MEMORANDUM OF UNDERSTANDING
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
INSTITUTE FOR SAFE MEDICATION PRACTICES
This Memorandum of Understanding (MOU) defines the framework for collaboration between the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) and the Institute for Safe Medication Practices (ISMP). FDA and ISMP (the Parties) share interests in promoting scientific progress through exchange of scientific capital in the area of medication error related training and research programs. This MOU and the collaborative framework establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs, including collaborative education and research.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act). In fulfilling its responsibilities under the FD&C Act, FDA among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements and cosmetics, as well as advancing the public health through regulation of tobacco products. To accomplish its mission, FDA must stay abreast of the latest developments in research and also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships within the ISMP will greatly contribute to FDA's mission.
The ISMP is a 50lc (3) nonprofit organization devoted to medication error prevention and safe medication use. ISMP has over 30 years of experience in helping health care professionals keep patients safe, and continues to lead efforts to improve the medication use process. ISMP's initiatives to improve the medication use process, built upon a non-punitive approach and system-based solutions, fall into five key areas: knowledge, analysis, education, cooperation and communication. Through its online portals and mobile applications, ISMP offers health care professionals and patients a variety of information resources and services. ISMP is also certified as a Patient Safety Organization (PSO) by the Agency for Healthcare Research and Quality.
ISMP recognizes that the potential for medication errors and adverse drug events is a reality, and that prevention efforts rely heavily on the knowledge and ability of individual healthcare professionals. The Institute strongly believes that ongoing education and development of healthcare professionals is key to ensuring safer medication-use systems. Through educational programs, easy-to-use tools, and hands-on learning opportunities, ISMP is making it possible for healthcare practitioners to grow in terms of their career as well as to make a real difference in medication safety.
III. Substance of Agreement
The parties will collaborate on a joint ISMP Safe Medication Management Fellowship Program. This fellowship program is an effort between ISMP and CDER, Office of Surveillance and Epidemiology, Division of Medication Error Prevention and Analysis. The fellowship program gives experienced candidates an unparalleled opportunity to learn from and work with some of the nation's top experts in medication safety. The fellow benefits from ISMP's years of experience devoted to medication error prevention and safe medication use. At FDA, valuable regulatory experience is gained by working with the division focused on medication error prevention. The fellow will spend 6 months at ISMP in Horsham, PA and 6 months at FDA.
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and ISMP. The types of initiatives expected to develop from this MOU include:
1. Opportunity to apply for a joint fellowship program at the FDA to advance student education. One of the mechanisms to enroll students/postdoctoral trainees/residents from ISMP into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. Prospective ISMP fellows shall adhere to the CDER ORISE Fellowship rules and regulations;
2. Opportunities to convene joint meetings for education and research;
3. Research collaborations; and
4. Access to unique facilities and equipment for scientific endeavors.
Under this MOU, joint efforts will be undertaken to support collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. The terms and conditions of any such agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of ISMP and FDA.
IV. General Provisions
1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
2. ISMP and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
4. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. ISMP individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
5. As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.
V. Resource Obligations
This MOU represents the broad outline of the FDA and ISMP's intent to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations and statutes under which FDA and ISMP operate.
Vi. Liaison Officers
FDA's Center for Drug Evaluation and Research (CDER) is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:
Gerald J. DalPan, MD, MHS
Food and Drug Administration
Acting Director, Office of Surveillance and Epidemiology
10903 New Hampshire Avenue, W022, Rm. 4304
Silver Spring, MD 20993-2000
The individual(s) to whom all inquiries to the Institute of Safe Medical Practices should be addressed is:
Allen Vaida, Executive Vice President
Institute for Safe Medication Practices
200 Lakeside Drive, Suite 200
Horsham, PA 9044-2321
PHONE: 215-947-7797 FAX 215-914-1492
Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.
VII. Term, Termination, and Modification:
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. It may be renewed by mutual written agreement of both Parties. It may be modified at any time by mutual written agreement of both Parties. It may be terminated by either Party upon 60-day advance written notice to the other.
VIII. Statutes, Regulations, Rules, and Policies
This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and ISMP operate.
Approved and Accepted
for the Institute of Safe Medical Practices
Signed by: Michael R. Cohen
Date: April 6, 2012
Approved and Accepted
for the Food and Drug Administration
Signed by: Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research
Date: April 6, 2012