BMJ  2004;329:182-183 (24 July), doi:10.1136/bmj.329.7459.182

Editorial

Which drugs should be available over the counter?

The criteria are clear and include safety, timeliness, and opportunity cost

The first 150 words of the full text of this article appear below.

As contraception after intercourse, levonorgestrel is available by prescription in the United States and in most other countries. In over 30 countries it is available without prescription.1 Levonorgestrel recently came to wide attention when the US Food and Drug Administration (FDA) acted on an application to switch the drug to non-prescription or "over the counter" status.2 The application was supported by essentially all internal scientific staff and the external advisory committee of the FDA, but the FDA rejected the application. The reason given had to do with the ability of women to understand the appropriate use of the product,3 but this issue had been explicitly discussed and settled to the satisfaction of the FDA's scientists and external advisory committee4 The FDA's explicit denial that the decision had been the result of political pressure has been received with scepticism.5-8

How should policy makers decide which drugs should be available over . . . [Full text of this article]

Robert R Fenichel, consultant

3922 Ingomar Street, NW, Washington DC 20015-1916 USA (bob@fenichel.net)


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Relevant Article

Impact on contraceptive practice of making emergency hormonal contraception available over the counter in Great Britain: repeated cross sectional surveys
Cicely Marston, Howard Meltzer, and Azeem Majeed
BMJ 2005 331: 271. [Abstract] [Full Text] [PDF]

This article has been cited by other articles:

  • Aronson, J. K. (2009). From prescription-only to over-the-counter medicines ('PoM to P'): time for an intermediate category. Br Med Bull 90: 63-69 [Abstract] [Full text]  
  • Marston, C., Meltzer, H., Majeed, A. (2005). Impact on contraceptive practice of making emergency hormonal contraception available over the counter in Great Britain: repeated cross sectional surveys. BMJ 331: 271- [Abstract] [Full text]  

Rapid Responses:

Read all Rapid Responses

Unsafe sex: treat the whole condition!
veronique verhoeven, et al.
bmj.com, 23 Jul 2004 [Full text]
Hazards of isotretinoin
Javier Borja, et al.
bmj.com, 23 Jul 2004 [Full text]
POM to P in the UK
John S Watts
bmj.com, 23 Jul 2004 [Full text]
Drugs with high dose of Vitamin A should not be available
Umesh Kapil, et al.
bmj.com, 24 Jul 2004 [Full text]
isotretinoin
Sonya M Havill
bmj.com, 28 Jul 2004 [Full text]
Dr
Robert R. Fenichel
bmj.com, 29 Jul 2004 [Full text]
The answer is simple. All drugs should be available over the counter.
N Portman
bmj.com, 10 Aug 2004 [Full text]
..simple. All drugs should be available .. to competent adults
Sam Lewis
bmj.com, 11 Aug 2004 [Full text]
In Mexican "pharmacias" one can buy Thalidomide over the counter.
Dr. Herbert H. Nehrlich
bmj.com, 11 Aug 2004 [Full text]
Levonorgestrel is hazardous
Ellen C G Grant
bmj.com, 15 Aug 2004 [Full text]
recent travels
Robert R. Fenichel
bmj.com, 17 Aug 2004 [Full text]
Chaos and control
Phillip J. Colquitt
bmj.com, 18 Aug 2004 [Full text]
Hormonal contraceptives should not be OTC
Ellen C G Grant
bmj.com, 18 Aug 2004 [Full text]
To travel does not mean one has arrived
Dr. Herbert H. Nehrlich
bmj.com, 19 Aug 2004 [Full text]
questions and answers
Robert R Fenichel
bmj.com, 26 Aug 2004 [Full text]
OTC progesterones are dangerous
Ellen C G Grant
bmj.com, 27 Aug 2004 [Full text]



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