Causes and contributing factors of the medicines shortage
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Causes and contributing factors of the medicines shortage
Andy GrayLuc Besançon
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PUTTING MEDICINES SHORTAGES AND THEIR CAUSES / CONTRIBUTING FACTORS IN THE CONTEXT OF A BIGGER PICTURE
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National accessible stock–The overall amount of a specific pharmaceutical
products accessible through the whole supply chain.
–It consists of:Stock at national level of the manufacturer / importer+ Stock of the different wholesalers/distributors(+ Stock in public sector pharmaceutical depots/national medical stores)+ Stock in community and hospital pharmacies+ other stock (emergency / stockpile/ military stock…)
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The environment of medicines shortages
National Accessible Stock
(disseminated through the supply chain)
(Inter)national Supply
National Use /Demand
Other countries’ National
Accessible stocks
Recalls
(Parallel)
trade
$
$
Expiry / destruction Diversion$
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Supply vs. demand
–Production / entry supply ≥ demand– In principle a safe situation, BUT need to consider:
– Losses in the supply chain (exports, diversion…)– Affordability and capability to pre-finance medicines through
the supply chain
–Production / entry supply < demand– May not necessarily lead to a shortage if
– For a short period of time – The buffer effect of the national accessible stock (quantity,
distribution, accessibility…)
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Challenges of the supply chain with regards to medicines shortage
–Limited predictability of needs–High vulnerability to changes–Limited reactivity
–Globalisation of manufacturing – at the active pharmaceutical ingredient (API) and finished pharmaceutical product (FPP) level - while regulators are (largely) national
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MAIN REASONS AND CONTRIBUTING FACTORS OF MEDICINES SHORTAGE
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No shortage of diagnoses ….
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IIHI report 2011 – US data only
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Not an injectable-only problem
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An overview of reasons of previous and current cases of medicine shortages
Inspired by Beerten E, Bonheure F. Autour du monde – des indisponibilités de médicaments. Annales Pharmaceutiques Belges 2011; Nov 15: 11-14.
Brazil: Shortage of benznidazole (Chagas disease) resulting from the inability of the sole world manufacturer (owned by the state) to meet increasing demand
Canada: Shortage of generic IV products (US FDA had concerns with a product produced in Canada but not marketed there to implement corrective measures, Sandoz had to decrease its production)
USA: according to GAO, the primary causes of 15 sterile injectable drug shortages between Jan 2009 and Jun 2011: 80% were related to manufacturing problems, while 20% were related to the disruption in the supply chain of Active Pharmaceutical Ingredients
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An overview of reasons of previous and current cases of medicine shortages
Spain: Shortages related to the long delay (up to 1 year in some provinces) to reimburse medicines to pharmacies
Czech Rep.: According to Nal institute, 20% of medicines for the national market are exported (parallel trade) resulting in shortage
Greece: Hospitals unable to pay the manufacturer + cut in the price of medicines makes parallel trade more profitable
Denmark: Current tender policy for generic (2 tenders per month, and only the cheapest products are reimbursed) can lead to temporary shortages
France: Buffer effect of the supply chain (12% of orders of wholesalers not delivered, vs. 4-5% for community pharmacies). 4% of shortages associated with exports (parallel trade)Role of “mega tenders” for groups hospitals in destabilizing the market but main reasons are similar to those experienced in USA
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An overview of reasons of previous and current cases of medicine shortages
Inspired by Beerten E, Bonheure F. Autour du monde – des indisponibilités de médicaments. Annales Pharmaceutiques Belges 2011; Nov 15: 11-14.
Iran: Shortages resulting from international sanctions (exchange rate, access to foreign currencies..)
Algeria: Difficulties for foreign companies to repatriate profits + issues from a plan to promote national production
Senegal: New rules implemented for international tenders and import contracts
Zambia: Donors suspended their support on HIV drugs on suspicion of corruption
South Africa: Amphotericin B was no longer available after a quality problem was detected by the manufacturer on 2 batches not yet released
Madagascar: Insufficient funding, inappropriate evaluation of needs (annual tenders) and organisation of supply chain
Tunisia: Libya war (migration of Libyan staff + export of medicines to Libya), boycott of Israeli products, strikes at plants
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An overview of reasons of previous and current cases of medicine shortages
Inspired by Beerten E, Bonheure F. Autour du monde – des indisponibilités de médicaments. Annales Pharmaceutiques Belges 2011; Nov 15: 11-14.
China: Major shortage of protamine sulfate (related to the cessation of production by several local companies following a significant reduction of its price decided by the Authorities)
Japan: after the tsunami of 11 March, several manufacturing sites have been severely damaged of destroyed resulting in world shortage of Rivotro and Madopar.
Australia: rationalisation of Penicillin G in hospitals as the only provider was not able to cover the increasing demand
Papua New Guinea: Shortages were developed to bypass the tender process (associated with corruption)
Bhutan: Prescribers would not comply with the essential medicines lists (e.g. for antibiotics)
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Specific to a setting and product type?
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More broadly applicable?
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Common factors?
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Globally relevant …. though less visible
“ …. a longer-term solution may lie in careful policy-making that avoids winner-takes-all procurement decisions, that promotes the development of a sustainable local and global pharmaceutical manufacturing capacity, and that identifies and protects particularly fragile markets”
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Summary of these main reasons and contributing factors–Supply side:
– Delay / temporary interruption in manufacturing without alternative
– Cessation of production– Quality deficiencies– Supply chain characteristics
–Economic side:– Financial capability to pay– Profitability / return on investments requirements
–Demand side:– Difficult predictability of demand and market (Role of price
and tenders)– Increase demand