Welcome to the voluntary adverse drug reaction (ADR) reporting page!

Join Us in Promoting Global Patient Safety & Public Heath.

PSV- Public Safety & Vigilance facilitates all the health care professionals and consumers of pharmaceutical medicinal products across the world in voluntary reporting of side effects directly to their respective national health authority.

Improving Patient Safety by promoting culture of voluntary reporting of adverse drug experiences, medication errors, efficacy & quality complaints associated with pharmaceutical medicinal products.

What is Voluntary ADR reporting?

Reporting of adverse drug experiences with the use of a pharmaceutical medicinal product to national health authority by health care professional or by a patient/patient’s care provider.

Importance of Voluntary ADR reporting:

Each medicine has its own benefits and risks. However, the safety information (information related to risks of medicine) is inadequate in establishing the real-time benefit-risk profile of a medicine.

In order to hasten the accumulation of evident safety information for medicinal products in the market, voluntary ADR reporting is a key source to fulfil the lacuna for strengthening the signal detection (identification of potential safety concerns/findings/issues/risks) and evaluation activities (confirmation of a safety concerns/risk/finding/issue) which helps national health authorities to take regulatory actions at the earliest possibility thereby preventing occurrence of the potential safety hazards on lager group of populations.

Voluntary ADR reporting promotes patient safety and overall public health in terms of safe medicine usage with the early identification of potential safety concerns and early implementation of risk minimizing measures.

Promoting Safety Reporting Culture:

What Health Care Professionals need to do with respect to voluntary ADR reporting?

  1. Should be aware of the existence of platforms for reporting adverse experiences (adverse drug events & adverse drug reactions).
  2. Should be cautious while prescribing (physicians), dispensing (pharmacists) and administering (nurses) medicines with the complete awareness of expected safety concerns and the respective risk minimizing measures.
  3. Should be vigilant in the identification of signs and symptoms of a adverse drug event/reaction and report proactively whenever the safety incident occurs.
  4. Should inform patients and patient’s care providers to observe and monitor for any possible adverse drug experiences (both expected & unexpected).
  5. Should educate patients and patient’s care providers to report the side effects/adverse drug experiences.
  6. Should familiarize the patients and patient’s care providers about voluntary reporting of adverse drug experiences to national health authority and the available channels for reporting.
  7. Should report adverse drug experiences to national health authority at the earliest possibility.

What patients and patient’s care providers need to do with respect to voluntary ADR reporting?

  1. Should be aware of the existence of platforms for reporting adverse experiences (adverse drug events & adverse drug reactions).
  2. Should be cautious while administering (self & patient’s caregiver) medicines with the complete awareness of expected safety concerns.
  3. Should become familiarize with the available reporting channels for submitting the adverse drug experience information to national health authority.
  4. Should take responsibility to report the adverse drug experiences to respective health care professional or to respective national health authority.

Join Us in Promoting Global Patient Safety & Public Heath.

If ‘You’ (either health care professional or patient or patient’s caretaker) are aware any side effects or adverse events or adverse reactions, medication errors, or having quality concerns associated with medicinal products use, you can report the same to your respective national health authority directly.

Select your nation and the corresponding national health authority from the below list for direct ADR reporting.

Voluntary ADR Reporting

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