PerspectiveAvastin Doesn't Blind People, People Blind People
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Compounding and Ophthalmology
Compounding drugs for physicians serves a vital function in medicine. Pharmacists routinely are asked to formulate sterile preparations, especially in ophthalmology, when suitable alternatives simply do not exist from pharmaceutical manufacturers because of incompatibilities of drug strength or composition, route of administration, or the need to eliminate potential allergens. However, there are potential serious pitfalls. In 2001, a well-publicized incident in California involved Serratia
United States Pharmacopeia Standards
Before 2004, pharmacies had a long history of well-intended practice standards aimed at improving quality control when compounding sterile preparations.19, 20, 21 Unfortunately, compliance with these voluntary standards was poor.22, 23, 24 Consisting mostly of best practice recommendations, they were not enforceable by federal regulatory agencies such as the FDA. Limited resources and a variable commitment among states to regulate compounding also contributed to lax adherence with these
United States Pharmacopeia Chapter 797: Intravitreal Bevacizumab-Specific Recommendations
An in-depth review of USP <797> is beyond the scope of this paper. Table 1 provides a breakdown of the major sections in the chapter. In addition to the many compounding requirements detailed in the 61 pages of USP <797>, there are recommendations that have specific relevance to bevacizumab. Bevacizumab comes in a sterile solution 25 mg/mL (i.e., 1.25 mg/0.05 mL), so it does not need to be diluted, reconstituted, or altered in any way. The solution just needs to be transferred aseptically into
Selection of Compounding Pharmacy
One of the easiest steps to take when evaluating a compounding pharmacy is to perform an Internet license search of the pharmacy, the pharmacy manager, and its pharmacists. In some states, information is even available about pharmacy technicians. This will help to identify any disciplinary action or infractions filed against a pharmacy by the state board of pharmacy. A quick search on the FDA's web site also may reveal problems with a particular pharmacy.
Another way to protect yourself and your
Bevacizumab is Innocent
It is wrong to condemn bevacizumab for the recent outbreaks of endophthalmitis and vision loss. Based on the information currently available, these episodes seem to be the result of human error, not a direct result of the drug. By strictly adhering to USP Chapter 797 standards, we can ensure the highest quality product for our patients. When comparing the methods used to prepare a syringe of bevacizumab and a syringe of ranibizumab (Lucentis; Genentech/Roche), it should be apparent that the
Serafin Gonzalez, PharmD, is the Director of Pharmacy Services at Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine, Miami, Florida. He received his doctoral degree in Pharmacy from Nova Southeastern University and worked as a Clinical Pharmacist at Doctors’ Hospital in Coral Gables prior to joining Bascom Palmer in 1999. A specialist in ophthalmic compounding, he was the first to compound bevacizumab for intraocular injection and his protocol is currently used
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Cited by (82)
Clinical manifestations of intravitreal bortezomib injection
2020, American Journal of Ophthalmology Case ReportsCitation Excerpt :Unfortunately, these five cases do not represent the first time bortezomib has been injected in place of bevacizumab. The similarity in the names of the two drugs caused a similar compounding error that blinded six people in Portugal in 2009.9 When a drug is drawn up and repackaged into syringes for injection at a later time, well thought out protocols must be strictly adhered to with careful reading of all vial and syringe labels, especially if similar sounding names exist for multiple drugs.
Lessons Learned From Avastin and OCT–The Great, the Good, the Bad, and the Ugly: The LXXV Edward Jackson Memorial Lecture
2019, American Journal of OphthalmologyCitation Excerpt :He had been compounding drugs for off-label intravitreal use in ophthalmology for years, and these drugs included antibiotics, steroids, and another Genentech product known as tissue plasminogen activator. After reviewing federal guidelines and Chapter 797 of the US Pharmacopeia (USP), he said that it was legal and safe, as long as strict guidelines were followed.28 My chairman, Carmen Puliafito, approved the compounding of bevacizumab for intravitreal injection and permitted my off-label use intravitreal bevacizumab as salvage therapy only in patients losing vision, only after they had failed routine clinical care—in other words, only after the approved therapies were tried.
Estimating Medicare and Patient Savings From the Use of Bevacizumab for the Treatment of Exudative Age-related Macular Degeneration
2018, American Journal of OphthalmologyProphylaxis measures for postinjection endophthalmitis
2020, Survey of OphthalmologyA real-world disproportionality analysis of anti-VEGF drugs from the FDA Adverse Event Reporting System
2024, Expert Opinion on Drug Safety
Serafin Gonzalez, PharmD, is the Director of Pharmacy Services at Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine, Miami, Florida. He received his doctoral degree in Pharmacy from Nova Southeastern University and worked as a Clinical Pharmacist at Doctors’ Hospital in Coral Gables prior to joining Bascom Palmer in 1999. A specialist in ophthalmic compounding, he was the first to compound bevacizumab for intraocular injection and his protocol is currently used worldwide.
See Accompanying Article on page 204.