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Management of Product Information
– Summary of PIPA Webinar
By Charlotte Mason
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In March 2021, Harpreet Sandhu, from the PIPA Committee, presented a PIPA MI webinar on the management of product information. Harpreet was joined by Nat Knight and Claire Cox from Datapharm. The session was structured around these topics: - The Ireland/Northern Ireland Protocol
- The importance of the NHS Dictionary of Medicines and Devices (dm+d) and keeping it up to date - Best practice on managing digital prescribing information
In this article, I have summarised the salient points relating to the Protocol on Ireland/Northern Ireland and the NHS Dictionary of Medicines and Devices.
Protocol on Ireland/Northern Ireland
Claire and Nat kicked off the webinar with an explanation of the various marketing authorisation (MA) procedures and what has changed with the implementation of the Ireland/Northern Ireland Protocol.
Essentially, since the end of the transition period on 31-December-2020, the Ireland/Northern Ireland protocol applies. Medicines that are marketed in Northern Ireland fall under different obligations than the rest of the UK. From 1 January 2021, EU pharmaceutical law applies to the UK in respect of Northern Ireland only. All Pharmaceutical companies had until 31 December 2020 to ensure that their centrally and nationally authorised medicines complied with EU law in order to remain on the EU market.
According to the Ireland/Northern Ireland protocol, the national MAs for medicinal products issued by the United Kingdom in respect of Northern Ireland, UK(NI), must comply with Article 17 and 18 of Directive 2001/83/EC, i.e. they have to go through the decentralised procedure (DCP) or the mutual recognition procedure (MRP) if the applicant already holds an MA for the same product in an EU/EEA member state (MRP), or applies for MAs for the same product in any EU/EEA member state(s) (DCP). There are several different Marketing Authorisation application procedures: • Centralised Procedures • Decentralised and Mutual Recognition Procedures • National Procedures
• Unfettered Access Procedures
Centralised Procedures
Products that were approved by the European Medicines Agency (EMA) are centrally approved products (CAPS). All existing CAP MAs automatically converted into UK MAs, effective in GB only. As a result of the Ireland/Northern Ireland Protocol, existing CAPs will remain valid in NI. Under the Ireland/Northern Ireland Protocol, Medicinal Products authorised via the centralised route will be directly authorised for use in Northern Ireland. Any variations to these Marketing Authorisations will be centrally managed by the EMA in accordance with relevant procedures. A separate MA will not need to be issued by the Medicines and Healthcare products
Regulatory Agency (MHRA) for Northern Ireland.
Decentralised and Mutual Recognition Procedures
Under the Ireland/Northern Ireland Protocol, Medicinal Products authorised via the mutual recognition procedure/ decentralised procedure from 1 January 2021, where Northern Ireland is specifically included as a concerned member state (CMS), may be authorised for use in Northern Ireland only.
National Procedures
Under the national procedure, the MHRA can grant MAs for UK, GB, or NI. MAs authorised in the UK by the MHRA before 1st Jan 2021 continue to have effect across the UK (GB & NI). This includes MAs that are currently, and will continue to be, part of any MRP/DCP. For new active substances there is a Rolling Review route.
Unfettered Access Procedures
Unfettered Access Procedures (UAP) relate to MAs approved in Northern Ireland. This procedure allows Great Britain MA approval for an existing MA that covers Northern Ireland and is available to NI MAs approved via centralised procedures or MRPs/DCPs.
What is the dm+d database?
The NHS Dictionary of Medicines and Devices (dm+d) is the standard dictionary for the medicines and devices used across the NHS. The dm+d provides [1]: • The recognised NHS standard for uniquely identifying medicines and medical devices used in patient care • Clear, consistent recording and communication of information relating to medicines and devices used in patient care • Consistency in how medicines and medical devices are written through a robust published editorial policy The Standardisation Committee for Care Information (SCCI) has approved the dm+d as the NHS standard for communicating medicines information. [1]
What information is stored in the dm+d database?
The dm+d contains standardised codes, descriptions and metadata for every product entry as well as the following [1]: • whether a product will be reimbursed by the NHS, if submitted for reimbursement by a dispensing contractor
• the indicative price of each pack of a product (where a price is maintained by the NHS) • current and discontinued products and packs available from manufacturers and suppliers
When to update dm+d
Harpreet formulated a checklist of situations where you will need to update the dm+d with information about your
company’s products. I have created the graphic below to illustrate the checklist:
The process will vary from company to company, in terms of which department is responsible for updating dm+d about product changes. You can check the emc (www. medicines.org.uk) website for further details on the service they offer for updating dm+d, or you can contact the NHS Business Service Authority (BSA) directly to provide updates on your company’s products: www.nhsbsa.nhs.uk/nhs-prescription-services If you’d like to learn more about dm+d, I can recommend spending 10 minutes watching a webinar on what the dm+d database is, the background to its implementation and why it is so important for the NHS. The introductory webinar is accessible via the following website:
https://dmdlearning.s3.eu-west-2.amazonaws.com/ dmd_Introduction/index.html I was grateful to have the opportunity to watch the recording of this PIPA webinar and I found it to be very informative and insightful. I’d like to thank the presenters, Harpreet, Nat, and Claire for their efforts. I hope our MI members also found it beneficial.
Don’t forget - we always welcome ideas for topics for our webinars. If you have an idea for one or would like to help present on a particular subject, please do get in touch via pipa@pipaonline.org. We would really like to collaborate with the PIPA membership and present medical information topics that you are interested in and find relevant to the industry.
References
The NHS Dictionary of Medicines and Devices (dm+d) website: [Last accessed 04-Nov-2021]
Charlotte Mason
Associate Director Medical Information Jazz Pharmaceuticals
