The Pharmaceutical Journal Vol 266 No 7153 p852-856
June 23, 2001

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Monitored dosage systems

Stability evidence needed

From Mr M. E. Q. James, FRPharmS

Andrew Calder (PJ, June 16, p819) makes an important point. There is little good evidence of the suitability of any of the monitored dosage systems (MDSs) for repackaging, or information as to the continued stability of medicines when removed from a manufacturer’s original packaging for long periods before use. In fact, the opposite is true: there is a good deal of confusion.This is of particular concern when one considers the variety of “officially” supported schemes around this activity.

I have been working on this over the past three years, and some two years ago I encouraged a preregistration trainee, who was then undertaking his training with Basildon and Thurrock NHS Trust, to carry out a postal survey of manufacturers, using as examples the medicines we were then repackaging for a care of the elderly unit without qualified nursing staff.

My student obtained a variety of responses (including none from several major companies). Since he left I have been following up the issue, particularly in my capacity as a nursing home inspector, and I am in touch with colleagues in other hospitals who are also concerned. I have not myself seen a response similar to that described by Mr Calder (that medication was, as a result of such repackaging, outside the product licence) and I would be most interested to know to which medicines this refers. Company representatives have told me that they “have never come across people repackaging medicines in this fashion” and I have even been led to believe that head offices of major manufacturerers have never heard of the practice of redispensing into MDSs. I do think, in fairness, that it is extremely difficult for manufacturers. They obtain a marketing authorisation based upon certain specifications, including the packaging, and if we ask them if it is OK to ignore this, what can they, legally, say? I do think, though, that they ought to exhibit some awareness of what is happening to their products in the real world. The manufacturers of MDSs have a responsibility in this as well.

There are some MDSs on the market which, I suspect, should only be used for short times since they are unquestionably neither light- nor air-tight. But MDS manufacturers have their difficulties, too. Are we to ask them to carry out stability tests on everything that might go into their packaging? I do not think this is feasible, but should the products be marketed without some tests? We ought to have basic data on permeability of seals, protection of blister contents from light, or parts of the light spectrum, and it would be interesting to see what the situation is in North America, where, I understand, these systems are also widely used. I believe that Manrex, for example, “complies with USA standards” but I have not yet identified what these are, or whether the product in Britain is the same.

The information I have indicates that colleagues should have concerns over a number of preparations frequently included in MDSs, particularly amlodipine, atenolol, co-careldopa and venlafaxine.

There are also differences between different manufacturers’ advice, for example, on ranitidine. When asked for an MDS for a patient, my colleagues and I now enquire of the manufacturers, if we have no recent information, as to whether their medicines can be safely removed from their blisters for repackaging and, if so, for how long. Experience suggests that a product ought to be stable outside its manufacturer’s packaging for at least 35 days to be suitable for repacking into an MDS.

Obviously issue one is patient safety. Are we, in supplying medicines in MDSs, failing to ensure this? However, if we do not so supply, and the patient takes either all or nothing, where do we stand? Secondly, there are many social services departments and other care agencies whose staff have been instructed only to administer clearly identified doses. My opinion is that a “patient pack” from the manufacturer should be adequate in such circumstances, but at least one local social services department takes the opposite view.

I will be most interested to learn of other pharmacists’ information and experiences and I am happy to share what information I have.

Miall James
Pharmacy Department,
Orsett Hospital,
Orsett,
Essex RM16 3EU

e-mail Miall.James@btgh-tr.nthames.nhs.uk

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