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---------- 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 %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%