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MHRA Drug Safety Update February 2019

Date issued 18th February 2019 A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (Vol 12 Issue 7¬† February 2019:1) has been published and includes articles on: Carbimazole: Increased risk of congenital malformations; strengthened advice on contraception. Carbimazole: risk of acute pancreatitis. SGLT2 inhibitiors: reports of Fournier’s gangrene (necrotising fasciitis of the...

15 hours ago

Class 4 MHRA Drug Alert – Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe (Laboratoire Aguettant)

Drug Alert No: EL (19) A/05 Date Issued: 18th February 2019 The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for certain batches of Atropine Sulfate 3mg/10ml Solution for Injection in pre-filled syringe (Laboratoire Aguettant) Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (Laboratoire Aguettant) PL 14434/0016 Batch Number...

17 hours ago

PSNC agrees strategic plan for 2019/20 at latest meeting

The PSNC Committee held the first of its new-style quarterly meetings this month, and agreed its plan for 2019/20. The Committee held important discussions on the NHS Long Term Plan, Brexit contingency planning, price concessions, service updates, and of course the commitment to Primary Care Networks (PCNs) made in the GP funding deal. The Committee...

17 hours ago

Advanced Services

There are four Advanced services within the NHS community pharmacy contract. Community pharmacies can opt to provide any of these services as long as they meet the requirements set out in the Secretary of State Directions.

Information on the services can be found by clicking on the links below which will redirect you to the PSNC website.

Flu Vaccination Service


Medicines Use Review (MUR) and Prescription Intervention Service

Secondary Care Referral for Targeted Medicine Use Review and New Medicine Service

MUR Submissions 


New Medicine Service (NMS)

NMS Submissions


NHS Urgent Medicine Supply Advanced Service (NUMSAS)


Appliance Use Review (AUR) Service

Stoma Appliance Customisation (SAC) Service



Provision of advanced services by pharmacy and dispensing appliance contractors.

West Yorkshire Area Team policy

This policy includes details about the provision of MURs off-site, in patients’ homes and over the telephone.  This is a nationally agreed policy which Community Pharmacy West Yorkshire has had no input in to. We will be considering the implications of this policy at our next meeting. 

NHS England policy on advanced services

Forms for completion (PREM2 forms) can be found on the PSNC website by here.

You should send completed forms to your West Yorkshire Area Team contact. These can be found on our website by clicking here.



NMS & MUR Submissions

The NHS Business Services Authority (NHSBSA) now administers the collection of completed MUR and NMS electronic reporting templates from pharmacy contractors on behalf of NHS England.  Pharmacy contractors will no longer receive any reminder and will therefore need to remember to submit their completed quarterly MUR and NMS electronic reporting templates to the NHSBSA via the Information Services Portal.

For further information please click on the link below:




Secondary Care Referral for Targeted Medicine Use Review and New Medicine Service

Secondary Care Referral Form

Guidance for the use of secondary care referral form 



NHS Urgent Medicine Supply Advanced Service (NUMSAS)

NUMSAS Service Specification


NUMSAS Toolkit 

The updated NUMSAS toolkit has now been published online and can be accessed here: https://www.england.nhs.uk/commissioning/primary-care/pharmacy/national-urgent-medicine-supply-advanced-service-numsas-pilot/.

Tackling inappropriate supplies of Controlled/High Risk Drugs

There have been a significant increase in incidents reported to NHS England where patients have frequently presented through the Pharmacy NUMSAS Service; attended OOH GP Care Providers or A&E Departments and successfully managed to obtain supplies at multiple sites across the Yorkshire and Humber region in a very short period of time.  Furthermore there has been a report of a patient who consecutively attended five different A&E Departments in our region and managed to obtain supplies of Pethidine.  

All these incidents have highlighted the potential for patient harm.  Each one of us has a duty of care to identify, manage and reduce risk within our organisations.  A multidisciplinary approach has been established to tackle this issue of inappropriate requests for supplies of controlled drugs/high risk medicines.    

Access to the Summary Care Record is an invaluable tool and should be checked to support decisions for any requests for urgent supply of medicines.

Please read the letter below to find out more detail on the safeguards that have been out in place for General Practices and pharmacies:

NHS England Letter - NUMSAS: Inappropriate Supplies of CDs


Signing up to provide the service

Before signing up to provide NUMSAS there are a number of tasks that community pharmacy contractors should complete. PSNC Briefing 033/17: Checklist for the NHS Urgent Medicine Supply Advanced Service (NUMSAS) contains a checklist of tasks to complete before providing NUMSAS.

Contractors are able to notify NHS England of their intention to provide the NUMSAS pilot by completing the notification form on the NHS Business Services Authority (NHS BSA) website.

All contractors that meet the requirements set out in the service specification for the NUMSAS, including the requirement that the pharmacy has a shared NHSmail mailbox, are able to register; however, contractors will only be able to receive referrals from NHS 111 and provide the service when the service goes live in the contractor’s area (see ‘Roll out of the service’ section). 


Requirement for a shared NHSmail mailbox

A requirement in the service specification is that if a contractor intends to provide the service, they must have a shared NHSmail mailbox for each of the pharmacy premises from where the service will be provided. Contractors should not register for the service until they have such a mailbox.

To access a shared NHSmail mailbox, users must have their own personal NHSmail address which is linked to the shared mailbox. This is to allow different staff members to access the mailbox without sharing of login details. Currently, only a small number of pharmacies have premises specific shared NHSmail mailboxes.

Information on how to obtain an NHSmail account



Key benefits of using the PharmOutcomes service for community pharmacy contractors are:

  • Structured service templates – These allow registration and follow up of all patients accessing the service. This makes the identification of repeat users easily identifiable that in turn can trigger relevant discussions about medicines management and medicines optimisation.
  • Clinical record – A clinical record of all supplies and the ability to show a clear audit trail of activity and claims made.
  • Automated GP notification – Saving data will automatically generate and send a notification form to the patient’s GP practice.
  • NUMSAS submission tokens – The PharmOutcomes service will allow the required information, which needs to be included on the FP10DT EPS dispensing tokens, to be printed on the forms in a clear legible format.
  • NUMSAS claim submission form generation – The NUMSAS claim form will be automatically system generated using recorded data and made available for printing on the 1st day of every month (please note this form must be posted to the NHS Business Services Authority, it cannot be submitted via PharmOutcomes).

Communicating with GP practices

Notifying the patient’s GP practice when a supply of a medicine or appliance is made is a requirement of the NUMSAS. 


Contractors must ensure that a notification is sent to the patient’s GP practice on the same day the medicine or appliance is supplied or as soon as possible after the pharmacy opens on the following working day. This can be undertaken by secure email or secure electronic data interchange. If necessary the pharmacy should contact the GP practice for details of their secure email address. Where electronic notification is not possible, the pharmacy contractor should send the notification via post, hand delivery or “safe haven” fax (this should only happen where the pharmacy has confirmed with the GP practice the number of the fax and that it is a “safe haven”).

Where the notification to the GP practice is undertaken via hardcopy/fax the national GP Practice Notification Form should be used:

NUMSAS – GP practice notification form (Word)

NUMSAS – GP practice notification form (PDF)

NUMSAS Briefing for GP Practices


Claiming payment

To claim payment for this service, contractors must complete the NHS Urgent Medicines Supply Advanced Service Pilot claim form and submit it to the NHS BSA, along with the completed FP10DT EPS dispensing tokens (completed as part of the NUMSAS), not later than the 5th day of the month following that in which the urgent supply was made.

The process will be separate to the submission of other FP10 forms, do not send the claim form with your prescription bundle at the end of the month. The completed form should be sent to Prescription Services, Bridge House, 152 Pilgrim Street, Newcastle upon Tyne, NE1 6SN in a secure manner that enables tracking and tracing of the delivery. 

PSNC Briefing 034/17: NHS Urgent Medicine Supply Advanced Service (NUMSAS) – checklist for completing an FP10DT EPS dispensing token and end of month submission process contains a checklist for completing an FP10DT EPS dispensing token after each referral and a checklist for submitting the tokens and claim form at the end of the month. 

PSNC Briefing 035/17: Services Factsheet – NHS Urgent Medicine Supply Advanced Service (NUMSAS) – how much will I be paid?  is a quick reference guide to see how much contractors will be paid for each referral they receive depending on the outcome of the referral.




Additional information can be found on the PSNC website at http://psnc.org.uk/services-commissioning/urgent-medicine-supply-service/

If you have any queries please contact Melissa Burnley, melissa@cpwy.org.



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Flu Vaccination Advanced Service 

The service specification and Patient Group Direction (PGD) for the community pharmacy Flu Vaccination Advanced Service 2018/19 has now been published and can be accessed on the links below.

Service Specification for the Flu Advanced Service - August 2018

The PGD for the 2018/19 service is available to download here.

There have been a number of changes for the 2018/19 flu service which contractors should familiarise themselves with before the start of the flu service on 1st September 2018. These include: 

  • The requirement for contractors to register to offer the service with NHS BSA has been removed.
  • Inclusion of additional patient cohorts  (hospice care workers have been added as an eligible group and social care workers, added as a temporary eligible group in November 2017, continue to be eligible for 2018/19).
  • Contractors can now administer vaccinations in patients’ homes.
  • Pharmacists need only undertake face-to-face training for the service every three years (this is an extension from the previous requirement for training every two years).
  • Payment claims from pharmacies can now be made electronically.

There has also been an uplift to payment for the service which has increased to £9.48 per vaccination.

Please ensure you read the service specification and Patient Group Direction and any other associated documents so that you are fully briefed on these changes. PSNC have published a useful summary of the changes here:

PSNC Briefing 041/18: Changes to the Seasonal Influenza Vaccination Advanced Service for 2018

AND also a useful guidance document (recommended read) here:

PSNC Briefing 042/18: Guidance on the Seasonal Influenza Vaccination Advanced Service for 2018 (the last 2 pages of this briefing (annex 1) is a helpful checklist for pharmacies to work through to ensure they have everything in place for the flu service.  You may want to print out this checklist and start to work through the actions so that your pharmacy is ready to provide NHS flu vaccines to patients as soon as vaccines are available on or after the 1st September 2018.

The service is due to commence on 1st September 2018, subject to amendments to the Secretary of State Directions being made by the Department of Health and Social Care. PSNC will notify contractors when the amendments have been made and the date they can commence provision of the service.

PSNC are holding a 60-minute webinar on the Flu Vaccination Service on Tuesday 21 August @ 7pm which will also be available to watch a few days after the event. This is a highly recommended watch for contractors and pharmacy team members who are involved in the service and will also include guidance on managing the vaccination of the 65 years and over group with Adjuvanted trivalent influenza vaccine (aTIV). See here.



Frequently Asked Questions

The PSNC website is a great source of information and resources for pharmacy teams. This includes a useful Frequently Asked Questions (FAQs) and answers page which are updated on an ongoing basis:

Flu Vaccination FAQs



Training Requirements for the National Flu Vaccination Service 2018/19

All pharmacy staff involved in the provision of the Flu Vaccination Service should receive appropriate training relevant to the role they will undertake. Contractors are required to demonstrate that all pharmacists providing the service in their pharmacy have the skills needed to do so. There are a number of organisations offering training and support for provision of flu vaccination services and contact details can be found on the PSNC website. See PSNC Flu Vaccination Training. 

Face-to-face training for injection technique and basic life support (including the administration of adrenaline for anaphylaxis) for pharmacists who intend to provide the service now needs to be completed at least every three years; previously this training was required every two years. 

The Community Pharmacy Competence Group has published a new combined Vaccination Services Declaration of Competence (DoC). Previously, there were two separate DoC frameworks for vaccination services; the NHS Seasonal Influenza Vaccination Advanced Service and other locally commissioned Immunisation services; these two have been merged into a single DoC. 

Therefore, pharmacists who intend to provide the Flu Vaccination Service and a locally commissioned influenza service will now only be required to complete one DoC. Pharmacists must review their DoC every two years; there is no need for all pharmacists to immediately complete the new single vaccination DoC unless they have not previously completed a DoC for flu vaccination or they are due to review their DoC.



Vaccines for 2018/19

The vaccines which can be used in the service are those listed in the national flu immunisation programme 2018/19 (DHSC/NHS England/PHE) and authorised for use by the PGD:


For the 2018/19 flu vaccination season, adjuvanted trivalent influenza vaccine (aTIV) (Fluad, Seqirus) should be offered to all those aged 65 and over, whilst adults aged under 65 in clinical at-risk groups should be offered a quadrivalent influenza vaccine. 

See links below for further information on this:

Poster - Flu Vaccines for the 2018/19 Season

PSNC Guidance For Contractors

NHSE Guidance - Flu Programme Delivery 2018

Guidance for Healthcare Professionals- Inactivated Influenza Vaccine Info

NHSE Guidance for Community Pharmacists: Advice for Patients Aged 65 and Over



Record Keeping & Data Requirements

In light of the General Data Protection Regulations and to facilitate the expansion of the post-payment verification process to cover the Flu Vaccination Service, the consent form and record form have been separated into two different forms for the 2018/19 service.

It is therefore important to discard any previously printed versions of the Flu Vaccination record and consent forms from previous years and ensure that the new forms are used.

The record form and patient consent forms can be downloaded from the PSNC website here.



Patient Questionaire 

Patients must be asked to complete a copy of the national patient questionnaire (annex E of the service specification) following administration of the vaccine. See PSNC website here.



Service Delivery Resources

Patient Leaflet - PHE Flu Vaccination 2018/19 (Who Should Have It & Why) (Hard copies of the leaflet can be ordered free of charge, via the online ordering portal or calling 0300 123 1002 and quoting the product code: 3079111C.)

CPWY Flu Poster 17/18

Tear Off Appointment Slip / Flyer

Key facts about flu and flu vaccination - to support discussions with patients

Myth Buster - to support discussions with patients

Identifying carers for flu vaccination

Patient Leaflet - PHE Flu Vaccination (easy read version)

Patient Leaflet - PHE Pregnancy & Flu

Patient Leaflet - Pregnancy & Flu (Kirklees)

Patient Leaflet - Carers

CPWY Flu Poster - 65 and Over

CPWY Flu Poster - Asthma

CPWY Flu Poster - COPD

CPWY Flu Poster - Diabetes

CPWY Flu Poster - Heart Condition

CPWY Flu Poster - Pregnant

Chapter 19 of the Immunisation Against Infectious Disease, “The Green Book”, can be downloaded here: https://www.gov.uk/government/publications/influenza-the-green-book-chapter-19



Resources to Support Pharmacy Teams

Factsheet: Eligible Groups For the National Flu Vaccination Service 2018-19 

Pharmacist Checklist for the Flu Vaccination Service

Flu Service - Are You Ready Check List



Flu Service Updates

Flu Service 18/19 Update - June 18

Flu Service 18/19 Update - August 18

Flu Service 18/19 Update - September 18

Flu Service 18/19 Update - October 18

Flu Service 18/19 Update - November 18 

Flu Service 18/19 Update - PSNC (050/18): Adjuvanted Trivalent Inactivated Influenza Vaccine (aTIV)

Flu Vaccination Service - Ordering Flu Vaccines for 2019-20



PharmOutcomes & Claiming Payment 

Claims for payment for the service can be made either electronically, using the NHS BSA webform or using the paper claim form, however, contractors should ensure they are making a single claim each calendar month. 

For electronic submissions, the NHS BSA will send a unique link to the webform to all community pharmacy premises-shared NHSmail accounts monthly which contractors can use to make a claim (further information on this process to follow).  

Contractors claiming using the paper form will be able to download and print copies of the claim form from the NHS BSA website (please note, this has not yet been published – further information to follow).  This form should be sent to the NHS BSA as part of the end of month script bundle submissions process and contractors are encouraged to submit claims for the service each month where they have been administered.

Claims will be accepted by the NHS BSA within six months of administration of the vaccination, in accordance with the usual Drug Tariff claims process. Late claims will not be processed.

It is expected that the NHS Flu Service will be available on PharmOutcomes by 1st September 2018 for West Yorkshire pharmacies. If you are using PharmOutcomes to record your flu vaccination delivery for the Advanced Service it is important to remember that for the national Flu Advanced Service PharmOutcomes will NOT automatically make a claim for payment. It does however generate a pre-populated pharmacy monthly return which you can print off or use when submitting your claim to the NHS BSA. Details of how to do this are in Provider User Guides on the Help tab on PharmOutcomes. The pharmacy monthly return is available to download on the first day of every month from the claim tab.



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Flu Vaccination for Carers

Now that carers can have a free NHS flu jab at their local pharmacy, Carers Trust has produced a range of resources to help pharmacy teams identify carers and offer them support.

Further information can be found at:  https://professionals.carers.org/flu-vaccinations-carers-guidance-community-pharmacies


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