Published: September 2001

Publications

Your Guide to Adverse Reaction Reporting

Information on this subject has been updated. Read the most recent information.

Prescriber Update 22: 21–25
September 2001

The Centre for Adverse Reactions Monitoring (CARM) in Dunedin is the national repository for adverse reaction reports.  New Zealand health professionals can be proud of their high rate of adverse reaction reporting.  These reports help to identify local patterns and contribute to international pharmacovigilance.  The reports can also result in safety alerts to prescribers, and national database warnings for individual patients.  All health professionals are encouraged to continue reporting adverse reactions to CARM.  Please provide as much information as possible.  Personal patient details supplied to CARM remain confidential.  Reporters of adverse reactions will receive supportive feedback from CARM.

Your adverse reaction reports contribute to the world data pool
Reports can help identify NZ patterns and potential safety issues
Ultimately patients benefit from improved safety
Anyone can report adverse reactions to CARM
New yellow reporting form, same information needed
Reporting is as easy as 1, 2, 3
IMMP events too

Your adverse reaction reports contribute to the world data pool

New Zealand has the highest rate of reporting adverse reactions to medicines in the world, both in terms of reports per 1000 doctors and reports per million population. This does not reflect a bigger problem in New Zealand; rather we are more diligent about reporting these events. However, it is estimated that only 5% of all reactions are reported so there is still room for improvement.

The goal of adverse reaction reporting is to improve the safety of medicine use. The Centre for Adverse Reactions Monitoring (CARM) in Dunedin is contracted by Medsafe to collect voluntary reports of adverse reactions to medicines, vaccines, herbal products, dietary supplements and blood products. The CARM database holds over 48,000 reports from around New Zealand, providing a local pattern of adverse reactions to medicines. These reports also contribute to international knowledge of pharmacovigilance. They are anonymised and pooled with other countries' reports in the World Health Organisation's International Monitoring Centre database in Uppsala, Sweden. Participating monitoring centres can use this database to complement their own reports.

Reports can help to identify NZ patterns and potential safety issues

A medical assessor evaluates each report received by CARM to determine whether there is an association between the adverse reaction and a medicine, and the strength of any association. CARM monitors its database for patterns, clusters and unusual events that could have significance for medicine safety and prescribing practices in New Zealand. The database is also used to support enquiries from health professionals regarding the possibility of adverse reactions as the cause of a diagnostic dilemma.

Ultimately patients benefit from improved safety

When a serious adverse reaction is reported, CARM enters a danger (where re-administration of the medicine is likely to be life threatening) or warning (where re-administration of the medicine is likely to cause a clinically significant reaction) against the patient's name in the National Health Index (NHI) database. Most hospitals access this database when patients seek health care.

The Medicines Adverse Reactions Committee (MARC) meets four times a year to review published material, all fatal reports and selected reports of significant, unusual or serious reactions reported to CARM. The MARC may recommend that Medsafe alert prescribers to an adverse reaction through an article in Prescriber Update or a 'Dear Doctor' letter. The MARC may also recommend that the pharmaceutical company update the data sheet with advice to improve the safe use of a medicine.

Anyone can report adverse reactions to CARM

Reports from health professionals are preferred, in particular from doctors and other prescribers, pharmacists and nurses. Interestingly, 65% of the reports CARM receives are from community doctors (mostly general practitioners) while hospital doctors contribute 17% of the reports. Pharmacists (community and hospital) submit 2.3% of the reports lodged with CARM. Pharmaceutical companies are another source of reports but unlike other countries where the majority of reports originate from industry, in New Zealand they contribute only a small proportion of the total reports CARM receives.

CARM accepts reports from consumers but where possible an attempt is made to involve the patient's practitioner who often may be unaware of the reaction.

CARM sends replies to reporters of adverse reactions. These written responses may include information about causality, similar reactions and prescribing advice to assist with risk:benefit assessment of future treatment for the patient involved.

New yellow reporting form, same information needed

In June 2001, the CARM adverse reaction reporting form changed back to a pale yellow colour. This was partly due to a trainee intern survey at Dunedin Hospital in April 2001 that showed one barrier to reporting was lack of access to the reporting forms. It is hoped that a return to yellow might help to make it easier to find. This new form was included in the June 2001 issue of Prescriber Update and is stapled in the centre of this issue too. Please also note that forms can be downloaded from both the CARM and Medsafe web sites (www.otago.ac.nz/carm/reporting.html or www.medsafe.govt.nz/safety/report-a-problem.asp), or obtained by phoning CARM on (03) 479 7185 or e-mailing to carmnz@otago.ac.nz

Reporting is as easy as 1, 2, 3

Please follow these steps for recording details of adverse events on the reporting form, and then forward it to CARM by post (Freepost 112002, CARM, PO Box 913, Dunedin).

Step 1: The patient

Patient details (name, address, date of birth, sex and ethnicity) are needed in case a danger or warning needs to be entered in the NHI database, as explained above. The patient details are held at CARM and remain totally confidential. They also help to identify duplicates if a report has already been received from another source. Please provide the NHI number, if known.

Step 2: The medicine(s) including OTC and alternative health products

The name of the medicine (and brand name if available) suspected of causing the reaction and dose is necessary. Ideally list all medicines including OTC and herbal or alternative remedies, and asterisk the suspected medicine if known. Also provide dates of starting and stopping the medicines as this information is particularly helpful when assessing causality.

Step 3: The event

It is important to provide the date of onset of the adverse reaction as this is crucial for causality assessment. The more details, the better; list symptoms, signs, laboratory results, past medical history. Also describe what happened later: did the person fully recover after withdrawal of the medicine (dechallenge), did they have a similar reaction if the medicine was used again (rechallenge), and was the event severe or fatal? Give any alternative diagnoses that have been excluded. More evidence will provide the CARM medical assessor with more certainty when deciding whether the medicine caused the adverse reaction.

If in doubt, report!

Please do not hesitate to report any suspected reaction of clinical concern, even if you are unable to supply all the details outlined above. A copy of the patient's discharge letter from the hospital or specialist is always helpful. It is particularly important to report reactions that are serious, unexpected or of clinical concern, or involve new medicines or interactions.

MARC has a list of medicines with adverse reactions of current concern. Health professionals are additionally encouraged to report these reactions to CARM for causality assessment before review by MARC. This list of Adverse Reactions of Current Concern can be found in each issue of Prescriber Update and on the Medsafe web site (www.medsafe.govt.nz/Profs/M2MedicinesMonitoring.asp).

IMMP events too

Any adverse events in patients taking medicines on the Intensive Medicines Monitoring Programme (IMMP) can also be reported on the CARM reporting form.  A list of the IMMP medicines can be found in Prescriber Update, on the CARM and Medsafe websites, and in the New Ethicals Catalogue (on page 8).