Lisa Hedman June 2016 At the 69 th World Health Assembly in May 2016 Member States proposed and accepted two resolutions related to shortages of medicines Promoting innovation and access to quality safe efficacious and affordable medicines for ID: 654078
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Slide1
Update to the
IPC
WHA resolutions on shortages
Lisa Hedman
June 2016Slide2
At the 69th World Health Assembly in May 2016, Member States proposed and accepted two resolutions related to shortages of medicines:
Promoting innovation and access to quality, safe, efficacious and affordable medicines for childrenAddressing the global shortage
of medicines and vaccinesWHA resolutions on shortagesSlide3
Sponsors
China, Ghana, Italy, Malaysia, Pakistan and Thailand
Calls on Member States and the DG WHO to:
Improve research and development for medicines for children
Promote ethical clinical trials for children's medicines
Strengthen related regulatory capacity
…and other relevant issuesSlide4
Sponsors
Colombia,
India
,
Kenya, South Africa, and USACalls on Member States and the DG WHO to:Develop key definitions
Promote national, regional and global systems e.g., advance notification
Improve supply chain data
Quantify the problem at a global level
…and other relevant issuesSlide5
Support from the WHO SecretariatDecember 2015 :Technical consultation on preventing and managing global stock outs of medicines
Report to the WHO Executive Board: Addressing the global shortages of medicines, and the safety and accessibility of children’s medication May 2016: Technical Consultation on medicines for
ChildrenSlide6
Excerpts from the technical consultationsSlide7
Excerpts from the technical
consultationsSlide8
Ammonium Chloride Injection
(
Shortage) Atropine Sulfate Injection (Shortage) Atropine Sulfate Injection (Discontinuation) alcium Chloride Injection, USP (Shortage) Calcium Gluconate Injection (Shortage) Cefazolin Injection (Shortage) Cefepime Injection (Shortage)
Cefotaxime Sodium (Claforan
) Injection (Shortage) Chloramphenicol Sodium Succinate Injection (Shortage) Chloroquine
Phosphate Tablets
(
Shortage
)
Cidofovir
Injection
(
Discontinuation
)
Dexamethasone Sodium Phosphate Injection
(
Shortage
)
Dextrose 5% Injection Bags
(
Shortage
)
Doxorubicin (Adriamycin) Injection
(Shortage) Epinephrine 1mg/mL (Preservative Free)23 (Shortage) Epinephrine Injection (Shortage)
Fentanyl Citrate (Sublimaze) Injection (Shortage) Leucovorin Calcium Lyophilized Powder for Injection (Shortage) Leuprolide Acetate Injection (Shortage) Levetiracetam (Keppra) Injection (Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Shortage) Liotrix (Thyrolar) Tablets (Shortage) Lorazepam (Ativan) Injection (Discontinuation) Magnesium Sulfate Injection (Shortage) Mecasermin [rDNA origin] (Increlex) Injection (Shortage) Meloxicam (Mobic) Oral Suspension (Discontinuation) Meropenem for Injection, USP (Shortage) Methyldopate Hydrochloride Injection (Shortage) Methylin Chewable Tablets (Shortage) Methylphenidate Hydrochloride ER Capsules/Tablets24 (Shortage)
Ondansetron (Zofran) Injection (Discontinuation) Pancuronium Bromide Injection (Shortage) Peritoneal Dialysis Solutions (Shortage) Piperacillin and Tazobactam (Zosyn) Injection (Shortage) Potassium Chloride Injection (Shortage) Reserpine Tablets (Shortage) Sodium Chloride 0.9% Injection Bags (Shortage) Sodium Chloride 23.4% Injection (Shortage) Sodium Chloride 23.4% Injection (Discontinuation) Sufentanil Citrate (Sufenta) Injection (Shortage) Thiotepa (Thioplex) for Injection (Shortage) Tiopronin (Thiola) (Shortage) Tobramycin Injection (Shortage) Trace Elements (Shortage) Vancomycin Hydrochloride for Injection, USP (Shortage)
USFDA 28 October 2015: http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
Excerpts from the technical consultations
Tracking paediatric
dose forms in shortageSlide9
Web site locationsTechnical consultation on preventing and managing global stock outs of medicinesReport to the WHO Executive Board: Addressing the global shortages of medicines, and the safety and accessibility of children’s medication
Technical Consultation on medicines for ChildrenWHA Reports and documentsSlide10
Many thanks, Lisa HedmanEssential Medicines and Health ProductsWHO/ GenevaHedmanL@who.int