Suspected Medicine Adverse Reaction Search (SMARS) Disclaimer
Essential information about SMARS
What to remember when using SMARS
About the release of this information
Use of SMARS data
Further information
Essential information about the Suspected Medicine Adverse Reaction Search (SMARS)
An assessment of the safety of a medicine cannot be made using only the information contained in the Suspected Medicine Adverse Reaction Search (SMARS).
Medsafe advises patients NOT to make any changes to their medicine treatment based on information contained in SMARS. Changes to treatment should only be made following consultation with a healthcare professional.
What to remember 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 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.
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.
About the release of this information
This information is released in keeping with the purpose of the Official
Information Act 1982 to increase the availability of official information to the
people of New Zealand. Data contained in SMARS does not include any personal
information within the meaning of the Privacy Act 1993.
Medsafe's copyright statement
Use of SMARS data
If you wish to copy or circulate information from SMARS, please ensure that a
copy of these guidelines is provided. Prior to any publication of data you must
contact CARM and Medsafe and include in the publication:
- the source of the information
- the limitations of the information
- that the information does not represent the opinion of CARM or Medsafe.
Further information
If you require further information, please contact Medsafe.
Email:
medsafeadrquery@health.govt.nz
Phone 04-819-6800