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World Patient Safety Day 2022

Medication Without Harm - Global Patient Safety Challenge

September 13, 2022

Synergy Pharm keeps you informed about medication safety, the theme chosen by the World Health Organization (WHO) for the 2022 edition of World Patient Safety Day.

Regulatory documents for drug safety:

Several regulatory documents are required to ensure the safety of a drug before it is made available on the market.

  • One of the first key steps is the drug benefit/risk assessment included in the CTD (Common Technical Document) submitted to the health authorities.
  • Additional specific documents may be requested at the time of submission, such as the “120-day safety update” and the DALA (Drug Abuse Liability Assessment) for the Food and Drug Administration (FDA) in the United States.
  • Once the product is available on the market, various pharmacovigilance systems are set up to allow the safety of the product to be monitored during its use by patients. Several safety reports are thus issued during the drug development phase (DSURs) and are periodically updated (PSURs/PBRERs).

Raising patient awareness on medication safety:

Ensuring the safe use of medication is essential for reducing patient harm. Especially since the COVID-19 pandemic has significantly exacerbated the risk of medication errors and associated medication-related harm. There are several interventions that can help to limit the frequency and impact of medication errors.

  • Starting a medication
  • Taking a medication
  • Adding a medication
  • Reviewing medication
  • Stopping medication