Presentation on theme: "Consumer Safety and Drug Regulations"— Presentation transcript:
1Consumer Safety and Drug Regulations Chapter 1Consumer Safety and Drug Regulations
2Introduction Health care practitioners: Inform patients with knowledgeable answers about medicationsHave a serious, responsible attitude about all aspects of drug therapy
3Drug Laws 1900s in the United States Drug standards Laws were passed with regard to the dispensing of drugsDrug standardsSet to assure consumers that they are getting what they pay forAll preparations with the same drug name must be of uniform strength, quality, and purity
4Drug Laws ( cont’d.) Drug preparations Illegal (illicit) drugs Drug companies must not add other active ingredients or varying amounts of chemicalsIllegal (illicit) drugsLack of enforcement of drug standards poses consumer dangerNo controls on quality can lead to deaths from overdose
5Drug Laws ( cont’d.) Three major acts 1906 Pure Food and Drug Act 1938 Federal Food, Drug, and Cosmetic Act and Amendments Of 1951 and 19621970 Controlled Substances Act
61906 Pure Food and Drug ActFirst attempt to establish consumer protection in drug and food manufactureRequired drugs to meet minimal standards of strength, purity, and qualityDemanded labeling for preparations containing dangerous ingredientsEstablished United States Pharmacopeia (USP) and National Formulary (NF)
71938 Federal Food, Drug, and Cosmetic Act Established more specific regulations for preventing adulteration of (tampering with) drugs, foods, and cosmeticsExample: “Warning” labels must be present on certain preparations“May cause drowsiness,” “may cause nervousness,” “may be habit-forming,” etc.
81970 Controlled Substances Act Established the Drug Enforcement Administration (DEA)Set tighter controls on depressants, stimulants, psychedelics, narcotics, and anabolic steroidsProvided guidelines for five schedules of controlled substancesRefer to Table 1-1.
9Additional Drug Legislation The 1983 Orphan Drug ActGives financial incentives to develop medications for diseases that affect a small number of peopleOmnibus Budget Reconciliation Act (OBRA) of 1990Mandates that OTC drugs be documented as part of a medical recordMandates that pharmacists provide drug use review and patient counseling
10FDA and DEA Food and Drug Administration (FDA) Oversees drug testing before releaseInspects plants where foods, drugs, medical devices or cosmetics are madeReviews new drug applications and petitions for food additivesInvestigates and removes unsafe drugs from the marketEnsures proper labeling of foods, cosmetics, and drugs
11FDA and DEA (cont’d.) Drug Enforcement Administration (DEA) Created as the need for better control of addictive drugs became urgentHandles all the needs and safety controls for the more dangerous drugs
12FDA and DEA (cont’d.) Specific areas of control FDA DEA Concerned with general safety standards in the production of drugs, foods, and cosmeticsResponsible for the approval and removal of products on the marketDEAConcerned with controlled substances onlyEnforces laws against drug activitiesMonitors need for changing the schedules of abused drugs
13Health Care Practitioners and the Law Guidelines for those who dispense medicationsKeep a current drug reference source available at all timesKeep controlled substances locked securelyLocked safety box in a locked cupboardConceal and secure prescription padsProperly destroy expired drugs and old records
14Health Care Practitioners and the Law (cont’d.) Keep accurate records of each controlled substance dispensed, received, or destroyed during past two yearsKeep up-to-date with current FDA news, DEA activities, and registration renewalsEstablish a working rapport with a pharmacistIf you work in an office, maintain a professional rapport with pharmaceutical representatives