ADDRESS BY MRS. YETUNDE ONI, ACTING DIRECTOR-GENERAL (NAFDAC) AT THE WORKSHOP ON GOOD DISTRIBUTION AND STORAGE PRACTICES FOR PHARMACEUTICAL PRODUCTS
LAGOS. August 8, 2017
Protocol
I am delighted to address you at this workshop organized by NAFDAC in collaboration with United States Pharmacopeia (USP) on Good Distribution and Storage Practices for Pharmaceutical Products.
NAFDAC in collaboration with the World Health Organization (WHO) and other relevant stakeholders developed five (5) guidelines in 2016 of which NAFDAC Good Distribution Practices (GDP) Guidelines for Pharmaceutical Products 2016 is one. The Honourable Minister of Health, Prof. Isaac F. Adewole officially presented the GDP Guidelines to the public on 5th April 2016 along with four other NAFDAC Guidelines. These Guidelines are designed to assist stakeholders in the pharmaceutical sector to comply with NAFDAC regulations.
The Agency in collaboration with USP conducted a survey on the quality of Antimalarial, Maternal and Child Health (MCH) Medicines (Oxytocin Injection, Magnesium Sulphate Injection, Calcium Gluconate Injection, and Misoprostol tablets) and the report was presented to stakeholders on 11th April 2017.
The report of the survey revealed that:
4.3% of antimalarial medicines failed quality tests while 95.7% passed
6.76% of Calcium Gluconate Injection failed quality tests while 93.24% passed
2.4% of Magnesium Sulphate Injection failed quality tests while 97.6% passed
33.7% of Misoprostol tablets failed quality tests while 66.3% passed
74.2% of Oxytocin Injection failed quality tests while 25.8% passed.
The high failure rates of 74.2% for Oxytocin Injection and 33.7% for Misoprostol tablets (essential medicines used in the management of Postpartum haemorrhage (PPH) are unacceptable and we resolved to urgently address it.
This workshop is therefore organized to discuss and strategize towards improving the quality of Oxytocin Injection, Misoprostol tablets and other essential medicines in Nigeria.
As a result of the unacceptable high failure rates, NAFDAC strengthened surveillance on Oxytocin Injection and Misoprostol tablets in the thirty-six States and the Federal Capital Territory. During the surveillance activities, Oxytocin Injection and Misoprostol tablets that were improperly stored were mopped up from circulation to prevent their sale to unsuspecting patients. The surveillance and mop up exercise will be sustained to prevent public health hazards that may be associated with the use of substandard Oxytocin injections and Misoprostol tablets. In addition, the Agency resolved that only manufacturers and importers of Oxytocin Injection that have suitable distribution and storage facilities will be granted Marketing Authorization.
The collaboration of NAFDAC with USP has assisted the Agency to come up with reliable data on quality of critical medicines required to improve treatment outcome in Nigeria. It has also assisted the Agency to identify gaps that need to be strengthened in our determined efforts to make quality medicines available to the members of the public.
One of such gaps identified is inadequate compliance with the provisions of NAFDAC Good Distribution Practices (GDP) Guidelines for Pharmaceutical Products 2016. We have therefore invited experts in Quality Assurance of Pharmaceutical Products to facilitate this workshop in order to strengthen the capacity of manufacturers, importers and distributors on Good Distribution and Storage Practices to enhance compliance.
I implore participants at this workshop to pay attention to the facilitators and utilize the knowledge and experience acquired to improve compliance with the provisions of NAFDAC Good Distribution Practices (GDP) Guidelines for Pharmaceutical Products 2016. NAFDAC will sustain surveillance on Oxytocin Injection, Misoprostol tablets and other essential medicines to detect noncompliance with the provisions of GDP and enforce appropriate sanctions.
I urge manufacturers, importers, distributors and retailers of pharmaceutical products to ensure proper distribution and storage so that the products retain their quality along the distribution chain.
Thank you for your attention.
