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The Pharmaceutical Journal Vol 264 No 7091 p544
April 8, 2000 Letters

Patient information leaflets

Disappointed and dismayed

From Mr D. L. Coleman, FRPharmS

SIR,-I was disappointed, dismayed and decidedly apprehensive about the Law and Ethics Bulletin (PJ, March 11, p401).
Disappointed, because it is the sort of article which gives the impression that there is little understanding of the realities of practice which so often makes Lambeth look out of touch with the membership.
Dismayed, because several years on after the legal requirements were known about we are still having to work in ways which are unethical and against one set of regulations in order to comply with another set.
Straight questions have to be asked and straight answers given: how does the requirement to give a patient information leaflet at every dispensing apply to (a) monitored dosage systems, (b) single individual doses (eg, methadone), and (c) daily or weekly compliance aids?
How should pharmacists deal with emergency supply? Is an original pack now acceptable whatever the quantity in order that a leaflet is included? Is it legal to photocopy leaflets or are they copyright? If a pharmacist has a stock of leaflets how will he know to which batch they refer? Can a "generic" leaflet be used irrespective of manufacturer? Can it ever be right to refuse to dispense a prescription on the ground that no leaflet is available? Is this a legal question or an ethical one?
And my apprehensions? I fear that pharmacists will be forced to dispense defensively, turning away prescriptions for which they have no leaflets or where the prescriber has failed to prescribe an original pack. I fear, too, that the Society may be unable to defend a pharmacist who dispensed medicines required by a patient but was unable to supply a leaflet where a subsequent complaint was made.
The issue of patient packs and patient leaflets remains totally unacceptable. Cutting off odd tablets cannot be right, yet we are forced to do it.
The Society, from both a law and practice perspective, must say to the Government: "Your regulations are contradictory and unworkable. Sort out the patient pack problems and, until you do so, the Society will back pharmacists when they do their best to get appropriate medication to patients even if no leaflet is available."
The problem of leaflets and patient packs has gone on for far too long. We must not let individual pharmacists be the scapegoats for the Government's incompetence.

David Coleman
Stalham, Norfolk

Mr STEVEN LUTENER (head of pharmacy law, professional standards directorate, Royal Pharmaceutical Society) states: The Law and Ethics Bulletin was published after it was drawn to the attention of the Society's Hospital Pharmacists Group committee that a complaint about a failure to supply a leaflet, made against a hospital pharmacist, was being investigated by the Medicines Control Agency.
The Society is not able to defend a pharmacist who fails to comply with the regulations, if another enforcement body decides to take action, nor can it defend a pharmacist against a claim for damages if harm results from a pharmacist's failure.
The Society is, though, and has been for some time, working with the industry, the Department of Health and others to try to find a practicable way to comply with the regulations.