INOPP Forum
SMARS DATABASE - Suspected Medicine Adverse Reaction Search
Quote from VigiServe Admin on January 8, 2021, 3:00 PMSuspected Medicine Adverse Reaction Search - SMARS
About SMARS
This project was launched in 2012 to provide public access to reports on suspected adverse reactions to medicines. This is in keeping with the purpose of the Official Information Act 1982 to increase the availability of official information to the people of New Zealand. By increasing transparency, Medsafe is able to address the growing need from the public for more access to information about their medicines.
An assessment of the safety of a medicine cannot be made using only the information contained in SMARS. The information in SMARS can be helpful to identify possible medicine safety issues. SMARS reflects the reporter’s opinion and does not contain enough information, for example the medical history of the patient, to provide a complete overview of the risks associated with specific medicines.
For more comprehensive information about the risks of particular medicines you should refer to the medicine data sheet, medicine consumer medicine information (CMI) or talk to your doctor, pharmacist, nurse or midwife.
Understanding the information in SMARS
SMARS contains anonymised information from reports of suspected adverse reactions to medicines but does not include:
- reports not causally related to the medicine (assessed by CARM)
- any report where it is considered that the patient may be identifiable (eg, due to the rareness of the reaction)
- reports from the last three months.
Please note that some non-causally related suspected adverse reactions may be included in SMARS if the report also contained a causally related suspected adverse reaction.
The database is updated once a month.
The reports sent to CARM often only contain limited details about the suspected reactions. Reports vary in quality, completeness, and detail. In some instances reports may include information that is incorrect, despite the efforts made by CARM to verify the information in these reports. Coincidental events unrelated to the medicine may also be reported.
Data contained within SMARS can change due to on-going quality control, and receipt of follow up information.
It is important to remember the following when using SMARS.
- The likelihood of experiencing an adverse reaction to a medicine cannot be estimated from this database as there is no information on how many people have taken the medicine and the extent of under-reporting is not known.
- For these reasons, it is also not possible to directly compare the risks of different medicines using SMARS.
- Reports are sent to the Centre for Adverse Reactions Monitoring (CARM) if the reporter suspects that a medicine caused a reaction. This does not necessarily mean that the medicine caused the reaction.
- CARM and Medsafe staff consider many factors when assessing whether a medicine has caused an adverse reaction.
- The number of reports for a medicine can be influenced by how many patients are taking the medicine, media attention, the nature of the reactions, and other factors which vary over time.
- The quality of the information in SMARS is limited by the quality of the original report.
- The information contained in SMARS may change over time due to quality control procedures and/or receipt of further information.
- Reactions may also be caused by other ingredients present in the medicine (excipients).
- The reports in SMARS do not represent all the available information on the benefits and risks of a medicine. This information should not be used in isolation when making treatment decisions.
- Any treatment concerns must be discussed with a healthcare professional. Medsafe advises patients not to make any changes to their treatment based on the information contained in SMARS.
Searching for more information on vaccines
To search for a vaccine in SMARS, type the first few letters of vaccine into the search box. Then scroll down the list to select the vaccine that you want to search for.
Advice for industry
To avoid creating duplicate reports, cases viewed in the Suspected Medicine Adverse Reaction Search (SMARS) should not be submitted as new reports back to CARM. The SMARS database contains anonymised information from reports that have previously been received by CARM. If follow-up information is required to be submitted for a case, please quote the original report number when submitting so this can be linked to the original report.
Use of SMARS data
If you wish to copy or circulate information from SMARS please ensure that a copy of the SMARS disclaimer is provided. Prior to any publication of data, you must notify CARM (carmnz@otago.ac.nz) and Medsafe (medsafeadrquery@health.govt.nz) and include in the publication:
- the source of this information
- the limitations of this information
- that the information does not represent the opinion of CARM or Medsafe.
Suspected Medicine Adverse Reaction Search (SMARS) Disclaimer.
Further information
If you require further information, please contact Medsafe.
Email: medsafeadrquery@health.govt.nz
Phone: 04 819 6800
Suspected Medicine Adverse Reaction Search - SMARS
About SMARS
This project was launched in 2012 to provide public access to reports on suspected adverse reactions to medicines. This is in keeping with the purpose of the Official Information Act 1982 to increase the availability of official information to the people of New Zealand. By increasing transparency, Medsafe is able to address the growing need from the public for more access to information about their medicines.
An assessment of the safety of a medicine cannot be made using only the information contained in SMARS. The information in SMARS can be helpful to identify possible medicine safety issues. SMARS reflects the reporter’s opinion and does not contain enough information, for example the medical history of the patient, to provide a complete overview of the risks associated with specific medicines.
For more comprehensive information about the risks of particular medicines you should refer to the medicine data sheet, medicine consumer medicine information (CMI) or talk to your doctor, pharmacist, nurse or midwife.
Understanding the information in SMARS
SMARS contains anonymised information from reports of suspected adverse reactions to medicines but does not include:
- reports not causally related to the medicine (assessed by CARM)
- any report where it is considered that the patient may be identifiable (eg, due to the rareness of the reaction)
- reports from the last three months.
Please note that some non-causally related suspected adverse reactions may be included in SMARS if the report also contained a causally related suspected adverse reaction.
The database is updated once a month.
The reports sent to CARM often only contain limited details about the suspected reactions. Reports vary in quality, completeness, and detail. In some instances reports may include information that is incorrect, despite the efforts made by CARM to verify the information in these reports. Coincidental events unrelated to the medicine may also be reported.
Data contained within SMARS can change due to on-going quality control, and receipt of follow up information.
It is important to remember the following when using SMARS.
- The likelihood of experiencing an adverse reaction to a medicine cannot be estimated from this database as there is no information on how many people have taken the medicine and the extent of under-reporting is not known.
- For these reasons, it is also not possible to directly compare the risks of different medicines using SMARS.
- Reports are sent to the Centre for Adverse Reactions Monitoring (CARM) if the reporter suspects that a medicine caused a reaction. This does not necessarily mean that the medicine caused the reaction.
- CARM and Medsafe staff consider many factors when assessing whether a medicine has caused an adverse reaction.
- The number of reports for a medicine can be influenced by how many patients are taking the medicine, media attention, the nature of the reactions, and other factors which vary over time.
- The quality of the information in SMARS is limited by the quality of the original report.
- The information contained in SMARS may change over time due to quality control procedures and/or receipt of further information.
- Reactions may also be caused by other ingredients present in the medicine (excipients).
- The reports in SMARS do not represent all the available information on the benefits and risks of a medicine. This information should not be used in isolation when making treatment decisions.
- Any treatment concerns must be discussed with a healthcare professional. Medsafe advises patients not to make any changes to their treatment based on the information contained in SMARS.
Searching for more information on vaccines
To search for a vaccine in SMARS, type the first few letters of vaccine into the search box. Then scroll down the list to select the vaccine that you want to search for.
Advice for industry
To avoid creating duplicate reports, cases viewed in the Suspected Medicine Adverse Reaction Search (SMARS) should not be submitted as new reports back to CARM. The SMARS database contains anonymised information from reports that have previously been received by CARM. If follow-up information is required to be submitted for a case, please quote the original report number when submitting so this can be linked to the original report.
Use of SMARS data
If you wish to copy or circulate information from SMARS please ensure that a copy of the SMARS disclaimer is provided. Prior to any publication of data, you must notify CARM (carmnz@otago.ac.nz) and Medsafe (medsafeadrquery@health.govt.nz) and include in the publication:
- the source of this information
- the limitations of this information
- that the information does not represent the opinion of CARM or Medsafe.
Suspected Medicine Adverse Reaction Search (SMARS) Disclaimer.
Further information
If you require further information, please contact Medsafe.
Email: medsafeadrquery@health.govt.nz
Phone: 04 819 6800