The Compounding Controversy

Laura A. Stokowski, RN, MS


July 03, 2013

In This Article

Editor's Note: This article is the first of a 2-part series (see part 2 here) on compounded drugs -- agents that fulfill an important need in patient care -- and compounding pharmacies -- the entities that provide these drugs. This aim of this series is to give clinicians what they need to know to safely procure and use compounded drugs and avoid a public health tragedy, such as the fungal meningitis outbreak of 2012.

Drugs in Ophthalmology

Many of the most important advances in ophthalmology in recent years involve new ophthalmic agents, such as ocriplasmin, aflibercept, and ranibizumab. Ophthalmology practitioners will say that they could not provide the appropriate standard of care for eye diseases today without the ready availability of sterile ophthalmic agents. According to the leading professional organizations for ophthalmology professionals,[1] it is also imperative to have certain ophthalmic drugs on hand in the ambulatory setting. If the ophthalmology clinician was forced to delay treatment while waiting for these preparations, the patient could suffer adverse consequences:

Intravitreal antibiotics for treatment of endophthalmitis, a serious infection of the eye requiring emergent antibiotic intervention. Delayed treatment can result in permanent loss of vision, and even loss of the eye itself.

Fortified topical antibiotics for bacterial corneal ulcers, where delayed treatment can result in corneal perforation, corneal scarring, or partial or complete blindness within a short period.

Intravitreal vascular endothelial growth factor (VEGF) inhibitors (eg, bevacizumab) for emergency treatment of such conditions as neovascular glaucoma, where immediate and aggressive treatment is imperative and delayed treatment can result in complete loss of vision.

Mitomycin C for emergency treatment of failing glaucoma filtration procedures and intraoperative treatment at the time of glaucoma filtration surgery, to prevent fibrosis, scarring, and blindness.

Combination dilating drops for diagnostic use in pediatric patients, in whom it is difficult to give multiple eye drops.

The problem is that some of the agents needed in ophthalmology are not supplied by drug manufacturers in ready-to-use formulations, leaving a potential gap in the ability to provide timely ophthalmic care. Ophthalmology clinicians rely on local and national compounding pharmacies to fill this gap and supply the agents required to treat or prevent eye diseases. Without ready access to a hospital pharmacist, many adult and pediatric ophthalmology specialists depend on these sterile compounded drugs for unanticipated treatment needs.

Of course, ophthalmologists are not the only clinicians who use drugs from compounding pharmacies. For years, many other medical practices, such as ambulatory surgery, orthopedic surgery, and pain management, have relied on compounding pharmacies to supply frequently needed sterile drugs. In this era of drug shortages, some practitioners have turned to compounding pharmacies to supply drugs that have been prepared from nonsterile bulk ingredients, as well.


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