Special Report

Ensuring Patient Safety: Mbarara Hospital sets bar high in Pharmacovigilance

Abiaz Rwamwiri, NDA Spokesperson speaking at the launch of the pharmacovigilance program at Bwizibwera Health Center IV in Mbarara district on 21st April 2023.

MBARARA, UGANDA: The Ministry of Health has been making efforts to instil a culture of reporting adverse drug reactions (ADRs) to safeguard medicine users against drug-related problems.

Unfortunately, the call has been falling short of the set target by the World Health Organization which recommends over 200 ADRs reports per 1,000,000 population.  

But, all is not lost as Mr Halson Kagure, the Spokesperson of Mbarara Regional Referral Hospital expounds on the “pharmacovigilance program” and how USAID support to the hospital has paid off.

Ronald Ampaire was managed by clinicians at Mbarara Regional Referral Hospital (MRRH) after he reacted to the COVID-19 vaccine.

Winding bumpy lanes coupled with rising dust is what welcomed us as we made our way to Keigosora village, Rubaya subcounty in Mbarara district. 

Keigosora, one of the 987 villages which make up Mbarara district; is the ancestral home of 28-year-old Ronald Ampaire.

By the time Covid-19 pandemic struck Uganda in March 2020, he was receiving treatment for the preexisting conditions.

Characterized by acute respiratory illness, Covid-19 was taking a toll on people with comorbidities.

For Ampaire to survive the pandemic which has claimed lives of 3,632 Ugandans since its outbreak, Covid-19 vaccination was paramount. 

At first, he had cold feet about the vaccines due to social media misinformation but was demystified.

“I couldn’t risk it all with my conditions. I had to vaccinate on 23rd June 2022, all was well until a week. My hand was paralyzed, I couldn’t move, the stomachache was unbearable. I was scared, he explains.”

He recalls receiving a phone call from a staff attached to Mbarara Regional Referral Hospital inquiring about his condition.

“I explained to the caller what I was going through and he advised me to report to the hospital. When I went there, I was assessed and managed. I really appreciate their services,” he adds.

Ampaire (left) shares his experience with Halson Kagure at his home.

His experience is almost no different from that of Michael Twinomuhangi, a resident of the Nyamitanga division in Mbarara City.  He reported swelling on the arm in a couple of days following his first shot of Covid-19.

“The swelling which started as minor grew bigger. Fortunately. I returned to the hospital where I was diagnosed and put on treatment. I was worried but I am now feeling better.”, he says.

He expressed commitment to taking the campaign of reporting suspected drug effects to peers.

Michael Twinomuhangi receiving prescriptions at MRRH Pharmacy from Mr Alex Ahimbisibwe the hospital pharmacist.

Beatrice Namuli, not her real name, spent about six months complaining of diminishing libido to her husband. This, after she opted for a contraceptive implant, a hormonal birth control device placed underneath the skin in the arm.

Though she had treated it as a normal symptom without medical intervention, it could have been a different story. “At Mbarara Hospital, I was assessed and counselled on how to go about this mode of family planning and it has worked”, she said.

The Health Ministry through National Drug Authority (NDA) has been striving to boost medicine user feedback through Pharmacovigilance Program.

The National Pharmacovigilance Center was entirely established to monitor the safety of medical products across the country.

“Eighteen years down the road since we rolled out the National Pharmacovigilance Program, patient feedback on medicine use has been increasing but we are not yet there. We know that we are on the right track with the support of partners like USAID, local authorities, even you the media,” says Mr Abiaz Rwamwiri, NDA Spokesperson.

Pharmacovigilance is the pharmaceutical science which deals with the detection, assessment, prevention and management of adverse drug reactions.

Adverse drug reactions occur after the administration of medical treatment and may present mild, moderate severe and lethal symptoms.

“All drugs including vaccines can produce adverse drug reactions but not all patients develop the same level and type of ADRs”, Prof. Robert Tamukong an Associate Professor of Clinical Pharmacy at Mbarara University.

Prof. Tamukong was part of the research team that conducted an assessment study into the prevalence and associated factors of ADRs among heart failure patients at Mbarara Regional Referral Hospital.

He stresses that every medicine user can experience adverse drug reactions triggered by patient-related factors, inappropriate prescriptions, alcohol consumption, preexistent medical conditions among others.

“Age is a very important factor which affects the occurrence of ADRs.  Infants and very young children are particularly vulnerable and at high risk of ADRs because drugs are less likely to be studied extensively in these extremes of age, and drug absorption and metabolism are more variable and less predictable in this group of individuals”, he adds. 

Racheal Akampwera a health worker at Mbarara Regional Referral Hospital administering Inactivated Polio Vaccine (IPV) to a baby to offer protection against polio.

Adverse drug reactions can include abnormal swelling, visual disturbances, dizziness, abnormal heart rhythms among others.

Medicine users who develop severe reactions are advised to stop and report back to the hospital for medical intervention. Apart from using ADR reporting forms in health facilities, drug users can as well send in feedback through NDA’s established digital channels.

Whereas the World Health Organization recommends a minimum of 200 cases of ADRs per 1,000,000 population in a year, Uganda records about 135 ADRs reports.

Dr Julius Mayengo, the National Pharmacovigilance Officer at NDA explains how the national-wide reporting rate has been falling below the WHO set standard. “In a country where our current population stands at 47 million people, we should be looking at generating 9,400 ADRs reports. But in the past year we managed to collect 6,345 ADRs reports”, he says.

But all is not lost. There has been an improvement in the reported cases from previous years. And with partners helping hand, the National Drug Authority is set to hit the set target. 

USAID support to Mbarara Regional Referral Hospital pays off.

Mbarara Regional Referral Hospital serves a population of over 4.6 million people in Ankole region and the neighbourhood. Despite being named among the best in service delivery; it used to be ranked below performers in ADRs reporting.

In the financial year 2019/2020, the hospital recorded a paltry 58 cases ranking fifth out of the 209 facilities that participated.

The Health Facility Master List indicate that Uganda has 6,937 health facilities each established under unique administrative units. The above, literary means that a whopping 6,728 facilities didn’t take part in ADRs reporting.

Nevertheless, in the subsequent financial year 2022/2023, adverse drug reactions reports grew by leaps and bounds at MRRH. The strides made in reporting and managing adverse drug reactions at the hospital are attributed to USAID support and the Health Ministry.

Gerald Manzi, MRRH Pharmacist displays the award recently scooped by the hospital.

“In this financial year, the hospital reported close to 600 reports compared to last year’s 300 ADRs reports. In Ankole region where we have a population of about 5,000,000 people we submitted 870 reports to NDA. Though our target was about 1000 ADRs reports, there is a great improvement compared to what we used to get”, Gerald Manzi, the Mbarara Regional Referral Hospital Pharmacist says.

He attributes the improvement in adverse drug reactions reporting to USAID Mbarara Regional Referral Hospital Strengthening Activity which supports the hospital pharmacovigilance team.

Clinicians have been re-trained in identifying and managing adverse drug reactions presented by patients.

From the left: Gerald Manzi & Alex Ahimbisibwe both hospital pharmacists at the hospital’s Out-patients pharmacy. Patients are also advised on the safe drug use to minimize side effects.

Mbarara Regional Referral Hospital was honored with a national award for ensuring patient safety by the National Drug Authority. The hospital has in turn empowered selected health facilities in the region to build the capacity in drug detection, monitoring and management of adverse drug reactions.

Bwizibwera Health Center IV, located in Mbarara district is one of the health facilities which beat its counterparts and emerged victorious in ADRs reporting. 

“We are grateful to the support given to us by USAID through Mbarara Hospital. My team was trained in identifying the category of patients susceptible to ADRs, managing those who present severe drug reactions and report to NDA through the established systems. This year, we captured 106 ADRs, down from only 4 reports in 2019,” Dr Richard Atuhaire, the In charge of Bwizibwera HCIV reveals.

Participants after the launch of the pharmacovigilance campaign at Bwizibwera HCIV on April 21st 2023.

April this year, MRRH and NDA launched the campaign at Bwizibwera health facility to raise awareness about adverse effects in the region.

The event attracted Mbarara district local leadership, village health teams, National Medical Stores officials and health workers.

The Mbarara Regional Referral Hospital’s Deputy Director Dr. Francis Oriokot commended efforts to raise awareness which he says is the best practice in improving healthcare service delivery.

Severe ADRs if not managed can cause persistent disability, birth defects among expectant mothers, organ failures which can turn fatal.

Medical scholars recommend a nationwide study to ascertain the actual prevalence rate of ADRs. However, across the healthcare settings, the latter ranges from 19% to 53% according systematic reviews.

Across the globe, latest findings by the National Institutes of Health, the United States primary agency responsible for biomedical and public health research put ADRs on fourth and sixth most common causes of death.

About the Author(s)

▪  Halson Kagure, Public Relations Officer, Mbarara Regional Referral Hospital
▪  Dr Celestine Barigye, Hospital Director Mbarara Regional Referral Hospital
▪  Dr Winnie Muyindike, Director ISS Clinic/ Consultant Physician, Mbarara Regional Referral Hospital
▪  Dr Denis Nansera, Consultant Pediatrician, Mbarara Regional Referral Hospital
▪  Dr Sunday Nighty Atwine, Coordinator USAID Mbarara Regional Referral Hospital Strengthening Activity

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