Role of the nurse and legal issues in pharmacology:
Drug regulation, development, names, and information Landmark drug legislation - 1906 = federal pure food and drug act 1938 = food, drug, and cosmetic act 1962 = harris-kefauver amendments 1970 = controlled substances act 1992 = permission for accelerated drug approval 1992 = prescription drug user fee act 1997 = food and drug administration modernization act 2002 = best pharmaceuticals for children act - 2003 = pediatric research equity act . 2007 = FDA amendments act 2009 = family smoking prevention and tobacco control act 2016 = comprehensive addiction and recovery act o New drug development - Randomized controlled trial - Use of controls - Randomization - Blinding Drug names Over-the-counter drugs Sources of drug information Controlled substances act Comprehensive drug abuse prevention and control act of 1970 Record keeping Drug enforcement agency schedules I through V Prescriptions Labeling State laws Stages of new drug development Preclinical testing Clinical testing . Phase 1 . Phases 2 and 3 Phase 4: post marketing surveillance Limitations of the testing procedure o Limited information about the majority of people Women - Children Failure to detect all adverse effects Exercising discretion regarding new drugs Be neither the first to adopt the new nor the last to abandon the old
o Balance potential benefits against inherent risks New drugs generally present greater risks than old ones Which name to use: generic or trade o Use of drug names Written and oral communication about medicines Labeling medication containers o The little problems with generic names More complicated than trade names The big problems with trade names Single drug can have multiple trade names U.S. drugs and drugs outside the united states may have different active ingredients Products with the same trade name may have different active ingredients Generic products versus brand-name products Are generic products and brand-name products therapeutically equivalent? Would a difference between brand-name and generic products justify the use of trade names? Over-the-counter drugs 0 Americans spend about $20 billion annually on OTC drugs OTC drugs account for 60% of all doses administered 40% of americans take at least one OTC drug every 2 days 4x as many illnesses are treated by a consumer using an OTC drug as by a consumer visiting a physician For most illnesses (60% to 95%), initial therapy consists of self-care, including self-medication with an OTC drug Sources of drug information People Clinicians and pharmacists Poison control centers Pharmaceutical sales repres