Responsible Pharmacist

Responsible Pharmacist

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Pharmacy Regulations 2013
Responsible Pharmacist Regulations 2008

During the period after the Responsible Pharmacist Regulations came into force, allowing absences, and before the provisions relating to supervision have been examined, clarification is needed about the extent to which a pharmacy with a single pharmacist can operate, with respect to the NHS Terms of Service.

The Department of Health has been asked for its stance on the extent to which an NHS pharmacy can operate, during the absence of a pharmacist (for example, during the permitted absence of the Responsible Pharmacist). It has confirmed that the current Terms of Service were formulated (through negotiation with PSNC) on the basis that a pharmacist would be present at all times that the pharmacy is open for the provision of pharmaceutical services. This was the position during negotiations, as the Medicines Act 1968, required a pharmacist to be in personal control – and this had been interpreted as meaning on the pharmacy premises. The Department of Health has not had discussions with PSNC about whether the Terms of Service should be amended in light of the Responsible Pharmacist Regulations, and therefore NHS pharmacies should continue to have a pharmacist on the premises at all times that NHS pharmaceutical services are being provided. This is the case during both the core and declared supplementary hours.

In a joint statement issued on 1 October 2009 DH and PSNC stated: “Introduction of the responsible pharmacist requirements have been achieved through the amendment of medicines legislation. No changes have been made to NHS Pharmaceutical Services Regulations, including the terms of service for community pharmacy contractors. The Department of Health and the Pharmaceutical Services Negotiating Committee will undertake a review of the community pharmacy contractual framework and NHS Pharmaceutical Services Regulations in light of the responsible pharmacist changes to medicines legislation.


FAQs

Q. If the Responsible Pharmacist is absent for up to 2 hrs and there is no other pharmacist present is the NHS contract broken?
A. The Department of Health has confirmed that the Terms of Service were formulated (through negotiation with PSNC) on the basis that a pharmacist would be present at all times that the pharmacy is open for the provision of pharmaceutical services. This was the position during negotiations, as the Medicines Act 1968, required a pharmacist to be in personal control – and this had been interpreted as meaning on the pharmacy premises. The Department of Health has not had discussions with PSNC about whether the Terms of Service should be amended in light of the Responsible Pharmacist Regulations, and therefore NHS pharmacies should continue to have a pharmacist on the premises at all times that NHS pharmaceutical services are being provided.

Q. I have read that NHS pharmacies should continue to have a pharmacist on the premises at all times that NHS pharmaceutical services are being provided. This is the case during both the core and declared supplementary hours. Is it correct that in this respect the introduction of the regulations have not changed anything as this has always been the case?
A. Yes. Introduction of the responsible pharmacist requirements have been achieved through the amendment of medicines legislation. No changes have been made to NHS Pharmaceutical Services Regulations, including the terms of service for community pharmacy contractors.

Q. If the Responsible Pharmacist has a 2 hour absence during any 24-hour period in a 100 hour contract pharmacy, will they always have to have a second pharmacist on the premises to meet the requirements of their NHS contract to provide pharmaceutical services?
A. If the Responsible Pharmacist has an absence up to 2 hours absence during any 24-hour period a second pharmacist must be present during any hours the RP is absent, if these are the declared hours during which the pharmacy is providing pharmaceutical services.

Q. Can dispensed and checked prescriptions be handed to a patient if the Responsible Pharmacist is absent and there is no second pharmacist?
A. No. In both NHS and non-NHS pharmacy, there is still a requirement set out in the medicines legislation for supervision by a pharmacist.

Q. Can dispensed and checked prescriptions be handed to the delivery driver if the Responsible Pharmacist is absent and there is no second pharmacist?
A. No – for the reasons given in the FAQ above.

Q. Can any prescription (for GSL, P and POM medicines) which is accepted during the Responsible Pharmacists’ absence (and without the presence of a second pharmacist) be assembled by the dispensers in readiness for checking (and supply) when the Responsible Pharmacist returns?
A. In an NHS pharmacy, there must be a pharmacist present whenever pharmaceutical services are being provided. The hours that the pharmacy is open for the provision of pharmaceutical services, must have been declared to NHS England – and pharmaceutical services cannot therefore be provided outside those declared hours. The scenario in the question is therefore not expected to arise in an NHS pharmacy.

Q. A pharmacy operates 8am-6pm. Responsible Pharmacist (Pharmacist A) signs in at 8am and signs out at 4pm. A second pharmacist (Pharmacist B) arrives and works from 10am-6pm. Pharmacist B does not want to work as a Responsible Pharmacist. Can Pharmacist A still be classed as the Responsible Pharmacist until 6pm even though he/she have no intention to return?
A. Theoretically this is possible but the Responsible Pharmacist would have to remain contactable and be able to return with reasonable promptness and do so where they feel it is necessary.

Q. In the case of pharmacies with more than one pharmacist, the Responsible Pharmacist is still able to leave the pharmacy and pharmaceutical services can still be provided as there is at least one pharmacist remaining on site. Am I right in thinking that there will not be any change?
A. The Responsible Pharmacist would have to fulfill his/her obligations regarding the regulations including making a record of who the responsible pharmacist is, recording absences and remain contactable and be able to return with reasonable promptness. The responsible pharmacist must also be satisfied that the pharmacy can continue to operate safely during the period of absence.

Q. There can only be one Responsible Pharmacist signed on to a pharmacy at any one time. What happens if a Responsible Pharmacist, say a locum who lives a long way away, forgets to sign out at the end of the day: can the regular pharmacist sign on at the start of the next day while there is still technically another Responsible Pharmacist signed on? If we never employ that locum again, how are we expected to complete the RP record?
A. A Responsible Pharmacist has to personally sign in and sign out. If the pharmacist fails to sign out or record the beginning of an absence and is away for more than 2 hours then another Responsible Pharmacist can sign in and maintain their own record which is dated and specifies the time that they commenced being the Responsible Pharmacist. It would be good practice to inform the pharmacist who has failed to complete the record and he or she will need to decide how to complete the record for which they are legally responsible.

Q. Does the requirement to complete the Responsible Pharmacist record remove the need to send a record of the Pharmacists to the local NHS England Team for the purpose of contract monitoring?
A. The Responsible Pharmacist (RP) regulations may affect this issue.  In the Pharmacy Manual, the current policy is for NHS England to monitoring opening hours for contractors open for more than 40 hours per week (see page 282 onwards).  This includes the pharmacist’s name, signature, GPhC registration number, and hours worked.  It may be possible to use this record (see Annex 18) as a starting point for keeping responsible pharmacist records (and so avoid duplication), but care should be taken to ensure that any documents used, comply with both the NHS requirements, and the responsible pharmacist provisions.

Related resources

Responsible Pharmacist Regulations 2008

Royal Pharmaceutical Society guidance (members only)

General Pharmaceutical Council standards for owners and superintendent pharmacists that employ Responsible Pharmacists

CPPE e-learning package on Responsible Pharmacist issues



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