How to improve access to safe, effective, cheap drugs

Elijah N. A. Mohammed is a consultant pharmacist and the Registrar/Secretary to the Governing Council, Pharmacists Council of Nigeria (PCN). Mohammed in this interview with The Guardian among other things gave a blueprint on how to improve access to safe, effective and affordable drugs as well as reduce incidences of counterfeiting. He, however, said weak laws and regulations, inadequate personnel, logistics, and funding are the major obstacles faced by the Council towards meeting its mandate. CHUKWUMA MUANYA writes. Excerpts

Several reports have associated the uncoordinated and chaotic drug distribution system in the country with a rise in fake drugs as well as drug abuse and misuse. What is PCN doing to address the situation?
THE National Agenda adopted by the Federal Government through the auspices of the Federal Ministry of Health (FMoH) to address the uncoordinated and chaotic drug distribution system in the country is the National Drug Distribution Guideline (NDDG). The implementation of the NDDG would ensure the closure of all open drug markets and the relocation of the stakeholders operating in the markets to the Coordinated Wholesale Centres (CWCs) which are regulated entities within the second layer of the framework for drug distribution as approved by the FMoH.

So far, PCN has inspected and approved the siting of CWCs in some states and we are closely monitoring developments in relation to the construction activities across these States to ensure compliance with the approved standards and specifications. I want to put on record that the present administration of President Muhammadu Buhari has demonstrated strong political will towards the full implementation of the National Drug Distribution Guidelines in order to achieve the permanent closure of the open drug markets and also streamline the drug distribution system in Nigeria. This would improve access to drugs that are safe, effective and affordable while also reducing incidences of counterfeiting.

Similarly, the national enforcement team of the PCN has been strengthened to checkmate the proliferation of unregistered pharmaceutical premises within the drug distribution system. Last year alone, 2019, the national enforcement team sealed 4,448 illegal premises across various states while several people arrested by the law enforcement agents in the process are currently facing prosecution accordingly. Let me reiterate that PCN is determined to intensify this activity this year, 2020 despite the challenges.

What are you doing about the rising cases of drug abuse, misuse, and adulteration in Nigeria?
The factors that are contributing to drug abuse and misuse are multidimensional and include chaotic drug distribution systems particularly, characterised by the existence of open drug markets; the proliferation of illegal and unregistered premises particularly the PPMVs; easy access to substances of abuse; and peer pressure, among others.

As highlighted earlier, the full implementation of the National Drug Distribution Guidelines, which in effect would ensure the closure of all open drug markets is key to addressing this problem. The regulator’s platform, which comprised the PCN, National Agency for Food and Drug Administration and Control (NAFDAC), and indeed Federal Ministry of Health is very committed to this project. The progress recorded so far, as mentioned earlier, in the on-going construction of CWCs where the stakeholders operating in these markets will be relocated to, clearly indicates that the closure of these markets is imminent and will happen sooner than later.

Also, the on-going enforcement activities by PCN is targeted at checkmating the proliferation of illegal premises. The PCN also undertook advocacy programme to critical stakeholders that are the vulnerable groups in line with the recommendations of the Codeine Control and Other Related Matters Working Group (CCRWG) as approved by the Federal Ministry of Health. The goal is to reduce the influence of peer pressure and discourage the indiscriminate use of drugs. Similarly, Information, Education, and Communication (IEC) materials were produced and distributed among registered community pharmacies to serve as a public health approach to reinforce positive behaviour in relation to medicine and substance abuse.

Let me state that these efforts in collaboration with relevant Ministries Departments and Agencies (MDAs) have contributed largely to the reduction of this menace particularly as it relates to codeine and related substances abuse among the vulnerable groups in the country.

What have been the challenges?
The challenges facing PCN cut across the areas of weak laws and regulations, inadequate personnel, logistics, and funding.

Nevertheless, I wish to state that the reviewed PCN Bill, which is currently at the final stages of the law-making process is all-encompassing, provides adequate provisions for sanctions and has adequately addressed the gaps inherent in the current law amongst other benefits

The challenge of inadequate logistics particularly in the area of operational vehicles is of great concern to the PCN. It is noteworthy that operational vehicles are very essential for inspection, monitoring, and enforcement activities and other regulatory functions such as accreditation, internship monitoring, etc. Unfortunately, majority of the few operational vehicles currently available are gradually becoming unserviceable. We are, however, making concerted effort to address this problem.

Also, PCN operates eight Zonal offices and 35 state offices across the country. Currently, the number of personnel in these offices are grossly inadequate for effective regulatory activities. To improve the impact of regulatory activities of PCN, which was the primary purpose of decentralisation, we are working through FMoH with relevant MDAs to secure waivers for the employment of additional personnel.

How many pharmacists and pharmacies are regulated by PCN?
The total number of registered pharmacists as at December 31, 2019 was 25,870. However, the pharmacy profession like other professions in health care also suffers a lot from brain drain.

The PCN registers and licenses pharmaceutical premises which include manufacturing, importation, wholesale/distribution, and retail pharmacies, among others. The total number of those facilities licenced last year was 6,495.

In addition to the above-mentioned facilities, PCN also registers and licenses hospital pharmacies as well as Patent and Proprietary Medicines Vendors (PPMVs).

What are the penalties for offending pharmacists and pharmacies?
The PCN Act 91 of 1992 (Now Cap P.17, LFN, 2004) makes provision for the establishment of an Investigating Panel and Disciplinary Tribunal. An Assessor from the Office of the Attorney-General of the Federation participates in the trial of an offending pharmacist by these organs of the Council, who, if found guilty during trial, the Tribunal may direct the Registrar to strike off the name of the erring pharmacist for a period of time. Such decisions are usually circulated widely in print and electronic media. It is pertinent to state that for the period that the pharmacist’s name is struck off, he/she shall not be entitled to practice pharmacy anywhere.

On the other hand, the provisions of the Poison and Pharmacy Act serves as the instrument for prosecuting pharmaceutical premises in breach of regulation. However, the sanctions in this Act are weak and not deterrent enough. This is one of the reasons that necessitated the initiation of the review of the current pharmacy and drug laws by the National Assembly. As a result, the Pharmacy Council Bill earlier referred to, has comprehensively made provisions for offences by pharmaceutical premises with adequate sanctions.

What have been your achievements especially in the last year?
It is imperative to state that in the last one year we achieved several successes in the areas of effective regulation of personnel, pharmaceutical premises and the practice of the profession.

The tempo of enforcement activities during the period under review resulted in the closure of 4,448 illegal premises and on-going prosecution of 37 persons by law enforcement agents. This effort would be sustained in the current year and even beyond. To complement these efforts, PCN last year commenced digitalising her operational tools especially inspection tools with a view to promoting efficiency, effectiveness, and transparency. This activity is being supported by PharmAccess through Integrat- E with funding from Bill and Melinda Gates Foundation.

PCN also received the World Health Organisation (WHO) Global Benchmarking Team (GBT) on the assessment of her regulatory functions, processes, and procedures to ensure it meets up with the international set standards for National Regulatory Systems. This assessment was undertaken both for NAFDAC and PCN and I must commend the leadership of NAFDAC for the collaboration with PCN so far, in this regard. The target of both NAFDAC and PCN is to attain Level 3 out of 4 from this global benchmarking assessment so that pharmaceutical and related products locally produced can achieve international acceptability and also effectively compete on International bidding platforms.

The agenda of my administration, which focuses on the New Partnership 4 Progress Initiative also received great attention in the past year. The goal is to promote partnership and collaboration with stakeholders as well as implementing/development partners and Non-Governmental Organisations (NGOs) with a view to improving partnership and regulation.

Several manpower development programmes were organised for the staff of the Council with the goal of improving performance output and service delivery. An organisational capacity assessment was also conducted for PCN last year by HOWES Consulting through the platform of INTEGRAT-E Project with funding from Bill and Melinda Gates Foundation. The outcome of the National Organisational Capacity Assessment has served as a template in developing an organisational performance improvement activities and training plan for the PCN.

Additional Faculties of Pharmacy, as well as more Schools/Colleges of Health Technology, received PCN accreditation during the period. This would no doubt improve the frontline health professionals gap as in the case of pharmacists and as well improve sub-cadre manpower, in this case, pharmacy technicians.

Do you have any legislation empowering you or are you seeking one?
There are many legislations that PCN uses as instruments for regulations. These include PCN Act 91 of 1992 (now Cap P17 LFN, 2004); The Poison and Pharmacy Act, Cap 152; and Poison and Pharmacy Act, Cap 535, LFN, 1990.

Other regulations include: Official Federal Government Gazette No. 79 and 81 of 2005 which are Registration of Pharmaceutical Premises and Location and Inspection of Pharmaceutical Premises Regulation; there is also the Code of Ethics for Pharmacists, and the; and Four-Part Compendium of Minimum Standards for the Assurance of Pharmaceutical Care in Nigeria, amongst others.

Has the PCN Bill been signed and passed into law?
The PCN Bill is currently at the final stages of law-making after proper scrutiny by the Federal Ministry of Health. In view of this, I am confident that Bill will soon become a law of the Federation to address the current gaps in the pharmaceutical landscape.

What are the requirements for patent medicines vending?
The Patent and Proprietary Medicines Vendors (PPMVs) are non-pharmacists licensed to stock and sell simple medicinal remedies as entrenched in the 1958 Poisons and Pharmacy Act Cap 152, Poison and Pharmacy Act Cap 535 and Pharmacists Council of Nigeria Decree 91 of 1992 (Now Cap P17, LFN, 2004). This was an attempt to redress the lopsided distribution of the very few healthcare facilities available at that time. The need remains a relevant aspect of Nigeria’s healthcare system today.

The target is to ensure that efficacious, affordable and genuine simple medicines are available within the reach of every community, in line with the National Drug Policy.

The PCN takes this responsibility very seriously, indeed, and has mobilised all resources at its disposal to ensure effective regulation of this sub-sector. This background is to open our minds to the position of PPMVs in the healthcare system.

In order to obtain a Patent and Proprietary Medicines Vendor’s Licence, an applicant must adduce evidence to the satisfaction of the licensing authority (PCN), which must be in line with the laid down guidelines.

After satisfying the eligibility criteria, an applicant should forward an application made in the applicant’s own handwriting, indicating location and address where the intended business is to be undertaken addressed to the Registrar, Pharmacists Council of Nigeria. The application should be accompanied by a duly completed application form obtained at a prescribed fee and forwarded to the PCN State offices nationwide where the applicant wants to operate. The applicant is also required to attach a current income tax clearance certificate.

The Director of Pharmaceutical Services (DPS) in the State Ministry of Health serves as the Chairman of the State Patent and Proprietary Medicines Vendors Licence Committee while the PCN State Officer-in-Charge serves as Secretary to the Committee.

The PPMVL Committee undertakes processing of the application including inspection after which the recommendation arising therefrom is forwarded to the Registrar.

Licenced shops are subjected to periodic monitoring and inspection by accredited Pharmaceutical Inspectors who submit their reports to the Pharmacists Council of Nigeria, through the State PPMVL Committee.

A license so granted is not transferable and expires on 31st December of the year in which it is issued and should be renewed during the month of January every subsequent year while still in business.

The PPMV’s mandatory attendance at Orientation Course after licensure and regular (two-yearly) Continuous Education Programme (CEP) is also organised to equip the vendors with appropriate and up to date knowledge required to undertake the business.

What other things would you like Nigerians to know regarding the activities of PCN?
Pharmacists Council of Nigeria is the Parastatal of the Federal Government established by Act 91 of 1992 (Now Cap P.17, LFN, 2004) charged with the responsibility for the regulation and control of pharmacy education, training and practice in all aspects and ramifications. These include the regulation of sub-cadre Pharmacy Technicians and Patent and PPMVs.

PCN had always injected new ideas with the deployment of feasible strategies towards efficient, effective and meaningful implementation of her regulatory mandate. This has resulted in the creation and sustenance of enabling environment for pharmacy practice in Nigeria. The overall goal is to promote access to safe, effective and affordable medicines by Nigerians from premises that are inspected, approved and licenced by PCN.

https://guardian.ng/features/how-to-improve-access-to-safe-effective-cheap-drugs/