We recognize that when people take our medicines and vaccines, they must have confidence in their efficacy and safety. Ensuring this confidence is crucial to us.

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. Click here for more information on 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 Merck National Service Center can assist you Monday through Friday from 8 AM to 7 PM ET. Adverse experiences and product-related emergencies can be reported at any time by dialing 800-444-2080.

Monitoring & Compliance

The Global Clinical Compliance (GCC) and Global Pharmacovigilance Compliance (GPVC) function at Merck are part of the MRL Compliance organization, which resides in the Global Compliance Organization (GCO). Both groups are responsible for conducting independent, periodic audits of the processes, computerized systems, technology and collaborative partners supporting Merck clinical development and pharmacovigilance. The GCC group has a comprehensive audit program that encompasses a broad range of audits and assessments of the following:

• Clinical Investigator Sites: Audits to assess compliance with the protocol and with Good Clinical Practice and Good Pharmacovigilance Practice regulations and guidelines
• Collaborative Partners: Pre-contractual assessments and post-contractual audits of contracted research organizations (CROs), central laboratories and other third-party vendors
• Computerized Systems and Technology: Audits and assessments of the computerized systems and technology supporting clinical development
• Internal Process Audits: Systematic evaluations of compliance of clinical development processes with Standard Operating Procedures, Global Development Procedures, ICH-GCP and applicable regulations
• Country Operations Audits: Periodic and systematic assessments of the clinical trial operations of our subsidiaries worldwide

GPVC has a comprehensive risk-based audit program for pharmacovigilance, which includes the following:

• Country Operations Audits: Periodic audit of Merck subsidiaries globally to assess pharmacovigilance compliance
• Systems/Process Audits: Periodic audits of the various elements of the PV system utilizing a systems audit approach that evaluates the complex interdependencies (both within MRL and other business units within Merck) inherent in a global PV system
• Business Partner Audits: Audits of companies external to Merck where a licensing or development agreement exists, in which compliance with contractual and regulatory requirements is assessed
• Verification Audits: Audits to verify that the corrective actions that have been implemented are effective at remediating the noncompliance

The primary objectives of the audits are to assess compliance with GCP and pharmacovigilance (PV) regulations and guidelines, clinical study protocols and contractual agreements, divisional and departmental standard operating procedures and applicable corporate policies and procedures; and to assure the accuracy and integrity of the clinical trial data in support of our regulatory applications.

Risk Management

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. This team is responsible for the formation of a proactive clinical safety risk management strategy, including the Risk Management Plan, which is a regulatory requirement for marketed drugs and vaccines.

Development of the overall risk management strategy incorporates all available internal (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 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 team ensures patient safety using product labeling, physician and patient educational programs and other risk minimization strategies, as appropriate. The Risk Management Safety team also implements strategies to determine the effectiveness of these interventions, as appropriate.

Adverse Event Reporting

Merck Global Safety manages a global system for the collection, management and reporting of adverse experience (AE) reports received by Merck worldwide. Learn more.

SafetyMatters Initiative

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 the SafetyMatters initiative is to explore and implement appropriate use of emerging technologies and methods for HOI identification and evaluation, and thereby further enhance post-licensure monitoring and evaluation of our marketed products. A cornerstone of the SafetyMatters initiative 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. To date, the Merck Pharmacoepidemiology and Database Research Unit has successfully created and utilized 16 SafetyMatters Disease Cohorts in nine product-specific areas.

Product Label Reviews

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 on an ongoing basis to regulatory agencies worldwide.

Observational Medical Outcomes Pilot (OMOP)

The Observational Medical Outcomes Pilot (OMOP) initiative is a partnership between PhRMA and FDA to comprehensively identify and assess the optimal applications of large claims and electronic health record databases in order to continuously evaluate the benefit/risk profiles of marketed drugs. 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 health outcomes of interest 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. We continue 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 the benefits and risks of our products.

Communicating About Product Risks

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, to communicate these findings to patients through appropriate mechanisms. This might include such activities as "Dear Doctor" letters and media releases.