There are strong indications that fake Teva Amlodipine and Lisinopril anti-hypertensive medicines have resurfaced in drug markets across the country and this is coming as the new director- general of NAFDAC is sending a strong warning to promoters of counterfeit medicines to desist from their criminal activities or face the consequences.
The circulation of fake versions of Teva Amlodipine and Lisinopril became subject of media headlines late 2016 when the National Agency for Food, Drug Administration and Control (NAFDAC) officials, apparently acting on a tip-off, paid unscheduled visit to a popular drug market in Lagos and consequently, sealed about 5 shops in connection with un-registered Teva products.
The Lagos visit by NAFDAC officials was the first in a move planned by the agency to cover the whole country according to official reports then. It was gathered that a combination of NAFDAC unscheduled visit and the spontaneous support the agency received from the leadership of the market Union in Lagos instilled fear among promoters of the fake medicines and consequently they went underground and had been operating secretly till recently when they resumed their criminal activities.
Teva Pharmaceutical Industries Ltd is an Israeli multinational pharmaceutical company headquartered in Petah Tikva, Israel. It cannot immediately be confirmed if the makers of the original generic Amlodipine and Lisinopril used for the management and treatment of hypertensive conditions is aware of this development since no official statement has been issued by the pharmaceutical giant on the proliferation of fake versions of its popular drugs in Nigeria.
Teva Pharmaceutical Industries according to industry experts, is among the leading generic makers around the world with a credible track record in genuine drug formulation and could not have been in the know concerning the circulation of fake versions of its anti-hypertensive medicines in Nigeria. Instead, it is believed that promoters of the fake versions of Teva products in Nigeria may be cashing-in on the popularity of Teva anti-hypertensive brands that are in high demand in the country to reap-off and endanger the lives of innocent Nigerians who use the medications.
Those who share this view believe that if the pharmaceutical giant was aware of such ugly development, it would have acted swiftly to stop it to avoid its reputation being smeared. To support this line of thinking, reference is made to similar challenges Teva had faced in recent past around the world, but it however, took steps to nip them in the bud.
For instance in April, 2013 the Financial Times of London reported how Teva discovered sophisticated fakes of its Omeprazole, a popular off patient heart burn medicine in Germany.
According to a statement credited to Robert Koremans, head of speciality medicines at Teva, the Israeli-based generics manufacturer, said his company had begun purchasing its own products from pharmacies to test after discovering fake versions of its omeprazole. “This is making us rethink our approach,” he said. “Patient safety comes first. We were surprised to discover the counterfeiting.”
Ratiopharm, a subsidiary of Teva, the report further said, was alerted by a patient in Germany who became suspicious of spelling mistakes in the instructions on a packet of its omeprazole, a gastric reflux treatment. The drug contained genuine pharmaceutical ingredients but was not produced by the manufacturer, as claimed on the box.
Similarly, The United States Food and Drug Administration (FDA), had in May 2012 said that consumers and health care professionals should be wary of counterfeit versions of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that are being sold on the Internet.
The FDA according to the Wall Street Journal report said its preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients.
The activities of promoters of fake Teva anti-hypertensive medicines in Nigeria appear to be bearing the footprint of determined syndicates who would stop at nothing to ensure that drug markets across the country are flooded with counterfeit versions of the popular Teva Amlodipine and Lisinopril.
Meanwhile, the newly appointed director general of NAFDAC, Prof. Moji Adeyeye, had in her maiden address to the staff of the agency recently in Abuja assured of her administration’s commitment to sustain the tempo in the war on counterfeit medicines in Nigeria until the country is rid-off it.
Pharm. Lekan Asuni is the President, Association of Nigerian Representatives of Overseas Pharmaceutical Manufacturers(NIROPHARM). He is also the founder and CEO of LEFAS Pharmaceuticals Limited. In this interview with PharmaTimes Correspondent, GABRIEL IFINNWA, he reveals how drugs manufactured locally can meet international standards, and why the pharma industry still needs government support. Excerpts:
What are your major achievements as chairman, Association of Nigerian Representatives of Overseas Pharmaceutical Manufacturers (NIROPHARM)?
As you are aware NIROPHARM represents multi-national pharmaceutical manufacturing companies locally. The Association sets and operates on a very high standard. We ensure that the international best practices are met locally. This we do through every company that represents the multinational pharmaceutical companies or through their representatives. Since, assumption of office, we have had some modest achievements. Principally, one major achievement is in the area of bridging capacity gaps – making sure that the international best practices are implemented locally.
So there has been heavy investment, in both material efforts and monetary resources to ensure an upscale, especially in the training of personnel in the relevant areas. Still, on the issue of capacity building, we have held several of this for some of our regulators like NAFDAC and other local agencies in different areas just to see how the global best practices can be implemented locally. We have also held capacity building for diverse stakeholders outside the pharmaceutical industry. Also, we have been able to champion the innovative deployment of technology in the fight against counterfeit and unwholesome medicine/drugs. We were the first to embrace technology in the fight against fake and substandard drugs. Another achievement is that we have played significant role in ensuring effective collaboration and harmony across various other trade groups and professionals within and outside the sector. In addition, we have expanded the membership strength of the Association to a very large extent. Under my tenure we have been able to organise different fora where stakeholders in the industry converge to talk on a number of topical issues.
What can be done to regulate the challenge of open drug market in Nigeria?
In the early colonial days, things were more structured. We had about 2 to 3 drug stores distributing products across Nigeria. But we started getting it wrong with the crisis in the late 80s when we had recession. The government started issuing import permits and lots of people used this import permit to do whatever they liked. That is how it started. Ideally, there should not be an open market. But going forward, I believe that it is important for those in the industry to practice in an environment where there is adequate regulatory oversight. What is lacking in the open market is that there is no access to regulation. We don’t know exactly in what conditions the drugs are being stored. Once there is no regulation, you find sub-standard drugs in circulation. I believe that those that operate in the open market have their reasons.
Some of them believe they will get more patronage and all that. But, this can still be achieved through what government is proposing with the national drug distribution guideline. This guideline will show underserved areas where people will be encouraged to set up their practice. The issue we have in Nigeria is the lack of appropriate data. I think the critical element of this guideline is the ability to map existing practice outlets with population. It can be able to tell people that there are some un-served population. It will detail the areas where the market is sizeable for you to cater for. So, I believe that once people get to know about some of the benefits of having effective regulation, through enlightenment, education, provision of adequate facilities needed, it will make it easy for those in the industry to imbibe the change. Ideally, let people practice in an environment where there could effective regulatory oversight. When this happens, the issues we have with our distribution system will be minimised as this will enable all the regulatory bodies like NAFDAC, PCN, and Nigeria Customs among others, to have access to these places. Sincerely, I think the way the industry is evolving with the deployment of technology in drug distribution it will help to curb some of the challenges in the industry.
How can drugs manufactured in Nigeria be able to meet highest international standards?
Firstly, before a product is released into the market you need to go through the regulatory body, NAFDAC. And NAFDAC ensures that the products meet the required standard. NAFDAC also ensures that the facility meets the minimum required standard for it to operate, especially in regards to its capacity to meet good manufacturing best practices. But you know after the first batch of that process, I am not sure if there is subsequently, a follow-up after the initial stages. This is not an indictment on NAFDAC because there is so much that the regulatory body can handle. In some developed countries, they have bio-equivalent centres to run tests on some of the drugs and their compositions to determine the effects on the body. There are so many other measures put in place to check aside the chemical constituents. More importantly, for imported products, coming into the country, we need to have a proper process to ensure that they conform to standards.
There has to be constant testing and data gathering, even if the data they submit possess the relevant Quality Certificate (QC); the regulatory agency must ensure these things are in order. For the local manufacturers, the drugs can meet international standards. And some of the local companies in Nigeria are already doing this. A few years ago no factory in Nigeria was WHO accredited, but nowadays we have 3 to 5 companies coming up, and more others are coming up. What this shows is that anybody that wants to set up a drug factory should ensure from the onset that it meets the international best practices, especially WHO certification. That is the only way you can be sure of the quality and it makes them competitive in the international market to be able to partake in tenders for relevant products.
As I mentioned earlier, the Pharma industry in Nigeria is still heavily import dependent. The machineries, raw materials and the addictives are still imported. So my point is that, the quality of the products starts from the quality of the manufacturers input. The big multi-national companies audit those they source their raw materials from, because they want to be sure. So, over here we should do the same. Apart from this we need to consider how these raw materials can be sourced locally. If we cannot source the active raw materials, what about sourcing the additives? The availability of machinery still needs to be resolved too. Next is the manpower, which is making sure that the personnel that will work in the industry are well trained. The university training those to work in the industry and the industry itself must work together to ensure that the quality and quantity of people employed can deliver on the role and what is required. Again, we must ensure that the quality of the processes and procedures are strictly adhered to. The manufacturers need to be diligent to follow through on this.
Again, the manufacturers still need to have access to cheap funds. Majority of the manufacturers source their funding through the banks. The banks sometimes charge high interest rates on the loans. This is still a big issue. This prevents a lot of the manufacturers in investing heavily on the quality of their products. The other element is to also ensureconstant monitoring of the industry by the various regulatory bodies. In other advanced countries, they do this. So, we should do same here in Nigeria. Nigeria has a huge population, so we can be a huge player in the West African sub-region.We need to build on our image not only locally but internationally. This will obviously help.
How do you think the Government can help pharmaceutical manufacturers in the country?
I think the pharmaceutical industry is still not considered a key sector in Nigeria. If the government could have a bank of Agriculture, what stops them from having bank of Health or Pharmaceutical industry? This issue should not be diluted with other various sectors. Funding through a proper mechanism is very important. This will help to drive focus and convergence of efforts in all that we are doing. I have nothing against the Bank of Industry (BOI). But I think we need to have a bank of health or pharma industry to drive forward our agenda. If you look at what the Asians are doing for instance, we should learn from them. For instance, they have dedicated cluster development parks. In India, they have this. In Nigeria, we are all aware that getting a parcel of land is not easy, in terms of the monetary aspect. If you bring in the issue of roads, power, and the rest, it is really a challenge. Imagine, if we have a pharma park in Nigeria, all of the issues of associated with infrastructure will be addressed there. There will be concentration on skills and expertise.The land will be on lease. When we have such places, global developers can come in and build structures along the line.
How do you see the fight on fake drugs and what strategy do you think should be employed to effectively tackle the menace?
Counterfeiting is an illicit trade. It is like blood money. People will always try to circumvent whatever the government is doing because of financial benefits. So many efforts have been made to fight substandard medicines. And these efforts need to be sustained. The regulators need to be proactive all the time. The regulators need to be steps ahead of the counterfeiters. Firstly, I am of the opinion that the penalties to deal with those who deal in counterfeit drugs is like a slap on the wrist. I think the penalty is not stringent enough. Another way to fight this is adoption of the drug distribution guideline. This guideline if effectively implemented with transparency and leveraging on technology, will go a long way in minimising fake drugs. Another issue is speedy dispensation of justice. Most of these cases stay too long in the law courts. Even when you apprehend and decide to prosecute, it takes so long before the case is completed. Some people do not have that length of time to wait for court judgement, so they give up and will rather move on.
Pharm. Gbenga Falabi is the General Manager Green Life Pharmaceuticals Limited, and the National Chairman of Association of Industrial Pharmacists of Nigeria (NAIP). In this interview with PharmaTimes Correspondent, GABRIEL IFINNWA, he gives an insight into how the pharmaceutical industry in Nigeria can stop being import dependent, and why a pharmacist should be appointed as the Director General of NAFDAC. Excerpts:
What are your achievements as National Chairman of the Association of Industrial Pharmacists (NAIP)?
First, we set out (I and my executive) to ensure unity of purpose within the industry. That was the mandate we were given. Secondly, as an association we looked at ways we can improve on the welfare of our members. Also, to strategise on ways the profession can contribute to overall growth and advancement of the health care sector in the country. Looking back, I will say, we are happy that with God’s grace we achieved much in 4 years. Foremost, we have in place the February bi-monthly economic meeting which has become an event the whole industry look forward to. We bring in economic experts during this meeting to speak on various economic issues relating to different aspects of Nigeria’s economy. I can say that members/pharmacists are more knowledgeable and can discuss much better about the industry. On our agenda to improve welfare of members, capacity building is very important. For instance, if I am relevant to a business, the employer/organisation should be able to appreciate what I can offer that business or organisation.
This will definitely bring about value creation, more money in business, thus more money will be accrued to the individual. This was the approach the National Executive took. Our national conference in the last 4 years witnessed a lot of turn-out of members. Members/pharmacists/stakeholders were scampering to attend. In an association of over 250 corporate members, you find close to 150 members willing to attend. Some members who could not attend, you find that they usually request for the keynote speakers address/presentation. We also took advantage of technology and set up a website for the association. Every 72 hours we upload all papers at our various meetings. This has gone a long way in improving our membership and also helped to bridge the gap within the industry. Right now we have 3 major trade groupings within the industry (i.e. local manufacturers, Importers and representatives of multinationals within the country). What NAIP has done is to create a platform for interaction. Also, NAIP was able to intervene in collaboration with the Pharmaceutical Society of Nigeria (PSN) to discuss the government’s import tax adjustment. The reaction could have been worse, if not for the intervention.
The issue of drug over-dose has resulted in deaths in Nigeria. What do you think should be done?
This is one of the things, which unfortunately I was not able to do during my tenure. To raise enough funds to create awareness campaigns and sensitisation programmes for some of these issues. I certainly believe that the Government through the National Orientation Agency (NOA) has a budget and so do have a major role to play in sensitising the citizenry. The first thing they tell you at the school of pharmacy is that all drugs are poison. It is important we get Nigerians to recognise this fact. I have been in a pharmacy where a patient walks in and asks for ibucap, paracetamol and other drugs of the same mechanism. This is really wrong. The Pharmaceutical Society of Nigeria also has a role to play alongside the other technical groups such as NAIP, ACPN, among others. Intensive awareness campaign should be the focus instead of the constant bickering in the sector.
Do you think the substantive DG NAFDAC should be a pharmacist?
The law says a Pharmacist /pharmaceutical scientist should be appointed as the Director General of NAFDAC. I do believe that those that made the law are very competent enough, that is why the law was made. I was in chat with some group where we all noted that it is only in this profession where we do minimally 6 pharmacological training. No other health profession in the country go through such amount of training. Pharmacologists are trained to know what the effect of drug in the body is. So, who else should be at the helm of affairs to regulate the drug sector, if not someone who is trained for that purpose?
Do you think the new drug distribution guideline has reduced the scourge of fake drugs in Nigeria?
Drug distribution is a major tool in fighting counterfeiting. The drug distribution guideline in Nigeria was launched few years ago. As we speak it is already in place. In July this year, the enforcement will begin. Pharmaceutical Council of Nigeria (PCN) as part of the guideline will ensure that we no longer have sales/medical representatives hawking pharmaceuticals. PCN will also be able to look at companies itself where these drugs are being sold. I believe strongly, if well enforced it can be able to curb the scourge of fake drugs in the country which unfortunately has gone up in the last couple of months. This is due to the fact that genuine manufacturers were not able to access foreign exchange. And also, I believe that the delay in appointing a substantive D.G NAFDAC is not helping matters.
How can the pharmaceutical industry stop being import dependent?
During our last national conference held recently, we focused more on this. Right now about 70% of pharmaceuticals are being imported into the country. The local manufacturers have come to say that their members are producing at less than 20% of installed capacity. What we have been driving through NAIP is for our local manufacturers to see today’s importers as potential prospects/customers. Right now, we have 70% of people who want to trade within the pharmaceutical industry who have found such capacity and capability to outsource outside the shores of Nigeria. The onus lies with the local manufacturers to take the initiative. In the same way, the Indian exporters/ manufacturers come into Nigeria to organise a trade engagement with potential Nigerian manufacturers. Local manufacturers should do the same. Rather than bring machine owners from India, let them have an expo or forum where manufacturers or Technical Directors’ capabilities in Nigeria are targeted in tandem with current happening in the sector. Also, during my opening remark during the last conference I talked about the vaccine laboratory wasting away in Yaba, Lagos. We called on the government during that conference to look at the facility. Just recently, the Federal Executive Council approved the laboratory to produce vaccine in collaboration with the MOU signed between the federal ministry of health and May & Baker. This is a good step in the right direction, taking into consideration the recent meningitis outbreak in the country. The Government at all levels should make the health sector a major priority in Nigeria. The Oil & Gas sector has become a major priority for all. For some, it is okay to have scarcity of drugs. This is not a good sign at all. When health is put as the number one priority, we then can build a healthy society. We have the health insurance scheme, but how can we make the scheme more sustainable and thus create more awareness for the scheme. This should be the way to go.
What role should the government play to make drugs become more affordable in Nigeria?
My association and other trade groups within the industry made several representations to the Ministry of Trade and Investment, Ministry of Finance and Health Ministry, and other agencies to get more access to needed funds. Even the local manufacturers, 98 percent of their input are import based. If you consider those with their manufacturing business outside the shores of the country, you will find that the industry is highly import-dependent. And we need access at a very good rate. What the government should do now is to grant more access at the official window to the needed forex. Also, the government needs to become more transparent with the bidding process especially for medicines. Thirdly, I think NAFDAC should look beyond bio-equivalence before products are registered. I am not saying that bio-equivalence is not a pointer, but NAFDAC needs to take it a step higher and look at bio-availability. Price should also not be mainly the basis. I want to add that we have some local manufacturers who are in the process of getting the WHO qualifications for some products. We also should look at the products in circulation.
What roles should a pharmacist play in the health care system, taking into consideration their training?
The training of pharmacist, I think has little to play in improving our health care indices. It is important for other health care players to recognise that all professionals in the sector all have a role to play. Let us take a look at a football team for instance. There is no way a striker will not play with the midfielders, talk-less the goalkeepers cannot do without his defenders. So the health care system is all about team work. The Doctor knows everything about the disease, so also the pharmacist knows about the drugs. Where then is the competition? At the end of the day the patient will suffer – unfortunately. The patient plays a big role too in all of this. The patient knows where it hurts. On getting things better, it is on recognising the roles of each professional in the sector.
This is to inform all our corporate members that Annual dues payment will commence in January 2018. Kindly visit the secretariat or our representative at PSN Lagos office, Ogudu.
Payment for NAIP dues for the year 2018 can be made @ the NAIP Secretariat or PSN lagos office, Ogudu.
5 Eleruwa Street, Wemabod
Estate, Off Adeniyi Jones,
Pay into any of our bank account and submit details to the office or our representative at PSN Lagos Office.
Account Name:NIGERIA ASSOCIATION OF INDUSTRIAL PHARMACISTS
Account No: 0007592033
Account Name: ASSOCIATION OF INDUSTRIAL PHARMACISTS OF NIGERIA
Account No: 0036753009
Bank: Diamond Bank
Manufacturers under the aegis of the National Association of Industrial Pharmacists (NAIP) have made a clarion call to the federal government to declare a state of emergency in the manufacturing sector.
In a recent interview with Pharmanews, Pharm. Moses Oluwalade, managing director of Miraflash Nigeria Limited, an indigenous pharmaceutical manufacturing company, explained that, given the right attention and support, the manufacturing sector had the potential to yield billions of dollars in annual revenue.
“There should be a deliberate effort to encourage manufacturers by creating an enabling environment for them and opening up channels for loans at affordable lending rates. We are advocating for a special fund that local manufacturers can access,” he said.
Oluwalade noted that the main reason many big companies were folding up was because of unfavourable operating environment.
While expressing firm confidence that the local manufacturing holds the key to Nigeria’s future, the pharmacist canvassed that certain drastic measure must be put in place to promote the sector to rapidly develop the economy.
“We want the present administration to declare a state of emergency in the manufacturing sector and provide an enabling environment so that more companies can come up,” he said. “Instead of providing jobs in other countries, we can actually create jobs here in Nigeria for our populace.”
Shedding more light on his position regarding the Nigerian business landscape, Oluwalade said: “There are several businesses that have closed down due to hostile environment. When I say hostile, I mean no light, no water and no good road. If these problems are properly addressed, more businesses will thrive. At the current rate of lending in commercial banks, no manufacturer will survive. The interest rates have to be reasonable for manufacturers to survive.”
It would be recalled that Miraflash was one of the two local pharmaceutical companies selected by Standford Seed Innovation Programme (West Africa) in March 2015 for transformation of developing economies through the scaling of medium to large companies by intensive training and development of manpower and structural capacity.
Concurring with him, Dr Lolu Ojo, immediate past chairman of the association in Lagos, argued that the manufacturing arm of the pharmaceutical sector was long due for such considerations.
Ojo noted that local manufacturing was quite a difficult terrain, particularly given the many hurdles that must be surmounted in the Nigerian environment.
The managing director of Merit Healthcare Limited observed that it was quite easy to import products and make quick profit, but strictly warned that this should not be the focus of an economy aspiring for growth.
“We cannot continue to live on commerce to the neglect of industry,” Ojo cautioned. “Whether we like it or not, we must have factories like Miraflash that can produce locally. Even if it is intermediate production, once it is mastered, we can start primary production, using available locally sourced raw materials,” he said.
Ojo futher said that he agreed with the notion that the time was ripe for Nigeria to consider declaring a pharmaceutical village where local pharmaceutical production would be stimulated.
“All these monies being used or not being used to buy arms could be used to set up a pharmaceutical village. Let it be divided into industrial plots, encourage people to come, provide amenities and loan out money at five or six per cent, the sector would develop massively,” he said.
The ex-NAIP boss also emphasised the importance of government patronage of locally-manufactured products, noting for example that if the Ogun State government decided to buy pharmaceuticals from companies in the state, there would be more than enough of multivitamins, ampiclox, ampicillin, among others that are used in the state.
“That, to me, is how to make manufacturing attractive and I believe this development will make more people to come on board,” he said.
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.
National chairman of the Association of Industrial Pharmacists (NAIP), Pharm. (Prince) Gbenga Falabi, has said that anybody found guilty of involvement in drug counterfeiting should be jailed for life.
The According to the NAIP boss, the present sanction of a fine of 200,000 naira or a six-month jail term for convicted drug fakers is grossly inadequate and cannot serve as deterrents to those involved in the nefarious business.
Pharm. Falabi said NAIP wants the National Assembly to change the penalty for drug fakers to life imprisonment because those involved in dealing in fake drugs resulting in deaths of Nigerians should not have any opportunity to walk away.
He reiterated the determination of NAIP to push for an industry and civil society led anti-counterfeiting war on fake drugs, adding that NAIP is initiating the establishment of an intervention fund that will be used to assist the agencies saddled with the responsibilities of fighting drug counterfeiting in Nigeria.
Pharm. Falabi explained that it is very important to raise awareness on fake drugs because ensuring patients get genuine drugs for treatment is very crucial in the treatment chain. He said that while the hospital may be good, the diagnosis right and the doctor’s prescription correct, with the challenge of fake drugs, all the other efforts made to help the patient will be a waste.
The NAIP boss also said that the pharmaceutical industry has great expectations from current government in Nigeria because the Buhari government has shown that it takes what affects Nigerians as a priority, adding that the pharma industry, being an essential sub-sector of the health sector, will get the support and encouragement it required to back up its investments.
Speaking on the theme of the conference “Transforming the Nigerian Pharmaceutical Industry: The Big Picture”, Mr Bismarck Rewane, MD/CEO, Financial Derivatives Company Limited, said that the local pharmaceutical manufacturers are faced with challenges of high cost of production, counterfeit drugs/parallel importation, low purchasing power within the population, poor health care infrastructure, irregular government purchase of drugs and delayed payments, as well as weak enforcement of policies.
On growth options for the industry, Mr Rewane who was the keynote speaker at the NAIP conference urged the stakeholders in the pharmaceutical industry to explore the possibility of development and local manufacture of pharmaceutical grade raw materials, as well as pooling of resources to increase their market share through partnership, mergers and acquisitions.
Rewane noted that the growth of the pharmaceutical industry would have a trickle-down effect on the Nigerian economy by helping to create more employment opportunities, reduce expenses on health care abroad, and help improve the life expectancy of Nigerians.
The highlight of the occasion was the presentation of awards to some distinguished pharmacists for their contributions to the pharmaceutical sector.
he Association of Industrial Pharmacists of Nigeria (NAIP), has charged the pharmaceutical industry to come up with strategies that will deliver inclusive growth, build vital competences, create wealth for all stakeholders and contribute substantially to the nation’s Gross Domestic Product (GDP).
NAIP charges pharma industry on workforce development
L-R: Mr Uche Attoh,the keynote speaker and Pharm. N.A.E. Mohammed, registrar, PCN, during NAIP’s 19th Annual National Conference, held in Lagos recently.
Pharm. (Prince) ‘Gbenga Falabi, the national chairman of NAIP, gave this charge during the recent opening ceremony of the 19th Annual National Conference of the association, held at Sheraton Hotel, Ikeja, Lagos, chaired by Dr Christopher Kolade, former Nigerian High Commissioner to the United Kingdom.
According to the NAIP boss, stakeholders in the pharmaceutical industry must begin to embrace Systems Thinking and Disruptive Thinking in developing human capital assets across board, while leveraging on technology to build capacities.
He further noted that the pharma industry will need to reinvent itself in order to effectively match, with required skills and competences, the emerging challenges confronting it at the moment, warning that the dearth of production pharmacists will pose a challenge for the current push to encourage the industry in favour of local production in line with the inclusive growth policy of the federal government.
The NAIP national chairman stated further that the pharma industry fully identifies with the commitment of the Buhari administration in restoring investors’ confidence in the nation’s economy, as well as its zero-tolerance for corruption across board.
He, however, urged the government to treat the health sector and the pharma industry as vital segments of the economy, which deserve special attention and preference as a result of their strategic roles in the nation’s well-being.
Pharm. Falabi bemoaned the paucity of foreign exchange to import finished pharmaceutical products and essential pharmaceutical raw materials for local production, adding that the situation portends a very dangerous development with serious negative consequences for the nation in terms of the availability of essential medicines for the citizenry.
He urged the federal government to urgently consider preferential allocation of vital foreign exchange to the pharma industry.
Speaking on the theme of the conference “Workforce Development: Imperative for Industrial Pharmacy Development,” Mr Uche Attoh, the keynote speaker, urged stakeholders in the pharmaceutical industry to take the issue of mentoring of the next generation of pharmacists seriously, noting that young pharmacists can learn a lot from notable professionals in the industry.
He also urged pharma industry stakeholders to market the industry – not only to attract the best brains but to retain such, despite the increasing cutthroat competition for the best personnel in the industrial sector.
Also speaking at the event, Dr Christopher Kolade congratulated NAIP for its 19th national conference and its choice of theme for the conference.
The distinguished elder statesman and seasoned industrialist also urged pharma industry stakeholders to take the issue of mentoring serious, adding that every generation must have a generation to follow.
While expressing confidence that the future of Nigeria would be great, he urged every Nigeria to contribute positively towards making this a reality soon enough.