Existing national reporting and learning systems

The primary objective of a medication error reporting system (MERS) is the enhancement of patient safety, by learning from adverse events, errors and near misses. Reporting and collection adverse drug events, near misses and medication errors is the first step to learn from patient safety incidents, however a MERS is meaningful only if each report is subject to an in-depth analysis, is evaluated and feed-back is given to the professionals involved in, and to all other who could learn from this medication error.
A variety of MERS have been established at a national level. According to each country healthcare system, medication errors may be reported to a specific MERS or to broader patient-safety incident reporting systems, including pharmacovigilance systems. Click bellow on your country to find information on the existing medication error reporting system.

Canada


The Canadian Medication Incident Reporting and Prevention System (CMIRPS)
The Canadian Medication Incident Reporting and Prevention System (CMIRPS) is managed by the Institute for Safe Medication Practices Canada (ISMP Canada) with the partnership of Health Canada, the Canadian Institute for Health Information (CIHI), and the Canadian Patient Safety Institute (CPSI). Medication Incident and Near Miss Reporting Programs are provided to:

Denmark


Styrelsen for Patientsikkerheds læringsenhed
Danish Patient Safety Authority

According to the Danish Act on Patient Safety put into force January 1, 2004, practitioners report mandatory adverse events to the national reporting system.

  • The case processing of the individual incidents reported by healthcare practitioners takes place locally, so that learning can be learned locally. The data is then anonymised and sent to the Danish Agency for Patient Safety:
    https://dpsd.csc-scandihealth.com/Form/PublicSubmission.aspx?form=DPSD_Public
  • In the case of adverse events that include "falls" and "medication not given", where the severity is "no harm" or "mild harm", a collective reporting record individual incidents on paper forms, which are in front of the workplace, after which they are reported to the DPSD for one month at a time: https://dpsd.csc-scandihealth.com/Form/PublicSubmission.aspx?form=SAMLERAPPORTERING
  • Patients or relatives have the opportunity to report unintended events, including errors, to the Danish Patient Safety Database (DPSD). The report will be sent to the person responsible for patient safety at the scene of the incident. Here, the incident will be analyzed to find out how to prevent something similar from happening to others. The report is then anonymised and sent to the Danish Agency for Patient Safety, which uses the unintended events for learning in the health care system in general: https://dpsd.csc-scandihealth.com/Form/PublicSubmission.aspx?form=PatientPaarorende_PAA

France


National French Portal for Adverse Events Reporting

Since March 2017, an internet portal is accessible to all, caregivers and patients, ensuring the collection and orientation of electronic reports according to the risks and their managers: https://signalement.social-sante.gouv.fr/psig_ihm_utilisateurs/index.html#/accueil
Reports of medication errors are sent at regional level and follow different ways according to the event (serious adverse event (Regional Healthcare Authority), adverse drug reaction (Regional PharmacoVigilance Centres), product related defect) before been sent to the French Medicine Agency. Read on (in French)...

Since 2007, Prescrire’s Programme Preventing the Preventable aims to improve the professional practices of Prescrire subscribers mainly belonging to the primary healthcare sector deprived with specific risk management structures. It does not replace their various reporting obligations to official health surveillance systems. This reporting system allows Prescrire subscribers to report errors, preventable adverse health care events and risky situations in complete confidentiality. The aim is to get the message across by informing caregivers of an identified risk. Read on (in French)...

Germany

Medication error reporting system currently in progress: read on (in German)...
The Drug Commission of the German Medical Association (AkdÄ) currently gives brief feedback of medication errors as part of the assessment of suspected pharmacovigilance cases.

Morocco

Morocco Poison Control and Pharmacovigilance Centre (CAPM)

The Morocco Poison Control and Pharmacovigilance Centre (CAPM) provides a reporting portal for adverse drug reactions, poisonings or requesting information: http://www.capm-sante.ma/

Saudi Arabia


Saudi Vigilance System
Saudi Food and Drug Authority

Saudi Vigilance Allow to Report Adverse Drug, Cosmetic, and Medical Device Events here.
This service allows all stakeholders to report adverse drug and medical device events, medications error, or any defect in products quality and aims to simplify the reporting process. Since the system’s success is best ensured by active and ongoing participation, Saudi Food and Drug Authority (SFDA) strongly encourages all members of the drug and medical community to take part. The service also allows receiving reports of drug shortages from health authorities and establishments.

Medication Error Reporting Form
Saudi Food and Drug Authority (SFDA) relies on your reports of Medication Errors related to the naming, labeling, packaging, and design that are associated with drug products, including circumstances such as look-alike container labels or confusing prescribing information that may cause or lead to a medication error, to drive safer practices and prevent patients harm.

Spain

Instituto para el Uso Seguro de los Medicamentos (ISMP-España)

Since its creation in October 1999, the Instituto par el Uso Seguro de los Medicamentos (ISMP-España) has maintained a national medication error reporting programme. This programme is voluntary, confidential and independent. It collects observations and experiences concerning those potential or actual medication errors that health professionals voluntarily report. The information is independently analysed, with neither conflicts of interest nor administrative pressure, and all information is treated confidentially.

Health professionals may either notify the ISMP-España online through an electronic formulary, or send an e-mail to ismp@ismp-espana.org, or download and fill out the reporting formulary and send it by post to report medication errors in complete confidentiality. Read on (in Spanish)...

When an error is reported associated with labeling or packaging prone to error, it is possible to attach a photo at the end of the electronic formulary.

ISMP-España carefully reviews and analyses all reported errors, and depending on the characteristics sends a copy of the report to the Spanish Medicine Agency (AEMPS) and to the pharmaceutical companies whose products are mentioned in the reports.

Netherlands

Instituut Verantwoord Medicijngebruik - Voorkomen Medicatie-Incidenten (ivm VMI)

The Instituut Verantwoord Medicijngebruik - Voorkomen Medicatie-Incidenten (ivm VMI, Institute for Responsible Medication Use - Prevention of Medication Incidents) is a continuation of the Portal for Patient Safety / CMR. CMR (Central Medication Incidents Registration) was established in 2006 as part of the NVZA. The Dutch Pharmaceutical Association (KNMP) joined in 2009. In 2012, the CMR continued as an independent foundation under the name Portaal voor Patient Safety.

On January 1, 2021, the Portal for Patient Safety merged with the Institute for Responsible Medication Use (IVM) and the activities were incorporated into the IVM's Preventing Medication Incidents (VMI), the actual national reporting point for medication incidents: https://www.medicijngebruik.nl/vmi

  • Both healthcare organizations and individual healthcare providers can report medication incidents. If necessary, identified risks are also shared with industry and professional organizations, MEB, Lareb, NICTIZ, VZVZ, IGJ and software suppliers. This gives them input to make patient care safer, for example by adjusting guidelines and protocols, IT systems and patient information.
  • Patients can report medication incidents to the IVM’s Medicines Hotline: https://www.meldpuntmedicijnen.nl/

United Kingdom

NHS England and NHS Improvement

The National Reporting and Learning System (NRLS), has been launched in 2004 to collect information on “patient safety incidents”, including medication errors reports, from all NHS organisations in England and Wales. The NRLS is the world’s largest and most comprehensive patient safety incident reporting system and receives over two million reports each year from all health care settings, i.e. primary care, acute care, learning disabilities, mental health and ambulance care. Designed to complement local reporting systems, the information is stored anonymously by the NRLS.

All reports related to patient safety are entered into the organisation’s own risk management system and then sent automatically direct to the NHS Improvement, where the information relating to individuals (staff or patients) is removed. An electronic web-based reporting form is also available.

  • Healthcare staff are encouraged where possible to record all patient safety incidents on their local risk management systems. These reports will then be routinely uploaded to the NRLS to support national learning. Healthcare staff unable to use a local risk management system can also record incidents directly on the NRLS via the e-forms below:
  • The general public record incidents directly on the NRLS via an e-form for patients and public.

United States of America

Institute for Safe Medication Practices

The medication error reporting programme of the Institute for Safe Medication Practices (ISMP) collects reports from health care practitioners since 1975. In 1992, the Food and Drug Administration (FDA) started monitoring medication error reports. Health care practitioners and consumers can submit reports and associated material confidentially. The information is anonymously forwarded to the Food and Drug Administration (FDA) and to the manufacturer after removal of name and contact information to inform them about pharmaceutical labelling, packaging and nomenclature issues that may foster errors by their design.

Central to ISMP’s medication safety efforts is a set of national error reporting programs. These free programs use the thousands of reports gathered each year to educate the healthcare community and to develop strategies for preventing medication errors in the future. Through ISMP’s follow-up with reporters, expert analysis, and extensive communication with stakeholders, the contributing factors and causes of the errors are identified. Findings and strategies are communicated through ISMP newsletters, educational programs, and discussions with the healthcare community, consumers, and accrediting and regulatory bodies. ISMP’s error reporting programs include the following.

  • ISMP National Medication Errors Reporting Program (ISMP MERP)
    Started in 1975, the cornerstone of ISMP’s medication error prevention efforts is the ISMP National Medication Errors Reporting Program. The ISMP MERP is the first and only voluntary, practitioner-based medication error-reporting program. The objectives of the ISMP MERP are:

    • Learn the underlying causes of reported medication errors or hazards
    • Disseminate valuable recommendations to organizations to prevent future errors
    • Provide guidance to healthcare community, regulatory agencies, and pharmaceutical and device manufacturers

Healthcare practitioners can report an error to:

    • The ISMP National Medication Errors Reporting Program (ISMP MERP): https://www.ismp.org/form/merp-form
    • The joint ECRI and ISMP Patient Safety Organization (PSO). As a PSO, federal legal protection can be provided for certain patient safety information prepared within the patient safety evaluation system and submitted to ECRI and the ISMP PSO. The protected information, called patient safety work product, includes information provided about why the error happened or why the hazard exists, along with any further analysis of the event:
      https://www.ecri.org/report-medication-safety-error
  • ISMP National Vaccine Errors Reporting Program (ISMP VERP)
    ISMP, in cooperation with the California Department of Public Health Immunization Branch, developed the ISMP National Vaccine Errors Reporting Program in 2012. This program is the only national vaccine error surveillance program in the U.S. The ISMP VERP captures the unique causes and consequences of vaccine-related errors, and ISMP’s analyses typically become the basis for recommendations on safe vaccine practices: https://www.ismp.org/form/verp-form
  • ISMP Consumer Medication Errors Reporting Program (ISMP C-MERP)
    ISMP’s Consumer Medication Errors Reporting Program was designed to enable consumers to report medication errors, near misses, or hazardous situations. Reports submitted to the nationally recognized ISMP C-MERP are a critical first step to protecting millions of patients from the possibility of similar medication errors: https://www.ismp.org/form/cmerp-form


Updated on March 29, 2023