Unknown Risks of Pharmacy-Compounded Drugs

Larry D. Sasich, PharmD, MPH, Chair;                      

1. Sana R. Sukkari, BScPharm, MPhil, Assistant Professor

+ Author Affiliations

1. Department of Pharmacy Practice
2. Department of Pharmacy Practice, School of Pharmacy, Lake Erie College of Osteopathic Medicine, Erie, Pa

 

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To the Editor: In August 2006, the United States Food and Drug Administration (FDA) announced that warning letters had been issued to three pharmacies that were producing and distributing thousands of doses of compounded inhalation medications not approved by the FDA.¹ These inhalation medications were used to treat patients with such respiratory diseases as asthma, bronchitis, cystic fibrosis, and emphysema.¹

Pharmacy compounding traditionally involves such practices as manipulating an FDA-approved dosage form, such as a tablet or capsule, to prepare a solution or suspension for individual patients who have difficulties in swallowing.² Traditional pharmacy compounding may also involve preparing an FDA-approved medication excluding a specific ingredient to which an individual patient may have a hypersensitivity.² The FDA permits such traditional practices by pharmacies.

By contrast, nontraditional practices of pharmacy compounding—such as those that prompted the FDA warnings—include the mass production of drug combinations from bulk substances that are sometimes of unknown origin.¹ These drug combinations may be exact copies or slightly modified versions of FDA-approved pharmaceutical products.² The FDA has expressed concern that such nontraditional practices of pharmacy compounding may expose patients to unnecessary health risks.^1,2

The true extent of nontraditional pharmacy compounding in the United States is unknown. However, the FDA and many state public health authorities have expressed serious concerns about quality and safety issues regarding compounded inhalation drugs.^2,3 For example, minutes from the May 2007 meeting of the Ohio State Board of Pharmacy reveal disciplinary action against one pharmacy-compounding facility.³ According to our calculations based on numbers provided in these minutes, between July 2005 and November 2005, the pharmacy in question compounded and dispensed 119 prescriptions for an estimated 7530 doses of inhalation medications, including five different drug-combination products.³ Two of the five compounded products were identical to FDA-approved medications, while three were unapproved combinations.³ Of the seven drug substances that were used to produce the combinations, five were available as FDA-approved inhalation medications, while two (betamethasone and dexamethasone) were not.³ 

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