BCI Supply Chain Workshop Thursday 13 th October, Belfast Harry Lyness Operations Manager for Movianto N.I. 1

BCI Supply Chain Workshop

Thursday 13th October, Belfast

Harry Lyness Operations Manager for Movianto N.I.1

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.


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


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.


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.


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.


Developing, clinical testing, producing, packaging

Manufacturer

Procuring, receiving, storing, processing, delivering

Hospital/Retailer Ordering, storing, supplying

The Patient Consumption & use

Distributor/Wholesaler

7Harry Lyness Operations Manager for Movianto N.I.

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)



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



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.


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.




‘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.’


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

Supply Chain Maintenance


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???


Any Questions?

Any Questions?


Documents

BCI Supply Chain Workshop Thursday 13 th October, Belfast Harry Lyness Operations Manager for Movianto N.I. 1