Surviving a board of pharmacy inspection
Thursday, June 08, 2017
Community pharmacy is stressful, even on our best days. There is the pressure to fill more prescriptions, check for drug interactions and answer questions at an increasingly faster pace.
But maybe nothing — except possibly dealing with a prescription error — is more stressful than getting a surprise inspection from your state board of pharmacy (BOP). I have been managing pharmacies for enough years to have experienced plenty of such inspections, and I'm happy to share some advice with the next generation of pharmacists.
Pharmacy inspections are a tool used by a state BOP to ensure licensed pharmacies are being operated in compliance with all relevant federal and state laws. And they are becoming more frequent.
For example, on the board of pharmacy website for the state of Washington, the page on inspections states, "Nationally over the past few years, there has been an increase in high-profile adverse events related to pharmacy practice. These adverse events have given rise to a heightened level of scrutiny of pharmacy practice as well as its regulators." As a result, the state has "adopted a more rigorous routine inspection process subjecting pharmacies to a more in-depth and comprehensive standards review."
It is important for pharmacists — and especially pharmacy managers — to understand the role of the BOP. Sometimes new graduates mistakenly believe that because pharmacists often sit on the board that the job of the board is to advance the profession of pharmacy.
However, while boards of pharmacy may be supportive of the pharmacy profession, their primary focus is to help protect the public. Therefore, when members of the BOP are inspecting your pharmacy they are especially focusing on compliance and patient safety.
One of the most important things a pharmacy manager can do to prepare for an inspection from the BOP is to regularly review any materials provided by the board for this purpose. For example, the California BOP website provides a 30-page self-assessment that actually must be completed every other year by the pharmacy manager. Other states like Oregon and Massachusetts also provide self-assessment forms online.
However, not every BOP appears to offer such materials, so contacting the board might be a good idea. If you happen to be a pharmacy preceptor in a community pharmacy, you could assign a student the job of doing a full inspection of the pharmacy during his/her rotation.
My next piece of advice for surviving a BOP inspection is to take careful notes as you talk with the inspector about any areas of potential improvement he/she might observe. Experienced inspectors will often share advice that doesn't necessarily amount to a violation, but can help you manage your pharmacy better in the future. Write these things down and keep a log of such notes for future reference.
I recommend regularly updating your staff about important inspection-related issues that could be considered violations if they are forgotten. Making sure licensees are up to date, proper signing is in place, name tags (when required) are worn and visible, expired drugs are managed appropriately, narcotic perpetual inventories are meticulously kept and many other such rules should be regularly communicated.
It is a good idea for pharmacy managers to regularly visit the BOP website for other important updates that might be coming. For example, Massachusetts recently announced that it would be including gabapentin as part of the prescription monitoring program (PMP) requirements for retail pharmacies starting in August 2017. Reading minutes from recent BOP meetings may help you understand what some of the current issues are which the board is facing.
Finally, follow up on any issues uncovered during the inspection promptly and completely.
It has been my experience that the vast majority of inspectors from the BOP want to help pharmacists run a safe and compliant pharmacy. Being prepared and knowing what to except will greatly improve your chances of survival and success.
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