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- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Reporting Serious Problems to FDA
MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.
However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.
Voluntary Reporting by Consumers, Patients and Health Professionals
In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products. Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.
If the link to the PDF voluntary reporting form (below) does not automatically open the form in your browser, try installing the latest version of the free Adobe Acrobat Reader .
Related Information for Consumers
- If you need information or if you have questions or comments about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.
Guides to Reporting Problems to FDA
- MedWatch Learn - Teaching students, health professionals, and consumers how to report problems to FDA
- FDA 101: How to Use the Consumer Complaint System and MedWatch
- MedWatch Minute for Consumers
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Resources For You
- Where to Send Completed Form FDA 3500A MANDATORY Reporting Form
- Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers
- Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting
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Clinically important medical product safety alerts and timely information about the products you use, prescribe, or dispense every day.
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How to report a side effect
The reporting of side effects is normally carried out by healthcare professionals , and you are therefore recommended to speak with a healthcare professional, such as your doctor or pharmacist.
Patients are also able to report suspected side effects directly through various methods such as online patient reporting forms hosted by national medicines regulatory authorities or by telephone. Consult the appropriate authority from the list of national medicines regulatory authorities in the EEA for information on how to report a side effect.
If you are experiencing a side effect or think you may be experiencing one, you should seek advice from a healthcare professional . The European Medicines Agency cannot accept side-effect reports directly from patients or consumers. The Agency is also not in a position to provide individual medical advice or to confirm whether your symptoms are being caused by your medicine.
More information: Did you know? You can report side effects yourself
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Report a side effect
For industry information about COVID-19, visit our COVID-19 health product industry section.
Anyone can report a side effect to a health or cannabis product. Your report can help make these products safer for all Canadians.
Report the issue as soon as possible after the reaction or problem occurred. You should do this even if you are not sure if a particular health or cannabis product was the cause.
Every report counts. Together they tell a story. Report!
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Drugs More Info
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Veterinary drugs More Info
Drugs include pharmaceutical drugs, biologics and radiopharmaceutical drugs.
Pharmaceutical drugs include prescription drugs (require a medical prescription to be dispensed) and non-prescription drugs (obtained without a prescription).
Biologics (biotechnology products and blood products) are drugs that come from living organisms or from their cells. They are used to treat medical conditions such as diabetes and some forms of cancer.
Radiopharmaceuticals are pharmaceutical drugs that have been made radioactive for the purpose of diagnosing illness.
Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and pacemakers. They also include in vitro diagnostic devices, such as cancer screening tests, blood glucose monitors and pregnancy test kits. They are used to treat, diagnose or prevent a disease or abnormal physical condition.
Natural health products
Natural health products are naturally occurring substances. They are often made from plants, but can also be made from animals, micro-organisms and marine sources. They are used to prevent or treat an illness or condition, reduce a health risk or maintain good health. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.
Vaccines are products that produce immunity to a specific disease. Most vaccines are given by injection (needle) but some are given orally (by mouth) or nasally (sprayed into the nose). They protect people against serious and potentially deadly diseases, such as diphtheria, measles, polio and tetanus.
Cannabis refers to the plant Cannabis sativa, which is used for its effects on the mind. It is also used for medical, social or religious purposes. Marijuana is a slang term for the dried flowers, leaves, stems and seeds of the cannabis plant.
Veterinary drugs (prescription and non-prescription) are used to diagnose, treat or prevent diseases in pets and food-producing animals.
Veterinary health products (such as vitamins and minerals) are low risk drugs used to maintain or promote the health and welfare of pets and food-producing animals. They are not used to diagnose, treat or prevent diseases.
Why you should report
All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed in Canada. However, some adverse reactions or problems may become evident only after a product is in use by consumers.
Your report helps to indicate if there is an issue with a health or cannabis product (a signal). Each single case has to be looked at and considered as unique. However, more than 1 report is usually needed to generate a signal.
A signal is an initial indicator of an issue with the drug, health or cannabis product. However, it is not proof the drug, health, or cannabis product caused the adverse reaction or problem. We evaluate every signal to confirm or disprove a connection between the product and the reaction or problem.
Controlled substances can also cause potential risks to your health.
Reporting a suspected adverse reaction or medical device problem helps us:
- identify potential safety issues
- improve health product safety for all Canadians
- identify previously unrecognized, rare or serious adverse reactions or problems
- add to international data on the benefits, risks or effectiveness of drugs, health and cannabis products
- communicate changes in product safety information to industry, hospitals, health care providers and consumers
- undertake regulatory actions, such as changing the product label or removing a product from the Canadian market
We monitor all reports and take the appropriate steps to protect Canadians.
- Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report
- MedEffect Canada
- Advisories, warnings and recalls
- Adverse Reaction Database
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- Medical devices establishment licence listing
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- Serious adverse drug reactions and medical device incidents reported by Canadian hospitals
Reporting Adverse Drug Events
Mark H. Mayer, PharmD, MBA Principal Consultant in Global Scientific Policy Eli Lilly and Company, Indianapolis, Indiana Sherie A. Dowsett, PhD Consultant in Global Medical Communications Eli Lilly and Company Kalpana Brahmavar, PharmD Pharmacy Coordinator, St. Vincent Medical Center Northeast, Indianapolis, Indiana. At the time of this writing, Dr. Brahmavar was with Global Medical Information, Eli Lilly and Company
Kenneth Hornbuckle, DVM, PhD Senior Epidemiology Advisor Global Patient Safety, Eli Lilly and Company William P. Brookfield, MS, RPh Consultant in Global Patient Safety Eli Lilly and Company
US Pharm. 2010;35:HS-15-HS-19.
A decision by the FDA to approve a drug for market is based on a thorough review of that drug’s safety and efficacy to determine whether the benefits outweigh the risks associated with its use. While clinical trials help to establish the efficacy of a drug and to reveal common adverse events, there are limitations in identifying safety concerns in this setting. For example, study participants may not necessarily represent “real world” patients receiving the drug once it is on the market. Pharmacovigilance involves the continued monitoring of the safety profiles of products throughout their life cycles, and particularly once in the marketplace, through scientific data-gathering activities relating to the detection, assessment, and understanding of adverse events.
Adverse events are undesirable experiences associated with the use of a medical product. In the regulatory setting, adverse events are categorized as adverse drug events (ADEs) and, as a subset of ADEs, adverse drug reactions (ADRs) ( TABLE 1 ). 1
It is challenging to estimate the true incidence of ADEs in the general population, with uncertainty about the number of patients exposed to a given drug, poor documentation, and underreporting, as well as the effect of publicity around a particular drug on the reported frequency of an event. In 2008, the FDA received more than 530,000 reports of suspected ADEs, of which some 33,000 were submitted directly to the FDA; most were submitted by manufacturers. 2 That same year, there were 320,000 serious adverse events and nearly 50,000 deaths. 3 While reporting of ADEs is a vital component in ensuring drug safety postapproval, the FDA’s Adverse Event Reporting System is believed to capture only a small portion of ADEs that occur. 4
While adverse event reporting guidelines are frequently in place at both institutional and professional-society levels, health care professionals (HCPs) are currently not required by federal law or regulation to submit reports of ADEs on any medical product, due to the challenges of enforcing such a mandate. 5 Many ADEs are likely never reported because they are not recognized as safety concerns, perhaps because the HCP is unfamiliar with the reporting process and its importance. Moreover, incomplete fields or inaccuracies in the submitted data may limit the utility of the data.
Patients, HCPs, and the pharmaceutical industry all have an interest in enhancing drug safety by reporting suspected ADEs to the FDA. To encourage this, the FDA recently released a final rule entitled, “Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products,” requiring the following statement to be distributed with dispensed new and refill prescription drugs: “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.” 6 Moreover, the recent focus on safety concerns surrounding several widely used products has intensified the focus on the drug safety system, and timely and complete ADE reporting continues to be an integral component of this.
The aim of this article is to familiarize the reader with the process for ADE/ADR reporting for drugs currently in the U.S. marketplace. This will include discussion of how the ADE reports are handled by the FDA and the pharmaceutical industry, and the measures currently being used and those under development to monitor patient safety. While there are global ADE reporting requirements, this article will center on ADE reporting to the FDA. Also, for simplicity of reading, the term ADE is used throughout to encompass both ADEs and ADRs.
REPORTING OF ADVERSE EVENTS THROUGH MEDWATCH
MedWatch, established by the FDA in 1993, was designed to expedite and broaden voluntary reports of serious ADEs by HCPs and manufacturers. 7 The FDA requests that a serious ADE (i.e., the ADE is fatal, life-threatening, permanently/persistently/significantly disabling, requires initial or prolonged hospitalization, causes congenital anomaly, requires intervention to prevent permanent impairment or damage) be reported if there is suspicion that it is related to the use of one or more medications. 7,8 Reporting of a nonserious but unexpected ADE (i.e., not listed in the product information) could also be useful in uncovering previously unidentified adverse effects of drugs. Reports should be submitted even where the HCP completing the report is not certain the product caused the event.
TABLE 2 lists the key information needed when reporting an ADE. 9 The importance of completing some of the fields (e.g., description of the event) is obvious. However, the value of information on other fields is often not so apparent. Reporting the lot number, for example, can provide relevant information if there is suspicion of involvement of a counterfeit product, and help with patient follow-up. Including the name of the manufacturer will help identify whether the brand manufacturer’s or the generic company’s product has been administered, to assist with finding the source of ADEs that may be manufacturer specific. All manufacturers, whether a brand or generic company, have the responsibility to appropriately conduct follow-up on ADEs. Currently, however, brand manufacturers are receiving and subsequently reporting to the FDA some ADE reports for products actually dispensed as generic and thus originating from another manufacturer. From January 2004 to December 2007, for example, prescriptions of fluoxetine HCl from Eli Lilly and Company made up only 4.5% of the prescriptions in the U.S., yet Eli Lilly submitted almost 50% of the fluoxetine HCl ADE reports in the publicly available safety database published by the FDA during that time frame (data on file, Eli Lilly and Company). 10 Ensuring that each manufacturer appropriately manages ADE reports specific to their own drug is only likely to become more challenging as the number of available generics in the marketplace increases.
While reports should be filed even when all the details are not available, an HCP reporting an ADE should gather as much information as possible when preparing to submit the report so that the FDA and the drug manufacturer have the information required to assess safety and to draw appropriate conclusions.
Channels for Reporting ADEs
ADEs can be reported directly by the HCP or consumer to the FDA using MedWatch, or they can be reported to the manufacturer who in turn reports them to the FDA ( FIGURE 1 ).
Reporting Directly to the FDA: There are three options for submitting a voluntary report: 1) Complete Form 3500 online at www.accessdata.fda.gov/scripts/medwatch; 2) call 1-800-FDA-1088 to report by telephone; and 3) download a copy of Form 3500 at www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf and either fax it to 1-800-FDA-0178 or mail it back (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) back using the postage-paid addressed form. This may be most appropriate where there are attachments to submit with the report.
Reporting to the FDA Via the Manufacturer: The majority of ADEs are reported to the drug manufacturer, whose contact information can be found at the relevant manufacturer Web sites. The manufacturer collects all pertinent information from the reporter and is required to send this information to the FDA. Serious and unexpected ADEs are expedited by the manufacturer to the FDA within 15 days of the manufacturer’s receipt of the ADE. All ADEs are also periodically reported by the manufacturer to regulatory agencies through periodic safety reports. These reports contain summaries of all ADE reports in a designated time period and include patient exposure (both postmarketing and clinical trial), presentation of case summaries, study findings, and overall safety evaluation.
WHAT HAPPENS TO ADE REPORTS AT FDA?
At the FDA, ADE reports, including manufacturers’ expedited reports of serious adverse events as well as the manufacturers’ other reports provided within periodic safety updates, are captured in a postmarketing surveillance database, the Adverse Event Reporting System (AERS) ( FIGURE 1 ). The AERS is a computerized database of adverse event reports, containing more than 4 million ADE records. 11 Not all ADE reports are entered into the database. 11 The FDA screens and assesses all ADE reports received, and prioritizes those entered based upon the associated safety and public health concern.
At the FDA, each ADE case report is evaluated for the adequacy of the information, the temporal association of the product and the event, potentially confounding factors such as patient comorbidities or concomitant drug therapy, and dechallenge-rechallenge information. This helps determine whether the ADE may be related to the use of the drug and whether there may be a safety signal. A safety signal can be defined as a co n cern about an excess of adverse events compared to what would be predicted to be a s sociated with a product’s use . 12 Safety signals may include new adverse events (particularly if serious) that were not seen in clinical trials and thus were not captured on the product label; an apparent increase in the severity of an event seen in clinical trials; occurrence of serious events thought to be extremely rare in the general population; new product-product, product-device, product-food, or product-dietary supplement interactions; identification of a previously unrecognized at-risk population (e.g., populations with specific racial or genetic predispositions or comorbidities); or concerns arising from the way a product is used (e.g., adverse events seen at higher than labeled doses or in populations not recommended for treatment).
It is often not possible to tell from an individual ADE report if there is a causal relationship between the drug and the medical event, and the importance of including as detailed case information as possible when submitting an ADE cannot be overemphasized. In addition to reviewing individual cases, the FDA will use further information provided by the drug manufacturer.
Case reports are assessed at the aggregate level to create a case series to characterize the potential safety risk and to identify risk factors. Creating a case series commonly involves an analysis of the clinical and laboratory manifestations and course of the event; demographic characteristics of patients with events, exposure duration, time from initiation of product exposure to the adverse event; doses used (including labeled doses, greater than labeled doses, and overdoses); use of concomitant medications; the presence of comorbid conditions; and the lot numbers for products used in patients with events. Data mining — utilizing statistical methods to identify potential safety signals from data in the AERS database, as well the large manufacturers’ safety databases — will also help in identifying ADE reporting trends and in directing safety questions to the manufacturer. Other activities to help with risk identification and assessment include the conduct of further trials and observational studies by the manufacturer to assess the risk attributed to drug exposure; creation of registries to collect information from multiple sources (e.g., physician records, hospital summaries, pathology reports); and the conduct of patient and HCP surveys.
OUTCOMES OF ADE REPORTING
If, on completion of review of all available clinical data, the safety signal or signals are confirmed, further steps and actions may be necessary in the interest of patient safety ( TABLE 3 ). Even before these definitive steps are taken, the FDA may at times communicate risk information about the drug safety issues that are under review to the HCP as well as to the general public. This occurs as a result of an early safety signal that suggests an association between the drug and the ADE being evaluated. These actions are designed to assist with decision making around use of these drugs, to prompt discussions between HCP and patient, and to stimulate additional adverse event reporting. Early risk information is communicated through various outlets (i.e., public health advisories, HCP sheets, indexes to drug-specific information, drug safety podcasts, drug safety newsletters, consumer information Web sites), available at the MedWatch and Center for Drug Evaluation and Research (CDER) Web sites of the FDA. An HCP can also sign up to receive safety alerts and information on safety-related label changes by e-mail. If, on clinical data review, a safety signal is not confirmed, the manufacturer and the FDA will continue to monitor relevant safety information.
THE FUTURE OF DRUG SURVEILLANCE
In this article, we have discussed the critical role of ADE reporting in the drug postmarketing safety system. While the resulting AERS data may provide the initial signal of a safety concern that can then be further investigated, there are certain limitations to data in the current system. For example, there is no information on the number of users of a specific drug that can be used to calculate the proportion of patients experiencing an event; there is often inadequate case documentation in the reports; and there is substantial underreporting of ADEs. 13
Due to these limitations, the FDA, drug manufacturers, and others (academics, HCPs, professional associations, patient advocacy groups, computer/software companies, managed care organizations, and think tanks) are working together to advance and improve the current system, develop methods for integration of ADE reports with other postmarket safety approaches, and to improve information sharing. In this regard, e-prescriptions, e-health care records, integrated electronic claims, patient information databases, and broad electronic communication targeted to the appropriate health care professionals and patients hold much promise.
While some of these advances may be years away, in a recent draft Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan, the FDA proposes to use the new user fees (fees collected from drug manufacturers to fund the drug review process) to add resources to monitor drug safety of marketed drugs. 14 Steps proposed include the adoption of new tools and the improvement of existing tools. Further, under the recently passed FDA Amendments Act of 2007, the FDA will be establishing a postmarket risk identification and analysis system utilizing federal and private sector health-related electronic data. 15 Progress to implement the postmarket risk identification system has already occurred. On May 22, 2008, the FDA launched the Sentinel Initiative with the goal of creating and implementing the Sentinel System, an integrated, electronic system for monitoring medical product safety, which will enable the agency to examine existing data sources from the private and public sector, such as electronic health record systems and medical claims databases, for information about medical products. Such a system could improve the FDA’s ability to monitor the performance of a product throughout its life cycle and facilitate data mining and other safety research-related activities.
In the future, HCPs will likely be able to access a patient’s electronic health care record on a wireless computer chart, submit an adverse event report, receive comprehensive information based on the patient’s medical history to communicate immediately to the patient, and order an alternative product all within a matter of seconds. Until then, it is important that the health care community optimize the current tools within the drug safety system, which include timely, complete, and accurate reporting of ADEs. The most updated information on the MedWatch program and ADE reporting can be found by visiting the FDA’s Web site.
As a result of recent safety concerns surrounding widely used drugs, there is an increasing focus on drug safety. Timely, complete, and accurate ADE reporting is an essential component of monitoring, and subsequently improving, patient safety.
The authors gratefully acknowledge Patrick DeLisle for his assistance.
1. Nebeker JR, Barach P, Samore MH. Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. Ann Intern Med. 2004;140:795-801. 2. US Food and Drug Administration. Reports received and reports entered into AERS by year as of December 31, 2008. www.fda.gov/cder/aers/statistics/aers_received.htm. Accessed April 17, 2009. 3. US Food and Drug Administration. AERS patient outcomes by year as of December 31, 2008. www.fda.gov/cder/aers/statistics/aers_patient_outcome.htm. Accessed March 31, 2009. 4. Drazen JM, Rainey J, Begg H, Butler AS, Rapporteurs. Forum on Drug Discovery, Development and Translation. In: Adverse Drug Event Reporting: The Role of Consumers and Health-Care Professionals. Washington, DC: National Academies Press; 2007:27. 5. Baciu A, Stratton K, Burke SP, eds. Committee on the Assessment of the US Drug Safety System. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academies Press; 2006:chap4:5. 6. US Food and Drug Administration, HHS. Final Rule: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products. Federal Register: October 28, 2008 (vol. 73, Number 209):63886-63897. 7. US Food and Drug Administration. MedWatch Web site. www.fda.gov/medwatch. Accessed March 31, 2009. 8. US Food and Drug Administration. What is a serious adverse event? www.fda.gov/medwatch/report/DESK/advevnt.htm. Accessed March 31, 2009. 9. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, FDA 2005. 10. IMS Health. National Prescription Audit (NPA). Plymouth Meeting, PA. 11. US Food and Drug Administration. www.fda.gov/cder/aers/statistics/default.htm. Accessed March 31, 2009. 12. US Food and Drug Administration. Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. March 2005. 13. Committee on the Assessment of the U.S. Drug Safety System, Baciu A, Stratton K, Burke SP, eds. The Future of Drug Safety: Promoting and Protecting the Health of the Public . Washington, DC: National Academies Press; 2006:chap2:20. 14. The FDA Draft PDUFA IV Drug Safety Five-Year Plan, March 2008. www.fda.gov/cder/pdufa/fedreg.htm. Accessed March 31, 2009. 15. The US Food and Drug Administration Amendments Act of 2007 (FDAAA), Pub L No. 110-85.
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- v.19(9); 2015 Sep
System of adverse drug reactions reporting: What, where, how, and whom to report?
National Coordination Centre-Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, India
Prabhakar mishra, gyanendra nath singh.
The continuous progress in medical and pharmaceutical sciences has made the availability of pharmaceutical products in the Indian market to prevent and control of several disease conditions. Irrespective of the benefits associated with the use of medicines adverse effects associated with them has emerged the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. World Health Organization (WHO) defined ADR as “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”[ 1 ]
To improve public health, the safe use of medicine must be monitored through an effective pharmacovigilance (PV) system. PV is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects, or any other possible drug-related problems.[ 2 ]
Indian Pharmacopoeia Commission (IPC), Ghaziabad is functioning as a National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI). One Hundred and fifty ADR monitoring centres (AMCs) were established in various medical institutions/hospitals across India to monitor and collect ADR reports under NCC-PvPI.[ 3 ]
What to Report
PvPI encourages all types of suspected ADRs reporting whether they are known, unknown, serious, or nonserious, frequent, or rare regardless of an established causal relationship between a drug and the reaction. ADRs related with the use of allopathic medicines, vaccines, traditional medicines, medical devices, contrast media, etc., can be reported.
Where to Report
All healthcare professionals (clinicians, dentists, pharmacists, nurses) and patient/consumers can report ADRs to NCC or AMCs. The pharmaceutical companies can also send individual case safety reports for their product to NCC.
How to Report
Suspected ADR reporting forms [ Figure 1 ] for healthcare professionals and consumers are available on the website of IPC to report ADR. To remove language barrier in ADR reporting, the consumer reporting form [ Figure 2 ] are made available in 10 vernacular languages (Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and Malayalam). ADRs can be also reported via PvPI helpline number (18001803024) on weekdays from 9:00 am to 5:30 pm.[ 3 ] The mobile Android application for ADR reporting has also been made available to the public.
Suspected adverse drug reaction reporting form
Medicines side effect reporting form (for consumers)
Whom to Report
A reporter can send filled ADR reporting form directly to NCC or their nearest AMC. In case of AMC, these reports are confirmed by healthcare professionals and entered into Vigiflow and sent to NCC for further assessment.[ 4 ] These reports are then finally reviewed at NCC and committed to WHO-Uppsala Monitoring Centre. The obtained information is entered in the drug safety database, analyzed, and assessed by the experts to identify new signals.[ 5 ]
The submitted ADR report does not have any legal implication on the reporters. The patients’ identity are held in strict confidence and protected to the fullest extent.
Therefore, healthcare providers are encouraged to report ADRs for better understanding of the risk associated with the use of medicines and to safeguard the health of Indian population.
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Conflicts of interest.
There are no conflicts of interest.
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Most of us will not experience any problems when using medicines. However, all medicines have some risks associated with their use and so a small number of people may experience side effects (also known as adverse reactions).
If you are concerned that you have had a suspected adverse reaction to a medicine, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to the HPRA on your behalf.
If you wish to directly report an adverse reaction, you can use our online reporting service . Anyone can report issues relating to the safety of medicines to the HPRA. This includes patients, carers, other members of the public and healthcare professionals.
How do I report an adverse reaction?
Covid-19 vaccines: reporting suspected side effects .
To report a suspected adverse reaction (side effect) to a COVID-19 vaccine, please visit our Report an Issue webpage. For more information, please visit COVID-19 vaccines and treatments: Reporting a side effect .
- To your doctor, pharmacist or nurse who can then notify the HPRA.
- By using our online form .
- By downloading a copy of our adverse reaction report form ( Word version ). You can e-mail completed forms to [email protected]
- By printing our adverse reaction report form ( Word version ) and posting a completed copy to the HPRA by freepost.
- By calling us on (01) 676 4971.
We have published a medicines and side effects consumer information page. This page provides more information about side effects and why it is important that they are reported to the HPRA.
See also: Patient Reporting of Side Effects Healthcare Professionals and Pharmacovigilance
Access to information from adverse reaction (i.e. side effect) reports
Adverse reaction reports received by the HPRA are processed and entered into the national database. These reports (with personal details excluded) are subsequently sent to EudraVigilance, the European Medicines Agency’s (EMA’s) database of suspected adverse reactions, where the data are analysed to detect new safety signals. Anonymised data from individual adverse reaction reports submitted to the EMA are publically accessible for review at www.adrreports.eu .
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Home ► Safety ► Adverse Reaction Reporting
Revised: 7 November 2019
Adverse Reaction Reporting
The information and links below explain how you can make medicine safer by reporting suspected side effects.
What is an adverse reaction?
Medical Device Adverse Event Reporting
Information on reporting an adverse event or a quality issue associated with a medical device.
How to Report a Problem
How to report a suspected adverse reaction or side effect.
View information on medicine adverse events reported in New Zealand.
Training on reporting suspected adverse reactions to medicines for healthcare professionals
Adverse Reaction Reporting Awareness Week
Medicines regulators around the globe join forces to encourage reporting side effects to medicines.
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Reporting adverse events
Everyone can play an important role in monitoring the safety of therapeutic goods in Australia
If you think you may be experiencing a side effect after using a medicine or vaccine or a problem involving the use of a medical device, seek advice from a health professional as soon as possible.
Overview of adverse events
Adverse events are unintended and sometimes harmful occurrences associated with the use of a medicine, vaccine or medical device (collectively known as therapeutic goods). Adverse events include side effects to medicines and vaccines, and problems or incidents involving medical devices.
Examples of adverse events are any unfavourable and unintended sign, symptom or disease associated with the use of a therapeutic good. An abnormal laboratory finding could be one example of an unfavourable and intended sign.
In the case of medical devices, an adverse event can also be a problem or incident that has caused, or could cause, harm to patients, caregivers, health professionals or others. These can include 'near misses' – events that might have led to a death or serious injury. It may be that timely intervention from a health professional prevented an adverse event.
Importantly, an adverse event is not always caused by the therapeutic good itself. An adverse event could be a result of incorrect user interaction or other circumstances such as two properly functioning devices that do not operate as intended when used in combination. The occurrence of an adverse event does not necessarily mean that there is something wrong with the therapeutic good.
Everyone can play an important role in monitoring the safety of therapeutic goods in Australia by reporting suspected adverse events to the TGA .
Frequently asked questions
Why report adverse events to the TGA?
When a therapeutic good is first registered and made available in Australia, information about its safety and effectiveness is usually only available from clinical trials.
Clinical trials provide information about many of the possible adverse events associated with a therapeutic good, but do not detect all possible adverse events because they:
- usually do not continue for long enough to detect adverse events that take a long time to develop
- do not include enough patients to detect adverse events that occur rarely
- do not include all of the different types of people who might eventually use the product and who might be more susceptible to some adverse events, such as older people, children, pregnant women or people with other medical conditions.
The TGA, like other regulatory agencies around the world, monitors the safety of therapeutic goods to contribute to a better understanding of their possible adverse events when they are used outside the controlled conditions of clinical trials.
Reports by consumers and health professionals provide important information for the TGA's safety monitoring program.
Who can report an adverse event?
Information about the number of adverse event reports received each year by the TGA can be found at Adverse events: Australian statistics on medicines and Adverse events: Australian statistics on medical devices .
Most adverse event reports are made by sponsors (e.g. pharmaceutical companies and medical device suppliers), but many are also made by state and territory health departments, hospitals, health professionals and consumers.
If you have any concerns about an adverse event it is important to also speak to a health professional.
Reporting medicine or vaccine adverse events
Consumers: report a side effect of a medicine or vaccine using the online form.
- report an adverse event of a medicine or vaccine
- report via email, fax or mail using the National Adverse Events Following Immunisation (AEFI) reporting form
All medicines and vaccines can cause side effects or other adverse events.
- prescription medicines
- over-the-counter medicines that are purchased without a prescription
- herbal medicines
- naturopathic or homeopathic preparations
- nutritional supplements, like vitamins and minerals.
For further information on the features and functionality of the online adverse event reporting forms, users should refer to the Adverse Event Management System (AEMS) Guidance for
- Health Professionals , and
Reporting medical device adverse events
Medical device consumers: report problems or incidents through the consumer online Medical Device Incident Report form .
Health professionals: report problems or incidents online through the health professional online Medical Device Incident Report form .
Sponsors and manufacturers: report using the TGA's online reporting system .
The TGA's medical device Incident Reporting and Investigation Scheme (IRIS) is responsible for the management of all reports of adverse events or problems associated with medical devices.
Medical devices range from a bandage that you would put on a scratch to high risk products such as pacemakers that are implanted in your body. Other examples of medical devices include:
- artificial hips
- blood pressure monitors
- breast implants
- lubricating eyedrops
- MRI scanners
- orthodontics, such as braces and fillings
- tongue depressors.
Typical problems with medical devices include:
- deficiencies in labelling, instructions or packaging
- defective components
- performance failures
- poor construction or design.
Which events should I report?
You don't need to be certain, just suspicious!
Every report counts. While an individual report may not be enough to determine whether a particular therapeutic good caused an adverse event. All reports help to build a picture of the safety profile of a product and assist with the TGA's safety monitoring program.
The work of the TGA is based on applying scientific and clinical expertise to decision making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines, medical devices and other therapeutic goods.
The TGA particularly needs to know:
- all suspected adverse events to new therapeutic goods
- all suspected medicine and/or vaccine interactions
- unexpected adverse events (that is, adverse events that do not appear in the Product Information , Consumer Medicine Information and/or product labelling)
- danger to life
- admission to hospital
- prolongation of hospitalisation
- absence from productive activity
- increased investigational or treatment costs
- birth defects.
What information do I need to report?
Reporters are encouraged to provide as much detail as possible, but at bare minimum are asked to provide:
- contact details for the reporter (name, address, phone number)
- patient identifier (such as initials, date of birth or age, but not their full name)
- details of the product involved
- details of the suspected adverse event.
By providing all information relevant to a specific adverse event, you can help TGA staff to assess the possible role of the product in causing the adverse event.
The TGA asks for contact details from people making reports so that it can seek further information about suspected adverse events - we cannot accept anonymous reports.
Providing as much information as possible will reduce the need for the TGA to follow up. However, it is important not to delay reporting an adverse event if some information is not available. If we need more information, we will contact you.
Any information identifying the reporter or patient is kept confidential. See the 'Privacy information' section below for further information.
What happens to reports
Medicine and vaccine adverse event reports that the TGA receives are entered into the TGA Adverse Event Management System (AEMS) . Medical device incident reports are recorded in the Incident Reporting and Investigation Scheme (IRIS) database.
Information recorded in the database includes the adverse event, the therapeutic good involved, and other relevant information, such as relevant medical history, laboratory results and how the adverse event was treated.
Serious reports are usually entered into the AEMS within two working days and a letter of acknowledgement is sent to the reporter. Each report is given a unique ID number. If you need to add more information about the case you can use the ID number to have it added to your existing report.
All adverse events are risk assessed and entered into the appropriate database for future reference. The information is used by TGA staff to help identify safety signals. A safety signal is a 'flag' for a possible safety concern. When the TGA identifies a signal, it undertakes a detailed evaluation to establish the possible role of the therapeutic good in causing the adverse event.
After a report has been entered into the AEMS (14 days) or IRIS database (3 months), information is transferred to the publicly accessible and searchable Database of Adverse Event Notifications . This time lag enables TGA staff to check and analyse the information in the report.
What can the TGA do in response to a safety concern
If the TGA identifies a safety concern relating to a therapeutic good, it can take regulatory action to ensure that the product continues to have acceptable safety, efficacy/performance and quality for its intended use. The TGA also seeks to ensure that health professionals and the public are aware of the safety concern and any changes to the availability and recommended use of the product.
Actions the TGA can take in response to a safety concern include:
- informing health professionals and consumers through alerts and articles in publications such as Medicines Safety Update and Medical Devices Safety Update (see the 'Publications' page for further information)
- requiring changes to product labelling, or adding warnings, precautions and adverse event information to the Product Information and Consumer Medicine Information
- cancelling the registration of the product, or limiting the population in which it can be used
- requiring the sponsor to undertake post-marketing studies to investigate the safety concern if more information is needed before a judgment can be made about the need for further action.
For safety-related publications, see the ' Safety of medicines and medical devices ' section of the TGA's publications page.
Reporting adverse events using General Practitioner software
Medical practices using the Best Practice or Medical Director software can download and install templates to their software to create Adverse Drug Reaction (ADR) reports. Completed reports can be emailed, faxed or posted to the TGA.
Note: the RTF documents below should not be opened using Word or they may become corrupted. Please read the 'How to install the ADR template' guidance before opening and downloading the template documents.
How to save a document to your own computer
- Best Practice: How to install the ADR template
- Best Practice: How to use the ADR template
- Best Practice: Adverse Drug Reaction report template (rtf,116kb)
- Medical Director: How to install the ADR template
- Medical Director: How to use the ADR template
- Medical Director: Adverse Drug Reaction Report template (rtf,542kb)
The TGA collects a variety of personal information in the course of performing its functions.
Information about how the TGA handles personal information under the Privacy Act 1988 can be found on the Privacy web page.
Medical Director Adverse Drug Reaction Report template [application/rtf, 541.88 KB]
Best Practice Adverse Drug Reaction report template [application/rtf, 116.02 KB]
- Biological medicines
- Over the counter (OTC) medicines
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Patient self reporting of adverse drug reactions
Patients who suspect they have suffered an unwanted side effect (an adverse drug reaction) to their medicines can report this, as can their carers or parents. The easiest way to report is electronically. You can submit reports:
- Online at www.mhra.gov.uk/yellowcard .
- By downloading the Yellow Card app from the Apple App Store or Google Play Store . The Yellow Card app includes the ability to receive updates on medicines of interest to you, and numbers of Yellow Cards reported to the MHRA.
- By downloading a paper reporting form . Paper forms may also be available from NHS outlets such as GP surgeries and community pharmacies,
- By telephone , by calling 0800 731 6789 for free, Monday to Friday between 10am and 2pm. You can leave a message outside these hours and a member of the MHRA team will get back to you.
For more information visit the MHRA website .
The Yellow Card Scheme is not able to give you medical advice . If you have concerns about your health or symptoms please discuss it with your doctor, nurse or pharmacist, or contact NHS 111:
- Visit 111.nhs.uk
- Call 111 from any phone. Ask for an interpreter if you need one
- Textphone: 18001 111
- Use the NHS 111 British Sign Language service for your country. For full details visit https://www.nhs.uk/nhs-services/urgent-and-emergency-care-services/when-to-use-111/ .