On Compounding Pharmacies

On Compounding Pharmacies

The art of pharmacy is an ancient one - when pharmacy was in its infancy, pharmacists not only dispensed medicines and remedies, but prepared them and offered medical advice, too. As medical science advanced and changed, however, so did the role of a pharmacist. Today, drugs are most often manufactured in FDA-certified facilities, where they are produced as identical, perfectly homogenous tablets or pills. Still, the early origins of pharmacy persist today in “compounding pharmacies”, where modern-day apothecaries mix up their own concoctions, creams, and ointments to tailor a drug to a patient’s distinctive clinical necessities.

The main benefit of compounding pharmacies comes from the ability to customize a treatment. Take for instance a patient who cannot swallow tablets due to a medical condition. Consider if this person were to develop a disease which has a singular, completely efficient oral treatment (e.g. take one tablet twice daily). Due to his inability to take oral medication, this would be impossible for him to do. Compounding pharmacists can alter the form of this medication, for example converting it from a tablet to a cream, so that the patient could receive the pharmaceutical dose he needs.[1] Compounding pharmacists can further change the form of pediatric medications to include “lollipops, lozenges, or popsicles” to facilitate treatment and ease therapies. [2]

But what about regulation? The “FDA approval process” applies to drugs produced by manufacturers, but notably not to pharmacist-prepared treatments. Gudeman et al. note that the “regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs”.[3] In fact, of the approximately 7,500 compounding pharmacies in the United States, only about 2 percent have been accredited,[4] a costly process that ensures pharmacies are up-to-par in terms of sterility, drug preparation, and patient education.

In the same vein, the production of drugs in compounding pharmacies is not subject to the same regulations as manufacturing of FDA-approved drugs. FDA-approved drugs are “manufactured under good manufacturing practice regulations (GMPs), which are federal statutes that govern the production and testing of pharmaceutical materials” (Emphasis added).[5] Compounding pharmacies are exempt from these same regulations, and “only undergo FDA inspections in rare instances”.[6] As a result, there is a risk that compounding pharmacies will use improperly calibrated or incompletely sterilized equipment.

While compounding pharmacies at the core are ideal for a singular patient’s idiosyncrasies, often times – in an attempt to exploit a business opportunity – a devious compounding pharmacy can produce batch orders of a “unique” concoction. These decisions can have devastating consequences for patients. In one notable case in 2012, physicians chose to obtain sterile methylprednisolone acetate injections for invasive diagnostic procedures from the New England Compounding Center (NECC) to lower costs[7]; unfortunately, over the course a few months, improperly sterilized batches were sent to 18 states. The latest CDC report notes that 753 patients have been affected by these suspect drugs, including 64 deaths.[8] A subsequent FDA inspection determined that the supposed “sterile” vials were not sterile at all, and that the NECC sterilization process was ineffective.[9]

There have been multiple other examples of contaminated compounded drugs in the literature: a 2001 outbreak of meningitis resulting in three deaths after patients received betamethasone injections contaminated with bacteria; in 2002, one woman died from and three others contracted meningitis from a steroid injection contaminated with a fungus; and in 2014, a contaminated fentanyl infusion caused infections in seven patients.[10]

Another potential problem with compounding pharmacies is the nature of reporting “adverse events”, such as the previously described infections. While it is a requirement to report errors that affect batches of an FDA-regulated drug, compounding pharmacies are not legally bound to report adverse events to the FDA.[11] This means that unless a major outbreak occurs, such as those previously mentioned, a ‘bad batch’ might not be reported and the defective production technique not rectified.

Despite the advantages that compounding pharmacies provide, I believe they must be used sparingly. While I do not advocate a total ban of such pharmacies because they do provide improved, necessary care and delivery of pharmaceutical interventions for the few patients that require them, I do believe that compounding pharmacies should be regulated more closely.

References:

[1] “What Is Compounding? - PCCA - Professional Compounding Centers of America,” accessed September 18, 2017, http://www.pccarx.com/what-is-compounding.

[2] John H. Perrin, “Pediatrician and Compounding Pharmacist: A Dangerous Liaison,” Archives of Pediatrics & Adolescent Medicine 150, no. 2 (February 1, 1996): 224–26, doi:10.1001/archpedi.1996.02170270106020.

[3] Jennifer Gudeman et al., “Potential Risks of Pharmacy Compounding,” Drugs in R&D 13, no. 1 (March 1, 2013): 1–8, doi:10.1007/s40268-013-0005-9.

[4] Sarah Kliff and Lena H. Sun, “Critics Charge That Drug-Compounding Pharmacies Require Government Oversight,” Washington Post, October 18, 2012, sec. Health & Science, https://www.washingtonpost.com/national/health-science/critics-charge-that-drug-compounding-pharmacies-require-government-oversight/2012/10/18/7b726132-17d8-11e2-9855-71f2b202721b_story.html.

[5] Gudeman et al., “Potential Risks of Pharmacy Compounding.”

[6] Ibid.

[7] Lucy E. Wilson, David Blythe, and Joshua M. Sharfstein, “Fungal Meningitis From Injection of Contaminated Steroids: A Compounding Problem,” JAMA 308, no. 23 (December 19, 2012): 2461–62, doi:10.1001/jama.2012.47932.

[8] “Multistate Outbreak of Fungal Meningitis and Other Infections | HAI | CDC,” accessed September 18, 2017, https://www.cdc.gov/hai/outbreaks/meningitis.html.

[9] “Food and Drug Administration Inspectional Observations (Form 483) New England Compounding Center,” n.d., https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm325980.pdf.

[10] Gudeman et al., “Potential Risks of Pharmacy Compounding”; “Exophiala Infection from Contaminated Injectable Steroids Prepared by a Compounding Pharmacy -- United States, July--November 2002,” accessed September 18, 2017, https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5149a1.htm; Rebekah W. Moehring et al., “Outbreak of Bacteremia Due to Burkholderia Contaminans Linked to Intravenous Fentanyl From an Institutional Compounding Pharmacy,” JAMA Internal Medicine 174, no. 4 (April 1, 2014): 606–12, doi:10.1001/jamainternmed.2013.13768.

[11] Gudeman et al., “Potential Risks of Pharmacy Compounding.”

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