Supply of medicines during the pandemic
Supply of medicines during the pandemic
There are growing concerns about how the COVID-19 pandemic might affect the supply of medicines.
The Department of Health and Social Care (DHSC) has well-established procedures to deal with medicine shortages and is working closely with industry, the NHS and others in the supply chain to ensure patients can access the medicines they need and to reduce the likelihood of future shortages.
Medicine suppliers have been asked to assess the impact that COVID-19 could have on the supply chain. In particular, DHSC has asked suppliers who still retain some of their EU exit stockpiles to hold onto these.
PSNC’s Dispensing and Supply Team has been monitoring the generic medicines affected by recent price hikes and is making applications to DHSC for price concessions in the usual way. Pharmacy teams should continue to report supply issues to PSNC via the usual reporting forms. (Note, we have also updated our quota reporting form so pharmacy teams can more easily report issues they are having obtaining stock due to drug quota restrictions being applied by wholesalers or manufacturers.)
We have also made clear the need for protection for pharmacies against these sudden price rises. See our Funding during the pandemic page for news of a £15m increase in reimbursement prices in June.
Since 20th March 2020, DHSC and the Medicines and Healthcare products Regulatory Agency (MHRA) have added over 130 medicines to the list of medicines which must not be parallel exported from the UK. The parallel export ban will help ensure there is an uninterrupted supply of medicines for NHS hospitals treating COVID-19 patients.
The rest of this page contains further information on dispensing and supply related topics during the pandemic. You may also find our COVID-19 Frequently Asked Questions page useful.
The following changes and guidance have been issued to support prescribers.
Period of treatment
Some LPCs have flagged local moves by general practices to extend the period of treatment. Following discussions with PSNC about this, NHSE&I and DHSC have issued guidance to practices that this should not happen. The below guidance was contained in a letter to general practices by Dr Nikki Kanani in early March 2020:
|Prescriptions: Practices should not change their repeat prescription durations or support patients trying to stockpile: these actions may put a strain on the supply chain and exacerbate any potential shortages. Practices should consider putting all suitable patients on electronic repeat dispensing as soon as possible. The whole repeatable prescription can be valid for a year but each repeat should be for no longer than the patient has now. For example, if the patient has prescriptions for a month’s supply now then the repeat dispensing should be set up as 13 x 28 days’ supply.|
The guidance has been repeated several times via different NHSE&I communications routes and the British Medical Association’s GP Committee.
If contractors see that this guidance is not being followed, please immediately raise this with your LPC for further escalation. Pharmacies have also been asked not to support any patients trying to stockpile.
PSNC is continuing to discuss with DHSC how the impact of any extension to the period of treatment could be mitigated.
EPS and eRD
Primary care is being asked to increase the use of electronic Repeat Dispensing (eRD) to better manage the situation with the NHS Business Services Authority (NHSBSA) helping GP practices to identify patients who may be appropriate for transfer to eRD. NHS Digital is also working to expand EPS to additional settings including GP hubs, paramedic prescribing and additional urgent care sites. Contractors are therefore encouraged to ensure that all staff requiring access to the national spine services, including EPS, the Patient Demographic Service (PDS) and the Summary Care Record (SCR), have active smartcards.
Temporary changes to eRD consent model
Patient consent requirements for eRD have been temporarily suspended to encourage wider use of the system during the COVID-19 pandemic. These changes are currently due to remain in place until 31st March 2021, at which point they will be reviewed.
NHS Digital’s COVID-19 EPS work
NHS Digital’s work to support the ongoing COVID-19 pandemic includes work across several EPS-related projects which may be relevant to community pharmacy teams. This includes:
- Continuation of Phase 4 roll-out – around a quarter of GP practices have systems which can send Phase 4 prescription, with the pace of roll-out being increased.
- EPS in urgent and other care settings – EPS is available within a number of urgent care prescribing systems and NHS Digital is now working with others so that EPS is an option for prescribers to use in extended access hubs, community, out of hours and urgent care settings.
- Piloting the ‘one-off nomination’ feature – TPP SystmOne is piloting a one-off EPS nomination feature for some prescribers using their system.
Guidance for prescribers using EPS remotely
Many GPs and other prescribers in general practices are now using EPS during remote consultations with patients as a result of the pandemic. NHS Digital has therefore updated its guidance for use of EPS within remote consultations.
The guidance is for EPS prescribers and pharmacy teams. The guidance notes that:
- Nominations should still continue to be used wherever possible.
- Phase 4 (non-nominated) prescriptions should only be used if other options are not suitable.
One-off nomination is an additional alternative to use instead of Phase 4, where available. It is currently only available within the TPP SystmOne GP system, but EMIS plans to add this functionality to their EPS prescribing systems in the future.
For EPS Phase 4 prescribing, if the patient cannot be given the printed Phase 4 token, other information should be provided to them instead. Ideally the Prescription ID should be provided where possible. Some GP practices can copy this and send it by email or text message to the patient using their clinical system.
If pharmacy teams receive the ID from the patient, it can be used to pull down the prescription onto the pharmacy PMR system.
As a last resort, the EPS Tracker may be used to locate an EPS prescription (e.g. via use of the NHS number).
Products used for the treatment of COVID-19
For information on testing for COVID-19 in pharmacies or selling test kits, please see our COVID-19 testing page.
Clinical trials are ongoing and being developed to assess the benefits of a number of different medicines in treating COVID-19. Suppliers of medicines being tested have been asked to monitor requests and restrict orders in line with historic ordering requirements.
Chloroquine and hydroxychloroquine: The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a press release highlighting that chloroquine and hydroxychloroquine are not licensed to treat COVID-19 related symptoms or prevent infection. Pharmacists and GPs are asked to restrict prescriptions and supply to only those with current clinical need for licensed indications or as part of a clinical trial.
Ibuprofen: The Commission of Human Medicines (CHM) Expert Working Group on COVID-19 has concluded that there is currently insufficient evidence to establish a link between use of ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and susceptibility to contracting COVID-19 or the worsening of its symptoms. Read the MHRA press release.
Yellow Card Reporting site
The MHRA has launched a dedicated Yellow Card reporting site for healthcare products that are used in Coronavirus (COVID-19) treatment to be easily reported: coronavirus-yellowcard.mhra.gov.uk.
Healthcare professionals are asked to report all suspected side effects to medicines or medical device adverse incidents related to COVID-19 treatment. This also includes medicines that patients and healthcare professionals are using off-label to treat COVID-19. Reporting for clinical trials should be in line with the trial protocols.
Reporting will enable the MHRA to rapidly identify new and emerging side effects and medical device issues which may not have been previously known about, including diagnostic tests for COVID-19. This includes any medicines taken by patients to manage long-term, or pre-existing conditions that may influence the disease or have any potential interactions. The MHRA is closely monitoring any new or emerging safety signals in relation to medicines and medical devices used in patients with COVID-19.
The following changes and guidance have been issued to support dispensers.
Requirement to sign prescriptions suspended
The Government has temporarily suspended the requirement for patients (or their representatives) to sign the back of NHS prescription forms or EPS tokens. This change came into effect from 1st November 2020 and has recently been extended until 30th June 2021.
As part of the social distancing measures to limit the spread of the coronavirus and to assist in the management of the serious risk or potentially serious risk to human health in response to the ongoing Covid-19 pandemic, Ministers in England have agreed to temporarily suspend the need for patient signatures on prescription forms.
The changes will be kept under review and further extensions may be granted if there continues to be a cross infection risk. The temporary suspension will be lifted once it is deemed safe for patients to resume signing of forms. The changes are outlined in Part XVI of the November 2020 Drug Tariff, as highlighted on the NHSBSA website.
Implementing these changes to the dispensing process
Whilst the suspension is active, pharmacy teams must:
- Mark the relevant exempt or paid category on the FP10 form or EPS token on behalf of the patient; and,
This is not required if a Real Time Exemption Check (RTEC) confirms a patient’s exemption.
For EPS, the patient charge (or exemption) declaration is made via the electronic message, with the token used solely for checking the exemption.
As per the usual dispensing process, patients should continue to be asked to pay any relevant prescription fee and, evidence of their entitlement provisions apply in the usual way.
Implementing these changes to the submission process
During this period, NHSBSA will not switch any unsigned paper prescription forms between exempt and chargeable groups. It will therefore be very important during the end of moth submission process for contractors to check that the reverse of every paper FP10 prescription form is clearly marked as exempt or paid and sorted into their correct exempt or chargeable groups before the bundle is despatched to the relevant NHS Prescription Services division.
Our Dispensing and Supply Team has published guidance on how the suspension affects the dispensing and end of month submission process.
Changes to EPS token submission
PSNC has received confirmation from the Department of Health and Social Care (DHSC) that it is no longer necessary for contractors to submit EPS tokens (other than those used for Serious Shortage Protocol (SSP) claims) to the NHS Business Services Authority (NHSBSA) whilst the suspension of signature requirements remains in place. The change to token submission affects prescriptions dispensed from December 2020 onwards.
The changes will be kept under review and the suspension date may be brought forward, or extended further if there continues to be a cross-infection risk. The temporary suspension will be lifted once it is deemed safe for patients to resume signing of forms at which point pharmacy contractors will be required to submit relevant tokens to the NHSBSA, as before.
EPS token submission guidance:
|Tokens to continue to be submitted to the NHSBSA during suspension period||Tokens (for non-payment) NOT required to be submitted to the NHSBSA during the period of suspension only||Tokens (for non-payment) NOT required to be submitted to the NHSBSA|
Whilst the suspension of signature requirements is in place, it is important that pharmacy teams check and confirm the patient’s current paid or exempt status and ensure the correct declaration is applied to the electronic message before it is submitted for payment to the NHSBSA. This is because in EPS, deduction of any prescription charge(s) by the NHSBSA is made against the declaration submitted in the electronic message and NOT the associated token.
Wholesalers and deliveries
The Healthcare Distribution Association (HDA) has updated PSNC on the work its members are doing to ensure the ongoing resilience of the supply chain. HDA wholesalers will be as flexible as possible regarding credit caps for pharmacy purchases at this time to continue to secure all necessary supplies.
Wholesalers are, however, vulnerable to staff absences as all businesses are at the moment. There was particular confusion following the Prime Minister’s address to the nation asking people to stay at home, so clarification that all those working in the medicines supply chain are key workers was helpful.
HDA has asked that community pharmacy teams support the increase in demand on the supply chain by ensuring delivery tote boxes are returned to suppliers of medicinal products as quickly as possible. Tote boxes are essential to safe medicines supply as they help suppliers to protect and track medicines. HDA is therefore asking pharmacy teams to return any totes to their supplier’s delivery driver when they are making a delivery.
Medicines re-use schemes in care homes and hospices
On 28th April 2020, DHSC and NHSE&I published guidance on running a medicines re-use scheme in a care home or hospice setting during the COVID-19 pandemic.
The guidance/standard operating procedure (SOP) is intended to support timely access to essential prescribed medicines during the COVID-19 pandemic for patients who are being cared for in a care home or hospice setting in England. It notes that under usual circumstances, the re-use or recycling of another patient’s medicine is not recommended by DHSC, as the quality of any medicine that has left the pharmacy cannot be guaranteed. Any unused medicines would normally be disposed of by returning them to a contracted external company or community pharmacy.
The document states that as there are increasing concerns about the pressure that could be placed on the medicines supply chain during the peak of the COVID-19 pandemic, a medicines re-use scheme for care homes and hospices could potentially ease some of that pressure in the coming weeks.
If a medicines re-use scheme is put in place, a care home or hospice must carry out a risk assessment for each potential re-use of a medicine. Three key indicators should inform the risk assessment and the subsequent decision on whether or not to re-use a medicine:
- No other stocks of the medicine are available in an appropriate timeframe (as informed by the supplying pharmacy) and there is an immediate patient need for the medicine;
- No suitable alternatives for an individual patient are available in a timely manner, i.e. a new prescription cannot be issued, and the medicine(s) supplied against it in the conventional manner quickly enough; and
- The benefits of using a medicine that is no longer needed by the person for whom it was originally prescribed or bought, outweigh any risks for an individual patient receiving that unused medicine.
The document sets out criteria against which a medicine must be checked by a registered healthcare professional to determine whether it is suitable for re-use. It also notes that such checking may be undertaken by pharmacists, pharmacy technicians or other registered healthcare professionals working for clinical commissioning groups, general practices or community healthcare trusts.
Community pharmacy’s role
Notwithstanding the pandemic’s potential impact on the supply of medicines, particularly those used in end of life care, the actual re-use of medicines via a scheme described in the guidance/SOP will hopefully be an extremely rare occurrence, so most community pharmacy teams are unlikely to come across such a scenario and it is those that regularly supply medicines to care homes and hospices that are most likely to need to be aware of the operation of medicines re-use schemes. Those pharmacies may want to discuss with the managers of care homes and hospices they provide services to, whether a medicines re-use scheme is being planned.
The guidance states that when medicines are out of stock and there is an immediate need for them, an alternative preparation should be prescribed and dispensed, as is usual practice where possible.
Where there is no suitable alternative or a prescription cannot be written for the alternative medicine (e.g. out of hours), the community pharmacy team that supplies the care home or hospice should ask the care home or hospice whether they run a medicines re-use scheme and whether they have any stock of the required medicine.
If stock of a re-used medicine is available in the care home or hospice, the community pharmacy team must share a copy of the prescription for that medicine with the home. Where the care home or hospice do not have a procedure in place to allow interim additions or amendments to MAR charts in their possession, the pharmacy could issue a new MAR chart for the product that is to be re-used.
A copy of the prescription could potentially be shared by sending an image of the prescription via NHSmail, where the care home has access to NHSmail. The supply of the medicine by the care home or hospice will need to be in accordance with that prescription; they cannot rely on a report of its contents.
Pharmacists and pharmacy technicians working within community pharmacies could potentially undertake checks at the care home or hospice on medicines being considered for re-use, but it should be noted that this is not a task that is required to be undertaken as part of the NHS Community Pharmacy Contractual Framework and any professional undertaking this role must ensure they have appropriate indemnity insurance arrangements in place.
Urgent medicine supplies
The COVID-19 pandemic is increasing the number of requests patients are making to pharmacies for emergency supplies of medicines. Where appropriate, these requests may be dealt with via a patient funded emergency supply, a referral to their general practice or the Community Pharmacist Consultation Service (CPCS).
Pharmacists who receive requests from a patient for an emergency supply or CPCS referrals for urgent supplies should use their professional judgement to determine whether an emergency supply is appropriate and legal to make.
Emergency supply where the dentist is unable to provide a prescription
A dentist may ask a pharmacist to supply medicines in an emergency, under the provisions set out in the Human Medicines Regulations 2012 and the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.
This should only be used when other alternatives have been exhausted – when a prescription cannot be provided – and this includes identifying a friend, family member or volunteer to collect the prescription on behalf of the patient and then take it to the pharmacy.
The pharmacist must supply the medicines in accordance with the directions of the dentist (and from a pharmacy); the pharmacist must be satisfied that the request is from the dentist (particularly if the request is made through the dental practice); and certain controlled drugs (see below) may not be supplied in this way.
It is the responsibility of the dentist to ensure the pharmacy receives the original prescription within 72 hours; if the pharmacy does not receive the prescription, even though it has been sent (lost in the post for example), the responsibility still lies with the dentist to provide the prescription.
Generally, a pharmacist may not supply medicines against a copy prescription, such as a fax, or scan of a prescription provided by e-mail. But, where an emergency supply is requested by a dentist, it is helpful if the dental practice send a scanned copy of the prescription to the pharmacy via their NHS.net email account, to ensure the pharmacist understands the prescriber’s wishes correctly.
During the pandemic, working closely with your local pharmacies is vital to securing safe and effective care for all our patients, so we encourage all dentists to contact their local pharmacies or local dental committees to contact local pharmaceutical committees, to agree good working procedures.
CD regulations amended for pandemic supply
On 30th April 2020 changes to the Misuse of Drugs Regulations 2001 came into force to provide Ministers with emergency powers for the supply of Controlled Drugs (CDs) in specific circumstances during a pandemic. The purpose of the changes is to ensure community pharmacies can continue to supply patients with essential medicines at critical times during a pandemic, such as the COVID-19 outbreak. The regulations are enabling so may be used only if ‘activated’ or ‘switched on’ by Ministers and apply in very limited circumstances.
The Royal Pharmaceutical Society (RPS) issued guidance for pharmacists on the legislation and associated professional practice considerations. The guidance was developed in consultation with the pharmacy sector including PSNC.
The three changes to the MDRs set out in the Misuse of Drugs (Coronavirus) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020 are:
1. Emergency supply of a CD without a prescription – at the request of a patient, medicines of Schedule 2, 3 and (Part 1) Schedule 4 to the MDRs may be supplied without a prescription, in accordance with the directions of a pharmacist, where:
- as a consequence of a current or anticipated disease that is a pandemic and a serious risk or potentially a serious risk to human health there has been an announcement by the Secretary of State (SoS) in respect of such CDs, to assist the management of that risk (the new MDRs have to be ‘activated’ or ‘switched on’);
- supply is part of NHS services (for example, an Enhanced Service) and the contractor complies with those NHS arrangements;
- the NHS arrangements are within the scope of the SoS’s announcement with regard to
- the area,
- particular circumstances (for example, a GP practice closure), and
- period in question (up to 3 months at a time, this can be amended, withdrawn, or extended);
- supply is from a retail pharmacy business (e.g. the contractor’s NHS pharmacy);
- the supervising pharmacist is satisfied that the patient has been receiving the medicine as part of ongoing treatment from a relevant prescriber and the dose is appropriate for the patient (linked to requirements in Reg 266 of the HMRs, see below);
- as with NHS services generally, the supervising pharmacist must also exercise appropriate professional judgement in accordance with accepted standards in the profession (in this case, the RPS guidance).
The new MDRs complement and extend existing legislation which allows the supply of POMs (and schedule 5 and 4 (part II) CDS) without a prescription during a pandemic (Reg 226 of the Human Medicines Regulations (HMRs)). So far as PSNC is aware, Reg 226 has been used only once for NHS supplies, early during the outbreak, following the closure of a GP practice. Patients of the practice who required essential medicines could not obtain prescriptions in a timely manner. So, an Enhanced Service was commissioned quickly by NHSE&I, with the involvement of DHSC and PSNC (DHSC amended the Directions for Enhanced Services accordingly). This enabled specified pharmacies in the local area to provide POMs to patients of the GP practice for 2 weeks or so – provided that the supervising pharmacist was satisfied that (i) the patient had been treated with the POM on a previous occasion by an appropriate prescriber and (ii) the dose was/remained appropriate for the patient (Reg 226 requirements), and the requirements of the Enhanced Service were satisfied. The Enhanced Service also provided the means for contractor reimbursement and remuneration.
2. Emergency supply of a CD against a Serious Shortage Protocol (SSP) – this provision is essentially the same as that for supply of a CD without a prescription. It enables medicines of Schedule 2, 3 and (Part 1) Schedule 4 to the MDRs to be supplied under SSPs, if there is a serious shortage of the medicine and the requirements for SSP supply are satisfied (reg 226A of the HMRs). Thus, requirements (a) to (d) and (f) above apply and more requirements relating to SSPs – please see the PSNC briefing on SSPs which also describes the relevant Terms of Service for SSP supplies and requirements for reimbursement and remuneration.
3. Emergency change to a CD instalment direction with the agreement of the prescriber – this provision allows pharmacists without prescribing rights to change the frequency of instalments on instalment prescriptions for medicines of schedule 2 and 3 of the MDRs, without the need for a new prescription from the prescriber. The changed intervals are treated as the intervals of the prescriber. Any changes MUST be agreed in advance with the prescriber or, if the prescriber is unavailable, a person specified by the prescriber who is a part of the same team responsible for treating that patient. The requirements (a) to (d) and (f) above apply.
For any queries, please contact Gordon Hockey, PSNC’s Director of Operations and Support.
Accessing medicines for detainees released during COVID-19
With the announcement of an early release of prison detainees, a guide has been published to support probation and youth offending teams and other teams supporting people released from custody on accessing medicines and pharmacy services during the COVID-19 outbreak.
NHS England and NHS Improvement (NHSE&I) and Health and Justice (HJ) have published Accessing medicines for detainees released during COVID-19 to advise community pharmacy teams of arrangements for prisoners released on temporary licence. The guidance contains information about how to access medicines in the community after their release. Contractors may want to take special notice that if releases are unplanned or due to a reduction in prescribing and pharmacy services for HJ, some people may be released without a supply of their medicines or a prescription. Therefore support from community pharmacies will be extremely beneficial in these circumstances.
The guide uses published information from the NHS and PSNC about GP and community pharmacy services which are a key service for these vulnerable patients.
NHSE&I directly commission pharmacy and healthcare service into prison, immigration removal centres and young offender institutions or secure training centres for young people. Out of the 140 or so sites this represents, most receive dispensed medicines via community pharmacies using subcontracted arrangements with our NHS commissioned healthcare providers. These services have been instrumental in supplying the detained population with medicines they need before and during the COVID-19 epidemic, and HJ will need community pharmacy teams to continue to support these services as the COVID-19 epidemic progresses.
Additionally, all community pharmacies can help support people released from health and justice settings in numerous other ways such as fulfilling FP10s issued by HM Prisons Service (HMP) and providing access to supervised consumption services or daily collections for substance misuse medicines.
The Chief Pharmaceutical Officer has requested that pharmacies restrict quantities of soap, hand sanitiser, formula milk and OTC medicines sold to each person, so that there is enough for everyone. Stockpiling causes problems with the supply chain and can lead to unnecessary shortages. Pharmacies should therefore put in place mechanisms to ensure they can supply a sensible quantity of all of these products to as many people as possible.
GPhC and CMA letter on pandemic pricing
This joint letter from the General Pharmaceutical Council (GPhC) and the Competition and Markets Authority (CMA) highlights reports that indicate a small minority may be charging unjustifiably high prices for essential products. It outlines the GPhC’s and CMA’s respective roles and expectations in relation to this issue during the COVID-19 pandemic.