The Pharmaceutical Journal
Vol 275 No 7362 p192
13 August 2005

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Is it ethical to use monitored dosage systems when efficacy is questionable?

By Bob Gartside

The Department of Health and the Pharmaceutical Services Negotiating Committee have decided that the supply of monitored dosage systems should be covered by the new pharmacy contract.

Initially it was proposed that patients should be assessed for suitability for MDSs and that their supply should be directly remunerated. Continuous assessment of patients is necessary because on the spectrum between normality and complete loss of mental function there is a narrow band of patients who might possibly benefit from MDSs. There has to be some deterioration of faculties before an MDS is necessary, but the patient must retain sufficient function to be able to operate the device. Difficulties arose, however, in determining which screening tests that could be applied in pharmacies would be both economical and effective.

Whatever the reason, direct individual payment for MDSs was ruled out and an extra payment for each and every prescription was decided upon as the funding mechanism, with pharmacy contractors making the treatment decisions in each individual case. It was also intended to have an approved list of MDS devices, but this has now been abandoned on grounds that are unclear.

It is also not clear whether MDSs can be prescribed or not and, if so, by whom. The position appears to be that pharmacy contractors are expected to make their own assessment of each patient, with global funding provided by a small additional amount added to the general payments for all prescriptions. The potential for confusion and conflict is obvious.

Now we live in an era of evidence-based medicine so we would expect pharmacy contractors to inform themselves, perhaps by way of their continuing professional development, as to the clinical evidence for the various types of MDS and their suitability for various types of patients. We might also expect contractors to weigh the clinical evidence in order to make cost/benefit decisions in individual cases so as to ensure that the strictly limited funds are deployed to maximum clinical benefit. Such treatment decisions, of course, would be made in consultation with the patient’s carers, whom we would also reasonably expect to be similarly fully informed of the costs and benefits of all of the different types of MDS.

Alas, there appears to be a paucity of peer-reviewed, published clinical evidence on MDSs. Let us be more specific: a number of different literature searches have produced little in the way of results, possibly pointing once again to a need for a “Journal of Negative Results”.

The best review paper found is a conference presentation by Nunney, Raynor and Knapp. They carried out an extremely thorough literature search using all the available medical search engines, covering the period 1982 to 2004, and found only 28 relevant papers. Of these, only seven reached an acceptable standard and, of these, three showed increased patient compliance with MDSs and four showed no improvement in patient compliance with MDSs. The researchers commented: “The number of trials identified was too small to produce evidence of effect.”

This raises an important ethical consideration. If there is no acceptable evidence that MDS does any good, is it possible that it is harmful? We cannot even answer this question because of the lack of evidence; the treatment must essentially be regarded as unproven. The question then arises as to whether we should be using unproven treatments for handicapped patients since we do not know the balance of risks and benefits. Most of the marketing for these systems appears to be no more than an appeal to common sense.

Now we do know that common sense is not a reliable guide to decision making because it has been shown so often by rigorous investigations in other areas that counter-intuitive results are surprisingly common. Indeed, the great physicist Albert Einstein was moved to remark that common sense is merely the sum total of our accumulated prejudices and, by implication, is no guide at all. We need only mention the manual dexterity needed to extract tablets and capsules from MDS trays to see where the appliances might be counter-productive. It is common for patients to return MDSs because they find them too difficult to use.

In addition, there is a lack of evidence about the stability of pharmaceutical products repackaged in MDSs, although it is known that certain products are so unsuitable that they should not or must not be put into them. This surely strongly suggests that there are likely to be more products that are unsuited to this form of supply but which have not been stability-tested for a variety of reasons. The fallback position surely must be that only those products that have been stability-tested in MDSs should be repackaged in MDSs, and then only in the type of MDS used for the stability studies.

There is, of course, a clear and compelling case for rigorous controlled clinical studies and we might express mild surprise that the schools of pharmacy, the manufacturers and the Department of Health have not taken up this challenge. But then there is a general crying need for research in the practice of pharmacy, of which this is but one example. All of this leaves pharmacists at the sharp end with an acute practical and ethical dilemma.

There is strong demand from patient’s carers (including their doctors) for MDSs but there is a lack of acceptable clinical evidence of efficacy and, in such a situation, the precautionary principle “do no harm” would suggest that MDSs be withheld. It should make no difference whether there is a notional Department of Health payment; it should make no difference if carers make demands for they almost certainly do not have the clinical pharmaceutical skills to make a judgement. What would make a difference is some professional and ethical guidance, which is now sorely needed.