W23 Workplace regulation- The responsible pharmacist, SOP's

Question 1

What is ‘The responsible pharmacist?’

Answer 1

In order to lawfully conduct a retail pharmacy business, a registered pharmacist must be in charge of the registered pharmacy as the responsible pharmacist.

*You can only be the Responsible Pharmacist in charge of one pharmacy at any given time.
*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.

Question 2

What are the roles of the responsible pharmacist? (4)

Answer 2

*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
*Establish, maintain and keeping under review pharmacy procedures for safe working

Question 3

The responsible pharmacist
Ask your self…
(for info)

Answer 3

• Are all members of staff present?
• Are the computer systems working properly?
• Are you aware of any messages left by the previous responsible pharmacist or the employer?
• Have you displayed the notice with your details?
• Have you completed the pharmacy record?
• Do you know where the pharmacy procedures are?
• Do the procedures cover all the required aspects?
• 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?
• Is an audit trail in place to show what changes have been made to procedures, by whom and when?
• If you conduct a review of a procedure, have you notified the person in position of authority of any changes you made?
• Are you intending to be absent from the pharmacy for up to two hours?
• Have you let staff members know if you are planning to be absent?
• Are staff aware of what procedures they should follow when you are absent from the pharmacy?
• Do the staff know who to contact if you are not contactable?
• Have you checked the fridge temperature and the log?
• Do you know where the CD cabinet keys are?

Question 4

Is it important to display a notice as a responsible pharmacist?
What must the notice include? (3)

Answer 4

*Displaying a notice is a requirement
Information must include:
* 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.
*If you are designing your own notice:
* Try make sure it is clear and professional in appearance
* Avoid handwritten, printed is preferable.

Question 5

What is the pharmacy record?

Answer 5

*Audit trail of who was accountable for the safe and effective running of the pharmacy
*Allows you to find out the Responsible Pharmacist on any given date and at any time
*The record must be accurate and made at the time by the Responsible Pharmacist.
*The record should also accurately record any absence.

Question 6

What details must be recorded in the pharmacy record?

Answer 6

• 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

Question 7

The pharmacy record:
How many years should it be kept for?

What format should it be kept in?

Answer 7

• 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
• 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 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 make entries in the pharmacy record.

Question 8

Examples of absences: (3)

Answer 8

*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

Question 9

How long is a responsible pharmacist allowed to be absent for?

Answer 9

*The Responsible Pharmacist may be absent for up to a maximum period of two hours during the pharmacy’s business hours between midnight and midnight.
*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.
*Do not remove the notice if you intend to remain the Responsible Pharmacist during your absence

Question 10

What conditions allow you to be absent as ‘The Responsible Pharmacist?’ (3)

Answer 10

• 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

*In circumstances when a Responsible Pharmacist cannot remain contactable, they must arrange for another pharmacist to be contactable and available to provide advice.
* although this does not need to be another Responsible Pharmacist

Question 11

What needs to be recorded if you are absent from the pharmacy premises as the responsible pharmacist? (3)

Answer 11

• The date of absence
• The time at which you leave the pharmacy
• The time at which you come back

Question 12

Which activities require a Responsible Pharmacist?

Answer 12

• Professional check (clinical and legal check) of a prescription
• Sale/Supply of pharmacy medicines
• Sale/Supply of prescription-only medicines (e.g. handing dispensed medicines to patient, patient representative or a delivery person)
• Supply of medicines under a patient group direction (PGD)
• Wholesale of medicines
• Emergency Supply of a medicine(s) at the request of a patient or healthcare professional

Question 13

What are the activities that can take place with a Responsible Pharmacist absent but supervising?

Answer 13

‘Supervision’ in this context may not require the physical presence of a pharmacist.

The assembly process:
* 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

Question 14

Activities (Responsible Pharmacist absent)

Answer 14

*Sale of general sale list (GSL) medicines
*Processing waste stock medicines or patient returned medicines
(excluding Controlled Drugs)

Question 15

What are the Activities that can be carried out in the pharmacy with no Responsible Pharmacist?

Answer 15

• Ordering stock from pharmaceutical wholesalers
• Receiving stock from pharmaceutical wholesalers into the building (excluding Controlled Drugs)
• Putting medicinal stock received from the wholesaler away onto the pharmacy shelves (GSL, P, and POMs, excluding CDs)
• Date Checking (excluding CDs)
• Stocking pharmacy with consumables
• Cleaning of the pharmacy
• Responding to enquiries (about medicine issues)
• Accessing the PMR
• Receiving prescription directly from patients or collecting from a surgery
• Processing of prescription forms that have been dispensed (eg. Counting number of items dispensed, sorting prior submission for reimbursement)
• Delivery person conveying medicines to patient
• Receiving patient-returned medicines (excluding controlled drugs)

Question 16

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?

Answer 16

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.

Question 17

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?

Answer 17

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.

Question 18

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?

Answer 18

• 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.

Question 19

What are the regulations (laws) that apply to SOP’s and The Responsible Pharmacist? (2)

Answer 19

*Medicines Act 1968 (as amended by the Health Act 2006)
*Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 (Regulation 4)

Question 20

What is the definition of SOP?

Answer 20

A standard operating procedure (SOP) specifies in writing what should be done, when, where and by whom.

Question 21

What are the benefits of SOP’s?

Answer 21

*Help to assure the quality and consistency of the service
* Help to ensure that good practice is achieved at all times
* Provide an opportunity to fully utilise the expertise of all members of the pharmacy team
* Enable pharmacists to delegate and may free up time for other activities
* Help to avoid confusion over who does what (role clarification)
* Provide advice and guidance to locums and part-time staff
* Are useful tools for training new members of staff
* Provide a contribution to the audit process

Question 22

Who should write SOP’s?

Answer 22

*The development of SOPs should be overseen by the responsible pharmacist.
*Alternatively, the superintendent pharmacist will be accountable for ensuring that SOPs are developed and implemented.
*It is good practice to involve all staff involved in the dispensing process in the preparation of SOPs or tailoring of SOP templates.
*This will help to engage staff and ensure that the procedures specified are followed.

Question 23

What are the Pharmacy Procedures (in legislation)?
- According to SOPs

Answer 23

• Arrangements for medicinal products
• Advice given by non-pharmacists
• Staff competence for tasks
• Record keeping
• Responsible Pharmacist absence arrangements
• Responsible Pharmacist handover
• Complaint’s procedures
• Incident management
• Changes to the procedures

Question 24

What are the different arrangements for medicinal products? (according to SOP’s)

Answer 24

*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

Question 25

Staff competence for tasks:

Answer 25

*Pharmacists who delegate parts of the dispensing process to others are required to document (within an SOP) the tasks that can be delegated and to which staff.
*This process provides an opportunity to clarify roles within the pharmacy.
*Staff will be clearer as to when they should refer to the pharmacist and be more aware of the limits of their own competence.

Question 26

Give examples of Pharmacy procedures (in practice) that are part of the day-day activities:

Answer 26

• Dispensing
• Receipt of the prescription
• Therapeutic review
• Transfer of the medicine
• Patient counselling.
• Dispensing high-risk medicines (Methotrexate etc.),
• Dispensing controlled drugs
• Sourcing of medicines
• Storage of medicines
• Expiry date checking
• Sale and supply of non-prescription medicinal products
• Sale and supply of non-prescription codeine-containing medicines
• Management of controlled drugs (including storage and record keeping)

and many more..

Question 27

All pharmacies operate differently, and will need to reflect this. However, there are some general principles that will apply, SOPs should: (3)

Answer 27

• Be pharmacy specific
• Be dependent on the competence of the staff working in that pharmacy;
• Under normal circumstances, be applicable at all times, i.e. not dependent on the presence of the pharmacist under whose authority the procedure was prepared.
  There is no single template that can be applied to all pharmacies.

Question 28

SOP’s
Pharmacy Staff
(info only)

Answer 28

*You need to be satisfied that 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.

Question 29

Preparing SOPs
What are the subheadings? (6)

Answer 29

1. Objectives
   - What is the procedure trying to achieve
2. Scope
   - What areas of work are to be covered by the procedure?
3. Process
   - Description of how task will be carried out
4. Responsibility
   - Who is responsible for carrying out each stage? (in normal and different circumstances e.g. when staff are sick/holiday)
5. Training
6. Review
   - How are you going to ensure that the procedure continues to be useful, relevant and up to date

Question 30

SOP Review:
When should they be reviewed?

Answer 30

*The pharmacy procedures must be reviewed regularly.
* RPS recommends once every two years or if an incident occurs.

The pharmacy procedures should identify:
* The Responsible Pharmacist who reviewed the procedure,
* The procedures in place
* which procedures were previously in place

Question 31

SOP’s should allow Temporary Adjustments

Question 32

You’ve forgotten your packed lunch today, so you decide to pop up the road to the
bakery to buy some food. The pharmacy, however, doesn’t close for lunch.

As the Responsible Pharmacist, how long may you leave the premises for?
What tasks can the pharmacy team undertake in your absence?

Answer 32

Up to 2 hours between midnight to midnight
Dispensing,