How Quality Compound Pharmaceuticals Can Help Meet Patient Needs During Drug Shortages
For patients in need of quality medications to treat injuries, pain, chronic conditions or general maladies, it can be hard to believe that the country’s supply of necessary drugs could run low. Since the early 2000s, however, drug shortages have been especially prevalent and problematic, often leaving health care providers scrambling to help patients get the care they need. In the increasingly common event of an important drug suddenly in short supply, compounding pharmacies and compound pharmaceuticals have a crucial role to play in alleviating the patient impact of drug shortages.
The U.S. Department of Health and Human Services estimated that since the early 2000s, shortages of key anesthetic, analgesic, cardiovascular and anti-infection drugs have almost quadrupled. The U.S. Government Accountability Office also reported last year that national drug shortages were two and a half times shortage levels from 2007. The Food and Drug Administration has been working proactively prevent drug shortages, including passing Title X of the FDA Safety and Innovation Act in 2012 which requires more notifications to help the FDA get ahead of issues. The FDA also recently released an app designed to help keep stakeholders in the drug supply chain, from manufacturers to compound pharmacists to health care providers, more informed about shortages and regulations. However, in the complex environment of drug manufacturing, supply, demand, patents and approvals, the availability of specific drugs can be difficult to project and shortages hard to diagnose.1
Shortages can occur when there simply isn’t enough of the drug being manufactured to meet patient demand, which can happen when there is an increase in demand or an interruption in supply for a key ingredient. Drug shortages can also occur when patents expire, lowering the incentive for some pharmaceutical companies to continue manufacturing the drug due to reduced profitability.2
Ways Compounding Pharmacies Can Combat Drug Shortages
There is no debate that drug shortages can severely and adversely impact patient care. Drug storage must be so tightly managed at every stage of the drug supply chain that oftentimes a facility’s first notification that a drug is in short supply is when an expected shipment is delayed or put on indefinite backorder, leaving the facility scrambling. In this situation, compound pharmaceuticals can play a key role in providing quality patient care. Compounding pharmacies can assist with achieving the same results as off-patent or short-supply medications, and much more cost-effectively.
In a 2012 interview with MedPage Today, Chair of Communications for the American Society of Anesthesiologists (ASA) and Director of the Washington Pain Clinic John Dombrowski, M.D., said, “Compounding pharmacies have fit a niche in terms of getting medication to patients.”
In the same article, Steven Gayer, MD and professor of anesthesiology at the University of Miami, also agreed that when critical drugs run short, for most health care providers, “the correct answer is to find a compounding pharmacy.”3
Additionally, the Association of State and Territorial Health Officials released a guidebook for providers in 2012, listing “Utilize Compound Medications” as one of its top three strategies in a Drug Shortage Mitigation Algorithm. The drug shortage issue remains acute, raising the stakes for health care providers to implement mitigation plans to ensure patients can continue receiving the care and treatments they need.4
For some hospitals and clinics, creating compound pharmaceuticals in-house can also be a potential solution. In these situations, however, it’s important that the facility be fully prepared for in-house compounding, including the proper equipment, personnel, training, quality control measures and a full understanding of the guidelines surrounding sterile and non-sterile compound preparations. For many facilities, the additional overhead in materials, compounds, personnel, training and storage can make in-office compounding challenging. Since most medications are compounded to meet specific patient orders and administered quickly, developing a relationship with a high-quality, reputable compound pharmacy or provider of active pharmaceutical ingredients can help facilities with efficient storage and supply.5
As with any use of any medication, compounded or not, monitoring by medical professionals and only working with reputable, accredited compounding pharmacies and compound suppliers is the key to making compound pharmaceuticals a viable option during drug shortages. With compounding pharmacies coming under increased scrutiny following the 2012 meningitis outbreak, where poor quality control by a single compounding pharmacy and breakdowns in the process led to unprecedented patient risk, facilities and compounding pharmacies need to work together to ensure the entire process is governed by strict quality controls and procedural integrity. Forging a strong relationship with a compounding pharmacy to create compound pharmaceuticals can help health care providers fulfill their ultimate mission of quality patient care even during increasingly common shortages of critical drugs.6
Pharmaceutica North America is the premier provider of high-quality active pharmaceutical ingredients compounding pharmacies and other health care providers trust. Contact us to learn more about our custom compounding kits, bulk APIs or additional products, and how our products can assist compounding pharmacies and health care providers during drug shortages.
- “Drug Shortages,” Aug. 11, 2015, http://www.fda.gov/Drugs/DrugSafety/DrugShortages/; “U.S. Drug Shortages Frustrate Doctors, Patients,” May 31, 2015, http://www.wsj.com/articles/u-s-drug-shortages-frustrate-doctors-patients-1433125793 ↩
- “Coping with and Mitigating the Effects of Shortages in Emergency Medications,” Dec. 2012, http://www.ems.gov/pdf/2013/ASTHO_Shortages_of_Emergency_Meds.pdf; “Unraveling the complexity of compounding drug shortages,” Feb. 1, 2013, http://www.pharmacist.com/unraveling-complexity-compounding-and-drug-shortages ↩
- “Drug Shortages Spark Use of Compounders,” Oct. 18, 2012, http://www.medpagetoday.com/MeetingCoverage/ASA/35406 ↩
- “Coping with and Mitigating the Effects of Shortages of Emergency Medications,” ibid. ↩
- “The Drug Shortage Crisis in the United States: Causes, Impact and Management Strategies,” Nov. 2011, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278171/ ↩
- “Drug shortages spur debate over role of compounding pharmacies,” April 3, 2013, http://www.modernhealthcare.com/article/20130403/NEWS/304039965 ↩