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Responsible Pharmacist: Answers to readers' questions Michelle Styles, formerly head of information services at the NPA, and Wing Tang, the NPA's specialist pharmacist advisor, answer questions from C+D readers about the Responsible Pharmacist regulations that came into force in October 2009.
The interactive Q+A service is now closed. On October 1, 2009 the Responsible Pharmacist legislation came into effect, however the legislation governing pharmacy practice will be subject to future change, including changes to supervision. Please note that the answers to the questions on this site, although correct at the time of writing, may change as guidance, case law or legislation is updated.
Hello, I have just come across the Responsible Pharmacist rules. I'm amazed to see that they don't contain anything that prevents pharmacists from selling remedies that are known to be ineffective. For example, pharmacies sell homeopathic remedies and they sell (to give you "energy") coQ10 tablets (the latter drew a reprimand from the ASA). This sort of behaviour seems to me to disqualify pharmacists from giving advice to the public about medicines. Is it really true that there is no reference to it in the Responsible Pharmacist rules? David Colquhoun D. Colquhoun FRS Professor of Pharmacology Michelle says Dear David, Thank you for taking the time to pose this question. The intention of the responsible pharmacist legislative changes were to improve clarity in the definition of the role of the pharmacist in charge of a pharmacy and also to introduce flexibility to allow pharmacists to undertake additional clinical roles and it is therefore true that they do not directly regulate or seek to prevent pharmacists from selling homeopathic remedies or health food supplements.
Dear Michelle, If a responsible pharmacist is off the premises for a lunch break and the shop remains open, does this fall under the new responsible pharmacist absence guidelines? This situation currently occurs at some of our retail pharmacies where the pharmacist goes for lunch and the dispensary is closed but the rest of the shop remains open. Some duties are still in operation even though the dispensary is closed (e.g. preparing scripts for the pharmacist's return, stocking shelves, etc). All staff are aware of the current restrictions and legal responsibilities when the pharmacist is absent. Many thanks Stuart Michelle says Dear Stuart, The Responsible Pharmacist regulations were not brought in to resolve the issue of pharmacist rest breaks but they do impact on it. Where the responsible pharmacist is away from the registered premises for lunch then the pharmacy business has two options* – the responsible pharmacist could sign out as responsible pharmacist and the registered pharmacy premises could close (this will depend on how much of the premises is actually ‘registered’ – eg in supermarkets, often only the dispensary and medicines counter will be registered) or alternatively they could remain the responsible pharmacist and use the absence provisions in the regulations. In the latter option the pharmacy business could continue to be “operational” in the absence of the responsible pharmacist ( DH and RPSGB interpret operational to include the continued preparation and assembly of medicines against prescriptions or putting away stock, although of course no POM or P medicines cannot be given to patients). * also consideration of the core hours of the pharmacy contract required.
Michelle, I sometimes work at a pharmacy that opens at 8:00am when the pharmacist starts, however there are dispensers in the store from 6:00am dispensing prescriptions ready to be checked when the pharmacist arrives. Under the RP regulations I understand that for this practice to continue the RP must sign in at 6:00am and that no dispensing activities can take place until the RP has signed in for that 24 hour period. Is this the case? To modify the scenario - could the RP sign out at the end of the day when the store closes and dispensing activities continue for a maximum of 2 hours (assuming the RP has not taken any other absence that day)? Michelle says Dear Colleague, You have posed some interesting scenarios here – so hopefully the following will help you plan for what needs to be done. The responsible pharmacist legislation requires every pharmacy premises to have a designated Responsible Pharmacist when the pharmacy business is operational. The key word here is ‘operational’. This has not been defined directly in legislation – however the Department of Health and the Royal Pharmaceutical Society of Great Britain have interpreted this as meaning more than just when the pharmacy is open to the public and could include assembly of medicines against a prescription or ordering of medicines before or after opening hours. Ultimately only a court of law can decide upon the scope of legislation. However if the DH and RPSGB interpretations are correct, then a pharmacist will need to have assumed the role of the responsible pharmacist or be legitimately absent under the responsible pharmacist regulations to legally allow the preparation of prescriptions as described in your scenario. This is not necessarily impossible to comply with as it is not a requirement to sign in and out as Responsible Pharmacist on a daily basis if the same pharmacist will be the Responsible Pharmacist continuously for a number of days. For example if you start work on Monday and finish on Wednesday evening you may sign in on Monday morning and sign out on Wednesday evening (providing of course there are no other absences in between). You could then legitimately be absent on Monday evening after hours for a period of time or Tuesday morning before opening. Remember that the law permits a total cumulative absence of up to 2 hours in any 24 hour period beginning and ending at midnight.
I'm a locum and undertake engagements for several well-known companies during the course of the year. Presumably, once the regulations come into force, I'll be the designated "responsible pharmacist" when I'm on duty in those pharmacies. It's very rare that I've worked as second pharmacist in recent years. Some of the pharmacies have, in the past and currently, in my opinion operated with unsafe staffing levels, over which I have had no control. I have voiced my opinion to higher management more than once but have been told, more or less, to like it or not take on the work!! "There's a recession and we don't have the budget to take on more staff or replace so-and-so who's left" is a common excuse. Will I, as the responsible pharmacist on the day, be held accountable for these inadequate staffing levels, especially if, god forbid, an adverse dispensing incident takes place? Another scenario that I've experienced is the removal of budgeted medicines counter staff to work in the rest of the shop and being expected to man the medicines counter and dispensary by myself. It's a quiet pharmacy, admittedly, but there is no dispenser either. Any advice would be welcome. Regards, Angela Dale Michelle says Hello Angela and thank you for taking the time to ask a question. You are correct: from October 1 2009, when you are working as a locum pharmacist, you will generally be the 'responsible pharmacist' for that pharmacy unless, as you say, there is a second pharmacist on the premises. The regulations permit only one responsible pharmacist per pharmacy. If you are a locum and there will be two pharmacists at the pharmacy, normally the employer will communicate to you whether you will be the responsible pharmacist on that day. If there are two pharmacists on duty it would be good practice to confirm whether you are acting as the 'responsible pharmacist' prior to arrival at the pharmacy either through the locum agency or by contacting the employer direct. At present, when you work as a locum pharmacist, you are in 'personal control' of the pharmacy. This concept has been poorly defined in legislation but has been considered by the Statutory Committee over the years. The pharmacist in 'personal control' of a pharmacy has always assumed professional responsibility for the sale and supply of medicines. The new regulations simply enshrine this duty in law. As responsible pharmacist, your duty will be to secure the safe and effective running of the business as far as it concerns the sale or supply of medicines so, in the same way in which you would currently deal with this scenario, you will need to use your professional judgement as to whether staffing levels are adequate and discuss this with the area manager or superintendent's office.
Dear Michelle, The new guidelines from the RSPGB make no mention of reasonable breaks from duty during a day's work. Will the responsible pharmacist have to sign out if he/she takes a lunch break? It doesn't seem to be considered a valid excuse - will we be breaking the law if we have lunch and don't note it in the register? Sarah Roberts Michelle says Hi Sarah, Thank you for your question. The regulations are very clear on recording absence from a pharmacy, and a record must be made each time the responsible pharmacist is away from the pharmacy while it is open. Considering your question there are two possible scenarios. If the responsible pharmacist takes a rest break and is absent from the pharmacy premises whilst it remains open for business, then the absence will count towards the maximum two-hour absence that is allowed and a record must be made. If, however, the pharmacy shuts during the pharmacist's rest break, then this will not count as an absence and no record needs to be made. It's worth remembering that the responsible pharmacist regulations were not designed to deal with rest breaks. The primary aim of the legislation is to allow flexibility for the development of new roles away from the pharmacy premises.
Dear Michelle Will the responsible pharmacist have to sign out when consulting in the consulting room of a supermarket? I understand only the dispensary and medicines counter will be registered. Ann Burling Hi Ann, Thank you for your question. Firstly you will need to speak to your superintendent if you are not aware which parts of your premises are registered and which are not. Technically if the RP is 'absent' from the registered premises for any reason (eg bathroom breaks in a different part of the store, undertaking a service in a consultation room that does not form part of the registered premises) then the law states he or she would need to sign out and RPSGB guidance states that the reason would need to be recorded as well. Of course, this may be interpreted differently by case law in the future so in the interim we would advise you to seek clarification from Head Office".
Michelle, With regard to your answers to questions posed by Stuart and Sarah Roberts concerning rest breaks, I am gravely concerned that you have offered guidance that is irreconcilable with employment legislation and court precedents. Surely a rest break, i.e. "an uninterrupted period during which work should not be undertaken" to be taken "away from your workstation", is incompatible with an absence under RP regulations during which the RP must remain "contactable throughout the period of absence" and able to "return to the premises with reasonable promptness if, in the opinion of the responsible pharmacist, this is necessary to secure the safe and effective running of the pharmacy business".
Therefore, in order to have a rest break, the RP must sign out and so, unless there is a second pharmacist present who could sign in, the pharmacy would thus have no RP and hence must close. Your suggestion that a RP could "use the absence provision in the regulations" to take a break for lunch during which he/she would remain legally 'responsible' and "the pharmacy business could continue to be 'operational' in the absence of the responsible pharmacist" could not possibly deliver complete mental and physical rest breaks that comply with the Working Time Regulations (WTR). Could you please clarify your advice? Furthermore, your reply to one colleague contains advice asserting that "it is not a requirement to sign in and out as Responsible Pharmacist on a daily basis if the same pharmacist will be the Responsible Pharmacist continuously for a number of days. For example, if you start work on Monday and finish on Wednesday evening you may sign in on Monday morning and sign out on Wednesday evening (providing of course there are no other absences in between). You could then legitimately be absent on Monday evening after hours for a period of time or Tuesday morning before opening."
In light of the Elizabeth Lee verdict, and bearing in mind that, from October 1 2009, the new RP regulations introduce a significant number of brand new professional misdemeanours and also a brand new criminal offence, would it really be sensible for a pharmacist to remain signed in overnight, and therefore 'responsible' for a pharmacy's continued operations — while absent, and unpaid to boot — for two hours before or after the working day? Or indeed during any absence under RP regulations if no alternative pharmacist is available on the premises? And where, may I ask, would rest breaks fit into your hypothesis? Surely the only proper course of action for responsible pharmacists would be to sign out when they go home — every time they go home — and not to leave vague periods for which they will be inevitably held responsible. Dear Mr Tyas,
I employ regular locums who will be responsible pharmacists when they are working. As owner of the business I will review my SOPs and make changes where necessary. It does not seem practical that a locum should read each pharmacy’s SOPs as the file contains many pages and would take half a day. What is the legal position?
Michelle says
According to guidance issued by the DH, a responsible pharmacist should check that the pharmacy procedures are available in the pharmacy and that these cover the minimum areas required by legislation and should be satisfied that the procedures support the safe and effective running of the pharmacy. In practice will may mean that the locum pharmacist should be familiar with the SOPs in advance. They could do this by contacting the pharmacy prior to working to enquire about standard operating procedures. However it is important to point out that there already exists a professional obligation in the Code of Ethics to “Take responsibility for your working practices” and this requires that pharmacists “be satisfied that appropriate standard operating procedures exist and are adhered to” Therefore although this has now been reinforced by legislation – there has always been an obligation on the pharmacist-in-charge to be aware of the SOPs and their content in a place in which they are working.
If a mistake is made in making up a script, on a previous day when I have the day off, and the script is given out in good fair when I am the responsible pharmacist - who will take the rap? This appears to be an existing issue rather than one specifically related to Responsible Pharmacist. Our understanding is that liability in these cases can depend upon the intricacies and variations of the individual circumstances and therefore it would be inappropriate to give a general answer. However, factors such as adherence to SOPs by the checking pharmacist or the supplying pharmacist would be important.
Hi,
Wing responds
Dear Himesh
Under the responsible pharmacist regulations each pharmacy premises requires a pharmacist to assume the role of the pharmacist in order to operate. Typically this will involve making an entry in the pharmacy record (signing in as the responsible pharmacist), ensuring that a compliant responsible pharmacist notice is on display, a check that the required SOPs are in place and that these are safe and effective.
In the first scenario you have given – it would not be possible to complete all of these steps and therefore the pharmacy premises does not have a responsible pharmacist and may not operate.
In the second scenario where the RP has already signed in from the previous day – then assuming the notice is still in place, the SOPs are in place and acceptable, then our understanding is that the absence provisions could be utilised. There are however additional conditions when absence is utilised such as being contactable or arranging for another pharmacist to be contactable and these will also need to be adhered to. It should be noted that in this scenario the RP will only be able to physically make a record of the absence upon arrival at the pharmacy rather than when absence commences and there is debate over whether this would be considered "contemporaneous". Our view is that this would be "contemporaneous" but have sought clarification from RPSGB and DH on the matter and we await their reply.
(1) Whilst writing our SOPs for the new RP role is it correct that members of staff need to be named or is it sufficient (as in the old set of SOPs) for a job title/grade to be stated? (2) Are the new SOPs for the RP meant to supplement or replace the existing SOPs? (3) Is there any guidance on the content of a written locum contract available?
Many thanks
Stuart J. Bowman B.Sc.(Hons), MRPharmS
Wing responds
Dear Stuart
The responsible pharmacist regulations require that a SOP is in place to identify members of pharmacy staff whom are competent to perform certain tasks relating to the pharmacy business. My understanding is that it would be sufficient that tasks are allocated according to job title/grade/role within the SOPs as long as it is possible for any responsible pharmacist to identify the job title/grade/role of the members of staff working within the pharmacy. However there is the option of using the SOP to identify individual members of staff who can perform additional tasks or restrict tasks for a specific member of staff.
In answer to your second question, some of the SOPs cover topics for which you will not have an existing SOP and these will therefore need to be implemented or you could write your own. For the topics where you already have existing SOPs then it is a matter of choice whether you review and improve your existing SOP using our new one as a guide or whether you adopt the new one in its entirety.
In your final question you ask about the locum contract. We have an existing template locum contract and guidance notes which are available from the members section of the NPA website or can be obtained by contacting NPA Information. We are currently reviewing this in light of the responsible pharmacist regulations.
"This is not necessarily impossible to comply with as it is not a requirement to sign in and out as Responsible Pharmacist on a daily basis if the same pharmacist will be the Responsible Pharmacist continuously for a number of days. For example if you start work on Monday and finish on Wednesday evening you may sign in on Monday morning and sign out on Wednesday evening (providing of course there are no other absences in between). You could then legitimately be absent on Monday evening after hours for a period of time or Tuesday morning before opening. Remember that the law permits a total cumulative absence of up to 2 hours in any 24 hour period beginning and ending at midnight."
I am interested in your comments above and have a few questions on this.
1) The statutory instrument document states that the particulars which must be included on the pharmacy record are – e) in relation to any absence of the responsible pharmacist from the premises on a day on which they were the responsible pharmacist a. Does this not mean we should sign out at the end of each day before we leave the premises? Even if we are working the next day.
2) If an employee was a absent responsible pharmacist in the morning before opening they would have to meet the regulations of that absence i.e. contactable and able to return promptly. a. This would mean the employee was on call thus on duty.
Just a few thoughts as this is an interested debate concerning before opening operations. I am enjoying your column so thank you, regards.
Mark Stone
Wing responds
Dear Mark
We are glad that you are enjoying the column and thank you for your additional questions.
In reply to your first question, it is not a legal requirement to sign out as the responsible pharmacist at the end of each working day if you are also the responsible pharmacist on the next day when the pharmacy opens. The section of legislation which you are referring to doesn’t relate to signing in or out as responsible pharmacist and instead relates to annotating the time and date of absence starting or ending. These are two distinct and separate requirements although admittedly confusingly similar. To illustrate, a pharmacist who was the sole responsible pharmacist, could sign in at the start of the week and sign out at the end of the week but any interim absences would need to be annotated into the pharmacy record.
For your second question, you are correct that if a pharmacist chooses to be an absent responsible pharmacist prior to opening to the public then they would need to comply with all the obligations of a responsible pharmacist and also the conditions for absence which can include either being contactable where this is reasonably practicable or where contact is not reasonably practicable then the legislation also allows for arrangements to be put into place so that another pharmacist can provide advice to the pharmacy team.
I don’t understand how a pharmacy company can require a single pharmacist to be an RP for one of its branches at all times?
Surely the whole point of the RP is that any single pharmacist is only the RP when they are actually working in that pharmacy and functioning as the RP. So equally a single pharmacist can not be appointed as the permanent RP for any specific pharmacy. To put in another way isnt the manager only the RP of the pharmacy at the times they are working there and functioning as the RP? Therefore there is no useful function in a company naming a specific person to serve as the RP at any branch?
Consider a scenario in a supermarket pharmacy which is open 100hrs a week. One pharmacist (the manager) works for 39h, they clearly cant be the RP for the whole 100hrs.
If each pharmacist who comes on duty, either employee or locum assumes the RP duties, who is responsible for ensuring the records are completed? Are there any circumstances under which an RP appointed for that branch could be held responsible?
Thanks
Max
Wing responds
Dear Max,
I am unsure as to the background context of your query, however I will try to clarify the situation as much as possible in light of this.
In theory a single individual could be the sole responsible pharmacist for the vast majority and in some cases the entire time. For example imagine a pharmacy owner acting as the responsible pharmacist for their 40 hour a week pharmacy.
It would be extremely unlikely that a single individual would be the responsible pharmacist for all of the time in a 100 hour pharmacy. In your scenario, clearly a pharmacy manager who works 39 hours a week would not be the responsible pharmacist for the whole 100 hours.
Each individual who assumes the role of the responsible pharmacist is legally responsible for making the appropriate entries and it is an offence not to do so. The pharmacy owner or superintendent pharmacist also has an overlapping legal responsibility and is responsible for making sure that these entries are made and that the pharmacy record is preserved, again it is an offence if this is not done.
This legal obligation and liability does not extend to the pharmacy manager or any other responsible pharmacist however the actual task of checking that entries are made by other responsible pharmacists could in my view be reasonably delegated to the pharmacy manager or other regular pharmacist.
Hopefully this addresses your concerns.
Hello Michelle, Ref: completing the pharmacy record. You are suggesting that if the same pharmacist is going to be the RP for the next few days, he or she does not have to sign out daily, only on the final day. Isn't this risky? What if that pharmacist is taken ill and not be able to work the following day? He would still be signed on for that pharmacy. Saroj
Dear Saroj Signing in and remaining the uninterrupted responsible pharmacist over a period of time is a legally valid option which is open to pharmacists and pharmacy business which can be exercised depending upon the circumstances. For example, consider the pharmacist that lives above his registered premises. Your point about risk if the pharmacist is taken ill overnight is important as it could be physically impossible for them to sign back out however this problem could just as easily take place in the middle of the day requiring the pharmacist to leave immediately without signing out. In both circumstances the pharmacy could no longer be “operational” until a replacement pharmacist could assume the role of the responsible pharmacist. We would hope that the state and the regulatory bodies would look at these issues on a case by case basis using common sense and pragmatism, but you will need to weigh up in your own mind what course of action is appropriate for your circumstances. To put this into context, also please bear in mind that there are other records within the pharmacy which have to be completed – for example the POM register or the CD register and it is an unfortunate fact that on occasion entries are sometimes missed or forgotten and need to be subsequently added retrospectively. At the beginning of the day and in advance of the RP arriving at the branch and logging in, would it be acceptable to accept scripts presented by customers. This would be on the understanding that no dispensing activity for those scripts takes place until the RP arrives. I understand that some will suggest that this is a professional activity that cannot take place prior to the arrival of the RP but to take it to it’s extreme , this would also mean we were not allowed to (physically) accept any posted or faxed scripts and would be breaking the, law if we did. Likewise could we justify accepting, unpacking and checking off the dispensary order prior to the arrival of the RP? This would be on the basis that it is only the putting of the order to shelf that requires a ‘skill’ and that the other tasks are logistically and financially focused and therefore prove no risk to patient safety. Regards
I am a locum pharmacist working 2 days in one shop and 2 days in another shop each week. One is a large multiple, the other a small chain independent and in my view both very ethical, responsible companies. I recently attended my local branch meeting to hear a speaker from the NPA giving a presentation about the new “Responsible Pharmacist” regulations. This was very helpful indeed, but please could you answer a few questions which have occurred to me since? At one of my shops, a member of staff is contracted to start work before other staff and before the shop opens to the public. My understanding from the talk was that she will be able to carry out general shop duties before the RP signs in for the beginning of their first day – such as cashing up, banking, timesheets, cleaning, putting away shop deliveries (nappies, toiletries etc) but cannot carry out duties which are specific to pharmacies such as putting away dispensary or medicine counter orders, making up MDS trays, dispensing prescriptions collected from surgery or put through the letter box, placing orders for dispensary/medicine counter stock. Please would you clarify whether any or all of the following duties are “forbidden” without a RP signed in?
I assume that answering the telephone is permitted, but what if it’s a patient asking us to order their repeat prescription or requesting a delivery? At the meeting we did establish that it’s OK to hoover the dispensary as well as the rest of the shop without an RP signed in! I don’t mean to be facetious, but you can never be too careful ………………. and I would like to be prepared for any questions fired at me by the staff at the beginning of October. I’m sure other pharmacists will be asked “hair-splitting” questions too so your input is much appreciated. Many thanks Teresa Shakespeare-Smith
Dear Adrian and Teresa We understand that the Department of Health and RPSGB are in active discussions on the interpretation of “operational” and will publish clarification which should clarify which activities can or cannot be conducted without a responsible pharmacist having assumed the role. We expect this clarification before the 1st October implementation date. In the interim our understanding is that core activities such as dispensing, assembly and supply would definitely be defined as operational. General shop activities of the type illustrated in your questions would be not be regarded as operational. The position for other pharmacy activities will hopefully be addressed by the clarification. However – in the event that it doesn’t make it clear we will issue guidance to address these scenarios. My wife and myself are both practising, registered locum pharmacists (a not uncommon pairing) and sometimes both work for the same pharmacy - we often split the shift morning and afternoon. My question is, assuming that if I work the morning and am the Responsible Pharmacist for that period, can I sign off for 14:00 for the lunch break at the time I leave (13:00) whilst remaining contactable as the Responsible Pharmacist? Then my wife can sign on at 14:00 when she returns, (I see that signing off in advance is allowed if a planned absence ends after the close of business). Graham & Belinda Wing responds Dear Graham and Belinda, Neither legislation or the professional guidance spell out whether or not an entry could be made in advance of real-time. The legislation requires that a record is made, and the professional guidance requires that entries are “contemporaneous”. The NPA has interpreted this pragmatically and until further guidance or clarification addresses this we are advising that, where possible, entries are made in real-time or as they occur. Where this is not physically possible (as in your example) then the entry should be made either at the last physical opportunity to do so prior to absence and sign off (as you are proposing) or at the next subsequent physical opportunity.
I work for an independent pharmacy which has several branches and work at three of them on three separate days covering for managers’ days off. One of the days I work is Wednesday so it’s right in the middle of the week and the regular pharmacist will sign in as RP on Monday morning and sign out on Tuesday evening ready for me to work on Wednesday. If she should forget to sign out on Tuesday evening and I sign in on Wednesday morning, are there any implications legal or otherwise for either of us because in effect there would be two RPs signed in? Many thanks Maxine Wing responds Dear Maxine, Technically it could be a criminal offence for a pharmacist to forget to sign out of the Pharmacy Record and possibly a breach of professional standards for not ensuring the entries applicable were “contemporaneous”. However, we hope that the authorities and the regulatory bodies will deal with these situations pragmatically and sensibly. Clearly a record riddled with gaps should be treated differently to one-off forgetfulness. The Responsible Pharmacist should subsequently personally make an entry at the next physical opportunity to do so and consider travelling specially to complete the record where possible. The next Responsible Pharmacist would not be accountable (unless they were the pharmacy owner or superintendent) for any missed entries made by the previous Responsible Pharmacist although it would be best if they made a note (as opposed to signing out for the other RP) in the Pharmacy Record indicating what they believe has happened. The “new” Responsible Pharmacist would in fact be the Responsible Pharmacist from the date and time they indicate this in the Pharmacy Record and not the pharmacist who has forgotten to sign out.
I am a part-time pharmacist who works 5 days a week from 9:30am to 3:00pm. The company I work with is opened from 9:00am to 6:30pm. I have been asked to take on the role of RP during my working hours (this is an exciting prospect) BUT I am worried that between myself and the pharmacist who signs on after me, in one day the total absence will exceed the total 2 hours stipulated! I work with 2 other full-time pharmacists (including the superintendent) and another part-time pharmacist. Is this so or am I interpreting the law 'wrongly'? Is it possible to have a scenario where more than one of us is the RP in one day? Can the RP be absent at the opening of the store as long as there is a second pharmacist available? Wing responds The maximum cumulative absence within a 24 hour period, starting and ending at midnight is 2 hours. Therefore if the first RP uses up absence time, then the subsequent RP has less absence time available. It is possible to have more than one RP in one day but not at the same time. So it would quite normal for you to be RP from 9am till 3pm and then for the next pharmacist to be RP from 3pm till 6:30pm. If you used up 1 hour and 30 minutes of absence time during your time as RP then the next RP would only have 30 minutes available. If you intend to be an absent RP first thing in the morning then this could be possible but you would need to make sure that a compliant notice was on display, that you were comfortable that the SOPs secure the safe and effective operation of the pharmacy business, you were able to make a contemporaneous entry into the Pharmacy Record, you were contactable and able to return reasonable promptly to the pharmacy or if you are not contactable, then arrangements have been made for another pharmacist to provide advice to the pharmacy staff. If these conditions can be satisfied then a store could open whether or not a second pharmacist was available although there would clearly be restrictions on the types of pharmacy activities which could be conducted if there were no pharmacist physically available. The fact that there may be a second pharmacist available of course also gives the business the option of having the second pharmacist assume the role of RP upon opening.
Is the locum PR legally required to maintain full records? Your answers have been very helpful even though some appear to be superseded by the recent "Guidelines" issued by the Society. I'm a locum and look at the RP regulations from that point of view. I understand that much of the legislation is formalising what we were already doing as "Pharmacist In Charge". One point doesn't seem to have been addressed at all... Is there a requirement for the locum to record their time as the Responsible Pharmacist? By this I mean is it a requirement to maintain a diary of days and times where I have acted as the RP independent of the RP register held in the pharmacy. I understand that normal practice for locums is to record that they were at a particular pharmacy on a particular day. Is there a statutory or ethical requirement that we record the exact hours that we were the RP and should this show any absences? (Note this is somewhat different from recording bookings and cancellations) Regards, Michael Swaddle Wing responds Dear Michael, Although there is a legal requirement for any pharmacist who becomes the Responsible Pharmacist to make a entry into the Pharmacy Record identifying him or her as the RP at that premises at that time and date, there is no further legal or ethical obligation for that pharmacist to record or maintain an additional diary with this information, although of course they could choose to do so.
Hello, I have been reading with interest your answers on the responsible pharmacist Q&A and was wondering if you could clarify somthing for me. Can a pharmacist sign in retrospectively i:e a dispenser starts work at 7am assembling medicines, and the pharmacist doesn’t start work till 8:30am and signs in as being the RP since 7am as the allowable two hour absense period? Many thanks Osman Malik Wing responds: Dear Osman, Legislation requires that an entry is made into the Pharmacy Record which identifies who is the RP at a premises at any particular time and date. The RPSGB has a requirement that the entry is “contemporaneous” but this is not defined with the practice standards. The NPA advises that where possible, entries into the Pharmacy Record should be made in real time (at the time they occur). However where this is not physically possible, for example if you intend to assume the role of RP and be physically absent prior to opening or subsequent to closing then we would advise that the entry and absence annotation should be made at the last physical opportunity or next subsequent physical opportunity. You should also be prepared to justify why a record was not made in real time. Regarding the record keeping for deliveries, can you please confirm the situation. · We do about 350-400 deliveries a week. · We keep a duplicate record of all deliveries. · We have on PMR any special instructions (eg leave with neighbour if out) · Any deliveries which are not suitable to be left (CDs, fridge lines etc) are labelled accordingly. · All deliveries are made at the request of the patient, their GP, or their carer, so consent is implicit. Are we doing enough to satisfy the regs? Many thanks, David McCrea Wing responds: Dear David, In terms of the responsible pharmacist regulations - they simply require that a SOP is in place to secure the safe and effective delivery of medicines and does not go into prescriptive detail of how this is satisfied. However the RPSGB has published professional standards within the MEP under ‘Delivery Services’ and these standards must be complied with and would be a component of making your delivery service safe and effective. They also include good practice guidance which also should be complied with. It is unclear from your description of your delivery service whether or not you would be compliant with all of these standards. For your convenience there is a template delivery SOP which can be used in your pharmacy in the SOPs section of this website at www.chemistanddruggist.co.uk/rpsops.
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