Only PCN And NAFDAC Can Inspect And Seal A Community Pharmacy

Community pharmacy is regulated by the pharmacist Council of Nigeria (PCN). However, because they sell products registered by the national agency for food and drug administration and control (NAFDAC), they are also regulated by NAFDAC. Registration of community pharmacy is done with PCN with periodic inspection by PCN on activities of the premises and NAFDAC on the sales of drugs.

NAFDAC inspector team on red jacket

There is no other agency in Nigeria that can inspect a community pharmacy shop. Not even the police, the army, the navy or any other security outfit. Community pharmacy and other health establishments are exempted from national, state and local government taxes such as environmental levies. This was done to reduce the cost of health care in Nigeria. The only levy on community pharmacy is the one paid to PCN. The payment to the pharmaceutical society of Nigeria (PSN) has nothing to do with the government and must not be enforced by the government. PSN cannot inspect and lock down a community pharmacy because of PSN dues. So, it is illegal for any of these agencies to come to the pharmacy for inspection and or lock up the premises.

PCN Inspection And Monitoring Team

The Department coordinates inspection and monitoring activities of the Registry regarding all categories of pharmaceutical premises and Patent and Proprietary Medicine Vendors (PPMV) shops. These include pre-registration and routine inspection of manufacturing premises, importation outlets, distribution outlets, wholesale, retail and hospital pharmacies, as well as monitoring of these categories of premises to ensuring compliance with established standards of practice; inspection of Mega Wholesale Centers (MWCs), Public Wholesale Centers (PWCs) for purposes of registration and monitoring of same; initiation of periodic review of inspection formats/checklist and guidelines in line with the PCN compendium for the minimum standard of practice, coordination of activities of State Pharmaceutical Inspection Committees (PICs) and Patent and Proprietary Medicine Vendors License Committee. The department also offers guidance to persons or establishments wishing to manufacture or sell Pharmaceutical products to ensure compliance with standards (GMP). Mounts Inspectors workshop for all accredited Inspectors, Have engagements with relevant stakeholders regularly to promote compliance to regulations. The department also organizes technical training for pharmacists among other duties.

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The Inspection and Monitoring Department has two divisions – the Inspection division, and the Monitoring division.

When they visit the pharmacy, all they need to do is provide a valid identification card to indicate they are from PCN. They have the right to search licence of the premises if it has expired or unregistered, ventilation system, temperature control, proper hygiene, documentation practice (poison book, expired drugs book), presence of registered pharmacist amongst others. They can seal the pharmacy when they see that it fails any of these or give a warning. A sealed pharmacy will have to go to the PCN office to process a new registration.

PCN Enforcement Department

The Enforcement department, as the name implies, is the arm of the PCN that deals with infractions on the rules, regulations and standards of pharmacy practice. To this end, it continuously liaises with the departments of Registration & Licensing to ascertain the registration status of premises, and Inspection and Monitoring for records of compliance directives issued to pharmaceutical service providers. The department is also responsible for: surveillance landscape to check the activities of quacks and unregistered premises and closing down such premises in liaison with security agencies, investigation of reported infractions in the various areas of pharmacy practice, and working with the Legal Unit of the Registry to provide necessary information for prosecution of cases of breach of standards. The department is also charged with enforcement of the PCN rules and regulations as well as standards, and enforcement of the decisions of the PCN Disciplinary Tribunal and conducts investigative inspection pertaining to enforcement activities. It also generates information for public enlightenment by the Council.

The Enforcement Department, headed by a Director has two divisions - the Surveillance and Investigation division and the Enforcement division.

NAFDAC Investigation And Enforcement

The Investigation and Enforcement Directorate was established in 2001 to frontally deal with the incidence of Counterfeit Drugs, Unwholesome Foods, Unsafe Medical Devices and other NAFDAC Regulated Products. Prior to the inauguration of the Investigation and Enforcement Directorate, the Federal Task Force on Counterfeit and Fake Drugs and Unwholesome Processed Food, a statutory body established by the Counterfeit and Fake Drugs Act, and a unit in the Federal Ministry of Health and subsequently transferred to NAFDAC at inception in 1993, was saddled with the enormous responsibility of curtailing the menace of Fake and Counterfeit Drugs. The Federal Task Force is domiciled in the Investigation and Enforcement Directorate. The Director of the Investigation and Enforcement Directorate doubles as the Chairman of the Federal Task Force.

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The Investigation & Enforcement Directorate team consists of the following cadre of officers

1. Regulatory Officers (RO).

2. Legal Officers (LO).

3. Drivers

4. Investigating Police Officers (IPOs): The Directorate has a unit of Mobile Policemen attached to it for security during operations; two units of Investigative Police officers (IPOs) for the Federal Task Force & Enforcement Police units comprising detectives from the Nigeria Police Force Criminal Investigation Department (FCID) to aid in carrying out investigations.

5. Mobile Policemen from the environment and special offences unit.

They don't work alone in most cases. They work with states PSN.

The following are their duties as it relates to Community Pharmacy;

1. Collection of Information

2. Surveillance/Intelligence gathering

3. Inspections and raids.

4. Interrogation

5. Sampling and packaging samples for analysis and exhibits

6. Compilation of case file

7. Participation in pre-trial meetings

8. Giving evidence in Court.

9. Destruction of spurious, expired, fake and unwholesome products

When they come, they also provide a means of identification. They focus on registration of the premises, environment, appropriate sales of products. However, they are not concerned with poison books as that is not in their jurisdiction.

PCN inspection team on carton colour jacket

From this post, you can see that two units of PCN and one unit of NAFDAC have the legal right to engage in inspection of community pharmacy. Any other body that comes will have to face the zone PSN chairman if you pay your dues or the court. One lesson learnt so far is that you have to ask for the presence of the pharmacist among the inspector. If none, don't keep your cool. Shout! They also come with jacket with the inscription of their organisation and unit. For example behind the jacket will come with the inscription NAFDAC enforcement team. NAFDAC jacket is red and PCN is carton colour. And they have a seal tape with their name on it. It read like 'PCN-seal-do not open.'