Responsible Pharmacist (RP)

Introduction

The Royal Pharmaceutical Society (RPS) has developed this one-stop toolkit as a source of comprehensive information to support pharmacists who will be working as a Responsible Pharmacist.

It can also be used by superintendents, pharmacy owners, pharmacy teams working with Responsible Pharmacists or those who are interested in finding out more about the role.

The Responsible Pharmacist is appointed by the pharmacy owner to be in charge in relation to the sale and supply of all medicines from the registered premises and a pharmacy cannot operate without one. He or she is responsible for the safe and effective running of the pharmacy. There can only be one at any one time, and a Responsible Pharmacist cannot be responsible for more than one premises at any one time.

Pharmacist-talking-with-patient-with-Benylin


This toolkit includes information on:

The law

Legislation introducing the role and responsibilities of the Responsible Pharmacist are set out in the Medicines Act 1968 (as amended by the Health Act 2006) and the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008.  

 

What being the responsible pharmacist involves

If you are the Responsible Pharmacist, you will need to:

  • Secure the safe and effective running of the pharmacy 
  • Display a notice with your name, registration number and the fact that you are in charge of the pharmacy at that time 
  • Complete the pharmacy record to identify you are the Responsible Pharmacist for the pharmacy at this time 
  • Establish (if not already established), maintain and keeping under review pharmacy procedures for safe working

Further information on each of the above can be viewed in the sections below.

 

Securing the safe and effective running of the pharmacy Securing the safe and effective running of the pharmacy

Remember that you can only be the Responsible Pharmacist in charge of one pharmacy at any given time. If you agree to become the Responsible Pharmacist you will need to secure the safe and effective running of the pharmacy. 

It could be useful to establish the scope of the responsibilities before taking on a role. If you are unsure about anything, do clarify with the pharmacy owner, superintendent, locum co-ordinators or others who can help. 

The following check-list could be useful.

  1. Are all members of staff present?
  2. Are the computer systems working properly?
  3. Are you aware of any messages left by the previous responsible pharmacist or the employer?
  4. Have you displayed the notice with your details?
  5. Have you completed the pharmacy record?
  6. Do you know where the pharmacy procedures are?
  7. Do the procedures cover all the required aspects?
  8. Do pharmacy procedures need to be amended or reviewed (due to changes in staff, other conditions or incidents) or because the procedures have not been reviewed for two years?
  9.  Is an audit trail in place to show what changes have been made to procedures, by whom and when?
  10. If you conduct a review of a procedure, have you notified the person in position of authority of any changes you made?
  11. Are you intending to be absent from the pharmacy for up to two hours?
  12. Have you let staff members know if you are planning to be absent?
  13. Are staff aware of what procedures they should follow when you are absent from the pharmacy?
  14. Do the staff know who to contact if you are not contactable?
  15. Have you checked the fridge temperature and the log?
  16. Do you know where the CD cabinet keys are?

If you believe a pharmacy is not safe or patients are at risk then you'll need to take steps to secure the safe and effective running of the pharmacy. It could help to speak to the pharmacy owner or superintendent. If it is not possible to secure safety and effectiveness then the pharmacy should be closed. 

Displaying a notice Displaying a notice

If you are the Responsible Pharmacist you are required to display a notice with the following information in the pharmacy where members of the public can see it, for as long as you are the Responsible Pharmacist:
  • Your name
  • Your GPhC registration number
  • The fact you are in charge of the pharmacy at the time.

The layout and design of the notice is at your discretion. We have developed a template notice which can be completed and printed. This is available here.

If you are designing your own notice:

  • Try make sure it is clear and professional in appearance
  • Avoid handwritten, printed is preferable.

Please note: If you are the Responsible Pharmacist and temporarily absent from the pharmacy (see below under “Absence”), you should not remove the notice even if there is a second pharmacist in the pharmacy. However, if the Responsible Pharmacist changes throughout the day, so too should the name and registration number on the notice.

The Pharmacy Record The Pharmacy Record

The pharmacy record is an important legal document. It is an audit trail of who was accountable for the safe and effective running of the pharmacy (the Responsible Pharmacist) on any given date and at any time. The record must be accurate and made contemporaneously by the Responsible Pharmacist. The record should also accurately record any absence.

The following details must be recorded in the pharmacy record:

  • The Responsible Pharmacist’s name
  • The Responsible Pharmacist’s registration number
  • The date and time at which the pharmacist became the Responsible Pharmacist
  • The date and time at which the Responsible Pharmacist stopped being the Responsible Pharmacist
  • If you are absent from the premises:
    • The date of absence
    • The time at which you leave the pharmacy
    • The time at which you come back

The pharmacy owner or superintendent pharmacist must keep the pharmacy record for a period of FIVE years. The record must be available at the pharmacy to which it relates.

The Pharmacy Record may be kept in the following formats:

  • In writing
  • Electronically
  • Or in both forms

An RPS template of the pharmacy record can be used can be downloaded here.

Please note if the record is kept electronically it needs to be backed up, kept on the pharmacy premises, and available for GPhC inspection if required. 

Any alterations or amendments based or electronic pharmacy records)need to identify when and by whom the alteration/amendment was made.This applies to both paper based or electronic pharmacy records.

The Responsible Pharmacist is required to personally makes entries in the pharmacy record. An entry may be made remotely as long as the record complies with all the relevant and professional requirements.

You may also want to check with your employer if they require you to record any additional information in the pharmacy record for audit purposes etc. For example, reason for the absence.

If you are not the Responsible Pharmacist, you do not have to legally complete the pharmacy record. Your employer may require you to complete other records detailing the times when you are in the pharmacy, but this is not the Responsible Pharmacist pharmacy record.

If the pharmacy wishes to undertake activities at the start or at the end of the working day which requires a Responsible Pharmacist to be in charge of the pharmacy premises but does not require the physical presence of a pharmacist the Responsible Pharmacist may be absent for up to two hours during these times. The pharmacy record must reflect this.

Pharmacy Procedures (also know as Standard Operating Procedures (SOPs) Pharmacy Procedures (also know as Standard Operating Procedures (SOPs)

As a Responsible Pharmacist you must establish, maintain and review the pharmacy procedures in the pharmacy you are working in.

Regulation 4 of The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 outlines the pharmacy procedures must cover the following:

1) The arrangements to secure that medicinal products are -

  • ordered
  • stored
  • prepared
  • sold by retail
  • supplied in circumstances corresponding to retail sale
  • delivered outside the pharmacy and
  • disposed of in a safe and effective manner

2)  The circumstances in which a member of pharmacy staff who is not a pharmacist may give advice about medicinal products

3) The identification of members of pharmacy staff who are, in the view of the Responsible Pharmacist, competent to perform certain tasks relating to the pharmacy business

4) The keeping of records about the arrangements mentioned in paragraph 1

5) The arrangements which are to apply during the absence of the Responsible Pharmacist from the premises

6) The steps to be taken when there is a change of Responsible Pharmacist at the premises

7) The procedure which is to be followed if a complaint is made about the pharmacy business;

8) The procedure which is to be followed if an incident occurs which may indicate that the pharmacy business is not running in a safe and effective manner and

9) The manner in which changes to the pharmacy procedures are to be notified to pharmacy staff

The pharmacy procedures can be kept in the pharmacy in the following formats:

  • In writing
  • Electronically (consider any back- ups required)
  • Or in both forms

The pharmacy procedures must be reviewed regularly. We strongly recommend once every two years or if an incident occurs which may indicate that the pharmacy may not be running safely and effectively (such as a dispensing error). The pharmacy procedures should identify:

  • the Responsible Pharmacist who reviewed the procedure,
  • the procedures in place
  • which procedures were previously in place

As a Responsible Pharmacist using your professional judgement you may want to make a temporary amendment to the pharmacy procedures if the circumstances in the pharmacy change (for example a key member of staff if off sick, etc). If temporary amendments are made you should maintain an audit trail to identify:

  • Which procedures are in place
  • Which procedures were previously in place
  • The Responsible Pharmacist who amended the procedure
  • The date on which the amendment was made

You need to be satisfied the pharmacy staff are aware of and understand the pharmacy procedures which are in place. This includes any amendments or changes to the pharmacy procedures during reviews. One way of ensuring this is keeping a log where once members of staff read and have understood the pharmacy procedures the log is completed to show this. Additional points to consider could include team training on procedures.


Absence

The legislation allows the Responsible Pharmacist to be absent for up to a maximum period of two hours during the pharmacy’s business hours between midnight and midnight. 

Please note: if there is more than one Responsible Pharmacist in charge of the pharmacy during the pharmacy’s business hours, the total period of absence for all the Responsible Pharmacists must not exceed two hours.

If the Responsible Pharmacist is absent, the following arrangements must be in place:

  • Only be absent if the pharmacy can continue to run safely and effectively
  • Remain contactable with the pharmacy staff
  • Be able to return to the pharmacy with reasonable promptness

The law recognises that there may be circumstances when a Responsible Pharmacist cannot remain contactable. If this is the case, the Responsible Pharmacist must arrange for another pharmacist to be contactable and available to provide advice (this does not need to be another Responsible Pharmacist).

The diagram below can be used to help you think about dealing with an absence:

Download FLOW DIAGRAM

 

RP flow diagram  

* PSNC FAQS FOR RESPONSIBLE PHARMACIST REGULATIONS

What you should do if you decide to be absent?

  • Complete the pharmacy record , as a minimum you must record the following:
    • The date of the absence 
    • The time at which the absence commenced (i.e. the time which the Responsible Pharmacist left the pharmacy)
    • The time at which the Responsible Pharmacist returned to the registered pharmacy premises

Your employer/pharmacy owner may want you to record other information such as reason for absence.

  • Do not remove the notice if you intend to remain the Responsible Pharmacist during your absence
  • Ensure your pharmacy staff have sufficient information (we have developed a template you may choose to fill in with useful information for your staff while the responsible pharmacist is absent

 

 

Which activities require a Responsible Pharmacist?

The following tables provide information on the operational activities which require:

1. The Responsible Pharmacist to be in charge of the pharmacy (they may be absent for up to two hours per day) and need to take place under the supervision of a pharmacist and the supervising pharmacist will need to be physically present at the pharmacy.

 

Activity Other points to consider
Professional check (clinical and legal check) of a prescription This check is required under the NHS pharmaceutical legislation
Sale/Supply of pharmacy medicines ‘Supervision’ in this context requires physical presence and pharmacist being able to advise and intervene
Sale/Supply of prescription-only medicines (e.g. handing dispensed medicines to patient, patient representative or a delivery person) ‘Supervision’ in this context requires physical presence and pharmacist being able to advise and intervene
Supply of medicines under a patient group direction (PGD) ‘Supervision’ in this context requires physical presence and pharmacist being able to advise and intervene
Wholesale of medicines ‘Supervision’ in this context requires physical presence and pharmacist being able to advise and intervene
Emergency Supply of a medicine(s) at the request of a patient or healthcare professional ‘Supervision’ in this context requires physical presence and pharmacist being able to advise and intervene      

 

2. The Responsible Pharmacist to be in charge of the pharmacy (they may be absent for up to two hours per day) and take place under the supervision of a pharmacist but who may not need to be physically present in the pharmacy.

 

Activity

Other points to consider

The assembly process (including assembly of compliance aids (monitored dosage systems)):

  • Generating a dispensing label
  • Taking medicines off the dispensary shelves
  • Assembly of the item (e.g. counting tablets)
  • Labelling of containers with the dispensing label
  • Accuracy checking

‘Supervision’ in this context may not require the physical presence of a pharmacist. The level of supervision required of the suitable trained staff who undertake this work will depend on what is regarded as good practice within the pharmacy profession (See Medicines, Ethics and Practice (MEP) for further reading)

 

3. The Responsible Pharmacist to be in charge of premises (they may be absent for up to two hours per day) but does not require the supervision of a pharmacist.

 

Activity

Other points to consider

Sale of general sale list (GSL) medicines

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Processing waste stock medicines or patient returned medicines (excluding Controlled Drugs)

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

There are also medicines disposal obligation in NHS pharmaceutical services legislation.

Responsible Pharmacists and Superintendents should give consideration to processing stock or patient returned medicines which are Controlled Drugs. See Medicines, Ethics and Practice (MEP) for further guidance on destruction of Controlled Drugs.

 

4. The following table does not require a Responsible Pharmacists to be in charge of the pharmacy but does require the pharmacy support staff undertaking the activity to be appropriately trained and for the activity to be done under standard operating procedures.

 

Activity

Other points to consider

Ordering stock from pharmaceutical wholesalers

Undertaken by suitable trained staff and operating within an agreed documented operating procedure

Receiving stock from pharmaceutical wholesalers into the building (excluding Controlled Drugs)

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Responsible Pharmacists and superintendents should give consideration to how the pharmacy receives orders containing Controlled Drugs taking into account the Misuse of Drugs Regulations 2001.

Putting medicinal stock received from the wholesaler away onto the pharmacy shelves (GSL, P, and POMs, excluding CDs)

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Responsible Pharmacists and Superintendents should give consideration to how the pharmacy handles Controlled Drugs taking into account the Misuse of Drugs Regulations 2001, also see Medicines, Ethics and Practice (MEP) for further guidance on Controlled Drugs.

Date Checking (excluding CDs)

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Responsible Pharmacists and Superintendents should give consideration to how the pharmacy date checks Controlled Drugs taking into account the Misuse of Drugs Regulations 2001 also see Medicines, Ethics and Practice (MEP) for further guidance on Controlled Drugs

Stocking pharmacy with consumables

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Cleaning of the pharmacy

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Responsible Pharmacists and Superintendents should give consideration to how access to the registered pharmacy premises is controlled, especially if cleaning of the pharmacy takes place overnight when the pharmacy is closed and/or if the cleaning services are contracted out.

Responding to enquiries (about medicine issues)

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Accessing the PMR

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Responsible Pharmacists and Superintendents should give consideration to how access to confidential information is protected in accordance with Data Protection and confidentiality requirements. See also GPhC Guidance on Confidentiality

Receiving prescription directly from patients or collecting from a surgery

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Obligations under NHS pharmaceutical legislation to ensure that prescriptions are dispensed with reasonable promptness.

Processing of prescription forms that have been dispensed (eg. Counting number of items dispensed, sorting prior submission for reimbursement)

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

NHS reimbursement covered under NHS legislation.

Delivery person conveying medicines to patient

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Responsible Pharmacists and Superintendents should give consideration to what will happen to undelivered medicines especially relating to Controlled Drugs. Also see Medicines, Ethics and Practice (MEP) for further guidance on Delivery and posting of medicines to patients (including abroad).

Receiving patient returned medicines (excluding controlled drugs)

Undertaken by suitable trained staff and operating within an agreed documented operating procedure.

Responsible Pharmacists and Superintendents should give consideration to how the pharmacy handles receipt of patient returned medicines which are Controlled Drugs in accordance with the Misuse of Drugs Regulations 2001. Also see Medicines, Ethics and Practice (MEP) for further guidance on Controlled Drugs.

 

Frequently Asked Questions

Being the Responsible Pharmacist

What does being the responsible pharmacist involve? What does being the responsible pharmacist involve?

If you are the Responsible Pharmacist, you will need to:

  • Secure the safe and effective running of the pharmacy 
  • Display a notice with your name, registration number and the fact that you are in charge of the pharmacy at that time 
  • Complete the pharmacy record to identify you are the Responsible Pharmacist for the pharmacy at this time 
  • Establish (if not already established), maintain and keeping under review pharmacy procedures for safe working

Further information on each of the above can be viewed in the sections below.

Can I be a Responsible Pharmacist at more than one pharmacy? Can I be a Responsible Pharmacist at more than one pharmacy?

No, the Responsible Pharmacist can only be the Responsible Pharmacist for one pharmacy at any given time.

Displaying the Responsible Pharmacist Notice

When do I need to display the Responsible Pharmacist notice? When do I need to display the Responsible Pharmacist notice?

If you are the Responsible Pharmacist, you need to display the notice with your information in the pharmacy for which you are responsible, and for as long as you are the Responsible Pharmacist.

Do I need to remove the Responsible Pharmacist notice if I am absent from the pharmacy and will remain the Responsible Pharmacist during my absence? Do I need to remove the Responsible Pharmacist notice if I am absent from the pharmacy and will remain the Responsible Pharmacist during my absence?

If you are absent from the pharmacy, you should not remove the Responsible Pharmacist notice even if there is a second pharmacist in the pharmacy.

What if the Responsible Pharmacist changes during the day? What if the Responsible Pharmacist changes during the day?

If the Responsible Pharmacist changes throughout the day, so too should the name and registration number on the Responsible Pharmacist notice.

The pharmacy owner already has a notice displayed, what do I have to do? The pharmacy owner already has a notice displayed, what do I have to do?

As the Responsible Pharmacist, you must ensure the notice contains your details (name and registration number).

You work in a hospital pharmacy that has registered premises with the GPhC. You are on-call and asked to go to the pharmacy department to make a supply of a POM for a ward patient. Do you need to display Responsible Pharmacist notice? You work in a hospital pharmacy that has registered premises with the GPhC. You are on-call and asked to go to the pharmacy department to make a supply of a POM for a ward patient. Do you need to display Responsible Pharmacist notice?

In this situation, although the hospital has registered premises with the GPhC, the activity you are undertaking (e.g. assembly and supply of POM to a patient on a ward) does not require the pharmacy department to be registered with the GPhC (For further information see GPhC Frequently asked questions on Registration and Renewal) This is because the assembly and supply you are making would be considered within the ‘course of the business’ of the hospital. Therefore there is no legal requirement for a Responsible Pharmacist to be appointed. You do not need to display the notice that you are the Responsible Pharmacist as the Responsible Pharmacist regulations do not apply.

I have arrived at a pharmacy, there is no notice provided and I have left mine at home? What should I do? I have arrived at a pharmacy, there is no notice provided and I have left mine at home? What should I do?

You can make a notice using the RPS template provided. 

Completing the Pharmacy Record

I am a full time employed Responsible Pharmacist from Monday to Friday. Do I need to complete the record every day or can I complete the record on only Monday morning and Friday evening? I am a full time employed Responsible Pharmacist from Monday to Friday. Do I need to complete the record every day or can I complete the record on only Monday morning and Friday evening?

A Responsible Pharmacist who is going to be in charge of the same pharmacy for consecutive days, for example Monday to Friday may decide to complete the pharmacy record on Monday morning (to show that they have become the Responsible Pharmacist) and then complete the pharmacy record on Friday evening (to show that they have ceased to be the Responsible Pharmacist). By completing the record in this way the Responsible Pharmacist must understand that they remain responsible for all activities that occur at the premises even when they are absent. 

Alternatively, they make the record daily. 

Either way, the pharmacist must be satisfied that the record is contemporaneous. If a Responsible Pharmacist chooses to complete the pharmacy record on Monday morning and Friday evening, they must ensure that the record in respect of 'absence' is held in a contemporaneous manner. A Responsible Pharmacist cannot complete their absence for the preceding week retrospectively.

The Responsible Pharmacist must be satisfied that the pharmacy record is compliant with the Responsible Pharmacist requirements (see guidance above “Pharmacy Record”). The pharmacy record must be contemporaneous and an accurate reflection of who has been the Responsible Pharmacist at any given time. 

If a pharmacist makes a record of the fact they are the Responsible Pharmacist then it can be assumed they are still the Responsible Pharmacist, when activities that require a Responsible Pharmacist take place, the next day.

You are the Responsible Pharmacist at one pharmacy all week and record this on Monday morning. If you are due in at 9am on Tuesday morning but are late and arrive at 10am, can you make the full record of the absence then? You are the Responsible Pharmacist at one pharmacy all week and record this on Monday morning. If you are due in at 9am on Tuesday morning but are late and arrive at 10am, can you make the full record of the absence then?

The situation described above is exceptional and unplanned.

In this scenario the Responsible Pharmacist is still in charge of the pharmacy because they were the Responsible Pharmacist at the pharmacy the day before, and they have not recorded that they have ceased to be the Responsible Pharmacist. This is an unplanned and exceptional circumstance as the pharmacist is unintentionally delayed. 

The pharmacist will need to make a professional decision and decide whether to allow the pharmacy to operate as it can during a period of absence and make the pharmacy record entry (i.e. record their absence) when they arrive at the pharmacy. The Responsible Pharmacist must understand that this is not a contemporaneous record and should be able to justify their decision. In doing this the Responsible Pharmacist should consider if they can comply with the legal and professional requirements with respect to being absent from the pharmacy, (i.e. securing the safe and effective running of the pharmacy, satisfying themselves that the pharmacy can continue to run safely in their absence, remaining contactable and able to return with reasonable promptness where it is necessary to do so or arrange for another pharmacist who is available to be contactable and able to provide advice). 

If however, the Responsible Pharmacist has not already been appointed and recorded that they are the Responsible Pharmacist in the pharmacy record, they cannot be absent until this has been done. A locum or relief pharmacist attending a pharmacy for the first time would not be in charge of the pharmacy or have recorded that they were the Responsible Pharmacist in the pharmacy record. Until the record has been made and absence established, no activities that require a Responsible Pharmacist to be in charge of the pharmacy should be carried out.

You are the Responsible Pharmacist at one pharmacy all week, Monday to Friday, you record this on Monday morning . Can you have an absence at the end of the day and then go home? You are the Responsible Pharmacist at one pharmacy all week, Monday to Friday, you record this on Monday morning . Can you have an absence at the end of the day and then go home?

This depends if the Responsible Pharmacist is in charge of the pharmacy premises and has recorded they are the Responsible Pharmacist in the pharmacy record and intend to return to the pharmacy the next day to continue working in this role.

If the pharmacist will not be the Responsible Pharmacist the following day they must make a record to show that they ceased to be the Responsible Pharmacist when they leave the pharmacy and therefore they could not take advantage of the absence provision at the end of the day.

Can someone else complete the Pharmacy Record on the Responsible Pharmacist’s behalf? Can someone else complete the Pharmacy Record on the Responsible Pharmacist’s behalf?

The Medicines Act 1968 requires that the Responsible Pharmacist makes the entry in the pharmacy record. The superintendent pharmacist or pharmacy owner would be advised to put in place adequate procedures that are robust enough to reduce the possibility that the Responsible Pharmacist could inadvertently leave before adequately completing the record.

A situation may arise where the Responsible Pharmacist fails in their duty to make the record, and it may not be possible for he/she to return to the pharmacy to record this. If the pharmacy operated an electronic pharmacy record system with remote access, this may provide a practical solution (for further detail see the FAQ Can a responsible pharmacist complete the record remotely?

Can a responsible pharmacist complete the record remotely? Can a responsible pharmacist complete the record remotely?

The pharmacy record must be contemporaneous, accurate and available at the pharmacy premises for inspection.The record can be kept as a hard copy or electronically. The record must be made by the Responsible Pharmacist and cannot be made by someone else on their behalf.

If the pharmacy had an electronic pharmacy record system in place that complies with all the Responsible Pharmacist legal and professional requirements, remote completion of the pharmacy log may be considered. In situations where emails are used the system should be designed to comply with the Responsible Pharmacist legal and professional requirements.

The RPS is unable to confirm whether or not individual electronic Responsible Pharmacist pharmacy record systems comply with the Responsible Pharmacist requirements. Suitable assurances should be obtained from the system manufacture and business indemnity providers.

Does sending in an e-mail constitute an electronic record? Does sending in an e-mail constitute an electronic record?

See response to question Can a responsible pharmacist complete the record remotely?

I have a consultation room for pharmacy services that is not on the registered premises. Should I log in and out of the record on each occasion, or complete the record at the end of the day? I have a consultation room for pharmacy services that is not on the registered premises. Should I log in and out of the record on each occasion, or complete the record at the end of the day?

If the consultation room is not on the registered pharmacy premises then you, the Responsible Pharmacist, are absent from the pharmacy while you are in the consultation room. This time will count towards the maximum two hours that you are allowed to be absent from the registered pharmacy premises.

The pharmacy record must document the date of the absence(s), the time at which absence(s) commenced and the time at which the Responsible Pharmacist returned to the premises. 

It is up to the Responsible Pharmacist to ensure that they are not absent for longer than two hours.

Absence

Can medicines continue to be assembled against a prescription when the Responsible Pharmacist is absent, and there is no other pharmacist in the pharmacy premises? Can medicines continue to be assembled against a prescription when the Responsible Pharmacist is absent, and there is no other pharmacist in the pharmacy premises?

For the assembly process to take place a Responsible Pharmacist must be in charge of the pharmacy premises (s/he may be absent for up to two hours per day) and take place under the supervision of a pharmacist but who may not need to be physically present at the premises. The assembly process includes generating a dispensing label, taking medicines off the dispensary shelves, assembly of the items, labelling containers and accuracy checking.

I am the Responsible Pharmacist and have already been absent for two hours. Later that day, I need to leave the pharmacy, as an emergency has risen. Can I leave the pharmacy? I am the Responsible Pharmacist and have already been absent for two hours. Later that day, I need to leave the pharmacy, as an emergency has risen. Can I leave the pharmacy?

As you have already been absent for the maximum allotted time, if you were to be absent no sale or supply of any medicines can take place (including GSL), as the pharmacy is considered to be without a Responsible Pharmacist. You must therefore weigh up the risks and benefits of your absence, taking into consideration the interests of your patients.

If I accidentally go over the two hours absence, should I notify anyone? If I accidentally go over the two hours absence, should I notify anyone?

Unless your pharmacy procedures require you to, the only people you may need to notify are the pharmacy staff. (The pharmacy procedure may require you to let the Superintendent, your CCG/Health Board know). This is to ensure that no sale and supply of medicines takes place once you have been absent for more than two hours. It is a good idea to note your reason for more than two hours absence in the pharmacy record for example delayed in traffic.

Are there any restrictions on why a Responsible Pharmacist can be absent? Are there any restrictions on why a Responsible Pharmacist can be absent?

No, but the list below gives examples of why the Responsible Pharmacist might be absent: 

  • To see patients in a consultation room in the non-registered area of the pharmacy 
  • To participate in a meeting with your local GP 
  • To visit patients at home or in a residential care home to advise on their medicines

If I’m leaving the registered pharmacy premises for a very short time, (e.g. nipping to the toilet off the registered premises), does a record of that absence need to be made? If I’m leaving the registered pharmacy premises for a very short time, (e.g. nipping to the toilet off the registered premises), does a record of that absence need to be made?

Yes if you are the Responsible Pharmacist and leaving the registered pharmacy premises for a short period of time an entry should be made in the pharmacy record as an absence.

The pharmacy record is an important legal document that records who was the pharmacist in charge of the registered pharmacy premises at any particular time. Certain activities may take place when the Responsible Pharmacist is in charge of the pharmacy but is absent (for up to a maximum of 2 hours).

The pharmacy record must accurately and contemporaneously record any absences.

Absence must be recorded in the pharmacy record if the Responsible Pharmacist wishes the business to remain operational during that period of absence.

Where another pharmacist is contactable because the Responsible Pharmacist cannot be contacted, can this person be the contactable pharmacist for a number of different pharmacies?Can they be the Responsible Pharmacist in another pharmacy? Where another pharmacist is contactable because the Responsible Pharmacist cannot be contacted, can this person be the contactable pharmacist for a number of different pharmacies?Can they be the Responsible Pharmacist in another pharmacy?

The contactable pharmacist is not restricted to being the contactable pharmacist for only one pharmacy. However they need to exercise their professional judgement to decide the maximum number of pharmacies for which they are the contactable pharmacist.

There is nothing to stop the contactable pharmacist also being the Responsible Pharmacist for another pharmacy. Again, they will need to decide whether they can do this safely and effectively.

Pharmacy procedures

What to do if you are unable to locate the pharmacy procedures in the Pharmacy? What to do if you are unable to locate the pharmacy procedures in the Pharmacy?

In relation to the pharmacy procedures, as a Responsible Pharmacist you must be satisfied that these exist, are maintained and reviewed.

If you cannot locate the procedures, it could be argued that you don’t know if they exist (i.e. whether they have been established). 

In the first instance, speak to the staff in the pharmacy. If they don’t know where the procedures are, you should contact the owner, superintendent or other person in a position of authority, e.g. a member of the pharmacy staff or an area manager. Another alternative is to contact the previous day’s Responsible Pharmacist. 

If they are unable to assist in locating of the procedures or they are not contactable, you will need to exercise your professional judgement as to whether to open the pharmacy. In this situation you must consider the consequences for your patients and the public if you: 

  • Keep the pharmacy closed and patients are unable to obtain their medicines and advice  
  • Open the pharmacy and cannot locate and follow the procedures

Do the risks of opening the pharmacy without being satisfied that procedures exist, outweigh the risks to patients if they cannot obtain their medicines? Whether you keep the pharmacy closed, or open the pharmacy you will need to justify your decision. 

If you decide to open the pharmacy, think about the procedures that you are required to have in place (see above under pharmacy procedures for detail on this). In order to open the pharmacy, what procedures are needed immediately? You may decide to implement brief procedures in relation to the sale and supply of medicines, and preparation of medicines, in the interim. If you introduce your own procedures ensure that the pharmacy owner/ superintendent is made aware of this and that staff see the procedures and understand these. 

If you choose not to open the pharmacy, you need to contact your employer and the CCGs/ Health Boards.

The RPS and PSNI commissioned research into the impact of the responsible pharmacist regulations on pharmacy practice, to help inform future decisions.

This research will be used to identify whether further change to pharmacy practice is warranted to optimise the safe and effective pharmaceutical care.

Find out more about the responsible pharmacist impact research