The Responsible Pharmacist requirements

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The Responsible Pharmacist requirements

• The Pharmacy Show
• Joy Wingfield
• Professor of Pharmacy Law and Ethics, October 2009

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Outline

• Who is affected by the RP rules?
• Clarifications, recent amendments
• Pitfalls and possible avoidance
• A good change or not?

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Owners/Employers/Contractors

• NHS law is unchanged (for now)
• Owner must ensure a RP in charge of sale/supply
  of medicines at all operational times
• Record of RP at any time maintained/preserved at
  each premises
• Notice displayed at the pharmacy with name and
  registration number of the RP in charge of
  business
• New offences
• Failure to ensure RP makes and maintains the RP
  record
• Failure to preserve RP record at each pharmacy
• RP must not have originally been registered in
  the EU if premises registered for less than three
  years

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Superintendents

• Legal position remains the same
• Every body corporate must have one
• Business, so far as sale or supply of all
  medicines is concerned, must be under the
  management of the superintendent and now
• A named RP is in charge and
• The RP is subject to directions of suptd.
• RPSGB standards refer to support and
  responsiveness to concerns

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Employees, Locums

• Agree to be the Responsible Pharmacist for
  specific premises at specific time
• If agreed, secure the safe and effective running
  of the pharmacy business at those premises
• Establish (if not already in place) maintain and
  review a range of SOPs
• Make a record of when s/he is the RP
• Decide if and when regulated absence is
  appropriate and make required arrangements

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clarification 21st Sep 09 (1)

• RP must be in charge and-
• Pharmacist present and supervising
• Professional check, s/s P meds, handing out POMs,
  PGDs, wholesaling, emergency supply
• Pharmacist may be absent but must still be
  supervising
• Assembly of scripts including mds
• Pharmacist need not supervise
• GSL sales, handling returns (except CDs)
• RP not needed but needs trained staff working
  under SOPs
• Ordering, receiving, putting away, date checking,
  cleaning, etc

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clarification 21st Sep 09 (2)

• Assembly of medicines for prescriptions (s10) and
  sale or supply of P or POM (s52) must be under
  supervision
• Pharmacy case law defined supervision for the
  sale or supply means being bodily present but
  less clear on assembly
• So used more recent case law to define
  supervision in a professional context as What
  is regarded as good practice within the
  profession (trained, experienced staff assemble
  but pharmacist not necessarily present)
• Still need to be there for the transaction (till
  the law is changed again) but not for assembly
  (group 2 activities)
• Thus reinterpretation of supervision is already
  in progress

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clarification 21st Sep 09 (3)

• When to sign in and out of pharmacy record
• It is important to remember that the pharmacy
  record is a record of who has been the
  responsible pharmacist (and any absences) and it
  is not a case that the pharmacist signs in and
  signs out as the RP
• So an RP for Mon to Fri can make the record at
  the end of the week or they may like to make the
  record each day
• So long as activities in groups 2, 3 and 4 are
  undertaken, the RP absence may be at start or
  end of day

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Pitfall avoidance?

• Agreeing to be a RP
• Proving you were not a RP
• Accepting liability for SOPs
• Taking a break
• Agreeing to take a RP absence
• operational hours even if closed

• Be assertive
• Be street wise and cover your back
• Engage with locums and agencies earlier
• Patient safety is first
• Negotiate conditions and back up advice
• Risk assess the need for a pharmacist

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A good change or not?
So, whats the worst that could happen? (A) Or
maybe (just maybe) whats the best that could
happen? (B)
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Scenario A

• Workload, rest breaks, stress and staffing
  realities are not addressed
• Attitudes harden, trade union style working to
  the rulebook grows
• Pharmacists continue to be held accountable for
  matters outside their control, disputes increase
  between employer and employee
• Pharmacists decline to be an RP

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Scenario A continued

• Closed door assembly, remote supervision, and
  ATM supply becomes the norm, no need to visit
  the pharmacy
• Pressure to increase length of RP absence
• Public access to pharmacist is reduced
• The public discern no difference between
  pharmacies and other retailers
• Need for pharmacy medicines disappears
• Patient and public service deteriorates

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Scenario B

• It takes two to provide pharmacy services
• Pharmacists become assertive, are valued and new
  responsibilities are recognised
• Flexible and improved employment conditions
  reduces dependence on locums
• AND locums are valued and supported
• Funding recognises value of walk in health
  centre for pharmacy services

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Scenario B continued

• Dispensing is rigorously routinised using
  computer and remote support - BUT
• Pharmacists remain as the front end of the
  dispensing process in the pharmacy
• They and/or second pharmacists deliver clinical
  services in the community
• Individual contracts with pharmacists become
  possible

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Or am I being hopelessly academic?