Good practice in prescribing and managing medicines and devices

 Good practice in prescribing and managing medicines and devices
RPS response to the consultation
The Royal Pharmaceutical Society (RPS) is the professional body for every pharmacist in
Great Britain. We are the only body that represents all sectors of pharmacy in Great Britain
and currently represent 37,900 members.
The RPS leads and supports the development of the pharmacy profession within the context
of the public benefit. This includes the advancement of science, practice, education and
knowledge in pharmacy. In addition, it promotes the profession’s policies and views to a
range of external stakeholders in a number of different forums.
Its functions and services include:
Leadership, representation and advocacy: promoting the status of the pharmacy
profession and ensuring that pharmacy’s voice is heard by governments, the media and the
public.
Professional development, education and support: helping pharmacists to advance their
careers through professional advancement, career advice and guidance on good practice.
Professional networking and publications: creating a series of communication channels
to enable pharmacists to discuss areas of common interest.
General comments
This consultation needs to take into account the likely outcomes of the ongoing Medicines
and Healthcare products Regulatory Agency (MHRA) review of the 1968 Medicines Act and
the separate review of regulation on unlicensed medicines.
We would like to emphasise and encourage the relationships between prescribers and
pharmacists, particularly working with pharmacists to manage the risks associated with
medicines and to improve patient safety. Pharmacists must be recognised as integral to the
healthcare team to support health literacy and improve medicines adherence.
The RPS would recommend that every general practice has access to a pharmacy team to
ensure safe and effective management of medicines across the whole prescribing arena.
1 RPS: final version Consultation Questions
1
Yes
Do you think it would be helpful to define ‘prescribing’ in the guidance?
If yes, please suggest an appropriate definition.
The definition should not be confined to prescription only medicines, but should encompass
all drugs and appliances, and whether ordered on a prescription (as in primary care) or on
an authority to administer (as in secondary care).
We do not believe that a medical practitioner should be considered to be ‘prescribing’ when
recommending that the patient purchases an over the counter medicine, since the actual
product to be sold should not be decided by the medical practitioner but be recommended by
the pharmacist who makes the sale. The reason for this separation of roles is to ensure that
the pharmacist retains his professional discretion to refuse to make an over the counter sale
if in his professional judgment, it is right to do so. If the medical practitioner wishes to
emphasise that the supply is made under his authority this should be evidenced by a
prescription.
Suggested definition: ‘’Generation by a medical (or an appropriate non-medical) practitioner
of a signed, written order (prescription) for the supply or administration to a named patient of
a medicine, medical device or appliance’
2
Yes
Do you have any other comments on the ‘About this guidance’ section?
Comment
The core guidance in the consultation (page 5 paragraph 1) says that all prescribing must
provide “effective treatments based on the best available evidence”. For many years, clear
guidance has been given to pharmacists that where a licensed medicine is available, then
that should be prescribed or supplied. Prescribing off-label or unlicensed medicines for
children is widespread and the BNF for Children attempts to provide “best evidence” to help
prescribers. In the General Guidance at the front of the BNF-C, it is made clear that the best
results occur when the child and the relatives are fully involved in therapy, reinforcing the
need to ensure patients are informed about the status of the medicine prescribed. However,
the GMC should make it clear what other “best available evidence” it would expect doctors to
rely on. Similar arguments are advanced to support the use of “specials” or ad hoc opening
of capsules and incorporation into foodstuffs for patients who cannot cope with medication
by traditional routes. When considering how best to supply essential medicines for a patient
unable to swallow tablets or capsules, RPS guidance states that pharmacists should use
their professional judgement to choose the most appropriate product for an individual
patient, taking into account the capabilities, wishes and clinical needs of the patient as well
as the views of their carers, where appropriate. We believe pharmacists and prescribers
should use their professional judgement to make a decision in the best interests of each
patient, to optimise treatment and to minimise the risk of harm.”
3
Do you think it is reasonable, at paragraph 11, to expect those to whom
doctors delegate responsibility for dispensing medicines to be registered with or
trained to the standard that would be required by the General Pharmaceutical
Council?
Yes, and we would recommend that no dispensing practice dispensary should operate
without a General Pharmaceutical Council registered technician ensuring that patients
receive the same safeguards and high standards of dispensing accuracy.
2 RPS: final version 4
Do you have any other comments on the Keeping up to date and prescribing
safely section?
Yes
Comment
One area of difficulty for some medical practitioners is knowing whether the products that
they intend to prescribe are licensed or unlicensed. This affects their decision making and
the discussion that they must have with their patients, before selecting the most appropriate
treatment. We make additional comments later in this consultation, but suggest that in
paragraph 6 of the guidance, there is reference to the need to ensure sound knowledge of
the licensed status of medicines that are prescribed.
This then links with paragraph 7 and the guidance to seek advice from experienced
colleagues (such as pharmacists). Sometimes the medical practitioner will simply not know
of the licensed status and will have no reason to doubt that products in the formulary are
unlicensed. To ensure that medical practitioners know that they are prescribing unlicensed
products, the Medicines and Healthcare products Regulatory Agency ‘Guidance Note 14’
and professional guidance for pharmacists, suggests that pharmacists should contact the
prescriber when an unlicensed product is prescribed, to ensure that the prescriber is aware,
and can make changes if appropriate. In these cases, the medical practitioner is not
‘seeking’ advice from experienced colleagues, but is receiving advice from experienced
colleagues. We suggest that an additional paragraph be added to encourage co-operation
when a healthcare colleague contacts the prescriber to discuss any prescription that has
been issued, and to ensure arrangements made within the medical practice support such
professional contact.
Prescribers should have access to hard copy versions of the current BNF and BNFC when
practising in locations where on line facilities are absent or inoperable.
5
Do you agree with the advice at paragraph 12 on prescribing to meet patients’
identified needs?
Yes
Comment
We agree with the text of paragraph 12, but would like to suggest an addition, either within
this paragraph or within this section.
When medical practitioners prescribe medicines, they may also face pressure from the
patient, their carer or from care homes, for the medicine to be issued in a compliance aid (a
multi-compartment device, labelled with days of the week and times of day), which may be
used under disability legislation, but more commonly as a convenient way for carers to
‘supervise’ the administration. When prescribing medicines the medical practitioner should
ensure that the decision is on clinical grounds and should not suggest that the medicines be
provided in a compliance aid, unless they support their use for the particular patient. When
prescribing for use in care homes the medical practitioner should avoid suggesting that
compliance aids should be used if this is solely for the convenience of the care home staff,
unless there are adequate arrangements in place to fund the provision
6
Do you think the guidance at paragraphs 13 to 16 on doctors prescribing for
themselves and those close to them is appropriate?
Not sure
If not, what guidance should we give to doctors?
3 RPS: final version Comment
We understand that self prescribing or prescribing for a person with whom the prescriber has
a close personal relationship is discouraged. The rationale for that position is clear and well
set out. But, there is a more stringent view taken when controlled drugs are involved. We
do not believe that there should be any difference between such prescribing of controlled
drugs and other prescription only medicines, since objectivity etc. can be just as impaired
when dealing with conditions for which a controlled drug is not required.
We suggest that paragraph 16 should be the principle guidance note under this section, but
that 16(c) should require in all cases, that the prescriber informs the patient’s general
practitioner of treatment provided. Removing the other paragraphs ensures that all patients
receive prompt treatment. The pharmacy profession would be able to rely on the medical
profession’s own standards, to ensure monitoring of the appropriateness of such
prescriptions. Pharmacists, or others dispensing the prescription, should have a mechanism
in place to raise concerns if a prescriber is prescribing for themselves or someone close to
them.
We need to explain why we believe that notification of the patient’s general practitioner
should take place even if the patient objects. If the patient’s general practitioner is notified in
all cases, this would allow the general practitioner to raise concerns if the prescribing was
inappropriate – that is probably a decision that only the patient’s GP can make.
Mandating that notification is sent in all cases to the patient’s GP will ensure that an
appropriate oversight mechanism exists, and will operate to support appropriate prescribing.
If prescriptions are issued for any medicine, including those available for purchase over the
counter, these should be notified to the patient’s GP. There are many drugs available over
the counter, which are capable of abuse, so notification provides the safeguards above. We
do not see any purpose in restricting a medical practitioner from being able to purchase over
the counter medicines but if purchasing as opposed to prescribing, the purchaser would
have to satisfy the pharmacist that the purchase is appropriate and in the interests of the
patient – whereas if a prescription had been used, the above oversight mechanisms by the
patient’s GP will act to safeguard patients.
7
No
Do you have any other comments on the Need and objectivity section?
8
Do you think pharmacists and other healthcare professionals are well placed to
provide patients with the information, advice and services suggested in paragraph
22?
Yes
Comment
We are pleased that the guidance recognises the benefit of the support to patients’ treatment
given by pharmacists providing advice – either at the point of dispensing prescriptions, or
during the course of reviews. The Minister, Earl Howe recently announced that community
pharmacists would soon be commissioned to provide a new service, which involves the
provision of advice about medicines when first prescribed for a patient for the treatment of a
long term condition, supplemented by follow up conversations. This service, based on
research based evidence, will ensure that patients newly diagnosed with a long term
condition, will have the best possible start to their treatment, which will improve adherence
and effectiveness. This new service demonstrates the government’s confidence in
pharmacists being the prime source of advice on prescribed medicines.
4 RPS: final version But to provide maximum benefit, it is important that patients are not overwhelmed with
advice. Paragraph 22 suggests that if the prescriber does not have the time to give advice
to the patient, pharmacists might be able to ensure that the patient has sufficient information.
Unfortunately, the pharmacist will not always know how much information has been given to
the patient by the prescriber, and so may not be in a position to fill in gaps. The prescriber
should encourage the patient to discuss the medicines themselves with the dispensing
pharmacist – the pharmacist would be able to discuss the precise method of administration,
the side effects, contra-indications, the delay before the medicine becomes effective and so
on, without the danger of duplicating (or contradicting) anything that the medical practitioner
had mentioned.
We believe that the first contact for patients who have concerns about their medicines
should be with the pharmacist, and this could be encouraged by the GMC guidance.
Pharmacists will ensure that the patient is referred to the medical practitioner if there are
important matters which only the prescriber can deal with. This makes best use of the
resources available to the medical practitioner whilst also ensuring the patient receives
adequate information to ensure safe and effective use.
9
Yes
Do you have any other comments on the Consent to prescribe section?
Comment
We have mentioned previously the prescribing of unlicensed products. These products do
not have the benefit of a marketing authorisation but are usually essential to ensure that the
patient receives appropriate treatment. Because they do not have a marketing authorisation,
the products have not been tested against the criteria of safety, quality and efficacy.
They will often be manufactured by a manufacturer licensed by the MHRA, so are made to
acceptable standards of quality, but the safety and efficacy are not guaranteed. A patient’s
informed consent to treatment must be obtained, and for these unlicensed drugs, the
prescriber will need to take particular care to ensure the patient understands that despite the
unlicensed status and the inherently greater risks, the treatment is still the treatment of
choice.
Because prescriber’s IT systems may not identify all the unlicensed products, there is a risk
that prescribers may not appreciate that the product they are prescribing is unlicensed, and
therefore may fail to have the conversation with the patient about the nature of the product.
There is a safeguard in that when pharmacies receive a prescription for an unlicensed
prescription which has not been received before for that patient, the pharmacist is required
by guidance published by MHRA and their professional Code, to contact the prescriber to
ensure that the prescriber is aware of the unlicensed status. Sometimes the pharmacist will
find it difficult to contact the prescriber in person. It is therefore welcome that the Council’s
guidance is encouraging medical practitioners to recognise the benefits of receiving advice
from pharmacists.
In this section on consent, we suggest that there is an additional paragraph reminding
medical practitioners of the additional steps to be taken when prescribing unlicensed
products, and also to encourage medical practitioners to welcome contact from pharmacists
about prescriptions, and put in place arrangements so that pharmacists can readily contact
prescribers directly to discuss treatments.
10
Does the guidance at paragraph 24 accurately describe the information that
should be provided with referrals?
Not sure
5 RPS: final version Comment
The RPS is currently leading on a piece of work, supported by other Medical Royal Colleges,
the Royal College of Nursing and the Chief professional officers, which raises the profile
about the risk to patient safety when information about patients’ medicines isn’t accurately
transferred across care settings. This guidance is entitled ‘Keeping patients safe when they
transfer care settings – getting the medicines right’. As part of this work the guidance
identifies the recommended core information about medicines that should be transferred
when a patient moves between care settings. This guidance applies to referrals and is in line
with recommendations made by the Care Quality Commission and a range of other national
organisations, including the National Institute of health and Clinical Excellence. The
professional and organisational guidance to support this is due to be launched on 12th July
2011. It would be beneficial to all concerned if the GMC guidance could make reference to
this multidisciplinary professional guidance. For further information please contact Heidi
Wright at [email protected]
We recommend that general practice develops systems that ensure a full list of current
medicines accompanies the referral letter.
11
Do you have any other comments on the Sharing information with colleagues
section?
Yes
Comment
We believe that all those healthcare professionals caring for patients should receive
sufficient information from other healthcare professionals in the shared care arrangements,
to secure safe and effective treatment. Medical practitioners should therefore positively
encourage patients to consent to sharing of necessary information with the pharmacist that
the patient chooses to visit. Community pharmacists are subject to the same information
governance arrangements as GPs so patients can be assured that their records would be
safe.
There has been extensive debate about the Care Record Service, with many comments
being made which alarm the public about the release of their confidential information. It
should be understood by patients that a medical practitioner will normally share information
with any nurse, pharmacist or other medical practitioner, involved in the patient’s care. We
suggest that the guidance emphasises the value of sharing information (whether directly
referred by the medical practitioner or not) with other regulated health professionals involved
in the patient’s care, and supporting patients in the process of obtaining consent. This will
help dispel some of the misunderstandings that have arisen in the minds of some.
We also return to the point made above about informing the patient’s GP when another
medical practitioner, or other healthcare practitioner, provides treatment. As the patient –
GP relationship is one built on trust, we can envisage no circumstances where a patient
would refuse consent to sharing such information, unless the patient was setting out on a
course which is not in their best interests (for example obtaining medicines liable to misuse
from more than one source). Although consideration must be given to consent, it is
appropriate to consider whether the best interests of patients is served only if, in all cases, a
patient’s GP is provided with prescribing information from other healthcare practitioners who
have provided treatment.
12
Do you have any comments on the Prescribing at the recommendation of a
professional colleague section?
Yes
6 RPS: final version Comment
There are now several non medical prescribers authorised to prescribe medicines, and in
NHS primary care, the NHS provides forms for that purpose. Sometimes, a form will be
completed by one person, but signed by another, which may in practice, amount to the
activity envisaged in this section of the guidance. It would be ideal if all prescribers only
signed their own prescriptions, currently pharmacist and nurse prescribers are only allowed
to sign their own prescriptions. However, the guidance outlined in paragraphs 28 to 31 are
sufficient to ensure that best practice is followed and patients receive the treatment they
require in a timely manner.
13
Yes
Do you have any comments on the Shared care prescribing section?
Comment
We would encourage an addition at 32d which would read ‘ensure any necessary clinical
monitoring arrangements are in place and that the patient and professionals involved in the
shared care arrangements understand them’.
The guidance should emphasise the importance of effective communication and continuing
liaison between the referring clinician and the clinician accepting the referral. There should
be clarity about roles and responsibilities. Agreement to shared care should be sought and
not expected as a right for complex specialist medicines.
While we support the concept of shared care we don’t think that the current infrastructure
adequately enables the safe implementation of dynamic prescribing situations. Our major
concerns are about the accuracy of prescriptions when patients are consulting with
numerous specialists. We recommend that there is an urgent review of the whole way in
which general practice deals with the shared care situation.
14
In addition to those mentioned in paragraph 38, are there other organisations
to which reports of medicines-related adverse incidents or near misses should be
sent?
No
15
Do you have any other comments on the Raising concerns and reporting
adverse incidents section?
Yes
Comment
The guidance states that all serious patient safety incidents are reported to NRLS. It is
important that the word ‘serious’ is sufficiently well defined, and that all who report into NRLS
adopt the same criteria for reporting. We suggest that the GMC works with the National
Patient Safety Agency and bodies representing other healthcare providers to ensure a
common standard for reporting. It is also currently unclear where the NRLS will sit in the
future but this vital role should not be lost.
It is very helpful to include in Paragraph 37 that medical practitioners should respond
constructively to concerns raised by colleagues.
16
Do you have any comments on the Repeat prescribing and prescribing with
repeats section?
Yes
7 RPS: final version Comment
There are two methods of prescribing repeat medication – by issuing a prescription on each
occasion the item is to be dispensed, and secondly, by issuing within the NHS, a repeatable
prescription. We make no comment on the guidance relating to the first type of repeat, but
we do have suggestions about repeatable prescriptions i.e. repeat dispensing.
A repeatable prescription is issued by the prescriber once, with a specified number of
occasions the medicines can be dispensed, over a set period of time. When a patient
requires a further supply on such a prescription, a pharmacist is required to determine
whether it is appropriate for the supply to take place, by asking a number of questions about
the stability of the condition being treated, the adherence to the treatment, and whether or
not there are any side effects or other reasons why a review by the medical practitioner is
appropriate.
Medical practitioners can be confident that issuing such repeatable prescriptions will provide
a more convenient service to their patients, whilst maintaining a safe system for supply. The
roll out of repeatable prescriptions has been modest, because the system would be easier to
operate with electronic prescribing. But, as electronic prescribing has not progressed as
quickly as anticipated, it is appropriate to try to encourage adoption of the paper based
repeatable prescriptions, so as to make best use of the resources available to GPs.
We suggest that the guidance includes an additional paragraph encouraging the use of
repeatable prescriptions (for patients for whom repeatable prescriptions are suitable). This
could include reassurance about the involvement of pharmacists in carrying out checks of
on-going appropriateness of supply.
There should also be assurance that all non-clinical staff who enter information into the
patient’s medical record are competent to do so, and work under an operating procedure
that clearly documents how any changes in medicines following an episode of care from
another provider are documented on the medication records which will be used to generate
repeat prescriptions. In particular, such staff must be clear when to refer queries to a clinical
colleague for resolution.
17
Yes
Do you have any comments on the Reviewing medicines section?
Comment
We welcome the guidance in paragraph 48 which draws attention to the reviews that
pharmacists may carry out. In circumstances where such a review indicates that there is
information of which the patient’s GP should be aware, the service specification for
pharmacist’s Medicines Use Reviews (MUR) requires a copy of the MUR Record to be sent
to the general practitioner. There have been varying responses from GPs to receiving these
records.
We suggest that the guidance be expanded to require GPs to consider, and take appropriate
action when receiving such referrals. Ideally, it would be good to obtain feedback from the
GP on actions that have been undertaken. However, the process to enable this would need
to be established.
In England, from October 2011, one of the target groups for MURs is patients that are
discharged from hospital and who have changes made to their medicines. The GMC could
recommend that GPs refer patients who fit these criteria, to their community pharmacist for
an MUR.
8 RPS: final version 18
Do you think the draft guidance on remote prescribing represents a reasonable
balance between patients’ autonomy and safety?
No comment
19
Do you think we should give advice on the remote prescription of Botox® and
similar treatments?
No comment
20
Do you have any other comments on the Remote prescribing via telephone,
video-link or online section?
Yes
Comment
The NMC Standards 11 and 12 for medicines management make it explicit that a ‘verbal
order’ (i.e. remote prescribing) to another healthcare professional should be restricted to
very exceptional and genuinely urgent circumstances only and must always be followed by a
prompt, written confirmation. It would be useful if NMC and GMC standards supported each
other.
Where GPs are providing services remotely e.g. to patients in care homes, they should
ensure they have adequate access to patient records, including the current prescription
medicines.
The absence of evidence of harm should not prevent investigation into this new service
model. We would recommend that the GMC should test the robustness of arrangements in
order to satisfy themselves that the model is safe and should be taken forwards.
21
Do you agree with the draft guidance at paragraph 58 that doctors can
prescribe off-label or unlicensed medicines if satisfied, on the basis of authoritative
clinical guidance, that it is as safe and effective as an appropriately licensed
alternative’?
Yes
Comment
There will be occasions when the use of an unlicensed medicine is, in the professional
judgment of the prescriber, in the best interest of a patient under their care. Such occasions
will be unusual and the first consideration should always be the use of a licensed medicine
used within its marketing authorisation. Therefore we agree that a doctor should be free to
prescribe off-label, even if there is another product whose Marketing Authorisation
addresses the situation concerned. This should occur when authoritative clinical guidelines,
such as NICE guidance, and the prescriber’s knowledge and competence supports such
prescribing. However, we would recommend that the prescriber considers the licensed
alternatives, the risks of prescribing off-label or unlicensed medicines and does this in
consultation with the patient.
We do not think that paragraph 58 adequately differentiates between the prescribing of a
medicine outside of its UK Marketing Authorisation i.e. off-label prescribing and prescribing
medicines with no current UK license. A decision to use an unlicensed medicine should be
driven by the special clinical need of a patient that cannot otherwise be satisfactorily
addressed by licensed medicine, either for a licensed indication or in an off-label context.
We see no need or justification to change existing guidance on prescribing unlicensed
medicines by a doctor. Prescribers should be aware of their own responsibility to prescribe
9 RPS: final version within their competence and the responsibilities of pharmacists to supply medicines of an
appropriate quality.
Another issue with prescribing in this way is the lack of reliable data for both prescriber and
patient. It may be helpful to obtain such information from medicine information centres in
local hospitals who may have more experience of using these medicines.
Para 58 should highlight the importance of complying with local policy and procedure.
Para 60 might refer to the BNF as a source of useful advice.
Para 61 might highlight specifically the risks of re-using devices intended for single use only.
22
Do you agree with the guidance at paragraph 60 that it may not be necessary to
draw patients’ attention to the licensing status of medicines routinely used off-label
and for which there is authoritative clinical guidance?
No
Comment
To decide that a patient does not need to be informed that the medicine is not licensed, on
the basis that the use of the product is routine, undermines the principle of ‘no decision
about me without me’. It should be the patient’s right to be informed if a medicine is
unlicensed, so that they are aware of the additional risks when giving their consent. The
approach suggested in paragraph 60 of the consultation seems to be totally out of step with
modern healthcare ethics of promoting autonomy in patients and indeed is contrary to
several other statements that the GMC makes elsewhere in the document:
P2 Background: “….standards of conduct and ethics expected of them by patients, the
public….”
P11 Paragraph 17 “For a relationship between doctor and patient to be effective, it should be
a partnership based on openness, trust and communication…”
P11 Paragraph 20 “You should reach agreement with the patient on the treatment proposed,
explaining the likely benefits, risks and burdens……”
P16 Paragraph 34 “Explanation should be given for the use of off-label or unlicensed
medicines…. And sufficient information ……must be provided to the patient and their GP”
Other professionals also have a requirement to carry out certain duties in respect to the
supply of off-label medicines. The supplying pharmacist is under a duty to be sure that the
prescriber has recognised the status of his prescribed medicine and should support and
reinforce the patient’s understanding of that status. There is a risk that confidence in a
doctor may be undermined and a patient may be alarmed if a pharmacist tries to explain this
but it has not been mentioned by the doctor. Also, the Patient Information Leaflet (PIL)
supplied with the medicine will not refer to the ‘off-label’ use and therefore, the patient may
believe that they are receiving an incorrect medicine.
23
Do you have any other comments on the Prescribing off-label and unlicensed
medicines section?
Yes
Comment
As mentioned earlier, there is a need for pharmacists to ensure that prescribers are aware of
the unlicensed nature of a product they may have prescribed, so that the appropriateness of
the prescription can be considered. Ideally, this conversation needs to take place before the
unlicensed product is ordered from the manufacturer (since these are bespoke products that
are usually expensive, and it would not be possible to cancel the order or return the stock).
10 RPS: final version We also suggest that the section could be expanded to remind medical practitioners that
pharmacists can provide advice about suitable equivalent licensed products in many cases,
and that before prescribing an unlicensed product, all reasonable steps should be taken to
establish whether the patient could be treated with a licensed product.
The preamble to the questions on page 25 of the consultation (immediately after paragraph
61) says, “….some medicines are routinely prescribed off-label, usually because there is no
appropriately licensed alternative; but also because there are cheaper medicines that are as
safe or effective”. We consider this statement to be unhelpful as the prescribing guidelines
should uphold the use of licensed medicines over unlicensed. When considering the use of
unlicensed medicines or prescribing off-label, it should be clinical appropriateness that is
considered and not cost. Increasingly in recent years the cost of a medicine is becoming part
of a decision to use a particular medicine. The complexity of such decisions is very hard to
address within the high level prescribing guidance under consultation here, and we would
suggest that this issue is dealt with through other mechanisms.
24
Do you think we have identified the main conflicts of interest relevant to
doctors’ prescribing?
No
Comment
There are issues about financial arrangements between doctors and pharmacists. The first
issue is about the direction of prescriptions to specific pharmacies which is outlined in more
detail in our response to Q25 below. The other issue is about the ownership of pharmacies
within the premises of doctors surgeries. The ownership of these pharmacies is through
limited company liability where the doctor has controlling interest in such companies. There
is a potential for loss of objectivity or abuse within the same professional entity or
commercial relationship.
In Lady Justice Smith's 6th Shipman report, there is a reference in a section which raises
concerns and can be applied to the relationship mentioned above. The Sixth Shipman
Report states that: “It is now generally accepted that the involvement of a pharmacist in the
process of providing medication to a patient acts as a safety check against error” and also
that “where prescribing and dispensing functions are carried out by the same person or
within the same commercial or professional entity, there is a potential for the loss of
professional objectivity or even abuse.”1
25
Yes
Do you have any other comments on the Conflicts of interest section?
Comment
We are keen to see patients being able to exercise their own choice over which community
pharmacy they should use. Pharmacy is practiced in a highly competitive market. If patients
have complete freedom of choice over which pharmacy to use, then the patient’s exercise of
choice will drive up quality.
The relationship between patient and medical practitioner is one in which there is a
presumption of undue influence, so great care must be taken by medical practitioners not to
influence a patients choice of pharmacy.
1
http://www.the-shipman-inquiry.org.uk/4r_page.asp?ID=3203
11 RPS: final version We suggest that the guidance is strengthened, to require medical practitioners to avoid
suggesting which pharmacy the patient should attend. This applies not only to the obvious
conflicts of interest where a medical practitioner has a financial interest in a pharmacy but
also avoids situations arising where a medical practitioner may appear to his patients, to
have a preference – which could suggest that other non preferred pharmacies are providing
a poorer service.
26
Do you have any comments on the Sports medicine section?
No comment
27
Do you think the draft guidance contains the right level of detail?
No further comments
28
Do you think the guidance is clear?
No further comments
29
Do you think the guidance accurately reflects the law that applies where you
live or work (in the UK)?
No further comments
30
Can you point to any other guidance documents, information or resources that
it would be useful for us to refer to in the published guidance?
Yes
Comment
We suggest referring to the Medicines and Healthcare products Regulatory Agency
guidance note on the use of unlicensed medicines (GN14).
31
Can you point to any important inconsistencies between the draft guidance
and guidance published by other relevant organisations? These might include, for
example, the health departments, the Medicines and Healthcare products Regulatory
Agency or the National Prescribing Centre.
No comment
32
Can you identify any changes to practice that would be needed in order to
meet the standards set out in the guidance?
Patient safety is at the centre of this guidance and this can be demonstrated where healthy
communication exists between prescriber and pharmacist and patients. It could be said that
currently prescribing is mainly a one-way communication and this could be improved if there
is reception of messages in all directions.
33
Do you think that applying the standards in this guidance will have an adverse
impact on particular groups of people? For example, will there be an adverse impact
on particular groups of patients in any of the equality strands (age, disability gender
reassignment, marriage and civil partnership, pregnancy and maternity, race, religion
or belief, sex, and sexual orientation)?
No comment
34
Do you have any comments on the consultation documents?
No comment
35
Do you have any comments on the consultation process?
No comment
12 RPS: final version Lindsey Gilpin Chair, English Pharmacy Board Sandra Melville, Chair, Scottish Pharmacy Board Nuala Brennan Chair, Welsh Pharmacy Board For further information or any queries you may have on our consultation response please
contact Heidi Wright at [email protected] or 0207 572 2602. 13 RPS: final version