aDSM is defined by the World Health Organization (WHO) as the active and systematic clinical and laboratory assessment of patients on treatment using new anti-tuberculosis (anti-TB) drugs, novel multi-drug resistant tuberculosis (MDR-TB) regimens or extensively drug-resistant (XDR-TB) regimens to detect, manage, and report suspected or confirmed drug toxicities.

1. To improve patient care & safety in relation to medicines and all medical interventions.
2. To improve public health & safety in relation to use of medicines.
3. To reduce risk from drug-related harm in patients on DR-TB treatment.
4. To promote understanding, clinical training, and effective communication to health professionals and the public.

aDSM applies to the following groups:

• TB patients treated with new medicines (e.g., Bedaquiline (BDQ) or Delamanid (DLM)), repurposed drugs, or new regimen;
• TB patients enrolled on treatment with novel regimens such as the shorter MDR-TB treatment regimen; and,
• All XDR-TB patients on second-line treatment.

The Administrative Order No. 2020-0025 dated 02 June 2020 provides the policy and guidelines on the implementation of the aDSM program.

The policy applies to all health facilities, both public and private, and health professionals providing treatment to all patients with TB using a new anti-TB drug, a repurposed drug or a new regimen, the DOH concerned offices, Centers for Health Development (CHDs), Ministry of Health – Bangsamoro Autonomous Region in Muslim Mindanao (MOH-BARMM), LGUs, and other stakeholders involved in aDSM.

Serious Adverse Events (SAEs) and Adverse Events with Special Interests (AESIs) shall be reported through the Pharmacovigilance Monitoring System (PViMS) or any prescribed web-based reporting system.

PViMS is a web-based monitoring tool, which enables the implementation of active surveillance activities in low- and middle-income countries (LMICs) by addressing the entire data collection, data analysis, and reporting process.

In health facilities where PViMS or any prescribed web-based reporting system is not available, the Food and Drug Administration (FDA) Suspected Adverse Reactions Form v5 (4/2012) shall be completed.

Adverse Events of Special Interest (AESI) include the following:

1. Acute kidney injury (acute renal failure)
2. Hepatitis (defined as increases in alanine aminotransferase [ALT)] or aspartate aminotransferase [AST] ≥5× the upper limit of normal [ULN] or increases in ALT or AST ≥3× ULN with clinical manifestations, or increases in ALT or AST ≥3× ULN with a concomitant increase in bilirubin ≥1.5× ULN)
3. Hypokalemia
4. Myelosuppression (manifested as anemia, thrombocytopenia, neutropenia, or leucopenia)
5. Optic nerve disorder (optic neuritis) or retinopathy
6. Ototoxicity (hearing impairment, hearing loss of any degree)
7. Pancreatitis
8. Peripheral neuropathy (paresthesia)
9. Prolonged corrected QT interval (Fridericia formula) of >500 ms or an increase from baseline of >60 ms
10. Psychiatric disorders and central nervous system toxicity (e.g., depression, psychosis, suicidal intention, seizures)