Transcript An Introduction to - BCI Files Archive

BCI Supply Chain Workshop
Thursday 13th October, Belfast
Harry Lyness Operations Manager for Movianto N.I.
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Legislation and Adherence to GDP
 Movianto - Largest Pharmaceutical Distributor
in Europe.
 Pre-Wholesaler of Specialist Medicines to
Hospital Pharmacy / Wholesalers (and others)
 Movianto - Extension / Partner of the
Manufacturer.
Harry Lyness Operations Manager for Movianto N.I.
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Legislation & Adherence to Good Distribution Practices
 The Pharmaceutical Industry is very highly
regulated by the MHRA (Medicines Health
Regulatory Authority)
 The MHRA is the Government Agency
responsible for ensuring the safety, quality and
efficacy of medicines in the UK.
 Movianto holds a Wholesale Dealer’s Licence
issued by the MHRA
Harry Lyness Operations Manager for Movianto N.I.
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Legislation & Adherence to Good Distribution Practices
 The MHRA will conduct audits of wholesalers to
ensure adherence to Good Pharmaceutical
Distribution Practice (GDP) and that product
integrity is maintained at all time.
 Failure to adhere to GDP guidelines can result
in suspension or revocation of licence and/or
prosecution of company and of RP(s)
individually which would effectively put the
company out of business.
Harry Lyness Operations Manager for Movianto N.I.
4
Supply Chain Logistics
 When I leave my car in for repair at Nissan
(who have an excellent supply chain) they may
tell me they need a part from Japan – ‘ it’ll be
here tomorrow afternoon.’
 And generally it’ll arrive on time and the repairs
completed – but if it doesn’t arrive it may be an
inconvenience but that’s all.
Harry Lyness Operations Manager for Movianto N.I.
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Product Integrity?
 When the end user is a patient in a hospital bed
– supply chain management takes on a new
meaning.
 So - What do we mean by Product Integrity?
 Delivered on time, in full and in the correct
condition
 100% accuracy every time.
Harry Lyness Operations Manager for Movianto N.I.
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Developing, clinical testing, producing,
packaging
Manufacturer
Distributor/
Wholesaler
Procuring, receiving, storing, processing,
delivering
Hospital/
Retailer
The Patient
Harry Lyness Operations Manager for Movianto N.I.
Ordering, storing, supplying
Consumption & use
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Supply Chain Management
 As an example we distribute a product
manufactured in Switzerland which is used to
treat severe Sepsis .
 Severe Sepsis – is a serious medical condition
involving infection and generalized
inflammation, treated in the Intensive Care Unit
(ICU)
Harry Lyness Operations Manager for Movianto N.I.
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Supply Chain Management
 This product is over £600 for a single 20mg
pack and has to be kept between +2 – +8
degrees Celsius at all times.
 Under no circumstances can Movianto be
without this (unique) product or similar items.
 (manufacture issues must controlled and communicated
to Pharmacy well in advance)
 Resilience of supply chain..
 Stock holding
 Plans with Manufacturer to fly it direct from Source
Harry Lyness Operations Manager for Movianto N.I.
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Supply Chain Management
 Movianto invest to ensure pharmaceuticals are
handled in the correct manner...
 In particular the cold-chain maintenance
 back-up condensers, dual warehouses, dual fridges and
back-up generators etc.
 Not to mention servicing, maintenance, calibration
and validation of all measuring equipment by
independent UKAS accredited sources.
 24/7/365 Alarm monitoring and call-out list.
Harry Lyness Operations Manager for Movianto N.I.
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Supply Chain Management
 Similarly with transportation – vehicles must be
equipped to maintain product integrity..
 Real-time temp monitoring
 Back-up equipment etc
 This audit trail can be requested at anytime by
Hospital Trusts, Manufacturers or the MHRA
even several years later.
Harry Lyness Operations Manager for Movianto N.I.
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Supply Chain Management
‘In my opinion, Investment (which
needs to be reflected in the cost of the service
provided)
being taken out of the
supply chain maintenance will
increase the risk to product
integrity and ultimately patient
safety.’
Harry Lyness Operations Manager for Movianto N.I.
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Supply Chain Maintenance
 Imagine the scenario.....
 You here a short news bulletin whilst driving to work relating to
a person that had died at a local hospital after taking a reaction
to some medication. You disregard it but feel pity for the family
of the person.
 Several days later your company is asked to provide evidence
that a drug you supplied had been stored and transported
within the manufacturer specification
Harry Lyness Operations Manager for Movianto N.I.
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Supply Chain - Question?
‘QUESTION?
What evidence could we produce to
prove cold-chain maintenance had
been maintained from the point of
despatch to delivery at hospital
pharmacy for any product???
Harry Lyness Operations Manager for Movianto N.I.
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Any Questions?
Any Questions?
Harry Lyness Operations Manager for Movianto N.I.
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