Oxytocin in Uniject with TTMs Overview and Status
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Transcript of Oxytocin in Uniject with TTMs Overview and Status
Oxytocin in Uniject with TTMs Overview and Status
Reproductive Health Technologies in Crisis Settings
May 13 – 14, 2008
What is the UnijectDevice?
• Single dose for minimal waste of drug or vaccine.
• Prefilled and sterile for use by a wide variety of health workers.
• Nonreusable to prevent the spread of HIV and other diseases.
• Now commercially available from Becton Dickinson (BD).
The Uniject device* is an injection device developed by PATH in 1987 in response to WHO’s call for improved injection delivery designs.
* The Uniject device (hereafter called Uniject) is a trademark of BD.
Uniject Components
Blister
Needle
Valve
Cap
Making Drugs Available in Uniject
• Not as simple as “just ordering a syringe”
• BD provides Uniject to pharmaceutical companies who fill with final product.
• BD and PATH collaborate with pharmaceutical companies to make drugs and vaccines available in Uniject.
Successful Uniject Applications
UN
ICE
F/G
iacomo P
irozzi
• Hepatitis B Vaccine in China and Indonesia1,2,3
• Tetanus Toxoid in Afghanistan, Bolivia, Burkina Faso, Ghana,
Indonesia, and Mali4
• Oxytocin in Angola, Indonesia,5 and Vietnam
Why Oxytocin in Uniject?
• Post-partum hemorrhage (PPH) accounts for 130,000 maternal deaths per year.
• WHO recommends 10 IU of oxytocin as part of AMTSL for prevention of PPH.
• Prefilled, easy-to-use Uniject ideal for delivery of oxytocin during third stage of labor, especially in rural settings and home deliveries.
Oxytocin in Uniject: Field Activities South Africa: Summer 2008
• PATH and MOH of KwaZulu-Natal state to conduct operational study comparing oxytocin in Uniject to traditional vial and syringe for quality and coverage in AMTSL efforts.
Argentina: Spring/Summer 2008
• IECS, PATH, Tulane to study Oxytocin in Uniject as a tool to increase use of prophylactic oxytocin for management of third stage of labor.
Latin America, India, and beyond 2008+
• Various countries interested in pilot introduction for PPH reduction
Time-Temperature Indicators (TTIs)—a useful option
The problem
• No easy way to track exposure to heat during transport or storage.
• Health workers may either use spoiled drugs or discard good drugs.
The solution
• TTI permanently changes color with cumulative exposure to heat.
• Allows more flexible transport and storage options.
• Minimizes use of spoiled product or waste of good product.
“Over 3 billion TTIs have been used with vaccines purchased by UNICEF!”
Next Steps
• Instituto Biologico Argentino (BIOL) expected to obtain Argentine registration of oxytocin in Uniject – Spring/Summer 2008
• Indian producer (Gland Pharma) expected to obtain Indian registration of oxytocin in Uniject Winter 2009
• Both companies to apply for new WHO oxytocin prequalification process
• Could this be useful in your crisis and relief settings?
References
1. Levin CE, Nelson CM, Widjaya A, Moniaga V, Anwar C. The costs of home delivery of a birth dose of hepatitis B vaccine in a prefilled syringe in Indonesia. Bulletin of the World Health Organization. 2005;83(6):456–461.
2. Nelson C, Widjaya A, Wittet S. Using Uniject™ to Increase the Safety and Effectiveness of Hepatitis B Immunization. Seattle: PATH; 2002. Children's Vaccine Program (CVP) Occasional Paper, No. 6.
3. Otto BF, Suarnawa IM, Stewart T, et al. At-birth immunisation against hepatitis B using a novel pre-filled immunisation device stored outside the cold chain. Vaccine. 1999;18(5-6):498–502.
4. Quiroga R, Halkyer P, Gil F, Nelson C, Kristensen D. A prefilled injection device for outreach tetanus immunization by Bolivian traditional birth attendants. Pan American Journal of Public Health. 1998;4(1):20–25.
5. Tsu VD, Sutanto A, Vaidya K, Coffey P, Widjaya A. Oxytocin in prefilled Uniject injection devices for managing third-stage labor in Indonesia. International Journal of Gynaecology and Obstetrics. 2003;83(1):103–111.
Steve BrookeCommercialization AdvisorUniject Applications Teams [email protected]
Thank You!