Announcement of extension to FMD ‘use and learn’ period in Ireland

8^th May 2019

Decision to extend ‘use and learn’ phase

New FMD safety feature requirements came into effect on 9th February. During this time, the system in Ireland has been in ‘use and learn’ phase to ensure the continuity of safe supply of medicines to patients while all parties gained a better understanding of the new system.

The national Safety Features Oversight Group comprising the Irish Medicines Verification Organisation (IMVO), the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the Health Service Executive (HSE) and the Private Hospitals Association (PHA) has been closely monitoring progress since go live on 9th February. Taking all factors into account, the group has decided that the use and learn period will be further extended until 9th September 2019 to allow additional time for the system to stabilise. The situation will be reviewed again at that stage.

Progress since go live

Significant progress has been made on several fronts since 9th February:

The vast majority of pharmacies, hospitals and wholesalers have registered with IMVO and are connected to the national system.
Between 50,000 and 60,000 thousand scans are taking place daily in Irish pharmacies, hospitals and wholesalers and this number is growing week on week.
Barcode data for over 100 million packs has been uploaded to the national system by manufacturers. The number of packs bearing 2D barcodes in pharmacies will increase over the coming weeks and months as these packs work their way through the supply chain.
Extensive analysis of alerts is taking place across Europe, resulting in greater understanding of their root causes and the rollout of initiatives to reduce the number of alerts being generated.

Alerts

It was anticipated that significant numbers of alerts would be generated by the verification system across Europe after go-live due to technical glitches and other teething problems as the system bedded in. Over 600,000 alerts have been generated in Ireland since 9th February. There are many root causes for these alerts including system bugs, data not uploaded or uploaded incorrectly by manufacturers, as well as actions related to the scanning of packs by pharmacies, hospitals and wholesalers, including scanner configuration issues, errors in how FMD systems handle barcode data, and the wrong type of barcode or non-FMD packs being scanned.

Across Europe, national medicines verification organisations (NMVOs) – including IMVO, the European Medicines Verification Organisation (EMVO), manufacturers/marketing authorisation holders (MAHs) and bodies representing end-users (pharmacies, hospitals and wholesalers) have been sharing knowledge and experience relating to alerts and how to eliminate them. Actions taken to address the known causes include bug fixes, the issuing of guidance on configuration of scanners and end-user systems, as well as contacts with end-users and manufacturers generating the largest numbers of alerts.

What will happen during the next phase of use and learn?

During the next phase of use & learn, efforts to eliminate avoidable errors will intensify across Europe. Here in Ireland, this will require co-operation between IMVO, pharmacies, hospitals, wholesalers and manufacturers/MAHs. It is expected that all parties will take whatever action they can to support this objective, including co-operating with alert investigations by IMVO and complying with guidance issued by IMVO and regulatory authorities such as the HPRA and PSI. IMVO will not be investigating individual alerts during this period but will continue to focus on trends and unusual events.

The instructions issued at the start of the use and learn period in February will continue to apply during this next phase, i.e:

All medicinal products released by MAHs for the Irish market since 9^th February should bear the safety features as required i.e. a tamper proof seal (anti-tamper device) and 2D barcode.
Wholesalers, pharmacies and hospitals must scan all medicines bearing the safety features and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved.
All alerts generated in pharmacies, wholesalers and hospitals, upon scanning a pack during the ‘use and learn’ phase are forwarded by the system to the IMVO, the HPRA and the manufacturers/MAHs so that they can be investigated and monitored.
Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the HPRA (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack.

National legislation including the provisions of Article 23 of the Delegated Regulation was introduced in February, however, offences for breaches of the legislation will not be commenced until after the use and learn phase.

What am I expected to do now?

Pharmacies/ hospitals

Continue with the instructions as outlined at 2-4. above. Additional information obtained since the system went live that may be helpful is detailed below:

Check that your scanner is correctly configured. If unsure, contact the supplier of the scanner or IMVO for further guidance (email: info@imvo.ie or 01-5715320).
Start scanning if you haven’t already done so but only scan FMD packs. Do NOT scan the following as doing so is likely to generate alerts:

- Packs without an anti-tamper device, even if there is a 2D barcode. The absence of the anti-tamper device is an indicator that the pack is not an FMD pack.
- Linear barcode or QR codes
- OTC packs that carry 2D barcodes. These are not FMD packs.
- Medical devices that carry 2D barcodes. These are not FMD packs.

(See Figures 1 and 2 for more information on what an FMD pack looks like and what barcodes to scan/not scan)

Make sure your FMD system is set in the correct mode when scanning, e.g. ‘supply’, not verification, if you want to decommission the pack.
Co-operate with requests for information from IMVO when they are investigating alerts.

Final reminder to register with IMVO / connect to national system if you haven’t already done so:

See IMVO website for details of how to register.
If you have registered with IMVO but not yet connected your FMD system to the national system, you must do so as soon as possible using the technical details that were emailed by IMVO after your registration application was processed. Contact your FMD system provider for support with this step.

Wholesalers

Continue with the instructions as outlined at 2-4. above. Additional information obtained since the system went live that may be helpful is detailed below.

Check that your scanner is correctly configured. If unsure, contact the supplier of the scanner or IMVO for further guidance (email: info@imvo.ie or 01-5715320).
Start scanning if you haven’t already done so but only scan FMD packs. Do NOT scan the following as doing so is likely to generate alerts.

(See Figures 1 and 2 for more information on what an FMD pack looks like and what barcodes to scan/not scan)

Make sure your FMD system is set in the correct mode when scanning, e.g. ‘supply’, not verification, if you want to decommission the pack.
Co-operate with requests for information from IMVO when they are investigating alerts.
Consider scanning (with the scanner set to ‘verification’ mode) one pack from each incoming batch to verify that all is in order. Remember to set the scanner back to ‘supply’ mode when going to decommission packs. If the verification scan flags an issue relating to the data, it would be helpful if feedback can be provided to the relevant manufacturer/MAH, so they can take action to correct the problem.

Final reminder to register with IMVO / connect to national system if you haven’t already done so:

See IMVO website for details of how to register.
If you have registered with IMVO but not yet connected your FMD system to the national system, you must do so as soon as possible using the technical details that were emailed by IMVO after your registration application was processed.

Manufacturers / MAHs

Continue with the instructions as outlined at 1. above. Additional information obtained since the system went live that may be helpful is detailed below.

Ensure that data is correctly uploaded to the EU Hub for serialised packs.

- Upload corrected data if you become aware of errors with a batch.
- Upload data for serialised packs that were placed on the market in Ireland prior to 9^th February. Otherwise, these packs will generate alerts when scanned by an end-user.
- Ensure that expiry dates being uploaded to the EU Hub are identical to those encoded in the 2D barcodes on packs – see recent EMVO letter of announcement re expiry date mismatches for further details.
- Contact the EMVO Helpdesk if you any queries about data upload:

- Email: helpdesk@emvo-medicines.eu

- Tel: +372 611 90 44

Co-operate with requests for information from IMVO when they are investigating alerts.
See HPRA website for MAH-specific information about alerts and quality defect reporting obligations.
If you have any queries about alerts generated in the Irish system, please contact IMVO (email: alert.support@imvo.ie).

New medicines security features further protect supply chain for medicines

8th February 2019

A new national and European system, giving patients further protection from the threat of counterfeit medicines comes into effect tomorrow (Saturday 9th February 2019). Throughout Europe, medicine packs will have enhanced tamper-proof measures and will now carry a barcode with a unique serial number so that each pack can be scanned in a pharmacy. It will be checked against a central database to ensure the product is legitimate before handover to a patient. Established and managed by the Irish Medicines Verification Organisation (IMVO), the new national system provides an additional layer of security to protect the supply of medicines at pharmacy and patient level. Ireland is now in compliance with the EU Falsified Medicines Directive (FMD), which provides more safeguards and security to ensure Irish patients will continue to have absolute confidence in the medicines they receive from their pharmacy.

According to Pat O’Mahony, Chair, IMVO, “Setting up this advanced and robust verification system is a significant undertaking as a result of over three years of collaboration by the key Irish stakeholders including pharmaceutical manufacturers, parallel distributors, wholesalers as well as community and hospital pharmacists. Substantial work and investment has been required by everyone in the medicines supply chain to have the system up and running and in place as appropriate to the legislation coming into effect.
“Although there has been no risk or reported incidents at pharmacy level from counterfeit or falsified medicines in Ireland, other countries have had issues so this new system provides further security and protection for Irish patients now and into the future. Counterfeit medicines can pose serious risks to health, as there is no guarantee of their quality or safety,” he says.

The initiative has involved the collaboration of over 2,000 pharmacies, hospitals and wholesalers in Ireland who distribute dispense over 95 million prescription medicines every year, as well as the manufacturers who make the products. Each pharmacy now has a scanner to check each pack before it is dispensed to the patient. The scanner connects to a central database of prescription-only medicines manufactured, distributed and supplied for sale in Ireland.

Patients will see the new safety features appear on medicine packs as they come onto the market this year. Each pack will have a:

Barcode (2D matrix barcode) containing data unique to that pack; and
Anti-tamper device to provide assurances that the pack has not been interfered with, e.g. glued flap, sticky seal, plastic break-seal.

Speaking today, Minister for Health Simon Harris, TD, said: "The purpose of the regulation is to improve patient safety and maintain confidence in the safety of medicines supplied to patients. Nothing in the new regulations seeks to alter the existing legal and regulatory responsibilities of persons authorised to place medicinal products on the market or supply them to the public. It will apply to manufacturers, wholesalers, pharmacy owners and pharmacists equally. This new national system provides further security and protection for Irish and European patients now and into the future.”

The system is based on providing an alert if the barcode is not identified when scanned. A clear protocol then follows to investigate these alerts, involving the location where the pack was scanned, the manufacturer, the Health Products Regulatory Authority (HPRA), the IMVO and its European counterpart, the European Medicines Verification Organisation (EMVO).

For the next number of months, medicine packs with and without the individual serial number will be available at the same time as the existing stocks are gradually replaced by new packs with safety features. There is also a period of time allowed to bed in the new system across the country so alerts will be monitored and managed without any impact on medicine supply during this ‘use and learn’ phase.

IMVO advises that purchasing prescription-only medicines from the internet or other unauthorised sources is illegal and there is a high risk that these products are counterfeit, not safe for use, and do not contain the active ingredient required to make the medicine work. When you receive medicines from your pharmacist, always listen to their advice and follow the steps outlined in the package leaflet.

For Further Information:

Weber Shandwick PR 01 679 8600

Siobhan Molloy / Jo Twamley 086 817 5066 / 085 143 8320

Notes to Editors

IMVO is a not-for-profit organisation established by the key stakeholders across the medicines supply chain in Ireland to manage the national medicines verification system for Ireland:

Association of Pharmaceutical Parallel Distributors (www.aippd.ie) which represents active parallel importers in Ireland.
Irish Pharmaceutical Healthcare Association (www.ipha.ie) which represents the international research-based pharmaceutical industry in Ireland.
Irish Pharmacy Union (www.ipu.ie) which is the representative and professional body for community pharmacists in Ireland.
Medicines for Ireland (www.medicinesforireland.ie) which represents Irish-based manufacturers and suppliers of generic OTC, biosimilars and hybrid medicines.
Pharmaceutical Distributors Federation Ireland which represents full-line pharmaceutical wholesalers.

IMVO has worked extensively over the last three years with the relevant State organisations to ensure a successful system is in place. This includes close collaboration with the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI) and the Health Service Executive (HSE). There has also been extensive collaboration with the European Medicines Verification Organisation (EMVO) and other national medicines verification organisations to ensure that the system across Europe is ready for the 9^th February deadline.

This new initiative is part of the European Commission’s Delegated Regulation (EU) 2016/161 on Safety Features on Medicinal Products for Human Use. The Delegated Regulation supplements the Falsified Medicines Directive 2011/161/EU, by setting out detailed rules for the safety features appearing on the packaging of medicinal products for human use.

IMVO is part of a European-wide network of national medicines verification organisations, all operating national databases connected together via an EU Hub managed by the European Medicines Verification Organisation. This advanced and robust verification system ultimately captures the data of all medicines legitimately manufactured and supplied across Europe.

Counterfeit medicinal products are now officially known as ‘falsified medicinal products’ under EU medicines legislation. Falsified medicines may contain ingredients which are of poor quality or in the wrong dose.

Announcement of national approach to safety features implementation – initial ‘use and learn’ phase

5th February 2019

Following discussions at a national level between the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the HSE and Private Hospitals Association (PHA) stakeholder representatives and IMVO, it has been decided to adopt a pragmatic approach to the implementation of the Delegated Regulation (and the associated statutory instrument) after the go live date, to ensure the continuity of safe supply of medicines to patients while all parties gain a better understanding of the new system. This means that:

All medicinal products released by MAHs for the Irish Market after Feb 9^th should bear the safety features as required i.e. a tamper proof seal and 2D barcode.

During the initial period of operation, the system will be considered to be in ‘use and learn’ phase. Therefore wholesalers, pharmacies and hospitals should scan medicines bearing the safety features and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved.

All alerts generated by FMD system in pharmacies, wholesalers and hospitals, upon scanning a pack during this ‘use and learn’ phase will be forwarded by the system to the IMVO, the HPRA and the pharmaceutical companies so that they can be investigated and monitored.

Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the HPRA (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack.

National legislation including the provisions of Article 23 of the Delegated Regulation will be introduced, however, the offences provided for in the Regulations will not be commenced for a period of time to let the new system bed in.

During this period, the alerts generated will be analysed by the Department of Health, IMVO, HPRA, PSI, HSE and the private hospital pharmacies to determine why they are occurring and develop appropriate protocols for their resolution. Manufacturers (and marketing authorisation holders (MAHs) will also be involved in the investigation of alerts generated against their products. The system will be reviewed again in three months’ time. This approach will ensure that medicines continue to be provided to patients without delay and also ensure that all stakeholders, manufacturers, wholesalers, pharmacists and other healthcare professionals work to build confidence in operating the new safety system.

Formal notification of this agreed national approach has been issued today to pharmacists, wholesalers, MAHs and manufacturers by the PSI and the HPRA. IMVO is very appreciative of the careful consideration given to the matter by the authorities in Ireland and we will continue to work closely with them over the coming months to maximise the learnings about the system during this ‘use and learn’ period.

Online registration for pharmacies and hospitals now open

31st October 2018

IMVO is delighted to announce that online registration for pharmacies and hospitals is now open. This is an important milestone to assist pharmacies and hospitals in complying with new EU Falsified Medicines Directive (‘FMD’) requirements that come into effect on 9th February 2019. IMVO has contacted all community pharmacies and hospitals registered with the Pharmaceutical Society of Ireland with details of how to register. Registering with IMVO is a pre-requisite for connecting the system that community pharmacies and hospitals will use to scan barcodes, to the IMVO repository. For more information, include HSE updates, visit our pharmacies & hospitals page.

Wholesaler registration will commence shortly and wholesalers will receive a separate notification from IMVO.

We are delighted to announce that the first serialised pack was decommissioned in Ireland in Moore’s Pharmacy in Crumlin, Dublin, on 20th June. We believe this may have been the first pack decommissioned in a community pharmacy anywhere in Europe using the ‘blueprint’ system model . The pack scanned was a J&J product and the system used was ezFMD provided by HE Clissmann.

According to Leonie Clarke, IMVO Project Manager “IMVO is delighted that Ireland continues to be at the forefront of rolling out the European Medicines Verification System and we applaud everyone involved in reaching this important milestone. We are particularly appreciative of the support of all the pharmacies, hospitals, wholesalers, manufacturers and IT software providers who have volunteered to take part in our pilot.”

First serialised pack verified in Ireland

30th May 2018

We are delighted to announce that the first serialised pack was verified in Ireland by PCO Manufacturing on 30th May, using their wholesaler connection to the Irish Medicines Verification System and the EasyFMD system supplied by Quick Pharm Solutions. Ireland was amongst the first five countries in Europe to start scanning of serialised packs using a live connection to the national medicines verification system.

According to Leonie Clarke, IMVO Project Manager “IMVO congratulates PCO on this significant achievement and looks forward to many more packs being verified and decommissioned in Ireland over the coming months.”

Irish Medicines Verification System goes live

10th April 2018
We are delighted to announce that the Irish Medicines Verification System (IMVS) has been connected today to the production environment of the EU Hub. Reaching this important milestone means that IMVO can start its pilot and thus the implementation of the IT system to support the safety feature provisions of the EU Falsified Medicines Directive. Together with Germany, Slovenia, Denmark and Sweden, Ireland is among the first countries to go live in Europe.

A unique new not-for-profit organisation – the Irish Medicines Verification Organisation (IMVO) - has been established by the key players in the medicines supply chain in Ireland - pharmaceutical manufacturers, wholesalers, parallel distributors, and community pharmacists - as part of an EU-wide series of measures to tackle the growing problem of fake or ‘falsified’ medicines.

To set the problem in context, over 650,000 dosage units of falsified and other illegal medicines bought over the Internet were detained coming into Ireland in 2016, according to the Health Products Regulatory Authority (HPRA). To date, there have been no reports of falsified medicines being distributed through legitimate channels in Ireland, eight such cases were detected in the UK between 2011 and 2015 so the risk cannot be ignored.

To tackle this threat, new EU legislation will require all prescription medicine packs to carry a special barcode containing a serial number and other details which will be used to check that the pack is legitimate. Before supplying the medicine to a patient, the pharmacist will scan the barcode to check the data against a central database managed by IMVO. If the pack details are not found in the database, an alert will be generated and an investigation will take place to find out if the pack is fake. These new requirements come into effect from February 2019 and pharmacists and pharmaceutical manufacturers and wholesalers, individually and through IMVO, are already working to ensure that all the necessary systems are in place by then.

Speaking at the launch of IMVO, the Minister for Health, Simon Harris, TD, said “The stakeholders involved in IMVO are to be congratulated for coming together to oversee this important initiative which will help to protect Irish patients from the threat of falsified medicines. I am delighted to see that as a result of their efforts, Ireland is amongst the leading countries in Europe in terms of progress made to date on this project.”

IMVO’s chairperson, Professor Pat O’Mahony, commented: “Implementing these requirements by the 2019 deadline is a significant challenge for pharmaceutical manufacturers, parallel distributors, wholesalers and pharmacists but the organisations who represent them in IMVO are committed to building on progress to date and working towards meeting this deadline.”

News

31st October 2018