responsible pharmacist regulations Flashcards
definition of responsible pharmacist
a pharmacist who is responsible for securing the safe and effective running of the pharmacy
also responsible for securing the safe and effective running of the pharmacy during any periods when they’re absent
Health Act 2006 and responsible pharmacist regulations
legal requirement for every retail pharmacy to have a named responsible pharmacist on duty when the pharmacy is open
RP for more than 1 pharmacy?
NO not at one time
exception - pandemic
What does being the responsible pharmacist involve?
1.Secure the safe and effective running of the pharmacy, including during periods of absence
2. Display a notice with their name, registration number and the fact that they are in charge of the pharmacy at that time
3. Complete the pharmacy record to identify who the responsible pharmacist is for the pharmacy at any one time
4. Establish (if not already established), maintain and keep under review, procedures for safe working
time RP can be absence from the pharmacy
- may be absent from the pharmacy for a maximum of 2hrs, during the operational hours of the pharmacy, between midnight and midnight
- total period of absence allowed for (all) responsible pharmacist(s) during one 24 hour period for one pharmacy must not exceed 2hrs
if RP is absent they must…
- only be absent if the pharmacy can continue to run safely and effectively
- remain contactable
- be able to return with ‘reasonable promptness’ and do so where they feel it is necessary to secure the safe and effective running of the pharmacy
If RP can’t be contactable if away?
can arrange for another pharmacist to be contactable and to provide advice
** but the absent pharmacist remains the RP
Why may a pharmacist need to be absent from the pharmacy?
- Attend a meeting with local GPs
- Visit a patient at home
- Visit a residential or nursing home to provide advice on medication or to train staff
- Attend a training event
When do the 2hrs of absence RP can have start?
when RP leaves the pharmacy and ends when RP returns to the pharmacy
GSL meds when RP absent and only pharmacist
GSL medicines may still be sold
P meds when RP absent and only pharmacist
P medicines must NOT be sold
dispensed and bagged prescriptions waiting for collection when RP absent and only pharmacist
must not be given out
Supply of medicines on a PGD and RP absent and only pharmacist
supply of medicines on a PGD must NOT take place
Wholesale dealing and RP absent and only pharmacist
must NOT take place
Emergency supply and RP absent and only pharmacist
must NOT take place
Prescriptions taken in and RP absent and only pharmacist
prescriptions can taken in
Can assembly of medicines take place if RP absent and only pharmacist?
depends on staff, the assembly activity, the pharmacist
needs to be ‘supervised’ but may not need to be present
Can supply of assembled medicines to a patient take place if RP asbent and onyl pharmacist?
NO
what must be on RP notice
- pharmacist’s name
- pharmacist’s GPhC registration number
- the fact they’re in charge of the pharmacy at this time
displaying a notice
- must be displayed in a place where members of the public can see it (‘conspicuously displayed’)
- must remain on display even when RP absent from premesis
What must pharmacy record legally include?
- pharmacist’s name
- pharmacist’s GPhC registration no.
- date and time at which they became RP
- date and time they ceased to be the RP
- if they’re absent from the premises, date of absence, time they left pharmacy, time returned
How long keep pharmacy record for?
5 years
what type of offence to not keep pharmacy record
criminal offence
GPhC advice about pharmacy record
- should be completed personally by the RP
- reason for absence should be noted
- amendments/alterations should ID who made them and when
- record should be completed in real time and not retrospectively
- record must not be completed until the pharmacist assumes the role of the RP (i.e. the safe and effective running of the pharmacy is secured), pharmacy must not open until this is done
- record provides an important audit trail of responsibility
- electronic records must be backed up regularly
How often should SOPs be reviewed?
at least every 2 years
(date when written and date for review)
What needs to be in place if SOP amended by RP?
audit trail in place to show who amended it & date
if there’s no RP for a pharmacy
- pharmacy has to close for the sale and supply of medicines
- but likely to be in breach of its NHS contract to dispense prescriptions if it closes
- display of restricted titles (chemist/pharmacy) is unlawful if there is no RP signed in
- safer to close the pharmacy
- but NHS Local Area Team should be contacted
definition of ‘Retail Pharmacy Business’
a business which consists of or includes the retail sale of medicinal products other than medicinal products on a GSL
(from the Medicines Act 1968)
Who can legally conduct a retail pharmay business?
- pharmacist
- partnership where each partner is a pharmacist
- a body corporate
- a representative of a deceased, bankrupt or mentally ill pharmacist
What is the superintendent pharmacist?
person who has the overall management of the ‘keeping, preparing and dispensing of medicinal products other than medicinal products on a GSL’
MUST BE A PHARMACIST (on GPhC register)
When can the title ‘chemist’ only be used?
can only be used by the business if the superintendent pharmacist is a member of the board of the body corporate
Does hospital pharmacy need to be registered with GPhC?
no as long as the supply of medicines is within the same legal entity
(supply of meds to patients in that hospital)
When must hospital pharmacy be registered with GPhC?
if it suplies medicines to a separate legal entity, then must be registered with the GPhC
What is separate legal entity?
- hospital which is not part of the same NHS Trust
- any business/organisation which is not part of the same NHS Trust as the hospital
if hospital suppleis to patients who are not patients of that hospital…
then it must be registered with the GPhC
When do RP regulations apply to hospital pharmacy?
if the pharmacy department is REGISTERED with the GPhC then the RP regulations DO apply to the pharmacy
hospital pharmacy and wholesale dealing
if registered with GPhC doesn’t need wholesale dealers licence
hospital pharmacy and manufacturer’s licence
if registered with GPhC and manufacturers meds, doesn’t need manufacturer’s licence
You work in a hospital which includes a private IVF clinic in the same building. A patient presents a valid prescription at the hospital pharmacy issued by this clinic for IVF treatment. Can you dispense it?
- private clinic is a separate clinic, not part of the hospital
- can only dispense it if hospital pharmacy is registered with GPhC
- supplying medicine to patient who is not a patient of the hospital
A hospital pharmacy has a contract and a service level agreement (SLA) to provide medicines to a local prison
- people in the prison are not patients of the hospital, are a separate legal entity
- hospital pharmacy will be making money out of the contract
- only way hospital pharmacy can do that is by registering with GPhC, having RP in place and then can supply medicines to the prison
A community pharmacy has run out of amoxicillin and is unable to get further supplies for 72 hours. They are asking the hospital pharmacy to sell them 20 boxes of amoxicillin capsules 250mg to help them out
** Wholesale dealing
- if the hospital has wholesale dealers licence they can do it (likely do)
- can also do it if registered with GPhC, can use the exemption for wholesale dealing (need RP, notice displayed, RP signed in)
A hospital pharmacy regularly transfers medicine stock between itself and another hospital pharmacy based in the new A and E department, located in a hospital on the other side of the town
- if A&E is in the same trust, suppling within the trust, not wholesale dealing because not supplying to separate legal entity
- might charge A&E department, but an internal charge, between each department to balance the books, money stays within the organisation
- if A&E is in separate hospital of a different trust, need to be registered with GPhC, have RP etc.
hospital pharmacy and another pharmacy in same town. First decided to register with GPhC. Do both need to register separately?
- yes, because they are in separate geographical locations
- both need to be registered separately
- eg. Boots, all pharmacies have to be registered separately
2 pharmacies in same building - do both need to register separately?
- if in same building and can get from one to the other without going in a public area of the building, then only need 1 registration
(eg. 1 upstairs and 1 downstairs and there’s a staircase between them that the public doesn’t have access to, then only need 1 registration) - eg. if 2 pharmacies and no staircase and only way to get from one to the other is to leave pharmacy and walk along corridors that public have access to, then have to register both pharmacies separately
problems with the legislation of RPs
- conflict/unclear responsibilities between RP and SP
- problems of locums reading/amending SOPs and responsibitity for area outside their control
- grey area: remote signing in of pharmacists to RP
- lack of clarity about activities that can/can’t be done if pharmacist absent
- poor application to hospital pharmacies
law change December 2022: Pharmacy Order 2022
GPhC will now control RP/SP roles
roles and responsibilies now enforced via professional standards (& GPhC) rather than legislation and criminal courts
