Q&A: Balancing Patient Care, Compliance Amid Controlled Substance Challenges | AAP 2025

Pharmacists today need more than technical skills—they must develop emotional intelligence, preparedness, and professional awareness, especially when managing controlled substances. Planning ahead is essential for handling unexpected challenges. Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS, clinical assistant professor and director of experiential learning at West Virginia University School of Pharmacy, compares this to Disney’s storyboarding, encouraging pharmacists to anticipate complex situations and respond with empathy and precision.

Q&A: Balancing Patient Care, Compliance Amid Controlled Substance Challenges | AAP 2025 / Jacob Lund - stock.adobe.com

At the American Associated Pharmacies (AAP) Annual Conference, held April 10 to 12 in Austin, Texas, Drug Topics® sat down with Garofoli to discuss effective strategies for balancing excellent patient care with strict regulations surrounding controlled substances, how pharmacists can manage red flags while maintaining a positive patient experience, and key advice for new pharmacists on maintaining professionalism and empathy in high-pressure situations.

READ MORE: Independent Pharmacies Must Be Prepared For DEA Inspections | AAP 2025

Drug Topics: What are effective strategies for balancing excellent patient care with strict regulations surrounding controlled substances?

Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS: First things first, breathe. We in pharmacy, we in healthcare for that matter, there's always a lot going on. There's noise everywhere. Planning ahead goes a long way. You can't plan for everything, but in running a pharmacy, sooner or later, unfortunately, you'll have a patient have an asthma attack. It's worth thinking ahead, “Oh, hey, what are we going to do?” Of course, we know what to do, but how we do it and staying calm along the way really can help that patient there. Thinking ahead, dare we say, scripting it, or storyboarding like Disney does. You can't plan for everything. It comes down to really training people, training teams and leaders how to handle scenarios in the bigger picture—feedback skills, service skills, thinking skills and compassion skills along the way.

Drug Topics: What common DEA red flags should pharmacists be aware of and how can they manage them while maintaining a positive patient experience?

Garofoli: Luckily, the vast majority, if not all pharmacists, are well aware of red flags. We usually say controlled substance red flags, they are detailed to the Nth degree in the most granular version that any of us have ever seen in the relatively recent 2023 National Opioids Settlement. You can actually go to the website, nationalopioidsettlement.com. When you do, you're going to get access to an 800 page document. So, you know, good luck. But within them, they have a very granular listing of what these red flags are. It's not necessarily anything new that pharmacists haven't been educated on. The art is what to do about it.

The big picture is taking red flags—like somebody traveling a larger distance, somebody paying cash, high risk doses, the drug-drug cocktails—and recognizing that they're there. Have the conversations, document it, and oftentimes it comes across as something that's daunting and time consuming, and there's no way around that. But, diving a little bit deeper, it might not be always a 45 minute process. For example, distance from a pharmacy. Maybe it's just where somebody works. That's a 15 second conversation, including all the nice little pleasantries along the way. That's not always the case, but sometimes we have those opportunities along the way. It's really about recognizing them, conversation, document, and go from there.

Drug Topics: What key advice should be given to new pharmacists on maintaining professionalism and empathy in high-pressure situations?

Garofoli: You're going to have your moments, because we're human. We are human, we are adults, we are professionals. We strive to be professional in every aspect of life. Some of it's relatively straightforward and easy. Does somebody have to be a professional to be on time? I think we call it adulting. We all have our stumbling blocks, and just because somebody graduated from pharmacy school, or, quite frankly, medical school or nursing school or physician assistant school, you name it, it's not like, magically, someone says, “Oh, you're good for 40 years.” We're going to continue learning, not just with CE but with experiences along the way. Expect those stumbling blocks.

Always try and remember that you could be wrong or assess the situation incorrectly, because we don't know everyone's story, particularly when you're talking about these tricky situations, or we mentioned red flags. You don't know. It's like an iceberg, not the one from Titanic, but you know, you see what's here, but there's this much underneath, and we all have a story. I'm not telling you my life history here, but you might make some presumptions if it's a tricky situation. It's really just that, pause, and realizing we're going to make mistakes. How we handle ourselves along the way. I believe they call some of this emotional intelligence—lots of books, lots of seminars for everybody about that.

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