According to a recent study by the American Hospital Association (AHA), health systems, hospitals, and PAC providers spend $38.6 billion nationally each year on administrative activities related to regulatory compliance. Pharmacy compliance is a crucial matter, but without a systemized method for tracking and maintaining it, facilities stand to face serious consequences.

Here are five ways pharmacies can ensure they maintain compliance.

1. Maintain comprehensive documentation.

Documenting pharmaceutical care promotes efficient communication between patients and staff and allows other health providers to provide better continual care. 

Pharmacies’ lack of documentation may be due to one of several reasons:

• Your staff may be unaware that documentation is a required practice to maintain pharmacy compliance.
• Your facility may be providing superior customer service and staff members assume they don’t need to document patient interaction for quality assurance. 
• When an error does occur, there is little-to-no documentation of the circumstances or how the issue was resolved, leaving no precedent for future procedures.
• Appropriate clinical documentation can increase pharmacy quality improvement while also preventing serious compliance issues.

2. Stay up-to-date on individual state and federal requirements.

Federal and state regulations are in constant flux and tend to be complex. Find a reliable way to be alerted of upcoming regulation changes and have a set of sources to turn to if you need help interpreting laws or advice for adoption and implementation. The Health Care Compliance Association (HCCA) offers a range of resource guides, publications, and a compliance dictionary to promote compliance education.

Standards that go through continual updates, such as those set by the United States Pharmacopeial Convention (USP), require especially close attention. As of December 2019, USP has changed its requirements for handling and use of hazardous drugs in healthcare settings, USP <800>. This chapter revision expands on previous protection standards issued in USP <795> and USP <797> which addressed pharmaceutical compounding for sterile and non-sterile preparations.

3. Create pharmacy compliance policies and training programs for staff.

Your staff needs to understand the importance of tasks and processes that keep your pharmacy in compliance. Creating policies and accessible materials for all staff members help to address any lingering questions and ensure that everyone is receiving the same up-to-date information. 

Staff training programs can also improve your pharmacy’s quality assurance (QA). Aspects of QA are often disregarded until an audit or inspection occurs and the pharmacy is then faced with avoidable heavy fines or chargebacks. When developing a QA program, make sure to determine the specifics: what will be checked, who is responsible, and how frequently QA checks will be run.

4. Develop an annual checklist and schedule.

A complete compliance checklist prevents pharmacies from being caught unawares by due dates, audits, and unexpected inspections. An audit checklist, for example, could contain potential questions that may be asked during a site visit or help pharmacy staff measure the efficiency of new processes and policies.

Different items also need attention on a daily, weekly, monthly, quarterly, or annual basis, or might have to be checked off as-needed. Developing a calendar and schedule with reminders will keep your staff informed and on board with compliance practices and able to track all due dates.

5. Choose a secure, centralized location for all compliance-related resources.

All compliance resources and information should be accessible from a central location in order to promote ongoing communication and workplace efficiency. Consider storing them on a shared drive that can be shared across pharmacy areas. 

Resources to include:

• Information about regulatory bodies
• State and federal requirements
• Documentation of pharmaceutical care and documentation guidelines
• Compliance checklist and calendar or schedules
• Policies and training programs 

In a world of constantly-changing regulations with frequent updates, it is essential that pharmacies develop their own policies and procedures. The practice of prioritizing pharmacy compliance day-to-day will not only streamline your workflow but also enhance the quality of patient care. 

Originally posted on May 17, 2018 and updated February 25, 2020.