Information for Pharmacists and Pharmacies COVID-19

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• Delivery of Pharmacy Vaccination Services

  Pharmacists and pharmacy teams play an important role in providing vaccination services, in delivering the national immunisation programme, and providing reliable advice on vaccinations to the public. During the COVID-19 pandemic, the way that vaccination services are provided will need to be adapted to ensure recommended public health measures are in place to help protect patients and staff, and minimise the risk of exposure to, and transmission of, COVID-19.

  COVID-19 Vaccine

  National roll-out and sources of information 
  The national COVID-19 vaccination strategy and implementation plan has been published by Government and is currently being implemented by the HSE. This plan is being rolled out at a national level and on a phased basis. The PSI understands that the vaccination plan is currently at the initial roll-out phase, which involves long term stay facilities and large scale health care sites (See national plan for further details). The roll-out is not yet at the ‘mass ramp up’ phase, which would involve primary care service like GPs or community pharmacies. The PSI are continuing to work closely with the Department of Health, HSE and other stakeholders, to facilitate and prepare for this phased roll-out.

  As part of the roll out of the national COVID vaccination programme, the Department of Health has issued the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2020 (SI 698 of 2020) on 24 December. The purpose of these Regulations is to allow for Covid-19 vaccinations, listed in the Eight and Twelfth Schedules, to be administered by pharmacists, nurses and midwives, advanced paramedics, paramedics, emergency medical technicians and physiotherapists, as per Regulation 4F as part of the national COVID vaccination programme.

  The regulations require each authorised health professional to have competed training approved by their regulatory body. The PSI is working closely with the Department of Health, HSE and the National Immunisation Office, to facilitate the implementation of this provision for pharmacists. We will circulate further information as this becomes available.

  Pharmacists as a trusted key information source
  There is huge public interest and media reporting on COVID-19 vaccines with information emerging and evolving rapidly. The public place a high degree of trust in their pharmacists and, as we know, pharmacists are an important source of accurate and reliable information for patients and the public on the potential COVID-19 vaccines. People will have questions as to how the various vaccines will work, both for individuals and as regards controlling the spread of COVID-19 in our communities. Pharmacists are in an ideal, and very influential, position to respond to these questions and to provide up-to-date and evidence-based information relating to the safety and efficacy of the COVID-19 vaccines.

  We particularly point you some helpful information in the recent statements on COVID-19 vaccines from Deputy CMO Dr Ronan Glynn and Lorraine Nolan CEO, HPRA and also an overview from the European Medicines Agency (EMA) on how the development and approval process for COVID-19 vaccines has been accelerated and compressed while still assuring the same quality safety and efficacy requirements;COVID-19 vaccines: development, evaluation, approval and monitoring.

  National preparations for the roll-out of COVID-19 vaccine 

  As you will be aware, a high-level task force has been established by Government to oversee the development and implementation of the national vaccines programme. The task force has been tasked with developing the key policy direction in relation to the national roll-out of the vaccination programme including identifying the key priority groups. This task force has reported on its proposals to Government and the national COVID-19 vaccination strategy and implementation plan has been published. The PSI will with work closely with the Department of Health, HSE and the other stakeholders involved, to facilitate the implementation of the agreed national strategy.

  Vaccine information
  As the vaccines are still undergoing the regulatory review and approval process, there is a limit to the usual clinical information available that is available yet. This will change as the vaccines receive the required European authorisation. In the meantime, information and resources are available from a number of official agencies involved in the development, authorisation and procurement processes:

  • Ireland is currently signed-up to the EU central procurement arrangements, which is being operated by the European Commission on behalf of members states to procure suitable, safe and effective vaccines in sufficient quantities to combat COVID-19. The EU Commission has published a comprehensive vaccine strategy and fact sheet, which outlines the coordinated European approach.
  • The authorisation process for vaccines in Europe has been undertaken centrally on behalf of the EU countries via the European Medicines Agency (EMA). They have a number of very useful information pages on the evaluation, approval and monitoring processes in place for the vaccine.

  - COVID-19 vaccines: key facts

  - Transparency: exceptional measures for COVID-19 medicines
  

  • Nationally, the HPRA has a dedicated section on their website relating to the approval of COVID-19 vaccines, and Frequently Asked Questions on COVID-19 vaccines. The HSE also has information available.
  • In addition, the World Health Organisation (WHO) keeps an up-to-date draft landscape of COVID-19 vaccine candidates. This contains information on vaccine candidates and information that has been provided to WHO by vaccine developers. The landscape is generally updated twice a week based on the latest information. WHO also has a useful “Vaccines Explained” series which is aimed at providing information for the general public on vaccines and covers; How do vaccines work? and How are vaccines developed?

  PSI Guidance

  The PSI has published practical guidance to support pharmacy owners, superintendent pharmacists and supervising pharmacists put in place policies and procedures for the continuation of safe and effective vaccination services during the COVID-19 pandemic.

  • Read the Practical Guidance when Providing a Pharmacy Vaccination Service during the COVID-19 Pandemic
  • Additional guidance on vaccination services and providing an influenza vaccination service offsite from the pharmacy premises is available on this website.

• COVID-19 Operational Standards

  
  

  In response to the COVID-19 pandemic, the PSI has developed new COVID-19 Operational Standards to apply across all pharmacies. The Standards aim to provide concise, outcomes focused statements to guide those people involved in the governance and leadership of pharmacies in providing safe, patient centred care and in delivering quality pharmacy services during this challenging period. The Standards are also intended to inform patients and the wider public as to what they can expect from their pharmacies and to provide assurance that pharmacies are a safe and supportive healthcare environment despite the ongoing risks arising from COVID-19. We are currently in the ‘use and learn’ period. More information is available on our COVID-19 Operational Standards webpage.

• Advice on reducing Infection Transmission in Pharmacies

  • HPSC guidance on reducing infection transmission in pharmacies. This guidance has been revised and updated to include further details and new information in the following sections: transmission, survival in the environment, environmental cleaning/disinfection and person/staff member with symptoms, and infection prevention and control precautions required when delivering patient contact services.
  • HPSC guidance on the use of surgical masks in the healthcare setting
  • HPSC updated poster for delay phase-circulated to pharmacies
  • HPSC video resources
  • IPU Poster for pharmacy entrance – Don’t enter if waiting for COVID-19 results

• Looking after your Mental Health

  
  

  A health professional can only continue to provide care and support to their patients so long as they remain well and able themselves. Just as you might advise patients not to ignore their general health concerns during the COVID-19 crisis, please also remember how important it is to follow this advice yourself.

  
  

  As the current stressful and demanding situation continues, all of us will experience loss, worry, anxiety and tiredness. Please make sure to call on your peers, family or employer for support, as well as taking time to seek out your doctor, other support services or online resources as may be needed to stay physically and mentally well as you provide continued care for the public. These are some helpful resources and supports to help maintain good health during this challenging time.

  • The HSE website offers information about minding your mental health during the coronavirus outbreak, general mental health tips and resources, and the HSE has been providing access to a series of stress control classes that are available online. 
  • As shared in our email to registrants on 22 May, the HSE has announced the availability of a free mental health service for community pharmacists during the COVID-19 pandemic. As a Community Pharmacist, you can use up to 6 free appointments between now and 31 May 2021. More information, including details on how to book an appointment with MyMind is available on the MyMind website.
  • The Practitioner Health Programme offers its services as an empathetic ear for health professionals during the current pandemic. The programme is available for pharmacists, doctors and dentists who may have mental health issues such as stress, anxiety or burnout or who may have a substance misuse problem.
  • The Irish Hospice Foundation provides a range of materials to support people in times of personal grief, to aid those who support others during bereavement, and a new section specific to the challenges of dealing with death and bereavement during the COVID-19 pandemic.

  Further information on mental health resources is available on the IIOP COVID hub.
  

• Pharmacy Contingency Planning

  • PSI and HSE Joint Guidance on Business Continuity Planning for Community Pharmacies During the COVID-19 Pandemic (version 2)
  • HSE Guidance on Contingency Planning for People who use Drugs and COVID-19
    
  • HSE PCRS community pharmacy FAQs on measures to reduce administrative burden during COVID-19
    

• Prescription Regulation Amendments and Guidance

  Changes have been made to facilitate how prescription-only medicines, including controlled drugs, can be supplied to patients by pharmacists during the COVID-19 pandemic to ensure continued care and treatment for patients.

  The changes amend the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended) and the Misuse of Drugs Regulations 2017 (as amended).

  The purpose of these changes is to ensure continuity of care and access to treatment for patients during the Covid-19 pandemic and to reduce some of the burden on prescribers and the broader healthcare system.

  Joint Guidance
  To assist pharmacists and prescribers, the PSI, Medical Council and HSE have published joint guidance setting out the amendments to the legislation for supply of prescription-only medicines during the Covid-19 pandemic.

  Key Changes
  - National electronic prescription transfer: The electronic transfer of a prescription between the prescriber and pharmacy is provided for through the use of the HSE Healthmail® system. This will remove the requirement for paper copy of a prescription to be forwarded to a pharmacy once this closed-system electronic service is used.

  - Maximum validity of prescriptions: This has increased temporarily from 6 months to 9 months from the date specified on the prescription (some restrictions continue to apply around the dispensing of Controlled Drugs); only where in the pharmacist’s professional judgement, after consultation with the patient, and if needs be the prescriber, continued treatment is required and it is safe and appropriate to do so. 

  - Repeating prescriptions: The number of repeats which may be supplied for both S1A and S1B medicinal products has been increased temporarily to enable pharmacists’ continuity of patient care without necessarily requiring a new prescription.

  - Emergency supply provisions: 
  

  • A pharmacist can dispense up to 10 days’ emergency supply of a prescription only medicinal product at the request of a patient, including the Schedule 4 Part 1 Controlled Drugs: midazolam, clobazam and clonazepam for the treatment of epilepsy.
  • A pharmacist can dispense up to five days’ emergency supply of a Schedule 2, 3 or 4 Controlled Drug in defined circumstances, at the request of a prescriber or a patient.
  • In addition to the existing provisions for emergency supply at the request of a prescriber, a prescriber can also request an emergency supply of the Schedule 4 Part 1 Controlled Drugs - midazolam, clobazam and clonazepam for the treatment of epilepsy.

  Full details of the amendments are provided in the joint guidance.

  You can access the updated regulations using the links below: 

  • S.I. No. 98/2020 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020
  • S.I. No. 99/2020 - Misuse of Drugs (Amendment) Regulations 2020

  Professional judgement and collaboration
  Changes in the legislation enable pharmacists to make additional supplies of prescription-only medicines to patients without obtaining a new prescription from the prescriber, where in the pharmacist’s professional judgement it is safe and appropriate to do so.

  Pharmacists should discuss the patient’s treatment with them to ensure that it is appropriate and necessary for their continued care for further supplies to be made. This places significant emphasis on a pharmacist’s professional decision making, and the Code of Conduct can be used as a supportive framework within which pharmacists feel able to exercise their professional judgement, including in emergency or exceptional situations, motivated only by the core concern to provide safe and appropriate patient care.

  Collaboration between prescriber and pharmacist remains vital, and the pharmacist should contact the prescriber to discuss the patient’s care if in doubt as to whether it is the intention of the prescriber for a continued supply of a medicine to be made, or the pharmacist wishes to obtain further information on whether it is safe or in the patient’s best interest to do so.

  We have developed frequently asked questions and answers to assist pharmacists when supplying prescription-only medicines during the Covid-19 pandemic. The HSE has also developed frequently asked questions and answers to assist pharmacists. 

• Home Delivery of Medicines

  During the current public health emergency, there will be greatly increased need for medicines to be delivered to patients, particularly the more vulnerable members of our communities who are cocooning at home. While some pharmacies routinely provide delivery services, it will be a new development for others to be involved with Covid-19 delivery services. There is a significant national community effort organised to facilitate those deliveries, which may be provided by staff of public bodies, local authorities, An Post, An Garda Síochána, pharmacy staff members and/or voluntary organisations or groups. Each local authority (council) has established a Community Response Forum to coordinate COVID-19 related community supports, including volunteers to support those remaining in their homes.

  The PSI and the HSE have published joint guidance to support patients, volunteers and pharmacists with the safe delivery of medicines at this time.
  

  • Home delivery of medicines by public servants and volunteers during the COVID-19 pandemic

• Registration Applications and Pharmacist Education

  Due to COVID-19 operating arrangements, the PSI can only accept registration applications by email, or using the online registration portal where relevant. Please see the relevant section of our website or contact us for information if you are making an application at this time. Read more

  COVID-19 Emergency Restoration Process
  In line with the Emergency Measures in the Public Interest (COVID-19) Act 2020, a restoration route has been introduced to the Pharmacy Act, referred to as a Section 77 registration. This enabled former PSI registrants, including pharmacists and pharmaceutical assistants, who either voluntarily withdrew from the register or were removed due to non-payment of registration fees, to have their registration restored for a temporary period only.

  The legislation currently provides the end date for temporary registration as 30 June 2021. After this date the registration will cease. Should a pharmacist/pharmaceutical assistant wish to retain registration and continue to practise beyond 30 June 2021, they must make application to do so under the relevant provisions.

  Questions about restoration and registration can be sent to registration@psi.ie

  You will find further guidance on the process here.

  CPD during the COVID-19 public health emergency
  
  We appreciate that this is a challenging and unprecedented time for pharmacists and time may be more limited during the pandemic. It is still expected, and important, that pharmacists maintain their CPD and keep their knowledge and skills up-to-date, particularly in a time where pharmacists may need to quickly update their knowledge. Pharmacists are encouraged to continue to record their professional development and learning activities. All actions taken in responding to patient and public needs during the pandemic may be documented in a practitioner’s ePortfolio .

  The next ePortfolio Review will take place in January 2021 and information on this will be communicated to selected pharmacists over the summer. 

• Medicines Availability

  The Department of Health, with others involved in the medicines supply chain, is closely monitoring the availability of health services including medicines. There is continuous work to review the supply of medicines to Ireland so that, as far as possible, we can anticipate and respond to any potential vulnerabilities in medicines supply as a consequence of the outbreak of COVID-19.

  Based on this ongoing assessment, there is no evidence to suggest that Ireland is likely to face general medicines supply issues, now or in the near future, caused by COVID-19 related issues. There are already additional stocks of medicines routinely built into the Irish medicine supply chain. In the event that there are some supply issues for individual medicines, it is expected that other forms, strengths, brands, and generic medicines will be available to provide alternative options to ensure continuity of treatment. In those instances, pharmacists’ consultation with patients about those medicines will be vital, as is encouraging patients with any concerns about their medicine to speak with their pharmacist or GP.

  While Ireland is unlikely to face general medicine supply issues, this is based on normal use of medicines. Continuity of care must be everyone’s priority, and to prevent hampering of the supply of medicines for others and disruption to existing stock levels:
  

  • pharmacies, hospitals and other healthcare professionals should not order extra quantities of medicines,
  • doctors should not issue additional prescriptions, and
  • patients and the general public are also asked not to seek supplies of medicines over and above their normal requirements.

  The existing HPRA Medicine Shortages Framework is in place to help prevent shortages from occurring and to reduce the impact of shortages on patients and healthcare professionals. International authorities, including the European Medicines Agency, remain vigilant to any potential risk and the Department of Health and the HPRA are also working as part of this wider EU response to COVID-19. The situation remains under review as authorities seek to facilitate continuity of care and treatment.

  Work also continues to identify evidence-based treatments and vaccines for COVID-19, in Ireland and around the world.

• COVID-19 and Medicines

  
  

  • HSE repository for COVID-19 clinical guidance and evidence. The HSE repository provides a national easily-accessible repository of clinical guidance to equip the clinical community in Ireland with the requisite information whilst working within the current COVID-19 environment.
  • National Medicines Information Centre update on COVID-19 and medicines.
  • The HSE website has clear information about the treatment of COVID-19 symptoms including the use of medicines and advice on the continued use of medicines that people are already taking.
  • COVID-19 and testing kits

  We have received queries on the COVID-19 testing kits being offered to pharmacies. The HPRA has issued the following advice:
  ‘The National Public Health Emergency Team (NPHET) is coordinating the management of and response to COVID-19 in Ireland. All testing for COVID-19 in Ireland is currently conducted in the National Virus Reference Laboratory (NVRL) and in a number of regional laboratories on samples taken by healthcare professionals. Any decision to change from the current testing strategy will be directed by the NPHET. Stakeholders (manufacturers, distributors) of invitro diagnostics should contact the HPRA prior to supplying IVD test kits for COVID-19 to the Irish market at devicesafety@hpra.ie.’

  
  

  This and other information is available on the HPRA’s website.