• What is an adverse event?

  An adverse event is an unwanted effect that you experience as a result of taking a medication, using a medical product, or device.

• What is Adverse Event Reporting?

  PatientsLikeMe provides you access to side effect surveys and treatment evaluations to report your experiences with medications and other treatments you use, including your experiences with adverse events. By completing these reports, you can help improve the outcomes and safety of patients by contributing real world safety data to drug manufacturers and regulators, including the U.S. Food and Drug Administration (FDA).

  (Note:  AE Reporting is currently only available to Multiple Sclerosis patients, Epilepsy patients and Organ Transplant recipients)

• Why does the FDA need to hear from patients like you?

  While there is much information learned from clinical trials, they do not fully reflect the way a medical product is used in real life.  Through the experiences of patients like you, manufacturers of drug and medical products can expand their understanding of a product’s safety profile.  In turn, manufacturers are required to inform regulators such as the FDA about these experiences.   As we integrate Adverse Event Reporting across PatientsLikeMe, you will be able help improve outcomes and safety for everyone using your particular treatment – a goal that’s at the core of the company’s mission.

• What do I need to know about Adverse Event Reporting and Drug Safety on PatientsLikeMe?

  Drug Safety activities are an important part of monitoring the use and effect of prescription and over the counter drugs.  As part of the drug safety efforts at PatientsLikeMe, we collect, monitor, research, and evaluate information about the side-effects associated with medications used by our members.  By sharing your adverse event experiences through a side effect survey, you help researchers, drug makers and, most importantly, patients like you.  Data collected from certain side effect surveys and treatment evaluations are processed by our Drug Safety team. If the side effect is considered a “Serious Adverse Event” (based on FDA established guidance), PatientsLikeMe will submit a report to the manufacturer that day.   “Non-serious Adverse Events” are also sent to the manufacturer weekly or more often as requested.

  (NOTE:  This is only currently available for specific medications used by Multiple Sclerosis and Epilepsy patients, as well as Organ Transplant recipients, but will be expanded over time.)

• Is the information I provide through Adverse Event Reporting confidential?

  All reports sent to manufacturers and the FDA from PatientsLikeMe are submitted without any personally identifiable information about you.  If a manufacturer or the FDA want additional information, they must contact PatientsLikeMe.  In turn, our Drug Safety Manager will contact you by private message and you will make the decision if you want to provide additional information.

  (NOTE:  This is only currently available for specific medications used by Multiple Sclerosis and Epilepsy patients, as well as Organ Transplant recipients, but will be expanded over time.)

• What is the connection between Adverse Events and my profile on PatientsLikeMe?

  The information you report in your side effect survey and/or treatment evaluation is displayed on your profile and available in treatment reports.  If the side effect meets criteria for a “Serious Adverse Event,” PatientsLikeMe submits a report to the manufacturer and/or the FDA.  You will receive a private message from our Drug Safety Manager that includes a case number and contact information for the manufacturer’s Drug Safety Group in the event that you would like to discuss your experience with them directly.  

  (NOTE:  This is only currently available for Multiple Sclerosis and Epilepsy patients, as well as Organ Transplant recipients, but will be expanded over time.)

• Why is PatientsLikeMe integrating drug safety on the website?

  PatientLikeMe is committed to finding opportunities to improve the safety of care provided to patients.  Drug safety is an important place to begin.  PatientsLikeMe partners with pharmaceutical companies to assist them in gaining insight into your real-world experiences with your diseases and treatments. Drug and medical device companies have regulatory responsibilities to identify and report potential adverse experiences associated with their products to the U.S. Food and Drug Association (FDA) and other regulatory agencies in a timely manner. Together, PatientsLikeMe and our partners will use the information you share to help improve and find new treatments.

• Who is responsible for patient safety at PatientsLikeMe?

  Sally Okun oversees patient safety initiatives at PatientsLikeMe.  Sally, along with David Blaser, is responsible for drug safety activities. Feel free to email them at   DrugSafety@patientslikeme.com at any time with your questions about our drug safety activities.
  
  
  

• Where does the patient safety team find drug safety information within the PatientsLikeMe Community?

  Of all the information sources on PatientsLikeMe, Treatment Evaluation Reports provide a structured set of questions that is the richest source of drug safety information. When completed, they provide specific data including effectiveness, the burden of taking the drug, side effects you experienced, cost, and advice and tips to share with other members of the community.
  
  In some cases, the patient safety team may contact you for more information. The more you share about your potentially adverse experiences with specific drugs, the more you will be helping the community. You can choose whether or not to provide the information requested by the patient safety team.

• Would the patient safety team ever contact me? If so, why?

  Yes, there are a few situations when the patient safety team will send you a specific message to help collect as much data about your experience as possible.  This information is needed for two important reasons.  First, it allows other patients in the community to share in your experiences, and second, to allow the makers of the drug to get as clear a picture as possible as to the circumstances surrounding the side effects you experienced. Here are a few examples of when and how the patient safety team would contact you:

  • You've completed a Treatment Evaluation and report that you've experienced an adverse event that required hospitalization as a result of using a specific drug. You will receive a message that tells you how to contact the pharmaceutical company in case you wish to provide additional information about your experience to help them learn more about the impact of their drug.

  • If you are pregnant and on certain medications, you will receive a message from our patient safety team with information on how to contact the pharmaceutical company in case you want to share more about the results of your pregnancy. Pregnancy is an important consideration for drug safety. When a drug is being developed and in clinical trials, pregnant women rarely use them. Once the drug is more widely used, it is important to learn about any effect it might have for the mother and the baby. The FDA requires drug companies to collect and report as much information about these experiences as they can obtain.
    
    
  • If you experience a side effect with a drug and post a message about it in the Forum or mention it in your bio, the patient safety team may send you a message encouraging you to complete a Treatment Evaluation for that drug (if you haven't already done so). Our lively Forum includes lots of conversations about your real-world experiences with a disease, including those about side effects and other reactions to drug products. We encourage you to not only share in the Forum, but also complete a Treatment Evaluation so the community can learn from you, and so you can compare your experiences with others. All of the information you share about how these drug products impact your experience with epilepsy is helping drug companies, the FDA and other patients like you learn more and live better.

  (NOTE:  Drug safety activities are available only for specific medications, but will be expanded over time.)    
  
  

Need more help? Email support@patientslikeme.com