Switching prescription drugs to over the counter

British Medical Journal

Volumn 330, Issue 7481, 2005, Pages 39-41

  Cohen, Joshua P ^a   Paquette, Cherie ^a   Cairns, Catherine P ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHISTAMINIC AGENT; CETIRIZINE; ESOMEPRAZOLE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LANSOPRAZOLE; LORATADINE; NON PRESCRIPTION DRUG; OMEPRAZOLE; PRAVASTATIN; PROTON PUMP INHIBITOR; SIMVASTATIN; ZOLPIDEM;

ALLERGY; CARDIOVASCULAR DISEASE; DRUG APPROVAL; DRUG COST; DRUG INDUSTRY; DRUG USE; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL DISEASE; GOVERNMENT; HIGH RISK PATIENT; HUMAN; HYPERLIPIDEMIA; NATIONAL HEALTH SERVICE; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; SELF MEDICATION; SWEDEN; UNITED KINGDOM; UNITED STATES;

EID: 11244346687     PISSN: 09598146     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmj.330.7481.39     Document Type: Review

References (10)

1. OTC statins: a bad decision for public health. Lancet 2004;363:1659.
2. Medicines and Healthcare Products Regulatory Agency. Consultation document: ARM 18 Request to reclassify a product from POM to P. London: MHRA, 2003. www.mca.gov.uk/inforesources/publications/arm18.doc (accessed 13 Sep 2004).
3. Cohen J. Switching omeprazole in Sweden and the US. Am J Ther 2003;10370-6.
4. World Self Medication Industry. OTC ingredients table. www.wsmi.org/otc.htm (accessed 13 Sep 2004).
5. Cohen J, DiMasi J. Modeling a switch of loratadine from prescription to over-the-counter status. J Res Pharm Econ 2001;11:43-54.
6. Wellpoint. Issue paper: FDA petition for prescription to over-the-counter switch for Claritin, Allegra, and Zyrtec. www.fda.gov/ohrms/dockets/dockets/ 98p0610/cp00001.pdf (accessed 8 Mar 2004).
7. US Food and Drug Administration, Center for Drug Evaluation and Research. Public hearing on OTC part 15. June 28, 2000. www.fda.gov/ohrms/dockets/ dockets/00n1256/tr00001.rtf (accessed 8 Mar 2004).
8. Nonprescription Medicines Academy. Joint FDA advisory committee recommends approval of Prilosec (omeprazole) for OTC switch at full prescription strength. www.nmafaculty.org/news/prilosec.htm (accessed 5 Feb 2004).
9. US Food and Drug Administration. FY 2004 FDA budget in brief: promoting public health through&c#10;patient, food, and consumer safety. www.fda.gov/oc/oms/ofm/budget/2004/BIB.htm (accessed 29 Jan 2004).
10. Bristol Myers Squibb. Advisory committee meeting briefing book: for the Rx-to-OTC switch of: NDA 21-198 Pravachol® (pravastatin sodium) 10mg tablets. www.fda.gov/ohrms/dockets/ac/00/backgrd/3622b2a_part1.pdf (accessed 30 Jan 2004).