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Home  »   Latest News   »   The Boots Advance Declaration for the RP; the PDA view

The Boots Advance Declaration for the RP; the PDA view

Alliance Boots introduced a new sign-on procedure for absent RPs in August 2010 to enable them to operate their pharmacies normally before opening to the public. The PDA has serious reservations about the use of such a procedure and is issuing further guidance to members.

Thu 4th November 2010 The PDA

Background

The PDA alerted its members to a new procedure that Alliance Boots were introducing in August 2010, regarding how the company wished its pharmacists to use the two hour absence that they are permitted under the RP regulations. Since then we have been engaged with our legal and professional teams to identify the issues relevant to our members who work as employees or locums and who are being required, or in some cases very actively encouraged by their managers to use the Advance Declaration Template (ADT) to sign on and take responsibility as RP ahead of attending the pharmacy.

To date the PDA has not received any formal response to the questions it put to the Pharmacy Superintendent of Alliance Boots about its ADT proposals. However there is a document circulating within the Company which is entitled ‘Response to PDA website Article on Boots’ Responsible Pharmacists’ Advance Declaration Template’. This document can be accessed here.

The Company has now provided a response to its own employees and managers to our questions; consequently, we are able to provide more detailed guidance to PDA members based upon that response.

The current position

From reading the Company response, the PDA comes away with the impression that the ADT has received the approval of the RPSGB; however, we are not aware of any guidance or information that has been circulated by the RPSGB to the wider membership or other pharmacy representative organisations to indicate this.

We are aware that Alliance Boots and other multiples have been discussing their ideas for the use of the two hours absence with the RPSGB, but the details of these discussions had not been publicised. We are concerned that this type of “behind closed doors” discussion may not enable pharmacists to fully understand what the true thinking of the regulator is on this matter and that this could still inadvertently lead pharmacists to regulatory conflict. We therefore submitted a Freedom of Information request to the RPSGB about its dealings with Alliance Boots and have used the response to finalise our advice in this area.

In respect of the ADT process, we believe there are two significant areas of concern around the procedure the Company has formulated in its ‘out of hours’ pharmacy operations using the absence provisions within the Responsible Pharmacist (RP) regulations. These areas of concern have professional and employment implications.

Professional

Risks to patients

Our concern about the ADT system relates to the increased risk to patients and pharmacists. It has always been our belief that when staff are assembling and checking prescriptions whilst the RP is absent, the process is inherently less safe than when a pharmacist is present. Technicians following protocols will be able to deliver a certain level of performance and in principle should be able to adhere to standard operating procedures. However, technicians “don’t know what they don’t know” and situations will arise where despite protocols being observed, left unsupervised, problems and errors will emerge which go unnoticed by staff members because they simply do not possess the professional level of knowledge and expertise of a pharmacist. Consequently, this puts any period of absence at a higher level of risk for the patient.

Professional autonomy and judgement

During their absence, RPs are not in a position to supervise and intervene when their professional expertise dictates they need to; due to the fact that they are statutorily liable for what happens in the pharmacy during their absence, their personal risk increases significantly. For the safety of the public, it is enshrined in the RP regulations that the absence will only be used, if the RP is satisfied that they wish to take the additional risk and that only the RP (and no-one else) may make that professional judgement and decide whether or not to utilise the absence provision.

We believe that the Alliance Boots ADT process has the effect of turning the absence into a routine working practice that employee pharmacists are simply expected to comply with by virtue of the master servant relationship with their employer. In effect the ADT process is replacing the pharmacist’s professional judgement with a standardised employer expectation by which the pharmacist would face considerable difficulty in exercising any professional autonomy by preferring not to use such an absence in the manner defined by Alliance Boots.

We also believe that the design of the ADT system may result in significant conflict for any pharmacist who chooses not to ‘toe the line’. These concerns are further re-enforced by episodes that are being brought to our attention where managers appear to be pressurising pharmacists to sign on using the absence provisions. Beyond that, we are involved in a number of grievance and disciplinary processes where we are supporting Alliance Boots pharmacists who have indeed tried to exercise their professional autonomy as the RP due to patient safety matters and came into conflict with company managers.

Disrespecting the spirit of the legislation

There is a strong professional view emerging that absences should be restricted to situations where the benefits of being absent outweigh the risks to patients. These benefits should be healthcare related benefits – such as travelling to a patient’s home in an emergency to retrieve wrongly dispensed medicines, or to attend a meeting at the surgery to discuss medication issues. The absences should not simply be scheduled in by employers and used as a mechanism to reduce operational costs. The use of the absence provision must be an active professional judgement taken by the RP. Ideally, RPs should consider the use of the absence provision when they believe that the act of leaving a pharmacy without a pharmacist is acceptable and the benefits of doing so outweighs the risks.

The PDA believes that the introduction of the ADT is at odds with the principles of the regulations

There was a meeting in which RP issues were discussed by the Society and the superintendents of large employers, at which the superintendent of Alliance Boots was present. The information received from the RPSGB via a Freedom of Information request recorded that the following principles were set out:

  • Completing the record is not a tick box exercise.
  • In the event that a record is completed remotely and the RP is absent it is important that the RP can comply with the absence requirements i.e. return with reasonable promptness and remain contactable.
  • [The Record] must indicate the identity of the RP, that the RP has accepted the responsibility and that the RP has acted in a way as to personally secure the safe and effective running of the pharmacy.

Consequently, we believe that the Alliance Boots ADT process is at odds to these principles and other legal requirements in several material ways;

Is the record ‘contemporaneous’?

The legislation and Code of Ethics require the RP record to be accurate and completed contemporaneously; the RP toolkit describes the record as an important legal document. An advance declaration completed up to 24 hours beforehand, could never be described as a contemporaneous record; at best it is an informed prediction whereby the RP postulates what the conditions in the pharmacy may be like at some point in the future and accepts responsibility based on this prediction. A lot can happen between accepting responsibility in advance and when the pharmacy commences its operations in the morning; key staff may not arrive due to unforeseen circumstances; a wholesaler delivery may have gone awry or a physical emergency at the premises such as a fault with the computer system may have occurred. All of these things render an advanced declaration useless as they will impact upon the pharmacist’s assumption that they are able to secure the safe and effective running of the pharmacy at some future point in time.

Has Alliance Boots reduced the RP recording process to a ‘tick-box’ exercise?

As the RPSGB minutes indicate, agreeing to operate as an absent RP must not be a box ticking exercise. In order to demonstrate due diligence in the event of an adverse incident occurring during a period of absence, a minimum of a phone call to the pharmacy at the time the absence commences should be made in order to enquire as to the skill mix of the team in case there has been any sickness, and to verify that there are no unexpected operational issues that have arisen. The guidance that we have seen appears not to make any direct reference to the fact that an important professional activity is the contact that is made with the pharmacy at the time of the absence commencing. Unless an RP does indeed initiate contact, albeit remotely at the time a period of absence actually commences, then the RP may have difficulty in demonstrating that they have made a professionally considered decision based upon accurate and up to date information when they assumed responsibility.

Does the ADT fulfil the additional requirements for being signed on and being absent?

As the RPSGB minutes indicate, after assuming the signed-on RP role during any absence, the pharmacist must also be able to fulfil all of the additional requirements of a RP under the absence provisions, namely that they are available, remain contactable and able to return within reasonable promptness. The information that we have seen provided by Alliance Boots to its pharmacists appears unsatisfactory in so far as it states ” The term reasonable promptness is not defined within the RP regulations and by completing the ADT, the pharmacist has already indicated his time of arrival.” This explanation misses the point altogether, the requirement is that if the pharmacist is contacted due to an untoward incident occurring, then the pharmacist may need to cut short their two hour absence and return more promptly. If the Alliance Boots interpretation was correct, then the RP regulations would not require the pharmacist to return within reasonable promptness at all, but merely be able to ensure they could always return at a pre-defined time.

Neither does Alliance Boots appear to place any major emphasis on the other absence condition (as confirmed by the RPSGB minutes) of being contactable. Alliance Boots has not set out any proposals which we are aware of that would allow RPs to comply with this legal requirement, such as that the RPs must have mobile phones switched on and on their person at all times during the absence, nor does it provide its RPs with a company mobile phone to facilitate this. Instead it gives the impression that ‘contactability’ and hence the ability to return promptly may be unnecessary by stating in its guidance that

“this template is intended for situations when a pharmacy is not trading, it is difficult to envisage a situation when a pharmacist would be required to attend the pharmacy more urgently. Any queries about the assembly process would be easily deferred until the pharmacist’s arrival time”.

Whilst this may seem like an attractive proposition to an employer, we believe it is entirely contrary to the RP Regulations and also the most recently clearly stated guidance from the RPSGB (as seen in the RPSGB minutes described above). If RPs are neither contactable nor able to return with reasonable promptness when requested to do so, then they will fail to fulfil the legal requirements for the absent RP. As a result they will place themselves at legal and professional peril. The argument that just because a pharmacy is not trading then this somehow absolves the RP from complying with the law is analogous to a suggestion that it is acceptable to break the legal speed limit on the motorway at night because it is less likely that an accident will occur.

Creating extra pressure on pharmacists

The Company has stated that the use of the ADT will free up pharmacist’s time and allow the assembly of medication to take place out of hours. It does not address the fact that when the pharmacist arrives at work they may have a backlog of pre-assembled scripts to check and queries to resolve, as well as attending to all the other duties associated with opening and running the pharmacy. Far from freeing up pharmacists time, this will likely have the adverse affect of placing significant extra pressure upon pharmacists.

PDA advice on the Professional implications

Pharmacists should consider the following points when considering whether to sign on as absent or not.

  • The RP should only sign on as absent if they are happy to take responsibility in their absence and not simply because they are required so to do by line management.
  • The RPs should only use the absence provision in situations where a demonstrable healthcare or safety benefit outweighs the risks of absence for patients and themselves.
  • The RP must make a professionally cognisant decision to sign on whilst absent at the time of the commencement of the absence. This can only be done if contact is made with the pharmacy at the time the absence commences, to ensure that they can secure the safe and effective running of the pharmacy at that time.
  • After the RP has signed on under the absence provisions, they must be contactable and able to return with reasonable promptness and prior to any pre-agreed two hour absence period if contacted to do so . If an RP is not contactable due to being on public transport or driving, or if they could not return with reasonable promptness if called, then they would be unable to comply with the legal requirements for absence imposed by the RP regulations. They should not use the absence provisions as doing so may put them at risk of legal and professional sanctions.

Employment

Is Alliance Boots the only employer which dictates what actions and responsibilities its employees should perform during what it defines as ‘non-working’ time?

The general principle in an employment relationship is that an employee receives remuneration commensurate with the skill or qualification required to perform the job as a whole and the level of responsibility and risk incumbent with their position. The hours of work are normally defined and an employee is at liberty to do whatever they wish in their free non-working time, subject to any provisions explicitly set out in the employment contract. Having required the RP to sign on whilst absent, Alliance Boots not only expects the pharmacist to take full legal and professional responsibility for the pharmacy’s operation but as things currently stand, also refuses to pay the RP whilst the pharmacy staff are assembling and checking medication, solely for the reason the pharmacy is not yet open to the public.

Alliance Boots states that

“working time is any period during which the worker is working at the employers disposal and carrying out his or her activities or duties”;

however, it then contends that when an RP is signed on but absent outside of normal trading hours, the RP is not working because the pharmacist is not at his or her workplace and is not engaged in his or her normal duties.

This must be wrong; the absent signed-on RP is at the employer’s disposal and ensures that the pharmacy is operating safely, by being contactable and through being able to return to the pharmacy with reasonable promptness. The fundamental issue to consider in this argument is whether or not the pharmacy can operate without the RP being signed-on. If the business cannot operate without the individual’s presence or agreement to sign-on, the PDA’s argument is that this is a strong indication that the time spent in this role, is working time which should attract payment.

More fundamentally, the RP shoulders the legal, professional, civil and criminal liability in the event that something goes wrong in the pharmacy during their period of absence. Should an RP decide not to sign on, the entire pharmacy ‘out of hours’ operation would cease as it would be unable to operate lawfully. It is therefore inconceivable that this is not working time and that the RP is not at the employer’s disposal.

If the company’s contention is correct that this is not working time, then this development is the only example we are aware of, whereby an employer has imposed detailed processes, conditions and legal responsibilities that employees are expected to comply with in their own free time and for which it seems they have not been offered any additional remuneration or recognition .

The impact on pharmacists’ terms and conditions of employment

Such changes should be the subject of consultation with staff in order to come to agreement on the terms and conditions for up to 10 additional working hours per week when an employee pharmacist will be the signed on RP, but designated as absent. The fact that Alliance Boots suggests that they feel that no consultation is necessary because the RP regulations do “not involve express contractual terms regarding hours of work” is incorrect. To comply with the law a pharmacist is required by Alliance Boots in their own personal time to make an assessment of whether they are able to sign on as RP at the time the absence commences, must be able to return to the pharmacy with reasonable promptness and must remain contactable during the entire absence period. This seems to the PDA to be a fundamental change to terms and conditions and must be the subject of a consultation.

The impact under the Working Time Regulations (WTR) and indirect discrimination of women

The Company does not explain how it expects its pharmacist to fulfil the legal requirements of being contactable and being able to return promptly within the two hour period of absence before the pharmacy opens. This obligation is likely to impact more on females and carers, due to their conflicting duties towards dependants and has the potential to fall foul of discrimination legislation. Furthermore, it is possible a full time employee contracted to work 40 hours per week could exceed the maximum 48 hours per week (under the WTR) by agreeing to work an additional 10 unpaid hours, when recorded as the absent RP.

Pharmacists who use the ADT and/or the absence provisions to take an unpaid lunch break are also exposing themselves to an extended window of risk for reasons that have already been described.

Second pharmacist cover may be the way forward

As a result of customer comments, Alliance Boots has now introduced in some regions a new pharmacist role which focuses on providing additional pharmacist cover for rest breaks across a number of stores. Although this seems to be another example of just how unworkable the RP regulations have become since their implementation, nevertheless we believe that the second pharmacist approach is also the correct way to deal with the issue of out of hours pharmacy activity.

PDA advice on employment implications

Don’t be intimidated

Since the introduction of the ADT we have received reports of a senior manager allegedly bullying and intimidating pharmacists into using the ADT. Another pharmacist was called to a disciplinary meeting to face serious allegations of “breach of conduct and trust” after exercising his right not to sign on as the RP when trained staff levels were inadequate in a busy pharmacy. Other evidence from members indicates that some company managers are taking an aggressive stance towards pharmacists who exercise their rights as the RP relating to patient safety issues. Since the introduction of the RP regulations a significant number of pharmacists have been represented by the PDA at meetings or otherwise been supported by the PDA Union through conflicts with company managers regarding the RP role.

Use these ‘clarifications’ that the PDA has obtained from Boots in the past when putting your case

During interactions with the company on these matters, the following written clarifications have been provided by Alliance Boots;

“The decision as to whether to sign in as RP in the manner discussed is a matter for the professional judgement of each pharmacist concerned under the prevailing circumstances at the time rather than a definitive direction to be applied in all situations such that disciplinary action could flow from non-compliance”

Our interpretation of this statement in relation to the use of the ADT system is that it is the free choice of the individual pharmacist whether they wish to use the ADT system or not. Our employment team are confident that Alliance Boots employees would have substantial grounds to successfully defend any disciplinary action taken as a result of being unwilling to sign in as absent using the template, particularly where the company maintains its stance that it is not going to recognise this as working time and whilst it continues to refuse to remunerate its pharmacists for the additional risks that they face. The PDA has a proven track record of success in supporting members through grievance and disciplinary hearings and any PDA member who feels intimidated in any way for being unwilling to use the ADT is guaranteed our full support. Any pharmacist who has concerns about how the application of the ADT is affecting them can contact the PDA for advice.

If you exceed your contractual hours by signing on, seek consideration.

Signing on in advance is an extension of your contractual hours Pharmacist employee’s are strongly advised not to exceed their contractual hours as the RP (including periods when designated as RP, but absent) unless satisfactory agreement has been reached on the level of remuneration for working additional hours when acting as an absent signed on RP. The Company has already confirmed that it is the choice of the pharmacist whether to sign off as the RP (as opposed to sign on as being absent) when taking their contractual or statutory (20 minute) break. RP’s are also urged to discuss reimbursement of the costs incurred when contacting the pharmacy at the commencement of their RP absence and the provision of Company mobile phones.

Implications for Locums

Locum pharmacists have an entirely different contractual relationship to employees and must negotiate an additional payment if they are prepared to take on this additional responsibility and believe they can discharge their legal and professional duties appropriately as indicated above.

Summary

The use of the ADT could extend the working time of a pharmacist by up to 25% and we believe it extends the window of risk of regulatory or other legal action by a greater margin. This is due to the fact that activities are being undertaken which the pharmacist is not directly supervising, nor in a position to intervene, but for which the pharmacist takes statutory responsibility,

The PDAU calls upon Alliance Boots to enter into consultation with its workforce about the use of the ADT and to reward those pharmacists appropriately who chose to take on the additional risk in order to enable its out of hours pharmacy operations to proceed. In excess of 1,000 Boots pharmacists are already PDA Union members and the Union is keen to handle these consultations on behalf of Alliance Boots pharmacists.

Alliance Boots have previously indicated that it consults on various matters with the Boots Pharmacists’ Association (BPA) and it is content with that arrangement. It is therefore of great concern to the PDA, that the Boots Pharmacists Association, an organisation which prides itself on a close working relationship with senior company managers, appears to have welcomed the introduction of the ADT and sees this procedure as a satisfactory solution, despite the fact it enables the Company to increase the pharmacists working day and liability without any consideration.

In welcoming this process the BPA announced in its recent members newsletter “We are pleased to report that there has now been an agreement between the Society and the Company Chemists Association on the interpretation of the word ‘contemporaneous’ completion of the required records.” We can find no record in the information disclosed to us from the meeting with the Society that any such agreement was arrived at; what was agreed however were the principles that must apply when interpreting the regulations which we have demonstrated appear not to be encapsulated in the ADT process.

The PDA holds regular meetings with the new regulator, the General Pharmaceutical Council and we will be bringing these concerns to its attention at the next meeting. We expect to be able to bring some further advice on the subject of the ADT in due course and will be notifying PDA members of any developments accordingly.

The Pharmacists' Defence Association is a company limited by guarantee. Registered in England; Company No 4746656.

The Pharmacists' Defence Association is an appointed representative in respect of insurance mediation activities only of
The Pharmacy Insurance Agency Limited which is registered in England and Wales under company number 2591975
and is authorised and regulated by the Financial Conduct Authority (Register No 307063)

The PDA Union is recognised by the Certification Officer as an independent trade union.

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