Dear Contractor

Update on the Falsified Medicines Directive (FMD) in Northern Ireland post 31 December 2020

Background

As you are aware, the UK has left the EU and the Transition Period ends on 31 December 2020.

On that date, some regulatory requirements will no longer apply but certain EU legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol (NIP) (part of the UK’s Withdrawal Agreement with the EU).

The UK FMD Working Group for Community Pharmacy has issued an update outlining the position of the Falsified Medicines Directive (FMD) in Northern Ireland post 31 December 2020 (attached).

Summary

Under the terms of the NIP, the FMD will still apply in Northern Ireland, for at least four years (until the NIP is due to be reviewed).

  • All end users in Northern Ireland, including pharmacy contractors, will remain connected to the UK National Medicines Verification System (UKMVS) run by SecurMed UK.  They need to continue to verify and decommission any packs with FMD safety features (unique identifiers and anti-tamper devices) in line with the requirements of relevant EU and UK medicines legislation.
  • SecurMed UK will continue to provide end user registration and necessary support to enable Northern Ireland end users to decommission packs with FMD identifier features into 2021 and beyond.

Action

Contractors are asked to:

  1. Ensure that their dispensary teams are aware of the content of this letter;
  2. Ensure that their pharmacy is registered with SecurMed UK (https://securmed.org.uk/what-do-you-want-to-do/registration-process/) if not already registered; and
  3. Continue to verify and decommission FMD-compliant packs of prescription medicines.  Refresher training should be carried out if needed.

For further guidance please contact your software supplier in the first instance, and check for further help on the SecurMed UK website (www.securmed.org.uk).

The CPNI team will continue to support you on these matters.

Kind regards

Mike

Sent on behalf of Prof Mike Mawhinney | Head of Regulatory Affairs

Download

Dear Colleague

IMPORTANT UPDATE to NORTHERN IRELAND CONTACT TRACING SERVICE & PERSONAL PROTECTIVE EQUIPMENT (PPE) ORDERING

Please find attached for your attention, correspondence from Joe Brogan, Assistant Director of Integrated Care, Head of Pharmacy and Medicines Management.

Summary

  • Northern Ireland Contact Tracing Service Update

It has been agreed with the Northern Ireland Contact Tracing service that community pharmacies will be recognised as a primary care clinical setting and that assessments will be performed by one of the PHA clinical leads.

  • PPE Ordering Update

The quantities of PPE mask type IIR that can be ordered by community pharmacies for normal pharmacy activity have been amended and allocation will be made based on the average number of staff working in each community pharmacy per day.

Contact Details for Local Integrated Care Offices:  

Yours sincerely

SENT FOR AND BEHALF OF GERARD GREENE | Chief Executive

Download

Dear Colleague,

CPNI appreciates there is an ever increasing volume of contractor emails to keep on abreast of. As a result CPNI will be sending out a weekly summary of ‘Drug Alerts’ and ‘Shortage Updates’.

In the meanwhile, pharmacy team(s) can keep updated with drug alerts and shortages information via CPNI’s contractor calendar here or via the BSO website here.

Weekly Summary 13.11.2020
Drug alerts available here: BSO Communications (Drug Alerts)
MPS 2732 – Medicines Recall – Ancotil 2.5g/250ml sol for infusion 12th November 2020
MPS 2731 – Medicines Recall – Sodiofolin 50mg/ml sol for injection 11th November 2020
MPS 2728 – Medicines Defect Information – Kolanticon Gel 200ml 10th November 2020
Shortages Information available here: BSO Shortages Information
MPS 2730 – Trifluoperazine 1mg in 5ml syrup – Supply Alert 11th November 2020
MPS 2729 – Dulcolax (bisacodyl) 5mg and 10mg Supp  – Supply Alert 11th November 2020
MPS 2725 – Nalcrom 100mg caps – Supply Alert Updated 11th November 2020
MPS 2722 – Konakion MM Paediatric – Supply Alert Updated 11th November 2020

Please bring this to the attention of your pharmacy team(s).

Kind regards,

Kerry

Sent on behalf of Kerry Grimes | Governance & Support Pharmacist

Dear Colleague

HSC (SQSD) 5/19 EARLY ALERT SYSTEM  – UPDATED CIRCULAR

Please find attached for your attention, correspondence from Dr. Lourda Geoghegan, Deputy Chief Medical Officer.

Summary

The Early Alert System provides a channel which enables HSC Chief Executives to notify the Department in a prompt and timely way of events or incidents which have occurred in the services provided or commissioned by their organisations, and which may require immediate attention by Minister, Chief Professional Officers or policy leads and/or require urgent action by the Department.

Action

Contractors should note:

  • The content of this letter
  • Family Practitioner Services should notify the HSC Board about events within the services they provide that meet one or more of the criteria as described in Annex A. The HSC Board will then notify the Department.
  • It is the responsibility of the reporting Family Practitioner Service practice to ensure that a senior person from the practice speaks in person to the Director of Integrated Care (or deputy) in the HSC Board regarding the event.
  • COVID 19 incidents/outbreaks that are being managed as part of usual business should not be routinely reported through the Early Alert system. Community Pharmacies should continue to provide regular updates to HSCB through established SITREP arrangements.

Yours sincerely

SENT FOR AND BEHALF OF GERARD GREENE | Chief Executive

Download

Dear Colleague

URGENT ALERT – Missing Prescription Pad

The Counter Fraud and Probity Services Department of the Business Services Organisation ask all Community Pharmacists to be vigilant about district nursing scripts that have gone missing, details of which can be found in the attached letter.

Please bring this to the urgent attention of your pharmacy team(s).

Yours sincerely

SENT FOR AND BEHALF OF GERARD GREENE | Chief Executive

Download