Statements & Publications:
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
-Millennium Development Goal 8 (essential medicines); WHO Global Health Observatory: availability and prices essential medicines
-WHO report presented at the annual FIP congress in Amsterdam 2012: ‘The Pursuit of Responsible Use of Medicines: Sharing and Learning from Country experiences’.
Government of The Netherlands:
From the report (‘The benefits of responsible use of medicines, setting policies for better and cost-effective healthcare’) at the Ministers Summit at the FIP congress in Amsterdam in 2012, Key Outcome number 4 stated: ‘Leverage information technology;
Greater sharing of best practices is needed in:
* building patient registries;
* linking electronic health records;
* enabling health data capture and analysis;
* using innovative ways to inform patient care and health decisions.
Through sustained long-term public-private partnerships the right infrastructure can be built to, forexample, reduce medication errors and improve compliance, as well as provide better data on medicines use and the effect of policy interventions. The recent roll out of e-health technology in Australia allows physicians to review two years of patient prescription records to inform patient care and practice. In limited resource settings, the power of mobile technology is bringing timely and useful information to local healthcare professionals, patients and policy makers’.
MSH (Management Sciences for Health):
-Adding medicines to UHC (Universal Health Coverage): “Every person, no matter where they live, should have access to quality health services without risking financial hardship. But accessing quality health services is only half of the equation,” blogs Francis Aboagye-Nyame. “Every person should also have available to them medicines that are affordable, safe, effective, and of assured quality.”
-SIAPS (Systems for Improved Acces to Pharmaceuticals and Services) works to assure the availability of quality pharmaceutical products and effective pharmaceutical services to achieve desired health outcomes. SIAPS is designed to build upon the work already accomplished by its predecessors Rational Pharmaceutical Management (RPM) Plus and Strengthening Pharmaceutical Systems (SPS). These two programs conducted extensive assessments of the capacity and readiness of the pharmaceutical and laboratory systems. Subsequent SPS interventions promoted medicines safety and rational medicines use and were designed to provide immediate response to urgent day to day pharmaceutical problems, while developing the policy framework and human capacity to strengthen the system in the medium and long terms.
SIAPS is particularly interested in long-term sustainability, which requires that the political and legal frameworks of the pharmaceutical system become better coordinated and cover all aspects of the pharmaceutical sector, including rational medicine use, drug quality and pharmacovigilance (medicine safety). This program is designed to improve governance, build capacity for pharmaceutical management and services, and improve pharmaceutical services to achieve desired health outcomes in the pharmaceutical sector.
European Medicines Agency
‘Medication errors are unintentional errors in the prescribing, dispensing, administration or monitoring of a medicine while under the control of a healthcare professional, patient or consumer. They are the most common single preventable cause of adverse events in medication practice.’
Official report by the EU Expert Group on Safe Medication Practices: ‘Creation of a better medication safety culture in Europe: Building up safe medication practices’.
Within the Center for Drug Evaluation and Research (CDER), the Division of Medication Error Prevention and Analysis (DMEPA) reviews medication error reports on marketed human drugs including prescription drugs, generic drugs, and over-the-counter drugs. The DMEPA uses the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) definition of a medication error. Specifically, a medication error is “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.”
ISMP (Institute for Safe Medication Practices):
The Institute for Safe Medication Practices (ISMP), based in suburban Philadelphia, is the US’ only nonprofit organization devoted entirely to medication error prevention and safe medication use. ISMP represents over 35 years of experience in helping healthcare practitioners keep patients safe, and continues to lead efforts to improve the medication use process. The organization is known and respected worldwide as the premier resource for impartial, timely, and accurate medication safety information.
The Global Fund:
Fight against HIV/TB/Malaria. Funding mainly (95%) by public money. The Netherlands is a top 10 donor.
Until end of 2013 almost 40.000.000.000 USD spend. Of these funds a great part was spend on medicines.
HARM-research (Hospital Admissions Related to Medication):
(Avoidable) medication related hospital admissions (estimate) in The Netherlands (2006): conclusions were; about 5% (20.000 a year!).
-Medication Safety is, and should stay, an important topic.
-Renowned institutions like the WHO, EU, MSH have given their thoughts about it.
-Already diverse actions have been undertaken.
-The use of software/ICT-structures untill now is fairly limited to logistics and specific diseases with great regional/national variability.
-Awareness on the subject needs to be further increased.