|
Tim Root is specialist pharmacist, clinical governance
and technical services for London East and South East specialist
pharmacy services, based at the Chelsea and Westminster Hospital,
London. |
A recent article in the Pharmaceutical Journal1 and subsequent correspondence
regarding “specials” in the NHS, have highlighted a number
of issues of importance to pharmacists involved in their use and manufacture.
It seems that management of specials is sometimes seen as an issue mainly
for technical services pharmacists, centred on “what product do
we want and where can we get it from?” Clinical governance must,
however, start at the point of prescribing.
Clinical pharmacists must satisfy themselves that a special is essential
and prescribers must be reminded that an unlicensed medicine will never
carry the same level of assurance of quality, safety or efficacy as a
licensed medicine. Only after a thorough exploration of all possible
options should the prescription for an unlicensed product be agreed and
written.
Hospital and community pharmacists should remember that while the prescriber
takes overall responsibility for patient safety, the pharmacist who buys
the special is responsible for its quality. Further guidance on this
is available from the Medicines and Healthcare products Regulatory Agency2 and the NHS QC Committee.3
In 1976, the Breckenridge report recommended that all intravenous drug
doses should be prepared in pharmacies.4 However, 25 years later in 2001,
the Audit Commission found evidence that high-risk injectable medicines
were commonly being prepared in near-patient areas in English hospitals.5 The scale of use and complexity of intravenous drug therapy has increased
faster than pharmacy service capacity, and risk-potential has increased
concomitantly.
Today’s pharmacy managers must take a holistic view of the demands
on technical service resources. Products for manufacture or preparation
in pharmacy should be prioritised primarily by clinical risk. Senior
pharmacists must consider the opportunity costs of continuing to make
specials with low risk-potential if alternative sources of supply are
available. NHS resources should be directed first at high-risk medicines
identified by local risk assessment as being made in clinical areas.
All manufacturers licensed by the MHRA to produce specials should be
working to the same standards of good manufacturing practice. Choice
of manufacturer may depend on factors including lead time and product
availability, labelling and packaging, formulation and price. It must
be explicit for every product whether it has been manufactured and subject
to retrospective quality assurance or dispensed under section 10 exemption
of the Medicines Act 1968.
We must also challenge the perception that non-NHS manufacture is always “expensive”.
Before drawing conclusions, we must be sure that our own costings are
realistic and accurate and our prices account for all relevant costs
and the need to generate income for reinvestment in the services and
facilities. Failure to do this in the past may have generated misleading
cost comparisons. The proposed inclusion of some specials in the Drug
Tariff is an opportunity to review prices.
Rationalisation
The scale of use and manufacture of specials can be considered as a
spectrum. At one end are those rarely-used products, made in very small
quantities, to rudimentary formulae supported by little, if any, stability
or shelf-life data. There is probably only anecdotal evidence of efficacy
and safety for these products. At the other end of the spectrum are products
which have been widely used for years and are made by several manufacturers
to validated formulae. In between these extremes lies a plethora of products.
Work done by the Department of Health in 2000 produced a list of over
6,000 items made by NHS hospital pharmacies, and there was evidence of
considerable product duplication.
Rationalisation is a key step towards development of a core of products
justified by defined clinical need, supported by evidence of safety and
efficacy and made to validated formulae.
If such rationalisation is to be acceptable to clinicians, they must
be involved in the process. By virtue of their proximity to patients,
clinical pharmacist colleagues and prescribers, managers of NHS manufacturing
units are in a unique position to facilitate rationalisation. NHS capacity
alone will never be sufficient to meet demand and the NHS and non-NHS
sectors should collaborate and play to their individual strengths rather
than compete.
The future
Doctors and pharmacists need access to comprehensive, accurate and objective
information about specials and manufacturers yet, historically, there
has been no single source of such information. The National Implementation
Board for modernisation of NHS medicines manufacturing and preparation
services, has developed Pro-File, a web-based decision-support tool to
provide NHS staff with detailed information about all specials made in
the NHS. Pro-File will be available to registered NHS pharmacy staff
in secondary care in the second quarter of this year. It will support
decision-making to identify and source specials and opportunities for
product rationalisation. Once the utility of Pro-File has been established,
it is hoped to expand access to community pharmacists.
References
1. Gross Z. Why specials manufacturing units are needed now as much
as they ever were. The Pharmaceutical Journal 2005;275:743-6 (PDF 70K)
2. Medicines and Healthcare products Regulatory Agency. Guidance Note
14. The supply of unlicensed medicinal products for individual patients.
London: MHRA; 2005.
3. NHS QC Committee. Guidance for purchase and supply of unlicensed medicinal
products — notes for prescribers and pharmacists, 3rd Edition.
The committee;2004.
4. Breckenridge A. Report of the working party on the addition of drugs
to intravenous infusion fluids [HC9769]. London. Department of Health
and Social Security; 1976
5. Audit Commission. A spoonful of sugar: medicines management in NHS
Hospitals. London: the commission; 2001. |
Hospital Pharmacist