Guidance on visits to pharmacies in Wales by external monitoring bodies
New legislation allows certain health care bodies to arrange visits to pharmacies for monitoring purposes. The Royal Pharmaceutical Society's Welsh Executive has produced the following guidance to assist pharmacists in Wales
Top tips
· Let the visiting organisation know when it is convenient to
visit the pharmacy (eg, when the regular pharmacist is present
and when
the pharmacy is most quiet)
· At no time should patient safety and confidentiality be compromised
· Ask to see identification at the start of the visit if it is
not offered
· Explain that interruptions are likely because the pharmaceutical
service must continue
· Ensure that the purpose of the visit is clear and, if necessary,
contact the review group leader beforehand to find out what documentation
is likely to be needed during the visit
· Ensure that staff are well prepared for the visit and that relevant
paperwork and documentation can be readily accessed during the
visit
· Introduce relevant members of the team and ensure that they have
prominent name badges
· Consider physical space in the pharmacy — where can the
review team meet with minimal disruption and risk?
· Because members of the public may be concerned to see people
inspecting a pharmacy, consider displaying a notice on the following
lines: “This
morning [—] is undertaking a routine inspection of this pharmacy
and the services we provide. Please be assured that no patient
confidential information will be disclosed during the course of
this visit”
· If possible, ask for a verbal summary at the end of the visit
and enquire when you can view the draft written report |
Who can visit? Under the new pharmacy services regulations the local
health board (LHB), Health Inspectorate Wales and community health
councils can arrange to visit any pharmacy that holds an NHS contract.
Pharmacists
may also encounter other persons with powers of entry such as chemist
inspection officers (Controlled Drug inspectors), customs and excise
officers, trading standards officers, and NHS Counter Fraud Services
staff.
What is new? The new regulations introduce the right of external monitoring
bodies to visit pharmacies and the responsibility to consider the recommendations
in any of the reports produced as a result of such a visit.
What do I need to do?
- Be aware of the rights of the visiting bodies
- Ensure that any communication on a planned visit is acted upon promptly
- Ensure that reasonable notice has been given and that the visit
is at a time when the health and safety of staff and patients will
not
be compromised
- If not stated, ask how long the visit is likely to take
- Ensure that the visit is conducted professionally, safely and protects
patient confidentiality (Particular care is needed to protect patient
details shown on computer monitors and prescriptions and to ensure
that dispensing activity is not made unsafe by distraction or interruption.)
- Ensure, whenever possible, that the regular pharmacist and clinical
governance lead is present at the time of the visit (If the regular
pharmacist cannot be present and the visit cannot be rearranged,
ensure the locum
pharmacist is well briefed.)
- Respond to any opportunity to comment on a draft visit report
- Ensure that relevant personnel (eg, pharmacy support staff, line
manager) are made aware of the visit
- At LHB inspection visits, the pharmacist may request the presence
of a Community Pharmacy Wales (CPW) representative
- Be aware of the types of information each body may request and be
prepared to challenge requests for information and/or documentation
outside that
body’s remit
- Review the recommendations raised in any report with pharmacy staff,
line manager and/or LHB and consider how they can be implemented
- Where the visit would compromise the effective provision of health
services or a patient’s safety, privacy or dignity then the
pharmacist should discuss any concerns with the person requesting
the visit and
ensure that adjustments are made to the visit plan to avoid any adverse
impact on patients
- It is important for the pharmacist to ensure that he or she has
the opportunity to comment on any draft report (Any draft reports should
be sent to the superintendent pharmacist of the organisation, whether
small or large.)
Content of visits
LHB visits Reasons for local health board members to visit a pharmacy
formally include:
- An annual clinical governance review
- A local pharmaceutical needs assessment
- Monitoring compliance with the new pharmacy contract (Society inspectors
may, in some cases, carry out the monitoring of the pharmacy contract
on behalf on the LHB)
- Investigating an unresolved complaint
- Looking at issues around poor performance
Visits should be formally notified to the pharmacy beforehand, whenever
possible and practicable. The LHB representatives may view some information
or evidence, such as standard operating procedures, at the visit. For
monitoring purposes the LHB is required to determine whether the pharmacy
has an appropriate SOP. It is not, however, required to carry out a detailed
analysis of the content of the SOP as these are bespoke to the individual
pharmacy. It is not a requirement under the terms of service for pharmacists
to forward documentation in advance of a visit and, with some documentation
there could also be issues of patient and commercial sensitivity should
it be removed from the pharmacy premises.
Prior collection of evidence by the pharmacy team is good practice but
the documentation should not leave the pharmacy premises before the visit.
Under Paragraph 37 of the chemists’ terms of services, if the pharmacy
contractor requests it, a CPW representative must be invited to be present
at the LHB inspection of the pharmacy.
Further information
Paragraph 37 of the Chemists Terms of Services — The National
Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations
2005.
Available at www.opsi.gov.uk
National guidance on
the contractual framework.
HIW visits Healthcare Inspectorate Wales (HIW) will assess LHBs, among
other organisations, against the Welsh Assembly Government’s “Healthcare
standards for Wales”. The 32 standards cover the four domains of
patient experience, clinical outcomes, health care governance and public
health. The full set of standards is available
as a PDF file
(240K).
Healthcare Inspectorate Wales (HIW) has developed a concordat between
external review bodies inspecting, regulating, and auditing health and
social care in Wales. The aim is to have an agreed a set of principles
and practices and eliminate any unnecessary burdens of external review.
HIW will not directly inspect independent contractors commissioned by
the LHB to provide services on behalf of the LHB. However, HIW will send
a questionnaire to all primary care contractors to ask about their experiences
of dealing with the LHB. The primary
care stakeholder questionnaire is available as a PDF file
(110K).
Additionally HIW has a role in investigations of serious incidents, protocols
for this work are in the process of being finalised and will be set out
in a Welsh Health Circular.
CHC visits The 20 community health councils (CHCs) in Wales act on behalf
of patients who receive treatment from the NHS. CHC representatives have
the power to “enter and inspect premises” owned or controlled
by the LHB, local authorities, NHS trusts and primary care providers
(such as GPs, dentists, pharmacists and opticians). The focus for the
visit will be the “patient experience”.
Anyone authorised in writing by a CHC may at any reasonable time enter
and inspect a pharmacy providing NHS services. You should ask to see
written authority before making arrangements to go ahead with the visit.
At the time of writing this guidance (January 2006), CHC representatives
have not commenced a visiting programme for pharmacies, and no protocol
of such visits has been developed.
Feedback mechanisms on visits
Pharmacists could ask those undertaking visits whether a feedback or
evaluation sheet is available for them to complete.
LHB visits If the pharmacist has a concern or complaint about the visit
they should raise this via the LHB’s complaints channels. Each
LHB may have a different set up in relation to complaints so the pharmacist
will need to know whom to approach within their locality.
ACKNOWLEDGEMENTS: Assistance is acknowledged from Boots The Chemists,
the National Pharmacy Association and the Pharmacy Services Negotiating
Committee.
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The
Pharmaceutical Journal