TFDA acts on adverse drug reactions

Dar es Salaam. Experts in Tanzania have voiced their concern about unreported cases of patients experiencing adverse drug reactions (ADRs).

They spoke following the introduction by the Tanzania Food and Drugs Authority (TFDA) of an electronic system—the TFDA ADR reporting tool—meant to help smartphone users across the country to report their “bad experiences” with medications taken orally or intravenously as injectables.

A local pharmacist, Mr Punit Solanki, told The Citizen yesterday that many Tanzanians were not aware that they were supposed to report ADRs to TFDA for possible intervention.

“Some people may even ask why they have to go through the trouble of reporting,’’ said Mr Solanki, adding that quick reporting was meant to protect them and others from hazards that may arise from medications.

The new tool makes it possible for TFDA to know what drugs need to be closely monitored and even withdrawn from the market after further research.

According to TFDA guidelines on monitoring and reporting adverse drug reactions, ADRs are likely to arise even from common medications in the market that have been correctly selected and prescribed.

“No drug is absolutely safe for use in all people and under all circumstances,” TFDA says.

Mr Solanki said common medications that were in use in Tanzania had been processed, tested and found to be safe for human use.

He added, however, that unexpected reactions could be discovered when a drug was already in the market.

“Usually, for a drug to be developed and allowed into the market, it has to pass through a number of stages and processes. It may take years before a drug finally makes it into the market.

“What follows (after the drug compounds have been developed) are clinical trials on healthy people first, then on a few patients followed by a few hundred patients,” Mr Solanki said.

He added: “But testing a medicine under controlled conditions and among small groups of patients is completely different from when the medicine starts to be widely distributed and used by many people. Some issues may arise after the medicine has entered the market, so a mandatory monitoring system is required.’’

Public health researchers in Tanzania have noted that ADR monitoring and reporting in the country is still weak and that most cases tend to go unreported.

Some experts argue that failure to involve healthcare professionals in reporting ADRs has contributed to under-reporting.

A study conducted in 2011, titled Adverse Drug Reaction Reporting – Knowledge, Attitude and Practices of Community Pharmacy Dispensers in Dar es Salaam, recommended the government’s intervention in addressing the matter.

“The staffing of community pharmacies with unqualified pharmaceutical professionals is the main reason for the lack of knowledge, thus sincere and sustained efforts should be made by the government through its national regulatory authorities and schools of pharmaceutical sciences to ensure that there is an increased output of qualified pharmaceutical professionals,’’ says the report.

This reporter is aware of people who have been complaining about adverse effects of some medications, although they did not know where to report their complaints. They include a 28-year-old Dar es Salaam resident, who has vowed not to take a certain antibiotic after experiencing “intolerable” headache and abdominal pains.

“It was a few months ago when I felt unwell and went to a clinic. After undergoing a number of tests, the doctor said I was suffering from typhoid and prescribed the antibiotic. Once I began taking the medication I developed severe abdominal pains and a throbbing headache for three days. I went back to the doctor, who told me that I could be allergic to the drug. I didn’t finish the prescribed course, and didn’t know what to do thereafter,’’ he said in an interview with The Citizen, adding that he would never use the antibiotic again following the “nightmare” he went through.

TFDA Director General Hiiti Sillo told the media at the launch of the ADR reporting tool in Dodoma on Friday that people with android smartphone could download the app and use it to report to the authority any adverse drug reaction they might experience.

He said the new tool, which was developed by researchers from the University of Dodoma in collaboration with TFDA, was linked to the World Health Organisation’s international system for monitoring ADRs.

Plans are underway to enable people who don’t have android smartphones to report ADRs through text messages.