Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

ARM 51: Request to Reclassify a Product from POM to P - Cystobid 100mg Capsules

Deadline for response:

14 April 2008

Background: The Medicines and Healthcare Products Regulatory Agency consulted sought views on a proposal to reclassify Cystobid 100mg Capsules from POM to P. The active ingredient is 100 mg Nitrofurantoin in the form of nitrofurantoin macrocrystals and nitrofurantoin monohydrate.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
ARM 51: REQUEST TO RECLASSIFY A PRODUCT FROM POM TO P - CYSTOBID 100MG CAPSULES

The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on consultation ARM 51: Request to Reclassify a Product from POM to P - Cystobid 100mg Capsules.  

The proposal to reclassify the Cystobid formulation of nitrofurantoin for treatment of cystitis is relatively safe and builds on proven efficacy.  However, an accurate response to the accompanying questionnaire is required to minimise the dangers of taking this drug outside Prescription Only supply.

The pharmacy protocol and questionnaire have not been included with the consultation document.  Questions remain over several factors, including how sensitive is the pharmacy protocol in detecting:

(a)        asymptomatic renal disease;
(b)        mild adverse reactions with previous courses of nitrofurantoin; and
(c)        verifying that the diagnosis of cystitis has been previously made by a physician.

Therefore, no comment can be made on the power of the protocol to reduce risk of the medication being consumed by patients who have contraindications. 

In the accompanying Patient Information Leaflet, kidney disease has been mentioned in section 2, 1st paragraph, under the title “Before you take Cystobid”.  Kidney disease should also be included in the subsequent paragraph titled, “Do not take Cystobid if:”, along with diseases of the lungs, liver or nervous system.

In that same section, an additional line would be worthwhile stating that, whether symptomatic or not, Cystobid should not be taken if the patient had been advised that previous courses caused abnormal test results.  Although it is already implicit, the presence of an indwelling urinary catheter should be stated as a specific contraindication to the use of this product in this way.

There are some minor spelling mistakes such as “symtoms” in the first paragraph, 7th line of the Patient Information Leaflet.            

Overall, the College supports this proposal to move nitrofurantoin from POM to P.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[8 April 2008]