FDA prescription drugs plan would empower you
When blockbuster prescription drug Claritin first went on sale over the counter in 2002, many allergy specialists and other doctors warned of dire consequences.
Fewer patients would go to doctors, they maintained, and people with more severe problems that might masquerade as simple allergies would go undiagnosed.
A decade later, Claritin is still on drugstore shelves, joined by many other medications that were once prescription-only, including other allergy pills and drugs used to treat acid reflux. The physicians' worst fears have proved unfounded. And millions of sufferers have easier, cheaper access to drugs when spring allergies or heartburn strike.
Now, some of the same naysayers are trying to derail a Food and Drug Administration proposal that could make more prescription-only drugs ― such as those to treat asthma, migraines, high blood pressure and elevated cholesterol ― more accessible without visits to a doctor. Today is the deadline for public comments.
The FDA says the concept might work in various ways. Some prescription-only drugs might be sold over the counter, with special advisories for safe use. Others could be sold from behind the counter, with a pharmacist's approval. Consumers might go to a pharmacy kiosk, fill out a questionnaire about their symptoms and take it to the pharmacist. Or pharmacists might be authorized to refill certain prescriptions without a follow-up visit to a doctor.
"Medicine needs to take medical care to where the patients are," Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, testified at a hearing in March.
The hearing, however, produced mostly special-interest pleadings ― from doctors' groups, pharmacists, drugstore chains, pharmaceutical companies and the like. The public, not so much.
For patients, the proposed changes might help to overcome three major obstacles:
― Cost. Many patients with no drug insurance, or high deductibles, avoid getting prescriptions. Easier access could help them save money.
― Ignorance. Many people suffer from chronic conditions and don't know it until they end up in an emergency room. About 15% of adults in the U.S. suffer from diabetes, high blood pressure or elevated cholesterol ― sometimes all three ― and have not been diagnosed. If they could go to a drug store kiosk and connect with a pharmacist, it could open a new path into the health care system. Perhaps they'd then take the second step, to a doctor's office.
― Lack of follow through. One-fifth of patients fail to fill their prescriptions in the first place. Others stop taking medication after a year or six months, when doctors require a return visit.
Some public health advocates think the FDA's concept has potential in an age when patients want to be in charge of their own care. "The more we can empower, educate and engage them, the lower health care costs would be and healthier they would be," says Georges Benjamin, head of the American Public Health Association.
Yes, people get better care when they see doctors. And the FDA would, of course, have to ensure that a new system wasn't used by drugmakers to promote easier access to drugs that are new to the market, have severe side effects or are prone to abuse. Each drug or class of drugs will have to be considered separately.
But for Americans with serious but controllable conditions who get no medication or fail to keep up with prescriptions, a little more flexibility could be just what the doctor ordered. Even if there is no doctor's order.
This article was published and distributed by USA Today.