Purpose
Pharmacy is one of the most regulated professions in the United States. We can interact with multiple regulatory bodies including state Boards of Pharmacy, DEA, OSHA, CMS, FDA, and local regulatory agencies. Any one of those bodies can impose penalties ranging from warnings to revocation of the pharmacy permit to practice. Each regulatory agency has it’s own stated goal, however, the end goal for all agencies is to promote public health and safety. Navigating the various rules, laws, and regulations of all these agencies, however, is a task that in my experience has always been most successful with meticulous organization, a set cadence of record review, and above all clear and open communication with staff about expectations.
This walk is meant to help identify areas of risk provide and to help formulate recommendations for improvement. The goal is to reduce the risk for severe penalties by identification of common causes of citations or disciplinary action. It does not guarantee elimination of risk, only reduction of risk.
Background and References
This walk is primarily focused on sections of Virginia pharmacy law and Board of Pharmacy regulations, the Code of Federal Regulations, and guidance from the Institute for Safe Medication Practices. Sources include:
- The Virginia Board of Pharmacy
- The Code of Virginia, specifically the Drug Control Act and related statutes
- The Code of Federal Regulations, specifically section 21
- The DEA Pharmacist’s Manual
- The Institute for Safe Medication Practices
In general, topics and questions are broken up into workflow standards, dispensing standards, patient safety standards, and record keeping. Additionally, based on risk items are flagged to help identify priorities. Risk is evaluated based on the amount of the monetary penalty that is associated with a deficiency, previous case decisions and results of those cases, and potential impact to the pharmacy permit (e.g., revocation, monetary penalty, etc.). For example, most controlled substance topics are high to very high risk:
- Typically multiple violations or failures with regards to controlled substances (record keeping or reporting) result in significant penalties or revocation of the permit (Westbury Pharmacy, 2015 or Partner’s Pharmacy, 2020)
- Controlled substance stewardship is a targeted enforcement action currently, resulting in heightened scrutiny and awareness
- Both state and Federal agencies are involved in audits; depending on the severity of the violation penalties can range from a warning to revocation of the DEA license.
However, ignoring or not enforcing multiple low-risk or even best practice items can result in permit revocation. Best practice items are in place to improve patient safety; if ignoring best practice results in errors, this increases the overall risk as it increases the likelihood of a inspection, and multiple violations, even of items that normally wouldn’t be considered high-priority or high-risk, may result in a finding of negligence and danger to public health, resulting in either significant monetary penalties or even revocation of the pharmacy license.
Completing the Walk
This walk is best done in 1 session but you can save and return to it. An email will be sent with a temporary save and return link that will expire after 5 days. Once submitted, you will receive a PDF copy of your answers and any attachments; results are retained for 5 days before permanent deletion in the event you need another copy or lose the original email.
Answer each question/statement truthfully; if in doubt be conservative rather than assume it will just “slide by”. Board focuses shift, and inspectors have different priorities and methods; what one auditor may consider important another auditor may only comment on it and move on (e.g., pharmacy working conditions, legislatively, are a focus and it would be expected that Board inspectors will pay closer attention to those topics at this time versus making sure signatures are collected for non-safety closures). In practice, I took an all-of-the-above approach and assumed I could be fined or cited for any and all non-compliant findings and ensured the pharmacy was inspection-ready in all aspects and at all times.
After the walk
Once submitted you will receive an email with the full set of answers as well as the associated laws and regulations for each question. Additionally, the document will have a scoring guide at the end based on you answers that will categorize scored sections into low, medium, and high risk. Importantly, risk stratification is based on subjective experience rather than any hard source. Frankly, a low score indicates a tight ship. Higher scores indicate that ship may have some leaks that need addressed. Take that as you will. The threshold has purposefully been set low.
Importantly, once the walk is completed and you have compiled a set of action plans, communicate these to staff with clear instructions on the changes and why those changes are being made. When all staff are involved in making sure compliance is a priority, the overall risk is reduced.
Key
As you progress through the walk items will have an icon beside them. This icon indicates the associated risk or if the item is informational/best practice. Risk is based on associated potential fines according to the VA BOP monetary penalty guide, risk to the license (e.g., just a warning or potential revocation based on previous case history and the scoring index on the Board page), and practical experience with inspections.
Very High Risk
Associated with high monetary penalties if non-compliant ($1000+), is a focus item legislatively, or has been associated with permit revocation or restriction
High Risk
Often associated with higher monetary penalties ($500+) or require immediate remediation
Low Risk
Not generally associated with high fines (no fine or warning to $250) or not generally asked on inspections in previous experience, however, still a part of the law and could be cited if other deficiencies are found that result in a deeper dive by the auditor
Important to Note
Generally make the inspection easier to complete and/or may be requested by the inspector
Best Practice or Information Only
Typically not enforceable as it is not in the regulations, but is considered best practice. It is important to note, however, that best practice guidance can eventually become regulated (e.g., pharmacist lunches were considered best practice by ISMP initially, and now are regulated by the Board).
Scored Answer
This item is counted towards the risk score. Items counted have either been directly observed in an inspection (e.g., the auditor or inspector point-blank asked about it), noted on Board or DEA case history, or are directly stated in DEA/State law/regulations.
When you’re ready, plan on at least an hour, hit the “Get Started” link.
