Causes and contributing factors of the medicines shortage

Andy GrayLuc Besançon

PUTTING MEDICINES SHORTAGES AND THEIR CAUSES / CONTRIBUTING FACTORS IN THE CONTEXT OF A BIGGER PICTURE

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…)

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$

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…)

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

MAIN REASONS AND CONTRIBUTING FACTORS OF MEDICINES SHORTAGE

No shortage of diagnoses ….

IIHI report 2011 – US data only

Not an injectable-only problem

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

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

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

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)

Specific to a setting and product type?

More broadly applicable?

Common factors?

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”

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