Consultation outcome

Original pack dispensing and supply of medicines containing sodium valproate

Updated 19 March 2023

Background

Regulation 214(1) contained in part 12 of the Human Medicines Regulation 2012 requires 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 Health and Social Care Act 2008 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 providing the amount prescribed in a dispensing box or bottle. 

This has many consequences, for example:

1. If a patient receives the manufacturer’s original pack but with some dosage units missing, 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 their prescription.

2. If a patient receives their medicine in a dispensing box, they may get lots of small ‘snips’ from a blister strip making it difficult to manage their supply, ensure compliance and identify whether they have taken their tablet that day.

3. If a patient receives their medicine in a dispensing box or bottle, they may not get all the patient information such as the manufacturer’s patient information leaflet (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 any prescription where this is required, it must be done outside of the automated process.

Proposals

Our intention is to introduce amendments to Part 12 of the Human Medicine Regulations 2012, so that when dispensing medicines, pharmacists may utilise manufacturer’s original packs. Our proposal is that:

• 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

• however, the amendments will include a transitional provision, so the flexibility does not automatically apply in NHS pharmaceutical services in England, Northern Ireland and Wales, to enable these administrations to decide how they want these to apply in their respective NHS services. In Scotland, the Scottish government is not seeking such a transitional provision because of arrangements already made so pharmacists will be able to utilise the original pack dispensing (OPD) flexibility within their NHS service provision straight away

• the supply of sodium valproate must always be in original packaging regardless of the conditions we set around OPD

• we propose to use the enabling powers in Part 2 of the MMDA. Currently, we are only proposing a flexibility around quantity, not around formulation or strength

Impacts

As part of this consultation we are asking responders to let us know of any measurable impacts or impacts we have not considered. An impact assessment will then be completed following this consultation considering information we gather through responses.

Efficiency of OPD

By allowing community pharmacies to dispense medicines in their original packs, we believe OPD will help them to become more efficient and to free up their time for other tasks such as providing clinical services to patients.

A further way in which we committed to supporting efficiencies in the sector is through pursuing legislative change to enable all pharmacies to use “hub and spoke” dispensing models. Hub and spoke dispensing is where parts of the dispensing process are undertaken on a separate pharmacy premises, a “hub”. The assembly of prescriptions takes place on a large scale in a hub and therefore is much more likely to be able to make the use of automated processes viable. OPD will mean more prescriptions can be assembled using an automated process and so there will be synergistic efficiencies gained by use of hub and spoke dispensing and automation.

Further to an initial consultation in 2016 on hub and spoke dispensing, in January 2021 we began pre-consultation engagement with stakeholders to enable hub and spoke dispensing across legal entities, with the view to launching a full public consultation in due course. Previously, stakeholders have pointed to OPD as a main factor in determining whether hub and spoke dispensing will create efficiencies. If OPD is not enabled, the potential efficiencies of hub and spoke dispensing will be curtailed, as automated processes rely on being able to dispense full packs.

Patient safety considerations for OPD

Safeguarding public health was one of the critical considerations of the Medicines and Medical Devices Act 2021 (the MMDA) and was central to the development of these proposals. We think that as well as increasing efficiency, OPD would lead to clear patient safety benefits. By dispensing medicines in their original packs, it will be easier for pharmacies to ensure that patients will receive the PIL, which provides detailed information on the safe and effective use of the product. 

Enabling OPD would also make it more likely that patients will get complete packs where the days of the week are marked. In turn making it easier for patients to see whether they have taken their medicine that day and how many they have left.

We are proposing a 10% flexibility to deviate from the prescribed amount. A deviation of 10% provides sufficient flexibility to cover the majority of the mismatches in pack sizing due to the quantity prescribed, for example a 28 pack (or multiple) when 30 is prescribed, or a 30 pack when 28 is prescribed.

We have considered the risk of giving too much medicine and alongside that the risk of not giving patients enough. In giving a patient too much medicine there is a potential increased risk of either accidental or intentional overdose, or patients taking medicines longer than they medically need to (for example unnecessary extended use of antibiotics or steroids). The other aspect is the risk of not giving patients enough medication, which could mean they receive a suboptimal dose. We have considered this against the evidence that repeat prescriptions make up around 77% of all prescription items (NHS England and Improvement, June 2020 – letter template (PDF, 151KB)). Given this high percentage, an increase or decrease would most likely mean that the patient would access their next repeat prescription either a few days earlier or later than they would have done.

However, judgement by the responsible pharmacist will remain an important part of the dispensing process; for instance there are some prescriptions such as a course of steroids or antibiotics where a decision may need to be made not to give people less, so they have enough to finish their treatment. Alternatively, a decision may need to be made not to give people more, so they do not take medication for longer than the course of treatment such as steroids or strong pain relievers. Furthermore, we are not at this point proposing any flexibility on the quantity of controlled drugs supplied compared to dispensed.

Business impact of OPD

It is our expectation that in enabling original pack dispensing additional costs would not fall on businesses. We anticipate that these changes could release staff time in pharmacies as they utilise OPD to maximise efficiency.

However, by allowing community pharmacies to dispense medicines in their original packs this could lead to changes that could impact manufacturers. For example, it may lead to changes in pack size purchasing patterns that would then have a knock-on effect in terms of demand for particular pack sizes from manufacturers.

We anticipate that OPD will also mean a reduction in the use of boxes currently required. While a minimal cost reduction as there is a small price per unit, this could be positive in reducing the carbon footprint of the medicines supply process.

NHS impact of OPD

The proposed amendments would be enabling and not mandatory. The policy intention is for the proposals to cover NHS and private prescriptions. However, we propose to place a transitional provision in the Human Medicines Regulations 2012 so that the flexibility does not automatically apply in pharmaceutical services in England, Northern Ireland and Wales. This will enable these administrations to consider how they want to implement this enabling flexibility within their respective NHS services. The Scottish Government is not seeking such a transitional provision because of arrangements it has already made, so pharmacists will be able to utilise the OPD flexibility within their NHS service provision straight away.

It is not clear whether these changes will result in a significant increase or decrease in total medicines dispensed, nor a significant increase or decrease in the quantity of medicines that patients can access compared to what has been prescribed for them.

From our internal analysis, we estimate that approximately 75% of prescription items are already prescribed in quantities that align with available pack sizes (DHSC, April 2021). Therefore, as the flexibility is capped at 10%, the majority will not need a change to the quantity supplied. Of the remaining 25%, not all will be suitable for the flexibility to be applied. As a result, the number of prescription items that are affected is likely to be small, and it may be the case that any impact will either balance out or be marginal.

For example, a patient who receives a 10% decrease in supply compared to a prescribed quantity may access their next repeat prescription a few days earlier and may in turn need to see their GP earlier. However, a patient who receives a 10% increase in supply compared to a prescribed quantity may access their next repeat prescription a few days later and may in turn need to see their GP later. Under this scenario the knock-on impact on GP appointments, will therefore balance out. If, however, more patients get less medicine than those patients who get more, the increase in access to repeat prescriptions earlier, and in turn need to see their GP earlier, will be more than those who need to see their GP later and therefore may marginally increase the number of GP appointments needed. If, however, more patients get more medicine than those patients who get less, the increase in access to repeat prescriptions later, and in turn need to see their GP later, will be more than those who need to see their GP earlier and therefore may marginally decrease the number of GP appointments needed.

We welcome any views from stakeholders on the likely balance of patients receiving more or less medicine so that this can be factored into our impact assessment.

Alongside how the flexibility is implemented as part of NHS services, each administration will need to consider the consequences for NHS reimbursement. It is therefore difficult at this point to consider the impact on NHS medicine spend; however, again similar to patients’ earlier or later access to GPs, it may be cost neutral or, any any change in costs will be marginal.

Alternative options to OPD

In proposing OPD as our preferred approach we have considered alternative options that would provide commonality in packs, for instance, if all manufacturers supply in the same pack size. However, we do not have the power to enable this and, critically, it would also have adverse impact around multi-market packs and could lead to unnecessary shortages where a manufacturer could not supply in a pack of that size. Another alternative option could involve asking all prescribers to prescribe consistent quantities, for example, if all prescribers prescribed 28 days’ supply for a monthly supply. However, this could reduce clinical freedom, and add an extra burden on GPs in terms of aligning pack sizes. GPs also would not know what pack sizes pharmacies had available.

The proposal being put forward through this consultation allows for flexibility, with their judgement, by the pharmacist.

Particular safety concerns with medicine containing sodium valproate

Sodium valproate is an effective treatment for epilepsy and bipolar disorder. It is a commonly used anti-epileptic and it may be the only effective treatment for some patients. However, the use of sodium valproate was, however, 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 sodium valproate is taken used 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.

In order to try to minimise the risk of unborn babies being exposed to the effects of this medication, any woman who could become pregnant must be enrolled in a Pregnancy Prevention Programme (PPP) if they are prescribed a product containing sodium valproate, which involves an annual specialist review, coupled with an acknowledgement of risk form, and supported by clear sodium valproate product information and labelling.   

To support the implementation of the sodium valproate PPP, pharmacists received a written notification from the MHRA Chief Executive and the UK’s four Chief Pharmaceutical Officers which, among other things, stressed the need to provide a PIL with every valproate prescription even when sodium valproate is dispensed in dispensing boxes or bottles and not in its original packaging.

However, despite these initiatives, sodium valproate patient groups have continued to raise concerns that PILs are not always being provided by pharmacists where sodium valproate medicines are dispensed in dispensing boxes or bottles rather than the manufacturer’s original packs, and evidence continues to emerge suggesting many women remain unaware of the significant risks posed to their unborn baby should they fall pregnant while taking sodium valproate.

Therefore, the proposal is that where a prescription is not for a quantity in an original pack size, 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 dispensing boxes.

The impacts on patient safety, efficiency, business and the NHS, will be similar to those outlined above for OPD. Other than the difference between the quantity prescribed and the quantity dispensed could be more than 10% and the pharmacist does not have the ability to make a professional judgment as to whether to supply the quantity prescribed or an original pack. However, we have assessed that the ability to always dispense sodium valproate (which can pose risks to unborn children) in its original pack to ensure that all of the necessary safety information will be provided to the patient is of particular importance to outweigh any potential downsides to this. We welcome views from stakeholders around further impacts of whole pack dispensing of sodium valproate.

We have considered alternative policy options to ensure women are aware of the risks where sodium valproate medicines are dispensed. For example, as highlighted above for OPD, introducing other mandatory measures, such as manufacturers or prescribers to always supply or prescribe in set quantities but for the same reasons set out under OPD, we do not consider these appropriate. Furthermore, manufacturers have been required to supply sodium valproate only in small pack-sizes for some time but this has not always resulted in patients receiving original packs and the associated risk minimisation measures as pharmacy professionals continue to supply multiple packs in single dispensing boxes without the additional information resources.

Dispensing doctors

The policy intention is for both OPD and supply of complete packs of sodium valproate to apply to dispensing doctors. This does not need additional amendments to the Human Medicine Regulations 2012. However, as with community pharmacies, to enable OPD will require an amendment to their NHS pharmaceutical terms of service.

Equality assessment

In considering the amendments to the Human Medicines Regulations 2012, ministers must comply with the Public Sector Equality Duty (PSED). We will develop an equality assessment based on the following proposals:

• enabling the use of original pack dispensing

• requiring the dispensing of sodium valproate in the manufacturer’s original pack

Questions

Original pack dispensing

To what extent do you agree or disagree that we should remove current restrictions preventing original pack dispensing?

• strongly agree

• agree

• neither agree nor disagree

• disagree

• strongly disagree

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?

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?

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%?

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

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

Supply of medicines containing sodium valproate in original packs

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.

Impact assessment

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

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? If you don’t think there will be time savings, why not?

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

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?

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

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

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

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?

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?

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

NI respondents

In Northern Ireland new policies must be screened under Section 75 of the Northern Ireland Act 1998 which places a statutory duty on public authorities, to mainstream equality in all its functions – so that equality of opportunity and good relations are central to policy making and service delivery. In addition new or revised policies must be rural proofed in line with the Rural Needs Act (NI) 2016 which requires public authorities to have due regard to rural needs.

The Department of Health in NI do 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.

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.

Equality assessment

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

Demographic information

Have you been prescribed sodium valproate in the past?

• yes

• no

Do you have professional experience of sodium valproate use?

• yes

• no

Confidentiality of information

We manage the information you provide in response to this consultation in accordance with the Department of Health and Social Care’s Personal Information Charter.

Any information received, including personal information, may be published or disclosed in accordance with the access to information regimes (primarily the Freedom of Information Act 2000 (FOIA), the Data Protection Act 2018 (DPA 2018) and the Environmental Information Regulations 2004).

If you want the information that you provide to be treated as confidential, please be aware that, under the FOIA, there is a statutory code of practice with which public authorities must comply and which deals, among other things, with obligations of confidence. In view of this it would be helpful if you would explain to us why you regard the information that you have provided as confidential. If we receive a request for disclosure of the information you have provided, we will take full account of your explanation, but we cannot give an assurance that confidentiality will be maintained in all circumstances.

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The department will process your personal data in accordance with the DPA 2018 and, in most circumstances, this will mean that your personal data will not be disclosed to third parties.

Legislative background and basis

Section 45(1) of the MMDA includes a statutory requirement for the appropriate authority (here the Secretary of State for Health and Social Care and Northern Ireland Department of Health) to carry out a public consultation on proposed amendments to the Human Medicines Regulations 2012. This consultation is conducted in line with that requirement.

Section 2(1) of the MMDA requires that, in making regulations about human medicines, the appropriate authority’s overarching objective must be ‘safeguarding public health’. In considering whether the proposed changes would contribute to this objective, section 2(3) states that the appropriate authority must have regard to:

a) the safety of human medicines

b) the availability of human medicines

c) the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to:

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

Section 2(4) of the MMDA specifies that where the regulations may have an impact upon the safety of human medicines, the appropriate authority may only make the regulations if the benefits outweigh the risks. In conjunction, section 45(3) requires that the consultation carried out by the appropriate authority must include a summary assessment of how proposed changes contribute to the overarching objective of safeguarding public health, including whether there is an impact on the safety of medicines.

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. In enabling pharmacists to supply in original packs there will be greater opportunity to provide additional clinical interventions within the pharmacy as time will be freed up from the dispensing process. The proposals also aim to ensure that every patient who is prescribed sodium valproate is provided with the important safety messages contained both on the label of the manufacturer’s original packs and in the accompanying patient information leaflet.

Having regard to section 2(1)(b), the proposed amendments may influence the quantities of medicines dispensed to an individual. However, the proposal includes a provision for pharmacists to use their judgement as to whether it is appropriate to deviate from the quantity prescribed by plus or minus 10% – 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 the impact on availability should be neutral. Further, as the provision is enabling where pharmacists cannot access a pack that enables them to use the flexibility to supply an original pack, they can continue to supply the patient with the exact quantity by snipping and splitting other pack sizes as now, so again the impact on availability should be neutral. These 2 elements of the proposal contribute to it being a better option to other alternatives, such as making all manufacturers supply in the same pack size or asking all prescribers to prescribe consistent quantities which could lead to shortages of certain pack sizes and so impacts on availability of medicines. Furthermore, we have had regard to section 2(1)(c). While we recognise that enabling pharmacists to dispense original packs may influence manufacturers’ decision-making around packaging, we do not believe these changes will impact on any part of the United Kingdom being seen as a favourable place to carry out research, conduct clinical trials or manufacture or supply medicines.

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