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Public consultation ARM 43: Request to reclassify azithromycin 500mg from POM (prescription only medicine) to P (Pharmacy)

Document details:

Type: Publication
Series No: 43
Audience: Healthcare professionals
Published: 21 June 2007
Format: Electronic
Size: A4
Pages: 24
Price: Free
ISBN/ISSN:
Author: MHRA
Copyright: Crown
   

Consultation ARM 43 (205Kb) sought  your views on the reclassification from POM to P of  azithromycin 500mg.  The reclassification summary and patient information leaflet included in the consultation document available to download below.

Outcome of consultation exercise ARM 43 - 6 August 2008
A total of 52 responses to the consultation were received, of which 37 supported the reclassification from POM to P, 6 did not support the reclassification, 7 raised issues but expressed no definitive views, and 2 had no comments.

Those in favour considered the reclassification would provide easier and effective access to treatment for patients, who may find difficulty in opening up about sensitive issues with GPs, especially teenagers. Early treatment of this prevalent infection may help reduce the chances of onward transmission and also help to reduce incidence of infertility in the long-term.

Pharmacy availability of azithromycin supports self care. Pharmacies are conveniently located and have more flexible opening hours including at weekends. Pharmacists are accustomed to dealing with patients who wish to discuss sensitive, confidential issues or symptoms, for example,  through the provision of emergency hormonal contraception. Some pharmacies are already involved in chlamydia services and have demonstated that provision through a community pharmacy is safe and effective.

Organisations supporting the reclassification

These included:

  • Medical colleges - the Royal College of General Practitioners (RCGP), the Royal College of Physicians (RCP), the Royal College of Obstetricians (RCOG), Royal College of Physicians and Surgeons of Glasgow (RCPSG) 
  • Pharmacy organisations - Royal Pharmaceutical Society of Great Britain, National Pharmacy Association, Company Chemists Association and other representative organisations, Chief Pharmaceutical Officer, Scotland
  • NHS organisation representatives – PCTs, NHS Trusts, Sexual Health Departments, NHS Boards (Scotland)
  • Other organisations including the British Association for Sexual Health and HIV, National Chlamydia Screening Programme, HPA Sexual Health Programme and Centre for Infections, Terrence Higgins Trust, Centre for Sexual Health and HIV Research, Independent Healthcare Advisory Service.


Organisations not supporting the reclassification
These included the British Medical Association, the Pharmaceutical Society of Northern Ireland and an NHS Trust. 

Organisations raising issues but not expressing a definitive view included the Advisory Committee on Antimicrobial Resistance and Healthcare Associated Infection (ARHAI) and the Royal College of Physicians of Edinburgh (RCPE).

A number of issues were raised by all respondents in relation to aspects of the pharmacy provision, including communication between pharmacy and local sexual health services, partner notification and treatment, suitability of IT systems for security/ patient confidentiality, and the emergence of antimicrobial resistance.

Copies of the responses (excluding those marked as "in confidence") are available below.

The following table broadly indicates how pharmaceutical bodies, medical bodies, and others responded to the consultation.

Professional Pharmaceutical Societies, Individual Pharmacists, Prescribing Advisers of PCTs etc and other pharmaceutical bodies

Yes to Reclassification

 Yes to reclassification but issues raised

No to reclassification

Medical Colleges, Clinicians and other medical/professional bodies

Yes to reclassification

 No comment

 No definitive views on reclassification but issues raised

 Yes to reclassification but issues raised

 No to reclassification

Industry

 No comment

Patient Groups, Consumer Groups, Charities and Members of Public

Yes to reclassification



Page last modified: 05 August 2008