Reporting Adverse Events and Harm
Accessing health care – seeing your doctor, having treatment, going to hospital – is supposed to make you healthier, repair and heal injuries, and cure or help you manage diseases and conditions you may contract or develop over your lifetime.
As part of the treatment you might receive from your GP and other health practitioners, you might be prescribed drugs and medicines, and undergo procedures and have medical devices implanted in your body. All medicines, procedures and devices carry risks and while for many or most people these things improve your health and/or quality of life, all of them can cause adverse events, side-effects and reactions that range from making you sick, causing you discomfort and pain to in some cases causing death.
It is important to understand the risks and side-effects of treatment recommended by your doctor before you consent to that treatment, and it is equally as important that if you suffer an adverse event, side-effects or reactions that you report it to your doctor, and get treatment for it if necessary. You can also report these adverse events yourself.
In New Zealand, there are two agencies for reporting adverse events:
Medsafe for the reporting of adverse events and quality issues associated with medical devices (for example, surgical mesh, breast implants, hip replacements, pacemakers, etc.)
The Centre for Adverse Reaction Monitoring (CARM) for the reporting of reactions to and adverse events caused by medicines, including vaccines.
In the first instance you should report an adverse event to your doctor or other health professional and get advice and additional care if need be. Ask your doctor to lodge an adverse event report with the appropriate agency. If you doctor refuses to lodge an adverse event report, or even if they do, all consumers/patients have the right to lodge a report themselves.
As part of the treatment you might receive from your GP and other health practitioners, you might be prescribed drugs and medicines, and undergo procedures and have medical devices implanted in your body. All medicines, procedures and devices carry risks and while for many or most people these things improve your health and/or quality of life, all of them can cause adverse events, side-effects and reactions that range from making you sick, causing you discomfort and pain to in some cases causing death.
It is important to understand the risks and side-effects of treatment recommended by your doctor before you consent to that treatment, and it is equally as important that if you suffer an adverse event, side-effects or reactions that you report it to your doctor, and get treatment for it if necessary. You can also report these adverse events yourself.
In New Zealand, there are two agencies for reporting adverse events:
Medsafe for the reporting of adverse events and quality issues associated with medical devices (for example, surgical mesh, breast implants, hip replacements, pacemakers, etc.)
The Centre for Adverse Reaction Monitoring (CARM) for the reporting of reactions to and adverse events caused by medicines, including vaccines.
In the first instance you should report an adverse event to your doctor or other health professional and get advice and additional care if need be. Ask your doctor to lodge an adverse event report with the appropriate agency. If you doctor refuses to lodge an adverse event report, or even if they do, all consumers/patients have the right to lodge a report themselves.
How to lodge a report to Medsafe
It is really important that your medical device injury is reported to Medsafe. This process is easy and Medsafe can help you with this:
“Anyone can report an issue associated with a medical device. An issue may relate to an adverse event, or a quality issue. Patients, caregivers, healthcare professionals and suppliers are all encouraged to lodge an adverse event report if an incident has occurred and there is a concern about the safety of the device or its use”.
All the information you need for reporting a medical device adverse event, definitions and a link to the form itself is available on this Medsafe webpage.Fill in as much of this form as you can and don’t worry if you don’t know everything. If you give permission at the end of the form, Medsafe will be able to contact the healthcare provider to request the additional information.
If you need assistance to complete this report please contact + 64 4 819 6800 to speak to a Medical Device Advisor.
How to Report a Problem to Medsafe
Consumer Form for Reporting an Adverse Event
How to lodge a report to CARM
CARM says that any suspected adverse reactions to any medicine, vaccine or complementary medicine should be reported. This should include those that are self-medicated as well as those prescribed.
An adverse reaction should be reported even if it is not certain that the drug has caused it, or if the reaction is well recognised, or if other drugs have been given at the same time. Even if you only thought it could be an adverse reaction, report it – if in you are in doubt, report!
You can find more information on what to report, who can report, what information to include in the report, and links to reporting forms on the CARM website.
Adverse reactions and harm associated with the Covid-19 vaccine can also be reported through CARM and there is a link on their website to a special Covid-19 vaccine adverse reaction form to do this.
Adverse events are a major cause of illness and death globally
In their page on Patient Safety, the World Health Organisation says:
- The occurrence of adverse events due to unsafe care is likely one of the 10 leading causes of death and disability in the world.
- In high-income countries, it is estimated that one in every 10 patients is harmed while receiving hospital care. The harm can be caused by a range of adverse events, with nearly 50% of them being preventable.
- Each year, 134 million adverse events occur in hospitals in low- and middle-income countries (LMICs), due to unsafe care, resulting in 2.6 million deaths.
- Another study has estimated that around two-thirds of all adverse events resulting from unsafe care, and the years lost to disability and death (known as disability adjusted life years, or DALYs) occur in LMICs.
- Globally, as many as 4 in 10 patients are harmed in primary and outpatient health care. Up to 80% of harm is preventable. The most detrimental errors are related to diagnosis, prescription and the use of medicines.
- In OECD countries, 15% of total hospital activity and expenditure is a direct result of adverse events.
- Investments in reducing patient harm can lead to significant financial savings, and more importantly better patient outcomes. An example of prevention is engaging patients, if done well, it can reduce the burden of harm by up to 15%.
Patient Safety, as a discipline within health care, aims to prevent and reduce risks, errors and harm that occur to patients during provision of health care. It is vital that, in order to reduce harm to patients, health practitioners, researchers, regulators, and pharmaceutical and device manufacturers learn from errors and adverse events.
Passive Reporting Systems
In New Zealand we have what is called a passive reporting system; that is, there no absolute requirement for doctors and other health professionals to report adverse events or suspected adverse events, and reporting of adverse events, and reactions or side-effects is voluntary.
For example, on the Centre for Adverse Reaction Monitoring (CARM) website they say “Any suspected ADRs to any medicine, vaccine or complementary medicine should be reported… Healthcare professionals and coroners are asked to report all serious suspected reactions and other reactions of clinical concern to established medicines.”
“For newly introduced medicines and vaccines, or those being used for new indications or being delivered by a different route CARM asks that all suspected reactions (including minor reactions) are reported.”
However, globally under-reporting of adverse events in health care is a significant problem and a number of studies have concluded that less than 10% of detected adverse events are effectively reported to medicine regulatory authorities. In some studies it was found that many doctors either did not know that her was an adverse event reporting system or did not know how to make a report.
The Importance of Reporting
Reporting of adverse events, drug reactions and side-effects, and harm caused by medicines and medical devices leads to patterns of medical injury and harm being picked up more quickly, problems being investigated and rectified, or removal of dangerous medicines and devices from sale or warnings about their safety being issued, and improvements in patient safety.
If adverse events are not reported, they cannot be investigated and this may lead to significantly more people suffering harm as a result of the treatment they receive.