The document discusses the implications of the Falsified Medicines Directive (FMD) for hospital pharmacies in the UK. The FMD requires unique package numbers for all medicine packs to help identify counterfeit drugs. However, there are several operational issues with implementing this for hospital pharmacies given complexities of their supply chains. Hospitals may split drug packs, return unused stock, and source drugs through various channels. National regulations will need to address how to handle package numbers in these hospital situations to ensure successful tracking of drugs across Europe by the 2018 deadline.

1. The Falsified Medicines Direc1ve (FMD)
and the implica1ons for Hospital
Pharmacy
Dr Rod Beard
Principal Pharmacist
Sunderland Royal Hospital
Rod.Beard@chsC.nhs.uk

2. 2011/62/EU
• This direc1ve made it a requirement for all medicine
packs to carry a unique pack number.
• EMVO ( European Medicines Verifica1on
Organisa1on) responsible for much of the soCware
and support for making this work across Europe.
• Emvo works across all EU countries to help the
implementa1on by 2018 ( tough target)

3. • The concept is that by tracking individual packs
through the supply chain across Europe, any
counterfeit medicines entering the supply chain can
be iden1fied early, and the loophole closed to these
counterfeit goods.
• The support soCware allows tracking of products
within each country, and this feeds into a European-
wide database to track the goods, and to also allow
de-ac1va1on of the unique product number once a
pa1ent supply has been made.
• Once with pa1ent, the product is no longer in the
supply chain, and a key element is that this number
Unique pack number (UPN) is de-ac1vated

4. • This means each individual pharmacy must have the
soCware that can de-ac1vate these numbers, in the
na1onal system, and also that transfers across all the
systems in all the EU countries.
• This process starts to highlight different prac1ces in
different countries, and gives each country problems
in how this will be implemented.
• For example, in Britain, there is a lot of hospital out-
pa1ent dispensing, which is less of a feature than in
Germany.

5. It is envisaged that prac1ces across community
pharmacy would be fairly standardised across Europe,
and should be possible to have a similar system across
Europe. But hospitals may be more varied.
From a UK perspec1ve, once a medicine is delivered
to a hospital several things can happen to that
product:
• Products can be dispensed as ward stock
• Ward stock can be returned to pharmacy for re-use
• Some hospitals have wholesaler dealers licenses and
could supply to other customers
• Some hospitals have MS licenses, and could over-
label packs, or split the packs down for pre-packing.

6. • If items pre-packed, hospital may use ‘Coding for
Success’ principals, and use their own product bar
codes….would these need a UPN, and would these
products need to be registered with Emvo?
• Much depends ( from UK perspec1ve) on at what
point the product is deemed no longer in the
supply system.
• Delivery to a UK hospital means that there could be
a series of sub-supply systems, but it depends on
how implementa1on is planned at a na1onal level as
to how this will work.

7. • If it is decided a UPN is only de-ac1vated when it
reaches a pa1ent, then there are poten1al problems
in the UK hospital system. Many hospitals split packs
of tablets, and there needs to be a procedure to
allow for the issue of products against a ‘dead’ UPN
• For some injec1ons issued to wards, it may be they
are returned to pharmacy stock, so a ‘dead’ UPN
could be re-ac1vated ( but this is against what FMD
is all about).
• It could be that a hospital is deemed an end user,
and at the point of delivery, all products with UPN’s
are de-ac1vated.

8. • The sheer volume of this would make it horrendous !
• Each and every pack would have to be de-ac1vated
before it could be accepted into stock.
• Because of the scale, there would need to be an
area set aside to quaran1ne deliveries prior to
accep1ng into pharmacy stock
• Such areas may not be easy to iden1fy for many
hospitals.
• How would invoices and Goods received notes from
wholesalers work? Would UPN’s need to be on
those?

9. • Whilst mainline wholesalers might have the
capability to de-ac1vate UPN’s on shipment, this
would not be the case for all wholesalers, and there
are many smaller wholesalers around Europe
• The requirements would have to be consistent for
all suppliers.
• This makes draCing na1onal regula1ons tricky if
implementa1on is to be successful

10. • In UK, supply chain is rickety, and hospital
pharmacists are spending increasing amount of 1me
searching for imports for ‘rou1ne’ products.
• The rise in specialist importers is almost a proxy
measure of the ‘ricke1ness’ of the supply chain.
• So, if a product was unavaialble in UK, and an
unlicenced (in UK) import was used ( say from
Austria), how would the ENVO system work?
• Will the linkages between na1onal systems allow
de-ac1va1on of the UPN from another country?

11. • What happens if the UPN of an imported
product is not recognised in the na1onal
system ?
• Presumably this will trigger an alert in the de-
ac1va1on system that the product cannot be
verified. What does the pharmacist do then?
• How does he know it is safe to use this
product?
• How will specialist importers be brought into
the EMVO scheme?

12. • Given that there are so many opera1onal issues,
we need some perspec1ve at na1onal level how this
will work.
• It is 2016, and only 2 years leC to implementa1on.
• If there is a large volume of work to fall on hospitals
to de-ac1vate UPN’s then this needs to be factored
into business cases. These are oCen slow moving
processes.