Australia has a comprehensive system for regulating and monitoring medicines to ensure their safety. One component of the system is a process for collating and analysing information about adverse reactions to medicines.

Adverse reactions

All medicines can have undesirable and unintended  effects. These effects are known as side effects or adverse reactions. Most adverse reactions to ‘old’ medicines are well known because the medicines have been used for many years. However, our knowledge about adverse reactions to ‘new’ medicines is often incomplete.

In Australia, all prescription medicines must undergo a comprehensive evaluation of their safety and effectiveness before being marketed. The more common adverse reactions are usually detected during the clinical trials that form part of the evaluation process. However, uncommon  reactions may not show up during clinical trials, because the trials are not usually large enough  or long enough for every reaction to appear. In addition, clinical trials may not involve people who are taking medicines for other conditions, so some interactions may not show up during trials.

Adverse reactions can have marked effects on people’s health. Therefore, it is important that we have a system for collating and disseminating information about adverse reactions that appear when a medicine is in general use. In Australia, the responsibility for this task lies with a committee of medical experts known as ADRAC (Australian Adverse Drug Reactions Advisory Committee).

Reporting process

The reporting process usually starts with the GP, pharmacist or hospital managing the consumer thought to have experienced an adverse reaction. If they feel that the suspected reaction warrants reporting, they submit the details of the medicine and the reaction to ADRAC. About 10,000 suspected reactions are reported each year. Two thirds of the reports come from GPs and hospitals.

Every suspected adverse reaction report is reviewed by professional staff, who enter the details into the national database of adverse reactions. The database, which dates from 1972, contains the details of over 182,000 reports. The details are then analysed to see if the report may contain a medicine-related safety issue. If an issue is identified, the record is comprehensively  analysed to determine if the reported reaction is a real adverse reaction or not. ADRAC meets  eight times a year to discuss the reports received.

What happens to a report after the review process is complete depends on its importance and its safety implications. If the reaction is well known and not serious, nothing further may be done. If the report raises further questions or possible concerns, more information may be sought, or ADRAC may decide to wait and see if other similar reports are submitted.

If the adverse reaction is new and significant, steps may be taken to amend the official information about the medicine (known as the Product Information), change the medicine’s labelling, or inform doctors, pharmacists and consumers about the reaction and its implications. In the case of more serious reactions, restrictions may be imposed on the availability and use of the medicine. In some cases, it may even be taken off the Australian market. Fortunately, this needs to happen only rarely. 

Priority areas

The main reason for collecting and analysing reports of adverse drug reactions is to improve the safety of medicines by increasing the body of knowledge about adverse reactions and identifying potentially dangerous situations. Therefore, most of ADRAC’s efforts are directed towards reports likely to achieve those goals, rather than trying to document thoroughly every adverse reaction experienced. Reports of reactions to new medicines, serious reactions and interactions between medicines are strongly encouraged. Every issue of ADRAC’s regular bulletin includes the ‘Drugs of Current Interest’, which is a list of medicines of particular interest to ADRAC. Doctors and pharmacists are asked to report all suspected adverse reactions to medicines on the list. The information gathered about reactions and interactions strengthens and augments the body of knowledge about medicines.

Reporting your reactions

You can contribute to the process of adding to the body of knowledge about medicines by telling your doctor about any adverse reactions you think you may have experienced. The information may help your doctor better understand you and your situation, give them a better understanding of the medicine and its effects, and give them the opportunity to report the reaction to ADRAC. Reporting an adverse reaction also gives you and your doctor the opportunity to discuss the reaction and its implications. This may enable your doctor to alleviate the problem by changing the medicine, modifying the dose, or suggesting another solution. It may also give your doctor greater insight into your health problem, which may enable them to modify and improve your management.