|1. Current legislative and regulatory requirements (31/3/20)
|We understand that during these exceptional times, pharmacy teams, pharmacists, superintendent pharmacists and pharmacy owners are all having to make decisions in the best interests of their teams and patients. Each of you will may be required to make decisions about the unique circumstances that you and your teams will be facing using your best professional judgement to take a pragmatic approach in your pharmacy practice. As part of this, there may be occasions when you may have to operate outside your established procedures, taking a pragmatic, flexible approach to ensure continued patient care.
We understand this and are here to support you. However, this does not mean that it is permissible, even during the current pandemic, to start operating outside of established legal and good practice procedures. All existing legislative and regulatory requirement remain in place and all applicable laws and regulations pertaining to medicines, devices, and professional requirements remain in place and in force.
• For example, the Human Medicines Regulations, the Misuse of Drugs legislation, and NHS Pharmaceutical Services legislation, etc. all remain in force.
• This means that currently, all legal requirements pertaining to Controlled Drugs (CDs) prescribing, as well as normal prescription requirements remain in force.
New legislation, or specific exceptions may be introduced which may allow the Government / NHS to make some amendments to existing legislative requirements; however, until it is activated and communicated by the relevant organisations (Government, NHS, PSNC, CPNI, CPS, CPW et al), normal legislative requirements continue to apply.
Similarly, current regulatory requirements set by the pharmacy regulators remain in place. To allow professional flexibility, the regulators have issued guidance on various topics that is applicable during the current pandemic. You are strongly advised to review this guidance:
• General Pharmaceutical Council (GPHC): https://www.pharmacyregulation.org/contact-us/coronavirus-latest-updates
• Pharmaceutical Society of Northern Ireland (PSNI): https://www.psni.org.uk/psni/about/covid19-regulatory-statements-and-information/
The GPhC has asked that we remind members that they published, in conjunction with the Pharmaceutical Society of Northern Ireland (PSNI), a joint statement on their regulatory approach in light of the current circumstances. In brief, this sets out:
• That whilst the regulatory standards are flexible in nature, pharmacists must continue to act within their professional competence
• That pharmacists should ensure they have indemnity cover
• Guidance with regards to the responsible pharmacist
Please read this letter while you are in the process of making your decisions so you can understand the impact of this statement: https://www.pharmacyregulation.org/news/letter-trade-associations-emergency-situations
The key consideration in everything is patient safety. This can be achieved by ensuring a risk-assessed approach to decision-making and robust, contemporaneous record keeping. This is especially important so that if required, you are able to demonstrate your sensible approach to decision-making and approach to continued patient care.
• Patent safety means implementing the safest way to provide care for your patients, while also maintaining safe practice for you and your team
• Make clinical and professional decisions on a case-by-case basis for all patients
• Ensure shared care decisions are made wherever possible between yourself and the patient, as well as between yourself and prescribers
• Make robust contemporaneous records of all decisions and shared care arrangements, being extra careful when you are having to make any decision which take you outside of your usual established procedures, or current legislative/regulatory requirements/expectations
• Involve the whole team in ensuring that they practice according to this advice
• Ensure that you review and update your standard operating procedures (SOPs) business continuity plan regularly to reflect changing circumstances and / or procedures as you adapt your practice and make new decisions to ensure patient care
|2. Supplying methadone to housebound patients due to self-isolation or shielding (updated 31/3/20)
|A number of pharmacies have raised concerns about how to manage patients who require supervised administration of medicines (e.g. methadone, buprenorphine) in the pharmacy during the Coronavirus (COVID-19) pandemic. This also extends to how to manage such patients when they are in isolation or shielding in their homes as preventive measures, so that the risk of infection can be prevented/controlled. In this section, we have covered the key considerations regarding the supply of methadone, and similar medicines, to housebound patients during the COVID-19 pandemic to prevent and/or reduce risk of infection while supporting patient care.
Managing risks while providing patient care
Each patient must be risk assessed on a case-by-case basis, in consultation with the prescriber, to ensure that the risk of infection is mitigated as much as possible, while providing the patients with the care they need in the safest way possible.
It is not appropriate to make a blanket decision to not supply any methadone (or instalment prescription item) by delivery service to housebound patients. Patients under treatment for substance misuse are more vulnerable. They have taken the decision to seek support to help them recover and it is important that their recovery be supported. They may also be at higher risk due to other co-existing health conditions such as hepatitis C for example. Disruption to their treatment may increase their vulnerability and has the potential to impact on not just themselves, but also others in their family, which may include children.
Weigh up the risks of making the supply by delivering the medicines versus not supplying – what are the risks to the patient, and/or their family members of making the supply or not? Clinical as well as practical considerations?
• Would it be appropriate to consider providing a different frequency of supply, after discussion with the prescriber?
• Consider the potential for the patient (or others in their home) to overdose. There are child protection issues – what if a vulnerable child finds methadone lying about in the house?
• Delivery drivers carrying a large quantity of methadone (or other instalment prescription item) are putting themselves at risk of robbery and other crime.
• What to do about the requirement to supervise the administration?
Supervising administration or not?
This is not a legal requirement; it is a good practice recommendation to support treatment. Therefore, where a prescription calls for supervised administration but it is not possible to do so, pharmacists may still proceed with supplying the treatment without supervision. When this happens, ideally, the prescriber should be contacted to advise them of the situation, and contemporaneous records made on the Patient Medication Record (PMR) to record the actions taken and decisions made. Based on the outcome of your risk assessment of each patient, you can make a decision regarding each patient about whether to continue to supervise administration of their medicine, or whether the risks of doing so outweigh the potential benefits. It is advisable to liaise with the prescriber to omit the supervision requirement from future prescriptions for such patients until this requirement can be followed again.
In Northern Ireland, pharmacists have been advised to stand down arrangements for supervised opioid substitution treatment (OST) effective from 19 March 2020. Pharmacies should liaise with local Trust OST keyworkers to make appropriate arrangements for safe supply. This is particularly important in the instance of a client who is currently self-isolating.
Supplying medicines to a representative
Where supplies of medicines such as methadone and buprenorphine are to be made to the patient’s representative, a letter of authorisation should be obtained from the patient, at each collection where possible, for their representative to collect on their behalf. However, whether a letter of authorisation has been obtained or not, the patient should be contacted to confirm the supply to their representative.
There are key considerations involved in delivering instalment prescription items, regardless of whether it is supervised or not. These include:
• Methadone (or other instalment prescription item) may not be delivered by pharmacies as part of their usual delivery service; before starting this, risk-assess the patient in consultation with their prescriber / local Drug and Alcohol Team:
– Ensure there is close liaison with prescribing teams
– Consider other methods in which the patient can obtain the methadone, for example, a representative coming to collect
– Consider whether another pharmacy is better suited for the patient to travel to
• Undertake a risk assessment in consultation with their prescriber / local Drug and Alcohol Team before starting such a delivery service in which a clear, robust process, with safeguards, are in place
– Consider who will deliver the methadone – the delivery driver or pharmacist
– Record potential risks in delivering
– Consider how you will ascertain the methadone has reached the patient – see advice published on delivering medicines during COVID-19 outbreak
• For supervised patients, following the joint risk assessment with the prescriber, work through the process and have them amend the prescription accordingly
• Record all conversations with any parties (for example, GP, drug clinic) and decisions made on the PMR
– Add discussion of concerns, for example, patient’s stability, vulnerable children at home
• If you need to close, then patients with instalment prescriptions would need to be signposted to another pharmacy
– This is a good reason why a shorter duration of prescription, post-dated, can be issued to the patient so there is continuity of care
– See the Continued Pharmacy Services document
Ensure your delivering medicines standard operating procedure (SOP) is reviewed and updated before initiating the home delivery service for such medicines.
|NPA Professional Indemnity statement
When considering delivery to a supervised methadone patient, treat each case differently. The pharmacy needs to talk to the GP and prepare a risk assessment and the best way forward. Members must write detailed notes of their discussions with the GPs and record these notes/risk assessments against the patients’ PMRs.
Although, it is not a legal requirement to provide supervision, ideally new prescriptions should be requested without this requirement. In terms of deliveries, it is best that these should be for as little of the methadone delivered, as frequently as possible.
|3. COVID-19: Chloroquine and hydroxychloroquine (correct as of 31/3/20)
|In recent days, many pharmacies have received requests for over-the-counter (OTC) sales of chloroquine for preventing or treating coronavirus (COVID-19) infection. We have also been made aware that doctors and other prescribers are prescribing chloroquine and hydroxychloroquine for personal use or for friends/family with the intention of preventing or treating coronavirus (COVID-19) infection.
• The MHRA has issued guidance that chloroquine and hydroxychloroquine are not licensed to treat coronavirus (COVID-19)-related symptoms or prevent infection. Clinical trials are ongoing to test whether chloroquine and hydroxychloroquine can be used to treat or prevent coronavirus (COVID-19) infection. These clinical trials are still ongoing; they are not completed – no conclusions have been reached yet on the safety and effectiveness of chloroquine or hydroxychloroquine to treat or prevent coronavirus (COVID-19) infection. Until clear, definitive evidence is available that these potential treatments are safe and effective for the treatment of coronavirus (COVID-19) infection, they are meant to be used only for this purpose within a clinical trial.
• There is currently no specific treatment for coronavirus (COVID-19) infection. Any treatment provided for ill patients in hospitals aims to relieve the symptoms while the body fights the infection.
• It is vitally important that everyone follow the Government advice on self-isolation, social distancing and shielding as preventive measures.
NPA Professional Indemnity insurance will not cover:
• OTC sales or supplies of chloroquine intended to be used for prevention/treatment of coronavirus (COVID-19) infection.
• Dispensing of prescriptions for supply of chloroquine and hydroxychloroquine prescribed for prevention/treatment of coronavirus (COVID-19) infection.
If the UK Government/NHS advice on the use of chloroquine or hydroxychloroquine for prevention/treatment of coronavirus (COVID-19) infection changes, we will issue updated advice.
Pharmacists and pharmacy teams are strongly advised:
• Not to sell/supply any chloroquine OTC for preventing/treating coronavirus (COVID-19) infection. Be cautious of any requests for OTC chloroquine; in the current pandemic situation, it is unlikely that OTC requests for chloroquine will be for malaria prophylaxis/travel purposes.
• Not to sell/supply chloroquine OTC to themselves for personal use or for friends or family for preventing/treating coronavirus (COVID-19) infection.
• Not to prescribe chloroquine or hydroxychloroquine (if you are an independent pharmacist prescriber) for your personal use, or for friends or family for preventing/treating coronavirus (COVID-19) infection.
• Not to dispense prescriptions for chloroquine or hydroxychloroquine intended for preventing/treating coronavirus (COVID-19) infection. This also applies to circumstances when the prescriber has prescribed these drugs for personal use, or for friends or family for preventing/treating coronavirus (COVID-19) infection.
|4. Repackaging paracetamol during the coronavirus (COVID-19) pandemic
|While pharmacies continue to be able to procure Prescription Only Medicine (POM) packs of paracetamol (pack size of 100 tablets, or more), many pharmacies are reporting ongoing shortages of paracetamol tablets 500mg as Pharmacy (P) and General Sales List (GSL) packs. We have sought advice from the Medicines and Healthcare products Regulatory Agency (MHRA), and our professional indemnity advisors, advice regarding repackaging the POM packs of paracetamol (pack size of 100 or more) to create smaller packs of containing maximum of 32 tablets for over-the-counter sale/supply to patients.
Under Regulation 4 of the Human Medicines Regulations 2012 (HMR), a pharmacist is able to break down a larger pack to prepare a single supply of a non-prescription item for retail sale. In these circumstances, the requirements within Part 13 of the HMR are disapplied.
• The labelling requirements set out in Part 2 of Schedule 26 to the HMR will apply.
• Additional specific labelling requirements for paracetamol will also apply as set out in Part 4 of Schedule 25 to the HMR.
• The sale and supply provisions in the Regulation 236 of HMR do not apply if the quantity of paracetamol (or aspirin) sold or supplied to a person at any one time does not exceed 100 tablets. This regulation does not exempt any other drug.
To enable you to repackage the larger packs of paracetamol tablets 500mg to meet patient need please ensure you comply with the following requirements:
• Every pack supplied must comply with the labelling provisions as set out in the
– HMR 2012 Part 2 of Schedule 26 , (Part 1 of Schedule 26 is not necessary for over the counter (OTC) supply) and in
– Part 4 of Schedule 25 to the HMR
• Patients must be supplied with the corresponding patient information leaflet (PIL) – this must be of the exact Product Licence (PL) used. This must be a printed or photocopied PIL; sending the patient an electronic link to access the PIL remotely is not acceptable.
• Patients are expected to be provided with sufficient information to ensure that they can use the medicine safely in an informed manner. What specific information needs to be provided to the patient should be a matter of professional judgement for the pharmacist.
• Keep an audit trail/record of broken bulk supplies with your Business Continuity Plan.
• The total quantity sold to any patient must not exceed 100 tablets.
• Different batches of medicine must NOT be mixed when repackaging into smaller packs.
However, please note the following important points:
• The decision to take this step should be taken only be considered if your pharmacy/business has completely run out of the ready-made ‘P’ and ‘GSL’ packs of paracetamol, and repackaging larger packs will support patient care during this public health emergency.
• Repackaged medicines should only be used within the same pharmacy business/legal entity.
• We expect all members who take the decision to repackage medicines in this manner to supply ready-made packs whenever available, and definitely once the current emergency situation with coronavirus (COVID-19) pandemic has resolved and regular supply chains are reinstated.
• Repackaging should not be carried out in the normal course of your business, or because of financial reasons only. OTC packs should be procured and supplied whenever available.
• The POM packs of paracetamol must be authenticated and decommissioned to comply with FMD legislation
• It is important that members charge a reasonable price for the smaller packs of paracetamol and do not exploit the current situation by charging excessive price — the General Pharmaceutical Council (GPhC) has issued a strong statement condemning pharmacy pandemic profiteering
|Professional indemnity insurance
• NPA professional indemnity insurance will indemnify members who are required to break bulk of the typical OTC painkillers and medicines, e.g. paracetamol, ibuprofen and aspirin, in circumstances where they are unable to obtain original packs of those medicines in ‘P’ and ‘GSL’ pack sizes.
• Where pharmacies have bulk packs of paracetamol, ibuprofen, and aspirin, we will cover the breaking down of those bulk packs into the equivalent of ‘P’ packs; that is to say, each pack must contain no more than the maximum number of tablets permitted for the relevant ‘P’ pack size as applicable for each drug.
• Each pack must be labelled in accordance with Part 2 of Schedule 26 and any other specific labelling requirements pertaining to the relevant drug.
• Labelling requirements set out in Part 4 of Schedule 25 are applicable to paracetamol.
• It is imperative labelling requirements are complied with and records of broken bulk supplies are retained so that the integrity of the stock can be maintained and, from an audit perspective, traced back to the original manufacturer if required.
• In addition, a printed PIL (or a paper copy) must be supplied with each pack to patients.
• Members should keep records of broken bulk supplies and details of batch numbers so that the integrity of the stock can be maintained and, from an audit perspective, traced back to the original manufacturer if required.
|5. COVID-19: Dispensing medicines in monitored dosage systems (MDS) (updated 31/3/20)
|During the current Coronavirus (COVID-19) pandemic situation, your pharmacy may be under a lot of pressure, for example, due to staff shortages, and may struggle to continue to provide medicines to relevant patients in MDS trays. Supplying medicines in an MDS is one of the reasonable adjustments that can be made to help a patient with disability to overcome obstacles which prevent them from receiving goods and services. However, the critical element is that patient safety is foremost and patients continue to receive their medicines as promptly as these extremely difficult circumstances permit, irrespective of whether it can be loaded into an MDS.
However, please ensure that the decision as to whether to discontinue supply in an MDS is made on a case-by-case basis, and not applied as a blanket policy. This is especially important so that the most vulnerable patients are not left without being able to take their medication. If you decide to supply patients with original packs instead of MDS trays, this should ideally be a shared decision with the patient, and communicated clearly to the patients, as well as carers and family members as applicable.
The NPA will continue to support members when exercising their professional judgement when deciding if they can supply via MDS or dispensing medicines in their original packs. We understand that the Equality Act may potentially be breached on occasions. However, faced with the decision of being able to supply the medicines or not, it is better to ensure that the patients receive their medicines rather than go without treatment at all. This would be a pragmatic approach. As with all the other pragmatic decisions you will make during these trying times, it is vital that good contemporaneous records are made of any actions/decisions you take, and especially when they fall outside your usual procedures.
Please note that in Scotland, for MDS supplies, dispense weekly means strictly supply weekly, so any variance from this again would need risk assessed on an each patient basis, prescriber should be contacted to agree variance from prescribing instruction, recorded as such on PMR and adjustment claim made.
|6. Yellow card reporting during the COVID-19 pandemic
|Following the Government’s recent announcements, the MHRA, like many other organisations, are now working remotely from 23 March 2020. Therefore, the MHRA as requested all healthcare professionals to submit reports of suspected side effects to medicines via the electronic Yellow Card Scheme, and not paper. This will allow them to manage the reports more effectively.
IMPORTANT: if you have sent a paper suspected side effect Yellow Card after 17 March 2020
MHRA staff do not have access to the building, therefore, if you have not already received an acknowledgement, please resubmit your suspected side effect electronically.
Submitting reports of suspected side effects to medicines electronically – please provide url links for this section
You can submit reports through one of the following methods:
• The Yellow Card website
• The free Yellow Card App available from the Apple App Store or Google Play Store
• Through some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank) for healthcare professionals
If you do not have online access, please call 0800 731 6789 for free:
• Monday to Friday: 10-2pm
• Leave a message outside these hours and someone will call back
Submitting reports of adverse incidents to medical devices
You can report medical device problems as follows:
• In England and Wales: go through the Yellow Card website
• In Northern Ireland: go through the Northern Ireland Adverse Incidents Centre (NIAIC)
• In Scotland: go through the Incident Reporting and Investigation Centre (IRIC)
Submitting reports of defective, fake medicines and medical devices, and e-cigarettes
You can submit reports through the Yellow Card website on suspected incidents/problems involving:
• A defective medicine if it is not of an acceptable quality
• A falsified product, for example, fake medicine or medical device
• A safety concern with e-cigarettes or their refill containers (e-liquids)
|7. Patient safety incident reporting
|We appreciate you are all extremely busy with a massively increased workload currently. However, patient safety incidents may occur in the course of your practice. It is important to continue to manage and report all patient safety incidents in line with your usual pharmacy process and requirements in your relevant UK country. This includes completing the recording of the incident details carefully and fully.
Patient safety incident reporting support
• England: report via NPA portal: https://irp.npa.co.uk/ or NRLS: https://www.eforms.nrls.nhs.uk/staffreport/
• Scotland: Pharmacies can choose to use NPA Scotland Patient Safety Incident Report
• Northern Ireland: Members in NI can access an online reporting tool enables pharmacists and pharmacy staff to download a version for their pharmacy and record and analyse near-misses and errors in an anonymous, systematic and quick to use format. Access the tool here.
• Wales: report to NRLS: http://www.patientsafety.wales.nhs.uk/patient-safety-incidents