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Causes and contributing factors of the medicines shortage

Causes and contributing factors of the medicines shortage. Andy Gray Luc Besançon. Putting medicines shortages and their causes / contributing factors in the context of a bigger picture. National accessible stock.

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Causes and contributing factors of the medicines shortage

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  1. Causes and contributing factors of the medicines shortage Andy Gray Luc Besançon

  2. Putting medicines shortages and their causes / contributing factors in the context of a bigger picture

  3. 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…)

  4. The environment of medicines shortages (Inter)national Supply $ $ Recalls National Accessible Stock (disseminated through the supply chain) Other countries’ National Accessible stocks (Parallel) trade $ Expiry / destruction Diversion National Use /Demand

  5. 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…)

  6. 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

  7. Main REASONS AND CONTRIBUTING FACTORS OF MEDICINES SHORTAGE

  8. No shortage of diagnoses ….

  9. IIHI report 2011 – US data only

  10. Not an injectable-only problem

  11. An overview of reasons of previous and current cases of medicine shortages 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 Brazil: Shortage of benznidazole (Chagas disease) resulting from the inability of the sole world manufacturer (owned by the state) to meet increasing demand Inspired by Beerten E, Bonheure F. Autour du monde – des indisponibilités de médicaments. Annales Pharmaceutiques Belges 2011; Nov 15: 11-14.

  12. An overview of reasons of previous and current cases of medicine shortages Denmark: Current tender policy for generic (2 tenders per month, and only the cheapest products are reimbursed) can lead to temporary shortages 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 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 Spain: Shortages related to the long delay (up to 1 year in some provinces) to reimburse medicines to pharmacies

  13. An overview of reasons of previous and current cases of medicine shortages Iran: Shortages resulting from international sanctions (exchange rate, access to foreign currencies..) Tunisia: Libya war (migration of Libyan staff + export of medicines to Libya), boycott of Israeli products, strikes at plants 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 Madagascar: Insufficient funding, inappropriate evaluation of needs (annual tenders) and organisation of supply chain South Africa: Amphotericin B was no longer available after a quality problem was detected by the manufacturer on 2 batches not yet released Inspired by Beerten E, Bonheure F. Autour du monde – des indisponibilités de médicaments. Annales Pharmaceutiques Belges 2011; Nov 15: 11-14.

  14. An overview of reasons of previous and current cases of medicine shortages 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. Bhutan: Prescribers would not comply with the essential medicines lists (e.g. for antibiotics) Papua New Guinea: Shortages were developed to bypass the tender process (associated with corruption) Australia: rationalisation of Penicillin G in hospitals as the only provider was not able to cover the increasing demand Inspired by Beerten E, Bonheure F. Autour du monde – des indisponibilités de médicaments. Annales Pharmaceutiques Belges 2011; Nov 15: 11-14.

  15. Specific to a setting and product type?

  16. More broadly applicable?

  17. Common factors?

  18. 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”

  19. 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

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