27 December 2003
|% Change||Absolute Change|
|Pain Relief Total||465.4
|Adult Oral Analgesics||335.5
|Oral Lesions and Toothache||26.1
|Skin Treatments Total||353.1
|Cold Sore Treatments||25.2
|Dry Skin Treatment||61.7
|Feminine Care/Lub Jelly||18.2
|Insect Bite/Antiseptic Sprays||11.5
|Infestation (Head Lice)||17.6
|Cold Flu Decongestants||185.1
|Irritable Bowel Syndrome||5.1
|Stomach Upset Remedies||22.8
|Eye Care Treatment||39.2
|Sleeping Aids (incl. Herbal)||28.0
|Vitamins and Minerals||295.7
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
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.