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).
Specialized in medical writing, our experienced team can assist you in the drafting of these regulatory documents. Synergy Pharm is member of France Biotech and holds the accreditation for French research tax credit (CIR) as a service company involved in research and development (R&D) projects.
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.
On 17 September 2022, the WHO is organizing a global campaign on the theme of “Medication Safety” with “Medication Without Harm” as the slogan to raise awareness among the public and health professionals about safety issues related to the use of medication. This program aims to reduce severe avoidable medication-related harm by 50%, globally, in the next 5 years. To help achieve this goal, the WHO has developed a patient engagement tool called “5 Moments for Medication Safety” to facilitate and empower patients to be more involved in their own care. This tool includes a list of questions that can be asked at different levels of care and in different settings and circumstances:
- Starting a medication
- Taking a medication
- Adding a medication
- Reviewing medication
- Stopping medication
More information on this campaign and on the series of medication safety webinars organized by the WHO can be found at: https://www.who.int/campaigns/world-patient-safety-day/2022