That the Nigerian pharmaceutical market is in a messy state is not news to many in the industry or even the customer. The problems and challenges facing the industry are known to many of us. They have been identified, analysed and endlessly discussed at various forums and yet we sit in the same cesspool of failure to perform at the highest professional level. What’s even more shocking is the failure of stakeholders to find and implement solutions to the problems. And so, the malaise persists.
But all is not lost. There are solutions that we can begin to implement now and they begin with the superintendent pharmacist, the one key player that can take a leadership role in resolving some of the challenges we face today. In subsequent articles, I will address other segments and players in the industry and offer some practical steps we need to take as an industry to avert further disaster. For now, though, we must evaluate the role of the superintendent pharmacist in both creating and getting us out of the current embarrassing situation.
Superintendent pharmacists occupy a unique role in the practice of Pharmacy in our society. In a normal environment, they anchor the industry, serve as principal officers responsible for maintaining the integrity of the system and, where necessary, act as agents of change. In that last capacity, they are sorely lacking in Nigeria today and I would like to call on them to step up to this role. In doing so, they can move the industry forward and help reverse some of the damages that years of neglect have done to the pharmaceutical market.
A superintendent is “a person who manages or superintends an organisation or activity.” A direct extrapolation of this definition will make the superintendent pharmacist the overseer, administrator, manager, supervisor or controller of the organisation that he presides over. By law, he is the legal “face” of the pharmaceutical outlet, premise or factory. He is the representative of the Pharmacist Council of Nigeria (PCN) and without him the pharmaceutical organisation will not be registered.
The superintendent pharmacist is the protector of the public interest, ensuring that there is a balance between the profit-making goals of the enterprise and the discharge of ethical responsibilities expected of a pharmaceutical business.
The failure of superintendent pharmacists to play their part has contributed in no small measure to the mess that we are currently in. We would have been able to eliminate or, at least, control the battery of unethical practices that currently pervade the entire system.
How did we get to this level where more than 90 per cent of commercial activities in Pharmacy are out of control? If you are a superintendent pharmacist, you bear part of the blame for this malaise. Many superintendent pharmacists like the title and the financial compensation associated with the position but often fail to discharge the corresponding duties. The failures are stunning: abdication of responsibilities demonstrated in the popular but nefarious “Register and Go” activities, and shocking lack of appreciation of the enormous responsibility associated with the superintendent pharmacist’s office.
Over the years, the pharmaceutical regulatory authority has also been permissive and complicating its oversight of the profession: registration is “static”(occurring once a year) and there are no institutionalised procedures in place to interface with the organisation and the superintendent pharmacist, apart from sporadic inspections, usually following pressure from other pharmacists.
The superintendent pharmacist can help change the face and practice of Pharmacy for good in Nigeria. The duties associated with the position entail more than premises and product registration. Everything involving pharmaceutical products should start and end with the superintendent pharmacist, including raw materials procurement, manufacturing, quality control, distribution, sales and dispensing of drugs.
We must, therefore, do everything possible to empower the superintendent pharmacist. They must be sufficiently equipped to discharge the responsibilities attached to the post; this goes beyond the possession of a Bachelor of Pharmacy degree. They must also be held accountable for their performance. Furthermore, the industry needsto organise regular workshops for all pharmacists who have chosen to work as superintendent pharmacists.
In 2012, the Association of Industrial Pharmacists of Nigeria (NAIP) organised a special workshop for superintendent pharmacists as part of its 15th Annual Conference. The workshop was attended by more than 250 superintendent pharmacists and the PCN, led by the then acting Registrar, Pharm (Mrs) Gloria Abumere, FPSN. At the end of the workshop, a standard operating procedure (SOP) for superintendent pharmacists was produced and sent to the PCN for action. Regrettably, nothing has been done to give effect to the SOP, which we consider a good tool for the superintendent pharmacists.
I am reproducing the SOP with this article, with the hope that the relevant authorities in PCN and PSN will make use of it as appropriate.
God bless Pharmacy in Nigeria.
Draft Procedure to Operate as a Superintendent Pharmacist in the Pharmaceutical Industry
This document prescribes the conduct of a Superintendent Pharmacist in the Pharmaceutical Industry with the objective of ensuring a compliance with the code of ethics guiding the practice of Pharmacy as regulated by the relevant authorities.
This procedure is applicable to all Pharmaceutical Industries as regulated by the relevant authorities.
It is the responsibility of the Superintendent Pharmacist and the relevant authorities with the cooperation of the top management of Pharmaceutical Industries to ensure the implementation of this standard operating procedure.
To operate as a Superintendent Pharmacist, the following attributes and standard are expected:
- He/she should be knowledgeable, skilled, licensed by and responsible to the Pharmacists Council of Nigeria.
- He/she should have the overall professional control of a set standard of planning, implementing and executing the approved Pharmaceutical Policies of a premise in accordance with Act. P17 LFN, 2004.
- He/she should set standards and policies for the pharmaceutical aspect of the business.
- He/she should ensure that all Legal, Professional and Regulatory requirements in relation to pharmaceutical aspect of the business are complied with.
- He/she should ensure that there are appropriate policies setting on the number of staff and their required experience.
- He/she should respond appropriately to any system failures or concerns that may arise.
- He/she should ensure that all professional activities undertaken within the premises are adequately covered by professional indemnity.
- He/she should ensure the registration and annual licensure of the premises and also of all Pharmacists working in the organization.
- He/she should set standards and policies for the pharmaceutical aspect of the business.
- He/she should be professionally accountable for the day to day level of practice.
- He/she should be responsible for the over-all quality assurance of the establishment, according to Section 4(3) of the PCN Act.
- He/she should be sufficiently positioned:
- to supervise the Production and Quality Control Managers or at least have a dotted line relationship with the key officers in accordance with Section 4(4) of the PCN Act.
- To review the Sales marketing practices of the company and bring them in line with ethical practices.
- He/she should ensure that every agreement pertaining to the pharmaceutical aspect, entered into by his company is done according to professional ethics and within the ambits of the law.
- He/she should ensure that starting materials are purchased following due process in line with specified standards.
- He/she should ensure that all processes and procedures that are necessary for compliance to the principles of good manufacturing practice are properly carried out by qualified personnel on a timely basis.
- He/she should approve all working document before implementation by production and quality assurance/control department.
- He/she should approve all test results before release for use or sale.
- Where the business is IMPORTATION only:
- He/she should be aware and approve the source(s) of supply.
- He/she should approve the product for sales after receipt into the warehouse.
- He/she should order periodic testing of the products to ensure that they are safe for public consumption.
- In all cases, He/she should review, at a regular interval(monthly), the sales procedures in the company, confirm that customers are fit and proper person or companies licensed to handle drugs.
- A written report of the exercise in (s) above should be kept in the company record for PCN inspection.
- He/she should be personally involved in all decision making that may impact on products.
- He/she should liaise with regulatory agencies as the sole responsible officer of the facility.
- He/she should ensure that standards of practice are up to date, understood and followed by both management and staff of the facility.
- He/she should ensure proper documentation by institutionalizing a culture of accurate, up to date and accessible record keeping, with controls where necessary.
- He/she should make sure clear lines of accountability exist and that a retrieval or recall process is in place in case of product failure.
- He/she will be held RESPOSNSIBLE and ACCOUNTABLE for any unethical practices that may take place in the procurement, production, marketing, Sales and distribution of the products in the company.
References for Implementation:
- Laws of the Federation of Nigeria, Pharmacists Council of Nigeria Act (1992 No. 91)
- Pharmacists Council of Nigeria Act (1992 No. 91). Registration of PharmaceuticalPremises Regulations, 2005
- Pharmacists Council of Nigeria Act (1992 No. 91). Inspection, Location and Structureof Pharmaceutical Premises Regulation 2005
- Code of Ethics for Pharmacists in Nigeria.
- Membership of Association of Industrial Pharmacists(AIPN).
- A testimonial of compliance to be obtained from AIPN before PCN is approached for registration.
References for Continual Improvement:
- A forum or an Association of Superintendent Pharmacists within the ambit of AIPN is imperative to encourage interactions, sharing of experiences, counselling, personal development and networking.
- At least 3 years post qualification experience or 1 year post NYSC exposure is necessary before a registered Pharmacist becomes a Superintendent Pharmacist or handles importation of drugs.
iii. The Pharmacists Council of Nigeria should develop computer software that would detect multiple full time employments of Pharmacists.
Implementation of the responsibilities of the suprintendent pharmacist as enumerated in the S.O.P require the cooperation of the employer who in most instances is interested in profit. Where there is friction between ethics and emplyer’s interest, the regulatory authority should be informed and is expected to act promptly. This is where suprintendent pharmacist is faced with challenge wether to resign his appointment or compromise. If the regulatory authority fails to act, the organisation may continue bisiness without a pharmacist.