Kenya’s national drug safety system in trouble – study

By Gatonye Gathura

A multi-million shilling system installed by the Pharmacy and Poisons Board in 2013 to monitor the quality of drugs has failed to take off.

This means doctors, pharmacists and nurses are not reporting which, how and when drugs hurt their patients.

The study shows upon introduction in 2013 the number of reports fell dramatically from about 2,350 to just 1,000 in 2014 and 700 in 2015 and still falling.

The project supported by USAID was to digitize the reporting of poor quality drugs and adverse drugs reaction by health workers from facilities countrywide.

Working effectively, the system should help identify substandard drugs and have them pulled out of the market as well as secure patients from non-working or dangerous drugs.

“As seen in the reported data for the country, the system has yet to achieve the desired objectives, and reporting rates have declined following its introduction,” says the evaluation.

Key reasons for the failure, the report says, was lack of internet services at the workplace and absence of a culture of reporting drug performance among health workers.

The Pharmacovigilance Electronic Reporting System (PvERS), the report shows is performing worse than the 2010 manual technology it was supposed to replace.

Through the system, data from hospitals is sent to the pharmacy board in Nairobi and onwards to the World Health Organization’s affiliated Uppsala Monitoring Centre in Sweden.

But the board has defended the system saying it is a major success which is being studied for replication by Afghanistan, Angola, Tanzania, Zimbabwe, Ethiopia, and Somalia.

The evaluation was done by among others Oscar O Agoro and Sarah Kibira of the Medical Department at the Ministry of Health.

“This evaluation is helpful for the ministry to see what works best and how to do such projects better,” Prof Hamish Fraser of Leeds University and study co-author told the Standard.

The report sanctioned by the pharmacy board was published last month by the Oxford University Press on behalf of the American Medical Informatics Association.

Other key reasons for the system failure, the study says is lack of support from management and an overworked health staff.

The researchers had looked at reporting trends before and after the digital system and recorded declining performance while elsewhere, they say reporting is on the rise.

They also went out to find out the cause of this poor performance from 115 pharmacists in public health facilities in six counties.

Among reasons discouraging the pharmacists from reporting, they said was lack of acknowledgment and feedback from the pharmacy board after submission of reports.

Outcomes of such reports, the pharmacists said were never disseminated back to the health workers or their patients.

Consequently the report says an already overwhelmed health workforce then view pharmacovigilance reporting as extra “non-essential” work.

“We were privy to this work,” the board said in an email to our enquiries on Thursday.

Despite this acknowledgement, and indication the study had been sanctioned by the board it says the findings and conclusions are largely wrong.

A response by Dr Christabel Khaemba of the board and Dr Ndinda Kusu, for the American NGO Management Sciences for Health (MSH), which is involved in the project, insists the system is a big success.

A comprehensive look at the reporting trends the duo says shows the number of reports to have actually gone up though they accept there have been challenges.

“Reporting is a voluntary exercise and people choose to report or not, and that does not mean system failure but lack of use of the system and PPB cannot force people to use a system,” says the email.

The two organizations also cite the disruption of services during the health sector devolution period as a possible cause for a decline in reporting.

Other factors that can be attributed to the decline, the officers say is the shortage of health workers making pharmacovigilance reporting be viewed as extra non-essential work.

Study authors however say all is not lost if only the board would move fast to address the problems identified in this study.

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