PHAR 1004 notes for module 1
PHAR 1004 notes for module 1 PHAR 1004
U of M
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This 4 page Class Notes was uploaded by ziyue zhang on Thursday September 17, 2015. The Class Notes belongs to PHAR 1004 at University of Minnesota taught by Amy Pittenger in Fall 2015. Since its upload, it has received 75 views. For similar materials see Common Perscription Drugs & Diseases in Pharmaceutics at University of Minnesota.
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Date Created: 09/17/15
1848 imported drugs Name The Drug Importation Act Time 6261848 By James Polk Reason imported adulterated drugs from Europe high mortality of American soldiers in MexicanAmerican War gt The Drug Importation Act Result work out at firstpolitica spoil proliferationpatent 1902 Biological Therapeutics Name the Biological Control Act of July1 Time 1902 By Congress Reason death because of the post vaccination tetanus gt mandated annual licensing of establishments to manufacture and sell vaccines Biologics had to be labeled 1906 Labeling Drugs 1906 Pure Food and Drugs Act Reason corrupt food and drug marketplace lack of standards red clausesnostrum about prohibit interstate commerce of adulterated drugs presence and amount of certain dangerous substances had to be labeled shortcomings no regulation of medical devices cosmetics explicit authority to conduct factory inspections control of what drugs could be marketed prosecution of false therapeutic claims 1938 Drug safety Food Drug and Cosmetic Act June 25 1938 President Roosevelt Reason The Elixir Sulfanilamide disasteruntested solvent cause death about new drug had to be proved safe before marketed new drug application cover medical devices cosmetics authorized factory inspections outlawed bogus therapeutic claims 1951 Prescription DurhamHumphrey Amendment Reason drugs that needs to be labeled and sold only through a physician or dentist39s prescription about what a prescription was who would be responsible for identifying prescription Prescription legend drugnot necessarily quotsafequot reason OTC Drug and disease interactions mask signs and symptoms of serious disease overdosepoisoning 1962 Drug Efficacy Time 10101962 KefauverHarris Amendment Reason a drug was distributed to physicians for investigational use before FDA approve it About control over clinical in investigation requirement of informed consent FDA39s authority to regulate advertising of prescription drugs establish good manufacturing practices as a means to promote quality assurance and access certain company control and production records to verify production procedures 1983 Rare diseases The Orphan Drug Act time 1983 reason rare diseasesgt little attention about development grants assistance form FDA in planning its animal and clinical protocols to the companies who are willing to develop drugs for rare diseases Orphan drugs easier to gain market approval extended exclusivity tax incentives rare disease affecting less than 20000 people in the US low profit low funding OTC Nonprescription selfcare same safety issues as prescription Herbal supplements dietary supplement NOT regulated by FDA as drugs can make efficacy claims but still monitored by FDA Control substance drugs with abuse and dependence potential Controlled Substances Act 1970 Established categories that rank abuse and dependence potential Why do you think the regulation of medications has changed over the years how do you think this has impacted how medications are used today to protect the consumer it provides physicians and consumers more source about the drugs FROM IDEA TO MARKET THE DRUG APPROVAL PROCESS Phase 1 2 3 4 5 Subject type Preclinical Application as Clinical New Further Using animal investigational phase application spost Effective new drug marketing Side effects IND studies Number of 1 1 1 healthy subjects humans 2 diseased human 3 diseased human Length of study 34 years 123 years 812 years the cost of developing a new drug to be 359 millionlg1 Newer figures place the cost at more than 500 millionlm1 After the medication is approved by the FDA gt pregnancy categories Pregnancy categories A B C D STUDY IN PREGNANT WOMEN yes NO NO benefits outweigh the risk STUDY IN ANIMAL YES YES HARM lN ANIMAL No YES Studied in pregnant women no harm to fetus No harm in animal studies amp no studies in pregnant women OR harm in animals but no harm in women studies Harm in animal studies amp no studies in women OR no studies in animals or women Benefit must outweigh the risk Evidence of human fetal risk but benefits may outweigh the risks in certain patients Evidence of human fetal risk abnormalities or adverse reaction Risk of use clearly outweighs any possible benefit 11 BEFORE 1938 1938 1951 1962 1997 Never been NEED TO BE OTC without Safe and Offlabel proven safe SAFE prescription effective uses are not and effective prescription what FDA approved Primary Literature original data Secondary literature summary review articles Tertiary literature connection of primary and secondary literature Where the website is reliable Authority Accuracy Objectivity Currency Structure The reputable sites The centers for disease control Mayo Clinic WebMD FDA Package insert for health care profession encyclopediasalmanacs Patient information for patientsconsumers Drug Advertisements directtoconsumer drug Helpseeking ad provide info about medical conditions and encourage patients to seek help from physicians Reminder ad product name strength dosage form or price Product claim ad product and indication including efficacy and safety claims Direct to consumer advertising should continue to be allowed in the US because DTCPA highly relates to sales and profit of the drug companies As we have learned in the first module the drug manufacturers have invested millions of dollars into the clinical phases their enthusiasm of investigating and developing new drugs may impaired if DTCPA is banned Furthermore although one might claim that few offlabeled DTCPA would misdirect the patients ban of DTCPA will not help patients to take charge of their health Patients can also learn about false advertising from other sources Thus I think directtoconsumeradvertising should continue to be allowed in US under certain regulations