When it comes to prescribing, physician is best
I have nothing against pharmacists. I value pharmacists as part of the health care team. In addition, I feel their role is substantially underutilized. Part of the problem with chronic disease is adherence to medication, a large part which has to do with education. Pharmacists are experts when it comes to informing patients about their medications, how to take them properly and why taking them is necessary. They can monitor adherence to medication and can also serve on the front lines to alert physicians if their patients aren't doing well and need closer attention.
However, when it comes to making a diagnosis and determining which therapy is best, pharmacists do not have the depth and breadth of training that physicians receive. As a primary care physician, I can tell you that even the most common conditions like asthma or sinusitis is not always that easy to diagnose, and even determining treatments for these conditions do not do well with cook book like algorithms.
Another concern I have with pharmacist essentially prescribing medications is that they are employed by the pharmacy that dispenses these medications, and thus have a potential direct conflict of interest. Now, I am sure skeptical readers will say that drug reps have been given physicians gifts and samples for years, and this is conflict as well. Though this may be true, a pen or a slice of pizza is a whole different level of conflict then direct money in your paycheck. Also realize that the pharmacy makes a bigger profit on generics, thus the pharmacist may be consciously or unconsciously biased to give you a generic when it may not be the best choice.
Patients Will Pay More
Usually when a drug goes OTC, it usually means the patient has to pay more. This is because most insurances do not cover over the counter medications. Ask any patient who suffers from seasonal allergies. OTC non-sedating antihistamines like Claritin, Zyrtec, and Allegra cost a lot more out of pocket, even when using the store brand, then when they were available by prescription. This is because the out of pocket cost for co-pay for a preferred drug (even when branded) is often less then the out of pocket cost for and entire supply of over the counter medication, even when generic/store brand. The same is true for acid blocking medicines such as Prilosec. Generic OTC Prilosec (Omeprazole) is just over 50 cents a pill, which means a patient requiring a daily dose will pay over $15 for a 30 day supply. This is generally much more than patients pay for a generic prescription of omeprazole, some paying as little as a $5 co-pay. (Some insurers have actually made the co-pays for the generic omeprazole more expensive then the acid blocking medicines that are not yet over the counter, like Nexium, to steer patients to buying the over the counter medication (full out of pocket cost), rather then request a prescription!)
Where is the Outcry?
What's most shocking to me is the lack of dialogue on this topic. My guess is that this may be due to lack of awareness, since the FDA seemed to slip this past the media. Physician representation at the March hearing was pretty poor. Few groups such as The America College of Physicians seem to be interested (or aware). The AMA did testify at the hearing , and according to their website:
"While the increased availability of certain prescription-based antidotes, such as Epi-Pens, appear to have few if any safety concerns, the FDA has not offered evidence that patients with hypertension, hyperlipidemia, asthma, or migraine headaches can self-diagnose and manage these serious chronic medical conditions safely on their own. This sort of self-diagnosis and treatment conflicts with the kind of care coordination and disease management that both the administration and private sector are trying to achieve through the new health care payment and delivery models."
To me the "conflicts with.....new health care payment and delivery models," is very interesting. This suggest to me that the government is trying to hedge their bets. In other words, if the new plans for health care reforms don't work, we can still lower cost and increase access simply by making many chronic disease drugs over the counter.
Most commentary that can be found on this issue seems to be coming from the pharmacist groups, who are not surprisingly supportive. However, there is at least one pharmacist that remains skeptical. Pharmacist blogger Eric Durbin at his blog Eric, Pharmacist states:
"I've never known our government or any of its agencies to move quickly on issues, especially when it comes to our profession. But for this issue, the notification for the hearing was filed on February 27, published in the Federal Register on February 28, with a deadline to present oral comments & presentations of March 9. That's less than two weeks. With the hearing being held less than two weeks after the deadline. 3-1/2 weeks from the notice of hearing in the Federal Register until the hearings begin seems to be moving rather quick to me. Which makes me skeptical"
Bottom Line: Though this may seem like an initiative that could improve patient access and chronic disease outcomes, allowing chronic disease medications to be over the counter is a way the government can cut health care costs by eliminating expensive doctor's visits and shift medication costs to patients.
What can you do?
Though the hearing was over weeks ago, the website still allows visitors to submit comments (due May 7, 2012) online ( CLICK HERE - also note the 20 minute lock out, so you may want to type in Word first and then copy/paste). You can also use the address below for regular mail
Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061
Rockville, MD 20852
In addition, you can send this post to those who know who might care about this issue and/or write your own post. You can Tweet, post to Facebook, etc. Social media has done wonders recently in getting the word out and making changes. However, time is of the essence.