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 with no adverse reaction as they are an invalid report
- 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.
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