1ST MEETING OF aDSM CAUSALITY ASSESSMENT COMMITTEE AT KNCV CONFERENCE HALL 24TH – 25TH JUNE 2021

1ST MEETING OF aDSM CAUSALITY ASSESSMENT COMMITTEE AT KNCV CONFERENCE HALL 24TH – 25TH JUNE 2021

1ST MEETING OF aDSM CAUSALITY ASSESSMENT COMMITTEE AT KNCV CONFERENCE HALL 24TH – 25TH JUNE 2021

Background

Active Drug Safety Monitoring (aDSM) is an active form of pharmacovigilance recommended by the WHO for active and systematic clinical and laboratory assessment of patients on treatment with new TB medicines, novel MDR-TB regimens or XDR-TB regimens to detect, manage and report suspected or confirmed drug toxicities. It defines the active and systematic clinical and laboratory assessment of patients on treatment for any new drugs for tuberculosis, including multiply drug-resistant (MDR) and extremely drug-resistant tuberculosis (XDR-TB). It includes detecting, managing and reporting suspected or confirmed drug toxicities.

The recording and reporting activities of aDSM primarily target the serious adverse events (SAEs) as a basic requirement. MDR-TB treatment sites with additional resources may also monitor other AEs which are of clinical significance or of special interest to the programme, as part of comprehensive aDSM. It is used to monitor and manage adverse events in patients who receive a particular medication or treatment regimen and to assess causality. It differs from active pharmacovigilance in that it is an activity focused on the specific needs and context of national TB programmes and is embedded within the patient monitoring function (e.g. cohort monitoring) of TB programmes. The management of patient safety is an inherent part of aDSM, inseparable from its monitoring component.

Due to the implementation of aDSM in Nigeria by the National TB and Leprosy Control Programme (NTBLCB), a Committee was inaugurated to enable assessments of aDSM forms received.  As part of the USAID LON 1 & 2 project, KNCV Tuberculosis Foundation in collaboration with the National Tuberculosis, Leprosy and Buruli Ulcer Control Programme (NTBLCP) and other Partners such as Pharmacovigilance in Africa project (PAVIA) and National Agency for Food Drug Administration & Control (NAFDAC) organized a two (2) day meeting (24th – 25th June 2021) to inaugurate a Causality Assessment Committee for the assessment of Adverse Drug Reactions received by the NTBLCP via the Active Drug Safety Monitoring and Management (aDSM) forms for DR-TB medicines. This meeting was held to cover two quarters of aDSM on the LON 1 & 2 project and will subsequently be held every quarter.

2.0 Meeting objective

The ultimate purpose of systematic data collection within aDSM is to enable causality assessment for the SAEs, determine the frequency and rates of occurrence and detect signals.
To evaluate the causal association between an exposure to a (TB) medicine and the occurrence of an adverse reaction, which is an integral part of the clinical management.

3.0 Results / Findings

The WHO causality assessment system was used for the classification of 41 aDSM reports. Most of the reports were focused on SAEs and AESIs being the main focus of the implementation of aDSM. Reference materials such as drug SmPCs, Emdex, BNF 2020/2021 edition etc were used to reach a conclusion on the causal relationship between the drug and Adverse Event reported.

The Most common SAE and AESI reported were Nausea /Vomiting, Hypokalemia, Ototoxicity, Optic Neuritis, Peripheral Neuropathy, Hepatotoxicity, Renal Toxicity, Prolonged QT -interval, Rash, Jaundice, Severe Anaemia and Gastro-intestinal disturbance, as shown in Table 2 below.

Causality assessment of the ADR forms showed that most patients experienced one or more adverse events due to multiple drug regimen. The probability that more than one drug may cause a particular adverse event can make it difficult to narrow down causality of particular drugs.

0 Conclusion

 It is recommended that more trainings are implemented for the Health Care Providers in the treatment facilities and further trainings on reporting of other adverse events other than SAEs/AESIs should also be encouraged. Reporting of any other ADRs encountered may possibly lead to detection of new signals related to the use of the drug.