Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks
نویسندگان
چکیده
CONTEXT Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. METHOD A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines. FINDINGS Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered. CONCLUSION A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.
منابع مشابه
The Tip of the Iceberg of Misleading Online Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
Kim’s overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most co...
متن کاملPrescribing Quality in Medical Specialists in Isfahan, Iran
Rational prescribing increases the quality of health care and patient outcomes. In this study, the quality of drug prescription in specialist physicians in Isfahan province of Iran was assessed for evaluating the rational use of drugs and improving the therapeutic outcomes.This retrospective survey was conducted on a total of 7999530 prescriptions from all general and specialist physicians. The...
متن کاملPrescribing Quality in Medical Specialists in Isfahan, Iran
Rational prescribing increases the quality of health care and patient outcomes. In this study, the quality of drug prescription in specialist physicians in Isfahan province of Iran was assessed for evaluating the rational use of drugs and improving the therapeutic outcomes.This retrospective survey was conducted on a total of 7999530 prescriptions from all general and specialist physicians. The...
متن کاملOverview of National Drug Policy of Iran
National Drug Policy (NDP) constitutes the specification of mid-term and long-term pharmaceutical objectives by the government and the determination of major strategies warranted to achieve such objectives. Stated in other words, NDP determines the frameworks for the pharmaceutical activities of private and state sectors. The specification of these policies and strategies will be an effective m...
متن کاملA review on precision medicine and conducting pharmacogenetics tests of drugs
Precision medicine, the selection of treatment based on the genetic characteristics of patients, is one of the new paradigms of medical science. Using genetic characteristics and biomarkers, patients' response to different treatments is evaluated and finally, a specific one is selected for them. In other words, using genetic information or biomarkers, the safety, effectiveness and outcomes of t...
متن کامل