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.
• Anyone living in New Zealand who thinks they may have experienced an adverse reaction due to a medicine or vaccine can report it. This does not necessarily mean that the medicine caused the reaction
• Medsafe collects and processes suspected adverse reaction reports and the physicians at the Centre for Adverse Reactions Monitoring (CARM) medically assess non-routine reports.
• 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:

• any report where death was the only reported reaction (to protect privacy)
• reported terms of death – the report is still included in the results, but the death term has been removed (to protect privacy)
• any report where medication error or product administration error was the only reported term (ie, no adverse reaction was reported)
• reports with no adverse reaction as they are an invalid report
• reports from the last two 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 Medsafe (medsafeadrquery@health.govt.nz) 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