Falsified Medicines Directive

Leyla HannbeckFRPharmS, MBA, MSc, MADirector of Pharmacy, NPA

Falsified medicines: the facts

• Approximately 100,000 deaths a year occur due to falsified medicines

• Approximately 30,000 illegal pharmacy websites

• Most common falsified medicines include hormones, steroids and medicines for HIV/AIDs

Fake medicines that are passed off as real, authorised medicines

Falsified medicines: the facts

Falsified medicines do not pass efficacy, evaluation, quality and safety required for EU and MHRA authorisation

MislabeledLow quality ingredients

Wrong dose

Wrong ingredients

Fake packaging

Falsified medicines may be:

Falsified vs. counterfeit

Counterfeit medicines: medicines that do not

comply with intellectual-property rights or that infringe trademark law

Falsified medicines: fake medicines that are

designed to mimic real medicines

FMD: background

• Approved by the European Parliament

• Two mandatory safety features

• Medicines to be verified & authenticated

• To be implemented from 9 February 2019• The impact of Brexit is currently unknown

• Affects UK, including Jersey, Guernsey (Bailiwick Islands) and Isle of Man• Depending on Brexit, there may be some difference to NI

• Overseas territories are excluded (such as Gibralter)

Aims to prevent falsified medicines entering the supply chain

FMD: background

All online pharmacies register and

display an EU wide logo

Two safety features on

packaging; an anti-tamper device (ATD) and unique

identifier (UI) in the form of a 2D

barcode

Restrictions on the import of

active ingredients

Heightened record keeping requirements

for wholesalers

FMD requires:

FMD medicine safety features

UK process: pharmacy Manufacturers enter each medicines UI code to the National Medicines Verification System (SecurMed UK)

Pharmacies will be required to authenticate medicines “at the time of supplying it to the public”

This includes checking the ATD is still intact

And scanning the UI on the medicines outer packaging –referred to as ‘decommissioning’

Enforcement and monitoring• Update legislation and set

penaltiesDepartment of Health

• Enforcement for manufacturers and wholesalers

Medicines and Healthcare products Regulatory

Agency (MHRA)

• Enforcement for community pharmacies

General Pharmaceutical Council (GPhC) and

Pharmaceutical Society of Northern Ireland (PSNI)

Verifying and authenticating medicinesThere are two potential messages displayed once the UI has been scanned:

• Medicine can be dispensed as long as the ATD is undamaged

• If the ATD is broken in order to dispense the medicine, this is exempt

• Successfully decommissioned

“Active”

• Cannot be supplied

• Additional messages include “already dispensed”, “recalled”, “withdrawn”, “stolen” or “locked”“Inactive”

Decommissioned medicines• Decommissioned medicine status change from:

• If the product is not supplied, the status can be reversed

“Active”“Inactive –dispensed”

Reversing the medicine status• Reversing the “decommissioned” status of a medicine can

only occur if:• It takes place at the same pharmacy it was decommissioned

• It occurs no more than 10 days after decommissioning – ‘10 day’ rule

• The product has not expired

• The product has not been recalled, withdrawn, stolen or intended for destruction

• The medicine has not been supplied to a patient

Scanning and decommissioning: aggregated barcodes

• ‘Aggregated barcodes’ can be used where more than one medicine is dispensed• Links multiple items together to allow decommissioning of all

items in one go by scanning the aggregated code

• No ‘expiry date’ to scan aggregated code

• If one item out of multiple under an aggregated code expires: in-date item will be accepted, expired not

“At the time of supplying it to the public” : Not defined; FMD process must be completed before medicine is supplied

Split packs and MDS

• Check the ATD and scan UI when first opening a pack

• Remainder of pack does not require further checks before use

Split packs

• Before dispensing, ATDs must be checked and UI scanned to decommission the product

• Use indefinitely

MDS and supervised

Potential decommissioning points

During assembly

During accuracy check

At point of hand out

At point of hand out with aggregated code

Decommissioning points and patient safety concerns

• Additional step/increase workload

• Time period between assembly and handing out

• Increased pressure/distraction

During assembly

or

during accuracy

check

Decommissioning points and patient safety concerns

• Prescription bags need to be re-opened

• Training required for all support staff

• Increased workload/pressure

At point of hand out

with/without aggregated

code

Implications for pharmacy contractors1. Need an FMD-compliant system via PMR

supplier or standalone• NPA Business Partner: FMD IT:

https://www.npa.co.uk/fmd-it-limited

2. Obtain equipment such as scanners

3. Register with SecurMed UK• Get username, password and digital certificate

4. Update SOPs and train pharmacy team

FMD solutions: things to think about• Not all scanners will be wireless

• Workflow may be affected

• There may be additional charges for different pieces of equipment• Find out what is available before implementing a system!

• Do not get tied into a long contract• Brexit uncertainty

Scanning error and alert messages: briefly explained