---------- Forwarded Message ----------

From:   Shaun O'Connell, 106161.1575
TO:     mailbase, INTERNET:[log in to unmask]
DATE:   16/12/96 23:00

RE:     Copy of: Changes to Paracetamol Availability: A disaster for GP?

GPs wake up to the proposed changes to paracetamol availability. Contact
the MCA for their discussion documents. Tel 0171 273 0270 and ask for
consultation MLX231 to be faxed to you. GPs are yet again going to have to
pick up the pieces of another MCA knee jerk reaction to calls to ban
paracetamol. Patients are going to lose any confidence they have to take
paracetamol as they won't be able to get it in any decent quantity to make
it worthwhile. See the letter I have written to the MCA. Feel free to copy
it. Responses have to be in by the 10th January. Great time to hold a
consultation exercise. Not!

Copy of Letter:

Dr John Price
Department of Health
Medicines Control Agency
Room 1106
Market Towers
1 Nine Elms Lane
LONDON SW8 5NQ

Dear Dr. Price

MLX 231: Analgesic Medicines Available without Prescription: Proposed
Changes to Product Information and Sale or Supply of Paracetamol
We wish to report our views on the above proposals.
Proposed Pack Size Limits
We cannot support the proposal to restrict the availability of paracetamol
on General Sale List (GSL) or from pharmacies. The paper MLX 231 does not
detail any aim of the proposal, other than ‘to reinforce [the] safe use of
an extremely safe medicine in normal usage’. No reason is given for why
pack sizes should be reduced, no comment is made on whether the changes are
expected to have any specific effect, and no evidence is presented to
support the rationale behind the changes.
The majority of users of paracetamol use it perfectly safely and
effectively. MLX 231 states this itself. The proposed changes will
therefore cause considerable inconvenience and expense to the overwhelming
majority.
We do not believe that the proposal adequately addresses the problem of
accidental or deliberate overdose. The sale of smaller quantities will
simply force those taking a deliberate overdose to purchase multiple packs,
if necessary from more than one outlet. The proposed limited quantities of
12 tablets on GSL is still sufficient to liver damage, if not fatalities in
children and 30 tablets from pharmacies is still sufficient to kill adults.
Therefore the proposals will not in themselves achieve a reduction in
overdose or in deaths. Any slight reduction in the numbers of overdoses or
their sequelae brought about by reduction of the overall pool of
paracetamol in the community will be at the expense and significant
disadvantage of the rest of the community who take these products perfectly
safely.
We believe there will be a huge knock on effect on Primary Care which may
be even greater than the cost of dealing with overdoses. The proposed
changes will affect all consumers of this safe medicine and will create a
belief that such analgesia is inherently unsafe. Already considerable
numbers of people believe paracetamol in normal doses is unsafe and are
unprepared to self medicate in situations where they have until recent
times done so. We see this frequently. Parents do not give their children
paracetamol for analgesia or as an antipyretic when it is needed. Many
people consult their GP before taking such medication themselves. We
believe this is a waste of NHS resources as many self limiting conditions
would be eased with paracetamol and do not require a GP consultation. The
public though do not feel sufficiently confident to self medicate and these
proposals will exacerbate that lack of confidence. Consultation rates in
general practice will escalate if these proposals are implemented. This
flies in the face of all attempts to encourage the public to act
responsibly and not to overuse primary care services. The proposals will
undo those efforts. Indeed we would prefer to see proposals which blacklist
the availability of paracetamol on prescription. The availability of
paracetamol on prescription wastes considerable GP time because parents
consult with children simply to obtain a free prescription of paracetamol
as do many others for whom prescriptions are free.
Those patients who are currently entitled to free prescriptions but do buy
their own paracetamol, because they can get it in large quantities fairly
cheaply and quickly, (i.e. without a GP appointment) will also turn to the
GP for their supplies if the number of tablets they can buy is restricted
when the number they can get on free prescription is unrestricted. This too
will push up consultation rates and costs in primary care and these costs
will be considerable. Such patients are not necessarily those who take
paracetamol for specific ‘chronic or recurrent conditions’ and so will not
be able to obtain multiple packs from pharmacists.
Many people take the medication for occasional aches and pains, headaches,
fevers and minor infections. These people are going to be greatly
disadvantaged by the proposal to limit pack size. The basic cost of the
drugs will inevitably rise as will the cost in time and money to obtain
them. Pharmacists will not be able to supply multiple quantities after the
proposed changes because these patients do not have chronic conditions.
Even those with minor recurrent conditions such as headaches or
dysmenorrhoea are unlikely to be able to obtain multiple packs as there
will be an expectation of the pharmacist of a responsibility to ensure such
supply is safe. Of course this is impossible. Pharmacists are unlikely to
be willing to take on such a responsibility alone.
The supply of paracetamol is analogous to speed restrictions. A maximum
speed limit of 20 miles per hour would be incredibly safe but incredibly
inconvenient. Similarly restricting the supply of paracetamol.
The real issue is individual responsibility and patient education. We
should not go down the road of becoming a nanny state. People must be
allowed to take responsibility for their own actions. These proposed
changes strike at the foundations of individual responsibility - the
ability to deal with minor illness.
Product Information
We warmly welcome the new warning label and inclusion into the patient
information leaflet. We think it would be helpful too if all over the
counter medicines contained the maximum recommended dose of paracetamol for
adults or children. This is generally accepted as 1000mg for adults but
many products available on GSL or from pharmacies do not contain this much
paracetamol and this is confusing. In order to receive the recommended dose
patients have to try and increase their intake with extra paracetamol
tablets which is hazardous. This issue should be given serious
consideration.
Yours sincerely


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