form occurs.
Pharmacies must incorporate the standards in Chapter <800> into their occupational safety plan. Components of your pharmacy’s health and safety management system must, at a minimum, include:
• A list of HDs
• Facility and engineering controls
• Competent personnel
• Safe work practices
• Proper use of appropriate personal protective equipment (PPE)
• Policies for HD waste segregation and disposal
The good news is that on September 29, 2017 USP announced its intention to postpone the effective date of these new standards that were to take effect July 1, 2018. The purpose of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceutical Compounding — Sterile Preparations, to provide a unified approach to quality compounding. The new effective date is December 2019.
If you want further information, and assistance in developing your strategies to meet these new standards please give us a call.