International Alliance for Better Medicine
PPAG: The Pediatric Pharmacy Association is a member of the International Alliance for Better Medicine. In 2007 Dave Knoppert, Chair of International Member Recruitment for PPAG and Chair of Pharmacists Recruitment for the Alliance, attended the Global Consortium of Pediatric Pharmacology (GCPP) in Shanghai, China. The Consortium resulted in a declaration, known today as the Shanghai Declaration. The Alliance presented the Declaration to the World Health Organization in 2016.
"The Shanghai Declaration" (endorsed by the PPAG Board of Directors)
We, concerned pediatricians and clinical pharmacologists and pharmacists of the world, representing the International Pediatric Association and the International Union of Pharmacology and its Children’s Committee, call urgent attention to:
The Convention on the Rights of the Child, which states the right of every child to the highest attainable standard of health, and
The Millenium Development Goals, which include calls for a fifty percent reduction in child mortality (MDG 4), improving maternal and newborn health (MDG 5), combating HIV/AIDS, malaria, and other diseases including tuberculosis (MDG 6); and availability of essential medicines (MDG 8).
We duly note that access to safe and reliable medicines for children worldwide and the rational use of such medicines are essential to attainment of child health and achievement the Millenium Development Goals.
We are gravely concerned that major impediments to achieving access to and rational use of better medicines for children worldwide exist in 2006, particularly in the developing world. These include the present realities that:
Many children, and especially those of the developing world, do not have access to safe and effective medicines in formulations which address children’s health needs.
Evidenced based treatment guidelines for major childhood diseases are not universally available.
A clear definition of medicines essential for the care of children does not exist.
Drugs are often used inappropriately in children, with insufficient attention to
the unique physiologic needs and developmental stages of childhood.
Pediatricians, other child health providers, and clinical pharmacologists and pharmacists are too often inadequately trained in the appropriate use of medicines in children, and there is a critical shortage of pediatric pharmacologists and pharmacists, particularly in the developing world.
Research focused on medicines for children is inadequately emphasized and supported.
Many medicines potentially useful to children are not tested in children, leading to wide off label use of adult tested drugs in children, and global principles to guide ethical, safe, and valid clinical trials of drugs in children are ignored or do not exist.
Regulatory capacities to support access to medicines through acquisition, distribution, and monitoring mechanisms and to collect and respond to reports of adverse drug reactions in children are inadequate and hamper the availability and safety of medicines for children at country level, particularly in the developing world.
Efforts to address the many issues of better medicines for children have been fragmented and uncoordinated, and there is no identifiable global partnership of concerned and informed stakeholders to advocate for and work together to achieve the reality of better medicines for children in countries throughout the world.
We therefore resolve that through an international alliance we will address these impediments through:
Bringing the combined strengths, knowledge, and expertise of our professions to advocating for and working for the reality of access to safe and effective medicines for all children at country levels worldwide
Responding to the need for evidenced-based clinical treatment guidelines pertinent to the important causes of newborn and child mortality and morbidity worldwide, with due attention to regional and country needs
Defining a global essential medicines list for children based on definition of the specific health needs of children in countries and regions throughout the world.
Building Human Resources through educational programs and enhanced teaching and training programs in the safe and appropriate use of drugs in children for pediatricians, general physicians, health workers at all levels, and clinical pharmacologists and pharmacists; promoting the training of more pediatric pharmacologists and pharmacists, particularly in the developing world; and developing educational materials to support the rational use of medicines for professionals, caregivers, governments, and consumers.
Promoting basic, clinical, and operational research important to safe and effective therapies for children, including safety evaluations, production of stable formulations for children, pharmacokinetic/pharmacodynamics, epidemiologic studies, and basic aspects of host responsiveness and toxicity.
Defining global standards for the testing of drugs in children and for the conduct of ethical and safe pediatric clinical trials, with attention to the infrastructure necessary for the conduct of such trials, and the issues of benefit to participating sites and participants.
Supporting the development of national regulatory capacity for market authorization, acquisition and distribution of drugs, counterfeit surveillance, and clinical trial authorization, with particular attention to medicines for children.
Working together as professionals, and promoting working relations with other stakeholders, including Civil Society and its Organizations, Governments, The World Health Organization, the United Nations Children’s Fund, Industry, and Donor Organizations.