Controversy Over Drug Regulation in Cross River


Posted on: Mon 06-01-2014

THE health of millions of people in Cross River State is at stake as some members of the Cross River State Task Force (CRSTF) on fake and counterfeit drugs and unwholesome foods have identified more than 50 pharmaceutical shops in Calabar Cross River State as illegal or fake.
This declaration is even as the National Association of the Pharmaceutical Technologists and Pharmacy Technicians of Nigeria (NAPTPTN) is stiffly resisting the Pharmacists Council of Nigeria (PCN) and CRSTF.
 
The big questions begging for answers are: who is a pharmacist or pharmaceutical technician and who is qualified to run a pharmacy or a patent medicine store? In the regulation of sales of drugs, what are the roles of the government agencies and committees such as the PCN, National Agency for Food and Drug Administration and Control (NAFDAC), the National Drug Law Enforcement Agency (NDLEA), Task Force on Counterfeit and Fake drugs and the Pharmaceutical Inspection Committee?
 
The Chairman, Association of Community Pharmacists of Nigeria (ACPN), Pharm. Ajah I. Ajah said, “drugs are controlled by the federal government and it is in the federal exclusive list in the constitution and to help the federal government do this control they set up regulatory agencies. One of them is the Pharmacists Council of Nigeria (PCN). Others are NAFDAC and NDLEA. Their functions sometimes overlap but generally, PCN deals with premises where drug products are made available to the public and the qualification of the individuals who should make those drugs available to the public.
 
“All of these are aimed at ensuring that only qualified persons deal in drugs. This is to protect the public and that drugs are given from specified premises so that we can look at the sourcing, storage, distribution and dispensing of these drugs. Pharmaceutical Inspectors appointed by the PCN usually inspect these premises to ensure compliance with set standards.
 
“NAFDAC on the other hand regulates products by ensuring that drugs, foods, and medical devices manufactured in the country or imported from other countries are of good quality. Such products must be registered by the agency before they can legally be sold in the country. Products which are not registered should not be used as their safety cannot be guaranteed.”
 
He said the NDLEA was set up to regulate the use of controlled substances and drugs such as narcotics and psychotropic drugs. The Task Force wilds the power of these agencies put together.
 
“In Cross River state as in all other states, PCN registers drug outlet in two categories according to the law. One is Pharmacy/Pharmaceutical Premises and the other is Patent Medicine Vendors’ shops. The patent medicine shops are to sell only a limited range of drugs that have been proven over long term use to be safe and they are supposed to sell them in packs with the labels so that people can read and use while pharmacies actually handle all the products because they have qualified Pharmacists in control of the premises.”
 
However, in Cross River State a group of persons under the umbrella of NAPTPTN has decided to operate outside the provisions of these laws. Now that this body went to court against PCN sometime ago to challenge the employment and promotion of pharmacy technicians in public health service institutions by the PCN. Somehow, they obtained a ruling to the effect that the PCN should not interfere with their employment and promotion.
 
He said “the Pharmacists Council has appealed and the appeal is still pending. A cursory look at the ruling reveals that no agency was given the responsibility of dealing with their employment and promotion or performance of their duties. This ruling does not deal with regulation of sales of drugs and licencing of pharmaceutical premises as these are not functions of pharmacy technicians or pharmaceutical technologists”.
 
But in Cross River, he said: “They took that judgment and said it gives them power to do as they like even on things that are not related to employment and promotion. The leaders of the NAPTPTN have been admitting all manner of persons including stark illiterates as “associate members” and issuing licenses to them to open drug outlets called “Pharmaceutical Shops”.
 
The Poisons and Pharmacy Act defines Pharmaceutical premises as premises where drugs, poisons and devices are mixed, compounded, prepared, dispensed and sold. These “Pharmaceutical Shops” are unknown to law. Pharmaceutical Inspectors have found that expired, banned and unwholesome drugs are being sold to the public from these premises.
 
Some of these “Pharmaceutical Shops” were sealed. These operators forcefully entered their shops and continued their nefarious businesses after breaking the seals of the Federal government agency (PCN). The cases have been going back and forth and we have not obtained any judgment yet.
 
“Recently, NAPTPTN began to raise alarm in the highest quarters. They wrote a letter through their lawyer to the governor alleging a plot to cause chaos by the PCN. They prayed the Governor to stop the PCN from regulating them. In other words they want to be allowed to continue to make these dangerous drugs available to the unsuspecting public.
 
Like I said they even issue licenses, certificates of associate membership, and even collect lots of money from people. They claim that by reason of that court ruling they obtained, they are now free to sell all kinds of drugs and that PCN and even NAFDAC does not have the power to regulate them.
 
“These people are not qualified to carry out any regulatory activities, i.e. Only government can regulate the practice of all professions: medicine, pharmacy, journalism, architecture, engineering etc through its agencies. The norm in law is that no Association can regulate itself. So, as far as regulation of drugs is concerned, which comes under pharmacy law only the PCN, NAFDAC and the NDLEA can regulate as I earlier said.
 
Many of them are stark illiterates and some of the literate ones among them have been trained as Pharmacy Technicians. Even the Pharmacy technicians among them are supposed to work under the supervision of a Pharmacist. They are not qualified to work independently. The NAPTPTN leaders are only using the brute force to counter the law.
 
Worried on this fraudulent practices, the Chairman of the Pharmaceutical Society of Nigeria (PSN), Cross River branch, Pharm. Paul Agbulu, said “now, the first thing the society is doing is to liaise with the PCN and NAFDAC. The idea is that we need to collaborate with them to ensure that at the end, their goals and objectives which are to protect people from counterfeit or fake medication as a result of poor practice is achieved”. “Secondly, being a professional association it is our duty to make sure that people are aware of the dangers that are prevalent if steps are not taken to prevent bad practices. And, that is why we are interested in this matter because we want to protect the people.
 
God will not forgive us, Nigerians will not forgive us, if we fold our arms and let things go the way it is going. Because the country, the people, the masses can never be fooled, people are catching on some of the loopholes that are prevalent in our bureaucracy and we must stand to support the PCN and to see that PCN is working. At the same time, we are also, using an opportunity like this to sensitize the government and the people of the dangers of wrong practices.
 
“The government is in court with this kind of issue. And this case has been in court for more than three years for one reason or may be because of our kind of bureaucracy or the way we look at things. There is no country where the government wants to sanitize her drug distribution network where an individual or a group of people with impunity will destroy federal government seal and, go free. The other thing I heard is that they are now trying to use the law enforcement agents even against the regulators in their personal and individual capacity.
 
They bring up frivolous allegations against these individuals. These are some of the strategies they are trying to use to frustrate the regulating agencies”.
The Director of Pharmaceutical Services and Head of the State Taskforce, Elder Ita Edem could not be reached for comments.
NAFDAC on its part has been battling this same problem of fake drugs. The Guardian made effort to speak with the Head of Department of NAFDAC in the state, but he declined to make any comment.
 
However sources in CRSTF described the situation as “horrible and embarrassing” saying, “If you have the opportunity to go to Ghana or Cameroon, nobody sells drugs except he is a qualified pharmacist but in the giant of Africa, we are far behind and the question is: what is the task force in Cross River State doing? The task force is made up of 7 organizations comprising the Police, the Ministry of Justice, the PCN, the NAFDAC, Consumers Protection Council (CPC), Custom, and NDLEA.
 
“We have a group that is surreptitiously taking over a responsibility that does not belong to them in the pharmacy section and our worry actually is that the rate that they are going if nothing is done about it, will put the public in serious jeopardy. Drugs must be handled by well knowledge persons but that is not the case now and unfortunately, it’s like they are using money to suppress anybody making any serious enquiry on what is happening. I am not aware of any other state that is having this challenge. Our fear and our concern is that beyond the fact that public health is being jeopardize specifically here in Cross River state, by the time it gains ground here definitely somehow it will spread out and by the time one come to know what is happening, it would have become something else. The Chairman ACPN lamented.
 
“You can imagine somebody who is just a school certificate holder who has not even gone for any training on drugs is prescribing drugs and not just over the counter drugs but what we call prescription drugs that people cannot just buy like that without proper prescription. They even sell controlled drugs. So when we have people who do not know how to handle such drugs, it becomes dangerous to the society. They claim to get training but who trained and regulate them and at where?”
 
In a reaction, the Deputy National President of NAPTPTN, Chief Lawrence Henshaw admitted that they have about 50 pharmaceutical shops in Calabar but there was no fake pharmacy or pharmaceutical shops as they are legally registered with the Corporate Affairs Commission to operate and empowered by the constitution of NAPTPTN.
 
He said, “we are one and the same person in the same profession and that is the pharmacy profession. The composition of the profession includes the Pharmacists, the pharmaceutical technologists, pharmaceutical technicians and the pharmaceutical assistants. What you are looking for is the difference. The difference is the pharmacists are trained in the University while the pharmaceutical technologists (the earlier ones) were trained at the old School of Pharmacy, Yaba Lagos. Those are the industrial experts. The technicians are today centralized to be trained per state across the country. Yaba has been closed. These cadres of workers are technical experts in the profession.
 
“The University trained pharmacists started in Nigeria in October 1973 in the then Primary Health Centre, Ibadan, Oyo state and we the product of Yaba trained them only as drug distributors and canvassers to the manufacturing company in Nigeria. Because of creation of states and lack of technician manpower, I in Cross River State, recommended them to be in service of the state in 1987 when Akwa Ibom was separated from Cross River due to lack of technician manpower. I brought into employment the current Director of Pharmaceutical Service. Until my retirement, we had no problems with each other and when I retired they intensified the monopoly of trade running down the technicians and technologists and giving wrong recommendation to government fostering only the progress of pharmacist to the detriment of the profession.
 
“Before 2004, when the law of the federation of Nigeria was not amended we were all under one umbrella the Pharmacists Board of Nigeria (PBN) without any discrimination. Before a graduate pharmacy is allowed to enter dispensary, he must pass through the technical training of a technician or technologists even before their registration.
 
“In 1994 the PBN being federal government parastatal was dissolved and the technicians and technologists registered their corporation under decree one of 1990 with legal immunity to sue and be sued with objectives to register license, regulate, permit, and control the activities of the subordinate members. When eventually the PCN came on board as a result of the amendment of the laws of the Federal Republic of Nigeria in 2004, the PCN monopolized the profession to the extent of circulating a letter to all government parastatals and agencies that they are the over lord to promote, transfer etc, the organization NAPTPTN in collaboration with the Medical and Health Workers Union of Nigeria which we technicians are affiliated to, jointly took the Council to court in 2006 and the ruling was in our favour”.
 
He said, “the pharmacists were restrained by court order not to interfere with the performance of duties of the technicians in government and government bodies parastatals anywhere in Nigeria up to even the training of pharmacy technicians. Technicians train technicians just as Nurses train Nurses”.
 
Besides, he said “the judgement of the Federal High Court, Lagos in 2006 restrained PCN “from further interfering with the employment, promotion and the performance of the duties of Pharmacy Technicians and Pharmacy Assistants by various public service health institutions and bodies in Nigeria”.
 
The ruling according to him further ruled that “the PCN by the law establishing it has not empowered them to register, license, train, promote, transfer, and employ pharmacists’ technicians, technologists and Assistants”.
 
He argued that “irrespective of this court order, the PCN is still disobeying the court order and taking laws into their hands. The federal government and each state of the country are also accomplished to the disobedience of the order by failing to implement the court ruling and we will sue them. That is the main problem. If the position of the court has been implemented the division of pharmaceutical technology would have been created to take care of the administrative processes of technologists, technicians and assistants in accordance with the ruling.
 
“All information they are giving is false and an intrigue to set aside the court ruling which is not possible. What are they making noise for let them go to the Supreme Court. We are the pharmaceutical technicians and our shops answer same. The PCN is only blackmailing and I am suing the State government because I see no reason why they should disobey court order”.
Source: the Guardian