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Letters to the Editor
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Compliance aids
Raising the profile of a serious clinical governance issue
From Mrs J. Smith, MRPharmS and Mrs C. Church, MRPharmS
We are pleased that the publication of our article “How stable
are medicines moved from original packs into compliance aids?” (PJ,
21 January, p75 PDF (60K)) has generated a lot of interest since one
aim of the article was to raise the profile of this topic. We have received
13
e-mails and one telephone call, in addition to the six letters published
in the PJ.
Every day pharmacists are faced with the dilemma of what they should
place in these aids, what communication is needed about this and the
implications resulting from whether a medicine is included or not. The
fact is there is still a shortage of short-term stability data for the
transfer of medication to compliance aids. The dispensing of medicines
in this way is unlicensed and remains the responsibility of the pharmacist
and/or physician.
We have heard reports that some retail pharmacy chains are using this
information and now advising their pharmacists not to pack any medicines
of questionable stability into compliance aids. This action obviously
risks complicating the medication regimen of a patient who already has
compliance problems. As pointed out by Peter
Williams in his letter (PJ,
11 February, p167), “what should actually be central to this issue
is the welfare of the patient.” We strongly agree with his comments
that caution should be shown in pharmacists hastily translating the “no
stability data available” to “do not transfer”.
With the lack of available data, we do not know if and which medicines
will deteriorate to a sufficient level to affect the treatment of the
patient. The majority of compliance aids contain just seven days’ worth
of medication, but the risk of significant deterioration is unknown.
This does not just affect compliance aids packed by pharmacists, but
also affects those transferred by patients and their carers and relatives.
If a stability issue exists for a particular medicine, then the patient’s
doctor may have increased the dose to compensate for this. If this patient
is then admitted to hospital and given medicine not stored in a compliance
device, the effect of this stable medicine may have a negative clinical
effect on the patient.
We have encountered situations where a community pharmacist has packed
an item that in hospital we would not normally pack. We are then faced
with the dilemma of what to do. A standardised list will help to some
extent but there may be instances where the doctor and pharmacist still
decide that it is in the patient’s interest to place an unstable
product in the compliance aid.
We will be working with South Gloucestershire Primary Care Trust in joining
the “Integrated medicines management programme for long-term conditions” collaborative
with a focus on compliance aids and hope that this forum will clarify
the situation locally. In our trust, we are also considering extending
the use of unlicensed indication forms. These ensure that the prescriber
is contacted verbally, is fully aware of the stability and unlicensed
issues, and retrospectively signs to accept responsibility for prescribing
drugs in these situations.
However, we believe that this is a serious clinical governance issue
for pharmacists practising in both primary and secondary care and for
this reason we urge the Royal Pharmaceutical Society’s practice
division to explore the opportunities for the development of guidance
on this difficult subject as soon as possible.
Jane Smith
Acting Principal Pharmacist, Service Development
Claire Church
Community Liaison Pharmacist, Southmead Hospital
North Bristol NHS Trust
Pharmacists need have no qualms
From Mr M. Reynolds, MRPharmS
Monitored dosage systems have been in use for many years. They were introduced
during a time when most tablets and capsules were supplied loosely in containers,
the quantity therein ranging from 100 to 5,000 (or even more). European
legislation is responsible for blister packaging, although some tablets
and capsules are still being supplied loosely in containers. There have
been letters in the PJ recently about the supply of tablets and capsules
being “repackaged” in MDSs and some doubt expressed over stability
and concern about the possible breach of the product licence.
Pharmacists contract to supply medicines against an NHS prescription. Part
II of Schedule 2 to the Drug Tariff Regulations under the NHS Regulations
prescribes the containers (glass, plastic, etc) that are to be used and
MDSs must comply with these regulations. It appears that the common practice
of pharmacists is to dispense MDSs to cover between one or two weeks’ supply,
and up to a maximum of four weeks’ (28 days), depending on the requirements
of the patient. Pharmacists are simply moving tablets and capsules from
one air tight “blister” to another. There surely can be no
question of stability problems within the short time span between dispensing
and swallowing. Pharmacists do not repack any tablets or capsules that
are hydroscopic.
My understanding is that the product licence ensures that we (and the general
population) receive medicines to a standard quality. The NHS dispensing
regulations then control the next process. Under the NHS Regulations pharmacists
are not selling a licensed product but making a supply. A new aspect now
within the NHS contract makes particular reference to MDSs, to meet the
requirements of patients covered by the Disability Discrimination Act.
However, protection against repetitive strain injury is provided by the
Health and Safety Regulations. In my opinion, pharmacists looking after
their patients’ needs by supplying MDSs, need have no qualms or uncertainties.
Michael Reynolds
Christchurch,Dorset |
The
Pharmaceutical Journal