Samples, Branded Products, Generic Formulations, Oh My
BY LEO SEMES, OD, FAAO
Samples are typically available only for proprietary formulations that are still patent-protected. We all know the appropriate uses of samples. Similarly, each of us has an obligation to do what is in the best interest of each patient. Selecting an appropriate medication is increasingly challenging. Let’s look at some forces shaping this environment.
Any drug manufacturer desiring to bring a pharmaceutical product to market must receive U.S. Food and Drug Administration (FDA) approval. That process is tedious, time-consuming, and costly. As we are all aware, patent protection is intended to allow manufacturers to recover the costs involved and to generate a profit. At the conclusion of patent protection, a generic manufacturer may apply to the FDA using an abbreviated new drug application. Ophthalmic drugs must contain the same concentration and active ingredient(s) as the original. This is a much lower standard compared to that for oral medications, which must demonstrate bioequivalence (FDA, 2015).
The Same but Different
For example, 1% prednisolone acetate ophthalmic suspension is available in both branded and generic forms. According to the FDA, the generic version could have 99% of the other-than-active ingredients different from the original formulation. A more extreme example is 0.005% latanoprost ophthalmic solution. The generic solution may contain 99.995% ingredients different from the original formulation.
The Right Prescription
There is a yin and yang to generics. Today’s insurance coverage, a shrinking generic manufacturing pool (Barlas, 2014; Fuquay, 2014), and concerns over efficacy (Zore et al, 2013) make ophthalmic pharmaceutical prescribing vexing. What the FDA has done is to distinguish ophthalmic pharmaceuticals from orals based only on specification and not on performance. The task of determining effective performance then lies with us. For instance, does a patient’s managed care plan allow the branded product that we feel is in the patient’s best interest at an “affordable” co-pay tier?
One way to determine this is using Fingertip Formulary (www.fingertipformulary.com). Beginning with the drug name and followed by your state jurisdiction, you can view a spectrum of insurance plans that may apply to your individual patient and determine the corresponding co-pay tier. Then, send the patient’s prescription to the pharmacy. The final wrinkle is that pharmacies may manipulate the average wholesale price of both generic and branded products to maximize profits; they also may offer an alternative medication that can cause patient confusion and potentially more time for resolution on our part.
Nonetheless, we still have the primary obligation to do what is best for our patients. This may require striking a balance between efficacy and cost when a generic version is available. For chronic management situations, such as glaucoma, it may take months to determine equivalent performance of a generic formulation based not only on intraocular pressure, but also on establishing stability or progression from a variety of measures.
Further confounding this is that patients may get a different manufacturer’s generic formulation from month to month. To assist us in these situations, ask patients to bring the bottles when attending for a visit. Stein et al (2015) suggested that glaucoma patients may be more adherent to the latanoprost regimen when using a generic. CLS
For references, please visit www.clspectrum.com/references and click on document #237.
Dr. Semes is a professor of optometry at the UAB School of Optometry. He is a consultant or advisor to Alcon, Allergan, and Regeneron, and he is a stock shareholder in HPO.