FDA Considering Making More Drugs Available Which Would Require The Intervention Of Just A Pharmacist

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharmacy / Pharmacist;  Public Health
Article Date: 03 Oct 2007 - 10:00 PDT

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The US Food and Drug Administration (FDA) is looking at the possibility of making more prescription drugs available over-the-counter, requiring the intervention of a pharmacist before dispensing. In other words, a consumer would not need to get a doctor's prescription, but would need to consult with a pharmacist at the retail outlet.

A public meeting will be help on 14th November where the FDA will hear suggestions about the idea. The Agency says it would like to hear from the medical community, advocacy groups and the pharmaceutical industry. It is crucial, says the FDA, that the role of a pharmacist in these circumstances is clearly laid out - how should the pharmacist go about counseling and monitoring the patients' use of the drug(s), how can the pharmacist make sure patient safety is optimized?

The FDA explained in a Federal Register notice that some groups have stressed that pharmacist interaction with the patient/consumer would make sure the drug, which would otherwise require a prescription, be used safely and effectively. As pharmacists are trained to provide certain interventions, they could make sure patients meet the conditions for use, as well as educating them on the correct use of the medication.

This move could be useful for patients who have no health insurance coverage, as they would be spared the expense of going to the doctor in the first place. If that person really needs to drug, he/she is more likely to get it as many people without coverage do not see a physician in the first place because they cannot afford it.

Several industrialized nations have a system whereby the consumer can access drugs by consulting the pharmacist, including Australia, Canada, France, New Zealand, UK, Denmark, Germany, Italy, The Netherlands, Sweden and Switzerland. The UK has what is called a "pharmacist-only" class of medications - some countries have more than three cases. The criteria used in other countries for switching from prescription to BTC (behind-the-counter) are:

1. The indications of the drugs are suitable for self-medication, including self-diagnosis, with the intervention of a pharmacist.

2. The drug's potential for side effects and/or overdose are low - and that the intervention by a pharmacist would minimize these risks.

3. Other considerations: Potential for abuse, patient choice and accessibility, and public health issues.

When a drug is classified as pharmacy-only, the pharmacist has to ensure the patient meets certain criteria before dispensing, as well as to provide education on proper use and monitoring.

"Behind the Counter Availability of Certain Drugs; Public Meeting"
Docket No. 2007N-03561
-- Click here to read the document (PDF)

Written by: Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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