A patient starts a new medicine at a health facility and returns home. Two days later, she develops severe dizziness and a rash. She is unsure whether the medicine is responsible. The facility may be kilometres away.
She does not know whether what she is experiencing should be reported, whom she should tell or whether her concern is serious enough to matter. So, she tells her family, perhaps a neighbor. But the health system may never hear about it.
For pharmacovigilance, that silence matters. Kenya, like many African countries, has made important progress in establishing pharmacovigilance systems and digital reporting mechanism for adverse drug reaction, medication errors, vaccine related events, and poor-quality products. But having a pharmacovigilance system is not the same as having a patient accessible safety system.
A national reporting portal may exist while a patient experiencing harm in a rural household remains effectively invisible to it. This is the last mile of medicine safety. Preventing medication related harm should begin during routine care. Health care workers need to recognise, document and report suspected adverse reactions, medication errors and product quality concerns as part of everyday practice.
Patient counselling is equally important. A patient who understands what to expect, what warning signs require help and where to raise concern is better equipped to participate in their own safety.
Yet much of patient’s experience with medicine happens after leaving the facility. In rural communities, side effects occur at home. A care giver may notice a child reacting badly to a medicine.
A patient may stop treatment because they believe it is making them worse. Distance from facilities, language barriers, limited medicine safety awareness, poor connectivity and uncertainty about reporting pathways can prevent these experiences from ever entering formal surveillance.
Let’s use routine pharmacovigilance data from West Pokot County to illustrate why these matters. A review of digital reports through June 2026 identified 20 suspected adverse drug reaction reports, five adverse events following immunisation, three reports concerning poor quality health products and technologies, and one medical device incident.
No medication error or transfusion reactions reports were identified and 85 percent of the adverse drug reaction report involved adults. These figures must be interpreted carefully.
Twenty reports do not mean only 20 reactions occurred. Zero medication error reports do not mean no medication error happened. Spontaneous reporting depends on someone recognising a problem, connecting it to a medicine or health product, documenting it and reporting it.
The absence of reports is therefore not necessarily evidence of the absence of harm. Sometimes it may reflect the absence of surveillance visibility.
Digital systems are vital because they help regulators and health systems detect trends and identify surveillance blind spots.
But technology cannot report an event nobody recognises. It cannot by itself overcome language barriers, low health literacy or poor connectivity. Digital systems must therefore complement, not replace, accessible human reporting pathways. This is where community health workers (CHWs) and community health promoters (CHPs) could become an important bridge.
Across Kenya and much of Africa, CHWs and CHPs already connect households with primary health care. They understand local contexts, communicate in familiar languages and often reach people far from facilities.
They do not need to become pharmacovigilance specialists or determine whether medicine caused a reaction. Their role can be practical; explain medicine safety messages, recognise possible concerns, identify warning signs needing urgent referral, support patients to raise concerns, and connect them with facility pharmacovigilance focal persons.
A simple two-way pathway could link the patient or caregiver, the CHP, the health facility and the national pharmacovigilance system. Information should also flow back toward communities, so patients and frontline reporters know that raising a concern leads to attention, learning and action. The objective is not to create a parallel pharmacovigilance system. It is to extend the reach of the existing one.
As African countries strengthen regulatory and digital health systems, we should measure more than whether reporting platforms exist.
We should ask whether patients know how to use them, whether someone can help when they cannot, whether rural communities are represented in safety data and whether health systems investigate areas that remain silent.
There is also a continental opportunity. Medicine and supply chains cross borders, and safety signals identified in one country may protect patients elsewhere. African countries and regional institutions should strengthen information sharing, harmonise core reporting approaches and develop common principles for community participation in medicine safety.
Ultimately, a patient experiencing possible medicine related harm should not need to understand the words “adverse drug reaction” or “pharmacovigilance”. They should simply know that something unexpected has happened, whom to tell and where to get help. A patient safety system becomes meaningful only when patients can access it, understand it and participate in it. If the patient cannot reach the system, the system has not yet fully reached the patient.
Winnie Chebiwot Kipchumba is a Pharmacist Kacheliba Subcounty Hospital, West Pokot County
