Blazing trail on medicines’ quality assurance programme

*PQM, NAU partner on PCN-approved PQS curriculum to ensure safe drugs, better-trained pharmacists
Committed to the provision of good quality assurance systems and to increase the capacity of training institutions to reflect education that produces competent pharmacists that can provide services that satisfy local and international needs, the Promoting the Quality of Medicines (PQM) programme and the Faculty of Pharmaceutical Sciences of the Nnamdi Azikiwe University (NAU) Awka, Anambra State, have started training educators on Pharmaceutical Quality System (PQS) Course Content for Nigerian Universities.

PQM is funded by the United States Agency for International Development (USAID) and implemented by United States Pharmacopeia (USP).

In recent times, there is increasing demand for policies that incentivize local manufacturing of pharmaceuticals.

The National Agency for Food Drug Administration and Control (NAFDAC) has increased focus on good manufacturing practices and quality-assured medicines. The Pharmacists Council of Nigeria (PCN) is not left out as it moved to align curriculum with workforce expectations.

In 2016, PCN formed a panel to review undergraduate and graduate pharmacy curriculum for quality assurance content. The panel included representatives from Nigeria’s pharmaceutical regulatory agencies, pharmaceutical manufacturers, academia, and PQM programme.

PCN identified a need for enhanced quality assurance curriculum and, with assistance from the panel, developed the PQS Course Content for Nigerian Universities.

The Pharmaceutical Sciences faculty of NAU is the first to incorporate the course content, by including it in the Phar.D. curriculum for the 2018/2019 academic session.

In preparation, NAU faculty participated in PQM’s workshop held March 12 – 15, 2018 at the Agulu campus of the University.

PQM workshop supports curriculum integration. PQM developed the content for the workshop to train educators in the PQS curriculum.

Nnamdi Azikiwe University is the first to participate in the workshop with 20 faculty members in attendance.

The workshop presenters include: the Acting Dean of Faculty of Pharmaceutical Sciences NAU, Prof. Ikemefuna Uzochukwu; Chief of Party, PQM, Dr. Chimezie Anyakora; Senior Good Manufacturing Practice (GMP) Specialist, Mr. Mopa Esuga; Senior GMP Specialist, Mr. Jonathan Ukwuru; Senior Quality Assurance/Quality Control Specialist, Mr. Adebola Adekoya; and Chief Executive Officer (CEO) of Juhel Nigeria Limited, Dr. Okoye Ifeanyi.

Okoye during his speech offered his manufacturing facility in Awka to be used for practical exposure/experience for the students to strengthen Quality Assurance (QA) knowledge and skills.

Anyakora said the curriculum would help develop a pool of future professionals well-versed in pharmaceutical quality assurance.

“Future professionals can bring their quality assurance knowledge to different areas of the pharmaceutical sector, including regulatory agencies, manufacturing, public health programs, and other policymaking positions in the country. In the future, Nigerian professionals may even support other countries in the sub-region,” he said.

Uzochukwu said: “The PQM workshop is a welcome development. This and future partnerships will help the University achieve our vision of becoming a first-class school of pharmacy. I promise to optimize the investments made by PQM and to increase the knowledge, attitudes and skills (KAS) acquired by our students and the pharmaceutical subsector.”

Okoye said: “We should not take this workshop for granted. This is a great gesture and a truly exceptional opportunity, as an important pathway toward developing future professionals.”

Anyakora added: “Securing the pipeline of professionals to advance medicines quality is one way we are ensuring the sustainability of PQM’s efforts. We thank USAID for funding PQM’s efforts and Pharmaceutical Sciences of the Nnamdi Azikiwe University for taking the lead. We hope many other universities will follow.”

Anyakora said PQM has helped NAFDAC develop the first Quality Assurance Policy in Nigeria and has supported three Nigerian national quality control laboratories to obtain and then expand their ISO/IEC 17025 accreditations, verifying their abilities to deliver accurate test results and operate according to international standards.

He said PQM has provided technical assistance to 11 manufacturers so they can comply with good manufacturing practices and then supply quality-assured medicines in Nigeria and support to NAFDAC for post-market surveillance to detect and confiscate poor-quality medicines.

Anyakora said the Pharmaceutical Sciences of the NAU and PQM would monitor the curriculum implementation to assess where they can make improvements to the rollout process or the content, and to use the experience as a model for expansion to other universities.

Indeed there have been renewed efforts towards ensuring enabling environment for local pharmaceutical manufacturers.

The Vice President, Prof. Yemi Osinbajo, in May 2017, signed Executive Order 003 approving: “Made-in-Nigeria products shall be given preference in the procurement of the following items and at least 40 per cent of the procurement expenditure on these items in all [Ministries, Departments and Agencies] of the FGN shall be locally manufactured goods or local service providers… pharmaceuticals.”

Also, the Nigeria’s National Drug Policy of Federal Ministry of Health (FMoH), February 2017, stipulates that Nigeria should aim at producing 70 per cent of its medicines needs.

The FMoH also said duties on imported drugs will remain, while waivers on tariffs will be sought on imported drugs yet to be manufactured in Nigeria and NAFDAC announced in October 2017 that it has reduced registration fees by 50 per cent.