Feedback on a notification portal for shortages of medicines and vaccines

June 2018

Background and progress

on WHA 69.25

WHA 69.25

Progress to date

• Systematic review of definitions

• Mapping of vaccines market

• Harmonized definitions of shortages

and stock outs

• Report on magnitude of the problem

pending

• Functional requirements and

specifications developed and portal

project launched

• Demonstration countries, other

users targeted for trials end of 2018

Addressing global shortages of medicines and

vaccine makes specific requests to the Director

General

Magnitude and nature of shortages: problem not going away, significant public health problem, limited visibility and capacity to respond

0% 5% 10% 15% 20% 25% 30% 35%

Increasing

No change

Decreasing

No answer/no opinion

Perception of trend in incidence of shortages

Questionnaire shared among National Health Authorities and procurement entities in 38 countries

0% 10% 20% 30% 40% 50% 60%

High income

Upper middle income

Lower middle income

Low income

Not applicable

Countries reporting existence of a national mechanism for notification by MAH (or others)

0% 20% 40% 60% 80% 100%

High income

Upper middle income

Lower middle income

Low income

Not classified

All

Perception of shortages as significant public health problem (by income level)

• All countries affected

• All medicines vulnerable, but some more

at risk (supply concentration, low profit)

• Increasing attention to solutions,

including regulatory flexibilities,

procurement/pricing considerations and

other market interventions

WHA 69.25

All medicines and vaccines are vulnerable, some appear more at risk

Anti-infectives

systemic Use21% Nervous system 23% Nervous system 21% Antibiotics 20%

Nervous system 17%Cardiovascular

system21%

Anti-infectives

systemic use16% Nervous system 18%

Cardiovascular

system9%

Anti-infectives

systemic use11%

Cardiovascular

system15% Electrolytes 18%

Cancer 10% Cancer 9%

Genitourinary

system and sex

hormones

8%Cardiovascular

system11%

Genitourinary

system and sex

hormones

7%Alimentary track

and metabolism8%

Alimentary track

and metabolism7% Chemotherapy 9%

Other 36% Other 28% Other 34% Other 24%

TOTAL 100% TOTAL 100% TOTAL 100% TOTAL 100%

Israel 2013-2015South America 2017 Belgium 2009-2013 US 2013-2017

08/10/2018 | Title of the presentation 6

Shortages of antibiotics

Monitoring of occurrence of shortages

indicate continued incidence, some over

long periods of time.

Consultations with manufacturers and

regulators indicate multiple causes for

these shortages, with critical aspects

related to quality and market economics.

Ongoing work: • Market assessment for 10 antibiotics at risk and stakeholder consultation to

identify actions that can be pursued to address risks (with ReAct)

Antibiotic shortages occurring in at least half of 8 countries

reporting shortages in August 2017 and February 2018. Records

are from reporting mechanisms in Australia, Belgium, Canada,

France, Germany, Italy, Spain and Switzerland.

Update on the Global Notification

System for Shortages and

Stockouts

Based on business processes mapped from different countries, other reporting systems

Mapping the business process

• Substandard and Falsified

medicines (why?)

• Tunisia, other case study

• Review of existing portals

(Available in

large print copy)

• Global shortages of medicines and vaccines

• Diagnostics and devices pending Scope

• Regulators, National and International Procurers

• Eventually to registered manufacturers Audience

• Look ups for Essential Medicines + ATC codes

• "Build your own" medicines from INN Key features

• Multiple options for capturing root causes

• Options for capturing shortage "symptoms" Root cause tracking

• Links to substandard and falsified data bases Interoperability

The portal is in design processes and occasional feedback from external

stakeholder is valuable to building a user friendly and meaningful system.

Portal for reporting global shortages of medicines and vaccines

Expanding to other products e.g., Dx and devices?

Medicines versus other products

Presentation Unit of measure option

aerosol powder for injection centiliter

capsule power for solution each cream solution, injectable gram gas solution, oral international unit gel solution, other liter Granule spray mg / L inhalation Suppository mg / ml Jelly Suspension microgram liquid capsule syrup milligram liquid drops tablet milliliter Lotion tablet, dispersible millimole Lozenge vaccine million unit ointment ZZ other thousand unit patch unit

other

Live Demonstration

(if it works, we skip to slide 14)

Question for discussion:

• What are the best approaches

for national uptake?

• Have we missed anything?

Thank you

Lisa Hedman

Francisco

Blanco