david w. parke ii, md Current Perspective

Ophthalmology and Compounding Pharmacies

ast fall, ophthalmologists were The FDA has long been concerned islation that will give them jurisdic- horrified as more than 500 about the compounding pharmacy tion over “higher-risk” compound- Lpeople developed fungal men- industry. A 2001 study by the FDA re- ing—loosely described as determined ingitis from contaminated steroids vealed that 31 percent of compounded by type of product, amount being compounded at the New England prescriptions analyzed for potency manufactured, interstate shipping, and Compounding Center (NECC). Many were subpotent. Similar studies con- dispensing to a third party. of our fellow ophthalmologists had ducted by state boards of pharmacy The states have not been silent ei- a personal concern as well. They ob- have revealed an alarming prevalence ther. At the time of press, intense regu- tained medications, such as Avastin of errors, with final prescriptions latory scrutiny has led to legislative (bevacizumab), from NECC for intra- ranging from the very subpotent to the activity in 15 states. In early December, vitreal administration. Fortunately, dangerously superpotent. The FDA’s ophthalmology offices in Georgia no infections related to compounded concerns are not limited to drugs for were visited by agents of the Georgia Avastin have been reported in this human use. Franck’s Lab compounded Drugs and Narcotics Agency, focusing case. NECC was shut down, and al- a vitamin supplement administered on whether compounded Avastin was legations surfaced of multiple breaches by injection to polo ponies during the being dispensed pursuant to a patient- in good compounding practice and U.S. Open Polo Championships in specific prescription. Although this sterile technique. Patients died, suits April 2009. After being injected, all 21 apparently did not represent a change were filed, and state and federal legisla- ponies collapsed and died. in regulations, it represented a change tors and regulators vowed action. The compounding pharmacy in- This NECC tragedy followed mul- dustry is complex. Compounding was tiple prior case clusters of endophthal- initially envisioned as the “combining, mitis occurring after intravitreal injec- mixing, or altering of ingredients by a tion of tainted compounded drugs. In pharmacist in response to a physician’s 2005, patients at a Washington, D.C.– prescription to create a medication tai- area Veterans Affairs hospital devel- lored to the specialized medical needs oped endophthalmitis from bacterially of an individual patient.” Only about contaminated trypan blue ophthalmic 7,500 of the approximately 56,000 solution. In summer 2011, over a pharmacies nationwide refer to them- dozen Miami-area patients developed selves as compounding pharmacies, streptococcal endophthalmitis follow- and only about 3,000 compound sterile ing injection of contaminated Avastin products. Of those, only about 180 obtained from a single compound- are accredited by the Pharmacy Com- ing pharmacy. In early 2012, Franck’s pounding Accreditation Board. They Compounding Pharmacy was impli- are generally not regulated by the FDA cated in an outbreak of more than 30 but by state pharmacy boards. cases of endophthalmitis associated In recent months, the issue has with use of two different intravitreal taken on new complexity and urgency. david w. parke ii, md medications. The FDA has recommended new leg- executive vice president/ceo

eyenet 15 Where All of o phthA lmology m eets

in interpretation and enforcement of existing regulations. New OrleaNs For ophthalmologists, while the general framework of the proposed tightening of regulations makes sense, it leaves open to interpretation the is- sue of anticipatory demand. How will we meet the emergent need for antimi- crobials compounded for intravitreal administration in endophthalmitis cases if they are not compounded in advance? Will patients requiring Avas- tin be forced to wait until the com- pounding pharmacy ships the drug upon receipt of a valid prescription in their name? This may not only lead to delay of care but may also increase the burdens of cost and life disruption for patients and families. The American Academy of Ophthalmology has joined with other medical societies to sensi- tize the FDA, states, and Congressional leadership to these issues. Ophthalmology’s concerns are clear. When a physician administers a compounded medication, there must be a very high level of assurance that it is accurately compounded in a process that renders it free from microbial con- tamination and dangerous impurities. sAve the DAte! Existing systems have failed to provide uniformly high protection for patients 2013 AnnuAl meeting November 16 – 19 and their physicians. New standards, subspeciAlty DAy November 15 – 16 regulatory oversight, and product testing must provide that protection. AAoe progrAm November 16 – 19 Concurrently and critically, however, regulations must not restrict the timely availability of medications when they cAll for AbstrActs may be urgently needed. Otherwise, instruction courses December 12, 2012 patients may not receive the care they to January 8, 2013 desperately need.

scientific pApers/ March 13, 2013 FOR ADDITIONAL INFORMATION posters & viDeos to april 9, 2013 Report: Limited FDA Survey of Compound- ed Drug Products. Jan. 28, 2003. www.fda. WWW.AAo.org/2013 gov/Drugs/GuidanceComplianceRegulato ryInformation/PharmacyCompounding/ ucm155725.htm. 2006 Limited FDA Survey of Compounded Drug Products. Updated March 2010. www. fda.gov/Drugs/GuidanceComplianceRegula toryInformation/PharmacyCompounding/ The American Academy of Ophthalmology is accredited by the ucm204237.htm. Accredidation Council for Continuing Medical Education to provide continuing medical education for physicians. Wynkoop K. Compounded Products: Use, Regulation, and Risk. OMIC Digest. Fall 2012.

16 january 2013