When used irrationally, medicines can have devastating effects on our well-being.

Dr. Christabel knows this fact all too well and strives, through pharmacovigilance, to support efforts that can limit the negative impact poor quality medicines, adverse events and medication errors have in the continent.

She is the Head of Pharmacovigilance at the Pharmacy and Poisons Board- the national drug regulatory agency in Kenya. A member of the African Medicines Regulatory Harmonization Technical Committee on Regulatory Capacity Development in Africa and currently, a PhD student at the Karolinska Institutet in Sweden.

Together with her colleagues in Kenya and within the continent, they have put in concerted efforts in ensuring the continent moves as one in upscaling the African pharmaceutical industry through harmonized, strong and robust regulatory systems.

As we mark the World’s Patient Day, Dr. Christabel helps us decipher how we can leverage on pharmacovigilance to enhance patient safety.

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How did your pharmacy career lead you to pharmacovigilance?

After graduation, I did my hospital internship at Kenyatta National Hospital (KNH) and was later posted to work as a hospital pharmacist at the now Nyamira County Referral Hospital (formerly a District Hospital).

At KNH, participating in ward rounds and managing medicines at the Comprehensive Care Clinic were a major part of the internship.

But in the case of Nyamira, I had to make a conscious effort to take part in hospital ward rounds with focus on reviewing patient treatments as well as offering guidance on the treatment options we had at the pharmacy.

[Smiles] The funny thing is that at the time, my other colleagues did not understand why the pharmacist in charge kept attending ward rounds instead of staying at the pharmacy to oversee the operations of the pharmacy.

I guess this bewilderment was born from the fact that clinical pharmacy practice in hospitals was a relatively new concept and had not been appreciated as an important contributor to good therapeutic outcomes. 

At the same time, I was managing the antiretroviral medication at the HIV clinic where the Government had just rolled out the free HAART therapy and as a pharmacist, one of the key roles I played in the program was monitoring compliance and adherence to the medicines.

In that regard, I noticed that patients would discontinue treatment either due to side effects which they labelled ‘unbearable’. Some would give feedback that they experienced different effects with different brands of medicines despite having the same active ingredients.

So, these incidents would be documented in the patient files but there was nowhere to report them, I remember we would call NASCOP to get guidance on how to manage the reported adverse events.

When the Pharmacy and Poisons Board (PPB) launched the National Pharmacovigilance System, I was lucky to be part of the team that was sensitized in Nyanza on the concepts of Pharmacovigilance and its potential impact in ensuring patient safety. 

Needless to say, I was intrigued by the conversations and I remember thinking to myself; “this is something I would like to pivot towards in my career.”

You mentioned about a personal experience?

Yes, I remember vividly a time when my dad was unwell.  So of course, he went to the hospital and was prescribed for medicines.

You see, when the medicine was dispensed, it was labelled 2×3 ostensibly meaning two tablets to be taken three times a day. But due to maybe old age or improper patient counselling during dispensing, he ended up multiplying that and taking 6 tablets one morning.

Fortunately, the effects that ensued were not as severe as they could have potentially been.

He developed xerostomia (dry mouth) and this was enough to convince him that there was a conspiracy against his life and swore not to continue taking the medicines.

Later we laughed about it that being a former teacher he decided to be smart and proceeded to carry out some mathematical calculation.

This literally hit close to home and only served to strengthen my resolve in pursuing a career leaning more towards patient safety through pharmacovigilance.

Fast forward a few years later, I get a posting from the Ministry to PPB and was deployed at the PV/PMS unit.

According to the World Health Organization, as many as one in ten medical products circulating in developing countries are substandard or falsified. Of all the falsified drugs reported to the WHO between 2013 and 2017, 42% of the reports came from the African region. Why is Africa this vulnerable?

Africa faces multiple economic, social, and political challenges in comparison to more developed continents such as Europe, North America, and parts of Asia.

These challenges include income inequality, infrastructure limitations, restricted access to essential services like healthcare, and political instability, among others.

Collectively, these factors create a conducive environment for the infiltration of substandard or counterfeit medical products into the supply chain.

Weak border controls, coupled with porous borders, have significantly facilitated the smuggling and illicit trade of medical products.

The upsurge in internet-based commerce also opens up multiple avenues for counterfeiters to directly engage with consumers, thus evading regulatory oversight.

Additional factors, such as limited access to affordable medical products and the high cost of certain prescription medications, may force consumers to seek more “cost-effective alternatives” typically outside the established, regulated distribution channels.

Lack of public awareness across the African population regarding the consequences and risks associated with substandard and counterfeit products is also a huge facilitating factor.

Africa, in general, struggles with a high burden of infectious diseases, including acute respiratory infections, HIV/AIDS, diarrhoea, malaria, and tuberculosis.  

You realize Access to these treatments has continued to grow in Africa, however, we need to appreciate that these efforts are not always matched with the capabilities of some of the National Medicines Regulatory Authorities to Monitor the quality, safety and efficacy of these products.

I would say in general; most regulatory authorities in Africa are still evolving in their quest to achieve level 3 or 4 WHO regulatory systems’ maturity.

Level 3 represents stable, well-functioning and integrated regulatory systems while Level 4 represents regulatory systems operating at an advanced level of performance and continuous improvement.

What are some of the negative effects of and challenges faced in the monitoring and management of poor-quality medicines, adverse reactions and medication errors?

Whenever a patient experiences any of these issues, the result generally is prolonged sickness, treatment failure, antimicrobial resistance, non-compliance (due to adverse events), increased treatment costs, and in unfortunate circumstances death.

Patients tend to lose confidence in healthcare systems when these eventualities occur, not well managed and not sensitized about them.

In terms of challenges, the major ones faced include absence of medication safety monitoring programs in hospitals, unbridged staffing needs, poor communication links between the patients and the healthcare professionals., underreporting of medication errors and ADRs due to fear of victimization.

Genetic differences in patients also make it hard to identify and manage ADRs.

 

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RELATED: Gambia: 70 children lost lives due to substandard cough syrups (africanpharmaceuticalreview.com)

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In Africa there are countries to this date don’t have a Pharmacovigilance department in their national drug regulatory agencies. The Gambia for example has only recently initiated the process of establishing one after the death of 70 children due to substandard cough syrups. Why is it such a challenge to set up and implement PV systems in the continent?

The confirmation that 70 children in Gambia lost their lives directly due to the consumption of certain cough syrups is undeniably a tragic and deeply unfortunate event.

This heartbreaking incident serves as a reminder of the critical importance of pharmacovigilance in ensuring the safety of medical products and highlighted the urgent need for systems to monitor and prevent such occurrences both in the continent and globally.

The disaster in The Gambia greatly mirrors past events that birthed PV systems.

Historically, safety monitoring was not something that was given much prominence and it is worth noting that the presence of diethylene glycol in sulfonamide elixir in the USA in 1938 and the Thalidomide tragedy in Germany in the early 60s prompted the setting up of safety surveillance systems.

Many regulatory authorities in Low- and Middle-Income Countries (LMICs) face resource constraints.

Establishing effective pharmacovigilance systems demands adequate resources and personnel, which can be particularly challenging to attain in such settings, this I believe contributed largely to the incident in the Gambia.

The lack of adequate regulatory frameworks in Africa also hampers the setting up and implementation of robust PV systems in the region.

Pharmacy and Poisons Board, The National Medicines Regulatory Agency in Kenya (credit PPB)

How has the Pharmacy and Poisons Board overcome these challenges?

I have to say there was both goodwill and passion from both the management at PPB and my predecessors in the setting up of the national pharmacovigilance system in Kenya.

This has made it easier for the current team to make the system resilient and in line with the growing global trends. The Institutionalization of Pharmacovigilance and systemic capacity-building approach have gone a long way in the growth of pharmacovigilance in Kenya.

Key factors that have worked for PV in Kenya include having a clear regulatory framework on pharmacovigilance and post-market surveillance; the pharmacovigilance and post-market surveillance rules enable the PPB to implement PV activities. 

Through these Rules, County Governments now are able to designate County Vigilance focal persons to coordinate the implementation of pharmacovigilance and post-market surveillance activities within the counties.

This I believe is a major step forward because these focal persons are in direct involvement with what is ongoing in the county and therefore communication is enhanced.

Market Authorization Holders are also now required to appoint Qualified Persons for Pharmacovigilance who are responsible in monitoring the products on the Kenyan Market.

Collaborations with different stakeholders has also been instrumental in the implementation of PV activities. These include academia, public health programs, counties and development partners especially when it comes to leveraging on the limited available resources.

Regional collaborations within economic blocs such as The East African Community and The Intergovernmental Authority on Development, IGAD have been instrumental in our progressive successes as well through the harmonization processes.

Capacity building of health care professions at both in- and pre-service levels has played a key role in cascading PV activities within the health facilities which in turn has an impact on patient safety.

A major criticism that has been directed to the Pharmacy and Poisons Board (the national drug regulatory agency in Kenya) is the lack of feedback when PV reports are submitted. Why is that?

(Smiles) I don’t necessarily look at it as criticism but more of feedback. And to me any feedback is good feedback because it helps us improve.

Although sometimes it may not be the feedback we want to hear as the people implementing these activities (laughs).

Different pharmacovigilance centers adopt varying approaches when it comes to the receiving, processing, and management of individual case safety reports.

These differences can be influenced by the complexity of their systems and the availability of personnel and resources. Although, there is a general framework that guides the handling of these reports.

The standard process involves the initial receipt of an individual case safety report, followed by diligent efforts to gather additional or missing information.

Subsequently, the report is validated, taking into account criteria for seriousness.

Confirmed serious cases undergo further investigation, and causality is assessed by expert committees.

Feedback arising from the causality assessment is then issued. It’s important to note that feedback on reported adverse events can occur at any stage of this process, and the timelines involved may vary depending on internal procedures and the complexity of the reported event.

However, it cannot be overstated that providing timely feedback to both reporters and the general public, especially for adverse events of public concern, plays a crucial role.

 It not only encourages continued reporting but also helps rebuild trust and ensures patient safety

At PPB we are continuously improving our Pharmacovigilance Electronic Reporting System (PvERS) to make it as interactive as possible.

Through the system you are now able to have a snap shot of what is being reported across the county. 

Quarterly reports that give a summary of what reports were received and trends are also published on the PPB website.

I believe this counts as feedback, right? (smiles)

Finally, feedback can be given inform of a joint communication to different stakeholders, for instance release of a safety alert to the public as a result of a report you submitted.

Are there any global or continental efforts to enhance patient safety through pharmacovigilance?

Yes indeed, there are ongoing global and continental efforts to enhance patient safety concerning medicines.

Globally, the World Health Organization leads a program for international drug monitoring that boasts over 155 full and 21 associate member states. These member states actively contribute individual case safety reports to a global repository known as Vigibase.

This collaborative effort allows for the identification of potential medicinal safety concerns on a global scale.

WHO has also put in place pharmacovigilance indicators, which basically help countries to be able to assess where they are in terms of the implementation of pharmacovigilance activities.

Through global benchmarking, WHO is working with regulatory Authorities to ensure the Pharmacovigilance Systems are fully functional.

Furthermore, regional pharmacovigilance harmonization initiatives have been actively pursued.

For example, the African Union Development Agency-NEPAD (AUDA-NEPAD) has launched the Smart Safety Surveillance Program, designed to bolster safety surveillance for priority medical products throughout the African continent.

Additionally, AUDA-NEPAD, through the African Medicines Regulatory Harmonization (AMRH) program, established Regional Centers of Regulatory Excellence (RCOREs) across various fields, including Pharmacovigilance, to enhance regulatory capacity development in Africa.

These efforts ultimately improve patient safety in multiple ways. 

As an example, Kenya’s national pharmacovigilance centre, which is located at the Pharmacy and Poisons Board and the Ghana FDA, serve as RCOREs in Pharmacovigilance for the region.

These initiatives collectively represent significant strides toward ensuring the safety of medicines, not only at a continental level but also within specific regions, ultimately benefiting patient well-being and public health.”

Through the onset of the African Medicines Agency, it is envisaged that AfriVigilance a continental database including data on the end-to-end safety lifecycle of priority medical products in Africa will be set up to enable the ownership and analysis of African data in the African context to inform key safety decisions.

The AfriVigilance will be complementary to the Uppsala Monitoring Centre where data will be linked and shared with the VigiBase.

I would also want to mention that through the European Development for Clinical Trials  Partnership (EDCTP), currently, there are two  consortiums running  within the continent that have been Key in supporting PV and PMS

Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa (PROFORMA) a joint venture between experts from academia, NMRAs and WHO-collaborating centres in pharmacovigilance and RCOREs to generate a cohort of pharmacovigilance trained human resources from all stockholders.

These include patients, healthcare providers, regulatory staffs that are engaged in pharmacovigilance data collection, analysis, interpretation and data sharing in Ethiopia, Kenya, Rwanda and Tanzania.

We also have the PhArmacoVIgilance Africa (PAVIA) consortium that aims to strengthen pharmacovigilance (PV) in four African countries: Ethiopia, Nigeria, Eswatini, and Tanzania.

What role can technology play in pharmacovigilance and patient safety?

Technology is vital. I’ll use PPB’s evolution to explain this.

The Pharmacovigilance Electronic Reporting System at the Pharmacy and Poisons Board has significantly enhanced the ease of reporting adverse events for healthcare professionals, marketing authorization holders, and the general public to the National Pharmacovigilance Centre.

This system, available in both electronic and mobile application versions (mPvERS on both Android and iOS operating systems), as well as through USSD code (*271#), has streamlined the process of submitting a wide range of adverse event reports.

From adverse drug reactions, medication errors, suspected poor-quality products, medical device incidents, to blood transfusion reactions PV reporting has been made easier.

The adoption of this electronic system has notably improved the completeness and quality of individual case safety reports submitted to the National Pharmacovigilance Centre.

Furthermore, it has facilitated the timely sharing of identified adverse event reports with the global database, VigiBase.

One of the most valuable aspects of the electronic system is its efficiency. It saves time by enabling reports to reach the National Pharmacovigilance Centre instantly for further processing and management.

Additionally, it allows for real-time interactions with reporters, further enhancing the overall effectiveness of the pharmacovigilance reporting process.”.

The timely processing of the reports has a great impact on patient safety by allowing prompt mitigation actions to be taken, providing feedback and also supporting PV activities such as causality assessment of serious cases.

Do you have to be a pharmacist or pharmacy professional to ensure patient safety in medicine use? Do patients have a role to play?

So interestingly, when it comes to patient safety, I’ll say it’s a collaborative responsibility and everybody including patients themselves, healthcare professional, pharma manufacturers, the government and the policy makers should be involved.

Everybody has a role to play.

Of course, traditionally the mention of ‘pharma’, tends to make people think it’s a pharmacist only initiative. That is far from the reality.

And that’s why we are moving towards the term ‘vigilance’ as opposed to ‘pharmacovigilance’.

The public, in particular, has several essential roles to fulfill in this endeavor.

Like adhering to instructions and guidance provided by healthcare professionals, promptly reporting adverse events and suspected poor-quality medicines, and actively participating in awareness programs aimed at promoting safe and effective healthcare practices.

What are your plans for World Patient Safety Day?

This year there is an exciting collaboration happening on Friday, 15th September 2023.

The Pharmacy and Poisons Board, in collaboration with the Ministry of Health, the Kenya Association of Pharmaceutical Industries, and patient advocacy groups, has organized a special awareness event – a walk aimed at educating the general public on the importance of patient safety.

This walk will start at Afya House and culminate at the Arboretum, where a series of engaging activities and initiatives will take place, all geared towards advancing the cause of patient safety.

I strongly encourage all healthcare professionals and members of the general public to join in this collective effort.

Additionally, I urge everyone to consider taking personal actions and measures that contribute to patient safety in their daily lives.

Together, we can make a significant impact on patient safety and improve healthcare outcomes for all.

Any parting shot?

I just want to appreciate how far pharmacovigilance in the continent has come.

Despite the teething problems that we had; I’ll say Kenya has made quite some strides.

We have now integrated pharmacovigilance into public health programs and formed cross-working technical groups to enhance the agenda of pharmacovigilance and post-market surveillance.

Automating the data-collecting process through our PvERS and acting as a benchmark for other African countries is something we are proud of.

A patient reporting platform, to me that’s also a big success in our quest to enhance patient safety.

I understand the responsibility on the hands of the pharmacists when it comes to pharmacovigilance hands but I also reiterate that patient safety is a collaborative effort for all stakeholders.

It’s not just about the pharmacist or the regulator.

All of us have a role to play in it, starting from the patient, the healthcare professionals, the Pharma industry, the policymakers, the media basically the country at large.

Pharmacovigilance ensures patient safety; patient safety ensures a healthy nation and a healthy nation ensures a working nation.

 

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