1. National Drug Authority Uganda
Oxytocin case study: Uganda's experience Optimal procurement of Maternal Health Commodities
Mrs. Kikule Kate
Ag. Executive Director.
National Drug Authority Uganda
10th September 2015

2. Scope Maternal Health statistics in Uganda.
National Drug Authority`s role in Maternal Health care pharmaceuticals regulation.
The Case of Oxytocin.

3. This is where we are!!!! The pearl of Africa. Karibuni!

4. Maternal Health Statistics
Country Population of 34,856,813 people (NHPC,2014).
Approximately 18million are female
Fertility rate of 6 (UNICEF, 2013).
Maternal mortality rate of 435 (UNICEF, 2013).
57% births attended by skilled health workers. (World Bank, 2011)
Fertility rate is the average number of children born to a woman in her life time if she were to live to the full extent of her child bearing age.
Maternal mortality rate is the annual number of female deaths per every 100,000 live births from any cause related to, aggravated or arising from pregnancy or its mismanagement.
A very high fertility rate and maternal mortality rate in Uganda underscores the importance of improving maternal health services, a major component of which are maternal health supplies.

5. Maternal health Statistics.
According to the “Millennium Development Goals Report for Uganda 2010”. Uganda is slow in progress towards its fifth Millennium goal and is unlikely to realize its target for maternal mortality ratio of 131 per 100,000 births by 2015.
According to UNICEF, women die due to complications including severe bleeding, infections, unsafe abortions and obstructed labor. Most of which could have been remedied if proper and adequate maternal health services and supplies were available at all levels. These statistics further emphasize the need to improve maternal health services including supplies.

6. National Drug Authority`s(NDA) Role in Maternal Health
National Drug Authority (NDA) was established by an Act of Parliament in 1993 currently the National Drug Policy and Authority (NDP/A) Act, Cap. 206 of the Laws of Uganda (2002 Revised edition)
Mandated to ensure access to efficacious and safe Medicines by the Ugandan population through the control of their manufacture, importation, distribution and use.

7. National Drug Authority`s(NDA) Role in Maternal Health
How does NDA Ensure quality and safety of Maternal Health Supplies?.
Inspection of all Maternal health Pharmaceutical Manufacturers for compliance with Good Manufacturing standards as a pre-requisite for registration and export of pharmaceuticals to the Ugandan market.

8. National Drug Authority`s(NDA) Role in Maternal Health
Registration of maternal health medicines through product dossier evaluations as a means of assessing their efficacy and safety.
Post Market Surveillance; including routine sampling and testing of authorized products and pharmacovigilance.

9. The Case of Oxytocin- Use Classification and availability
Oxytocin is hormonal drug available in Uganda as an injectable for use in the prevention and management of postpartum hemorrhage in pregnant mothers and also to induce contractions during labor.
Scheduled under class B- POM
Listed in the Uganda Essential Medicines List (2012)
Available from Health Center 3 level and also in the private sector through prescription.

10. The Case of Oxytocin- Use Classification and availability
Available at health center III, IV and hospital level in the public sector.
Available at distributor and retail pharmacy level in the private sector.
Recent report by Population Action International(2015) showed an increased availability and use of oxytocin in health centers in Uganda between

11. The Case of Oxytocin- Source of Oxytocin
Entirely from External drug Manufacturers

12. The Case of Oxytocin- Quality Assurance points
The Drug route from the manufacturer to retail outlet
A description of the drug route.
Manufacturer assuring quality before distribution, the manufacturer is assesed through complaince with GMP.
Distribution- Need for importers to comply with GDP to ensure intergrity of the product throughout distribution.(still a challenge)
Importation- Control of imports through inspection of medicines consignments at the port of entry.
Wholesale and Retail points.- Control of quality through inspection and licensing of wholesalers and retailers.

13. The Case of Oxytocin- Quality Assurance
6 NDA-GMP certified manufacturers of oxytocin.
1 – Switzerland.
3 - India.
2 – China.
8 Registered formulations of Oxytocin inj.

14. The Case of Oxytocin- Packaging and Storage
According to the United States Pharmacopeia;
Package in tight containers preferably type 1 glass.
Store under refrigerator conditions of 2-80C

15. Genesis of Regulatory Action
Through the Complaint Management system , market complaints were received from , National Medical Stores , Mulago Referral Hospital and regional referral hospitals in March 2013.
NDA instituted investigations which included review of dossiers ,Inspection reports , reference material USP , Eur Ph. and Physical Analysis of samples.
NDA engaged the stakeholder where the findings were shared in additions to other regulatory actions from Pharmacy and poisons Board Kenya on storage of Oxytocin
Residential Forum: 25th - 28th June 2013

16. The Case of Oxytocin- Packaging and Storage regulatory Action
In November 2013, NDA issued a circular to all manufactures/license holders of oxytocin to ensure their products are labelled with the appropriate storage conditions of 2-80C after certain products were labeled for storage at room temperature or less than 250C.
NDA suspended Oxytocin medicinal preparations that did not meet the labeling requirements. Reinstatement was done for those that met the requirements with exception of one preparation that never responded.
Several products were labelled for storage at room temperature which was shown to have a negative impact on the potency of the product

17. The Case of Oxytocin- Quality Assurance
Post Market Surveillance
Post Market Sampling and Testing in collaboration with the United nations Commission on life-saving Commodities Quality survey was carried out in 2014.

18. The Case of Oxytocin- Quality Assurance
Batch N0.
Parameters Analyzed
Parameters passed
Parameters Failed
Action taken.
120713
Appearance, identity, Assay, Impurities.
Appearance,
Identity
Assay
Impurities
Recalls effected.
Plan for increased testing.
130318
Recall effected. Plan for increased testing.
121237
All the batches were from Chinese manufacturers. They failed on inadequate quantity of active ingredients and More than the specified limit for impurities.

19. The Case of Oxytocin- Quality Assurance
Potency down
Impurity up
Possible explanation for Failure in product specifications is decomposition of the active ingredient due to poor storage outside the recommended 2-80C coupled with a concomitant increment in impurity level or a case of manufacture of substandard drugs??

20. The Case of Oxytocin- Challenges
Lack of adequate testing capacity for monitoring of the quality of oxytocin injectable on the Ugandan market.
Poor cold chain and storage conditions among importers and distributors of oxytocin in Uganda.

21. The Case of Oxytocin- Possible solutions to challenges
Improve testing capabilities for oxytocin and other maternal health care products by the NDA quality control Laboratory.
WHO donated equipment to the NDA Laboratory to facilitate increased testing.
HPLC
Analytical balance
Cold storage refrigerator

22. Residential Forum: 25th - 28th June 2013
Current Status
Ensure strict compliance with GDP guidelines for all importers and distributors of pharmaceuticals.
No complaints related to Oxytocin have so far been received in 2014/2015
Post Market Sampling and Testing plan for 2015/2016 includes Oxytocin
Residential Forum: 25th - 28th June 2013

23. References: Uganda Population and Housing Census, 2014.
“Uganda Statistics” (UNICEF, 2013). Accessed online at:
Uganda Population and Housing Census, 2014.
World Bank, Births Attended by skilled Health Workers.
Pharmacy and Poisons Board Kenya ,ref: PPB/PV/64 Quarantine of Oxytocins stored at room temperature
Reference USP 2013 and European Pharmacopoeia
Minutes of NDA Stakeholder meeting held on 13th November 2013
NDA Circular NO. 004/DAR/2013 Storage conditions for Oxytocin Preparations

24. THANK YOU very much for your attention
Greetings from National Drug Authority
Head office: Plot Lumumba Avenue
P.O Box Kampala, Uganda.
Tel. (+256) / /
Website:
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