Generic drugs online

Source: Evening Bulletin

Date: 19-Nov-2007

Author: Herb Denenberg

Here comes an idea that can lower the price of drugs, make them more readily available, make health care more accessible, improve the quality of heath care and do all that with virtually no risk or cost. It is an idea now being debated in front of the FDA - to expand a new class of drugs, BTC (behind-the-counter), which would move certain prescription drugs to a new status halfway between over-the-counter and prescription status. A BTC drug would be available without the necessity of a prescription but only upon the recommendation of a pharmacist, who would initially approve the use of the drug and monitor it thereafter.

Dr. Daniel Hussar, Remington Professor of Pharmacy at the University of the Sciences in Philadelphia, made an ironclad case for this reform in his testimony before the FDA on Nov. 14. He is one of the nation's leading authorities on pharmacy practice.

The Precedent For BTC Drugs: The FDA has already approved the emergency contraceptive levonorgestrel (Plan B) for BTC use. This was done in late 2006.

Impact Of BTC Drugs: Dr. Hussar argues as follows: "The access of patients to medications from which they can benefit will be markedly increased. For various reasons, many individuals rarely, if ever, see a physician unless there is a need for emergency treatment. The BTC availability of certain medications from a pharmacist will not only be of value in the treatment of conditions for which physician consultation is not necessary but will also facilitate and increase the referral by pharmacists of patients with potentially serious problems to physicians. Indeed, the interaction with a pharmacist regarding a BTC medication will, for many individuals, represent the first step into the health-care system and the subsequent availability/referral for the expertise and services that will be of benefit."

Training And Position Of Pharmacists For BTC Role: Dr. Hussar points out that pharmacists are already trained and positioned to review lab results, identify contraindications of drugs and their drug interactions and assist with other drug-related problems. They are also trained to counsel patients on the use of drugs and monitor that use.

Pharmacists are the most accessible professionals in the health delivery system, but they are often underutilized. Too often, they are relegated to the role of pill counters - taking pills out of big bottles and putting them in little ones. The BTC proposal would tap into their solid professional training, enhance their job satisfaction and utilize their capabilities to the advantage of their employers and their patients.

The Cost-Effectiveness Of The BTC Approach: The BTC system would make drugs more readily available with less delay and more efficiency. The BTC drugs would be closer to the OTC drugs, and the market for the latter is much more competitive than it is for prescription drugs. For example, Prilosec is now available OTC and is much less expensive than similar proton pump inhibitors now available only on a prescription basis.

There will be an insurance issue on BTC drugs. Now nonprescription drugs (such as OTCs) are usually not covered by insurance plans. But it would only be fair and in keeping with reasonable expectations to grant coverage for the BTC class.

Dr. Hussar further made his case by giving examples of prescription drugs that would be good candidates for BTC status.

Statins Such As Lipitor: Dr. Hussar noted the statins are among the most prescribed drugs, are the most effective ways to lower cholesterol and are usually well-tolerated, notwithstanding their potential for some serious musculoskeletal adverse effects.

There has already been one attempt to transfer lovastatin (Mevacor) and pravastatin (Pravachol) from prescription to OTC status. The FDA rejected that request. The main objection was that patients would have trouble determining the need for a statin and would not be equipped to monitor their progress. With BTC status, the pharmacist would be there to help the patient determine the need for the drug and to monitor progress in using the drug.

Dr. Hussar noted that many patients, rather than taking the time and incurring the expense of going to a physician, resort to herbal remedies and dietary/nutritional supplements for treatment of high cholesterol. He told the FDA, "These products have not been evaluated in clinical studies, there are little or no safety data, and there is no assurance of standardization of active ingredients." In my view, their use is often a form of Russian roulette with your health. In contrast, a BTC drug would provide a product that has been extensively studied, has a known safety profile and can be monitored by a pharmacist.

Oseltamavir (Tamiflu): This is one of the few antiviral agents that are effective for the treatment of influenza. But for the drug to be effective, it must be given as soon as possible (within two days). Patients who have influenza (and this would be especially important if there was a pandemic, a distinct possibility if not high probability) should have the easiest and quickest access to the drug when needed. Its BTC status would make it more readily accessible. In the event of a pandemic, getting to a doctor might be an excessively slow and even impossible process.

Auto-Injector With Epinephrine: Some people can experience life-threatening reactions to insect bites or stings or exposures to other allergens. The drug of choice in these cases is epinephrine, which is injected using a product such as Epipen, a prescription item.

What if you have an allergic reaction and do not have Epipen or have one that is outdated? A pharmacy might be closer than a hospital. Dr. Hussar concludes that Epipen should be available on a BTC basis and could be life-saving.

Varenicline, Nicotine Nasal Spray, And Nicotine Inhalation System: Smoking kills more than 400,000 people a year, and these products are prescription items that help smokers quit the habit. Dr. Hussar makes the case for their BTC availability as follows: "There are many smokers who want to quit but who will not set up an appointment with a physician to discuss other options. For these individuals, the nonprescription BTC availability of varenicline (Chantix), nicotine nasal spray (Nicotrol) and nicotine inhalation system (Nicotrol) will provide a pharmacist-monitored opportunity for a successful effort to stop smoking. ... Effective and safe smoking cessation aids should be conveniently available for smokers who choose not to visit a physician, and barriers to such access must be reduced."

Dr. Hussar says there are many other prescription items that make sense for BTC status. Some might require formulation of specific parameters and guidelines, but many can go BTC without need for further study and development of parameters and guidelines.

He concludes: "The increase in number of nonprescription BTC pharmacy available medications will not only result in increased patient access to helpful medications, but will also make them available on a more cost-effective basis. The opportunity that the FDA is providing is one in which all participants can 'win' - individual patients, society in general, the health-care system, pharmacists, pharmaceutical companies and the FDA."

With 78 million baby-boomers moving into Medicare eligibility and into the age-bracket of greater medical demand, we will soon be deeper in a cost and quality crisis in health-care delivery. We'd better start adopting cost-effective and quality-enhancing incremental reforms, such as a BTC-drug system, to help lower costs and enhance quality, or we will have a system that we can't afford or one that is destroyed by ambitious reformers who don't know how to implement even a tiny incremental reform, but are ready to try to restructure the entire health delivery system. They are only likely to make what is still the best system in the world a mirror image of failed socialized systems in vogue abroad. Be careful as Hillarycare II may be just around the corner, only one of many likely disasters a Hillary administration would visit on the country. Let us pray she can remain in her post as New York's junior senator.