Suspected Medicine Adverse Reaction Search

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 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.

When using SMARS you should remember that:

• 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 underreporting 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 did cause 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).

SMARS contains anonymised information from reports of suspected adverse reactions to medicines but does not include the following:

• Reports not causally related to the medicine (assessed by CARM).
• Any report where it is considered that the patient may be identifiable (e.g. 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 progressively increase the availability of official information to the people of New Zealand. The data contained in SMARS does not include any personal information within the meaning of the Privacy Act 1993.

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 this 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 by emailing medsafeadrquery@moh.govt.nz or by telephoning 04 819 6800.