Quality and Safety of Medicines
Medicines Safety Monitoring
How does Medsafe monitor medicine safety?
Medsafe uses a variety of methods to collect information on the safety and quality of medicines and vaccines after they have been approved. These activities are known as pharmacovigilance.
What is pharmacovigilance?
Before a medicine is marketed any experience of its safety and efficacy is limited to its use in clinical trials. However clinical trials do not always reflect the actual use of a medicine or vaccine in real life. For example, a medicine may only have been tested in a relatively small number of people for a limited length of time.
Although Medsafe may receive extensive information from clinical trials for a specific medicine, some adverse reactions are rare and may not be seen until a very large number of people have received the medicine. For this reason, it is very important to monitor all medicines after they have been approved.
Pharmacovigilance involves:
- Monitoring the use of medicines in everyday practice to identify previously unrecognised adverse effects or changes in the patterns of adverse effects.
- Assessing the risks and benefits of medicines to determine if action is required to improve their safe use.
- Providing information to healthcare professionals and consumers to promote safe use of medicines.
- Monitoring the impact of any action taken and assessing whether further action is required.
Information from many sources is used for pharmacovigilance, including:
- Clinical and observational studies.
- Published medical literature.
- Pharmaceutical companies.
- Other regulatory authorities such as the FDA (America), EMA (Europe) and TGA (Australia).
- Spontaneous adverse reaction reports submitted to the Centre for adverse reactions monitoring (CARM).
The main aim of pharmacovigilance is to identity medicine safety signals.
What are spontaneous adverse reaction reports?
Spontaneous adverse reaction reports are case reports of suspected adverse reactions that people have experienced while taking a medicine. The Ministry of Health (through Medsafe) contracts the collection of this information to the New Zealand Pharmacovigilance Centre at the University of Otago in Dunedin.
Healthcare professionals and consumers are encouraged to report any suspected adverse reaction to a medicine or vaccine to CARM (part of the New Zealand Pharmacovigilance Centre).
Pharmaceutical companies also submit adverse reaction reports associated with the use of their products to CARM in Dunedin.
For more information on CARM and how to report an adverse reaction see: http://www.otago.ac.nz/carm
What is an adverse reaction?
Adverse reactions are undesirable effects to medicines or vaccines.
Whilst some reactions may occur when a medicine is used at higher than recommended doses, adverse reactions may also occur when normal doses are used.
Reactions may be evident within minutes or years after exposure to the medicine and may range from minor reactions like a skin rash to serious and life-threatening events such as a heart attack or liver damage.
What are the advantages and the limitations of spontaneous adverse reaction reports?
These reports have been shown to be a very quick and effective way of finding potential or possible safety signals with medicines. They can be used to monitor the safety of medicines in real life use over the lifetime of the medicine and for all types of people.
The limitations of using spontaneous reports include under-reporting (i.e. some cases may not be reported), a lack of reliable information on the number of people taking the medicine, and incomplete information on diagnosis and history of the patient. Spontaneous reports are also not very effective at detecting adverse reactions that occur a long time after starting the medicine. For this reason spontaneous reports are only used to detect safety signals and are not used to investigate or confirm them. Information obtained from spontaneous reports need to be interpreted with caution.
What is a safety signal?
A safety signal is an indication that there may be a safety problem related to a medicine. This could be a previously unknown adverse reaction or a change in the frequency or severity of a known side effect.
What does Medsafe do with this information?
Medsafe analyses adverse reactions reports in conjunction with other information to determine if the safety signal is real. Medsafe seeks the advice of independent experts, via the Medicines Adverse Reactions Committee or may also form working groups of experts to provide advice. Medsafe also works closely with other regulatory authorities from around the world.
Medsafe undertakes a risk-benefit assessment on safety signals to assess if action is required. Further information on risk-benefit assessment is provided in the Medsafe Evaluation and Approval Process page
The majority of safety signals are not supported by any additional information and no action is taken although Medsafe may continue to closely monitor the issue.
A small number of possible safety signals are confirmed to be real. In these cases Medsafe takes appropriate action to ensure the safety of these medicines is improved.
What action can Medsafe take if a safety concern is confirmed?
- Provide information directly to healthcare professionals and consumers on medicine safety related issues.
- Require changes to warnings in the product information or on the product label.
- Restrict the conditions that the medicine can be used for.
- Recommend that the legal status of a medicine is changed, for example change from over-the-counter to prescription only.
- Ask the pharmaceutical company to commission a clinical study to investigate a particular safety concern.
- In rare circumstances Medsafe can recommend removal of the medicine from the market.
Communication with healthcare professionals and patients
Communication with health care professionals and consumers is one of the best ways to provide information about about adverse effects and the safe use of medicines.
Medsafe provides information by:
- Requiring pharmaceutical companies to update medicine data sheets and consumer medicine information (CMI).
- Sending letters to doctors or pharmacists by post or electronically to highlight urgent warnings about medicines.
- Publishing safety information in Medsafe's drug safety bulletin Prescriber Update. This bulletin is published four times a year and is designed to inform healthcare professionals of medicine related safety issues. If you are a healthcare professional and would like to receive a free copy, please subscribe using this link: Prescriber Update electronic subscription
- Publishing safety alerts, media releases and consumer recalls on the Medsafe website.
- Asking the pharmaceutical company to send letters to healthcare professionals.
Medsafe can also instruct other organisations to provide information to healthcare professionals or consumers eg pharmaceutical companies.
Neither Medsafe or CARM can say in individual cases that a medicine was the actual cause of a suspected adverse reaction. Any consumer who has concerns regarding medicines they are taking should discuss these with their GP.
Further information
Further information on the safety of vaccines, including spontaneous reporting profiles for vaccines, is available using the following link:
Further information on the safety of medicines, including reported safety profiles for medicines, is available using the following link.