Consultation outcome

Original pack dispensing and medicines containing sodium valproate: consultation response

Updated 19 March 2023

Executive summary

Between 1 November and 13 December 2021, the Department of Health and Social Care (DHSC) and Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposals to enable original pack dispensing and whole-pack dispensing of medicines containing sodium valproate in community pharmacies across the UK.

The consultation included 2 proposals to make legislative amendments to the Human Medicines Regulations 2012 (HMRs).

The first of these proposals sought to enable pharmacists (and pharmacy staff under the supervision of pharmacists) the flexibility to dispense up to 10% more or less of the medicine, compared with the quantity prescribed, if it means they can dispense it in the original pack. This is referred to as original pack dispensing (OPD).

The aim of OPD is to increase patient safety by ensuring the medicine is provided with the patient information leaflet (PIL), which contains information about the safe and effective use of a product. Judgement by the responsible pharmacist will remain a critical part of the process – for instance, there are some prescriptions, such as a course of steroids or antibiotics, where a decision may need to be made to supply the exact quantity prescribed.

A further aim for OPD, as part of England’s Community Pharmacy Contractual Framework 5-year deal 2019 to 2024, is to support efficiencies for pharmacies because pharmacy staff will not need to spend as much time splitting boxes, snipping blisters and repackaging medicines to dispense the exact quantity prescribed. OPD will free up pharmacists and their teams for other tasks such as providing clinical services to patients.

The consultation also included a proposal that medicines containing sodium valproate will always be dispensed to the nearest whole pack (either up or down). Sodium valproate is an effective medicine prescribed for the treatment of epilepsy and bipolar disorder, but is associated with birth defects and neurological disabilities. This measure is to ensure that patients receive the manufacturers’ specific and unique warnings and pictograms, including a patient card and the statutory PIL (in the whole pack), which alert patients to the risks to unborn children.

The proposed amendments to the HMRs also included a transitional provision for OPD so that they do not automatically apply in NHS pharmaceutical services in England, Northern Ireland (NI) and Wales. This is to enable each administration time to agree with the appropriate community pharmacy representative body how the OPD arrangements will apply as part of NHS pharmaceutical service provision. These amendments will come into immediate effect as part of Scotland’s dispensing practices.

Furthermore, the proposed amendment on medicines containing sodium valproate will apply to all prescriptions as soon as it comes into force in the HMRs.

This consultation response document outlines our intention to make the amendments to the HMRs as proposed, although there has been a revision to the sodium valproate proposal to include an exception in very specific circumstances.

The consultation proposals were UK wide so the regulation amendments could be progressed as a UK- wide statutory instrument. Alternatively, it may be that DHSC leads with the regulation amendments for Great Britain, allowing for NI to follow in due course.

Current dispensing arrangements

Regulation 214(1) contained in Part 12 of the HMRs provides that a pharmacist may not sell or supply a prescription-only medicine:

except in accordance with a prescription given by an appropriate practitioner.

Currently we interpret dispensing “in accordance with a prescription” to mean pharmacists must supply the exact quantity prescribed with a few exceptions, where it is practically impossible or very difficult to split the original pack.

This means, where the quantity prescribed on a prescription is not equal to (or multiple of) a pack size, pharmacy staff need to split a manufacturer’s original pack in order to dispense the prescribed quantity. In many circumstances, this will require splitting the manufacturer’s original pack and either providing the manufacturer’s pack, but with a quantity taken out (or some added), or providing the amount prescribed in plain dispensing packaging.

This has several consequences:

1. If a patient receives the manufacturer’s original pack but with some dosage units missing (or added), the tamper evident seal will be broken. The patient might be concerned either that someone has interfered with the medicine or that the pharmacist has accidentally underfilled (or overfilled) their prescription.

2. If a patient receives their medicine in plain dispensing packaging, they may get lots of small ‘snips’ from a blister strip making it difficult to:

• manage their supply
• ensure compliance
• identify whether they have taken their tablet that day

3. If a patient receives their medicine in plain dispensing packaging, they may not get all the patient information such as the manufacturer’s PIL.

4. Pharmacy staff spend considerable time splitting boxes, snipping blisters, and repackaging medicines.

5. It reduces the cost-effectiveness of automated dispensing – as, in the main, automation cannot ‘split and snip’ – so, for any prescription where this is required, it must be done outside of the automated process.

Note: ‘plain dispensing packaging’ refers to unmarked packaging, boxes or bottles (of any colour or even no colour such as see-through) that are used by the pharmacy to pack down medicines, instead of using the manufacturer’s original pack. Plain dispensing packaging typically displays limited dispensing information such as the names of the medicine and the patient.

Concerns with dispensing medicines containing sodium valproate

Sodium valproate is an effective treatment for epilepsy and bipolar disorder. It is commonly used as an anti-epileptic, and it may be the only effective treatment for some patients.

However, the use of medicines containing sodium valproate was already known to be associated with birth defects when it was first licensed in the 1970s, and further evidence has emerged since then about other adverse effects – in particular, neurodevelopmental disorders in children where medicines containing sodium valproate are taken during pregnancy. The risk of such neurodevelopmental disorders is estimated at 30% to 40%, which is in addition to an 11% risk of a congenital abnormality.

Our proposals for reform

The consultation proposed amendments to Part 12 of the HMRs, as follows:

1. For pharmacists to have flexibility to dispense more or less than the prescribed quantity (up to 10% more or less) if that means they can dispense in the manufacturer’s original packs, except where this would negatively affect the patient’s clinical treatment regimen – so they must make a judgement that this is appropriate. This would not apply to controlled drugs.
2. Dispensing of medicines containing sodium valproate must always be in whole packs in the original packaging regardless of the conditions we set around other products for OPD. The requirement will be that the nearest number of whole packs will be supplied (either up or down) so that the patient receives only the manufacturer’s complete original packs. These must not subsequently be re-packaged into plain dispensing packaging. However, note that, further to the consultation responses, an exception is being included: pharmacists will be able to make an exception to whole-pack dispensing of medicines containing sodium valproate on an individual patient basis, where a risk assessment is in place that refers to the need for different packaging, such as a monitored dosage system (MDS) and where processes are in place to ensure the supply of PILs.
3. To include a transitional provision – so the flexibility to dispense up to 10% more or less does not automatically apply in NHS pharmaceutical services in England, NI and Wales – to enable these administrations to decide how they want these to apply in their respective NHS services. The OPD 10% flexibility will apply immediately in Scotland. Furthermore, there is no transition for the amendments on whole-pack dispensing of medicines containing sodium valproate.
4. We propose to use the enabling powers in Part 2 of the Medicines and Medical Devices Act 2021 (MMD).

As per the proposal in 2 above, MDS is packaging that helps people take their medicines appropriately, such as containers with compartments marked with the time and day of the week. MDS is one option pharmacists can consider as a reasonable adjustment as required under the Equality Act 2010 to support people with protected characteristics to take their medicines.

Overview of consultation responses

We asked respondents to submit their feedback by completing an online survey. In total, there were 84 responses.

Respondent demographics

47 of the responses were from individuals and 37 were from organisations and groups, including 8 from independent pharmacies and 4 from patient groups.

We do recognise that organisations can represent a different number of individuals who have provided input to the response – however, the analysis represents each organisational response as one organisation regardless of the number of people it represents.

Are you responding as an individual or as an organisation?

• individual
• organisation

The results to this question were as follows:

Type of respondent	Proportion of responses received
Individual	56%
Organisation	44%

Which area of the UK are you responding from?

• East of England
• East Midlands
• London
• Northern Ireland
• North West
• Scotland
• South East
• South West
• Wales
• West Midlands
• Yorkshire and the Humber

The results to this question were as follows:

UK region	Proportion of respondents
London	15%
Yorkshire and the Humber	13%
Wales	13%
South West	13%
North West	13%
West Midlands	9%
East Midlands	6%
South East	6%
Scotland	4%
East of England	4%
Northern Ireland	4%

Consultation responses received by question

Original pack dispensing

Pharmacists have flexibility to dispense more or less than the prescribed quantity (up to 10% more or less) if that means they can dispense in the manufacturer’s original packs, except where this would negatively affect the patient’s clinical treatment regimen – so they have to make a judgement that this is appropriate. This would not apply to controlled drugs.

The consultation considers consequences such as patients receiving too much or too little medication and changes in pack size purchasing patterns. Do you think there are other consequences that need to be considered?

Summary of responses received

On this question, there were a few themes that emerged from the responses that explained why respondents agreed with the proposal and/or expressed areas of concern.

Several respondents, both individuals and organisations, stated that, where the pharmacist could dispense a different amount to that prescribed, there could be potential discrepancies between the prescriber’s records and the exact quantity of medicine supplied. It was considered that the discrepancies in records could eventually lead to re-ordering issues later.

For example, a GP practice may delay issuing a repeat prescription if, according to their records, the patient should still have a reasonable supply of medicine to use before another prescription is required. This might occur when the supply has been consistently rounded down over time compared with the quantity prescribed.

This could happen, for example, if a pack of 30 of medicine is prescribed, but only 28 supplied. Over a year, this would mean that the patient would present a month earlier than if 30 had been supplied each time. Additionally, this in turn may lead to more emergency supplies needing to be provided by community pharmacies.

There were some concerns that, where pharmacists dispense up to 10% more, it could lead to excess stock, which will be in the control of the patient, and that there would be increased risk of medicine abuse or overdose.

Some responses also mentioned that patients may be confused as to why they have received a different amount of medication to that of the prescription.

Government response

The government has considered the risk of giving too much medicine alongside the risk of not giving patients enough medicine.

In giving a patient more medicine than prescribed, there is a potential increased risk of:

• abuse
• accidental or intentional overdose
• patients taking medicines longer than they need to (for example, unnecessary extended use of antibiotics or steroids)

However, for repeat prescriptions where more is supplied, it would not necessarily change the amount of medication that the patient takes overall, but mean the patient requires a repeat prescription less often. Repeat prescriptions make up around 77% of all prescription items (PDF, 151KB), so this is the likely outcome for the majority of prescriptions where more is supplied than prescribed.

Furthermore, as part of the proposal, a pharmacist could continue to provide the exact amount if, in their judgement, this was best for the patient’s treatment. This clinical judgement should be applied whether the prescription is or is not a repeat prescription, but may be particularly relevant when:

• the prescription is not a repeat
• the pharmacist considers, for example, there is a risk of patients taking the medicine for longer than they should

In summary, the pharmacist could opt to employ their clinical judgement, rather than use the flexibility, and instead supply the exact quantity of medication prescribed.

In giving a patient less medicine than that prescribed, there is a potential increased risk:

• of the patient receiving a suboptimal dose
• that, due to discrepancies in GP practice records as to what is prescribed and what the patient receives, the GP practice may delay issuing a repeat prescription, thinking that the patient will still have some left

With regard to the former, judgement by the pharmacist will remain an important part of the dispensing process – for instance, a decision may need to be made not to give patients a reduced amount of medication so they have enough to finish their treatment (for example, antibiotics or steroids).

Regarding discrepancies in GP practice records and GP practice delays in issuing a repeat prescription, approximately 75% of prescriptions are already prescribed in quantities that align with available pack sizes (source: DHSC analysis in April 2021).

Of the remaining 25% of prescriptions, it will not always be suitable to supply these in line with the pharmacist’s clinical judgement so there are probably very few occurrences where the quantity supplied on a repeat prescription as part of OPD is less than that prescribed.

However, GP practices may need to check a patient’s ordering patterns and, if repeat prescription requests are a month early once or twice a year, consider whether this might be due to the pharmacist using the flexibility to dispense up to 10% less each time so that, over the course of a year, a patient needs their repeat prescription a month earlier.

We anticipate that – particularly in the initial first year – pharmacy staff will need to factor in time to disseminate the appropriate messaging and communicate with patients and those collecting medication about the changes and how they might impact them.

The consultation considers and dismisses other options such as making all manufacturers supply in the same pack size or asking all prescribers to prescribe consistent quantities.

To what extent do you agree or disagree that these other options suggested are not viable?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Do you believe there are alternative options that you feel should be considered?

Summary of responses received

Many respondents – 55% – strongly agreed or agreed that the alternative suggestions to OPD of manufacturers supplying standardised pack sizes and asking prescribers to prescribe in consistent pack sizes are not viable.

Around 31% of respondents disagreed or strongly disagreed.

Response	Percentage of respondents
Strongly agree	22%
Agree	33%
Neither agree nor disagree	14%
Disagree	20%
Strongly disagree	11%

Overall, respondents strongly supported the proposals outlined in the consultation, demonstrating agreement for:

• OPD
• pharmacists to have the flexibility of plus or minus 10%
• being able to apply their clinical judgement when not appropriate to use the flexibility

There were, however, a couple of options that some respondents felt should be considered.

One respondent mentioned that the alternatives to OPD should be given further consideration, including consistency of approach on pack sizes by manufacturers and prescribers, as these models have worked well in Europe without a detrimental impact on the supply chain.

This view was shared by a quarter of respondents, including some large organisations who suggested that pack sizes should be standardised.

Some of these respondents argued that a move towards standardised pack size combined with standardised prescription duration would encourage manufacturers to increase pack size volumes to meet any national policy on standardised prescription duration, and hence increase OPD without the need for dispensing flexibility on quantity.

Government response

While the government does recognise the potential of standardisation of pack sizes manufactured, the government does not have the authority to require that manufacturers only market certain pack sizes.

In addition to this, standardisation of pack sizes could lead to unnecessary supply issues – for example, where a manufacturer could not supply in a pack of authorised pack sizes. It would also lead to less competition and, in turn, increased costs.

Furthermore, a transition to only marketing authorised pack sizes could take years as manufacturers would have to re-plan production lines. Similarly, asking prescribers such as GPs to prescribe for standardised durations could restrict GPs’ clinical freedom when it is critical that the patient receives a certain quantity, and could also cause further issues around availability of certain pack sizes in stock in pharmacies.

Moreover, GPs do not typically know what pack sizes pharmacies have in stock, so this still may not achieve the desired outcome of patients more often receiving original packs.

To what extent do you agree or disagree with the proposed deviation of a different quantity that is not greater or smaller than 10%?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Do you have any comments on the proposed deviation limit of 10%?

Summary of responses received

Over half of respondents – 63% – agreed or strongly agreed with the proposed deviation of a different quantity that is not greater or smaller than 10%.

However, 23% of respondents disagreed or strongly disagreed with the proposed amount for deviation.

Response	Percentage of respondents
Strongly agree	23%
Agree	40%
Neither agree nor disagree	14%
Disagree	12%
Strongly disagree	11%

The responses to this question can be split into 3 categories of:

• 10% deviation is reasonable
• 10% deviation is insufficient
• 10% deviation requires a higher flexibility

Most respondents felt that 10% is appropriate and would help in most cases.

It was also highlighted that some respondents felt that, if there is a deviation, it should be that patients can be given 10% more medication but not less. An example of this would be to ensure that vulnerable patients who rely on their medication are always in possession of sufficient supply.

Furthermore, there were several respondents who felt the 10% flexibility did not go far enough and suggested it should be increased to 15% or even 20% to allow a broader range of items to be included in OPD.

Moreover, one organisation provided specific data that supported an increase of the deviation amount to 20%.

This organisation contended that the proposed flexibility for OPD of plus or minus 10% creates the opportunity for the average pharmacy to dispense up to between 2% and 3% more items in the original pack. However, they thought that if the flexibility was to increase to plus or minus 20% then the range as to how many more prescriptions could be dispensed via OPD would increase to between 2.5% and 3.5%.

Government response

The government has carefully considered the arguments put forward and has decided to proceed with the proposed deviation limit of 10%.

We recognise the benefits of increasing the deviation to plus or minus 15% or 20% – as we estimate that the percentage of prescriptions that could be dispensed via OPD would increase by 4.9% and 7.1%, respectively, compared with a deviation of 10% where we estimate the increase would be 3.7%. However, we consider that a flexibility of more than 15% would significantly change the quantity of medication supplied compared with that prescribed, and patients may find that the medication dispensed falls short of the prescriber’s intent.

For example, where a prescription is written for a quantity of 112 (because the patient needs to take one tablet 4 times a day), a flexibility of 15% or above would enable a pack of 100 to be supplied. However, this would only provide the patient with a supply for 25 days rather than the prescribed 28 days. We consider this to be significantly too far from the intention of the prescriber.

With this taken into consideration, we feel that 10% is sufficient as it will still capture a significant number of prescriptions (an increase of 3.7%). In particular, this deviation level of 10% allows for whole packs to be dispensed against prescriptions for 28 tablets when the original pack contains 30 or vice versa (and multiples such as 56 and 60) – that is, a month’s supply – therefore not altering the intent of the prescriber.

With regards to patient safety, a dispensing flexibility of 15% could mean that the patient receives substantially more or less medication than is stated in the prescription, with all the associated risks as outlined above. These risks will inevitably be greater than those associated with a plus or minus 10% deviation and so we consider this begins to ‘tip the balance’: meaning the risks of a 15% dispensing flexibility are more likely to outweigh the benefits.

To what extent do you agree or disagree that OPD should not apply to controlled drugs?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Please provide a reason for your answer and any evidence to support it.

Summary of responses received

While 64% of respondents either strongly agreed or agreed that OPD should not apply to controlled drugs, 19% disagreed or strongly disagreed with the proposal.

Response	Percentage of respondents
Strongly agree	38%
Agree	26%
Neither agree nor disagree	17%
Disagree	15%
Strongly disagree	4%

Respondents, including some independent pharmacies and patient groups, suggested that OPD should be applied to controlled drugs, as it was even more important that patients always had access to patient information about these medicines to understand the nature of the medicine and the importance of taking them correctly.

There was strong sentiment from patient groups that medicine prescribed for epilepsy – including those that are controlled drugs – should always be dispensed in original packs, again to ensure that patients and carers would always have access to the information provided by the pharmaceutical company that produces the drug.

Furthermore, respondents argued that OPD of controlled drugs would be beneficial if pharmacists were able to apply their professional judgement.

However, one of the patient groups did outline concerns around the additional safety considerations linked to controlled drugs. The concern was that repeatedly dispensing a different quantity of controlled medication to that prescribed may lead to either early repeat medication requests or an increased risk of stockpiling, which may increase the likelihood of accidental overdose. One respondent suggested that the additional supply could provide an opportunity for the diversion of medication to illicit markets.

Some organisations suggested that OPD of controlled drugs was not the best option for patients because they felt this could cause harm, confusion, stockpiling and possible accidental overdose. A large majority of respondents felt that the risks associated with OPD of controlled drugs far outweighed the benefits.

Government response

The government acknowledges the responses and concern from the majority of respondents on the position that OPD should not be applied to controlled drugs.

The government does recognise the potential positive impact of supplying controlled drugs in their original packaging (for example, as patients have more easy access to the PIL). However, on balance, considers that the negative consequences – such as accidental or intentional overdose and patients taking the medication for longer than they should – outweigh the benefits. Therefore, OPD will not apply to controlled drugs.

To what extent do you agree or disagree that OPD and the supply of complete packs of sodium valproate should apply to dispensing doctors?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Please provide a reason for your answer and any evidence to support it.

Summary of responses received

A large majority of respondents – 83% – agreed or strongly agreed with the position that OPD and the supply of complete packs of medicines containing sodium valproate should apply to dispensing doctors.

Only a small number of respondents – 2% – disagreed or strongly disagreed.

Response	Percentage of respondents
Strongly agree	57%
Agree	26%
Neither agree nor disagree	15%
Disagree	1%
Strongly disagree	1%

There was overwhelming support for this position, with nearly all respondents agreeing that the proposals should apply to dispensing doctors.

The clear message from respondents was that it should be essential that all those dispensing medicines have the same requirements and that there is consistency across dispensing, if not least to avoid patient confusion and disparity of approach.

One respondent pointed out that it is essential that the same rules apply so those that live in rural areas are not at a disadvantage.

Government response

The government recognises the need for equity, and that OPD and whole-pack dispensing of medicines containing sodium valproate should apply to dispensing doctors. The government acknowledges that the efficiencies gained should be available to all, regardless of whether a patient lives in a rural community or not.

However, enabling OPD and whole-pack dispensing of medicines containing sodium valproate for dispensing doctors is not dependent on an amendment to the HMRs but rather amendments to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, which will be considered separately.

Dispensing of medicines containing sodium valproate in whole packs

Sodium valproate is an effective treatment for epilepsy and bipolar disorder. However, the use of medicines containing sodium valproate is known to be associated with birth defects. To try to minimise the risk of unborn babies being exposed to the effects of this medication, a number of mitigations are in place or being considered, including product information such as pictograms and labelling, that will specifically alert patients to this risk. Such mitigations will highlight the need to be enrolled on a pregnancy prevention programme (PPP) and sign annual risk acknowledgement forms.

To what extent do you agree or disagree that requiring the dispensing of medicines containing sodium valproate in the manufacturer’s original pack will ensure patients are always provided with the safety information supplied on the label and in the PIL?

• strongly agree
• agree
• neither agree nor disagree
• disagree
• strongly disagree

Please provide a reason for your answer and any evidence to support it, including any experiences you or your organisations have had trying to provide patients with important risk minimisation measures.

Summary of responses received

A large majority of respondents – 85% – agreed or strongly agreed with the requirement that the whole-pack dispensing of medicines containing sodium valproate in the manufacturer’s original pack will ensure patients always receive the safety information supplied on the label and in the PIL.

A small number of respondents – 4% – disagreed or strongly disagreed.

Response	Percentage of respondents
Strongly agree	55%
Agree	30%
Neither agree nor disagree	11%
Disagree	3%
Strongly disagree	1%

There was wide-ranging support for this position from individuals, organisations, as well as patient safety groups, with all respondents highlighting the significant benefits to patient safety.

With regards to the responses from patient safety groups, one of these respondents highlighted the importance of always supplying the PIL in a box that features warnings as patients are not always aware of the risks.

Another respondent submitted results from a survey in 2020, which included findings indicating that, when medicines containing sodium valproate were dispensed in a plain package, 29% of respondents noted that the ‘white dispensing box’ did not have a sticker with the warning pictogram. Additionally, one patient safety group highlighted that, when supplying medicines containing sodium valproate in the original pack, there is no risk that the information is not included.

It was noted that, as the PPP has been highly publicised in the past few years, patients would have already been through multiple steps of counselling and risk assessment before medicines containing sodium valproate are prescribed, and therefore should be aware of all risks.

Another respondent felt that those patients who did not have English as their first language may still not be provided with information in a format they could readily access and that a link to a digital copy of the PIL (which is able to be converted into a different language) would be the best solution. This stance was also supported by several other respondents.

Several respondents felt there should be more detailed discussions between the patients and the healthcare professionals responsible for prescribing and supplying their medicines to ensure that patients fully understand the warnings in the safety information. This was highlighted as being especially important when English might not be the patient’s first language.

A respondent flagged that the medicines containing sodium valproate provision needs to allow for the occasion where an individual risk assessment has considered that alternative packaging, such as a MDS, better suits a patient’s needs – for example, where patients in secure and detained settings are supplied a weekly supply of medicine as a result of an in-possession risk assessment. It was also suggested that this would bring the amendment further in line with national guidance for the Specialist Pharmacy Service.

This view was shared by another respondent who flagged that such exceptions need to be built to ensure measures being taken to support patient compliance – for example, dispensing into MDSs – can continue. Otherwise, while dispensing in original packs may support increased access to patient information, there is a danger that it may undermine measures being taken to support individual patients to take their medicine appropriately.

Another respondent believed that there needs to be a national mechanism whereby a prescriber can indicate, through a nationally recognised code on the prescription, that only the exact amount prescribed should be supplied where individual patient circumstances demand.

Respondents who supported this proposal believed that this should be extended further because there are many medicines associated with serious side effects. Requiring all medicines to be dispensed in manufacturers’ original packs would ensure that patients always have access to the statutory product information.

Some patients who responded believed that the statutory information should already be available to them and saw the provision of medicine in original packs as a necessary tool to enable that to happen every time they were supplied with medicines from the pharmacy.

In relation to patient safety, respondents believed those receiving supplies of medicine containing sodium valproate should be given the same information in a consistent manner, and that this proposal should apply to all professionals dispensing medicines containing sodium valproate.

One healthcare professional respondent believed the proposal should be extended so that dispensing doctors are required to prescribe in whole packs to facilitate the supply of this statutory information.

Government response

Patient safety is behind the government’s decision to implement these proposals.

The government thinks this approach is particularly relevant for medicines containing sodium valproate because of the specific risks for unborn children. Patients need to have access to the warning pictogram and so the government strongly believes that the positive impact of these measures on patient safety will outweigh any negative impact.

However, following important feedback – including specific examples – from several organisations, we will be revising our proposal to add a provision to allow pharmacists the flexibility to make an exception to whole-pack dispensing of medicines containing sodium valproate.

The revised proposal for the whole-pack dispensing of medicines containing sodium valproate is as follows:

Dispensing of medicines containing sodium valproate must always be in whole packs in the original packaging regardless of the conditions we set around other products for OPD. The requirement will be that the nearest number of whole packs will be supplied (either up or down) so that the patient receives only complete packs. These must not subsequently be re-packaged into plain dispensing packaging.

However, pharmacists will be able to make an exception to whole-pack dispensing of medicines containing sodium valproate on an individual patient basis, where a risk assessment is in place that refers to the need for different packaging, such as a MDS, and where processes are in place to ensure the supply of PILs.

The amendment on medicines containing sodium valproate will come into effect as soon as it comes into force in the HMRs.

Impact assessment

Can you provide any evidence or comments that would help us to develop the cost benefit analysis on these proposed changes?

Summary of responses received

Several respondents commented on the cost and time efficiencies that could be gained with the introduction of OPD.

Furthermore, responses highlighted additional benefits, such as the minimising of dispensing errors, and that efficiencies will support pharmacies that use automation.

An independent pharmacy indicated that most medicines that would be eligible to be dispensed using OPD are inexpensive – however, it would be logical to assume that compliance and correct taking of medicines would be improved.

One large organisation felt that OPD would cause an adverse financial effect for contractors with up to 5 pharmacies who have no legal or financially viable access to automated dispensing.

It was mentioned that OPD could cause issues around reimbursement – for example, one response detailed a possible issue around the container allowance. The respondent highlighted that, when a prescribed medicine is dispensed in the manufacturer’s original pack, no container allowance is paid. The respondent argued that, as OPD usage increases, payments of this allowance decrease for community pharmacies. Therefore, increased use of OPD leads to a decrease in income for individual community pharmacies.

Overall, individuals, independent pharmacies and organisations agreed that there would be savings in terms of time and some costs. A small number of organisations agreed that OPD will result in time savings per item of between 60 and 90 seconds. One organisation estimated that this could lead to a time saving of 12 minutes per day.

However, given the number of items where it can be applied (as approximately 75% of prescription items are already prescribed in quantities that align with available pack sizes), the overall savings in a pharmacy per day are likely to be limited and variable.

One organisation provided data from 2021 and suggested that a limit of 10% flexibility would reduce split packs generated by 17%. The same organisation said split packs take 3 times longer to dispense in their automated operation, impacting both the cost of dispensing, and the speed, efficiency and overall volume of their facilities. This organisation therefore estimated that the cost reduction for a specific item dispensed as a full pack – where it would have previously been a split pack – to be 12p.

Some respondents felt that there would be a streamlining of activity but that does not necessarily mean a reduction in staff costs, and it is unlikely that the time saved will be significant for the pharmacy staff.

OPD could lead to:

• more discussion with patients
• less time dispensing
• increases in demand for the pharmacist’s time as they would need to oversee the changes

However, these are all things which would be mitigated over time, as both pharmacists and patients become more familiar with the process.

Furthermore, it is noted that some organisations felt that the 10% flexibility would only yield a small amount of time savings per day.

Government response

The government appreciates the responses and has noted the comments on potential issues with regards to reimbursement and for contractors with a small number of pharmacies.

However, at this point no conclusion can be drawn on the effect on contractors’ payments, including the container allowance as it will be for each devolved administration to determine how they implement OPD in their NHS pharmaceutical services and, therefore, the reimbursement arrangements. For example, in England this will involve negotiation with the Pharmaceutical Services Negotiating Committee.

The government agrees with the respondents who commented on the overall efficiencies that can be gained from introducing OPD. The government has also consulted on proposals to extend the use of ‘hub and spoke’ dispensing to all community pharmacies. If the proposals are taken forward, there will be synergistic efficiencies gained by using ‘hub and spoke’ dispensing and OPD.

The more prescriptions that can be assembled using an automated process that is likely to be used by hubs, the more prescriptions a hub can assemble and the more efficiencies there should be – freeing pharmacists and their teams from the assembly aspects of dispensing in spoke pharmacies so they can provide more clinical services to patients.

The government has considered the time it will take pharmacy staff to familiarise patients with the changes. Furthermore, we have estimated how much time this should take in our impact assessment, and we are confident this will reduce after the first year of rollout, resulting in long-term time savings.

To what extent do you agree or disagree that OPD will result in time savings on dispensing? If you agree, are you able to provide any evidence on the time savings, including anything around how long it takes to split a pack?

Summary of responses received

Most respondents – 78% – agreed or strongly agreed that original pack dispensing will result in time savings on dispensing. A small amount – 6% – of respondents disagreed or strongly disagreed.

Response	Percentage of respondents
Strongly agree	40%
Agree	38%
Neither agree nor disagree	16%
Disagree	5%
Strongly disagree	1%

Several respondents noted that there would be a potential saving of 1 to 2 minutes per item, and some respondents suggested the time saved could amount to approximately 6 hours per week. This additional time generated would therefore be a useful saving in time and resource for pharmacists.

While many respondents recognised there would be time savings, an equal amount pointed out that time would then need to be spent explaining the process to patients and dealing with complaints. This, of course, would lessen over time as patients become more familiar with the process.

There was, however, a consensus that OPD would be beneficial in enhancing patient safety measures.

Government response

As mentioned above in the previous government response, while there will be initial time costs for pharmacy staff to familiarise patients with the changes, the introduction of OPD will result in long-term time saving for pharmacies as patients become more familiar with the process.

Additionally, as mentioned previously, the proposed introduction of ‘hub and spoke’ dispensing in conjunction with OPD will lead to synergistic efficiencies being gained.

If you do not think there will be time savings, why not?

Summary of responses received

While there were a limited number of responses to this question, one respondent commented that the proposals will require input and judgement from pharmacists.

This organisation also mentioned that pharmacists may incur additional costs and that there was a possibility that medicine could be wasted. For example, pharmacies may incur additional costs in situations where they expand their stockholding to include a variety of different pack sizes.

With regards to medicine wastage, this may occur when medicines are required to be split (such as in 14-day dispensing) but only rarely. The remainder may stay in stock and may go out of date before another 14-day treatment period is prescribed.

Government response

The government appreciates that OPD could lead to additional input and judgement from pharmacists in deciding whether or not to dispense in an original pack – however, as noted in the previous government responses to the last 2 questions, it considers that there will be long-term efficiencies gained for pharmacists as a result of introducing OPD.

While approximately 75% of prescription items are already prescribed in quantities that align with available pack sizes, as explained in the government response to the first question, the pharmacist’s judgement will be required in some cases.

Do you believe that OPD will have positive patient safety impacts? Are you able to provide specific evidence about the size of these impacts?

Summary of responses received

Most respondents – 94% – agreed that OPD will have positive safety impacts.

Only a small minority of 6% thought that OPD would not have a positive impact on patient safety.

Response	Percentage of respondents
Yes	94%
No	6%

Where responses mentioned increased safety when dispensing, respondents commented that safety information was not always given with split packs and therefore OPD would ensure the PIL was always provided.

Respondents also noted that OPD means that pharmacy teams would not have to print additional PILs to supplement split packs. Moreover, many respondents suggested that OPD would lead to fewer dispensing errors, and that it would also be easier to identify expiry dates. Respondents also commented that OPD would lead to patients being able to recognise medicines.

Some of those supportive of the notion also pointed out that, with the increased use of OPD, there will be increased traceability of medicines post-dispensing. By ensuring batch numbers are not mixed, this will enable easier tracing of relevant packs following pack recalls.

One large organisation highlighted the important patient safety benefits of supplying medicines in the original pack – for example, of preventing some patients being dispensed a pack that contains tablets from different manufacturers, and with batch numbers and expiry dates missing, and to reduce the risk of wrong medicine being given out from multiple split packs.

Some respondents called for the use of electronic PILs to be made available and publicly accessible online to complement OPD by empowering patients with the most accurate and up-to-date information.

Government response

Although dispensing errors are a rare occurrence and most medicines are dispensed with the PIL, the proposals will help lead to reduced errors and ensure that the PIL is provided on more occasions.

As discussed within the government response to the previous question ‘To what extent do you agree or disagree that OPD and the supply of complete packs of sodium valproate should apply to dispensing doctors?’, patient safety is paramount, and the government believes that the benefits of OPD on patient safety will outweigh any risks.

The government recognises the respondents’ support for the introduction of OPD and their acknowledgement of the patient safety benefits. As mentioned in the ‘Current dispensing arrangements’ section above, there are an array of patient safety benefits that hail from OPD such as:

• OPD ensures that more patients always receive the PIL with their medicine
• OPD also removes the concern for patients that someone has interfered with their medicine, as the tamper evident seal will be intact
• if a patient receives their medicine in plain dispensing packaging, they may get lots of small ‘snips’ from a blister strip, making it difficult to manage their supply. Whereas, with OPD, the pack and the blisters inside remain intact. This should therefore support compliance as more patients will be able to identify whether they have taken their tablet that day
• as pointed out by respondents, increased use of OPD will lead to increased traceability of medicines, which will enable easier tracing of relevant packs following a recall or patient safety incident

Do you believe there will be impacts to areas in addition to those on patients and pharmacies? Is there any further evidence we should take into account?

Summary of responses received

Respondents were split on whether there will be impacts to areas in addition to those on patients and pharmacies, with 47% believing there will be and 53% believing there won’t be.

Response	Percentage of respondents
Yes	47%
No	53%

While respondents agreed that there will be positive impacts to patients and pharmacies – with some highlighting the benefits of increased time for patient-facing care – some respondents did not envision the impact going beyond this.

A small number of responses centred on the impact to manufacturers. One respondent commented that manufacturers could stop providing bulk medicine packs if OPD is taken forward and another respondent felt manufacturer forecasting could change. Additionally, one large organisation felt that there would be an additional impact on preventing parallel importation of medicines to the UK, as these are usually supplied by distributors outside of the brand originator pack size.

Another large organisation felt that time to implement the changes will be essential. For example, from a patient medication record point of view, code changes will be required to prevent workflow disruption and ensure correct endorsement information where OPD is implemented. This respondent also noted how, with different regions implementing OPD at different times, this could increase the complexity of changes and, if OPD applies to private prescriptions, this will require additional work.

Government response

The government recognises the different impacts outlined by the respondents and appreciates that the introduction of OPD will mainly impact patients and pharmacies.

The government anticipates that OPD will release staff time in pharmacies as noted in the government response to the previous question, ‘Can you provide any evidence or comments that would help us to develop the cost benefit analysis on these proposed changes?’

The government acknowledges that time to implement the changes will be essential, and familiarisation costs for the first year have been factored into the impact assessment.

Pertaining private prescriptions, the changes will be enabling so it will be down to individual pharmacies whether they decide to use the flexibility for private prescriptions.

Do you think that the OPD flexibility will create a cost burden for manufacturers if the demand for certain pack sizes changes?

Summary of responses received

Several respondents thought that there would not be a cost burden for manufacturers, and a few respondents commented on how manufacturers already produce appropriate pack sizes. There was recognition within a couple of the responses that manufacturers might change pack sizes, especially as there may be greater demand for calendar packs.

One respondent was concerned there may be an increase in smaller pack sizes, which could then lead to increased costs involved in packaging these smaller quantities. On the other hand, some respondents pointed out that this is unlikely to be an immediate shock to the supply chain and, if it affects the market, it will do so gradually.

One organisation noted how it may be that there is a long-term shift in the pack sizes available for some medicines, but this would be driven by market demand and allow manufacturers to respond to the changing market.

One large organisation stated that they are keen for the NHS to adopt a national prescribing policy, and that it is important to make sure that manufacturers have time to adjust their manufacturing process to make their product attractive to the UK market. This thought was shared by another large commercial organisation who noted that, if communication with manufacturers takes place as early in the process as possible, manufacturers can ensure forecasting and demand-planning can be adapted.

One respondent commented on how there could be an impact on MHRA licences, manufacturing equipment, shipping costs and storage space if smaller packs are required.

Government response

The government recognises that demand for specific pack sizes might change but anticipates that manufacturers will be able to respond and adapt over time to the changing market. The government considers that manufacturers will only proceed if it is commercially advantageous to them.

With regards to a national prescribing policy, the government believes that this will:

• restrict clinical freedom
• add an extra burden to those prescribing to know what pack sizes medications come in
• lead to difficulties as the prescriber will not know what the pharmacy has in stock

With regards to any potential increased costs, such as increased shipping costs or storage space, there are various measures in place to control drug prices. For example, branded medicines in the UK are controlled by the voluntary scheme for branded medicines pricing and access and the Branded Health Service Medicines (Costs) Regulations 2018 (the statutory scheme). While there are not equivalent schemes for generic medicines, competition between manufacturers is normally effective at keeping prices down.

Do you think there are any other impacts for the supply chain that we have not considered?

Summary of responses received

While some respondents did not believe there would be any potential impacts for the supply chain, a key theme throughout the responses was that pharmacy contractors should be reimbursed accordingly.

Additionally, respondents stated that it is important to engage in communication as early as possible with manufacturers to ensure forecasting and demand-planning can be adapted. This was further supported by a respondent stressing the importance of a phased approach. In addition to this, a phasing-in approach was suggested to avoid wastage of existing split packs and prevent redundant stock.

Another respondent pointed out that the provision of MDSs requires medication to be removed from original packs and placed into those devices. This normally relies on large ‘bulk packs’, particularly whenever automation of the production of MDSs is involved as the batch number and expiry dates can be easily mapped to the supply to patients. The introduction of OPD may result in manufacturers no longer providing these larger packs and thus increasing the workload associated with these devices. However, this respondent recognised that, on the other hand, OPD may reduce the need to provide such devices in the support of patient compliance.

Furthermore, there were several concerns over storage space as there would be a need to store an increased number of smaller packs of medication, which may put pressure on space for wholesalers and pharmacies.

Government response

The government acknowledges the concerns with regards to reimbursement, although this is yet to be determined through negotiations led by respective administrations and the pharmacy contractor representative bodies.

The government also understands that there may be concerns over storage space. However, as approximately 75% of prescription items are already prescribed in quantities that align with available pack sizes, the increase in medicine packages that need to be stored will not be hugely substantial for each pharmacy.

Furthermore, the amendments are enabling and not mandatory, so pharmacies will be able to choose whether they operate OPD. This also means individual pharmacy businesses will be able to decide when they start to implement OPD measures to ensure they minimise stock wastage.

Do you believe the reduction in the use of white dispensing boxes [plain dispensing packaging] will result in a minimal cost saving? And a positive impact on carbon footprint? Are you able to provide any evidence?

Summary of responses received

The large majority of respondents – 79% – felt that the reduction in the use of plain dispensing packaging will result in a minimal cost saving and a positive impact on carbon footprint.

However, 21% of respondents thought that it would not.

Response	Percentage of respondents
Yes	79%
No	21%

Overall, there was very clear support for the principle that the reduction in the use of plain dispensing packaging would result in a cost saving and a positive impact on carbon footprint. The proposal was welcomed as split packs require both extra cardboard boxes and printing of the PIL, thus OPD would minimise the use of these.

One large organisation noted that 1 million additional cardboard boxes are used each year due to split packs, alongside associated shipping materials. However, many respondents felt that the cost saving and environmental impact would be ‘minimal’.

Some of the organisations pointed out that the NHS will need to go one step further. For example, it was suggested that there needs to be improved management and recycling of medicines packaging and pharmaceutical waste. It was also suggested that advances in technology should be further employed – for example, the use of QR codes on medicines instead of paper PILs.

Government response

The government supports the consensus from respondents that the proposal will have a positive impact on carbon footprint, although recognises that this might be minimal.

To what extent do you agree or disagree with our assessment that the OPD flexibility regarding patients access to medicines and hence needing to see their GP will either balance out or be marginal?

Please provide a reason for your answer and any evidence to support it.

Summary of responses received

The majority of respondents – 63% – agreed or strongly agreed with our assessment that the OPD flexibility regarding patients’ access to medicines and hence needing to see a GP will either balance out or be marginal.

Only 5% strongly disagreed or disagreed, while 32% neither agreed nor disagreed.

Response	Percentage of respondents
Strongly agree	13%
Agree	50%
Neither agree nor disagree	32%
Disagree	4%
Strongly disagree	1%

There was very strong support for this assessment, with many respondents agreeing that the number of GP visits will either balance out or be marginal.

Some organisations stated that the measure could lead to additional time for GPs to discuss relevant issues with patients, and another respondent noted that good communication with patients will be important to explain the process.

Government response

The government recognises that, over time, the number of GP visits will balance out or be marginal.

However, as mentioned within the government response to the first question above, if the supply has been consistently rounded down over time (a patient given 10% less), it may be that the patient would present earlier for a repeat prescription. This could happen, for example, if a pack of 30 of a medicine is prescribed, but only 28 supplied. Over a year, this would mean that the patient would present a month earlier.

However, we expect this to level out as there will be patients who have consistently received 10% more medication, and therefore will not need to present until a bit later for a repeat prescription.

We anticipate that patients’ increased awareness of OPD, and good communication between GPs, pharmacists and patients, will ensure no break in patients being able to access their medicines.

Without knowing the detail of each administrations’ approach to reimbursement of the OPD flexibility, do you agree or disagree with our assessment that the impact on NHS medicine costs will either be cost-neutral or marginal?

Please provide a reason for your answer and any evidence to support it.

The majority of respondents – 67% – agreed or strongly agreed with our assessment that the impact on NHS medicine costs will either be cost-neutral or marginal.

25% neither agreed nor disagreed, while only 8% disagreed or strongly disagreed.

Response	Percentage of respondents
Strongly agree	23%
Agree	44%
Neither agree nor disagree	25%
Disagree	7%
Strongly disagree	1%

Most respondents agreed with the assessment that the cost will be neutral, and that there will be little or no impact on NHS costs.

There was also consensus among respondents to ensure that the reimbursement of medicines does not disadvantage community pharmacies. Some organisations commented on how it is important that pharmacy contractors should be reimbursed correctly for the medicine supplied, not prescribed, and that this should be done so in a way that is cost neutral.

Respondents were also supportive of the transitional period for the measure included in the HMR changes that means arrangements for OPD will not automatically apply as part of NHS pharmaceutical services until each administration has determined this, following discussions with their respective pharmaceutical representative body.

One large organisation predicted a marginal increase in cost to the NHS, but in a manner that will not lead to medicine being wasted. Their analysis shows that a transition to OPD will result in more switches to higher quantities than lower quantities. This respondent then commented on how a steady state will then be reached where the change in policy will not increase medicine costs to the NHS overall.

Another organisation noted that community pharmacies and GP practices are likely to have a higher level of initial patient queries around OPD and a continued residual level of query, resulting in additional patient consultation time. This is, however, expected to level out.

However, there was concern from some respondents that OPD would entail a risk to manufacturer costs that would therefore lead to NHS cost increases. Some respondents stated that manufacturers might move to different pack sizes (30 days for example) to sell more product, which could then result in an additional cost to the NHS.

Government response

The government anticipates that the impact to NHS costs will either be cost-neutral or marginal. The government can foresee that the OPD proposal would be extremely beneficial in the long run. However, without knowing detailed reimbursement arrangements, it is difficult to predict and, as stated in the government response to the previous question ‘Can you provide any evidence or comments that would help us to develop the cost benefit analysis on these proposed changes?’, it will be for each administration to determine – with their respective pharmaceutical representative body – how they implement OPD in their NHS pharmaceutical services.

The government notes that, if the flexibility of supplying up to 10% more often applies, there could be increased medicine costs to the NHS. However, as 77% of prescriptions are repeats, in these cases patients are expected to request their next repeat a few days later so, in most cases, over time the same amount of medication will be supplied to patients.

The government understands the concern that costs could rise for manufacturers if they were to move to different packs sizes – costs that could be passed on to the NHS – however, this is somewhat mitigated by various government price control schemes. The government also understands that pharmacies and GP practices may have to spend additional time with patients but has considered that this will level out over time.

Are there any potential costs or financial implications of the proposals that you do not think we have considered?

Summary of responses received

There were limited responses to this question, most of which were from organisations.

While a few respondents thought there wouldn’t be any potential costs or financial implications, one respondent commented on the possibility of implications on prescription payment processing costs due to changes.

Another respondent noted that the changes could be complex with different regions implementing OPD at different times, and that time to implement the changes will need to be factored in. This respondent also noted that there may be changes required to pharmacy patient medication record systems to prevent workflow disruption and ensure correct endorsement information where OPD is implemented.

One respondent requested that the changes are phased in and optional.

Government response

The government understands the concern with regards to possible implications on prescription processing costs as a result of these changes. However, this will depend on how reimbursement is implemented in each administration.

Furthermore, the changes for OPD are optional and include a transitional provision, which will allow each administration to decide how and when OPD can be implemented.

Northern Ireland respondents only

Department of Health in Northern Ireland (DoH NI) does not consider that our proposals risk impacting different people differently with reference to their protected characteristics or where they live in NI. We welcome views on this point.

Summary of responses received

Of the respondents who gave feedback to this comment, it was agreed that the proposals did not risk impacting different people differently with reference to their protected characteristics or where they live in NI.

However, an organisation commented that this position would require full equality screening.

Government response

DHSC and DoH NI will complete a full Public Sector Equality Duty (PSED) assessment to assess the concerns and mitigations for vulnerable patients.

Do you think the proposals risk impacting people differently with reference to their (or could impact adversely on any of the) protected characteristics covered by the Public Sector Equality Duty set out in section 149 of the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998? If so, please provide details.

Summary of responses received

The response to this question advocated for vulnerable people and came from a professional organisation.

This organisation outlined specific details on how the changes could potentially negatively impact people with protected characteristics, particularly those with learning disabilities. It argued, as an example, in relation to medicines containing sodium valproate, that any changes are likely to have more impact on people with a learning disability.

The organisation further stated that, while in theory the changes would improve their medication management, it is important this is assessed – for example, over-supply may be more detrimental to this group than the general population. According to this organisation, approximately 1 in 3 people (32%) who have a mild to moderate learning disability also have epilepsy. The more severe the learning disability, the more likely that the person will also have epilepsy. Around 1 in 5 people (20%) with epilepsy also have a learning disability.

Another example, due to disability, is that some patients require their medications to be administered via an MDS. The impact of the changes would need to be assessed and alterations made, where necessary, to the proposal. Age may also be a factor in this as older people will make up the majority of users of MDSs.

Government response

DHSC and DoH NI will complete a full PSED assessment to assess the concerns and mitigations for vulnerable patients.

As discussed within the government response to the previous question ‘To what extent do you agree or disagree that OPD and the supply of complete packs of sodium valproate should apply to dispensing doctors?’, we have revised the proposal so that pharmacists will be able to make an exception to whole-pack supply of medicines containing sodium valproate on an individual patient basis, where a risk assessment is in place that refers to the need for different packaging (such as an MDS) and where processes are in place to ensure the supply of PILs.

Moreover, we have found that the exception to whole-pack dispensing of medicines containing sodium valproate can have further benefits in the potential increased patient safety of individuals who have 2 or more protected characteristics – for example, if they are of child-bearing potential or pregnant yet need help to take their medicine appropriately, such as via an MDS.

Therefore, the government agrees to some flexibility for the pharmacist dispensing to determine which mitigation, OPD or different packaging to help compliance (such as an MDS) is more important. Whichever they decide, with the proposed amendment, the pharmacist is best placed to judge which is most suitable, and in either case the patient will receive the PIL.

Equality assessment

Do you have any evidence that we should consider in the development of an equality assessment?

Summary of responses received

Several individuals and groups expressed their concerns that OPD might disproportionately impact older and vulnerable patients. Responses highlighted the importance of recognising that some patients with protected characteristics are likely to be very confused by any changes.

Moreover, some respondents – specifically referring to whole-pack dispensing of medicines containing sodium valproate – said that these changes would be well received by vulnerable and older patients as they will appreciate the availability of the visual information.

Furthermore, an organisation highlighted the MHRA guidelines on the whole-pack dispensing of medicines containing sodium valproate and that the importance of medicines management, including balanced information, is the first line of defence against risks of epilepsy-related deaths.

Government response

The government will use this information in the PSED analysis when considering the impact of OPD on vulnerable people and those who have protected characteristics, and will consider the impact of whole-pack dispensing of medicines containing sodium valproate on patients with epilepsy.

Legislative background and basis

We propose making these legislative changes using powers in Part 2 of the MMD, which provides powers to make, among other things, amendments to the HMRs.

The consultation was carried out in accordance with the requirement in section 2 of the MMD that provides that patient safety must be the overarching objective of the appropriate authority when making regulations.

Section 2 requires that, when assessing whether regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to 3 factors:

1. The safety of human medicines and that the benefits of doing so outweigh any risks.

2. The availability of medicines.

3. The likelihood of the relevant part of the UK being seen as a favourable place in which to:

• carry out research relating to human medicines
• conduct clinical trials
• manufacture or supply human medicines

As set out in section 2(4) of the MMD, where regulations under section 2(1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.

The appropriate authority is the Secretary of State for Health and Social Care in relation to Great Britain and, in relation to Northern Ireland, it is the DoH NI and the Secretary of State acting jointly.

We have assessed the OPD proposals against each of these factors, as described in the public consultation exercise, and evidence submitted in the consultation responses has not changed those assessments.

The evidence received supported our original assessment that the introduction of these measures will enhance patient safety.

Patient safety is at the heart of these proposals. We consider the proposals to directly contribute to the overarching objective of safeguarding public health and the aim is to improve patient safety – respondents to the consultation agree.

In enabling pharmacists to supply in original packs, there will be greater opportunity to provide additional clinical interventions within the pharmacy because time will be freed up from the dispensing process.

OPD will mean that more patients will receive their medication with the tamper seal intact, which reduces concerns that someone has interfered with the medicine or that the pharmacist has accidentally underfilled their prescription.

Additionally, OPD will lead to a reduction in the use of plain dispensing packaging, where patients may get lots of small ‘snips’ from a blister strip, making it difficult to manage their supply, and so supports compliance as it makes it easier for patients to identify whether they have taken their tablet that day.

Evidence has been shared with the government that suggests OPD will reduce dispensing mistakes that are typically made by human error via the need for pharmacy staff to split boxes, snip blisters and repackage medicines.

Moreover, the proposals also included a provision for pharmacists to use their judgement as to whether it is appropriate to deviate from the quantity prescribed (up to 10% more or less) to supply an original pack. Where it is critical that the patient receives the exact quantity prescribed, the pharmacist should ensure the patient receives the exact quantity and therefore uphold the importance of patient safety.

The proposals also aim to ensure that every patient who is prescribed medicines containing sodium valproate is provided with the important safety messages contained both on the label of the manufacturer’s original packs and in the accompanying PIL. This is significant in efforts to help minimise the risk of unborn babies being exposed to the effects of medicines containing sodium valproate, if taken by an individual who is pregnant or of child-bearing potential.

The inclusion of the exemption pertaining to the whole-pack supply of medicines containing sodium valproate is also centred around patient safety to ensure that pharmacists can make a judgment for individual patients as to whether dispensing in original packs is more important than measures being taken to support patient compliance – for example, by packing medicines in MDSs. Whichever they decide, with the proposed amendment set out above, there must be arrangements in place for the patient to receive the PIL.

The government considers that impact on availability should be neutral. Firstly, the provision is enabling – where pharmacists cannot access a pack that enables them to use the flexibility to supply an original pack – meaning they can continue to supply the patient with the exact quantity prescribed as per the current arrangement. Secondly, the proposals have no direct requirements on manufacturers so there is no need for them to change what and how they supply medicines to the UK.

Lastly, we recognise that enabling pharmacists to dispense original packs and the whole-pack supply of medicines containing sodium valproate may influence manufacturers’ decision-making around packaging. However, we have not been provided with evidence to suggest that these changes will cause any part of the UK to be seen as a less favourable place to carry out research, conduct clinical trials, or manufacture or supply medicines.

Next steps

In light of the overall positive response, the government intends to progress the proposals for OPD and the whole-pack supply of medicines containing sodium valproate – including, in light of responses, the exception in certain circumstances – by using the enabling powers in Part 2 of the MMD to make amendments to the HMRs. These amendments will introduce the following provisions, which will apply across England, NI, Scotland and Wales.

1. For pharmacists (including pharmacy staff under the supervision of a pharmacist) to have flexibility to dispense up to 10% more or less than the prescribed quantity if that means they can dispense in the manufacturer’s original packs, except where this would negatively affect the patient’s clinical treatment regimen – so they have to make a judgement that this is appropriate. This would not apply to controlled drugs.

2. Dispensing of medicines containing sodium valproate must be in whole packs to the nearest quantity prescribed (rounding either up or down). However, pharmacists will be able to make an exception to whole-pack dispensing of medicines containing sodium valproate on an individual patient basis, where a risk assessment is in place that refers to the need for different packaging (such as a MDS) and where processes are in place to ensure the supply of PILs.

3. To include a transitional provision, so the flexibility to dispense up to 10% more or less does not automatically apply in NHS pharmaceutical services in England, NI and Wales, to enable these administrations to decide how they want these to apply in their respective NHS services. OPD will automatically apply in Scotland because the transition provision on the 10% flexibility will not apply in Scotland. Furthermore, there is no transition for the amendments on whole-pack dispensing of medicines containing sodium valproate, which will apply as soon as the HMRs come into force.

The regulation amendments could be progressed as a joint UK-wide statutory instrument. Alternatively, it may be that DHSC leads with the regulation amendments for Great Britain first, allowing for NI to follow in due course.

Separately and not part of these HMR amendments:

• administrations in England, Wales and NI will need to consider when and how they want the flexibility to dispense up to 10% more or less than the prescribed quantity, if that means pharmacists can dispense in the manufacturer’s original packs, to be enabled and reimbursed as part of community pharmacies’ NHS pharmaceutical service provision
• all administrations will need to consider when and how they want the flexibility to supply up to 10% more or less than the prescribed quantity, if that means dispensing doctors can dispense in the manufacturer’s original packs, to be enabled and reimbursed as part of dispensing doctors’ NHS pharmaceutical service provision
• all administrations will need to consider how they will reimburse both community pharmacies and dispensing doctors for the supply of medicines containing sodium valproate always being supplied in whole packs (original packaging), dispensing being to the nearest number of whole packs (either up or down) as part of NHS pharmaceutical service provision