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FDA Considers Permitting Popular Prescriptions To Be Sold Over-The-Counter

by on Monday, May 7, 2012 at 10:32 pm EDT in Healthcare, Politics

In an effort to make medications more easily available to Americans, the FDA may allow prescription drugs which combat chronic illnesses, such as high cholesterol, diabetes, asthma, and migraine headaches, to be purchased over-the-counter (OTC).

The FDA outlined the rationale behind its proposal:

Getting medicines into the hands of consumers has become troublesome over the last few years. Research shows that for a variety of reasons, 20 percent of patients with prescriptions do not get them filled. In addition, the time or cost required visiting a doctor to receive a prescription or refill often stops patients.

The Food and Drug Administration thinks that some of these doctor visits can be eliminated. It is exploring ways to make drugs for common conditions available as nonprescription products. Under this paradigm, the agency would approve drugs — that would otherwise require a prescription — for over-the-counter (OTC) distribution, if certain conditions are followed.

The agency is presently in an exploratory phase, encouraging input from all stakeholders, including doctors, pharmaceuticals, insurers, pharmacists, and patients.

It should come as no surprise that the move has pitted two powerful interest groups against one another: BigPharma, who stands to gain direct access to millions of consumers, and doctors, who stand to lose a lot of office visits, and their corresponding fees, for writing prescriptions and their refills.

Pharmaceutical companies have long complained that the restrictions placed upon them in getting their medications into the hands of those who need them is more cumbersome in the U.S. than anywhere else in the world.

For example, as early as 2004, the U.K. reclassified low-doses of a commonly used statin (generic: Simvastatin 10mg) from prescription drug to OTC drug. Statins lower cholesterol levels in the blood, thereby helping to prevent strokes and heart disease. Higher doses, however, continue to require prescriptions since the potential for serious side-effects, including liver or muscle damage, increases with the dosage.

But regardless of the dosage, all statins sold in the U.S. still require prescriptions. Why is easy access to drugs like statins so important? Reuters reports:

About one in three U.S. adults has high blood pressure, which contributes to heart disease and stroke. The condition cost the United States about $76 billion in 2010, according to the Centers for Disease Control and Prevention.

The FDA said about a third of those with high blood pressure stop taking their medication.

The FDA is hoping to knock down the barriers that discourage these millions of Americans from taking their life-saving prescriptions.

BigPharma is obviously ecstatic about the prospects of circumventing the gatekeepers that stand between them and the public. The industry spends tens of billions of dollars ‘enticing’ doctors to prescribe their medications. A 2008 study in PLoS Medicine found that pharmaceutical companies spend an average of US $61,000 per physician per year, on physician-targeted promotions. 

Doctors, however, contend that patient consultation is essential for managing chronic conditions. This Sunday, In a USA Today op-ed, American Medical Association president Peter Carmel panned the new FDA effort, by defending the physician’s role, as well as by questioning the projected cost benefits:

As a chronic condition evolves, treatment changes are often needed from a physician. Without physician involvement, patients might take the wrong medication or dose for their needs, potentially causing harm. Self-diagnosis and treatment conflict with the care coordination and disease management that new health care payment and delivery models are trying to achieve.

Contrary to claims that this will save patients money, out-of-pocket costs for insured individuals, including those under Medicare, would increase for drugs switched from prescription to OTC status because patients would need to cover the entire cost themselves. Higher costs would make it harder for patients to afford the medication they need.

But the FDA envisions pharmacists assuming more of the medication consultation responsibilities, presently reserved for physicians. And pharmacist groups have lined up in support of the FDA proposal, including the American Pharmacists Association (APA), the National Community Pharmacists Association, the Academy of Managed Care Pharmacy, and the National Association of Boards of Pharmacy. 

The FDA also plans to take advantage of new technological advancements. Its present OTC rules were written in a time when access to information technology did not exist. But today, the agency envisions utilizing consumer interactive mechanisms (through the internet and touch-screen kiosks at pharmacies), and incorporating electronic health record information, e-prescriptions, patient portals — all of which could effectively link pharmacy, patients and providers in a dramatically new way. 

The FDA does, however, acknowledge several potential roadblocks to its proposal, including Carmel’s point above, regarding the insurance industry’s current non-reimbursement policy for OTC drugs. Other potential roadblocks mentioned, include “liability concerns, disruption of workflow for often overburdened pharmacists, [and] equipment costs.”

Here is how a new OTC policy might work (as outlined by the FDA):

To ensure safe and appropriate use, special conditions would apply to types of nonprescription products. For example, before getting a medication, you might have to talk with a pharmacist, or need to have a diagnostic test. In other cases, you might have to visit a physician to obtain the original prescription, but not to get refills. FDA is also considering whether some drugs could be a prescription drug and a nonprescription drug with conditions of safe use.

Various technologies could support this model. Kiosks in pharmacies or questionnaires on the Internet could help consumers properly diagnose a health condition and select a drug product. Such types of systems could also help consumers decide if the warnings for a drug mean that they should not take a drug or they should not combine it with certain other drugs or foods.

Another scenario for enhancing self-care could involve pharmacists that could help consumers verify their diagnosis, or decide whether the medication is right.

“Pharmacists could also reinforce directions for use,” said Woodcock.

There are a number of potential benefits for consumers from this initiative: an increase in the appropriate use of medication, decreases in health costs, greater access to health screening, easier access to needed medications, and better, more consistent treatment of common conditions.

Though there are still significant hurdles to overcome — the insurance industry’s non-reimbursement policy for OTC drugs would likely make this proposal a “no go” for all Americans — I applaud the FDA’s attempts to confront some rather obvious inefficiencies in the system.

Many Americans with chronic illnesses cannot afford office visits to a doctor, much less repeat visits, for the sole purpose of having prescriptions filled or refilled. Others cannot take off from work each and every time they need a refill, so that a doctor can write out another prescription.

Barriers, like these, discourage millions of Americans from getting the medications they need to treat serious chronic diseases, and as a result, they often end up in the ER in critical condition. This is not good for our citizenry’s health, and it only exacerbates our nation’s runaway healthcare costs.