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!