TB meds side-effects a crisis

A study by the Human Sciences Research Council (HSRC) has red-flagged inadequate reporting of the
side-effects of drug-resistant TB (DR-TB) treatment in South Africa, with experts saying they were one of main reasons for defaulting on medication.

According to the results of the study, gastrointestinal reactions, peripheral neuropathy, as well as hepatitis abnormalities, are top on the list of at least 14 common side-effects associated with drug-resistant TB medication.

HSRC’s Dr Razia Gaida said while many cases of TB could be cured with six months’ antibiotic treatment, DR-TB does not respond to one or more antibiotics and, in some cases, can be difficult to cure.

She said DR-TB treatment was often influenced by adverse drug reactions and could impact patient outcomes, saying a spontaneous reporting system of adverse events has been adopted worldwide and is dependent on healthcare professionals.

“While the incidence of adverse events associated with DR-TB medication are well documented, the reporting to regulatory bodies is lacking,” Gaida said.

The survey’s primary aim was to understand the current adverse event reporting practices in specialised DR-TB treatment facilities in South Africa. Of the surveyed facilities across SA, only half – 50.6% – had submitted treatment adverse events forms to the relevant authority and 44.5% were “unsure”.

The survey also noted that there was a disparity in the reporting forms, with the facilities using at least up to five different forms to record an adverse reaction, as well as lack of training for nurses and community healthcare workers.

Professor Glenda Davison, head of the biomedical sciences department at the Cape Peninsula University of Technology and honorary senior lecturer at the University of Cape Town, said the construction and conclusions of the survey were very relevant not only during this time of Covid-19 but at all times and for all drugs.

She agreed there was a cause for concern, particularly in the backdrop of reports that many patients were defaulting on their medication.

“For TB treatment this is very concerning as the disease is well known to become resistant. This is known as multidrug-resistant TB or MDR-TB. This is caused by mutations in the genes of the bacteria which are targeted by two
main drugs. The names of these drugs are Isoniazid and Rifampicin,” said Davison.

“The main reason for this occurring is patients stop taking therapy before they have completed the six months course, or by not taking the medication correctly,” Davison said.

This could also lead to further mutations and patients could develop resistance to multidrug-resistant TB, which makes further treatment options very difficult. Davison said the biggest challenge was that patients were not
properly educated on how to take the medication and, according to the study, they may experience side-effects and decide to stop taking the medication.

“Without patients regularly attending a clinic or seeing a health care provider this could lead to MDR-TB or even X-MDR TB,” she said.

“If this is not controlled it could lead to a resurgence of tuberculosis after the Covid-19 crisis is over. The Western Cape has very high levels of TB so this is very worrying,” she said.

Dr Petronella Mugoni, a public health communication expert, said what she found significant in the findings was that the high proportion of healthcare workers have been there for more than 10 years and close to 100% of them
agreed that adverse event reporting is very important and that it is their role.

“[The study] shows that a large proportion would say they ‘arenot collecting’ or of the proportion that is collecting, they are not sending it anywhere…” she said.

Mugoni said her experience working in the TB sector in SA was that the data analysis capacity was also not always there within the health facilities itself or even the district and only at the provincial level.

The challenge with this, she said, is that data analysed at provincial level many weeks later might be too late to do anything about because the situation would have moved much.

“So I think all of this points to health systems gaps that needs to be addressed.

“Adverse events are one of the main reasons why people would not take their medication correctly or consistently,” she said.

Mugoni said in some cases side effects were not recorded as a problem, with patients told it was not a problem and to continue with medication. But, she said, if the medication makes them sick or bad, they might skip or totally
stop taking medication.

She agreed with the survey’s recommendations – including standardisation of the adverse event report forms across facilities; evaluation of various methods of incorporating the form into the daily routine or standard patient examination; as well as the training of all staff working with DR-TB patients (social workers, physiotherapists, pharmacists, community healthcare workers) regarding adverse event reporting and its value as part of a national intervention.

– siphom@citizen.co.za

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