Annex G – Response sheet
Instructions

If possible, please send responses electronically to [email protected] using the following table. Even if
you reply in hard copy, please use this table.

If any of your answers refer to specific regulations in the draft consolidated regulations, please provide the regulation number
and corresponding ‘j-number’ (this is shown in square brackets after the regulation number) in the relevant columns.

Please provide any other observations in the second table below. Use one row per comment, and add more rows if necessary.

Please also complete and return the confidentiality template at Annex H.
Respondent details
Please provide your details as requested below. The second and third pieces of information would assist us in delivering the
Government’s commitment to engage with small, medium and micro businesses.

Please provide your name and (if relevant) the organisation or body you represent:
Sarah Billington, Chief Officer for Hampshire and IOW Local Pharmaceutical Committee

Please tick this box if you or the body you represent are in the NHS or public sector:

If you represent a private sector company, please indicate the number of employees in the company by ticking the relevant box
below:
9 or less
10-49
50-249
250 or more
Question Question
Number
Response
1
Are there any benefits
and costs of
consolidation other than
those outlined in the
impact assessment? If
so, what are they?
Hampshire & IOW LPC welcomes the consolidation of the plethora of medicines
regulations in one single piece of legislation.
What other evidence is
there of the benefits and
costs of consolidation
for you or your
organisation?
Please review the
sections relevant to your
industry and/or body
and provide comments
on the accuracy of our
assumptions. In
particular, we would like
to know the following:
Approximately how
much time does your
firm or body currently
spend every year
understanding the
regulations as they are
currently drafted?
As above
What change in this
annual amount of time
We expect the amount of time we spend supporting contractors regarding legislation
to increase in the short term as the changes, particularly the proposed to S10, will
2
3
3a
3b
It is important that professionals and members of the public have access to all
relevant regulations without requiring knowledge of the existence of a specific
regulation, or having to take considerable research to find a specific regulation.
The LPC represents 350 Pharmacy Contractors in Hampshire and IOW
We respond to queries from contractors and their pharmacy teams which includes
advice on and interpretation of legislation as it applies to registered pharmacies
providing NHS community pharmacy services
We would estimate that we spend 3 hours a month providing information and advice
on legislative matters.
Regulation J-number
number (if (if relevant)
relevant)
3c
3d
3e
3f
4
would you expect as a
result of the
consolidated
regulations?
have a significant impact on community pharmacy
Roughly how much time
do you think your firm or
body
will
take
in
familiarising itself with
them?
Where relevant, how
much time do you
estimate your firm or
body will require to alter
your own guidance
material in response to
the consolidated
regulations?
What is the approximate
wage rate of the staff
who will engage in
understanding
regulations and revising
guidance?
Is our assumption that
small and micro
businesses generally
rely on their trade and
professional bodies for
regulatory information
correct?
Do you agree with the
structure of the draft
regulations? Why, or
why not?
We are fortunate to have some in-house expertise on this subject and we expect the
LPC members to be familiar with the changes through brifing papers and short
updates provided at LPC meetings ( 6 held each year)
Total time approx. 6 hours
We estimate the time we spend responding to queries will increase to 8 hours a
month, plus we will actively provide information through our website and Newsletters
which will add a further 1 hour a month
We will update our website and provide critical information to our contractors in the
quarterly Newsletters
Time= 1 hour per month
We agree and would add that Local Pharmaceutical Committees are also a valuable
conduit for information and source of assistance and advice.
We support the structure of the regulations which is logical, but as with most legal
documents is not particularly user friendly to non-legally trained persons.
5
6
7
8
Do the draft regulations
introduce any changes
other than those
outlined in this
document?
Are there any drafting
errors in the draft
regulations?
Are there any provisions
in the draft regulations
that could be made
clearer?
What should we do to
help users prepare for
the entry into force of
the consolidated
regulations?
We did not note any as there was limited time to respond to the consultation and
certainly not enough to proof read
Clear and user-friendly guidance needs to be supplied and sufficient time given for
those affected to assimilate and understand the changes.
The guidance should be tested on a range of non-legal stakeholders for readability
and ease of understanding
A range of communication strategies should be employed in order to reach all
stakeholders. Assumptions should not be made that all those affected are regular
internet users
9a
9b
Should we add more
requirements to Reg 3
[j002B] for medicinal
products that fall outside
the scope of the
consolidated
regulations? If so, what?
We have replaced the
term “prepared” that
was used in a few of the
exemptions in the
Medicines Act 1968 with
“manufactured”, as we
believe that term covers
Yes we do think this will cause difficulties
‘Manufactured’ implies the product is the result of a commercial process that is
subject to licencing requirements and which meets specific and appropriate
standards.
Products that are the result of being extemporaneously ‘prepared’ have clearly been
subject to a very different process, with different standards and legal requirements.
the making of any
product. Do you see any
difficulties with this?
9c
10
Is the provision too
narrow or too broad in
any respect?
Is the new definition of
advertisement sufficient
to cover all relevant
forms of advertising?
This change will confuse those producing the products and those who are
purchasing/obtaining them.
The LPC support the new definition of advertising,
We would like clarity on advertisements that appear as part of a website as there
have previously been difficulties with determining what constitutes a ‘price list’ when it
appears on a web page that can be readily accessed by a patient. Community
pharmacists who provide legitimate internet pharmacy services have been given
conflicting and confusing advice on how they can provide information (including the
price) about medicines, human and animal.
It would be helpful for guidance to cover other types of advertising such as products
featured in television programmes, cold calling by telephone and spam email.
11
12
13
Do you agree with the
proposals for the two
simplifications in relation
to herbal medicines?
Why, or why not?
Do you agree with the
proposal to remove the
requirement to dispense
certain medicinal
products in fluted
bottles? Why, or why
not?
Do you agree with the
proposal to remove
statutory warnings,
including for
We support the simplifications and welcome the wider reforms planned for this sector.
The LPC supports this proposal. In reality obtaining fluted bottles has been a problem
for some time and they have fallen out of use.
Patients do not associate fluted bottles with the purpose for which they were intended
so they no longer act as a safety measure.
We agree with the proposal with some reservation.
If the policy intent is to ensure clear and consistent warnings about safety issues
across products with the same ingredient, then the system that replaces statutory
paracetamol? Why, or
why not?
warnings must be robust and enforceable and not rely on ‘self-regulation’ by
industry.
If the current warnings are not well understood by patients then it is critical that work
is undertaken to ensure that the language and wording used in future warnings
improves this picture.
The LPC assumes that if a manufacturer fails to include evidence based and
consistent warnings as part of a MA application, then the MHRA would refuse to
grant it.
Adequately informing patients about paracetamol is an issue. Many commonly used
products contain paracetamol and are obtained and consumed without interaction
with a health professional. The LPC would want to see clear guidance for patients
and carers about the maximum daily dose and the dangers of accidental overdose
through the use of multiple products, whether that be through a statutory warning or
other mechanism.
14
15
16a
Do you agree with the
proposals to change the
persons appointed
process? Why, or why
not?
Do you agree with our
proposals to remove
exemptions that are
obsolete or no longer
relevant? If not, why?
Do you agree with our
proposal to extend to
other organisations
concerned with
research the provisions
allowing sale or supply
No comment
No comment on 9.4
We agree with the proposal in paragraph 9.6 and 9.7
Yes with the caveat that there is clear guidance on what constitutes an organisation
concerned with research which will help those community pharmacists approached to
make the supply.
Guidance must also be made available to assist community pharmacists on what
checks should be made regarding the signed orders submitted by these institutions
16b
17
18a
18b
of medicines to
universities and
institutions concerned
with research or higher
education. Why, or why
not?
as there is no register or single resource that can be used to verify the
signature/identity of the “principal or head of department in charge of a specified
course of research” who may sign the order.
If such a change were
introduced, should it be
subject to the exclusion
of any classes of
medicines in addition to
controlled drugs? Why,
or why not?
Should the limit on the
size of ampoule in
which water for injection
can be supplied be
extended to 5ml? Why,
or why not?
Should the existing
exemption allowing the
administration of
Adrenaline by injection
by any person for the
purpose of saving life in
an emergency be
amended to allow
injection up to and
including 1 in 1000?
Should an increased
range of Adrenaline
preparations be subject
to any limitations on the
route of administration.
We cannot comment on the classes of drugs that should be available for research.
The issue for community pharmacy is that they inadvertently make a supply that is
not covered by the exemption and/or the request for the supply is not a legitimate
one. Steps must be taken to mitigate these risks.
However the LPC would want it made clear what drugs, if any, are excluded from this
exemption to assist community pharmacists approached to make the supply. ( see
answer to 16a)
The LPC supports the recommendation to extend the size of ampoule in which
water for injection can be supplied but we disagree with it being limited to 5ml and
would argue that any risk can be mitigated by making it a matter of professional
judgement
The LPC supports this amendment
19
20
21
22
Why, or why not?
Should Paracetamol
and Ondansetron be
added to the list of
medicines that can be
administered parentally
by registered
ambulance paramedics
on their own initiative?
Why, or why not?
Should people be
allowed to obtain water
for injection for
purposes other than
parenteral
administration without a
prescription? Why, or
why not?
Should pharmacists be
allowed to sell or supply
water for injection
without a prescription
for purposes other than
parenteral
administration or for use
as a dilutent where no
dilutent has been
specified by the
prescriber? Why, or why
not?
Should holders of the
Council’s Advanced Life
Support (ALS)
certificate be allowed to
administer Adrenaline
and Amiodorone in
The LPC agrees that the availability of water for injection should be extended and the
supply should be made a matter professional judgement.
Where the product is being supplied as a diluent for a prescribed dry powder
injection, there should be the facility for the community pharmacists to endorse the
prescription and receive payment
Yes. See above and our answer to 17
The LPC support the proposal that will improve outcomes for patients by increasing
access to emergency medicines.
23
emergencies involving
cardiac arrest? Why, or
why not?
Do you agree with the
proposal to retain the
general structure and
requirements of PGDs
in their current form,
and to retain the
principle that only
registered health
professionals should be
able to use PGDs?
The LPC supports the retention of the structure and requirements of PGDs in their
current form.
We agree with the principle that only registered health professionals should be able
to use PGDs and would ask that this list be extended to include registered pharmacy
technicians
The LPC believes the purpose of PGDs is to be of benefit to services users and
facilitates health care provision within a framework that provides appropriate levels of
safety and accountability.
It is understandable that organisations will seek to gain the maximum benefit from
enabling legislation, such as PGDs, and it has to be accepted that one of the benefits
for an organisation may be economic even if that was not the intent of the legislation.
There are examples where PGDs are used at the very limit of their intended purpose,
for example by an internet medical service providing life-style medicines via a PGD.
We would welcome guidance that ensures that PDGs are used appropriately.
24
25
Should NHS bodies be
able to supply
medicines in
accordance with the
written directions of an
independent nurse,
pharmacist or
optometrist prescriber?
Why, or why not?
Should independent
hospitals, clinics etc. in
England continue to be
allowed to use PGDs
The LPC supports this proposal.
To ensure that commissioners ( of NHS services for the NHS) have the broadest
choice and providers have equal opportunities we would agree that any exemptions
in the legislation should be extended to independent non-medical prescribers.
All medicines supplied in this way should be subject to the labelling requirements for
dispensed medicinal products.
We support this proposal
If a service is eligible to register with CQC then that service is subject to regulation
and assurance by CQC and as such it would be suitable for inclusion in any
26
27
but by reference to them
being registered for the
following regulated
activities in England?
• treatment of disease,
disorder or injury
• assessment of
persons under the
Mental Health Act 1983
• surgical procedures
• diagnostic and
screening procedures
• midwifery services.
Why, or why not?
Should dental practices
and dental clinics
registered with the CQC
or private dentists
registered with its
equivalent in Wales be
able to sell, supply or
administer medicines
under PGDs? Why, or
why not?
Do you agree with the
proposal to facilitate the
optimisation of
medicines use? Why, or
why not?
exemption that allows the development of PGD’s.
The LPC supports this proposal for those medicines relevant to dental practices and
clinics for the treatment of matters within their area of expertise
The PGDs developed should require the input of a pharmacist
The LPC strongly support this proposal.
It is essential that pharmacists be allowed to use their professional judgement to
facilitate the safe and timely supply of medicines to patients. The LPC welcomes the
intention to produce guidance to support this change.
Waste is a significant issue and the LPC believes that pharmacists could make a
valuable contribution to reducing waste if they were allowed to modify quantities
prescribed for the purposes of synchronising prescriptions.
28
Do you agree with our
The LPC welcomes the consolidated regulations and the proposal to ensure they are
proposal for keeping the
consolidated regulations
up to date? Why, or why
not?
kept up to date. We agree with the proposal to maintain and make available an up to
date version of the regulations on the website.
However not all stakeholders will have the capacity or opportunity to monitor frequent
changes. Consideration should be given as to how changes will be communicated.
Further comments (please use a separate row for each comment and insert more rows if necessary)
Number Further comment
The LPC is disappointed that the consultation does not tackle decriminalisation of dispensing errors.
We disagree that the proposed course of action will resolve the problem or prevent inappropriate prosecution of
pharmacists and their teams. The CPS has had national guidance in place for some time, which had it been
interpreted and applied as intended should have prevented the prosecution of EL in 2009 and GM and JH in
2008 .
The purpose of the law is to protect the public. There is no evidence to suggest that having the criminal
offence within the medicine legislation reduces dispensing errors by pharmacists.
A review of medicine legislation is overdue and despite the considerable cost and complexity of the task it is
essential that it is undertaken as soon as possible to make is fit for purpose. Since the legislation was written,
delivery of pharmacy and other healthcare services has changed out of all recognition and in order to ensure
medicines reach patients safely and when needed, pharmacists and their teams make decisions on a daily
basis that potentially leave them at risk of breaching legislation.
4.21
The LPC is disappointed that section 10(7) of the medicines act is to be repealed.
By removing s10(7) a criminal offence is created, that of wholesaling without a licence. New exemptions are
being created and regulation and prosecution will be a matter of interpretation of these exemptions.
You are proposing that a WDL will not be required if
Regulation
number (if
relevant)
J-number
(if relevant)
 the pharmacist provides medicine to a health professional or other who needs them to pass on to their
patients, or
 the pharmacist supplies another pharmacist if it is occasional, not for profit and for individual patient
needs
For the proposal to work effectively it must be very clear how the terms ‘small quantities’, ’not for profit’ and
‘occasional’ will be interpreted.
The proposal appears to create a 2 tier system whereby supplying a healthcare professional such as a GP for
onward use for a patient is not subject to restrictions, whereas supplying another pharmacist also a healthcare
professional, is subject to the occasional and not for profit rule.
It would be fairer and more expedient if the proposed exemption simple required the supply to any healthcare
professional, including pharmacists, to be on the condition that this is the last ‘wholesale’ transaction in the
supply chain and the person receiving it does so in order to sell/supply the medicine to their patient.
The LPC is also concerned about the different terms used in the documents provided with the consolation. In
the guidance the proposed changes appear to make the transactions person to person whereas in s10(7) the
transaction was linked to the registered pharmacy, by or under the supervision of a pharmacist. Unless the
pharmacist is a sole trader it will be the pharmacy business that will make the supply on the decision of the
pharmacist. The Impact Assessment refers to exempting ‘pharmacies that sell only to individuals and
organisations that hold stock for onward supply to patients’. We would request there are clear and consistent
terms and definitions that support the policy objective.
NHS hospitals and Trusts commercially trade in medicines and many registered their pharmacies to enable
wholesale supply to other legal entities such as private and third sector healthcare providers. The LPC would
like assurances that whatever licencing arrangements and /or concessions are put in place for NHS
organisations do not disadvantage community pharmacies and thus prevent fair competition.
Professional guidance to support the implementation is essential and transitional arrangements must be put in
place manner to enable all community pharmacies to understand the proposals, review their current practice
and manage the changes to minimise the negative impact on their business.
We are confused by the conflicting information in the Impact Assessment.
In the Cost and Benefit section for the preferred Option 1, it states ‘All healthcare providers can gain their
supplies from the usual route as long as the healthcare provision is direct to patients’. Then later in the same
section reference is made to the 15,286 healthcare providers in the private sector who will have to get their
supplies from a wholesaler in the future. Why?
Your proposed option to give an exemption for the ‘supply to a health professional or other who needs them to
pass on to their patients’ makes no distinction as to whether the healthcare profession/provider or other works
in the private or NHS healthcare sector, therefore they could all obtain their supplies from community pharmacy.
Please could you clarify this.
The regulations continue to require that a patient information leaflet is supplied with all medicines.
There are many occasions when this is neither possible nor desirable to provide a PIL.
Many patients receive their medicines in monitored dosage systems and other compliance aids on a regular
basis and providing a PIL every time is problematic.
Many patients receive supplies at intervals of less than 28 days from packs that are split and there are not
enough PILs available to include one with each supply.
Supplies of medicines to care homes are done in bulk and the care home staff are left with bundles of PILs that
are often thrown away and do not add to the patient safety agenda
We would like to see a more flexible approach that allows the pharmacist to use their professional judgement
whilst still ensuring that patients receive information in a timely and effective way.