Pharmacy Inspections
Rachel Balick
Even a pharmacy that feels prepared can get spooked by the sudden sight of a state board of pharmacy (BOP) inspector. Inspections can be a reality check, or they can be a breeze. For the most part, the outcome is determined by a pharmacy’s ongoing vigilance and preparation.
Clean up your compounding
Whereas many BOPs have separate inspection and enforcement divisions, Alabama’s is all in one. Alabama investigators Todd Brooks and Scott Daniel, JD, come from a law enforcement background. “We investigate and inspect, and if there’s anything that needs to be handled, there’s a legal side,” Daniel said.
Brooks has a certification in sterile compounding inspections (CISCI) and primarily performs inspections in the sterile and nonsterile compounding space. “Pharmacists who have a good understanding of USP <797> and <795> and are organized really have no trouble with the Alabama [BOP] unannounced inspections.” When their grasp of the USP chapters is a bit weaker, Brooks might find lapses in documentation, logging and upkeep with cleaning, training, environmental condition requirements, and easy record retrieval.
Though learning from past inspections is the best way to stay prepared for the next one, just because something isn’t cited in one inspection doesn’t mean it won’t be in the next. “We may find [violations] on subsequent and follow-up inspections because compounding inspections evolve and improve,” Brooks said.
The community setting
It’s important that inspections are unannounced so pharmacies don’t clean up their act just because an inspector is coming.
“Some people are just poor housekeepers. The clutter doesn’t bother them, and they don’t consider the perspective that keeping things neat and orderly is good for a business,” Daniel said.
For example, pharmacies in Alabama must have hot and cold running water. “I’ve been in places where you couldn’t even use the sink because it was full of papers.”
Some pharmacy chains do themselves a favor by storing important paperwork in a “compliance box,” Daniel said. “We can go directly to that compliance box and find a good bit of what we need to look at. That cuts inspection time down considerably because their regulatory compliance box was generally in the same spot in every pharmacy.” It’s something Daniel recommends for all pharmacies.
“Pharmacists won’t have to step away from their responsibilities. They can continue to deal with patients and process prescriptions,” he said. It helps busy inspectors, too. “We don’t get tied up waiting for them to finish something so they can go find a piece of paperwork and go back and forth.”
On the flip side, being disorganized and unprepared forces pharmacists to stop working with patients and prescriptions. “It backlogs them, so when we do eventually leave they’ve got to play catch-up, and that probably hurts their customer service.”
While there are obvious threats to patient safety in a lax compounding pharmacy, community pharmacies can have their own dangerous quirks.
“We had a pharmacy that was taking a very potent antibiotic intended for injection, adding it to some mixture they came up with, and selling it to patients with diabetes as a foot bath,” Daniel said. “They were taking the cap off these injectable antibiotics and having the patient pour it into a foot bath if they had an open wound.”
The practice was illegal for more than one reason. “They were defrauding insurance, charging outrageous amounts for these foot baths, and the ingredients cost the pharmacy less than $100,” Daniel said. “You would not believe some of the things that people come up with to try to make a dollar.”
Lower the red flags
Eleanor Doss, PharmD, is a pharmacist inspector for the Pharmacy Quality Assurance Commission of Washington State’s BOP. One of the areas that trips up the pharmacies she inspects is not having someone who can guide the inspection.
A big issue is when the person who is in charge—a pharmacist in charge, pharmacist manager, or whatever title each state uses—is not there for an inspection and the staff do not know where to find important information, Doss said.
Washington State’s pharmacy commission has a self-inspection sheet on its website, as do many other states. “On the first few pages, the manager is supposed to list where those documents are, but sometimes staff don’t even know where the self-inspection sheet is,” she said. “Managers can help their staff by ensuring that more than one person knows where important audit documents are.”
A pharmacy that is more organized and appropriately staffed is better able to keep on top of tasks like pulling outdates, maintaining accurate patient profiles, and knowing where important documents are. “Understaffing is unfortunately becoming a chronic issue in many pharmacies.”
Staying organized can prevent pharmacy staff from being overwhelmed by their volume of work, and staff attitudes are an important factor in inspections. “A staff that is connected, gets along well with each other, and is focused on patient care usually has a better inspection.”
Memorable violations
“I have removed shopping carts of expired meds and OTC items from pharmacies that were intermingled in their general stock. I have seen staff working with expired licenses. I have seen unlicensed staff being allowed to perform tasks that are limited to licensed staff,” Doss said. “I once saw dust bunnies that were bigger than the prescription bottles on stock shelves. I have seen substandard sterile compounding conditions that warranted immediate action. I have been in pharmacies so cluttered that I couldn’t find a place to write.”
Doss said that most pharmacists want to do the best they can for their patients and often think they are performing quite well—but may be taken by surprise when an audit finds areas that need improvements.
“I have had managers thank me for helping to identify these areas so that they can make a plan for improvement. I have had others get very defensive and upset,” she said. “The important part is moving forward and trying to improve, and usually the inspector can offer advice or tips from their experience with so many other pharmacies. Better to catch deficiencies on an inspection than to have a deficiency cause patient harm.”
An inspection pro
Tiffany Bartke, PharmD, RPh, is the health care supervisor for Walgreens in Massachusetts. “As a pharmacy manager I had some inspections myself, and now I help new pharmacy managers and all pharmacy managers stay prepared for inspections.” Like Washington, Massachusetts posts audit sheets on its BOP website. “The answers to the test are right there,” Bartke said.
In states that don’t make such a resource available, the pharmacies she’s worked with refer to an old inspection report. “We ask the team to use that list monthly or bimonthly to essentially do their own board audit, because then they know exactly what the board auditors are looking for.”
Each inspection for a Walgreens pharmacy is an opportunity to improve practices across the chain. “Just assuming that everything is compliant is where people end up missing things and getting caught,” Bartke said. “If an auditor uncovers or mentions something at one store, we’ll try to spread that knowledge across other stores. Sharing information between pharmacists is very helpful for prep.”
Bartke goes through audit requirements with new pharmacy managers to ensure they fully understand them. “Once they feel really comfortable with all those questions, I have them ask their staff pharmacist to do it, ask their technicians to do it—the more the whole team knows the questions and what the board’s looking for, the better the audit goes,” she said. “I think sometimes pharmacy managers forget that the board could come at any time, including when they aren’t working.”
The common goal
In the end, pharmacies and inspectors are on the same side. “Pharmacists might be surprised to know that unless public and patient safety is at risk, we would like to help them versus automatically bringing them up on charges. If they’re making steps toward fixing problems, then we can work with them,” Alabama’s Brooks said.
Washington’s Doss said pharmacy inspectors are there to help. “I like to tell pharmacies that I could work at their store for a week and probably not see everything that is going on,” she said. “An inspection is a snapshot in time, and the idea is to catch patient safety issues before they cause harm. There is always an opportunity to improve.”
If pharmacies have questions or concerns, they can reach out to their BOPs. “I have had some pharmacies stockpile questions for when I come in next, but I like to let them know they are always welcome to call. Chances are you will not be the first or the last to ask me that question,” Doss said.
Double whammy: Same-day BOP and DEA inspections
Sometimes you get inspected by your BOP. Sometimes you get inspected by DEA. And on the rarest of days, lightning strikes.
“The BOP and DEA inspectors were not aware that they would be inspecting the same pharmacy on the same day. They both said it was the first time it had happened in their careers,” said Sagar Vegesna, PharmD, pharmacy operations coordinator at Johns Hopkins Specialty Pharmacy in Baltimore. “Pure dumb luck in my honest opinion.”
There was some overlap in their objectives. Both looked closely at controlled sub-stances—inventory management, ordering, proper labeling, and filling of scripts. “Although we could, we don’t stock or dispense controlled substances in this pharmacy because we’re focused on specialty medications,” Vegesna said. “So that went quickly for both inspectors.”
There were differences as well. BOP wanted to make sure all pharmacy employees had up-to-date state licenses and that the licenses were on display. They also identified which states the pharmacy shipped to and reviewed recent trainings on patient-centered topics, like HIPAA. DEA focused more on federal DEA certificates—their expirations and validity—and the accuracy of counts and inventory.
Vegesna advises pharmacies to check licenses on a monthly basis and keep previous inspection checklists where they can be easily found and readily reproduced. “One of the most important things we do is have regular internal audits, where our compliance officer checks things that are required by BOP, DEA, and other accreditation bodies, like URAC [Utilization Review Accreditation Commission].”
And be honest with the inspectors if you can’t locate something immediately. Ask management for help as needed to produce any unlocated articles. “Create a game plan for different types of audits, keep a running log of the things that are needed for each audit, and keep all previous audit results,” he added.