Medicines and vaccines are widely tested before they are approved for marketing. This testing is governed by a comprehensive regulatory scheme and our research policies. We assess the safety of our products in clinical trials over many years before our products are approved. Merck is committed to the timely registration of clinical trial information and disclosure of trial results-regardless of their outcome. Learn more about our clinical trials.
REPORTING AN ADVERSE EXPERIENCE IN THE U.S.
To speak with a Merck healthcare professional about Merck products, or to report an adverse experience with a specific Merck product, please call the Merck National Service Center at 800-444-2080. The center can assist you Monday through Friday, from 8 am to 7 pm eastern time. Adverse experiences and product-related emergencies can be reported at any time by dialing 800-444-2080.
Merck Global Safety manages a global system for the collection, management and reporting of adverse experience (AE) reports received by Merck worldwide. Learn more.
The Global Clinical and Pharmacovigilance Compliance (GC&PVC) function at Merck is part of the MRL Compliance organization, which resides in the Global Compliance Organization (GCO). This group is responsible for conducting independent, periodic audits of the processes, computerized systems, technology and collaborative partners supporting Merck Human Health, Merck Animal Health and Consumer Care divisions within Merck. MRL has a comprehensive, risk-based audit and compliance oversight program that encompasses a broad range of GCP and PV audits and assessments of the following:
Through the oversight and implementation of this comprehensive audit program, GC&PVC provides independent and continuous assurance to Merck senior management that the operations, processes and computerized systems and technology supporting Merck Human Health, Animal Health and Consumer Care development activities comply with applicable global regulations and guidelines as well as internal company policies and procedures.
Merck Global Safety leads the development of Risk Management & Safety teams for all products, from the beginning of Phase IIb throughout the product life cycle. Global Safety is responsible for the formation of a proactive clinical safety risk-management strategy, including the Risk Management Plan, which is a regulatory requirement in many countries for marketed drugs and vaccines.
Development of the overall risk management strategy incorporates all available intenal (e.g., basic research data, animal and human studies with the product and/or related products) and external information (e.g., literature and public data related to the class of drugs and/or therapeutic target) that contributes to the overall risk-benefit assessment of the product. The strategy focuses on activities needed to identify, evaluate and manage potential patient-safety risks. The Risk Management & Safety teams assess patient safety using product labeling, physician and patient educational programs, and other risk-minimization strategies, as appropriate. The Risk Management & Safety teams also implement strategies to determine the effectiveness of these interventions, as appropriate.
In late 2007, Merck senior leadership launched the SafetyMatters initiative to investigate potential enhancements to our already robust approach to identifying and evaluating health outcomes of interest (HOIs) in connection with our marketed products. The goal of SafetyMatters is to explore and implement appropriate use of emerging technologies and methods for HOI identification and evaluation, and thereby further improve post-licensure monitoring and evaluation of our marketed products. A cornerstone of SafetyMatters is the proactive development and utilization, as needed, of Disease Cohorts based on data contained in large medical claims and electronic-health-record databases licensed by Merck. As of March 15, 2012, the Merck Pharmacoepidemiology and Database Research Unit has successfully created and utilized 20 SafetyMatters Disease Cohorts in twelve product-specific areas.
Ongoing oversight and monitoring of our product labels is a major focus of our safety efforts. Our label review teams monitor information on our products and work with our product safety teams to develop or update product labeling. We communicate relevant information regularly to regulatory agencies worldwide.
Observational Medical Outcomes Pilot (OMOP)
The Observational Medical Outcomes Pilot (OMOP) initiative is a partnership between PhRMA and the FDA to comprehensively assess the validity of observational analyses methods to evaluate the safety of marketed drugs in large patient-level claims and electronic-health-record-databases. In March 2009, Merck, in collaboration with United BioSource Corporation (UBC), was recognized by OMOP as a leader in the development of coding algorithms for HOIs used in observational research, and was selected to pursue this work on behalf of the entire OMOP research community. The UBC-Merck partnership continues its efforts to help construct the OMOP clinical coding library. OMOP is complementary to our internal SafetyMatters initiative. Merck continues to support OMOP's activities in 2012 and conduct internal tests of distributed database systems and methods. We are continuing to explore synergies and linkages between OMOP and SafetyMatters to establish standards for the use of modern epidemiology data sources and analytic techniques to evaluate product safety in observational claims and electronic-health-record databases.
Our information leaflets in our product packaging contain information on possible side effects and, if appropriate, how to avoid some potential problems. We include contact details on our corporate website for patients, caregivers and health professionals to report adverse experiences in the United States. Outside the United States, adverse events are reported according to local laws and practices.
Depending on label changes and their context, we may determine, in consultation with regulatory agencies, that more extensive communications may be appropriate. In such cases, we work with regulatory authorities to contact healthcare professionals in a timely manner, so that they can communicate these findings to patients through appropriate mechanisms. Contacting healthcare professionals might include "Dear Doctor" letters and media releases.