Compounding pharmacies play important role in ophthalmic care

Ophthalmologists have several sources for the drugs they prescribe to treat their patients. First, there are the so-called branded proprietary patented drugs protected by nonexpired intellectual property typically manufactured and sold by a major strategic pharmaceutical company. Good examples in ophthalmology would be the branded antibiotics Vigamox from Alcon/Novartis and Besivance from Bausch + Lomb. These drugs have completed successful clinical trials confirming safety and efficacy resulting in FDA approval and specific labeling for their FDA-approved indications. They are available through a prescription written by a licensed provider for an individual patient and usually obtained at a local or mail-order pharmacy. When the patient has health insurance and has met his or her deductible, a significant portion of the costs are usually covered by third-party payers. The cost to navigate the FDA approval process for a branded pharmaceutical drug ranges from $500 million to as much as $2 billion just for approval. Significant human and financial capital is also expended to launch these products, educate doctors on their use and promote adoption.As practitioners, we know we can use these drugs in our patient’s best interest either “on label” or “off label,” but the manufacturer can only promote their use on label. Once branded drugs’ patents expire, the original manufacturer can continue to make and sell the drug, and then these drugs are typically called branded generics. In addition, other generic pharmaceutical manufacturers can produce the drug with “equivalent” active ingredients to the prior approved product at the same concentration. These so-called generic drugs can have different bottles, different vehicles, different preservatives and different buffers, but they must have identical concentrations of the active ingredient.