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It is difficult to imagine what it would be like to live and work through
an influenza pandemic. The possibility of such a pandemic, in which up
to half of the population could become ill, is daunting.
It will result
in high demands for information, advice and treatment, both from those
infected with flu and those with long-term conditions who are having
problems accessing their GP.
It is against this background that the Department of Health launched
a consultation on changes to medicines and associated legislation with
the aim of maintaining access to medication and health care products
during a pandemic.
Proposals include:
• Protocols for mass supply of key influenza-related medicines
• Extending powers for emergency supply of medicines by pharmacists
• Powers to enable medicines to be supplied on a repeat basis without
needing to go back to a doctor or other prescriber, including some Controlled
Drugs
• Increasing access to over-the-counter medicines and health care products
The legislation would be introduced in the UK at the beginning of a
pandemic and cease to be law once it is over — which could be up
to 15 weeks later. It would permit health and social care workers to
support patients flexibly, but within the law, in the complex and difficult
circumstances of a flu pandemic, write chief pharmaceutical officer Keith
Ridge and national director of pandemic influenza preparedness Lindsay
Davies in the consultation document.
David Pruce, director of practice and quality improvement at the Royal
Pharmaceutical Society, says that the Society is pleased that the DoH
is considering the potential impact of a pandemic on pharmacy.
“Pharmacy
is likely to be in the frontline when an outbreak occurs and it is important
that we have well thought out plans for empowering pharmacy to cope with
the implications of the outbreak. We would want pharmacists to be able
to use their professional judgement in an emergency without having to
worry about whether they are breaking the law or are out of pocket.”
Emergency supply and shortages Legislation currently allows pharmacists to give up to five days’ supply
of medicines to patients who request an emergency supply. The consultation
asks for views on extending this facility to enable pharmacists to give
28 days’ supply.
The Government proposes that people who need regular medicines during
a pandemic should go direct to a pharmacy rather than to their GP. In
tandem with this, arrangements would need to be made for these emergency
supplies to be available at NHS expense, the consultation says. Such
arrangements could be commissioned nationally or locally, it adds.
“Changes to NHS legislation, in particular the community pharmacy contractual
framework, would be needed, depending on the approach adopted. In exploring
such a possibility, consideration would need to be given to appropriate
safeguards. This would include communication between pharmacists and
the patient’s GP, and the avoidance of the risk of people accessing
repeated supplies of medicines via this route inappropriately,” the
consultation document explains.
“Arrangements for the reimbursement
of medicines supplied by community pharmacies through this route, as
well as remuneration, would need to be considered,” it adds.
Barbara Parsons, head of pharmacy practice at the Pharmaceutical
Services Negotiating Committee, told The Journal that the PSNC has examined
all
aspects of pharmacy practice that may require change to legislation during
a pandemic. “We have also been discussing possible changes to the
contractual framework that may be necessary during the emergency and
will be responding to the consultation [accordingly].”
Some medicines may be in short supply during a pandemic, due to disruptions
in the supply chain both inside and outside the UK. The consultation
proposes some amendments to legislation that would allow pharmacists
to use their professional discretion to supply medicines that they would
not normally issue.
“Pharmacists and other health care professionals would only be expected
to use their professional judgement within their professional confidence
and clinical competence,” the document explains. It adds that discretion
would only be necessary when there was a local or national shortage of
a medicine that was unlikely to be promptly resolved and that would cause
significant detriment to the health of patients.
The first suggested amendment would allow supply of medicines after their
licensed expiry date. “Continued supply after the expiry date could
help ease the effect of such a shortage and benefit patients, provided
that the patient has been informed and consented to such a supply,” the
DoH says.
The second suggestion is to permit the supply of unused or unwanted medicines
that have been returned to the pharmacy for safe disposal. The use of
returned medicines, if in their original packaging and looking fit for
purpose, could ease shortages, the DoH proposes.
The final suggestion is to allow supply of prescription-only pack sizes
of medicines such as paracetamol through combination of pharmacy only
and general sale list packs. Relaxation of restrictions so that pharmacists
are allowed to use a combinations of smaller packs in dispensing a POM
amount of medicine could help with shortages, says the consultation document.
However
it highlights that consideration would need to be given to NHS reimbursement
arrangements, which currently ensure cost-effective supply
of medicines. Controlled Drugs
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Hermann Danzmayr /Dreamstime.com
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Several suggestions are put forward that are aimed at reducing the
frequency with which CDs would need to be prescribed during a pandemic.
The first is to extend repeat prescribing to include Schedule 2 and
3 CDs.
The second is to allow pharmacists to use their discretion to supply
against instalment prescriptions. It is suggested that the legal requirement
is relaxed in circumstances when a patient has not collected their instalment
on the date specified, to allow the supply to be made subsequently at
the discretion of the pharmacist.
“If views favour implementing
this possible change, pharmacists will be given guidance on using discretion
to dispense more than one instalment per day or visit as per directions,
and also to part-dispense,” says the consultation document.
Another suggestion is that pharmacists should be able to dispense an
emergency supply of up to five days of treatment of Schedule 2 and 3
CDs. They should
do this only if they are satisfied that the patient has previously been
prescribed the medicine.
It is also proposed that pharmacists would be able to amend minor spelling
mistakes, typographical mistakes and other errors or omissions in all
CD prescriptions provided they are satisfied that the prescription is
genuine and that they are supplying the CD in accordance with the prescribers’ intention.
In addition, the consultation suggests lifting the requirement that a
doctor must have a licence to prescribe diamorphine for addicts.
The safe storage requirements for Schedule 2 and 3 CDs in pharmacies
could also be lifted, says the consultation. This would facilitate transfer
of stocks to another pharmacy if a relocation was necessary.
The consultation specifies that the possible changes outlined above are
predicated on the Home Office’s position that strict adherence
to the record-keeping requirements imposed by the Misuse of Drugs Regulations
2001, must be maintained.
“Access to medicines would not be assisted
by any relaxation in these requirements. Record keeping (and the audit
trail it provides, which can be monitored and inspected) becomes of even
greater importance when other flexibilities are introduced,” the
document says. Minor ailment schemes
The DoH proposes making minor ailment schemes widely available during
a pandemic to reduce demand on GPs and allow easy access to over-the-counter
products to treat flu symptoms. “DH could issue directions under
NHS legislation to require primary care trusts in England to establish
local minor ailment schemes, through pharmacies or other providers,
as part of their pandemic influenza planning,” it says.
The directions could set out what conditions or products should be
covered and could be limited, or not, to people exempt from prescription
charges,
it adds. These directions would need to be issued in advance to allow
the necessary planning and preparation to take place.
The consultation
notes that these directions could also be issued in Wales but that
Scotland and Northern Ireland already have national minor ailment schemes
in place. Further ideas and the financial impact
The consultation document also includes recommendations related to
relaxing the minimum staffing levels for pharmacies, allowing variation
in opening
hours, and facilitating temporary relocation of pharmacies at short
notice.
Changes to allow for specified authorisation and supply of antivirals
through protocols are also suggested. This would permit any person authorised
by the NHS to follow an algorithm to supply antivirals to people over
three years old. The Government’s latest national
framework for responding to a pandemic (p609) proposes that patients’ eligibility
for antivirals is authorised via a national flu line. Eligible callers
would be referred to an antiviral collection point where non-clinical
staff would be authorised to issue medicines. This would allow clinical
staff to focus on people with more urgent or complex needs.
Possible changes relating to the manufacture, distribution and importation
of medicines, the licensing of new medicines and variations to existing
marketing authorisations are also included in the consultation. Shortages
in medical devices, for example syringes, diagnostic test kits and associated
pathology laboratory equipment, are also addressed. It might be possible
to make arrangements for a blanket derogation for use of non-CE-marked
devices in order to mitigate shortages, the DoH suggests.
Mr Pruce argues that some of the proposed plans should already be in
place. “For example, requiring PCTs to establish schemes to provide
influenza-related over-the-counter medicines without prescription on
the NHS would be unnecessary if a national minor ailment scheme was agreed.
It would be better to have gained experience of running such a national
scheme and of educating the public to go to their pharmacy for minor
ailments, than to have to introduce the scheme in the middle of a pandemic.”
An appendix to the consultation looks at estimated financial costs if
the proposals were implemented. It assumes that the dispensing error
rate will double for the duration of the outbreak, resulting in additional
hospital fees of £35m.
A cost of £118m is allocated to prescriptions
being filled with more expensive pack sizes or brands. And a loss of
income for contractors of £11m is calculated, for which they may
seek compensation. This is based on the proposed measures reducing pharmacists’ £1.5bn
annual revenue by 50 per cent, says the consultation document.
These, along with other estimated costs, when set against the projected
value of health benefits that the measures will bring, puts the net benefit
at £92m, the DoH estimates. Legal issues and implementation
Certain proposals in the consultation, if supported, would require
further consultation by the DoH, the Medicines and Healthcare products
Regulatory
Agency or the Home Office.
The document explains that, if a pandemic were to be declared, the
draft proposed amendments would be laid before Parliament, or the
relevant
devolved parliament or assembly, for approval and immediate commencement.
The consultation specifies that guidance on any proposed amendments
is expected to be published in early 2008 and will be incorporated
into
PCT planning arrangements for pandemic flu.
Comments can be sent to Michael Young by e-mailing Michael.young@dh.gsi.gov.uk or
by post to MPI pandemic flu legislation consultation responses, Department
of Health, Zone 406a Skipton House, 80 London Road, London
SE1 6LH.
The
consultation closes on 22 February 2008.
Guidance for primary care professionals
in England
Last week, the Department of Health published its
latest UK
framework for responding to an influenza pandemic (see
p609). The framework
is supported by guidance, which includes “Pandemic influenza:
guidance for primary care trusts and primary care professionals on
the provision of healthcare in a community setting in England”.
This guidance says that community pharmacies will play a critical
role in responding to an influenza pandemic and should be fully
integrated into the primary care response. Guidance on service
continuity planning
for pandemic flu has already been developed jointly by several
national pharmacy organisations (PJ, 14 July 2007, p34).
But pharmacies may want
to consider team working with neighbouring pharmacies, identifying
recently retired, preregistration or non-practising colleagues
who might be able to support service continuity and, if they are
to act
as an antiviral distribution point, discussing security arrangements
with their PCT, the guidance says.
In line with the Government’s strategy of treating patients
at home, pharmacies should not encourage symptomatic patients to
come to their premises. Support for these patients will, therefore,
be best provided via a patient representative or through leaflets,
web-based information or by telephone.
However, the guidance warns: “Pharmacies
will wish to ensure that communication with patients or their representative
over the telephone does not compromise their ability to receive
calls and communicate with their PCT, management and other partner
agencies.”
Pharmacies
will also have an important role in promoting public health messages,
including educating the public on how to protect themselves and
others from contracting and spreading flu.
The guidance lists key pharmacy services in the event of a pandemic.
They include:
• support for self-care
• dispensing and repeat dispensing
• signposting to other
available NHS and social care services
• accepting unwanted medicines
• supplying regular medicines
to care homes or
patients with long-term conditions
• maintaining medicines
supplies under contract, for example, to mental health
trusts
• supporting
and promoting national public health campaigns
In addition,
pharmacies may be called on to distribute antiviral medicines
and administer
pandemic-specific vaccine.
How changes in working practice that accompany pandemic influenza
could impact on the NHS income of community pharmacy businesses
will be discussed through the usual channels, the guidance
says. |
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The
Pharmaceutical Journal