COMMUNIQUE ISSUED AT THE END OF ONE DAY STAKEHOLDERS ENGAGEMENT ON ONLINE PHARMACY REGULATIONS 2021 ORGANISED BY PHARMACISTS COUNCIL OF NIGERIA (PCN) IN COLLABORATION WITH NATIONAL ASSOCIATION OF INDUSTRIAL PHARMACISTS (NAIP) HELD AT PHARM DAME OVIASU AUDITORIUM, PCN LAGOS ZONAL OFFICE, YABA, LAGOS STATE, ON DECEMBER 09, 2021
Online Pharmacy is an internet–based practice through which medicines are sold to the general public. The Pharmacy operates over the internet and sends orders to customers through mail or delivery companies. This internet base pharmacy operation is fast growing globally and some countries have put up regulatory framework to regulate the activities and operation of these internet base pharmacy, Nigeria cannot therefore be left behind.
The Pharmacists Council of Nigeria (PCN) in exercise of powers conferred upon it by PCN ACT P17 LFN 2004 made regulations on Online Pharmacy Practice in Nigeria (Online Pharmacy Regulations 2021) which was gazetted by the Federal Government in July 2021 and released to the public in October, 2021. In a view to commence implementation of the Regulations on January 01, 2022, PCN organized a stakeholders meeting in collaboration with NAIP to sensitize all interested stakeholders on the regulatory requirements for operation of Online Pharmacy in Nigeria.
The stakeholders meeting was chaired by the Registrar, Pharmacists Council of Nigeria (PCN), Pharm. N. A. E. Mohammed, Ph.D, FPSN, FPCPharm, FNIM. The President of Pharmaceutical Society of Nigeria (PSN), Pharm. Prof. Cyril Usifoh, FPSN, FPCPharm, was ably represented by the NAIP National Chairman Pharm. Ken Onuegbu. Also, in attendance were the National Chairman Association of Community Pharmacists of Nigeria (ACPN), Pharm. Adewale Oladigbolu. Other dignitaries included Pharm. Lawrence Ekhator, Chairman, Association of Community Pharmacists of Nigeria, Lagos State Branch; Pharm. (Mrs.) Abimbola Adebakin – CEO Advantage Health Africa; Pharm. Remi Adeseun – African Director, Salient Advisory, ably represented by Mr. Yomi Kazeem – Senior Consultant, Salient Advisory; Barr. Lawan Abana, Head of PCN Legal Unit; PCN Interpol Liaison Officer, Mr. Jessy Jebal (National Security II), Assistant Inspector General (AIG) of Police (Retired) Pharm. A.I.G. Okeke. Others were Directors and staff of PCN. Pharmacists from various technical arms of the Pharmaceutical Society of Nigeria and other stakeholders made up the physical and virtual audience.
Various presentations were made which included:
- Overview of Online Pharmacy Regulations, Providers Perspective on Online Pharmacy
- Online Pharmacy Regulations: Contemporary African Perspectives and Global Best Practices
- Legal Perspectives on Online Pharmacy Regulations, Registration, and;
- Licensing of Online Pharmacy.
Participants deliberated and resolved that:
A. REGISTRATION AND LICENSURE
- The Pharmacists Council of Nigeria should commence registration of online Pharmacy Practice in January 2022. The PCN shall issue licence to successful online Pharmacy provider after due registration processes.
- The PCN shall collaborate with Agencies such as Interpol, NAFDAC, MDCN, NDLEA, NCC, among others to ensure successful hosting and running of Online Pharmacy practice in Nigeria.
- Every online Pharmacy provider will be required to register with Pharmacists Council of Nigeria.
- Every Online Pharmacy will be an offshoot of a physical licensed Community Pharmacy, such as is the global trend. While, individuals that do not have a retail Pharmacy base will have a physical office and Superintendent Pharmacist in order to facilitate regulation, monitoring and enforcement of the practice. Meanwhile, such premises will not be converted to a retail Pharmacy at later time.
- Every registered online Pharmacy site shall be provided with a unique emblem or logo by the Pharmacists Council of Nigeria and such shall be displayed by all online Pharmacy providers.
- The Pharmacists Council of Nigeria is empowered to suspend or revoke Online Pharmacy licence provided there is a breach of the regulation.
- Every Online Pharmacy licence shall expire by December 31 of each year and shall be renewable in January the following year.
- A Pharmacist shall only register one internet-based platform and the name and address of the online Pharmacy shall be visible online. Any Pharmacist who registers or attempts to register more than one platform commits an offence and shall have the online site closed down and be referred to the Investigative Panel and Disciplinary Tribunal of Council for appropriate actions.
- The Online Pharmacy provider shall notify the Council of intention to suspend activity when the need arises. However, temporary suspension shall not exceed one year while renewal fee shall be paid for the period of closure.
- Online Pharmacy shall be solely owned by a Pharmacist or a group of Pharmacists as it is obtainable in Community Pharmacy practice and it is only a retail pharmacy that is eligible to host online practice.
- All online market places such as Jumia, Konga, Jiji, e.t.c shall be officially communicated by Pharmacists Council of Nigeria to ensure that everyone selling medicines on their platform must possess a Pharmacist Council of Nigeria clearance or shall be closed down.
- Online Pharmacy platform that do not operate within PCN regulation shall be pulled down.
B. INSPECTION, MONITORING AND ENFORCEMENT
- The Council shall carry out inspection of Online Pharmacy and shall from time to time carry out follow up inspections throughout the supply chain.
- Accredited inspectors of Council shall have powers to enter any premises which host the Online Pharmacy or visit the online platform or site(s) through the use of such force and or technology as it is necessary when there is a breach of the regulations.
- Accredited Pharmaceutical Inspectors shall have powers to assess the back end of the site and process information from the site(s) that is deemed to be a breach of the provision of the Online Pharmacy regulations.
- The Pharmacists Council of Nigeria shall seal all unregistered or unlicensed Online Pharmacy premises or site where access to records and documents or articles is not granted by the operator.
- Every Online Pharmacy provider shall operate in line with global best practices and with relevant regulations in telecommunication industry.
- Online Pharmacy providers shall ensure implementation of Good Pharmacy Practices on their sites with regards to dispensing of Pharmacy Only Medicines. The rule guiding dispensing of prescriptions medicines shall not be suspended as a result of Online Pharmacy services.
- Sales of OTC drugs shall comply with relevant laws regarding the sales and dispensing of the drugs.
- Only OTC medications shall be advertised publicly. However, classes of drugs available can be made public.
- Dangerous Drugs as contained in the Dangerous Drug Act Cap 9 1935 are not to be sold online
- Online Pharmacy providers shall maintain procedures that would ensure reasonable verification of identity of patients and prescriber.
- Online Pharmacy providers shall provide a system for sale and secure delivery of all medication and ensure that right temperature is maintained during mailing and delivery of products.
- Where the Superintendent Pharmacist is not on ground, there shall be a Resident or Locum Pharmacist to take charge of the internet services.
(i) Stakeholders commended PCN initiative for putting together the concept of Online Pharmacy and posited that they welcome innovation and regulation.
(ii) Online Pharmacy initiative will breech the gap of access to medicines and provide succour to patients.
- The appropriate nomenclature should be Online Pharmacy and not online shop.
- Online Pharmacy practice is a global phenomenon and the entire continent of Africa looks up to Nigeria to take the lead. All stakeholders should therefore cooperate and collaborate to make the regulation work.
- The Pharmacists Council of Nigeria shall always engage in dialogue and positive engagement with online practitioners and clamp down/closure of premises and sites shall be reserved for recalcitrant operators.
- The Pharmacists Council of Nigeria shall prepare an up to date directory of accredited Online Pharmacy providers.
- All licensed Online Pharmacy providers will notify council within 30 days any stipulated changes in scope of operation or operators of the site.
- Dispensing of POM will follow valid prescriptions.
- Stakeholders appreciated the Inspector General of Police for providing the Pharmacists Council of Nigeria with adequate manpower, logistics and capacity building support to ensure a successful hosting of the Online Pharmacy.
- There shall be no distance restriction between two Online Pharmacies. However, the regulation on distance between the physical Pharmacies hosting the Online Pharmacy shall subsist.
- Hybrid practice which incorporates both physical and online platform is allowed by practitioners.
- There shall be regular review of the regulation as more feedback and constructive engagement come up.