Counterfeit Avastin in India: Punish the Criminals, Not the Patients

Abstract Purpose To report the recent controversy surrounding the intraocular use of bevacizumab in India and its relationship to the broader problems of off-label drug use, medication compounding, and drug counterfeiting. Design Perspective Methods Data for this perspective was obtained from severa...

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Bibliographic Details
Published in:American journal of ophthalmology 2016-10, Vol.170, p.228-231
Main Authors: Stewart, Michael W., MD, Narayanan, Raja, MD, Gupta, Vishali, MD, Rosenfeld, Philip J, Martin, Daniel F., MD, Chakravarthy, Usha, MD
Format: Article
Language:English
Subjects:
Angiogenesis Inhibitors - adverse effects
Bevacizumab - adverse effects
Counterfeit Drugs - adverse effects
Counterfeit Drugs - supply & distribution
Counterfeiting
Criminals
Criminals - legislation & jurisprudence
Diabetes
Diabetic retinopathy
Drug and Narcotic Control - legislation & jurisprudence
Drug Compounding
Drug dosages
Edema
Endophthalmitis - chemically induced
Endophthalmitis - microbiology
Epidemics
Eye Infections, Bacterial - chemically induced
Eye Infections, Bacterial - microbiology
Fraud
Funding
Humans
India
Intravitreal Injections
Off-Label Use
Ophthalmology
Patient safety
Patient Safety - legislation & jurisprudence
Pharmaceutical industry
Prescription drugs
Vascular endothelial growth factor
Vascular Endothelial Growth Factor A - antagonists & inhibitors
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Summary:Abstract Purpose To report the recent controversy surrounding the intraocular use of bevacizumab in India and its relationship to the broader problems of off-label drug use, medication compounding, and drug counterfeiting. Design Perspective Methods Data for this perspective was obtained from several sources. Literature reviews for compounding-related endophthalmitis and drug counterfeiting were performed. Supplemental information was obtained through targeted Google searches for related published manuscripts. First-hand accounts of negotiations between representatives of the Vitreoretinal Society of India (VRSI) and India’s Central Drugs Standards Control Organization (CDSCO) were provided by two of the authors (RN, VG). Results In December, 2015, 15 cases of intraocular inflammation following injections of counterfeit bevacizumab occurred in Gujarat, India. CDSCO reacted by prohibiting the use of intraocular bevacizumab throughout the country. Intense negotiations between the VRSI and CDSCO resulted in the permission to use bevacizumab in accordance with new safety guidelines. These include an enhanced informed consent process, the stamping of the Kezzler code on all bevacizumab vials, a real-time digital verification process between the end-user and Roche Pharmaceuticals, and mandatory destruction of empty drug vials. Conclusion Counterfeit bevacizumab has caused outbreaks of sterile and infectious post-injection endophthalmitis in at least three countries during the past 5 years and has entered the supply-chain in other countries. Physicians and compounding pharmacists need to be aware that international counterfeiters have targeted bevacizumab.
ISSN:0002-9394
1879-1891
DOI:10.1016/j.ajo.2016.05.023