The Responsible Pharmacist

The responsible pharmacist regulations came into effect on 1 October 2009.

There are four key areas the law covers:

1. Display a notice
2. Pharmacy records
3. Pharmacy procedures
4. Absence from the pharmacy

The responsible pharmacist is the pharmacist appointed by the employer, who is responsible for securing the safe and effective running of the pharmacy. The responsible pharmacist continues to be responsible for securing the safe and effective running of the pharmacy during any periods of absence. 

If there is more than one pharmacist working in the pharmacy at any one time, only one can be the responsible pharmacist. A pharmacist cannot be the responsible pharmacist for more than one pharmacy at any one time.

It was recognised that, to improve the range of services available in pharmacies, pharmacists must be able to work more flexibly - to make better use of their clinical training and the skills of pharmacy staff.

In order to do this, changes needed to be made to the "personal control" and "supervision" requirements of the Medicines Act 1968. However, due to the complex nature of these changes, the Government decided that it would make phased changes to the Medicines Act. It agreed to first make changes to the personal control requirements to enable absence of the responsible pharmacist, and then at a later date amend the supervision requirements, following a public consultation.

The Medicines Act 1968 is concerned with the sale and supply of all medicines. Other pharmacy activities, such as diagnostic testing, smoking cessation and additional clinical services provided within pharmacies are covered by NHS law and 2005 NHS Contract.

Medicines Act 1968 (before 1 October 2009)

In order to conduct a retail pharmacy business lawfully, currently there must be a pharmacist in "personal control". The current interpretation of "personal control" is that the pharmacist needs to be physically present in the pharmacy. This interpretation created an anomaly regarding the sale of GSL medicines from pharmacies, as there is no requirement for other retail outlets (garages and convenience shops) to have a pharmacist present to allow the sale.

Furthermore, sales of P and POM must be under the supervision of a pharmacist. The Medicines Act does not define "supervision", although this is commonly interpreted as needing a pharmacist to be able to 'intervene and advise'. However, NHS legislation requires a pharmacist to supervise the supply of all medicines directly.

Medicines Act 1968 (after 1 October 2009)

The Health Act 2006 amends relevant sections of the Medicines Act 1968. Instead of requiring a pharmacist in "personal control", there must be a "responsible pharmacist" in charge of each registered pharmacy.

Responsible Pharmacist - Community

The Responsible Pharmacist Regulations come into effect on 1 October 2009

If you are the responsible pharmacist you will have to:

• Secure the safe and effective running of the pharmacy, including during periods of absence
• 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 who the responsible pharmacist is for a pharmacy at any one time
• Establish (if not already established), maintain and keep under review procedures for safe working

What does secure the safe and effective running of the pharmacy mean?
This requirement applies to the sale and supply of medicines. In order to comply with this you must complete the record and ensure the procedures, safeguard patient safety.

No additional training or qualifications are required to take on the role of responsible pharmacist. However, you must only work within areas in which you are competent and must be able to comply with the legal and professional responsibilities of a responsible pharmacist

Establishing your procedures

There is no specified format for your procedures, but they must be written down either as a hard copy or as a computer record and be available for inspection and amendment by any responsible pharmacist who works in the pharmacy. They can be as detailed as you choose but must ensure the safe, effective running of the pharmacy. It is important that your procedures are clear and unambiguous.

What you need to know if you are:

An employee pharmacist

Speak to your employer to determine who is the responsible pharmacist, and how the procedures will be established. Working together with your employer you should ensure that these procedures are in place and that staff begin to work to them as soon as is possible.

A Locum Pharmacist

You should make sure, prior to arriving at a pharmacy to be the responsible pharmacist, that the pharmacy procedures have been established. You should also check where they are located, and ensure that you can work to them.

The pharmacy owner or superintendent pharmacist

You may wish to provide company guidance to aid development of the procedures and should let your employees know how the pharmacies procedures are to be established. You must ensure the pharmacy procedures are established by 1 October 2009.

Maintaining and reviewing your procedures

In terms of maintaining and reviewing the procedures, we see these as inter-related functions. In essence, at any time that the procedures are not being reviewed or amended, they are being maintained.

The standards for responsible pharmacists clarify the difference between a review and an amendment, see below.

Amending a procedure

• A key member of staff is off sick
• There is an equipment failure

Reviewing a procedure

• You become aware of a significant dispensing error
• You realise that your procedures are not effective
• A new member of pharmacy staff is employed

We advise that following points are incorporated into the SOP:
1. Safe and effective ordering, storage, preparation, sale, supply, delivery and disposal of medicines:

• Ordering
  - The systems used for ordering medicinal products
  - Which staff members are authorised to order medicinal products
  - What to do if the systems are not working
  - Which staff check the orders
• Storage
  - Process for medicines that need to be stored under specific conditions e.g. fridge items
  - Stock rotation
  - Checking dates
  - Which staff put the orders away
• Preparation
  - Equipment that is used for preparation of products including gloves, masks etc
  - Area of pharmacy that is used to prepare products
  - Labelling of products
• Sale
  - Which products can be sold by whom
  - Which products can be sold when a pharmacist is not present
  - Systems for recording such products
• Supply
  - What the circumstances are e.g. PGD and which medicines they relate to
  - Who is authorised to make the supply
  - Where to find the relevant documentation
• Delivery
  - Methods of delivery
  - Times of delivery
  - Who is authorised to deliver
  - Emergency situations
• Disposal
  - Handling all waste
  - Sorting hazardous waste
  - Details of waste contractors and how to contact them

2. Advice about medicinal products:

• The level to which staff must be trained to be able to provide advice
• Which products they may / may not provide advice for e.g. cannot provide advice for any POM product but can provide advice for all GSL products
• The process that staff must follow when providing advice
• When staff should refer to a pharmacist and what to do in the circumstances that a pharmacist is not physically present (see No. 5)

3. Pharmacy staff who are competent to perform specified tasks:

• A list of staff, their qualifications and the roles they are competent
  to perform
• What to do if particular member(s) of staff are not present (amendment
  of the SOP and related SOPs)

4. Keeping of records about the matters mentioned in 1:

• Where such records are kept
• The keeping of invoices of wholesalers
• The keeping of invoices from waste contractor details
• Appropriate records for private prescriptions
• Any records for the extemporaneous preparation of medicines

5. Arrangements during absence:

• How the responsible pharmacist can be contacted - if they can't be contacted, details of the pharmacist who is to be contacted to provide advice
• How staff are informed of the responsible pharmacist's absence
• What medicines can / cannot be supplied during the responsible pharmacist absence
• How to handle prescriptions that require dispensing, especially urgent prescriptions

6. Change of responsible pharmacist:

• Completion of the pharmacy record
• Change the notice to reflect who the responsible pharmacist is
• How staff are informed of changes
• How outstanding issues are communicated from one responsible pharmacist to another
• How any changes that have been made to the SOPs are communicated from one responsible pharmacist to another

7. Complaints:

• The format of the complaints form and where to find it
• How complaints are handled
• Where are complaints sent to e.g. Head Office/pharmacy owner or primary care organisation
• How complainants are kept informed
• How staff are informed of the outcomes and any learning from complaints
• How necessary changes are made following a complaint

N.B. In the section above, complaint refers to a complaint made in relation to the sale and supply of medicines.

8. The procedure if an incident occurs:

• How incidents are recorded
• Process for dealing with an incident - who does what
• If the incident is reported to an external agency e.g. PCO
• How learning from the incident is shared
• Review of procedures

9. Changes to the pharmacy procedures and how staff are notified:

• Which members of staff should be notified as a priority
• Ensuring that staff read the updated amended SOP (as a matter of good practice staff could complete a log to indicate they have read the amended SOP)
• How the superintendent pharmacist or person in position of authority is notified of any changes where appropriate
• The SOP is signed and dated to indicate a change has been made
• The recording of the reason for any amendments
• Logging of any amendments to the SOP

Responsible pharmacists - locum pharmacist

Working as a locum pharmacist does not pose any differences to the requirements of the responsible pharmacist's legislation and standards, and the content of this toolkit must be read in full, as the responsibilities of a responsible pharmacist are equally applicable to locum pharmacists.

Things to consider as a locum pharmacist

1. Ensure that a contract exists between you and your employer. N.B. The Society advises that any contract made is in writing, to ensure cover for both the pharmacist and the employer. Before you sign the contract and begin to work ensure you understand what is expected of you.
2. Contact the employer prior to attending work to re-confirm dates and times.
3. Find out what (if any) indemnity insurance is provided. Ensure all your activities are covered by professional indemnity insurance.
4. Check the level of support staff available, and find out what level of experience/training they have.
5. Does the pharmacy operate with an accuracy checking technician (ACT)? Have you worked with an ACT before? Do you understand their role and how that may affect the way in which the pharmacy operates?
6. Check the volume of dispensing and sales and the nature of the work carried out in the pharmacy.
7. Check what additional services (e.g. blood pressure monitoring, number of supervised methadone consumption patients, care homes etc) the pharmacy provides, and be satisfied that you are competent to undertake and supervise these.
8. Find out in advance what type of computer system is in use.
9. Check the location of the pharmacy and consider traffic, access by public transport and parking.
10. Find out what resources the pharmacy has available. For example, the British National Formulary, the Medicines, Ethics and Practice guide, etc.
11. Ask your employer whether they have a handbook containing the information above

Responsible pharmcists - Hospital pharmacists

Not all pharmacy departments within hospitals are registered with the Society

The responsible pharmacist changes to the Medicines Act only affect those hospitals that have registered all or part of their pharmacy premises with the RPSGB. Therefore, if you are a hospital pharmacist, the first thing you need to do is determine whether the pharmacy has been registered with the Society. You can do this by checking with a senior manager. Alternatively, there is an online search facility at the RPSGB website.

If the pharmacy department is not registered with RPSGB, the details of this toolkit are not applicable to you.

Hospitals may choose to have registered pharmacy premises for a number of reasons including:

• Operate a retail pharmacy, which allows them to dispense prescriptions
  that have not originated within their hospital and sell P medicines to visitors and staff

If you do have a registered pharmacy within the hospital, then the law and standards for responsible pharmacists will apply. That means the registered pharmacy is required to have a responsible pharmacist when it is operating as a pharmacy business.

Activities that form part of the business of the hospital and do not require registration with the Society do not require a responsible pharmacist to be in place.

As a hospital pharmacist in the first instance you are advised to speak to your chief pharmacist for clarity in the area of responsible pharmacist within the pharmacy.

If you are appointed as the responsible pharmacist, ensure you have read and understood the content of this toolkit.

The Society has issued guidance titled Hospital Pharmacy Practice and the Responsible Pharmacist Requirements. This guidance clarifies the activities that take place within hospitals and whether the hospital pharmacy is required to register with the Society and/or obtain an appropriate licence from the MRHA.

Contact us on 020 784 32410

Email: info@resourcing.uk.com