ISMP-MERP
The ISMP Medication Errors Reporting Program [MERP] is operated by the Institute for Safe Medication Practices. It’s a confidential national voluntary reporting program that provides expert analysis of the causes of medication errors and offers recommendations for error prevention to regulatory agencies and manufacturers.
Without reporting, such events may go unrecognized. Errors include — but are not limited to — administering the wrong drug, strength, or dose of medications; confusing drugs with similar names or labels; misuse of medical equipment; and errors in prescribing, dispensing, and monitoring medications.
Consumers can submit reports and associated materials in confidence. With the patient’s permission, reports will be forwarded to the Food and Drug Administration, and the manufacturer to inform them about improper pharmaceutical labeling, packaging, and other issues that may cause errors. The reporter is never identified in case studies and ISMP always respects reporters’ wishes as to the level of detail included in publications.
Please do not submit any patient identifiable information within the form such as your name, social security number, or address when forwarding medication error reports to ISMP.
The electronic report form on their website is easy to complete. Once a patient completes and submits a report it will be housed in a secure database and ISMP nurse and pharmacist analysts will be notified within 24-48 hours of a submission. They’ll review the form and, if the reporter provides an e-mail address or telephone number, analysts will call or email if any necessary follow up information is needed. Please follow the link below to report to ISMP:
//www.consumermedsafety.org/merp.asp
FDA Medwatch
MedWatch is the Food and Drug Administration’s [FDA] program for reporting serious reactions, product quality problems, therapeutic failure, and product use errors with human medical products, such as drugs and medical devices.
If patients have experienced a serious reaction to a medical product, they are encouraged to take the reporting form to their doctor. Health care providers can provide clinical information based on the patient’s medical record that can help FDA evaluate a report.
Patients may not wish to have the form filled out by a health care provider, or a health care provider may choose not to complete the form since health care providers are NOT required to report to the FDA. In these situations, patients may complete the Online Reporting Form themselves.
Patients will receive an acknowledgement from FDA after a report is received and will be contacted only if MedWatch needs additional information.
General Guidance for Reporting Problems to the FDA:
- FDA 101: How to Use the Consumer Complaint System and MedWatch
- Your Guide to Reporting Problems to FDA
Report Problems with Medical Devices to the FDA:
Health professionals and consumers may submit reports of device adverse events or product problems to FDA via the MedWatch program in one of the following ways:
- online at: MedWatch Online Reporting Form 3500
- by telephone at 1-800-FDA-1088
- by fax at 1-800-FDA-0178
- by mail to:MedWatch at The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787
Search the Food and Drug Administration MAUDE Medical Device Database
Related FDA Reporting Information for Consumers:
- Report suspected unlawful sale of medical products on the Internet
- 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, followed by 1 for information, then:
- for dietary supplements, select 2
- for drug products, select 3
- for medical devices, select 4
- for biologics, including human cells, tissues, and cellular and tissue-based products, select 6
Safe Medication Practices - December 2000
What is a national medication error reporting and prevention program??
Recently, the Institute for Safe Medication Practices Canada was actively involved in assisting to resolve an unforeseen incompatibility between the Abbott Lifeshield syringes and the Baxter Continu Flo intravenous tubing sets. Because of preventative steps taken by the manufacturers, together with hospitals and ISMP Canada, medication safety was ensured. Details of the problem and resolution are available on our website [www.ismp-canada.org]. With the many changes in hospital products and with the many new technologies, there can be potential for new types of medication errors. Fortunately, conscientious practitioners are identifying risk for error and sharing information so that hospitals can learn from each other. ISMP Canada is currently involved in several other projects to address reported problems and concerns.
This brings us to a question, which has been asked for some time: why isn't there a national medication error reporting and prevention program in Canada? How does one define such a program? How does one begin to initiate such a program? ISMP Canada is partnering with several organizations in order to define a program for Canada and in order to work collaboratively to ensure initiatives are taken. The ultimate goal will be to enhance patient safety by improving medication process systems. System improvements will prevent or will reduce medication errors and this will result in prevention of patient injuries. A Canadian program will need to identify medication safety issues, determine the base problems, and make recommendations to the healthcare community. Information sharing will be an important component of the program. In many cases, medication problems are more complex than they appear. They are often related to system problems, which need an in-depth analysis and multidisciplinary [nurses, pharmacists and doctors] approach to solving the underlying problems.
Critical to a successful national reporting system will be collaborative partnerships with the various stakeholder organizations in Canada. ISMP Canada is working with Health Canada, Canadian Society of Hospital Pharmacists, Canadian Pharmacists Association, Canadian Healthcare Association, Canadian Nursing Association, Canadian Medical Association, Canada's Research-Based Pharmaceutical Companies Association, as well as, a representative from consumers in order to ensure we all work together to create a successful program. The national program will need to be a balanced, well-resourced and productive effort.
A national reporting and prevention program specific to medication errors and risk for medication errors, is not just a database that tracks errors and generates statistics. The mechanics of reporting and maintaining the error data is only one component. The other critical pieces include the reporting of errors by practitioners and institutions that identify problems. Disclosure of the error and full information of mishaps is needed, so that root causes can be determined. Most importantly, there needs to be a desire and commitment to make system changes and improvements. The database needs to have complete confidentiality and needs to ensure protection of the reporters when they are offering information about errors. Databases can be made anonymous, once full information is received.
Another key issue, that has sparked much debate, is whether or not, a national reporting system should be voluntary, or mandatory. It has been suggested in the US, that adverse events resulting in death and serious injuries should be reported on a mandatory basis. Many people feel, however, that mandatory programs may result in attempts to hide error for fear of punitive actions. One of the key guiding principles of voluntary reporting systems is that they encourage practitioners to willingly share information so that similar errors can be prevented. Voluntary programs also encourage reporting of hazardous situations, before an error has occurred, as well as, errors, which have already occurred. Voluntary programs promote a "non-blame culture". Voluntary programs recognize that most errors are complex in nature and result from a combination of factors, often outside the control of the practitioner involved in the error. Rarely, is there intent on the part of the practitioner to cause harm. Importantly, when practitioners and organizations report mishaps and hazardous situations on their own, they are always willing to provide the detailed information needed to perform root cause analysis. This results in the ability to determine what actually went wrong. Thus recommendations and prevention strategies can be disseminated back to the practitioners and system improvements can be implemented.
ISMP Canada stands by a voluntary reporting system. We work closely with practitioners, institutions and industry to resolve problems together. Take the recent successful project with the Lifeshield syringes mentioned above. The problem was reported voluntarily and resulted in an immediate solution, because of a desire of all parties involved to prevent error. We strongly believe that a national medication error reporting and prevention program is one that involves the collaboration of all health professionals, industry, consumers and the government. Fortunately, there is unanimous agreement amoung all the stakeholders, that Canada needs a voluntary national medication error reporting system.
In order to have an effective national medication error reporting and prevention program, we need to make efforts to change the culture of blaming one individual. Often, weaknesses in drug use systems are not discovered or reported, because of the fear that the practitioner involved in the error will be blamed and unfairly disciplined. Too often it seems easy to blame one person. It can be easier than investigating all the problems, which may have contributed to the error. If a blaming culture prevails, practitioners will be reluctant to discuss, let alone disclose information about errors. When this happens, only the person involved in the error has the potential to learn from the error. Changing a culture is a huge endeavor. Senior administration needs the vision and the commitment to make this happen. Hospitals must have a clear and forefront policy that encourages error reporting. The message to the practitioners should be a "thank you" rather than "reprimand" when error information is provided and hazardous situations identified.
Only by sharing the information can we ensure that everyone learns how to prevent the same error.
ISMP Canada publishes special alerts to practitioners and hospitals on important issues, which have been shared with us. Should practitioners or hospitals wish to receive these alerts, please send your email address to . The alerts will also be posted on our website.
ISMP Canada will also provide ongoing information, about the initiatives for a collaborative national medication error reporting program, as developments are made.