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Dialogue between physicians, regulatory oversight agencies critical to patient safety
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In medicine, “Safety first” — or, if we go back to Hippocrates himself, “Primum non nocere,” or “First, do no harm” — is a basic principle supported by all. However, there is no life-saving or sight-saving treatment or procedure that is risk-free, so to do any good for our patients, we must also accept the risk of occasionally doing harm. Thus, we have the classic day-in and day-out conflict between risk and benefit in every treatment decision we make, every day, one-on-one with our patients and their families.
It is hard enough to make difficult treatment decisions for an individual patient when the therapeutic effect for a pharmaceutical is known. Now, in addition to selecting the proper class of drug, we also must be concerned about the quality and origin of its manufacture. The most tightly regulated approval and manufacturing processes are those for proprietary prescription drugs that undergo a decade or more of testing for safety and efficacy by the U.S. Food and Drug Administration, as well as an exhaustive inspection and analysis to ensure good manufacturing practices are used in their production.
Next in line is the ever-growing number of generic drugs, much less tightly regulated and more variable in quality of manufacture, which now represents nearly 80% of prescriptions in the United States. Still, FDA oversight is engaged, assuring some level of regulatory oversight.
Finally, we have the specialty drugs and drops that are made by privately owned compounding pharmacies and occasionally by ophthalmologists or their employees who, for example, might add epinephrine to their irrigating bottles used in cataract surgery. In this category, regulatory oversight transitions to individual state pharmacy boards, or to the agencies that regulate surgery centers, and — to be direct — regulatory oversight is less intense and much more variable between states.
Most regulatory agencies respond aggressively to crisis, and we have been in a crisis mode since hundreds of patients were recently injected with contaminated triamcinolone. This has led many of our elected representatives at the state and federal levels to call for more stringent regulation over the compounding of pharmaceuticals by private companies and physicians themselves.
At first blush, more stringent regulation and oversight seems reasonable, since injecting a contaminated drug into someone’s spinal cord or eye is clearly nothing short of disastrous; however, we must also keep in mind the requirements of daily practice and the need for timely and cost-efficient delivery of drugs not commercially available, such as intraocular vancomycin to treat the patient with acute postoperative endophthalmitis or a sight-threatening corneal ulcer.
In addition, we have the awkward but real need for availability of intraocular Avastin (bevacizumab, Genentech) for those patients who do not have adequate insurance to cover the high costs of the FDA-approved alternatives. Medical practice today is increasingly complex, with extraordinary and increasing pressure being placed on the physician to provide cost-effective, high-quality care in a patient-centered, compassionate manner; some might consider this an impossible dream, and others perhaps an oxymoron. Neither overregulation nor underregulation supports this goal, and the challenge is to weed out those companies, compounding pharmacies and providers who are truly uncaring or incompetent, while allowing appropriate access to the caregivers, drugs and devices that our patients need to treat their disease and enhance their quality of life.
It is an extraordinary challenge for us as physicians as well as our regulatory agencies. There are no easy solutions, but open dialogue and communication between physicians and the regulatory oversight agencies at the state and federal levels is critical to avoid the catch-22 where more harm is done by preventing access to needed drugs and devices than is prevented by restricting access through inadvertent overregulation. In particular, all physicians should promptly report all adverse events and side effects of any drug, device or procedure to the FDA Medwatch Safety Information and Adverse Events Program. Information is available at www.fda.gov/medwatch/report.htm, or by calling 1-800-331-1088.
Prompt reporting can allow for rapid evaluation and, when appropriate, removal from the marketplace of drugs or devices that are placing patients at risk.