Pharmacy Supervision: Is It Time For An Update?

Introduction

The government has proposed changes to pharmacy supervision law, and is consulting on

the proposals until 29 February 2024. We urge pharmacists to respond to the consultation.

The consultation documents and response form can be found here:

https://www.gov.uk/government/consultations/pharmacy-supervision.

The Pharmacist Cooperative is run by pharmacists, for pharmacists. We have worked with

legal counsel (a specialist barrister) to examine the draft pharmacy supervision legislation in

respect of certain matters, and consider what questions may arise from it.

"The Pharmacist Cooperative is run by pharmacists, for pharmacists." 

Our Overall View

Prior to the consultation, a supervision practice group had been meeting, with little transparency or communication with the public or the profession in the course of its meetings, to discuss what changes the organisations comprising the group (c.f. the profession) wanted to make to the law. The Pharmacist Cooperative was not invited to or involved in these meetings. Had we been, we would have insisted that the profession be consulted and developments be shared publicly. We would not have agreed to join or participate in a group operating in the manner it did. We would also have consulted counsel – as we have now.

One of the issues with existing supervision law has been said to be the uncertainty of the meaning of “supervision”. It may be apparent from this article that the proposed changes would give rise to a great deal of additional uncertainty. We have been left wondering:

• Why has the government not addressed the issues raised in this article, in the consultation documents?

• Why have some of the pharmacy organisations who’ve been considering supervision law over the past few years, including through the supervision practice group, failed to draw important issues with the proposals to the attention of pharmacists?

• Why was the profession not consulted before this consultation commenced, to help inform the proposals?

• Does supervision law really need changing? Is it really causing a problem? Clinical services can be developed at present – why the need for change?

• Are the proposed legislative changes workable in their current form?

We are opposed to the proposed changes, and will remain so unless a compelling case is put forward for them. We do not know what that case could be. We want to see fulfilling roles for pharmacists, which utilise and develop our clinical practice. However, this consultation does not include any discernible plan for that, and when change occurs to our roles as pharmacists, it must not come at the expense of patient safety and care, and pharmacists’ career prospects, wages, job security, and professional status. We are concerned that these proposals, if enacted, would put each of these things at unnecessary and unacceptable risk.

Changes we would like to see

We would like to see changes to primary legislation to include:

a) a definition of “supervision”, to give certainty as to its meaning;

b) an express requirement for a pharmacist’s physical presence in a registered pharmacy throughout its operating hours; and

c) an express requirement for a pharmacist to clinically check each medicine sold or supplied, on the premises at which the sale or supply is made, in advance of that sale or supply.

Disclaimer

This article is intended only to prompt consideration of what response to make to the government’s ongoing consultation on pharmacy supervision. It contains our thoughts only and is not intended to be exhaustive. The law, a person’s obligations and pharmacy practice and operations will depend, for example, on how the government responds to the pharmacy supervision consultation; any changes ultimately made to the law as a result of this consultation; other legislation; changes to the law beyond those being proposed in the consultation; regulation and changes to regulatory requirements; and how the courts, tribunals, regulators and others interpret the legislation arising from the Pharmacy Supervision consultation and other legislation and factual circumstances generally. You must not rely on the contents of this article or any part of it for any decision you make (or do not make) or action you take (or do not take), whether directly or indirectly, in relation to pharmacy or otherwise, including in respect of the practice and operation of a pharmacy or as an individual. Seek legal advice about your own circumstances – including as to how the draft statutory instrument may affect you if it is brought into force.

Please note that for the purposes of readability, we have used male pronouns rather than citing the female alternative in each case; female pronouns should be read in the alternative on each occasion.

Proposed Changes

Broadly, the proposed changes would:

a) allow pharmacy technicians, with authorisation from a pharmacist, to supervise or carry out the dispensing, assembly and preparation of medicines (new s.10A and amendments to s.10 of the Medicines Act 1968) and the transactions that relate to prescriptions received at the registered pharmacy in the authorisation (new reg.220A of the Human Medicines Regulations 2012). Currently these activities have to be done by or under the supervision of a pharmacist.

b) allow a pharmacist to authorise others to carry out, on his behalf in his absence, the transaction relating to a medicinal product dispensed under his supervision and which is ready for sale or supply (new reg.220B).

c) allow pharmacy technicians to carry out or supervise aseptic dispensing, assembly and preparation in hospitals that have a chief pharmacist (new reg.4A).

d) change wording in the Human Medicines Regulations 2012 to permit the sale or supply of medicines “at or from” (c.f. “on”, the current wording) registered pharmacy premises.

e) change wording in the Misuse of Drugs Regulations 2001, including to authorise pharmacy technicians, subject to the detailed provisions and circumstances provided for in law, to:

    i. have in their possession certain controlled drugs which have been supplied on prescription or in accordance with a patient group direction and which have been supplied to them for the purposes of destruction (reg.6).

    ii. supply articles such as citric acid for administering or preparing controlled drugs (reg.6A).

    iii. manufacture or compound certain controlled drugs (regs.8(1)(a) and 9(1)(a)).

    iv. supply certain controlled drugs to individuals who may lawfully have them in their possession, subject to exceptions (regs.8(2)(b), 9(2)(b) and 9(3)(i)).

    v. supply certain controlled drugs on prescriptions containing minor typographical errors or spelling mistakes, or where the total quantity of the preparation/drug/dosage units is specified in words or figures but not both, or in certain circumstances where certain other                      technical requirements have not been met (reg.16).

f) implement further changes to the Misuse of Drugs Regulations 2001, including to:

    i. exempt pharmacy technicians from the record keeping requirements of reg.19 in the case of a drug supplied to them for the purpose of destruction in pursuance of regulation 6(2) or (3).

    ii. introduce an exemption to the provisions of reg.27 (such as record keeping requirements) in relation to the destruction of a drug which has been supplied to a pharmacy technician for that purpose in pursuance of regulation 6(2) or (3).

    iii. amend reg.15(1B) such that there is nothing preventing the issue of certain prescriptions, on certain forms, for certain controlled drugs, where the person issuing the prescription believes on reasonable grounds that the drug will be supplied by a pharmacy technician in              a hospital.

Meaning of “Supervision”

“Supervision” in current medicines legislation (the Human Medicines Regulations 2012 and the Medicines Act 1968) has not been interpreted by the higher courts. As such, it is necessary to look to definitions in statute outside of medicines law, and interpretations in case law pertaining to previous medicines legislation and beyond, to try to determine how the courts might interpret the word. 

If the courts were asked to determine the meaning of “supervision” in current medicines legislation, the requirement for supervision might be found to mean that the supervisor has to be in a position to intervene, by being on the premises and in the same room as the work being supervised. It is not clear whether supervision can be effected by a person who is in a consultation room, perhaps aware of what is going on generally elsewhere in the pharmacy but not within earshot or aware otherwise. However, in respect of some pharmacy owners, this does not appear to have resulted in any insistence that medicines dispensing, assembly, preparation, sale and/or supply cease when the pharmacist is in a consultation room. Any uncertainty could have been addressed by defining supervision in statute – what better time to do it?

Would the proposed legislation change the requirement for the physical presence of a pharmacist? 

The requirement for “supervision” under current law may well mean that the pharmacist must be physically present to enable him to supervise. If medicines dispensing, assembly, preparation or the transaction takes place without supervision, where supervision is required by law, the person in breach (arguably, the pharmacy owner) could face up to two years in prison and/or a fine – a strong incentive for pharmacy owners to ensure that they stay on the right side of the law.

If the proposed legislation is adopted, a pharmacist may authorise a pharmacy technician to supervise certain activities. There is nothing within the proposals to suggest that the pharmacist would need to be present in the pharmacy, whilst the pharmacy technician was

supervising. Put another way, the pharmacy technician could supervise in the absence of a pharmacist, unless there were some other legal requirement for a pharmacist to be present in the pharmacy, or present at the same time as the pharmacy technician was supervising.

There is also nothing within the proposed legislation to require that the pharmacy technician be authorised to supervise by the pharmacist who is present on the day. The authorisation could be given by another pharmacist, and seemingly can only be revoked by that person, with no ability for the pharmacist present on the day to suspend, revoke or vary the authorisation. Indeed, if there is no pharmacist present on the premises on that day, that consideration would not arise.

One must look to other areas of medicines law: if the requirement for pharmacist supervision is removed from the law, is there any other requirement at law for a pharmacist to be physically present in a pharmacy, during its hours of operation? In the consultation document, the government explains that it is not making provision in the proposed legislation for the physical presence of a pharmacist in a pharmacy. It says: “Although the presence of a pharmacist in retail pharmacy is not explicitly stated in law, section 70(2) of the Medicines Act 1968 requires that a responsible pharmacist must be in charge of what happens at a retail pharmacy. This means, in law, the ‘physical presence’ of a pharmacist is inferred by virtue of the specific rules regarding their absence. Therefore, it is neither necessary nor appropriate to restate a requirement for physical presence in the new provisions permitting delegation.” Note here that the government is saying that physical presence is inferred – perhaps inviting you to infer the requirement yourself, or perhaps it is saying that that is what it has inferred itself. It does not say that physical presence is implied by the statute – which would be a more strident assertion.

However, the consultation document fails to provide an important piece of information which is fundamental to understanding the law relating to a pharmacist’s physical presence.  The “specific rules” seemingly being referred to (1) (the Responsible Pharmacist Regulations)

have been revoked, but continue to have effect (2) until the first rules made by the regulator (3) relating to the responsible pharmacist in respect of pharmacy premises come into effect. The “specific rules” seemingly being referred to provide4 that “The maximum period for

which the responsible pharmacist may be absent from the premises is two hours during the pharmacy’s business hours.” The moment that the relevant regulator (the GPhC or the PSNI) makes rules under s.72A of the Medicines Act 1968 relating to the responsible pharmacist, the Responsible Pharmacist Regulations will cease to have effect. At that point, the only other current legislative provision outside of supervision law identified by the government as relating to the physical presence of a pharmacist, will be gone.

1 Presumably The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008.

2 By virtue of Art. 8(2) of The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022

3 Under s.72A of the Medicines Act 1968

4 At r.3(1) of The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008.

When the regulator writes the aforementioned rules under s.72A of the Medicines Act 1968, relating to responsible pharmacists, it will be legally required by statute to have regard to the principle that the burdens imposed on businesses by those rules should be the

minimum necessary to secure the benefits, considered in general terms, expected to result therefrom. The regulator may or may not write into the said rules that a pharmacist is to be physically present on the pharmacy premises during the pharmacy’s operating hours. If it

does, it may or may not specify a maximum period of absence, or circumstances in which such a period does not apply. Bearing in mind the regulator’s aforementioned duty, will it write into the rules something which may not otherwise be required by law?

Such rules, when the regulator writes them, will be subject to change at relatively short notice, at the whim of the regulator and those who are able to influence it. In any event, there is a question as to whether the potential consequences for a breach of those rules would act as an effective deterrent to operating without a pharmacist. If the regulator does write into rules that a pharmacist must be present on the premises (for example, for all but two of the pharmacy’s operating hours), if a pharmacy doesn’t have a pharmacist present, or the maximum permitted absence period (if any) is exceeded:

a) What is the likelihood that the regulator will be made aware?

b) If the regulator is made aware, will it take steps to confirm the facts of the report it has received?

c) Will it be able to confirm the facts of the report it has received – for example that the pharmacist was not merely absent as part of any permitted absence period?

d) Will the regulator then take action to bring sanctions?

e) If it does, against whom would it bring the sanctions?

f) What history does the regulator have, if any, of issuing sanctions in respect of pharmacy premises at bricks-and-mortar pharmacies? What would be the likely sanction if it imposed one? Would that be severe enough to act as a deterrent to operating without a pharmacist          present, or to doing so for longer than the regulator’s rules allow? Would the regulator, for example, attempt to remove a pharmacy from the register – removing from the public the services of that pharmacy altogether – for (by way of example) one or more breaches     involving operating without a pharmacist for longer than the permitted time?

5 The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 Art. 6A

A further consideration is the Misuse of Drugs (Safe Custody) Regulations 1973 (amended most recently in 2019). These regulations require certain controlled drugs to be under the “direct personal supervision” of a pharmacist when they are not in a controlled drugs

cabinet, safe or room constructed and maintained as to prevent unauthorised access to the drugs. In practical terms, the aforementioned requirement could result in a pharmacist being physically present in a pharmacy, whenever such controlled drugs need to be dispensed, assembled, prepared, sold or supplied. No change to these regulations is proposed in the consultation. However, the regulations are made by the Secretary of State (a government minister) using powers under s.10(2)(a) and s.31 of the Misuse of Drugs Act

1971. Amending these regulations involves a different process to amending primary legislation (the current consultation involves amending primary legislation). The regulations can be amended by the Secretary of State – and that may potentially follow this consultation. It may have been premature to amend those regulations without first making the amendments to primary legislation proposed in the draft statutory instrument in the supervision consultation. As such, the fact that this supervision provision remains in place for now in the Misuse of Drugs (Safe Custody) Regulations 1973 provides little if any indication that it will remain indefinitely after the draft statutory instrument is brought into force.

It is also worth noting the requirement for “direct” supervision in certain circumstances which appears in The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (see later). Similar to the supervision requirement in the Misuse

of Drugs (Safe Custody) Regulations 1973, this may potentially be removed after the draft statutory instrument is brought into force.

Authorisations

An aspect of the proposals which raises questions is the authorisation of pharmacy technicians, and how this would work in practice. In giving authorisation, due regard must be given to patient safety, but the validity of the authorisation will not be affected if this has

not been done.

Below are some examples of the questions raised by the proposals. It should be borne in mind that the draft statutory instrument makes no provision for pharmacy regulators to set out rules or guidance relating to authorisations, or to recognise regulatory rules or guidance

pertaining to authorizations which the regulators made using their existing powers. As such, even if the regulators attempted to make such rules, or to provide guidance, the courts would not be bound by this in relation to supervision law. A person could still commit an offence under criminal law irrespective of anything the regulator had done, if supervision was held not to have taken place where it was required.

The consultation document states: “Government legislation will not set out practice matters (for example, who is competent to perform specific tasks, using professional judgement to determine if a task is within their scope of practice, the keeping of records concerning an

authorisation, expectations around reviewing authorisations and so on). This allows for the pharmacy regulators to consult on and set out the detail in their rules, regulation and/or standards. Professional bodies can then support with associated guidance.” For the reasons

set out above, this is not good enough to ensure that provisions made by the regulators will result in the legal requirement for supervision being met. Further, the regulators may not be able to resolve all of the questions raised by the authorisation proposals, including those

questions set out below. Furthermore, regulation only applies to the regulated and not, for example, to unregulated individuals who may be authorised by a pharmacist to carry out transactions in the pharmacist’s absence. Such individuals need pay no heed to a pharmacist’s regulator or professional body unless, for example, insofar as they were required to do so by an employer.

It may be possible to answer some of the questions below by examining the draft statutory instrument. However, we have posed the questions so that people can consider the issue for themselves and decide how to respond to the consultation. It should be borne in mind

that the existence, validity and scope of an authorization to supervise may affect whether

supervision occurs, and therefore whether a criminal offence is committed.

1. If a pharmacist posted on social media:

            “I hereby authorise all pharmacy technicians appearing on the public register here [insert link to the register] to:

            a. supervise or carry out transactions, at or from all registered pharmacy premises appearing on the public register here relating to the prescriptions received at the aforementioned registered pharmacy premises, and

            b. to supervise medicines dispensing, assembly and preparation in all aforesaid registered pharmacy premises and in the hospitals, care home services and health centres listed here 

            would that have effect under the legislation? If it would, would it render substantial parts of the legislation moot – because no further authorization would be required? If it would not, is that because the premises would need to be named individually? Could a mass        

            authorisation be given using a spreadsheet which specifically named the premises?

        2. Could a pharmacist superintendent in a chain pharmacy authorise pharmacy technicians to supervise at or from all of the pharmacies in the chain? Could this be done by putting the authorisation in a standard operating procedure?

        3. Could a pharmacist authorise a pharmacy technician he has never met and with whom he has never communicated and has no connection, to supervise in a premises he has never visited and to which he has no connection?

        4. If authorisations could be given easily and en masse, how are the proposed changes to legislation any different in practical effect to those leaked from the “rebalancing board” to the Chemist and Druggist on 13 September 2017?

        5. Why is there no requirement in the draft legislation for a written record of authorisations given (whether or not the authorisation was written or oral), or for what must happen to any written records which are made (for example, as to how long they must be kept)?

        6. How could the validity of a written authorisation be checked – for example if it appeared in a written SOP? How would individuals reading the SOP know that the authorisation was in fact given by a pharmacist, and remained valid? What steps would they need to             

             take to confirm this?

        7. How could the validity of a purported oral authorisation be verified? For example, if a pharmacy technician said that he has been told he is authorised, how could it be checked whether this is true and that the content of the authorisation met the legal requirements to         

            make it valid?

        8. How could the authenticity of a written authorization be checked? If it were fake, would that mean that there was no effective supervision, if that authorisation was the thing being relied upon?

        9. If an oral authorisation was given, how could the scope of it be determined, unless what was said orally was recorded?

        10. How would pharmacy staff or a pharmacy owner check in real time that an authorisation of a pharmacy technician had not been withdrawn? A withdrawal could occur at any moment?

        11. Could a pharmacy technician be authorised to supervise without this being communicated to him?

        12. Could a pharmacy technician be authorised to supervise without his consent? If consent were to be required, what would be needed to obtain it, beyond informing him of the intention to authorise?

        13. If a pharmacy technician’s consent to authorisation were to be required, could a pharmacy technician withdraw said consent, after it had been given?

        14. Could a pharmacist withdraw a pharmacy technician’s authorisation without informing him?

        15. If a pharmacy technician was not aware that he is authorised to supervise, could he be taken to have supervised in any event – for example, if he were in a position to intervene in the activity requiring supervision, and any other requirements for effective supervision         

                were met?

        16. If a pharmacy technician purported to supervise but was not authorised to do so, would this mean that supervision did not occur? Would this mean that an offence had been committed by a pharmacy owner (for example), if no other person was supervising? Who         

               would be liable? Would there be regulatory consequences for the pharmacy technician, or in respect of the pharmacy premises, for the failure to confirm that the authorisation was still in place at the moment it was being relied upon?

        17. Could an authorisation be withdrawn in a different manner to that in which it was given? For example, could a written authorization be withdrawn orally?

        18. What requirements must be met to withdraw an authorization? Could a withdrawal be made by a pharmacist whispering it under his breath? What words would need to be used?

        19. Can any manner of condition be imposed in the authorisation e.g. geographic, physical, temporal, environmental, administrative, performative? For example, could the authorisation be limited to cover specific geographical areas or premises, at specific times, only if         

               certain events occur or if certain resources are available, or only if a pharmacy technician does a particular thing? How would all of those conditions be interpreted by the courts – such that the pharmacy owner could have confidence that supervision would be         

            effective?

        20. Does a supervisor have to know he is supervising, in order for supervision to be effective? If he does not know, does this mean that there was no supervision? Put another way, is there a mental component on the part of the supervisor, to supervision?

        21. Does a staff member have to know the identity of the supervisor, and/or that the task he is doing is being supervised by the supervisor at that time, for the supervision to be effective? If the member of staff does not know the identity of the supervisor and/or that the         

               supervisor is supervising the task he is doing, does this mean that there was no supervision? Put another way, is there a mental component on the part of the supervised, to supervision? Does the framing of the wording from the perspective of the supervised – “acts        

            under the supervision” (from the Human Medicines Regulations 2012) or “under the supervision” (from the Medicines Act 1968) have any bearing on whether such a component exists?

        22. If two individuals are present (for example, a pharmacist and a pharmacy technician), and the pharmacy technician is authorised to supervise, who will be the supervisor? Does the supervisor need to be identified/designated? What if both individuals want to

                supervise – how would that conflict be resolved to decide who will be the supervisor? If two or more people can supervise simultaneously, how could it be subsequently confirmed which one of them, if any, was supervising a particular task? In relation to a specific

            task, is there a risk that each person may assume that another was supervising – and if that was not the case, no supervision would have occurred?

        23. If more than one authorisation is given, and the terms of the authorisations are different, which authorisation will prevail? For example, if one authorisation prohibits the pharmacy technician supervising controlled drugs supplies, but the other allows it, are both valid?

               The most recent? The one from the most experienced pharmacist? One given by the superintendent, in preference to one given by a non-superintendent? The most permissive? The one being relied on at the time? If both are valid, how is the conflict in scope

                resolved? Are any non-conflicting prohibitions imported from each authorisation, such that they become cumulative (for example if one authorisation prohibits one thing, and a second authorisation prohibits another, do both prohibitions apply)?

        24. Should pharmacy technicians be required to disclose to pharmacists and/or the pharmacy business owner of each pharmacy in which they work, all authorisations given to them, in case any of the authorisations conflict?

        25. Should pharmacy technicians be required to disclose to pharmacists and/or pharmacy business owners all withdrawals of authorisation of which they are aware, in respect of every pharmacy for which there has been a withdrawal?

        26. Should the reason for any withdrawal of authorization be recorded? Would this deter pharmacists from making withdrawals? If the reason were recorded, should provisions be made for the reason for withdrawal to be disclosed to any pharmacist for the purposes of

            his decision making as to whether to give or maintain an authorisation, and to any pharmacy owner of a pharmacy at which the pharmacy technician seeks to supervise? How would such disclosure requirements be given effect?

        27. If a pharmacist who has given an authorisation leaves the register, for example due to failing to renew his registration, does that invalidate the authorisation? Does this mean that pharmacy technicians and pharmacy business owners will need to keep checking the

               registration status of the pharmacists who gave authorisation, so that they know the authorisation remains valid if it has not otherwise been withdrawn?

        28. If the requirement for a pharmacist to be physically present were effectively removed, and no pharmacist were present, who would monitor the pharmacy technician’s adherence to the authorisation given?

        29. Should compliance with the terms of the authorisation have to be monitored by the pharmacist who gave it?

        30. If a pharmacist refused to withdraw an authorisation despite a request from the regulator, should the authorisation remain valid?

        31. Can a pharmacy technician who is authorized, refuse to supervise? Would such refusal be valid, if the pharmacy technician were in a position to supervise and the requirements for supervision to be effective otherwise (such as, if applicable, being in a position to

               intervene), were met?

        32. If there is no record of who supervised on what date, or that any person was authorised to do so, how would a pharmacy owner prove that supervision occurred? If he could not so prove, would he be liable to sanctions under criminal law?

        33. If the authorisation does not contain the specific wording set out in the draft statutory instrument (for example in relation to proposed regulation 220A(3)), will it be valid? By how much could the wording differ, if at all, for the authorisation to remain valid?

        34. Does an authorization last indefinitely, or does it need to be renewed periodically?

        35. Will an authorisation be invalid if it fails to correctly set out the address(es) of the premises in respect of which it is given? Could it lose validity if the same pharmacy business relocates to a new address?

        36. If the pharmacy technician was, due to the wording of the authorisation, authorised only to supervise others but not to carry out the activity himself, would supervision of the pharmacy technician still be required if the pharmacy technician were to perform the work             

               himself? Could the pharmacy technician be supervised either by a pharmacist or another pharmacy technician authorised to supervise? Does this mean that pharmacists will need to be careful in the way they word authorisations – deciding whether to give the        

            pharmacy technician permission to supervise, permission to carry out the work, or both?

        37. Considering art.7(2)(c)(ii) and the new reg.220A(1)(b), could a pharmacist authorise a pharmacy technician to authorise others to supervise transactions, provided that the pharmacy technician supervises the said supervision?

        38. Reg.220 and new reg.220A refer to the supervision of “transactions” and not of “sale or supply”. What is the definition of “transaction”? Considering reg.220, is it broader, narrower or in effect the same as the meaning of “sale or supply”? Without a definition of         

               “transaction”, how can it be known what activities a person can or must supervise, for supervision to be effective?

        39. Does the term “a pharmacist”, which is used throughout the draft statutory instrument in relation to authorisations, mean that the pharmacist giving the authorisation need not be registered with a regulator in the UK? Would the definition of “pharmacist” in reg.8 of

               the Human Medicines Regulations 2012 prevent pharmacists not registered in Great Britain or Northern Ireland from giving an authorisation? Or would the definition apply only to pharmacists who are registered in Great Britain or Northern Ireland when they give an

            authorisation, but without precluding a pharmacist not so registered from giving an authorisation? Does the absence of a definition of “pharmacist” in the Medicines Act 1968 mean that the definition for the purposes of that legislation (and therefore as applicable to

               dispensing, assembly and preparation) could be different to the definition for the    purposes of the Human Medicines Regulations 2012 (and therefore as applicable to transactions)?

        40. If “a pharmacist” who was not registered with a UK pharmacy regulator could and did give authorisation to a pharmacy technician under the new provisions, how could he face regulatory action under the proposals if he failed to have due regard to patient safety?

S220B Authorisations – for Supply in the Absence of a Pharmacist

1. Can the authorisation of a person under reg.220B to carry out a transaction in the absence of the pharmacist who gave the authorisation, be revoked, suspended or varied by a different pharmacist to the one who gave it, on the grounds that he doesn’t want the person         

     who was authorised to be able to carry out the transaction? If the transaction is carried out by the person in any event (on behalf of the authorising pharmacist), would the pharmacist who was seeking to prevent the person carrying out the transaction on the day

    nevertheless owe a duty of care to patients, and have liability in negligence, criminal law or to the regulator?

2. Could the person authorised under reg.220B to carry out a transaction in the absence of the authorising pharmacist be any staff member, whether pharmacy trained or not?

3. Could the person authorised under reg.220B to carry out a transaction in the absence of the authorising pharmacist, be someone who is not a staff member, such as an independent contractor visiting the pharmacy?

4. Could a pharmacist authorise a transaction in his absence under reg.220B, in advance – for example, would his authorisation remain valid if the transaction were to occur three months hence from the date of the authorisation? Would the authorisation be valid if the         

    pharmacist is not present at the pharmacy – for example, because he had not worked there for three months?

5. Could a pharmacist authorise a transaction days, weeks or perhaps months after he had supervised the dispensing of the medicine, for the transaction to occur in his absence (provided it had not already occurred)?

6. What is the significance of the phrase “anywhere in the United Kingdom” in the explanatory notes to the draft statutory instrument? Is it an indication that a pharmacist who has supervised the dispensing of the medicinal product can give an authorisation provided that he         

     is physically located in the United Kingdom when he does so?

7. Does only the “dispensing”, and not the getting ready for sale and supply of the medicine, need to be supervised under reg.220B(1)(a) in order for the pharmacist to be able authorise a transaction to take place in his absence? How does “dispensing” differ from getting

    the medicinal product “ready for sale or supply”? If an error is introduced in the process of getting the medicinal product “ready for sale or supply” – but the pharmacist has authorised the transaction to be carried in his absence merely because it was “dispensed” under

    his supervision – who would be liable, from a regulatory, civil and criminal perspective, for any harm caused to the patient?

8. Can the pharmacist give authorisation for a transaction to be effected in his absence if only part of the dispensing of the medicine has been done in his absence – for example, the generation of a medicines label but not the application of the label to the product?

9. What is the definition of “dispensed” in the draft legislation?

10. What is the definition of “ready for sale or supply” in the draft legislation?

11. If a medicine is inadvertently placed in the wrong patient’s bag, is it “ready for sale or supply to the person for whom it was dispensed”?

12. If the pharmacist who provided the authorisation is simply in another part of the pharmacy, and is for example on the phone, can the transaction be carried out by the authorised person on the basis that the pharmacist is not at that time “in a position to intervene” or

       “available to intervene” in the supply – and is therefore treated as “absent from the premises”? How far can the approach to treating him as absent, be taken?

13. Could a pharmacist working in an automated dispensing warehouse supervise the dispensing, assembly and preparation of thousands of medicines, then authorise all staff, or all named staff on a list, to, once the medicines are sent out to pharmacies, carry out in his         

       absence the transaction in relation to the prescription received?

14. How are “dispensing”, “assembly” and “preparation” different from one another? What is the definition of each?

15. Does the person authorised to carry out the transaction in the pharmacist’s absence under reg.220B have to be a named person? Could it be a category of people? How broad could the category be? How far in advance can the authorisation be given? Could it be made

       as a general authorisation, applicable at all times? For example, if a person put on his social media account “I authorise all individuals to carry out transactions on my behalf which relate to the prescription received in the pharmacy for any medicinal product that has

      been dispensed by or under my supervision”, would that be a valid authorisation in respect of any medicinal product he subsequently dispensed or of which he supervised the dispensing?

16. Could an authorisation to carry out a transaction on a pharmacist’s behalf and in his absence, cover the inadvertent supply to the wrong patient? Can a person be authorised to hand out a medicine to the wrong patient? If he cannot, and it was handed out to the wrong

       patient in a pharmacist’s absence, would this amount to a failure to supervise, and constitute an offence?

17. Could an authorization to carry out a transaction on a pharmacist’s behalf and in his absence under reg.220B be withdrawn by the pharmacist who gave it? Why is no express provision for withdrawal set out under reg.220B, as it is under reg.220A?

Due Regard to Patient Safety

1. In the course of giving authorisations, due regard must be given to patient safety. What degree of success would the following arguments have in establishing a defence to any regulatory action against the person who was expected to have due regard?

    a. if patient safety was at too great a risk, then parliament would not have made it possible for the authorisation to be given in the way it was and/or would have insisted on supervision by a pharmacist.

    b. if patient safety was at too great a risk, the regulator would have placed restrictions on the practice of the pharmacy technician(s) concerned, or taken action in respect of the pharmacy or pharmacies concerned, so it would not have been possible for the pharmacy

         technician to supervise.

    c. pharmacy technicians have to adhere to regulatory standards and must not work beyond their own competence.

    d. others involved in the process - including the regulated pharmacy technician - determined whether the pharmacy technician would actually be supervising in practice.

2. If the above arguments would succeed, is the requirement for due regard for patient safety meaningless, or of little value?

3. New s.10A(6) of the Medicines Act 1968 and new reg.220A(5) of the Human Medicines Regulations provide that “a” pharmacist must have due regard to patient safety when giving an authorisation. Does this mean that the pharmacist who has to have due regard for

     patient safety does not necessarily have to be the same pharmacist who gave the authorisation?

Hypothetical scenario

The following is a hypothetical scenario intended to illustrate some of the questions set out above. The draft statutory instrument can be analyzed against the details of the scenario.

John is a pharmacy owner. He was recently told that he is being prosecuted for allegedly allowing two medicines to be supplied from his pharmacy unsupervised, after two patients were harmed as a result of taking the medicines. He faces up to two years in prison and/or a

fine if found guilty. In relation to the first medicine, he was told by the pharmacy technician, Aneela, that she had, by way of oral authorisation some two weeks prior to the supply, been authorised to supervise transactions, provided that she stood not less than two feet away from the pharmacy counter when supervising. Aneela thinks she was standing three feet away at the time when attempting to supervise the handout, which was carried out by a counter-assistant. In any event the pharmacist who authorised Aneela says that he withdrew the authorisation orally the day before the supply whilst talking to himself at home. Aneela was not aware of this.

John has a separate written authorisation for Aneela to supervise, given some time before the oral authorisation was given, but it is not dated, does not contain the name of the authorising pharmacist, and the wording is slightly different to that in reg.220A(3). He thinks

the authorising pharmacist was Susan, but she denies this. He hopes that on cross-examination in court she will admit it, and he’s having handwriting analysis conducted on the note. Aneela cannot remember anyone telling her about the written authorization.

The second medicine was handed out by Amari, a dispensing assistant. Amari had been told orally by Rav, the pharmacist, that he could hand out the medicine in Rav’s absence. When Rav gave the authorisation, he said that Amari was authorised to carry out the transaction, but his practice was to not use the words “to the patient”, because he understood that this would mean his authorisation would cover the inadvertent handout to the wrong patient. 

On a day when Rav was the pharmacist, under Rav’s supervision, the label for the second medicine had been printed, and the medicine had been picked from the shelf. However, the label had been applied to the medicine on the following day, when Rav was not present.

Unfortunately, in getting the patient’s medicines ready for supply, the labels on the patient’s medicines were applied to the wrong products. The label for the second medicine was applied to a different product, and the second medicine itself was labelled with a label

intended for the other product. This resulted in, amongst other things, the incorrect dosage instructions on the patient’s medicines. Further, the patient’s bag of medicines had been handed out by Amari to the wrong patient. At the time of supply, some three months later,

Rav was absent, having not worked in the pharmacy since supervising the printing of the label and picking of the second medicine. Aneela was present on the day of handout alongside the duty pharmacist, Mohammed. Aneela and Mohammed objected to Amari

making the supply, but Amari told them they had no right to do so because he had authorisation from Rav. Amari also said that the handout didn’t need supervision, because it was being carried out in Rav’s absence. Aneela and Mohammed did not know whether this

was correct. In any event, Aneela and Mohammed hadn’t discussed who would be supervising on that day, or told the staff, and there was no record of either of them supervising.

Definition of Supervision – reg.220B

1. The draft statutory instrument does not expressly define “supervision”. However, it could be argued that there would be no need for reg.220B – which allows a transaction to take place in the absence of the pharmacist who supervised the dispensing of a medicinal product – if supervision of a transaction could take place ordinarily in the absence of the pharmacist. As such, does reg.220B impliedly define supervision as requiring the presence on the premises of the person supervising – and that he must be available and in a position to intervene in the transaction in order to supervise?

Aseptic assembly and preparation

1. For a pharmacy technician to supervise aseptic dispensing, assembly and preparation, under the new reg.4A, certain requirements have to be met. Would the technical tasks described in the new reg.4A(1)(c) ever in themselves constitute part of a clinical process, per reg.4A(1)(a)? If not, could the requirements of reg.4A ever all be satisfied? What is the definition of “clinical” or “clinical process”?

Further points

1. Are the words in art.4(2)(a)(ii) “after paragraph (b)” meant to say “in paragraph (b)(ii)”?

2. Is the change in wording of reg.220 of the Human Medicines Regulations 2012 to permit sales and supplies to be made “at or from” the pharmacy instead of “in” the pharmacy intended to give greater certainty that prescription deliveries are lawful – since at present, the         

     sale or supply can only be made “on” the premises? Could the change have more extensive effects? Should any such effects be considered and explained to the public in a consultation, before giving effect to the change?

3. Are prescription deliveries currently lawful, if the pharmacist is required to supervise them, but isn’t present at the point of delivery to the patient? Is the meaning of supervision under existing law broad enough to cover deliveries? If it is, then is it also broad enough to

     cover the other activities which currently take place in a pharmacy, and does supervision law need changing?

4. Why is the requirement for supervision under s.248(2)(b) of the Human Medicines Regulations 2012 not being considered as part of this consultation? Will a pharmacist’s supervision of preparation and dispensing continue to be required for the exemption for certain           

     collection and delivery arrangements to apply?

5. How will the proposed changes operate alongside The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, which require supplies to be by or under the “direct” supervision of a pharmacist in relation to SSPs (Sch.4 (5A)(3)(c))

     and Sch.7 (3A)(3)(c), and the provision of drugs or appliances ordered under the Electronic Prescription Service (Sch. 4 (8)(2))? Will these regulations be changed in the future? How does “direct supervision” under this legislation differ, if at all, from “supervision” under the

    Human Medicines Regulations 2012 and the Medicines Act 1968?

6. Are the listed “consequential amendments” to the Misuse of Drugs Regulations 2001, genuinely consequential on the other matters being consulted upon? For example, is the apparent intention to authorise pharmacy technicians to receive certain controlled drugs which

     have been supplied on prescription and which have been supplied to them for the purposes of destruction, consequential on anything else in the consultation? Would it be consequential if the intention was to operate a pharmacy in the absence of a pharmacist?

Criminal liability for inadvertent dispensing errors

1. If the law is not being changed to remove criminal liability for inadvertent dispensing errors, do the proposed changes to supervision legislation alter the prospect of who could be prosecuted, or the likelihood of certain groups of individuals being prosecuted? For

    example, if a pharmacy technician could be authorised to sell or supply a medicinal product, or was offering or exposing it for sale or supply, could he be prosecuted under s.63(b) of the Medicines Act 1968? Alternatively, is the way a pharmacy technician would be

    treated for the purposes of s.63(b) no different to the way he would be treated under existing law?

2. Under reg.214 of the Human Medicines Regulations 2012, would it be only a pharmacy owner who could be prosecuted for a supply which was otherwise than in accordance with a prescription? Alternatively, could others be prosecuted under this section? Are there any

     statutory defences to such a prosecution? Are there any other areas of medicines law under which could someone could potentially be prosecuted for an inadvertent dispensing, assembly, preparation, sale or supply error?

3. Does the risk of inadvertent errors, and therefore the likelihood of criminal prosecution therefor, increase as a result of the legislative changes being proposed? Should the prospect of prosecution for inadvertent errors in the medicines sale or supply process be removed

    from medicines law, or the shortcomings in the defences to prosecution under s.63 or s.64 of the Medicines Act 1968, be remedied?

4. Would individuals who are not registered with a regulator, who carry out medicines transactions in the absence of a pharmacist in accordance with his authorisation, be unable to invoke the defences to prosecution under s.63 and s.64 of the Medicines Act 1968? If they

    are not “registrants” or “acting the course” of a profession, does this mean that the defences at 67A-F of the Medicines Act 1968 are unavailable to them?

5. To whom are the defences at 67A-F of the Medicines Act 1968 available? They are available to a “registrant acting in the course of his or her profession”; “registrant” is defined at s.67E, but “profession” is not defined.

6. S.67C(2)(b)(ii) of the Medicines Act 1968 requires that for the defence to be available, the person who “dispensed” the product was either a registrant acting in the course or his or her profession, or was acting under the supervision of a registrant acting in the course of his

    or her profession. If the proposed changes will affect whether supervision was effective (took place) in a particular set of circumstances – will this have a consequential effect in some circumstances on the ability to invoke the defence at s.67C(2)(b)(ii) of the Medicines Act

    1968?

Political, Strategic and Practical Considerations

1. How will the changes affect public access to a pharmacist, and employment within the profession?

2. Will the changes reduce the number of pharmacists required in the UK?

3. What impact will the changes have on pharmacists’ professional status? If to be a “profession” the group constituting it must have exclusivity of its social object, is that being lost or substantially diminished through these changes? Does that result in the 

     deprofessionalisation of pharmacists?

4. What will be the long-term impact on patients and the public of deskilling the pharmacy workforce i.e. reducing the skill level of the individuals carrying out particular tasks?

5. There has been considerable focus on “modernising” the legislation or attacking it as “out of date”. Is this a mere slur in the absence of any accompanying compelling argument as to why it is said not to be fit for purpose? The legislation has been updated periodically

     since its introduction. Does the date that the legislation was introduced, as opposed to its effect, affect its suitability per se?

6. Can it be expected that some pharmacy businesses will alter their staffing budgets to reflect that a percentage of work done will now be supervised by a pharmacy technician? If so, will they then tell pharmacists to decide whether to authorise a pharmacy technician to

     supervise – knowing that if the pharmacists don’t give authorisation, the pharmacy will only be allocated the same amount of money for staffing and with the same staffing profile as it would if the pharmacists did give authorisation, meaning that that pharmacist and other

    pharmacy staff will have to cope with fewer staff, won’t meet their targets and will be performance managed for failing to do so?

7. The consultation impact assessment states “We are also proposing a transition period before this legislation commences to allow regulatory rules and standards, and professional guidance to be issued to ensure good governance supports the implementation of this             

     legislation in practice.” If the government plans to pause for regulatory changes before bringing this legislation into force, what aspect of regulation does the government think is currently inadequate? How will this interact with the legislation, given that the draft statutory

    instrument does not itself propose or recognise any new regulatory powers? Are any such new powers required?

8. What will be the impact if any on the quality of pharmacist training, if pharmacy technicians are supervising trainee pharmacists?

9. It has been suggested that:

    a. medicines dispensing, assembly, preparation could be done out of hours, en masse, supervised by a superintendent (who is or is not remote), and that the medicines would then be sold or supplied during the pharmacy’s normal operating hours (and from a different

         pharmacy if applicable).

    b. there might be a way of ensuring that the pharmacist at the supplying pharmacy does not have liability in negligence for the accuracy of the medicine – for example, by the superintendent assuming liability.

    It is not clear how that could work at law. As to civil liability for any accuracy error, if the pharmacist was in a position to intervene by being involved in the process in any way, under what circumstances would he not have a duty of care in negligence law? If he was in a         

    position to intervene, but harm was caused, would he have breached that duty? As to criminal liability for any error, this is determined by statute – and legislation giving rise to the risk of prosecution for inadvertent errors is not being altered in itself by the proposals in this

    consultation. As to accountability to the regulator, can the regulator really be expected to provide any guarantee to the pharmacist that there would be no risk of sanction? Would this not depend on the circumstances, and what the pharmacist did and did not do, and

    could and could not have done? If a pharmacist local to the patient has no involvement or liability, would the patient be adequately protected? If pharmacists were not accountable, would they continue to be a profession? Is it not in the public interest for pharmacists to

    retain a duty of care? Why would the dispensing, assembly, preparation etc. need to be done out of hours or at a different premises, if following this consultation pharmacists are not going to be involved in that process when it is completed during ordinary operating hours

    and on the premises?

10. Is the 350-word limit to responses to this consultation sufficient to ensure that the government is adequately informed by responses?