Nonprescription Drugs Could Address Chronic Conditions
As many as half of the individuals living with chronic conditions like diabetes or high cholesterol , a hugely expensive situation: Improved adherence to medications leads to better health outcomes, and could save $5 billion annually for diabetes alone. So how can we improve treatment for all Americans, including the 56 million who do not even have access to adequate primary care services? One reasonable solution is for the F.D.A. to make more medications available over the counter. This recognizes the rapidly evolving role of the consumer in medical decision making, the growing availability of medical information, and the imperative for cost-effective care
No one would deny that all drugs have some risk. However, hundreds of drugs demonstrate safe and successful switches from prescription to nonprescription: antihistamines, anti-inflammatory drugs and gastrointestinal drugs are widely used examples. Making nicotine therapy available over the counter increased access greatly, and patients are still seeing physicians and little misuse has been identified. Nonprescription levonorgestrel (Plan B, a contraceptive pill) is now available at most pharmacies, and adverse effects have not been widely reported.
Sufficient guidance and patient education is critical. Despite already-cumbersome regulations, controls should be considered for certain drug classes. In cases where drug diversion is a risk, such as pseudoephedrine, legislation has successfully limited medications to behind-the-counter status. Other classes of drugs, like statins, would require screening, lab tests or counseling at the pharmacy. Britain made statins available this way, which did not result in widespread misuse or harms. Quite the contrary, the first few years brought surprisingly minimal response to this policy change.
Some suggest that over-the-counter sales might result in overuse of drugs, but the benefits of improved access would outweigh such risks. Nonprescription status might place additional work on already burdened pharmacists, but industry groups have in the past supported F.D.A. proposals in concept for a new nonprescription drug category, requiring pharmacist counseling and use of innovative patient education technologies.
Finally, although a recent study notes the increased bias of advertisements for over-the-counter drugs versus prescription medications, does anyone actually believe that current prescription advertising is “balanced”? Patients are already seeking out their own information online and elsewhere. Approving more medications to be sold over the counter, on a case-by-case basis, is an important next step.
Red Flags Before a Drug Goes Over the Counter
Making more prescription drugs available over the counter clearly has some benefits. People could manage their conditions without incurring the cost and inconvenience of going to the doctor. This is significant even for those who have health coverage, and more so for those who lack it.
Easy access could also make people more likely to take medications they need to treat illnesses and maintain health. A Consumer Reports survey this summer found that nearly half of American consumers under 65 who lacked prescription coverage had chosen not to fill a prescription because of cost. If more people took their medicines appropriately, controllable illnesses would be less likely to advance to a more costly stage, which could save money in the long term.
Yet the idea of moving many drugs to nonprescription status raises significant questions about safety and cost.
For example, the F.D.A. must ensure that consumers can safely and independently make decisions about which over-the-counter medications they need and understand how to take them properly. It would be unwise to rely on drug company advertisements to educate the public; just last week, researchers reported that advertising for over-the-counter drugs (regulated by the Federal Trade Commission) provides less detail about side effects than advertising for prescription drugs (regulated by the F.D.A.).
No one knows how much pharmaceutical companies will charge for medications granted over-the-counter status. Some nonprescription drugs may actually cost more than generic prescription drugs. Since over-the-counter drugs are not typically covered by insurance, individuals who have health coverage could end up paying more out of pocket, a particular burden for those with chronic conditions.
Another concern about allowing more medications to be sold without a prescription is the difficulty in preventing drug interactions. Doctors and pharmacists already struggle to monitor everything that a patient is taking; the challenge would grow if more drugs were sold over the counter.
Research shows that older adults commonly use prescription and nonprescription drugs together, with at least 2.2 million potentially at risk for a harmful drug interaction. The risk of adverse reactions could increase as more medications become available over the counter.
While improving consumer access is important, regulators should not put drugs in easier reach until it is clear that these serious concerns have been addressed.
Consumers Benefit From Over-the-Counter Competition
A decade ago, my insurance company, WellPoint, advocated for Claritin to be offered over the counter, and within months of that change, the sticker price had fallen by half. Today, many other medications to reduce allergy symptoms or address minor conditions like heartburn have also become available without a prescription. Rather than making an unnecessary trip to the doctor and paying the co-payment for both the visit and the prescription, patients can simply go to the store and get the relief they need.
Most prescription drugs that switch to over-the-counter status do so only after their patent protection has expired. To become nonprescription, medications must have a well-established safety profile, and consumers must be able to use them safely and appropriately without the oversight of a “learned intermediary” like a doctor or pharmacist.
Once safety has been firmly established, the true key to affordability is the number of manufacturers making a particular drug. When Claritin first went over the counter, costs to consumers were temporarily higher than the co-payments had been for the prescription version. In response, WellPoint’s affiliated health plans offered consumers coupons for free or discounted over-the-counter Claritin until other manufacturers began producing generic loratadine.
As competition among manufacturers increased, over-the-counter costs fell quickly and significantly. Insurers like WellPoint have saved money because they no longer pay for Claritin, which was a very common prescription. Because of the competition, consumers are spending far less as well: a quick search today shows that a month’s supply of loratadine costs less than $1.50. That’s far less than the co-payments for brand-name prescription allergy medications.
Access and affordability in health care have never been more important, and WellPoint is still pushing for changes that benefit consumers across the health care system. With appropriate controls for safety and oversight, generic and over-the-counter medications can help to stabilize health care costs and provide consumers with convenient access to more affordable medications.
More Medications Should Be Available Over the Counter
Increased access to common medications, like for asthma, cholesterol, diabetes and contraception, would benefit many people. We have seen this in the past, when medications that were once dispensed only by prescription came to be effectively managed without a doctor’s close instruction: loratadine, hydrocortisone cream, Plan B, omeprazole, and minoxidil and yeast fungal creams, to name a few.
Increasing direct access to treatments helps not only patients but also doctors. Making a medication available over the counter saves time and money for patients, who no longer need to miss school or work to see a doctor. And allowing patients to pursue self-care for a known condition gives physicians more time for patients who need a medical assessment. Especially in my field, adolescent medicine, extra clinical time will be crucial as the Affordable Care Act is implemented and more adolescents and young adults have greater access to health care.
However, there are some drawbacks to be acknowledged when we consider making medications available without a prescription.
The first potential drawback is cost. In most cases, when a medication becomes available over the counter, insurance no longer covers it. This creates a new hardship for many insured people, even as it increases access for the uninsured. Although the price tag might be lower when the drug loses its prescription status, patients with prescription coverage will often end up paying more than they were.
Patients who are unemployed or underemployed are hit especially hard by this. Frequently for such patients, I find myself trying to recommend a prescription drug rather than an over-the-counter solution, because a patient qualifies for some financial help only for prescriptions. Our health care system should correct this; we need a mechanism to ensure that individuals can transition to an over-the-counter treatment without paying exorbitantly more out of pocket.
Another drawback to consider is the risk of some drugs. Of course, no medication, whether over the counter or prescribed, is without risk. Some over-the-counter medications like acetaminophen can be particularly dangerous when used incorrectly. We should strive to deliver health information on medication in more innovative and immediate ways, so people know the risks and benefits and can decide between treatments. The current system is inadequate; pharmacists can be helpful, but in most pharmacies there is no private setting in which a patient could ask questions or express concerns.
And the final downside is the power of advertising. Although prescription drugs are heavily marketed, the F.D.A. generally requires that ads disclose side effects. For nonprescription drugs, the Federal Trade Commission generally does not require that ads list side effects. As more medications are available over the counter, consumers need to be protected from the undue influence of pharmaceutical companies and advertising, which may lead patients to take medications they do not need — or would not want if they were fully informed.
It is absolutely smart to increase access to medications without the need of a doctor visit, but only if we can take the time to make the process safe and accessible to all who would benefit.
Statins Should Require a Prescription
Before regulators convert any prescription drug to over-the-counter status, two critically important criteria must be satisfied. First, patients must be able to easily and accurately diagnose the condition for which the drug is indicated. Second, patients must be able to quickly and correctly assess the response to the therapy – including symptoms of toxicity — and adjust the dose or stop therapy based on these assessments.
Some classes of drugs clearly meet these standards and should be sold over the counter. Others don’t. A comparison of antihistamines and statins provides a sharp contrast.
Consider antihistamines for the treatment of seasonal allergies. The symptoms of seasonal allergies are easily self-identified and include sneezing, an itchy and runny nose, and watery eyes. The effectiveness of antihistamines as allergy treatments can be readily assessed by monitoring these same symptoms. Serious side effects from antihistamines are rare but in most cases easily recognized by patients. Therefore, allowing antihistamines to be sold over the counter is reasonable.
On the other hand, consider statin drugs for treating high blood cholesterol levels. This condition is asymptomatic and cannot be self-diagnosed. Moreover, the decision to begin treatment with a statin drug should come only after a physician has carefully considered: cholesterol levels; other risk factors for, and signs of, cardiovascular disease; and whether other interventions, like dietary changes and increased exercise, have been unsuccessful. In addition, measuring a patient’s response to a statin drug and monitoring for subtle but serious adverse events requires periodic blood tests.
Statins clearly fail to meet the criteria for being safely sold over the counter. For these reasons, Public Citizen strongly opposed Merck’s failed attempts to obtain F.D.A. approval for over-the-counter sale of lovastatin in 2000, 2005 and 2007. The pharmaceutical industry’s desire to maximize profits through nonprescription sales must not be allowed to undermine these commonsense criteria.