If a compounding pharmacy is in the news, it's usually not for a happy reason. It probably doesn't come as a huge surprise that by nature of working with so many pharmaceuticals, compounding pharmacies can create big problems if their medicine is incorrect or contaminated.
One tragic example is the meningitis outbreak of 2012. One of the main issues of the case was that the company, the New England Compounding Center, was supposed to only create prescription medication for individuals. Instead, the company appears to have been making large quantities of its products and shipping them around the country. That means that the steroid injections that were contaminated were not limited to one patient, or even a few regionally. In fact, the company had shipped a whopping 17,676 vials of the stuff to 23 states [sources: Grady, Tavernise and Pollack]. Remember that each prescription is supposed to be made for one specific patient, so making compounds blindly in bulk (like our prepackaged apple pies) is illegal. And it's not the first time these pharmacies have been linked to contaminated medicines.
Compounding pharmacies don't have the same FDA regulations as pharmaceutical companies, so no one was monitoring the safety of the injections -- it was only after the outbreak occurred that the pharmacy was investigated. Which means that the New England Compounding Center had basically made itself into a drug manufacturer without the hassle of large-scale oversight. (If you're curious to hear more about the regulation surrounding these entities, read "Are compounding pharmacies regulated?")
Of course, that assumes that giant pharmaceutical companies don't have issues. One reason some advocate for compound pharmacies is that they avoid the cost of Big Pharma by using more inexpensive generics in mixtures. Sonia Gale, a pharmacy director in Washington state, says that lately insurance prices are creeping up on compounded prescriptions, however, as insurers ask pharmacies to charge on not just active ingredients, but on any inactive ingredients in compounds as well.
Some also argue that compounding pharmacies help patients seek out more natural forms of medication. For example, progesterone is a naturally occurring hormone that can't be patented by drug companies. Drug manufacturers instead patent Premarin and distribute it widely. Only issue? Their close-to-progesterone alternative is actually made from horse urine. If you're not into mare pee, a compound pharmacy can synthesize a generic alternative through a natural, plant-based method instead.
Whether you see compounding pharmacies as a good alternative to Big Pharma or a risky choice, read on for lots more information.
Author's Note: What's a compounding pharmacy?
Before compounding pharmacies were in the news, I had no idea that one of the biggest pharmacy retailers in our town compounded. Although I was initially skeptical about the point of compounding pharmacies, I've come around to see that there can be a benefit to a custom-made alternative to Big Pharma. Especially when my alternative is horse urine.
- The Associated Press. "Calls to regulate specialty pharmacies." SFGate.com. Oct. 14, 2012. (Oct. 19, 2012) http://www.sfgate.com/business/article/Calls-to-regulate-specialty-pharmacies-3948141.php
- The Associated Press. "FDA regulation of pharmacies has knotty history." National Public Radio. Oct. 12, 2012. (Oct. 19, 2012) http://www.npr.org/templates/story/story.php?storyId=162801940
- The Associated Press. "The brothers-in-law at the heart of the meningitis outbreak." NBCNews.com. Oct. 14, 2012. (Oct. 19, 2012) http://vitals.nbcnews.com/_news/2012/10/14/14434211-the-brothers-in-law-at-the-heart-of-the-fungal-meningitis-investigation
- Begley, Sharon. "Insight: How compounding pharmacies rallied patients to fight regulation." Reuters. Oct. 16, 2012. (Oct. 19, 2012) http://www.reuters.com/article/2012/10/16/us-usa-health-meningitis-compounding-idUSBRE89F05Y20121016
- Gaffney, Alexander. "Meningitis outbreak places spotlight on FDA's regulation of compounding pharmacies." Regulatory Affairs Professional Society. Oct. 5, 2012. (Oct. 19, 2012) http://www.raps.org/focus-online/news/news-article-view/article/2356/meningitis-outbreak-places-spotlight-on-fdas-regulation-of-compounding-pharmaci.aspx
- Gale, Sonia. Pharmacy Director (PharmD). Personal interview. Oct. 17, 2012.
- Grady, Denise; Tavernise, Sabrina and Pollack, Andrew. "In a drug linked to a deadly meningitis outbreak, a question of oversight." The New York Times. Oct. 4, 2012. (Oct. 19, 2012) http://www.nytimes.com/2012/10/05/health/news-analysis-a-question-of-oversight-on-compounding-pharmacies.html?_r=0
- International Academy of Compounding Pharmacists. "Web site." 2012. (Oct. 19, 2012) http://www.iacprx.org/
- Johnson, Carolyn Y. and Lazar, Kay. "A close look at compounding pharmacies." The Boston Globe. Oct. 15, 2012. (Oct. 19, 2012) http://bostonglobe.com/metro/2012/10/14/meningitis-outbreak-focuses-attention-niche-compounding-pharmacy-business/dapSiH7vHO4w7PrpZfgeOM/story.html
- Pharmacy Compounding Accreditation Board. "Web site." 2012. (Oct. 19, 2012) http://www.pcab.org/
- Pittman, David and Smith, Michael. "Compounding Pharmacies: Where's the Oversight?" MedPage Today. Oct. 12, 2012. (Oct. 19, 2012) http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/35294