Self-prescribing Patients?

The FDA considers making some drugs for diabetes, asthma, and other ailments available over the counter.

By | March 13, 2012

FLICKR, BARTIFICIAL

A new proposal being considered by regulators at the US Food and Drug Administration could eliminate the need for a prescription for a number of widely-used drugs, including those for diabetes, asthma, and migraines.

FDA officials say that thanks to new computer technologies such as touch-screen kiosks that allow patients to self-diagnose certain diseases, removing prescription requirements for a handful of drugs could help ensure more widespread distribution of important therapies, The Washington Post with Bloomberg Business reported. While more than 25 million Americans are believed to struggle with diabetes, for example, some 7 million have not been diagnosed and thus are not receiving available treatments.

“These are discussions that need to start happening as we think about people’s health needs and how to improve access,” FDA Commissioner Dr. Margaret Hamburg told The Post.

The move is not unprecedented. In the last decade, several prescription drugs, including AstraZeneca’s Nexium for heartburn, have been approved by the FDA for over-the-counter sale. Such a switch can be approved if the company has adequately demonstrated that the drug is safe on the basis of simply reading its label. The current proposal would grant drug companies the additional use of electronic questionnaires, diagnostic devices, and other technologies to help inform patients and guide their treatment.

Some drugs may still need an initial prescription before over-the-counter refills become available; others would need a pharmacist’s consultation. In all cases, drugmakers would have to apply for approval to switch to non-prescription sale for each drug individually. “We’re not talking about very specific drugs right now, we’re talking about the concept,” Janet Woodcock, director of FDA’s drug center, told The Post.

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Avatar of: EllenHunt

EllenHunt

Posts: 74

March 13, 2012

Yes!

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Posts: 0

March 13, 2012

Yes!

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Posts: 0

March 14, 2012

In general, this could be a good idea.  In the case of "minor" ailments (e.g. acid reflux, migraines), making certain medications more accessible would likely benefit the patient without posing any significant health risk.

However, as a pharmacist, I can see problems with such a decision, particularly if applied to medications for chronic/complicated conditions:
1) certain drugs for asthma can be easily "over-dosed" - bronchodilators such as "Ventolin" inhalers are easily abused by people with asthma, as the drug provides quick relief of symptoms and are a lot cheaper than steroid inhalers (which prevent symptoms); in an emergency, "Ventolin" will often lose effectiveness with over-use and death can result.  If the sale of "Ventolin" was no longer monitored, it could result in more abuse & injury.

2) there are hidden costs associated with making drugs available without a prescription - it is common practice for drug plans to not cover medications that are availalbe without a prescription.  Changing the status of a drug from prescription to non-prescription could shift the burden of cost from the insurance company to the patient.  If you have a chronic condition such as diabetes or asthma, it could suddenly become more expensive for you to get your needed medications if the drug plan that you most likely pay into stops covering those medications.

Avatar of: johndossantos

johndossantos

Posts: 8

March 14, 2012

In general, this could be a good idea.  In the case of "minor" ailments (e.g. acid reflux, migraines), making certain medications more accessible would likely benefit the patient without posing any significant health risk.

However, as a pharmacist, I can see problems with such a decision, particularly if applied to medications for chronic/complicated conditions:
1) certain drugs for asthma can be easily "over-dosed" - bronchodilators such as "Ventolin" inhalers are easily abused by people with asthma, as the drug provides quick relief of symptoms and are a lot cheaper than steroid inhalers (which prevent symptoms); in an emergency, "Ventolin" will often lose effectiveness with over-use and death can result.  If the sale of "Ventolin" was no longer monitored, it could result in more abuse & injury.

2) there are hidden costs associated with making drugs available without a prescription - it is common practice for drug plans to not cover medications that are availalbe without a prescription.  Changing the status of a drug from prescription to non-prescription could shift the burden of cost from the insurance company to the patient.  If you have a chronic condition such as diabetes or asthma, it could suddenly become more expensive for you to get your needed medications if the drug plan that you most likely pay into stops covering those medications.

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Mettler Toledo
Mettler Toledo
Life Technologies