Select Committee on Health Written Evidence


Annex 1

MARKET DATA


52 w/e
27 December 2003
% Change
Absolute Change
£ million

Pain Relief Total
465.4
4.2%
18.9
Adult Oral Analgesics
335.5
2.0%
6.4
Paediatric Analgesics
55.6
9.9%
5.0
Topical Analgesics
48.2
13.2%
5.6
Oral Lesions and Toothache
26.1
7.8%
1.9
Skin Treatments Total
353.1
7.8%
25.5
Anti-Fungals
60.6
7.4%
4.2
Anti-Haemorrhoids
20.2
0.8%
0.2
Antiseptic Liquids
19.2
-0.2%
0.0
Antiseptic Creams
22.8
4.9%
1.1
Cold Sore Treatments
25.2
5.9%
1.4
Dry Skin Treatment
61.7
11.7%
6.4
Feminine Care/Lub Jelly
18.2
13.4%
2.2
Insect Bite/Antiseptic Sprays
11.5
8.9%
0.9
Medicated Skincare
84.7
12.0%
9.1
Scalp Treatments
11.4
2.6%
0.3
Infestation (Head Lice)
17.6
-0.9%
-0.2
Cough/Cold/Sore Throat
375.5
3.9%
14.0
Cold Flu Decongestants
185.1
6.9%
12.0
Cough Liquids
98.3
1.6%
1.6
Medicated Confectionery
92.1
0.5%
0.4
Gastro-Intestinal
235.9
3.2%
7.4
of which:
Anti-Diarrhoea's
39.3
2.4%
0.9
Indigestion Remedies
114.7
3.8%
4.2
Irritable Bowel Syndrome
5.1
3.2%
0.2
Laxatives
47.3
5.6%
2.5
Stomach Upset Remedies
22.8
-0.4%
-0.1
Travel Sickness
6.8
-4.4%
-0.3
Medicated Mouthwash/Sprays
23.0
10.3%
2.1
Hayfever Remedies
79.2
13.5%
9.4
Eye Care Treatment
39.2
4.2%
1.6
Sleeping Aids (incl. Herbal)
28.0
4.9%
1.3
Smoking Cessation
77.8
11.3%
7.9
Vitamins and Minerals
295.7
-3.3%
-10.2
TOTAL OTC
1,972.8
4.1%
78.0

LEGAL STATUS FOR SUPPLY CONTROLLING WHERE MEDICINES ARE SOLD

  UK medicines legislation provides for products to fall into one of three categories for the purpose of defining the route by which they may be sold or supplied to patients/consumers, (ie their legal status or classification):

    —  Prescription Only Medicines ("POM") which is self explanatory.

    —  Pharmacy Sale medicines ("P").

    —  General Sales List medicines ("GSL").

  The system for classifying medicines centres upon consideration of the active ingredient(s) and its safety per se. This takes into account the dose, which is considered to offer optimum benefit/risk balance and the maximum effective dose, which could be safely taken in one day. On top of that the indications for which the ingredient is to be used are considered. The formulation or way the ingredient is presented may also be relevant, as may the pack size.

OTC medicines fall into two of these legal categories controlling access

  1.  Authorised medicines available without prescription but legally confined to pharmacy distribution ("Pharmacy" or "P" medicines). The law requires that the sale of these medicines occur in a registered pharmacy under the supervision of a pharmacist. "Supervision" means that the pharmacist must be aware of the sale and in a position to intervene if necessary. There is no list defining which products are P medicines. This category consists of products, which have not been classified either as "GSL" or "POM". Amongst the most significant P ingredients are codeine for pain relief, antihistamines for allergies, decongestants and a number of ingredients such as H2 antagonists and topical hydrocortisone which have moved from prescription control.

  2.  Authorised medicines legally saleable in any retail outlet ("General Sales List" or "GSL" medicines). These are defined as "medicines, which can with reasonable safety, be sold or supplied without the supervision of a pharmacist, and where wider availability would be a convenience."

  EU criteria define which products must be subject to prescription control (Directive 92/26/EEC Article 3). They include:

    —  the potential for abuse or misuse of the product;

    —  the possibility that the products could be toxic even if used correctly without medical supervision; and

    —  products containing substances requiring further investigation of side effects.

    —  All injectable products are prescription only.

  New drugs are restricted to supply on prescription for the first five years of marketing. For the first three years, the company holding the marketing authorisation and the MHRA intensively monitor these POM products, during which time their safety profile is more fully established. The start of a switch dossier is an extensive review of the adverse reaction reports held by the company and by the MHRA, and reports world-wide, to establish that it is safe enough to use the product without medical supervision.





 
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