National Drug Formulary Review Must not be a Onetime Exercise – Ebube

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 Dr Nkere Ebube is an accomplished scientist, author, pharmaceutical and biotech consultant, and adjunct professor of Pharmaceutics and Pharmaceutical Technology. He was the former president of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA). He has held various executive leadership positions at several pharmaceutical companies in the United States. He received both B. Pharm and M. Pharm degrees from the University of Nigeria, and Ph.D. from the University of Mississippi. He has published extensively in peer-reviewed journals. He is the author of two inspirational books, “Standing Tall” and “The Bridge Builder”.

National drug formulary review must not be a onetime exercise - Ebube
Dr Nkere Ebube

In this exclusive interview with Pharmanews, Ebube, who strongly believes that the national drug formulary needs a thorough review, queries results of efforts made so far in reviewing the formulary and emphasizes the need to continue such exercise. The former NAPPSA president also condemns the poor drug distribution system in Nigeria, while highlighting measures to mitigate proliferation of adulterated drugs and illegal distribution of prescription medicines in the country. Excerpts:

As a former president of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA) with an extensive experience in pharmacy practice and pharmaceutical sciences, can you elaborate on which area of practice you enjoy the most?

Great question! I certainly enjoy research and development. This stems from my deep sense of scientific and intellectual curiosity, which started early in my career. When I completed my first degree in Pharmacy (B. Pharm) from the University of Nigeria (UNN, Nsukka), I opted for a dual internship and Master of Pharmacy (M. Pharm) programme. Thereafter, I practised community pharmacy for few years in Kano from 1986-1988.

I knew then that I missed the laboratory very much. Later, I joined the National Institute for Pharmaceutical Research and Development (NIPRD) in 1989 as the first scientist. In 1990, I proceeded to the University of Mississippi, United States to pursue a PhD programme in Pharmaceutics.

Following my terminal graduate degree, I joined the academia and later the pharmaceutical industry. Any time that I visit a pharmacy, it is always gratifying to see some of the drugs or products that I helped to develop on the shelves. Similarly, it is fulfilling to see some of the students that I have taught or mentored become successful and occupy responsible positions in the society.

Research and development stimulates critical thinking. I like being mentally challenged, particularly in the areas of unmet medical needs, as well as the opportunity to improve wellness and public health.

Drug formulation or dosage form development is an intricate process, which has been marred in some cases by unintentional errors. How can pharmacists practising in Nigeria always get this right?

This is obviously a loaded question. However, I would attempt to respond to it by taking a holistic view of the entire spectrum of the pharmaceutical product development process by examining the role of pharmacists in each key segment, ranging from dosage form design and formulation development, compounding, drug manufacturing, clinical development, regulatory reviews and approval to ultimately making the drug available to the patient or consumer. These can be broadly grouped into the following common settings or potential areas of practice –the pharmaceutical industry, regulatory agencies and community pharmacy and hospital practice

Inadvertent errors during dosage form development may include calculation errors, weighing errors during batch manufacturing or compounding, dosing errors, analytical errors, etc.  In a well-structured and regulated system, medication errors resulting from miscalculations in the product formulations seldom occur due to extremely strict multiple layers of verification processes that guarantee the quality and integrity of the finished dosage form.

The complexity of the product development process involves an intricate interplay of formulation, process, and other biopharmaceutics variables; thus, multiple stage gates and layers of oversight are put in place to achieve the desired dosage form performance, and ensure patient and public safety.

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Pharmacists in the pharmaceutical industry can work as formulation or analytical development scientists, quality control chemists, quality assurance associates, clinical study monitors, regulatory affairs associates, and so on. Although the final composition of the formulation for a given product may be determined by the formulation scientists based on sound bio-pharmaceutics, process and risk assessments considerations, the master formula generated is reviewed and approved by multiple functions for accuracy and consistency.

Moreover, the analytical and QC chemists, and QA associates provide additional levels of verification and oversight to guard against errors. Any miscalculations or errors in the formulation that slipped through the cracks can be very costly and may lead to drug product recall.

For pharmacists in the regulatory agency, it is their responsibility to ensure that they review the CMC and the clinical development documents thoroughly to ensure that the science and data support approval of the drug product for public use. This would include identifying calculations errors and other issues that may impact finished dosage form performance, efficacy, quality, and public safety.

Pharmacists in community practice or in the hospitals, particularly those engaged in compounding, are responsible to ensure that appropriate ingredients are used in appropriate amounts to guarantee quality, efficacy, and safety of the finished dosage form. This involves instituting verification measures to ensure integrity of the batch information and associated records. The pharmacist’s oversight also extends to mitigating dispensing errors to avoid untoward hazards to the patient and the public.

I believe that pharmacists in Nigeria, particularly those engaged in compounding, product development, quality assurance or regulatory affairs have the right training to consistently ensure that products presented to the public are safe, effective and of acceptable quality. For imported drugs, extensive analytical testing is required to confirm the drug content, dosage form quality and safety.

It is not uncommon that despite every logical measures and compliance checks to minimise unintended formulation or medication errors, these mistakes happen. It is important to keep track of batch history, follow good cGMP practices, use appropriate statistics to ensure adequate batch sampling, test consistently using sensitive validated analytical methods, and thoroughly investigate any aberrant results using the right rubrics.

Some pharmaceutical companies have maintained their brands in Nigeria by successfully transferring the manufacturing process of their products to the country. How can this be replicated by other companies to ensure that patients receive high quality drugs?

Obviously, this is a business decision. Ideally, every pharmaceutical company wants to be profitable, keep the cost of goods (COGs) down, maintain a competitive edge or advantage, and incur minimal regulatory risk, without compromising on the quality of their products.

I believe that the decision by a pharmaceutical company to invest in local drug manufacturing and transfer of the brand technology to Nigeria may be determined amongst others by the desire to preserve their brand, guide against adulteration, and navigate through complex logistics constraints, regulatory issues, and the drug distribution networks.

In the long term, it may be cheaper and more profitable for the company to manufacture their products in Nigeria. The initial cost of building the manufacturing facility and conducting technology transfers may likely be offset by a possible increase in market share or sales volume over time. This is particularly true for a differentiated brand that is preferred by patients and consumers in terms of its efficacy, high quality, and safety.

Unfortunately, in most instances, it appears that some of these pharmaceutical companies simply ship their brite stocks to Nigeria and build a packaging facility for their finished goods. Research and Development (R&D), API and drug product manufacturing still occur elsewhere. Although this business model will guarantee the continued growth of the brand, it would have minimal impact on the growth of the pharmaceutical sector in Nigeria. These companies should be encouraged to invest in infrastructures, R&D and full operations in Nigeria.

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Nigeria has a tremendous opportunity to attract multinational pharmaceutical companies to invest in our country and grow the pharmaceutical sector. I feel that the private sector and the government must work collaboratively to provide requisite enabling environment, infrastructures, incentives, and resources to attract prospective foreign investors.   Developing safe and high-quality product brands that meet patients’ and consumers’ needs must be a key priority for all pharmaceutical companies in Nigeria.

Nigeria is blessed with enormous natural resources and cheap labour. I would encourage all the major pharmaceutical companies to consider investing a portion of their profits in R&D, as well as establishing full manufacturing operations in Nigeria.  This would extend the life cycle of their brands and further increase their market share. Furthermore, it would create good paying jobs, grow the pharmaceutical sector, make drugs available and affordable, contribute significantly to the GDP, and enhance the healthcare delivery in Nigeria.

As a pharmacist in the Diaspora, are there some policies you wish the government would adopt and implement to enhance the success of the healthcare sector in Nigeria?

In Nigeria, prescription drugs can be easily obtained from the open market. This continues to present a significant problem and poses considerable safety concerns to the patients and public health. Prescription drugs must be obtained from the pharmacy. The pharmacists have the right training to properly counsel the patient on the appropriate storage conditions, and proper use of the medication, as well as instructions on potential drug interactions and other possible safety hazards.

For several years, I have advocated for a thorough review and update of the national drug formulary. We must tailor the formulary to reflect affordable and safe contemporary drugs based on prevalent diseases in Nigeria. I was informed that a cross-disciplinary committee was set up few years ago to review the national formulary. However, I am not sure that I understand the extent of progress made in this regard. This effort should not be a onetime thing.

Another opportunity for the Nigerian health sector is to set up a serious multi-disciplinary task force to prepare for the next pandemic. We must learn from the Ebola crisis and the COVID-19 pandemic. We cannot afford to be caught unprepared. Nigeria must invest in local vaccine research and development.

The various healthcare professionals must work together to foster a patient-centred healthcare delivery. The academic curriculum in pharmacy schools in Nigeria needs to be consistently overhauled to encourage new graduates, as well as practising pharmacists, to specialise in specific disease states. Cross-disciplinary, patient-centred training must be embedded in the curriculum and emphasised for each healthcare profession. This way, the different healthcare professionals would learn to work well together early in their training, one another’s expertise and contributions to the overall healthcare delivery.

Finally, I would recommend a national licensure examination for pharmacy graduates in Nigeria. This would challenge the students and faculties to enhance the quality of pharmacy education in Nigeria.

Quality assurance is one huge challenge in Nigeria as it is difficult for patients to ascertain the genuineness of drugs available to them, despite the capabilities of the MAS technology. What would be your suggestions to mitigate this issue?

I feel that NAFDAC has done a lot to mitigate the proliferation of adulterated drugs in Nigeria, including assignment of NAFDAC numbers to track authenticity of medicinal products. Although a lot of work still needs to be done, I strongly believe that it is our collective responsibility to strive to achieve high quality standards for all the medications that are consumed in the country.

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Availability of authentic drugs can make a difference between life and death, particularly for patients afflicted with life-threatening conditions, such as diabetes and/or cardiovascular diseases. The quality and safety of these life-saving drugs are critical to ensure good and sustainable public health.

Some possible measures to mitigate the proliferation of adulterated drugs in Nigeria would include investing in developing validated, advanced, real-time rapid drug testing technology. This should be made available to drug inspectors, hospitals, pharmacies, and designated drug testing centres to quickly identify, confiscate, and remove adulterated drugs from the distribution networks.

Another is public education on identification and dissemination of information on the dangers of use of adulterated drugs. There should be easy access to drug information and reporting cases of fake drugs. A public fake drug reporting hotline is essential here.

There is also need to establish a safe drug enforcement task force with oversight by the Pharmaceutical Council of Nigeria (PCN). This group should be empowered to carry out periodic unannounced inspections and incursions, and coordinate activities and efforts with NAFDAC and the Pharmaceutical Society of Nigeria (PSN). Suspected drug samples should be submitted to designated drug testing laboratories and reports shared with regional and national enforcement and regulatory agencies.

Establishment of regional drug testing centres is also essential. These centres will share data and intelligence reports with NAFDAC and the drug enforcement agency.

Additionally, publishing a list of brands and names of offenders will be of tremendous service. So is establishment of strict controls at the port of entries of drugs into Nigeria. Heavy penalties must be meted to offenders and peddlers of adulterated drugs, including loss of license, fines and/or imprisonment.

Online drug procurement is popular overseas. Given the increasing incidents of cybercrime in Nigeria, would you advise pharmaceutical companies to invest in online drug distribution and sales?

Internet pharmacies and drug purchases are on the rise. It is estimated that approximately 4.5 per cent of all internet searches are linked to health-related questions or information. Online drug sales can be hampered by increasing rate of cybercrime, fake websites, jurisdiction issues, and drug counterfeiting or misbranding, etc.

Cybercrime is a critical global issue. Advanced countries have sophisticated operations and tools to detect, proactively monitor, and combat incidents of internet crimes. Cybersecurity is beginning to gain some attention in Nigeria.

I strongly believe that online pharmacy in Nigeria can be a lucrative business venture. However, the enormous challenges associated with it may outweigh the potential benefit. Some of the possible limitations would include slow speed of medication delivery, poor drug distribution network, cybercrime, poor traceability, cyber security, logistics constraints, and potential legal issues.

I would suggest that the Pharmaceutical Society of Nigeria (PSN) and the Pharmaceutical Council of Nigeria (PCN) collaborate to organise a workshop on online pharmacy programme. The outcome of the workshop would include development of a blueprint or required framework for a successful online pharmacy programme in Nigeria.

I believe that the success of the online pharmacy programme would require strict collaboration between the private sector, the government, and the international cybersecurity intelligence organisation.

What is your advice to your Nigerian counterparts?

We must keep on learning, be willing to set stretched goals, invest in the future of our young professionals, challenge one another in a professional manner, share best practices, think strategically and outside the box, and by all means stay current.

Never stop thinking, never stop dreaming, and never stop moving forward. Celebrate incremental individual and/or collective successes. Listen to one another, trust one another, and treasure diversity of opinions. Our best years are still ahead!

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