5 Tips to Keep a Pharmacy Regulatory Compliant

Regulatory compliance remains a priority for hospitals, health systems, and PAC providers. However, this compliance comes at a cost. The American Hospital Association reports that these organizations spend over $38 billion on administrative tasks to adhere to these regulations. 

A pharmacy offering IV Compounding Solutions, or any pharmacy today, must have a system in place to track and maintain compliance. Failing to do so leads to serious consequences. What methods can pharmacies use to maintain compliance? 

Comprehensive Documentation

Pharmacies must document all care to ensure effective communication between staff members and patients. Furthermore, this documentation improves patient care across all channels. A pharmacy may lack comprehensive documentation for several reasons. 

Staff members often lack understanding regarding the importance of documentation in pharmacy compliance. The staff might also focus on customer service and feel documentation isn’t necessary for quality assurance. This lack of documentation means there is no paper trail when an error occurs. As a result, the pharmacy cannot analyze the circumstances of the error and how staff members resolved it to prevent similar problems in the future. 

With the right documentation, pharmacies find they can improve on their quality. In addition, they avoid compliance issues. 

State and Federal Requirement Adherence

Pharmacies must monitor and adhere to federal and state regulations even as they remain in a state of constant flux. Every pharmacy needs a system that provides alerts to upcoming regulation changes and somewhere to turn when they need help to interpret the laws or adopt and implement them. Many pharmacies turn to the Health Care Compliance Association for this help. 

The United States Pharmacopeia Convention (USP) continually updates its standards. Pharmacies must closely monitor these updates. For example, in December 2019, the organization updated its standards on pharmaceutical compounding. Every pharmacy must use the updated standards, and this serves as only one example of revised standards issued by the USP.

Compliance Policies and Training

Every staff member must recognize the importance of compliance. To achieve this goal, a pharmacy should create policies and have tools accessible that staff members can use when they have a question. Furthermore, these materials allow every staff member to receive the latest information in a timely manner. However, the policies and materials only serve as part of the equation. 

Pharmacy managers need to implement staff training programs to improve quality assurance. Many pharmacies give no thought to quality assurance until an inspection or audit. The pharmacy then finds it must address chargebacks or heavy fines following this outside evaluation. To prevent this, the pharmacy should implement a rigorous quality assurance program that includes specifics regarding what outside parties will check, who bears responsibility for each task, and how often the checks will take place. 

Annual Schedule and Checklist

Every pharmacy needs a complete compliance checklist. This list ensures all staff members know due dates and an audit or inspection won’t surprise them. The audit inspection needs to include a list of questions the third party may ask. In addition, the questions should focus on areas such as the efficiency of policies and processes the pharmacy has implemented. 

Furthermore, each pharmacy should develop a schedule for items that need completion regularly. Include daily, weekly, monthly, quarterly, and annual tasks in this schedule. The schedule reminds the staff what needs to be done and ensures the organization remains in compliance and on top of all reporting due dates. 

Centralized Location

Create a centralized location for everything related to pharmacy compliance. This promotes communication and efficiency. Many pharmacies choose to use a shared drive that all employees can access. Items to gather in this centralized location include regulatory body information, pharmaceutical care documentation, the compliance checklist and schedule, state and federal requirements, and training materials. 

Pharmacy regulations undergo constant updates. To comply with these updates, every pharmacy must develop policies and procedures. Any organization that prioritizes compliance daily streamlines its workflow and enhances its patient care. 

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