Sir,
The National Drug Dependence Treatment Centre, Ghaziabad, Uttar Pradesh, mainly deals with the treatment of various disorders related to the use of all the substances including tobacco, opioids, alcohol, and cannabis. Treatment modalities include both pharmacological (i.e., with medications) and non-pharmacological (i.e., psychological/social) treatments. Treatment is provided in both inpatient (residential) and outpatient setting. Both long-term supervised medications (buprenorphine/ methadone/naltrexone maintenance therapy) and medically assisted and drug-free treatment related to drug use are provided. The National Drug Dependence Treatment Centre is functioning as one of the adverse drug reaction monitoring centers as approved by the Pharmacovigilance Programme of India (PvPI), Indian pharmacopoeia commission.[1] Pharmacovigilance in psychiatric and de-addiction units can play a significant role in detecting adverse drug reactions (ADRs) and alerting physicians to the plausibility and degree of such events, thereby protecting the user population from unnecessary harm.[2,3] Different classes of psychotropic medications and medications used for the treatment of substance-use disorders have different ADR profile. In addition, polypharmacy, i.e., prescribing more than one drug to the single person of the same chemical class (such as antipsychotics), can result in serious adverse reactions and exacerbate side effects and can lead to early death. PvPI encourages all types of suspected ADRs reporting whether they are known, unknown, serious, nonserious, frequent, or rare regardless of an established causal relationship between a drug and the reaction. ADRs related to the use of allopathic medicines, vaccines, traditional medicines, medical devices, contrast media, etc., can be reported to the PvPI. Regular and informed reporting practices can result in strengthened database about ADR, especially those which have late onset, or vary by genetic stock. Specific forms, endorsed by the PvPI, are available for reporting of ADRs by the medical professionals [Figure 1][4] or consumers [Figure 2].[5] Patients' details (age, sex, and body weight), adverse event history, history of medication suspected of having caused the ADR, and details of concomitant medication use are being recorded in the format followed in the PvPI ADR reporting form.[6] These reports are imported in the national database through the WHO-Uppsala Monitoring Centre's (WHO-UMC) Individual Case Safety Report management system, i.e., VigiFlow, which in turn contributed to WHO-UMC international database, i.e., VigiBase, for regulatory interventions. Causality assessment, which refers to the ascertainment of the likelihood of the suspected drug implicated in the causation of the adverse event, is done using the WHO causality assessment scale.[7] Safety alerts and signal detection are carried over using the collected safety database. Although this postmarketing surveillance study cannot provide true incidence or prevalence figures, it offers a representative idea of the ADR profile of psychotropic drugs and medications for treatment of substance-use disorders likely to be encountered in Indian patients. Constant vigil in detecting ADRs and postliminary dose adjustments can make therapy with psychotropic drugs safer and more efficacious. This, in turn, should improve compliance, which is often a major issue in the treatment of patients with psychiatric disorders and substance dependence. ADRs can also be reduced using less medication and with adequate knowledge of drug interactions. ADR database to psychotropic drugs built up on the basis of reports received from multiple drug addiction treatment centers. The active collaboration of psychiatrists and other health-care professionals, at these centers can provide in identification of early warning signals of drug-reaction combinations. Establishment of a psychotropic drug safety profile can be a worthy long-term goal in the Indian context and help in more informed clinical care of patients with substance-use disorders and other psychiatric disorders.
Figure 1.
Suspected adverse drug reaction reporting form (for healthcare professionals)
Figure 2.
Medicine side effect reporting form (for consumers)
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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