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Responsible Pharmacist: 10-part Countdown Across the UK, the profession must start getting to grips with the Responsible Pharmacist regulations before October 1. In the coming months C+D and the NPA, supported by McNeil Products Ltd, will be bringing you all the tools and advice you need to prepare for the legislation.
Part 1 Responsible pharmacist, irresponsible pharmacist, or just a pharmacist?
Part 2 What do you need to do and when?
Part 3 Updating your pharmacy SOPs
Part 4 Focus on independent contractors
Part 5 Absence of the responsible pharmacist
Part 6 Focus on superintendent pharmacists
Part 7 All you need to know about the new pharmacy record
Part 8 Locums and employee pharmacists
Part 9 All you need to know about pharmacy staff and accountability
Part 10 Last minute guide to the legislation if you still need to prepare
PART 1: Responsible pharmacist, irresponsible pharmacist, or just a pharmacist?
Like many other pharmacists, you may have been pushing these questions and others to the back of your mind until the new Responsible Pharmacist legislation comes into force.
Replacing the existing concept of personal control from October 1, the new rules state that every pharmacy must have a responsible pharmacist who is legally responsible for the safe and effective running of that pharmacy.
But the laws bring in new requirements for the entire profession. Locums and employees may find themselves assessing pharmacy procedures more closely and having to decide whether or not they want to take on the role of a responsible pharmacist. And superintendents and owners will need to ensure that effective procedures and systems are in place to allow their pharmacists to comply with the law.
There are some tough issues to grapple with, such as how and when you might want to be absent from the pharmacy and where accountability might lie in the case of errors. And there will be some immediate changes across the UK, starting with a requirement to keep a record of who was the responsible pharmacist at any given time.
So if you haven't already, it's time to start getting both yourself and your pharmacy prepared to ensure you are not caught out.
There is lots of potential for confusion, but C+D and the NPA have teamed up to give you over the coming months the facts, tools and advice needed to make sure you manage the law changes with ease. Look out for more advice in the columns, which will be published every two weeks in C+D.
PART 2 What do you need to do and when?
From now – Read, discuss and question as much material as you can from our series of Responsible Pharmacist articles and also read through the additional training resources and suggested Responsible Pharmacist SOPs at www.responsiblepharmacist.com.
Discuss the new principles, concepts and obligations with your colleagues or pharmacist friends and employer if applicable.
June – Read about the new SOP requirements and think about writing new ones or adapting existing SOPs to ensure they comply with the new requirements. Writing SOPs from scratch is a time consuming process so start as early as possible. To help you, together with the NPA and McNeil Products Ltd, we are publishing Responsible Pharmacist SOP templates at www.responsiblepharmacist.com.
July – By now most of our Responsible Pharmacist SOP templates will be ready for you to download from the RP website and adapt to your pharmacy. Make sure you are up to date – re-read the articles from C+D and continue work on your SOPs.
September – Now would be a good time to brief pharmacy staff to ensure everybody understands what these changes mean. Consider a live test run with your new and amended SOPs, new pharmacy record document and Responsible Pharmacist notice options.
October 1 – By now the processes should have been polished, but it might be a good day to review how they have been going with your staff and offer a quick refresher.
After October 1 – As well as keeping on top of your newly implemented processes, you should keep an eye out for and respond to the Department of Health’s consultation on supervision which is closely linked to the regulations.
PART 3 Updating your pharmacy SOPs
As the responsible pharmacist (RP) you are legally responsible for establishing, maintaining and reviewing pharmacy procedures. Even if you are not writing the SOPs, you must ensure they enable the safe and effective running of the pharmacy; check if they need amending, reviewing or updating; and ensure staff are aware of and work to them.
You can view template SOPs at www.responsiblepharmacist.com, where you can also find a full list of what your SOPs need to cover under the new regulations.
SOPs can be as detailed as you like as long as they ensure the safe, effective running of the pharmacy, but they must be easy to understand and follow. And there are a number of things to consider:
• Format: Electronic format is easier to update but printed SOPs can be easier to read and understand.
• Storage: Paper SOPs should be kept for 15 years from the date they were last effective and electronic copies kept indefinitely.
• Records: Old versions of SOPs should be marked as such and new ones marked with the date of preparation, the name of the person establishing them and their signature. New SOPs should be given a progressive version number.
• Staff: Pharmacy staff must be made aware of the content of SOPs that apply to them and these should be readily available. Even casual staff must read, sign and date the record sheet if the SOP applies to their tasks.
• Reviews: Review SOPs at least every two years or if patient safety is affected, such as by a dispensing error, or new guidance introduced. The date and person reviewing should be recorded on the SOP along with the next review date.
• Amendments: These are temporary changes due to a change in the pharmacy's circumstances, such as a staff member being off sick. They must be authorised by the RP, who should sign and date and check this amendment complies with the law and professional standards.
PART 4 Focus on independent contractors
If you’re a pharmacy owner, from October 1 the Responsible Pharmacist (RP) regulations require that for each pharmacy you own, an RP is in charge of the sale and supply of medicines at all times.
As an independent pharmacy owner, unless you have delegated the role, you will be responsible for the appointment of the RP and must ensure they are competent to take on the role.
If your pharmacy premises has been registered for less than three years, you must remember the RP cannot be someone registered in the UK with an equivalent pharmacy qualification awarded in a different EEA country. And you must make it clear to staff who the RP is.
In practice, many independent pharmacists will be the RPs themselves. But if you are away from the pharmacy for more than two hours you will need to appoint another pharmacist as the RP to take over your duties.
To comply with the regulations, a record must be kept of who the RP is at all times and a notice must be displayed on the premises stating the name and registration number of the RP currently in charge of the business.
Owners are also responsible for ensuring this record is preserved for at least five years from the date of the last entry in hard copy, or indefinitely if electronic. Failure to do this is a criminal offence. The NPA is developing a paper pharmacy record document for October.
As a pharmacy owner you must also support RPs in complying with their duties, and have systems for them to raise any concerns about the pharmacies. They must be able to access and assess the SOPs and have the freedom to make amendments to these and exercise their professional judgement. They will need to review the SOPs at least every two years. It may also be helpful to supply the SOPs to pharmacists, especially locums, in advance of their shifts so they are familiar with them.
Owners must also take responsibility for any staff employed in their pharmacies, ensuring they are all aware of and can comply with their professional and legal responsibilities and have systems in place to do this.
Part 5 Absence of the responsible pharmacist
Under existing legislation, it is generally accepted that if there isn’t a pharmacist available to be in “personal control” then a pharmacy may not open. The new RP regulations will enable a pharmacy to operate in a limited capacity in the absence of the RP. However, if a second pharmacist is not available, only GSL medicines may be sold, prepared POM medicines must not be handed out and P medicines may not be sold.
An RP (whether or not they change throughout the day) may be absent for a cumulative maximum of two ‘business hours’ within any 24-hour period (from midnight to midnight). These ‘business hours’ are hours in which the pharmacy is operational. This has been interpreted by the DH and RPSGB to include times when the pharmacy is not open to the public but when activities such as preparing prescriptions or ordering medicines might be taking place.
The intention is to allow a pharmacist to run services or attend work-related meetings while allowing the pharmacy to continue to operate legally. It is not mandatory to be absent and RPs must be able to exercise their professional judgement on whether to use the provision. For the pharmacy to operate safely and effectively when the RP is absent, you’ll need to ensure there are SOPs in place that define operations during this time. The RP remains responsible for the activities undertaken when he or she is absent, namely the sale of GSL medicines.
Remember, when the RP is absent only GSL medicines may be sold, prepared POM medicines must not be handed out and P medicines may not be sold. With the exception of Northern Ireland, there will be a professional requirement to record the reason for absence.
When absent, the RP should be contactable where possible and be able to return to the pharmacy reasonably promptly where necessary. If this is not possible then you must arrange for another pharmacist to be available to give advice (perhaps remotely) to staff.
The NPA’s comprehensive SOP – Operating in the Absence of the Responsible Pharmacist – can be dowloaded at www.responsible pharmacist.com. This provides further details on the conditions for being absent and what remaining pharmacy staff can or cannot do.
Part 6 Focus on superintendent pharmacists
A pharmacy or chain of pharmacies operating as a body corporate (a company) is required by legislation to be under the management of a superintendent pharmacist. This has not changed with the introduction of the RP regulations which will also require every pharmacy to have a responsible pharmacist.
Sometimes the superintendent will also be the RP for a particular pharmacy, however they continue to have an obligation to ensure the pharmacy complies with the law and professional standards.
To do this, superintendents must ensure arrangements are in place to appoint an RP for every pharmacy.
They must then make sure that RPs can fulfil all their obligations and ensure the safe and effective running of the pharmacy. While it will be the legal duty of the RP, and not the superintendent, to establish a pharmacy’s SOPs where these are not already established, in practice the SOPs are likely to be initially established by the superintendent or owner. As the RP is responsible for maintaining SOPs, superintendents should support RPs in this process.
Superintendents should check that all company SOPs meet the new RP requirements and cover all aspects of the regulations.
The DH advises that superintendents should not seek to impose procedures on RPs, but rather “allow sufficient flexibility... to allow the responsible pharmacist to tailor procedures to the specific operational needs of the pharmacy and to discuss any need for local variations”. Superintendents should be receptive to the views of the RPs working within their pharmacies if important changes are thought to be necessary to secure the safe and effective operation of the pharmacy.
Superintendents must also ensure RPs keep the pharmacy record up to date and the record is maintained for the time set out in the regulations. They must also decide how the pharmacy records are going to be kept and perhaps organise materials so that pharmacies can display the details of the RP publicly. The NPA will have products available for both these purposes shortly.
Area managers can support superintendents in their responsibilities, says the DH, but unless they are acting as the RP they will not be responsible for any individual pharmacy.
Part 7 All you need to know about the new pharmacy record
Under the responsible pharmacist regulations, every pharmacy must have a pharmacy record identifying who the RP is on any day and at any given time.
The record supports professional audit and accountability and will aid the investigation of any complaints, errors or incidents. It will be a legal document and it will be a criminal offence, punishable on conviction by a fine, for an RP to fail to complete or keep the necessary records. The regulatory body may also take action.
It will be the legal responsibility of owners and superintendents to ensure pharmacies have a record, with systems in place to support RPs in completing them, and that records are maintained properly.
The NPA has produced a template SOP on assuming the role of the RP and a pharmacy record paper document which is now available to order. Some things to think about when planning your record are:
Content: the record must include the name and registration number of the RP, the times they became and ceased to be the RP and any absences. Any changes to a record must be initialed and dated, and those made electronically must show who made them and when. Amendments to SOPs, however, should be recorded on the SOPs not the pharmacy record.
Recording: the information in the record must be accurate and should if possible be recorded contemporaneously, ie making entries at the time they occur.
Maintenance: you can choose to keep your record electronically or on paper, but entries must be kept for at least five years from the date they were created (if electronic) or from the date of the last entry (if on paper). Paper versions must be stored carefully and safely, ideally bound, and electronic versions must have appropriate back-up copies and be tamper-evident.
Availability: the record must be available for inspection at the premises if required, by the owner, the superintendent, the RP and staff or inspectors. And the DH warns it must be easy to access the record and get the legally required information.
Record checklist
The responsible pharmacist (RP) record should be:
Professional – loose pages could easily be lost
Tamper evident – bind the record with numbered pages
If electronic – safeguarded against over-writing or tampering
If electronic – able to be backed up easily.
Part 8 Locums and employee pharmacists
If you are going to work in a pharmacy, either as an employee or a locum, you must establish with your employer what role you will be taking on. Will you be the responsible pharmacist (RP)? If not, you should check who will.
The DH says whenever you become an RP you must do three things: check procedures are in place and that they support the safe and effective running of the pharmacy; enter the required information in the pharmacy record (‘signing in’); and display a conspicuous notice stating you are the responsible pharmacist and giving your registration number.
To ensure you can do this efficiently you should put in some preparation before going to work. If you are not familiar with a business you should ask to see pharmacy procedures before you start work.
As well as checking you are happy with the procedures (see ‘Procedure check’), you need to agree with your employer when it might be acceptable to sign off as the RP. You should also agree on whether your employer is expecting you to be absent from the pharmacy at any time or not. Remember if you do decide to sign off for a lunchbreak, medicines cannot be dispensed and preparations cannot be made up.
You may wish to consider keeping your own record, perhaps in a diary or log book, of when you were or were not a responsible pharmacist for any particular pharmacy.
Procedure check
1. An RP must establish pharmacy procedures “where these are not already established”, so you don’t need to set up new procedures each time you become an RP.
2. When you sign on as an RP you need to check procedures are available and support the safe and effective working of the pharmacy.
3. Ask to see procedures before you work in a pharmacy so you can assess them.
4. Check what support staff will be available and what they are trained to do, and check you are aware of the pharmacy’s dispensing volumes and additional services so you can be sure the procedures are appropriate.
5. Ensure procedures are up to date. You may need to change them if someone is absent, for example.
6. If you are working in a pharmacy regularly you will need to review the procedures from time to time; this could be in response to a dispensing error or change in staffing levels.
PART 9 All you need to know about pharmacy staff and accountability
If pharmacists haven’t already done so, now is the time to start getting staff up to speed with the Responsible Pharmacist (RP) regulations. Whether you are an owner or even work regularly with staff as a locum, you must be sure they understand what the new rules mean before October.
You should explain what an RP is, who is likely to be the RP, and tell them about the RP notice and also the pharmacy record and where it will be stored.
Perhaps the biggest change for staff under the new rules is that the pharmacy can stay open if the RP chooses to be absent. You must explain what this means and what staff can and can’t do in your absence. Remember:
1: Staff cannot sell P medicines or hand out pre-bagged or checked prescriptions unless a second pharmacist is there. This includes prescriptions for GSL medicines which also cannot be supplied.
2: With the prior permission of the absent RP, staff may sell GSL medicines and take prescriptions in from patients in their absence.
3: Staff may also assemble medicines but you must be sure of their competencies and capabilities and that SOPs cover this role.
You must outline what staff can do in SOPs, go through these to check they understand them and make sure they know where to find them.
Consider role play to practice dealing with customers during absences. For example, when referral is required, check they know how to contact the RP or nominated advisory pharmacist. Consider what should happen if neither can be contacted.
Staff should know where an absent RP is, how long they will be and how to contact them. Details of an alternative pharmacist to contact must be available if necessary. Staff should also know how to close the pharmacy and who to contact if you don’t return after two hours.
The RP is legally and professionally accountable for the procedures, and staff must work within those. If staff deliberately stray from them, then individual members of staff could be held responsible if problems arose.
Part 10 Last minute guide to the legislation if you still need to prepare
Learn the basics The RP regulations replace the concept of personal control and state that every pharmacy must have an RP who is legally responsible for the safe and effective running of that pharmacy. RPs are responsible for establishing, maintaining and reviewing pharmacy procedures. See a guide to the regulations at www.responsiblepharmacist.com.
Sort out your SOPs You will need to adapt your SOPs to comply with the RP regulations. The NPA’s templates can be downloaded from www.responsiblepharmacist.com.
Remember, SOPs must be reviewed at least every two years or if patient safety is affected, and amendments and changes recorded. When you become an RP you must ensure the SOPs enable the safe and effective running of the pharmacy.
Make a pharmacy record Pharmacies must have a pharmacy record identifying who the RP is on any day and at any given time and available to be viewed. It must be professional and preserved for five years from the date of creation (if electronic) or from the date of the last entry (if on paper). Paper versions must be stored carefully and safely, ideally bound, and electronic versions must have appropriate back-up copies and be tamper-evident. Failure of an RP to complete or keep the necessary records is a criminal offence.
Make a pharmacy sign You must also have a notice displaying who is the RP at any given time.
Update staff Ensure staff are aware of all the changes, understand the SOPs and pharmacy record and know what they can do if the RP is absent (see Get absence sorted, below).
Owners You must support RPs in complying with their duties and have systems for them to raise any concerns, as well as ensuring staff know what is going on.
Locums/employees As well as checking you are happy with SOPs, preferably reading these beforehand if working in an unfamiliar pharmacy, you need to talk to employers about signing on and off as RP and whether they expect you to be absent. You may want to keep your own record of when you were or were not an RP.
Get absence sorted
1. The RP regulations allow pharmacies to operate in a limited capacity without the RP present.
2. If a second pharmacist is not available, only GSL medicines may be sold, ‘bagged’ prescriptions must not be handed out and P medicines may not be sold.
3. An RP (whether or not they change throughout the day) may be absent for a cumulative maximum of two ‘business hours’ within any 24-hour period (from midnight to midnight).
4. When absent, RPs should be contactable where possible or another pharmacist must be available to advise (perhaps remotely) staff.
5. Staff should know where absent RPs are and what to do if they don’t return.
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