FDA

The Compounding Conundrum of Personalized Medicine

It is no wonder personalized medicine has been taking a rise, after all the one size fits all approach seen in manufactured medicine cannot work for everyone. For patients with unique healthcare needs, compounding can be incredibly useful but the catch is these medications do not actually go through a traditional approval process. Why is that important? It means these medications and products have not been reviewed, studied, and evaluated by a third party regulatory entity such as the Food and Drug Administration (FDA).

Compounding is defined as the process of “combining, mixing, or altering ingredients to create medications tailored to the needs of an individual patient”.1 For example, a patient with allergies to certain ingredients in a medication such as a preservative or dye can receive a modified compounded form instead.1 Another example is a patient who may require an alternate dosage form such as a liquid as opposed to a tablet which is especially prominent in pediatric or geriatric populations.1

Access to compounding services are invaluable for some patients, however, vigilance is critically important in this particular field of practice. In the absence of FDA review and approval, guaranteeing the safety, efficacy and quality of these medications can be tricky… so tricky you might even call it a compounding conundrum. The interactable module below outlines common pharmaceutical ingredients used in compounding.3

In 2012, a Massachusetts pharmacy caused more than 750 infections and more than 60 fatalities across 20 states due to fungal contamination.2 This event would lead to passing of the Drug Quality and Security Act (DQSA) which was officially enacted the following year.2 A prior blog post of ours outlined the need for REMS programs and Why We Can’t Be Hasty When It Comes to Drug Safety, the same is particularly true here as patients can be placed in serious harms way when appropriate measures or precautions are not taken in compounding. The following links below assembled by the United States Pharmacopeial (USP) Convention are highly useful in better understanding appropriate standards for compounding and have been linked below for your convenience: 

The FDA also provides a plethora of compounding guidance and resources found here as it is trying to gain a more involved approach given the recent deaths and news from a lack of quality assurance or sterility in compounded products causing patient harm. For example, there is a federal law that specifies a 5% limit on distribution for out of state drugs compounded by pharmacies and physicians under Section 503A of the FDCA. The FDA plans not to enforce this rule until after states sign and finalize the memorandum of understanding (MOU) as ultimately it is under the state jurisdiction and regulation to oversee compounding pharmacies. 

References

  1. U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. Accessed May 6, 2021. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
  2. U.S. Food and Drug Administration. Compounding Laws and Policies. Accessed May 6, 2021. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
  3. Ansel, HC, Loyd VA. Pharmaceutical Dosage Forms And Drug Delivery Systems. 10th ed. Lippincott-Williams & Wilkins; 2014.

Review of new and unique pharmacy careers

Review of new and unique pharmacy careers

It is undeniable that the role of a pharmacist has advanced from the traditional “pill counter” to trusted health care professionals who contribute to patient outcomes through extensive management of drug therapy. According to a published study by the American Association of Colleges of Pharmacy (AACP), the primary practice that PharmD graduates wish to pursue upon graduation is community pharmacy. To outline why this is relevant, the Bureau of Labor Statistics (BLS) anticipates a decline in employment for pharmacists within a traditional retail environment, thus posing a threat to many who wish to follow this route (our full post entitled, “Pharmacist market saturation and career outlook“ can be found here). While all of this may be concerning, pharmacists are fortunately well-equipped with suitable skills that allow them to rise above orthodox practice and pursue nontraditional opportunities while maintaining impactful frontline care. Favorably, the American Society of Health-System Pharmacists (ASHP) has acknowledged this matter and launched its Practice Advancement Initiative (PAI), providing pharmacists with future practice models that may act as an option for those exploring alternative career paths. The campaign advocates for advancing the role of a pharmacist by establishing changes to current pharmacy resources, ultimately promoting career opportunities and patient care simultaneously.

While the number of PharmD graduates continue to increase and advancement of traditional pharmacy begins to slow, you may be asking yourself “what other roles can be filled by pharmacists?” This article will dive into more nontraditional and innovative roles that remain both unique and effective in our dynamic health care world today.

Non-traditional career opportunities:


TypeDescriptionWhere to find information
Nuclear Pharmacy  Nuclear pharmacists focus on the preparation, monitoring, drug information, storage, and handling of radioactive medications. In addition to this, pharmacists in this role provide quality control, patient safety, and counseling to those who require a more unique class of medications. The need for a pharmacist within a nuclear medicine team is impeccable as it allows for a boost in pharmaceutical care to patients.  National Association of Nuclear Pharmacies (NANP)
Specialty PharmacySpecialty medications are typically referred to as high cost medications that focus more on intricate disease states such as cancer, transplant, hepatitis, HIV, and multiple sclerosis. The prevalence of patients who require specialty medication is increasing, thus necessitating an increased demand for specialty pharmacists who can provide comprehensive care and close management.   Due to the increased complexity in the delivery of specialty pharmaceuticals, many health plans have established approaches to help with the obstacles associated with the distribution of these drugs to patients (classified as insourcing and outsourcing):

Insourcing: Staff are hired to manage the high demand and cost of these medications. These pharmacists are responsible for purchasing, handling, educating physicians and patients, and monitoring patient outcomes.

Outsourcing: Contracting with pharmacies that have established specialty pharmaceutical services to access its expertise, technologies, and resources.   Regardless of the approach a managed care organization wishes to pursue, both insourcing and outsourcing have identical requirements that include: Negotiating discounted pricesEmploying staff with specific expertise (with respect to administration, utilization, and monitoring of specialty medications)Accessing centralized distribution points for specialty pharmaceutical manufacturers  
Academy of Managed Care Pharmacy (AMCP)
Veterinary Pharmacy  While veterinary pharmacy is not a new area of pharmacy practice, it is expected to expand each year and become classified as a more unique career opportunity. Veterinary pharmacists may establish a career with veterinary schools, pharmaceutical companies, manufacturers, and a variety of regulatory agencies (including the FDA through the Center of Veterinary Medicine). An individual interested in working with animals may make this a suitable option; however, additional education and training through residency is required and opportunities are limited usually to academic institutions or professional organizations.  Veterinary Pharmacy Association
Compounding Pharmacy  What originally began as physicians taking on both the prescribing and compounding role of patient medication has now evolved to become the responsibility of a pharmacist since the late 19th century. At one point, during the early progression of the 20th century, the manufacturing of mass medications monopolized the service of compounding pharmacies. Today due to the increased need to formulate patient-specific drugs to tailor drug therapy, there appears to be a resurgence in the demand for compounding pharmacists. Compounding services allow pharmacists to prepare medications that target pain management, dermatology, pediatrics, geriatrics, and hormone replacement therapy.  Alliance for Compounding Pharmacy  

APhA   National Community Pharmacists Association
Toxicology  Pharmacists in this role can serve as toxicology specialists within poison control centers. In these centers, they facilitate patients who have ingested or otherwise have been exposed to medications or household chemicals. Pharmacists will direct patients to the proper course of action and will subsequently follow-up with them depending on the severity of the situation.  American Association of Poison Control Centers
   TelepharmacyTelepharmacy aims to meet the needs of today’s healthcare consumers through the use of telecommunication. The application of this tool covers a wide and diverse scope, including drug review and monitoring, dispensing, sterile and non-sterile compounding verification, medication therapy management, patient assessment, patient counseling, clinical consultation, outcomes assessment, decision support, effective drug information, and electronic prescription filling. Telepharmacy technology allows pharmacists to provide communication and remote care delivery. It significantly improves quality of patient care and medication process and safety by increasing accessibility and efficiency through reducing the need to travel. Especially during the ongoing pandemic, telepharmacy has established itself as an attractive tool to positively impact patient outcomes. Individuals who have been tested for COVID-19 could have a consultation with the pharmacist on the phone or video conferencing platforms such as Skype or zoom for follow-up care. Telepharmacy aims to improve U.S. economy and healthcare efficiency.  ASHP’s Statement on Telepharmacy  
2019 NIH Study on Telepharmacy
Regulatory Sciences  Pharmacists also play a huge role in regulatory drug and biologic development at the Food and Drug Administration (FDA). Many pharmacists work at the FDA and if you are lucky, you may score a rotation site at the FDA to learn more what they do from drug labels, to drug reviews and ensuring regulations are met.  FDA Regulatory Fellowships  

Regulatory Affairs Professionals Society (RAPS)  

While additional opportunities may require fellowship training, pharmacists can also be involved within the pharmaceutical industry and strive in research and development, quality assurance, marketing, and regulatory affairs. There are still many other pockets of careers we did not dive into such as medication therapy management (MTM), pharmaceutical industry, consulting, and data analytics, the PharmD degree is versatile and allows the flexibility of pharmacists to create their own unique careers outside the ‘box’ of retail and hospital pharmacy. As health care transforms, pharmacy roles will also grow, allowing pharmacists to take on new and unique roles.

Best of luck in your career searches!

Sam Tamjidi

RxPharmacist Team

References:

  1. 6 Things to Know About Telepharmacy During COVID-19. (n.d.). Retrieved September 26 2020, from https://blog.cureatr.com/6-things-to-know-about-telepharmacy-during-covid-19
  2. ASHP Statement on Telepharmacy. (n.d.). Retrieved September 26 2020, from https://www.ashp.org/-/media/assets/pharmacy-informaticist/docs/sopit-bp-telepharmacy-statement.ashx
  3. Bai, S., Hertig, J. B., & Weber, R. J. (2016). Nontraditional Career Opportunities for Pharmacists. Hospital pharmacy, 51(11), 944–949. https://doi.org/10.1310/hpj5111-944
  4. Kramer, M.H. (2019, January 14). Retrieved September 22, 2020, from https://www.thebalancecareers.com/veterinary-pharmacist-125836
  5. Specialty Pharmaceuticals. (July 18, 2019). Retrieved September 27 2020, from https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/specialty-pharmaceuticals
  6. What is compounding? (n.d.). Retrieved September 22, 2020, from https://www.medisca.com/compounding/what-is-compounding
error: Content is protected !!