Sports Medicine - Falsified Medicine Directive

Sports Medicine - Falsified Medicine Directive

Sports Medicine – Falsified Medicine Directive – Advice for Doctors

With the impending introduction of the Falsified Medicines Directive (FMD) on February 9th, 2019 many healthcare professionals working within the sports medicine field may find themselves in a state of uncertainty. The aim of this blog post is to provide an informative overview of the new legislation and what it means for you as a healthcare professional going forward

FMD Safety Features
FMD Safety Features (Pharmaceutical Journal)

Why has the falsified medicines directive (FMD) been introduced?

Falsified medicines can be defined as a medicinal product which appears legitimate but may have the following inconsistencies or irregularities;

  • Packaging or labelling
  • Composition of ingredients including excipients
  • Form and strength
  • Source of manufacture
  • History and records

The primary purpose of the new legislation is to ensure that the pharmaceutical supply chain contains those medications which have been legitimately manufactured, sourced and supplied. Falsified medicines can present a considerable risk to both public health and safety.

How will it work?

There will be several steps throughout the pharmaceutical supply chain which will involve the use of a “unique identifier” (UI) in the form of a 2-D data matrix code. All Prescription Only (POM) medications will be required to have this 2-D code and an anti-tampering device (ATD). This will allow the UI to be uploaded to the European Medicines Verification System before being passed to the National Medicines Verification System where it is stored awaiting activation.

All medicines received by pharmacies, hospitals and “healthcare institutions” (including GP surgeries) MUST be verified through individual scanning of each pack where it is checked with the National and European Medicines Verification System (to ensure it has not been previously activated). At this point the medication’s status is changed to “active”, allowing it to be subsequently “decommissioned” upon supply to a patient. This provides reassurance for all involved in the supply chain that the patient has safely received a legitimate medicine and considerably minimises any risk of dispensing a falsified medicine.

Article 23

Whilst the new regulations state that those working within “healthcare institutions” are required to decommission medications upon dispensing to a patient there is a degree of flexibility concerning those healthcare professionals who currently don’t operate from a “healthcare institution”. A healthcare institution is defined as “a hospital, in or outpatient clinic or health centre”. (In the U.K. the MHRA has ruled that GP surgeries and Dispensing Doctors are considered as health centres.)
Article 23 covers those healthcare professionals who currently don’t practice from a healthcare institution. This includes;

  • Person’s authorised to supply medicinal products to the public and are NOT currently practicing within a healthcare institution.
  • Paramedics
  • Dentists
  • Optometrists
  • Veterinarians
  • Nursing Homes

For those doctors working within a sports team background (football, rugby, cricket etc) it is our view that they are not specifically working in a healthcare institution, therefore will fall under the article 23 exemption. In this case the wholesaler supplying the medicines should decommission the drugs on behalf of the doctor.

It is important for healthcare professionals to recognise the context in which they are supplying medication and distinguish whether they are operating from within a healthcare institution. Please be aware that those sports medicine doctors who operate from within a health clinic would probably not fall under article 23 and should prepare for incorporating the decommissioning process as part of their standard operating procedures.

Vivomed will be happy to advise and discuss the processes with regard to the appropriate method of decommissioning to ensure compliance with the new legislation. Adapting to the new changes imposed by the Falsified Medicines Directive may seem daunting at first but it’s important to recognise its role in protecting prescribers, patients and healthcare professionals long-term.

There are a few helpful links below to further your understanding whilst you can also feel free to contact us directly at any time for help and advice.

Phone: 028 44617666
Email: pharmacy@vivomed.com

For Doctors working in sport and wish to order their prescription on medications (POM’s) and all other medical consumables via Vivomed’s secure online portal WebMeds, please sign up here:

Helpful Links

  1. Additional Guidance on Article 23
  2. Directive 2011/62/EU
  3. NHS Toolkit
  4. Independent Doctor’s Federation
  5. Pharmaceutical Journal
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