All in a day’s work: balancing shortages and breakthrough therapies

Q&A

• Q: How have the challenges you face as a pharmacy leader changed in the past 3-5 years?

  A: The challenges are getting bigger and more complex. The expertise and knowledge required to manage through drug shortages, changing regulations, new medication therapies, and shifting care models are all becoming greater in a rapidly changing environment. In many ways, it’s like drinking from a fire hose every day. You have to be on top of everything because you realise that ultimately you’re affecting patient care. At the same time, it provides a greater opportunity for pharmacy to have a seat at the decision-making table with other healthcare leaders.

• Q: Given the pace and scope of changes you’re facing, what have been your primary focus areas?

  A: We continue to be very focused on drug diversion compliance and surveillance to ensure we continue to exceed the regulatory requirements.

  Drug utilisation is a big focus, in terms of balancing the budget and making sure that we're treating patients with the best, most appropriate medication options available.

  Another big focus is drug shortages. We’re facing another major shortage right now with heparin. For over 10 years now we’ve been in a constant state of battling shortages. It’s become so commonplace and takes so much extra labor that it can negatively impact our ability to focus on strategic priorities. We’re realising the shortage situation is never going to change, so we’re starting to look outside of the hospital at alternative ways to deal with it.

• Q: What’s unique about leading pharmacy at a renowned research-focused hospital?

  A: It’s exciting to be making an impact in so many different areas of both healthcare and pharmacy. We see things on a regular basis that most people may never see in their careers. We’re working more with gene therapies, immunotherapies, and targeted therapies. It’s not just putting potassium in a bag anymore. Ultimately, we want to be part of the disruption—to lead pharmacy innovation and improve patient outcomes. And while there are many facets that make this job challenging, those parts just come with the territory.

• Q: How does Mass General’s clinical trial initiatives influence your daily medication management practices?

  A: Through our clinical trials pharmacy, we’re involved in more than 800 different research studies. This gives us the advantage of seeing the potential impacts of trial therapies earlier, so we can evaluate if we have the capacity to try a new therapy and how we’d manage it once it becomes commercially available.

  Also, we are working to find ways to help patients afford their medications. Drugs are becoming extremely expensive. We added a recently approved drug to the formulary that is the most expensive drug in the world at $2.1 million: Zolgenzma. It’s a gene therapy used for spinal muscular atrophy for pediatric patients. With a drug that expensive, we take extra precautions to assure its overall appropriate use for the patient and preparation.

• Q: What’s your process for introducing, say, a new gene therapy, into your formulary?

  A: After a new therapy is reviewed and approved by our P&T (pharmacy and therapeutics) committee, which is a multidisciplinary team, there are a few considerations we take into account in pharmacy.

  First, we need to be compliant with the USPs (United States Pharmacopeia) and ensure we’re using the drug appropriately and in the proper doses.

  Second, we obviously have to be good stewards of our financial situation.

  Third, traditionally when a drug is in clinical trials, there is a greater potential that it is being prepared by a technician in a research lab than within the pharmacy. Each of these advanced therapies has unique preparation needs. So we need to have the right people with the proper training and the appropriate facilities to prepare these medications for patient use.

  Once we’re satisfied the clinical, financial, and operational requirements are met, we feel we are prepared to take on a new therapy.

• Q: What does the Autonomous Pharmacy mean to you?

  A: I define the Autonomous Pharmacy as one in which pharmacy technicians manage automated, intelligent systems to run the practice of medication storage, preparation, and distribution, taking the human factor out of that completely. In turn, pharmacists are free to focus on the clinical aspects of patient care and also use intelligent systems to improve outcomes.

• Q: In your view, how does the Autonomous Pharmacy change the skill sets needed for pharmacy technicians?

  A: The goal is to have more pharmacists at the bedside working clinically at the top of their license, and to have pharmacy technicians manage pharmacy operations. Unfortunately, there’s a national shortage of technicians right now. So we have to find ways to elevate the pharmacy technician practice and find alternative ways to attract qualified candidates. We need to train them and prepare them for continuous learning so they can proficiently manage the automation—troubleshoot and ensure proper throughput and performance. This will ultimately take pharmacy operations to the next level.