In-office dispensing may be best way for patients to receive branded pharmaceuticals
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Substitution of a generic pharmaceutical for a branded one prescribed by a physician is extremely common. Nearly 80% of drugs dispensed today in the U.S. are generic, and the percentage is growing. We have mentioned before that three of the key issues in medicine for the government and public include cost, access and quality. It is clear to me that cost and quality are increasingly in conflict.
Most American patients with insurance have experienced a high quality of health care to date, and many of them have come to consider quality care as a given. The typical American patient with insurance has also been quite insulated from the costs of care, and he does not like the fact that he is being asked to bear an increased personal responsibility for the expense of his medical care.
So, for example, when a pharmacy offers to substitute a generic drop with a lower patient co-pay for the branded drug prescribed by an ophthalmologist, most patients willingly agree. This easy switch, which happens thousands of times a day nationwide with little thought, occurs because patients believe that the quality of the generic drug being substituted is equivalent to the branded proprietary drug prescribed by the doctor. They trust that the state and federal regulatory agencies would never allow a generic drug to be on the pharmacy shelves and that their trusted pharmacist would never substitute a drug of lower quality than the one prescribed by their physician. Yet, anyone who has studied the way generic drugs are approved, manufactured and regulated knows that this trust is often misplaced. When careful, detailed studies are performed comparing a broad array of generics to proprietary branded drugs in regard to pharmacokinetics, pharmacodynamics, bioavailability, safety and efficacy in clinical trials or registries, there is strong and in some cases frightening information that suggests that some, perhaps many and possibly most generic medications are inferior to the branded proprietary alternative.
We ophthalmologists know that all fluoroquinolones are not the same; for example, ciprofloxacin and moxifloxacin may not generate equivalent outcomes in a sight-threatening ocular infection. When faced with severe inflammation, such as a corneal graft rejection or severe iridocyclitis, some generic topical steroids or NSAIDs may underperform the best branded proprietary drugs available, and they may expose the patient to a greater risk of side effects. At the extreme, when personally insisting that a patient be dispensed difluprednate to treat corneal graft rejection rather than the insurer’s or pharmacy’s preferred generic alternative, I have been told that the patient’s graft rejection has to fail to respond to generic prednisolone acetate before my recommended difluprednate can be accessed, and then only after medical director review. To translate this to reality, once the patient has suffered irreversible graft rejection, he can get the medication he needs to prevent it. This is more than annoying; it is unacceptable to me.
The trend toward substitution in broad classes — an antibiotic is an antibiotic; a steroid is a steroid; an NSAID is an NSAID — is growing and increasingly putting our patients with sight-threatening eye disease at risk. We physicians every day have less control, yet we remain responsible, committed and accountable to our patients. This ever-increasing conflict between how we want to treat our patients and how their insurance company or even pharmacist will allow us to treat them is a daily source of frustration and physician angst. So, are there any options we can employ to protect ourselves and our patients? The answer is yes, but none are totally effective.
First, we can advise our patients and their pharmacists when we believe it is truly important for them to get the branded proprietary drug and not the generic substitute. This makes sense in patients who have sight-threatening eye disease. In some cases, even if patients have to pay for the drug themselves, it is in their best interest to get the drug prescribed. The patient deserves to know when you believe this to be the case. Of course, the definition of these critical cases will vary from one physician to another, and one must insist on a specific drug only when convinced it really matters to the outcome or credibility will rapidly be lost. And the extra time involved is, at a minimum, an annoyance, and in a practice with a high pathology content, close to impossible.
Intriguing to many of us is the option of point-of-service in-office medication dispensing. Most of us prescribe no more than 10 to 15 medications to 90% of our patients, and if we dispense in office, we can be certain patients receive exactly the drop we believe is in their best interest.
At Minnesota Eye Consultants, we have offered over-the-counter medications such as lubricants and nutritional supplements to select patients and found that it is well received by many patients as a convenient service. We have not dispensed prescription drops or drugs but are investigating the options to do so, and I suspect we will soon engage in a one-office pilot program in the area. The laws regulating in-office dispensing of medication by physicians are significant, and noncompliance carries heavy penalties. Every state is different, and consulting knowledgeable local legal counsel is recommended.
The driving force for me to consider in-office dispensing is to assure that my patients receive the drugs I believe are in their best interest, rather than those that are in the best interest of an insurer, drug store or pharmacist. I do not expect this to be a profit center, and my gut instinct suggests it will be difficult but also not in our group’s best interest to generate meaningful profit from medication dispensing. I want the process to be truly driven by the best interests of the patient and would hope to provide quality drugs at an equivalent or lower cost than available at alternative sources.
There are many dispensing models available, including lock box systems and dispensing machines, the latter being especially attractive to me because a dispensing machine should reduce inventory management issues. I am especially intrigued by a system offered by InstyMeds, a Minnesota corporation (I have no proprietary interest). The practice management issues are also significant when adopting in-office dispensing, and consulting with experts in this area is appropriate to design a sustainable business plan.
As I look to the future, I see point-of-service in-office dispensing of pharmaceuticals as one of the best ways to get my patients the drugs I prescribe in a timely fashion.