Over the Counter Drugs: Good v. Evil

Yesterday morning @shelleypetersen tweeted an article in the WSJ about the FDA considering to make more drugs available over the counter (OTC) [If you're not following Shelley on Twitter,  you're missing some good stuff - head over and follow her].

After the initial tweet, Shelley and I went back in forth in 140 characters and had a mini-conversation about the impact. I had to leave the tweet-fest for a meeting but wanted to finish the conversation and thought I'd do so here (and break free of the 140-character bind).  There are many stakeholders in such an idea. To take a balanced look at the issue, I'll declare a winner and loser for each perspective. All of this my humble opinion, of course, and I welcome other points of view.

Also, keep in mind, the specific drugs the FDA decides to make available OTC will have significant impact on the outcomes of doing so. While I don't think Oxycontin would ever be on the OTC list it would most certainly result in a vast increase in sales. Winner? Pharma

Other Winners and Losers

1. Most prescription drug plans do not cover OTC medications unless they are deemed medically necessary by a physician (typically via a prescription). By increasing the kinds of drugs available OTC, fewer people would be likely to buy them because they would have to pay out-of-pocket. It may also increase the demand on our already overburdened primary care system as people seek prescriptions for these drugs so they are able to pay a co-pay vs. cash (see likely increase in demand #4). The total benefit dollars paid from prescriptions plans would decrease. Some patients simply wouldn't take the drugs any longer.

Winner: The people who pay for prescription drug plans (Medicare, some Medicaid, employers)
Loser: The consumer (particularly those with less discretionary income) and PCMs

2. The reduction in the total spent in prescription plans could make the overall healthcare system look less expensive (in the short term). The headline might read, "Health Reform Saves Billions in Prescription Drug Benefits." The article is not likely to go on to say how many people aren't taking the medication their doctors think they need. 

Winner: Budget people and the supporters of Health Reform

Loser: The consumer (particularly those without a "medical home" and an established relationship with a physician who they know and trust)

3. The costs of people skipping their medication won't hit the healthcare spend line (at least not enough to be noticeable) for a few years. When people stop taking their high blood pressure medicine because they can no longer afford it (or, possibly, they simply refuse to use their discretionary dollars on something that provides little instant gratification), they won't start dropping dead in the streets. It would take a few years before we'd see the likely increase in strokes and heart attacks. By then, revisionist history will take over and people won't relate A to B. 

Winner: Budget people and supporters of Health Reform

Loser: The consumer

4. When current prescription drugs become available OTC, sometimes, the manufacturer makes a less potent version available that is "safe" for unsupervised use. A patient taking a prescription at 150mg may only be able to get a 75mg OTC. This would have two results: More sales as patients would have to buy more pills and more sales as there would be more product on the market. And, of course the drug manufacturers would have to let Americans know about the health issues (some they don't know they have) while showing photos of people really, really happy because they are taking drug X or Y.

Winner: Pharma
Loser: Everyone who watches television -- can you imagine the volume of commercials? PCMs who will be flooded with patients requesting specific drugs because they have suddenly developed the latest Pharma-invented syndrome.

5. There are several Federal agencies with a role in the health of Americans. A quick overview: USDA deals with meat, dairy, agriculture and the food policy, FDA handles drugs and other foods, DHHS oversees health insurance programs, DoEd teaches our kids about health, DOI handles parks and outdoor space, DOT oversees transportation. The point being we don't have a way to budget for, or even understand, the true costs of health. If the FDA approves an increase in OTC drugs which negatively impact the cost of healthcare programs like Medicare and Medicaid, the FDA doesn't really need to worry about it. The FDA and DHHS don't share a budget, or accountability, for the health of Americans.

Winner: The agency accounting for "saving" money
Loser: The agency accounting for increased costs

6. One of the concepts behind additional OTC drugs is to increase access to the drugs which claim to combat epidemics like diabetes (first of all, one has to believe drugs are the best way to combat lifestyle diseases... I happen to think lifestyle changes are better and cheaper). The "improved access" could be done by kiosk-like devices to help patients self-diagnose to determine if they need a drug. What an opportunity here! I have many questions about the kiosk implementation: Who will write the questions? Will there be drug advertisements on the kiosk or as a commercial spot before the questionnaire? What reading level will written for? Are we going to track outcome (i.e., how many people who go through the kiosk would end up with a drug vs. those who visited their doctor)? Tricky policy and implementation here. And, forgive me, but too many interesting ideas get completely ruined in implementation. What is certain? More drug sales.

Winner: Pharma
Loser: Physicians (whose professional judgement will be replaced by a kiosk). Consumers (who will be even less likely to make lifestyle changes when all they have to do is go to the ADM (automatic drug machine)).

As I wrap this up, I have to admit feeling a bit discouraged. Is our system really as bad as this? I'll leave that up to you and would love your thoughts. In the meantime, I think I'll switch on the television to see what ails me and what magic cure might be available from my pharmacy.