Q: As both President of the Alliance for Pharmacy Compounding as well as an owner of a compounding pharmacy, what are you seeing lately in the world of pharmacy compounding?
It is really an interesting time in the world of pharmacy compounding. The demand and need for pharmacy compounding continues to grow, and compounding pharmacies are doing a great job to fulfill the needs of our providers and patients. The biggest challenge our profession is facing is keeping up with the constantly evolving standards, rules, and other regulations. While compounding pharmacists and their teams have done a great job in rebuilding their pharmacy labs to keep up with these standards, we are now seeing that these standards will constantly change. This constant change can be a challenge for a pharmacy to keep their pharmacy labs compliant and in turn, continue to compound preparations in a timely manner and at an affordable price to the patient.
Like every other profession, COVID-19 has impacted compounding pharmacies as well as vendors and wholesalers that supply to the pharmacies. However, the pandemic served as an excellent marker for how a 503A compounding pharmacy can offer aide to the healthcare space. Specifically, we worked with Congress, FDA, State Department of Health and Boards of Pharmacy to compound and deliver some of the drug shortage medications for our health systems. This was an amazing moment in that both the public and private entities quickly and efficiently worked together to provide medications necessary to treat COVID that were on the FDA shortage list until the pharmaceutical manufacturers were able to ramp up their production. It was great to see that 503A pharmacies, the state regulators, DEA, FDA, and Congress work together to help provide these products when patients needed them the most.
Q: What examples are you seeing that perhaps interrupt patient access to compounds?
One example is that the FDA is proposing a Memorandum of Understanding (MOU) with the boards of pharmacy and or state legislatures to report compounding pharmacy activities on behalf of FDA. What compounders are concerned about is that this is an unfunded mandate and the states will more than likely opt out - restricting pharmacies to ship only less than 5% of their products across state lines. Obviously, this is a huge concern for many pharmacies that are licensed in multiple states, and especially for those pharmacies that are located at a border with an adjacent state, and have a good number of patients in both states. Another example is more rural states which may not compound certain drugs or have the equipment required that pharmacies in other states specialize in. The patients in that rural state are succumbed to only what their state pharmacies have to offer.
Q: What can compounding pharmacists do to help ensure that patient access isn’t interrupted?
There are three major actions compounding pharmacists and their pharmacy team can take to ensure their patients maintain access to compounded medications.
First, make sure that compounding pharmacies strive for best practices, with the goal of formulating preparations to the highest standards of quality and safety. We’re constantly reminded of what transpired with NECC over 8 years ago, and everyone is responsible to ensure this never happens again.
The second is to join a pharmacy organization. Being a member of organizations like Alliance for Pharmacy Compounding provides pharmacy professionals the latest in regulations and rules, but is also a sounding board and advocate voice to provide feedback on the consequences of current and proposed rules.
The third action that a pharmacist and their team can take is to be engaged with their state Congressman and local government officials. Inviting a Congressman to their pharmacy for a tour and explanation of their operations gives the Congressman first-hand experience on what role pharmacy compounding plays for the community. It allows them to see inside a pharmacy compounder’s world and how they are serving patients in that Congressman’s valued area. It is best to have compounding pharmacists dictate the future of their profession rather than somebody else dictate it for them, and to have the support of your Congressman and local officials is crucial in ensuring the profession maintains strength and support.
Q: Looking forward, how do you see compounding pharmacies combat COVID?
The pandemic is a perfect example of how compounding pharmacists can take on a greater role for their profession and as the “drug experts”. Specifically, compounding pharmacists and the profession of pharmacy as a whole, have access to drug information resources, education, and drug knowledge. Pharmacists can give patients an unbiased view of which supplements or medications can support healthy immune systems and aide in the fight against coronaviruses and other infectious diseases. And although the data isn't perfect, it is adequate for a pharmacist to offer recommendations based upon their professional judgment. There is quite a bit of inaccurate intel floating around the internet and social media platforms. Unfortunately, patients are acting upon that inaccurate information, resulting in unsuccessful treatment plans or even possible harm to themselves. As pharmacists, we're accustomed to being worthy stewards of drug information, and it's our job to advise the healthcare community about the appropriate therapies available to help them manage patients.
Looking forward, there are opportunities for pharmacists to administer vaccines, for prevention of COVID and other viruses. There will undoubtedly be additional testing available and pharmacists are more than capable of administering those tests to patients in their communities. Now is the time for pharmacists to arm themselves with those skill sets and be prepared to take on these patient needs and demands.
Q: What other opportunities are available for compounding?
Although it's challenging to look forward as we're navigating through our current pandemic, we think there are a plethora of opportunities for compounding pharmacists. As mentioned before, we talked a little bit about point of care opportunities with respect to COVID. Also in this new environment, telepharmacy will play a greater role to continue patient access to compounds. In addition, there is an opportunity to partner with pharmaceutical companies who are looking to find a pharmacy to compound medications in clinical trials. It's a model that a few pharmacies used in the past, but now we're starting to see more of a need for pharmacy-pharma partnerships to supply products for drug studies.
In the not-so-distant future, enveloping a 3D printing model into compounding will help produce high-quality products using a level of precision never seen before. That’s an area that is fascinating and we can’t wait to see this model come to fruition.
Q: Do you think the future is bright for pharmacy compounding?
Absolutely! I think one of the most intriguing things about our profession is that we can constantly reinvent ourselves to fulfill our patients’ needs. Many compounding pharmacies are providing products today that weren’t necessarily at the forefront of our minds a few years ago. On the flip side, some of the products that we provided years ago are no longer available today. I think that's what's so interesting and fascinating about compounding is that we have the ability to adjust to what our patients, providers, and healthcare community needs.
Along those same lines, we're also seeing pharmacies get more specialized. Some pharmacies are adjusting their practice models to focus on compounding a smaller portfolio of compounds as opposed to being the jack-of-all-trades. For example, certain compounding pharmacies may provide only animal health products, or only eye care products, or only provide sterile injectables. I believe if pharmacies and pharmacy owners adopt the principle that, “The only constant in life is change itself”, they are in a much better position for a successful future. And that future is bright!
Q: What would you say to perhaps a reader that is a pharmacy student? Would you recommend that they consider a career in pharmacy compounding?
I think every pharmacy student should look at pharmacy compounding as a career option. Pharmacy compounding really encapsulates all that pharmacy has to offer and so many opportunities to use their pharmaceutical sciences background. Compounders support prescribers in a clinical setting by advising on unique strengths and dosage forms. We work under a collaborative practice arrangement to modify therapy, tailored to each patient’s unique needs. Compounders deep dive into pharmaceutical science by understanding the kinetics and dynamics of drugs, the chemical structures and properties of the medications, and math and calculations equations that support the compounded preparation. All these factors are used to formulate the best pharmaceutical compound which is then used for a patient’s specific condition. It’s a constant challenge, but we love it!
Shawn Hodges, PharmD, President/CEO, Innovation Compounding, Inc and President, Alliance for Pharmacy Compounding
Dr. Shawn Hodges graduated with a Doctorate in Pharmacy from Texas Tech University School of Pharmacy in 2001. Upon graduation he was awarded a one-year, fellowship program with Eli Lilly, focusing on the drug approval process. Upon completion of the fellowship, Shawn has practiced pharmacy in a community setting and worked as a Regional Director for the nation’s largest hospice pharmacy provider.
Currently, he is a pharmacist and owner of Innovation Compounding, a compounding-only pharmacy located just outside of Atlanta that employees 39 pharmacy team members. Shawn also consults both practitioners and their patients on men’s health, women’s health, and pain management.
Also, Shawn serves as the President for the Alliance for Pharmacy Compounding’s (APC; formerly IACP). On January 1, 2020, Shawn assumed the Presidency position. APC is a non-profit, advocacy/regulatory heavy organization that represents thousands of pharmacy compounders. On a personal note, Shawn, his wife and daughter reside in Marietta, GA. They enjoy rafting, running, riding their horse Pockets, and spending time on the trails of Kennesaw Mountain.