This is an example post, originally published as part of Blogging University. Enroll in one of our ten programs, and start your blog right.

You’re going to publish a post today. Don’t worry about how your blog looks. Don’t worry if you haven’t given it a name yet, or you’re feeling overwhelmed. Just click the “New Post” button, and tell us why you’re here.

Why do this?

• Because it gives new readers context. What are you about? Why should they read your blog?
• Because it will help you focus your own ideas about your blog and what you’d like to do with it.

The post can be short or long, a personal intro to your life or a bloggy mission statement, a manifesto for the future or a simple outline of your the types of things you hope to publish.

To help you get started, here are a few questions:

• Why are you blogging publicly, rather than keeping a personal journal?
• What topics do you think you’ll write about?
• Who would you love to connect with via your blog?
• If you blog successfully throughout the next year, what would you hope to have accomplished?

You’re not locked into any of this; one of the wonderful things about blogs is how they constantly evolve as we learn, grow, and interact with one another — but it’s good to know where and why you started, and articulating your goals may just give you a few other post ideas.

Can’t think how to get started? Just write the first thing that pops into your head. Anne Lamott, author of a book on writing we love, says that you need to give yourself permission to write a “crappy first draft”. Anne makes a great point — just start writing, and worry about editing it later.

When you’re ready to publish, give your post three to five tags that describe your blog’s focus — writing, photography, fiction, parenting, food, cars, movies, sports, whatever. These tags will help others who care about your topics find you in the Reader. Make sure one of the tags is “zerotohero,” so other new bloggers can find you, too.

Update from UK FMD Working Group for Community Pharmacy

Now that the UK has left the EU and the Transition Period ends on 31st December 2020, some regulatory requirements will no longer apply. However, certain EU legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol.

Pharmacies in Great Britain

The ‘safety features’ elements of the EU Falsified Medicines Directive (FMD, 2011/62/EU) and Delegated Regulation (2016/161) cease to have effect in Great Britain from 31st December 2020. This means that pharmacies (and other end users such as wholesalers, hospitals and others handling or supplying medicines) will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.

• End users in Great Britain will be disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK. This means that it will no longer be possible to verify and authenticate packs from 1st January 2021. Pharmacy operators and system suppliers need to check that any integrated pharmacy systems with FMD functions are no longer actively connecting to or seeking a response from the UKMVS after the end of 2020. Stand-alone FMD systems can simply be turned off.
• Integrated pharmacy systems can still use batch details, expiry dates or product details (GTINs) from packs’ 2D barcodes while these packs are still in circulation. However, pack serial numbers no longer have any function. These packs remain valid and can be dispensed for as long as they are still in date.
• SecurMed UK will continue to provide end user registration and necessary support up to 31st December 2020 for end users in Great Britain.

Pharmacies in Northern Ireland

Under the terms of the Northern Ireland Protocol, part of the UK’s Withdrawal Agreement with the EU, FMD will still apply in Northern Ireland, for at least four years (until the NI Protocol is due to be reviewed).

• End users in Northern Ireland will remain connected to the UKMVS. They need to continue to verify and decommission any packs with the 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 in to 2021 and beyond.

The UK participated in discussions with the EU to agree a phased implementation of medicines regulations in Northern Ireland, under the NI Protocol, by 1 Jan 2022. The UK published a statement, agreed with the EU, on 5 Nov 2020 confirming a 12-month phased implementation of the Falsified Medicines Directive and regulatory importation requirements for medicines moving from GB to NI. Work is continuing with the EU to agree operational specifics. Please check the latest guidance for industry, the first version of which was due to be published soon after the release of this document.

https://www.gov.uk/government/news/irelandnorthern-ireland-specialised-committee-05-november-2020

Future national falsified medicines system

The Medicines and Medical Devices Bill (progressing through Parliament) would enable the Government to make regulations aimed at preventing falsified medicines from entering the medicine supply chain. This could include establishing a national system based on the unique identification of individual packs that enables medicines to be authenticated and identified if tampered with. The Government will have to consult with industry stakeholders, including pharmacy organisations, before introducing any new Regulations. No timetable has been set by the Government for consultation.

Actions to take

Great Britain: End users should check that any integrated pharmacy systems are no longer actively connecting to or seeking a response from UKMVS from the end of 2020. Turn off or disconnect any stand-alone FMD systems after 31st December.

Northern Ireland: End users should ensure they are registered with SecurMed UK (www.securmed.org.uk), if they have not already done so. Pharmacy teams should continue to verify and decommission FMD-compliant packs of prescription medicines. Refresher training should be carried out if needed.

Q&A

How do I register for access to the UKMVS?
https://securmed.org.uk/what-do-you-want-to-do/registration-process/

How do I get help?
In the first instance please contact your Software Supplier. Check the SecurMed UK website: http://www.securmed.org.uk

Further information is available on FMD Source (fmdsource.co.uk).

The UK FMD Working Group for Community Pharmacy brings together the main pharmacy bodies representing community pharmacy to influence and inform the implementation of FMD in the UK

16.11.2020

The serialisation and authentication requirements of the EU Falsified Medicines Directive (FMD) came into force on 9 February 2019. The UK is still subject to EU regulations during the post-Brexit transition period which will run until at least 31^st December 2020.

The General Pharmaceutical Council has stated it will take action if pharmacies “blatantly disregard FMD”.

Negotiations on the UK’s future relationship with the EU, which are due to take place during 2020, will determine whether FMD still applies within the UK in the future.

There is a strong likelihood that the UK government will introduce its own version of FMD, should the European directive no longer apply. We do not expect any clarity on the long-term future of FMD until the second half of 2020 at the earliest.

SecurMed, the organisation which runs the UK Falsified Medicines Directive (FMD) hub, will be changing the wording of the eleven alert messages and one related system message produced by the hub when the data on the pack of a medicine gives cause for concern for its authenticity.

Both the “Description” and “Short Description” are being amended to make them more understandable to users of the system; this change follows discussions between SecurMed, the UK FMD Working Group for Community Pharmacy and some FMD system suppliers.

See the revised messages on the SecurMed website

The change will be made effective on Sunday 17th March 2019.

Implications for pharmacy teams

This does not alter the way you use your FMD system, but you may start to see the amended wording appearing when you use your system following the change. If your Standard Operating Procedures contain details of the FMD alert messages, you may want to update your procedures to reflect the new wording.

Updated UK FMD Working Group for Community Pharmacy interim guidance

The interim guidance published by the UK FMD Working Group for Community Pharmacy has been updated to reflect the revised FMD alert wording which will start to appear in FMD systems from Sunday 17th March 2019:

Interim guidance on dealing with FMD alerts (version 2 6/3/19)

The final phase of FMD implementation begins on 9th February 2019. FMD is a huge project and it is important that during the initial period, medicines are not unreasonably withheld from patients, unless there is a high degree of suspicion that the pack might be falsified.

At present, there are not many FMD-compliant packs in pharmacies. We also know that some generic medicine packs that have a 2D data matrix are not actually FMD-compliant packs (one indication of this is that they do not have an anti-tampering device). If you scan them the system will generate an alert.

In the initial phase of implementing FMD, many “false positive” alerts are expected; this does not necessarily indicate a falsified medicine, and in most cases it will be appropriate to dispense the medicine, subject to the normal checks. The alerts will reduce in number as more of the packs reaching pharmacy are FMD-compliant.

The UK FMD Working Group for Community Pharmacy has today (7/2/19) published interim guidance for pharmacy teams on dealing with FMD alerts generated when products are scanned.

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New MHRA guidance

The MHRA issued the following guidance on 7th February 2019:

Guidance on safety features: 7 February 2019

The United Kingdom is committed to meeting the 9 Feb 2019 deadline for the launch of EU FMD safety features Delegated Regulation, and we expect all stakeholders in the UK supply chain to be aiming to comply with these new requirements, indeed we know much of the UK supply chain is already prepared.

Despite the significant work undertaken to date in the UK and given the complexities associated with setting up the medicines verification system across the EU it is anticipated issues will arise especially during the initial operational/implementation phase. It is important that these issues do not compromise confidence in the medicines supply chain. The Government’s priority is the continued supply of safe medicines to patients.

For example, several Member States have formally advised those who may receive ‘unknown’ error messages to dispense anyway. Therefore, the MHRA will also be taking a pragmatic, flexible approach to how we enforce the new legal requirements, as long as the normal checks are carried out, and there is no reason to think that the medicine is falsified. This position will be kept under review.

We are also aware of issues around non-FMD compliant packs released to market before 9 February 2019, and wholesalers’ designated status, We will continue to work with UK stakeholders to help bring them into full compliance with the safety features regulation as soon as possible.

https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features#history

Community pharmacies must work towards compliance with the Falsified Medicines Directive (FMD) in time for February 9th deadline irrespective of any Brexit scenario, pharmacy bodies have said.

The guidance, from the UK FMD Working Group for Community Pharmacy, follows recent meetings between the regulators, the government and the Working Group itself.

In particular, it concerns the safety features Regulation under FMD that requires medicines packaging to have a unique 2D-barcode and an anti-tampering device, both of which must be checked at various points in the supply chain.

Chair of the Working Group, Raj Patel, said:

“All parties recognise the challenges around FMD and we are confident that the regulators will take a pragmatic and even-handed approach to enforcement.

“Nevertheless, pharmacies must make efforts to be compliant with the new FMD safety features, by the deadline.

“Pharmacies must act promptly, but they must also act properly to ensure they are prepared for the new FMD safety features.

“They must carefully consider the terms of any contract for FMD solutions and make sure they are futureproof in any post-Brexit scenario.

“Other practical adjustments might be required, such as modifying dispensing workflows and all pharmacies will need to update their standard operating procedures.

“However, there will be very few packs of medicines in pharmacies with the FMD safety features, on February 9th, as they will take time to come through the medicines supply system, so inevitably the sector is on a journey towards full implementation.”

From February 9th, pharmacies must check the integrity of the anti-tampering device and scan the 2D barcode to mark each pack as decommissioned (or dispensed) in the FMD database.

It is understood there will be significant quantities of medicines in the supply chain that do not carry the new safety features, after February 9th, but it can still be wholesaled and dispensed.

Pharmacies are expected to have clear standard operating procedures in place to empower individuals to make judgement calls they could later justify, rather than disrupt supply to patients.

General Pharmaceutical Council inspectors will not focus unduly on any single issue and will assess the pharmacy in the round considering the health, safety and wellbeing of patients and the public.

The MHRA and General Pharmaceutical Council (GPhC) have today (17th January 2019) published a joint statement on their respective roles in relation to the enforcement of the FMD legislation in England, Scotland and Wales.

The GPhC will use its existing inspection processes to assess whether pharmacies are meeting its standards. For those registered pharmacies that are found not to have met the standards for registered pharmacies, and where a contributing factor relates to breaches of the new safety feature provisions, the GPhC will use its regulatory powers, including improvement action plans, to make sure that pharmacies take action to meet the standards and requirements under legislation.

The MHRA is responsible for making decisions on and instigating any enforcement action in relation to the safety features legislation, which may include seeking compliance, enforcement notices or, as a last resort, criminal prosecution for the most serious, persistent breaches.

The GPhC and the MHRA will share information, as appropriate, to ensure that the purpose of the legislation is met and that medicines supplied from registered pharmacies are safe for the public to use.

Read the full joint statement

In July 2018, the Government launched a public consultation on the steps proposed to make sure the UK meets its obligations to transpose the provisions of the Falsified Medicines Directive (FMD) requiring ‘safety features’ to appear on the packaging of certain medicinal products.

The consultation closed in September, and the MHRA has published the following document which provides their official response to the more than 50 replies received from a wide range of stakeholders.

Final consultation response: FMD features

As with all EU regulations, the Delegated Regulation on ‘safety features’ will apply automatically in all EU Member States and therefore, as of 9 February 2019, these new requirements will be directly applicable as part of UK law.

The consultation focused on the national flexibilities in the Delegated Regulation, and the level of sanctions applied to a breach of each new requirement, for which the Government  is obliged to take additional legal steps, culminating in the laying of a Statutory Instrument in Parliament.

Overall, the responses broadly supported the Government’s proposed positions regarding the level of sanctions imposed and on each national flexibility, where the UK has legal scope to make changes. Therefore, the Government intends to implement as per the positions proposed in their consultation, with the exception of Article 26(3), which exempts those within a healthcare institution from decommissioning under certain conditions. The Government did not originally see any benefit of applying this flexibility, but now understands it could be beneficial for certain healthcare institutions, in line with the criteria fixed in the Delegated Regulation.

Their additional guidance on Article 23 providers, Healthcare Institutions and Article 26 exemption is available here:

Additional guidance on Article 23 providers, Healthcare Institutions and Article 26 exemption

The Royal Pharmaceutical Society (RPS) has launched professional decision-making guidance for FMD.

Extracted from the guidance notes available on FMD Source’s EU FMD scanning and error messages page, the guidance advises pharmacy teams on situations in which they should (and should not) dispense a product.

The new guidance is available at: https://www.rpharms.com/resources/ultimate-guides-and-hubs/fmd

The UK FMD Working Group for Community Pharmacy has issued new guidance for FMD early adopters. The presentation will help them train pharmacy teams to recognise the types of packs that will need scanning for verification and authentication, and the features they need to look out for, as well as the types of pack that will not need authentication.

The latter includes the vast majority of existing stock that does not carry the necessary safety features (both a 2D data matrix barcode and an anti-tampering device) – this can continue to be dispensed as normal. Products that are out-of-scope for FMD are also highlighted. These include non-prescription medicines, medical devices and specialist food supplements.

FMD presentation (3) Guide on which packs to scan

The guidance will be updated with new examples of the “right” and “wrong” types as the early adopter programme is extended.

View other FMD presentations