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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 Uniject Device ?. The Uniject device* is an injection device developed by PATH in 1987 in response to WHO’s call for improved injection delivery designs.

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Oxytocin in Uniject with TTMs Overview and Status

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  1. Oxytocin in Uniject with TTMs Overview and Status Reproductive Health Technologies in Crisis Settings May 13 – 14, 2008

  2. What is the UnijectDevice? The Uniject device* is an injection device developed by PATH in 1987 in response to WHO’s call for improved injection delivery designs. • 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 (hereafter called Uniject) is a trademark of BD.

  3. Uniject Components Blister Valve Needle Cap

  4. 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.

  5. Successful Uniject Applications • Hepatitis BVaccine in China and Indonesia1,2,3 • Tetanus Toxoid in Afghanistan, Bolivia, Burkina Faso, Ghana, Indonesia, and Mali4 • Oxytocin in Angola, Indonesia,5 and Vietnam UNICEF/Giacomo Pirozzi

  6. 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.

  7. 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

  8. 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!”

  9. 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?

  10. 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.

  11. Thank You! Steve BrookeCommercialization AdvisorUniject Applications Teams Leader206.285.3500sbrooke@path.org

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