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Letters to the Editor
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Compliance aids
Encouraging manufacturers to supply stability data
From Mr S. Eastham
At Boots The Chemists we support the view taken by Claire Church and
Jane Smith (PJ, 21 January, pp75–81 PDF (60K)) that there are insufficient
short term stability data available for medicines and we encourage manufacturers
to provide fact-based data on this subject in the future.
Increasing numbers of patients receive medicines in compliance aids to
help them get best use from their medicines and to reduce the likelihood
of mistakes in administration. Carers of patients welcome the additional
safety, security and compliance that such aids can bring to the management
of medicines and have been known to make strong representations to pharmacists
when a medicine is omitted from a compliance aid on stability grounds.
The experience that many pharmacists have gained though years of dispensing
suggests that manufacturers sometimes take a conservative stance on the
advice they give. Use of disposable systems eliminates cross contamination
and sealed units also minimise moisture damage.
Given that an increasing proportion of prescriptions will be provided
in the future to patients who would benefit from such aids, there will
be competitive advantage, in the future, for the manufacturer who provides
fact-based information on this issue. Boots The Chemists is willing to
work alongside manufacturers to obtain the required data for sealed disposable
systems and looks forward to manufacturers stepping forward with proposals
to undertake such research.
Steve Eastham
Head of Professional Governance
Boots The Chemists Ltd
No place in modern practice
From Mr R. Wakefield, MRPharmS
I write with reference to Chris
Toothill’s letter (PJ, 28 January,
p105) and the article on the stability of compliance aids (PJ, 21 January,
p75 PDF (60K)). The issues raised have only confirmed my beliefs that our keenness
to supply monitored dosage systems to patients has no place in modern
practice. Quite often we are asked to supply MDS to cover up shortfalls
in care from the social services.
What is the answer? Is it to have the appropriate agencies take on the
responsibilities rather than pharmacy? With the double edged sword of
clinical governance and professional liability never far away I would
be interested to hear the views of the National Pharmacy Association,
Pharmacy Mutual Insurance, the Pharmaceutical Services Negotiating Committee
and the Royal Pharmaceutical Society on what is effectively the use of
products outside their product licences.
Richard Wakefield
Oldham, Lancashire
Pharmacists would benefit from additional stability data
From Mr J. Kitchen, MRPharmS
The article on the stability of medicines moved from original packs to
compliance aids by Claire Church and Jane Smith (PJ, 21 January,
pp75–81 PDF (60K))
provides rather more insight into the concerned legal mind of the pharmaceutical
industry and the hide-bound bureaucracy that is European pharmaceutical
legislation than it does help the practising pharmacist.
From the list it is apparent that some companies are more forthcoming with
information than others and one is tempted to wonder whether, if the perception
was that sales might be affected, the company stance may be different.
Before the introduction of the patient pack, the vast majority of dispensed
solid dose forms came in tubs of various sizes, often in 1000s, to be dispensed
into co-plastics or glass dispensing containers over an indefinite period.
Many of the products listed as “unsuitable to be placed into a multicompartment
compliance aid (MCCA)” from the manufacturer’s advice are still
packaged in bulk containers for dispensing in vials elsewhere in the world,
including in the most litigation conscious North America. The formulations
used by the pharmaceutical giants in different countries usually remain
the same because to do otherwise would require duplicate testing for stability,
toxicity and pharmacokinetics, etc, which is massively expensive and unnecessary.
The article neglected to mention the differences between the various MCCAs
although reference was made to the “Report of moisture permeability
testing of monitored dosage systems” (PJ, 1 January 1994, pp18–19).
On the same page on that day in 1994 it was announced that the Royal Pharmaceutical
Society was to “seek British Standard for monitored dosage systems”.
Now, 12 years on and we still await such a standard.
In selecting a MCCA system it is prudent to consider technical aspects
including assurance that all component parts are suitable for pharmaceutical
application and that, in the absence of any EU standard, that it complies
or exceeds the relevant USP monograph. Responsible manufacturers of MCCAs
have such relevant information available to their clients on request.
For its intended purpose the product should be completely disposable and
provide good barrier properties to moisture, dust and, if applicable, light.
Tamper evidence is also essential. The pack should be sealed in the pharmacy
under the direct supervision of a qualified person engendering confidence
of all concerned, including GPs and nursing staff, thus also raising the
perception of the pharmacy as an essential part of the patient’s
primary health care team.
MCCAs never have, and never will be, a perfect solution to the problems
of all patients and their carers but for a substantial number they provide
an invaluable support, often enabling a degree of independence otherwise
not attainable. The provision of such a service can be rewarding because
of the dialogue that necessarily occurs between the pharmacist and his
patient. A large number of colleagues have been carrying out medicines
use reviews, albeit without the acronym, and current paperwork over past
years and many have experienced a large number of good outcomes from such “informal” dialogues
with patient, prescriber and carer.
The professional judgement of a pharmacist regarding the suitability of
the final dispensing container, taken in the light of knowledge that patient
and their individual circumstances, balanced with relevant stability data
over the expected life in service of the pack, can only be to the profession’s
and the patient’s benefit.
The lack of support shown by the drug companies to the pharmacist at the
sharp end may increase reluctance to provide MCCAs for individuals without
considering the overall domestic situation. This will lead to carers being
forced to adopt their own “systems” (such as a number of open
dishes to contain tablets — or ash trays from personal experience)
and places any judgements regarding suitability, stability and risk to
the patient firmly upon those least qualified.
I agree with the conclusions arrived at and am sure that all pharmacists
would benefit from some additional stability data including the kind of
packages, and the names by which the product is known by in other markets
would be helpful in the summary of product characteristics.
John Kitchen
Buckley, Flintshire |
The
Pharmaceutical Journal