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Physicians must keep patients’ best interests at forefront when dealing with generic drugs
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The generic drug issue is a complex one, and not without controversy. Interested parties include patients, physicians, manufacturers of patented proprietary drugs, manufacturers of generic drugs, pharmacies, pharmacists, third-party payers including our state and federal governments, and state and federal regulatory agencies. As I try to review this area, it is clear to me that each of these interested parties has a significant stake in this discussion and that they are often in conflict.
In the medical field today, our state and federal governments are the dominant payers for health care, but they also write the laws and control the regulatory agencies that control drug manufacture and distribution. It is estimated that today in the U.S., generic drugs represent about 70% of prescriptions dispensed, and their dominance is growing. To me, this is clear evidence that the politics of the controversy favor generic drug use over their proprietary competition for the majority of patients, and those expert in this area predict that we physicians and our patients can expect today’s 70% generic drug use to grow to 90% by the end of the decade.
Richard L. Lindstrom
I will share a few personal thoughts from the perspective of a practicing ophthalmologist, whose primary duty is to represent the best interests of patients as a first priority. Even then it is a complex subject.
Putting patients first and doing for them what I would want for myself and my family lead me to want a safe and effective drug that has a reproducible effect one bottle to the next, one drop to the next, and one tablet to the next. When drugs are equivalent in safety and effectiveness, providing the best value for my patients and indirectly for society as a whole is also an important consideration. Still, with patients in front of me, I am more concerned about treating them properly than saving them or society money. Thus, the first important issue to discuss is whether generic drugs really are equivalent to their proprietary competitors. As I study this topic, the answer is unfortunately a muddy “sometimes,” but not always.
There are extremely high-quality manufacturers of generic drugs, and we are blessed to have several of them in the ophthalmology field. Many of them make proprietary and generic drugs, and they manufacture to the same high-quality standards for both. In many cases, the exact same drug that a year or two ago was on patent and proprietary is now available in generic form, manufactured by the same company and available at a lower cost. There is little doubt this is a great value for patients and society. On the other hand, there are companies that are driven primarily by the desire to reduce drug manufacturing costs. In many cases, these companies are located outside the U.S., where quality control and regulatory oversight may be less strict. The physician’s dilemma remains the simple fact that when a prescription is given, faxed or emailed to the individual patient’s pharmacy, there is no way of knowing the manufacturer of the generic dispensed. In many cases, when treating a non-sight-threatening problem, this is less of an issue. However, when treating sight-threatening disease, the stakes are raised.
Again, it remains the physician, representing the best interests of the patient, who is responsible for deciding when to encourage or even demand that a patient receive the exact drug prescribed and that no generic be substituted. Deferring to physician judgment, a centuries-old concept grounded in the physician-patient covenant, is, however, unfortunately becoming a historical footnote. In a growing number of states, including my own, pharmacists have been delegated the ultimate responsibility to determine the drug dispensed, and in many cases, they are under significant pressure from their employer to steer patients to the drug that is most profitable for the dispensing company. In some cases, this leads to situations in which patients are not well served.
A notable recent example for me is the substitution of a less potent generic steroid for the more powerful proprietary one I prescribed in a case of graft rejection that led to graft failure. I was advised that the drug dispensed had to first fail to properly treat the patient’s disease before I could petition that my patient receive the drug I prescribed. In this sight-threatening situation, the patient had to suffer a complete graft rejection before receiving my recommended drug, and then it was too late.
Such is increasingly the daily nature of medical practice today, and some can and do argue that the number of patients harmed is small and the cost savings large and worth it. Still, when it is your patient, often your neighbor or perhaps even family, it is a frustrating and hollow argument. The solutions are not readily available. In states where it is still allowed, in sight-threatening cases, physicians can and do demand that pharmacists dispense the drug they prescribe. In states that allow pharmacist discretion, patients can be advised when appropriate that, in their particular case, substitution with a generic drug is not advised. Patients can usually demand that they receive the drug prescribed. As we all know, it is the patient who is the customer of the pharmacy and the third-party payer and not the physician.
Increasingly, it is necessary to educate our patients about the potential differences between drugs and what we recommend. It is then up to them to advocate for their and their families’ best interests, as we physicians are often powerless. In addition, I encourage my patients to bring their drugs with them to all office visits so I can see what they are taking. If the pressure in a glaucoma patient is suddenly less well-managed on a once-effective drug regimen, the answer in some cases is a newly substituted lower-quality generic drop.
The bottom line: Despite the fact that it is increasingly difficult to treat our patients as we wish, it remains our duty to provide the highest quality care we can inside the medical system in which we practice. In the U.S., this includes dealing with the growing use of generic drugs and the fact that one cannot be as sure of their potency and therapeutic safety or effectiveness.
Finally, one last but important issue remains. The transition to generic drugs is having a major impact on the ability of our pharmaceutical companies to justify the enormous expense required to bring a new drug to market. Thus, we can anticipate fewer new proprietary drugs in the future. It is hard to argue that this is in our patients’ best interests, and it seems to me it is not in the best interests of our economy because our pharmaceutical industry has been a great engine for economic growth and prosperity. Nonetheless, it is today a generic drug world, and in a decade, a new proprietary drug launch will be an extraordinarily rare event. The winds of change blow through our field, and we adapt.