2 IntroductionAll health-care workers who work with medications should understand the legal and ethical requirements of their jobs.Controlled substances are those drugs that are prone to abuse and fall under the 5 drug schedules established by the Controlled Substances Act.
4 The Need for Drug Control In the 19th century, there was virtually no regulation of the sale of drugs in the United States.Many people became addicted to opiates or relied on false claims of manufacturers of drugs and other substances, resulting in passage of the first Pure Food and Drug Act in 1906.
5 Pearson Education / PH College Figure During the nineteenth century in the United States, over-the-counter opium could be purchased at pharmacies and grocery stores. As a result, addiction became a problem, leading to programs such as the one advertised in this poster. However, in 1906, the Pure Food and Drug Act put an end to the sale of unsafe and untested drugs, such as opium.
6 Federal Drug ControlPure Food and Drug Act (1906): first law to regulate standards of drug strength and purity, and proper labelingSherley Amendment (1912): prohibits fraudulent therapeutic claims
7 Pure Food and Drug Act of 1906 (cont.) Ultimately proved to be inadequate because it did not:Cover cosmeticsProvide the authority to ban unsafe drugsProhibit false statements about drugsRequire labeling to identify product contents
8 Food, Drug, and Cosmetic Act of 1938 Prompted by the sulfanilamide disaster of 1937Limited interstate commerce in drugs to those that are safe and effectiveEstablished the Food and Drug Administration (FDA)Regulated labeling of drugsRegulated who could prescribe legend (prescription-only) drugs
9 Federal Drug ControlFederal Food, Drug, and Cosmetic Act (1938): ensures that drugs comply with standards of safety and efficacy; authorized FDA to approve new drug applicationsThis act was prompted in part by the sulfanilamide disaster of 1937, which caused many birth defects
10 Drugs and Birth Defects Drinking alcohol while pregnant can cause fetal alcohol syndrome, characterized by abnormalities of the face and head, growth disturbances, and mental deficiency.Smoking during pregnancy is linked to smaller birth-weight babies and abnormal infant reflexes.
11 Federal LawsDurham-Humphrey Amendment (1951): prohibits dispensing of legend drugs without a prescription; allows nonlegend (OTC) drugs to be sold without a prescription
12 Durham-Humphrey Amendment of 1951 Also known as the Prescription Drug AmendmentRequired prescription drugs to bear the legend, "Caution: Federal law prohibits dispensing without a prescription."Later amendments approved a substitute legend that reads "RX only."
13 Federal LawsKefauver-Harris Amendment (1962): passed in response to thalidomide disaster; requires adverse effects to be reported to FDA and proof of safety and efficacy
14 Federal Laws: Drug Abuse Drug Abuse Control Amendment (1965)Allowed only certain authorized registrants to manufacture stimulant drugsContained first guidelines for determining classifications of drugs subject to abuse
15 Pearson Education / PH College Figure Amphetamines, Schedule II drugs, have a high abuse potential and are sold illegally under many street names.
16 Keeping Medications Safe in the Hospital All restricted substances must be stored in locked storage facilities.This prevents access by unauthorized persons.
17 Occupational Safety and Health Act of 1970 Administered by Occupational Safety and Health Administration (OSHA)Revised in 1992: requires medical facilities to comply and prove compliance with the Bloodborne Pathogens Standard
18 Occupational Safety and Health Administration (OSHA) Division of the U.S. Department of LaborAssures the safety and health of American workers by setting and enforcing protective standardsEnforces occupational safety standards in all 50 statesProvides technical assistance and consultation programs
19 Michal Heron / Pearson Education / PH College Figure In 1992, the Occupational Safety and Health Administration’s Final Ruling on Bloodborne Pathogens became law. Safety measures, such as sharps containers for the disposal of needles and syringes, were implemented to stem the spread of HIV/AIDS and other bloodborne diseases.
20 Comprehensive Drug Abuse Prevention and Control Act of 1970 Also known as the Controlled Substances Act of 1970Combined all federal laws dealing with narcotics, stimulants, depressants, and abused designer drugsEstablished the Drug Enforcement Administration (DEA)Established five "classes" or schedules for controlled substances
21 Controlled Substances Act (1970) Gave sole drug control to the DEAClassified drugs according to abuse potentialProvided research into drug abuse and dependence and drug abuse treatment and rehabilitation
22 Schedule I Symbol: C-I No accepted medical use in the U.S. Example – heroin, LSD, marijuana
23 Schedule II Symbol: C-II No refills permitted Example – morphine, cocaine, Ritalin®
24 Schedule III Symbol: C-III May be refilled up to 5x – within 6 months Example – anabolic steroids, Noludar®
25 Schedule IV Symbol: C-IV May be refilled up to 5x – within 6 months Example – Vicodin®, Valium®, Librium®
26 Schedule V Symbol: C-V No refill restrictions – for up to one year Example – Lomotil®
29 Additional Control of Drug Abuse Anabolic Steroids Control Act (1990): placed anabolic steroids under CSA’s regulatory provisions
30 Anabolic Steroids Control Act of 1990 Anabolic steroids are hormonal substances related to estrogen, progestins, testosterone, and corticosteroids.This act was established to control illegal use of anabolic steroids to increase physical performance (mostly by athletes).
31 Anabolic Steroids Control Act of 1990 Abuse of anabolic steroids may lead to heart, liver, immune function, and mood-related conditions that may become fatal.
32 Orphan Drug Act of 1983Intended to stimulate the development of drugs for rare diseasesRare disease: affects 200,000 people or fewer
33 Orphan Drug Act of 1983 (cont.) Provides three primary incentives:Seven-year market exclusivity to sponsors of approved orphan productsTax credit of 50 percent of the cost of conducting human clinical trialsFederal research grants for clinical testing of new therapies to treat and/or diagnose rare diseases
34 Orphan Drug Act of 1983 (cont.) Congress created an additional incentive in 1997Companies developing orphan products receive an exemption from the usual drug application or user fees charged by the FDA
35 Prescription Drug Marketing Act Prohibits the reimportation of a drug into the United States by anyone but the manufacturer; adopted in 1987Prohibits the trading or sale of drug samples and controls their distribution
36 Prescription Drug Marketing Act of 1987 Enacted to address certain prescription drug marketing practicesDistribution of free samplesUse of coupons redeemable for drugs at no cost or low costSale of deeply discounted drugs to hospitals and healthcare entities
37 Prescription Drug Marketing Act of 1987 (cont.) These marketing practices helped create a secondary grey marketgrey market—an unofficial or unregulated market
38 Michal Heron / Pearson Education / PH College Figure Pharmaceutical company representatives provide drug samples to physician offices. These samples may not be sold.
39 Medical Device Amendment of 1976 Requires life-sustaining and life-supporting devices to have premarket approval from the FDA
40 Safe Medical Devices Act (1990) Requires reporting of serious injury, illness, or death caused by medical devices, including:Dialyzers and ventilatorsElectronic equipment and monitorsImplants, syringes, thermometers, and cathetersRestraintsComponents, accessories, software
41 Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) Focused on federal funding of Medicare and MedicaidIncreased the necessity for pharmacy techniciansMandated that pharmacists perform drug utilization reviews (DURs) and offer counseling to patients
42 Omnibus Budget Reconciliation Act of 1990 Requires pharmacists to offer to discuss prescription information with Medicaid and Medicare patientsLimits Medicare/Medicaid reimbursement to drugs approved as safe and effective
43 Combat Methamphetamine Epidemic Act of 2005 (CMEA) Regulates retail over-the-counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine products, including:Daily sales limits30-day purchase limitsPlacement of product out of direct customer accessSales logbooksCustomer ID verificationEmployee training
44 Health Insurance Portability and Accountability Act of 1996 Also known as HIPAA; has four parts:Electronic health transaction standardsUnique identifiersSecurity and electronic signature standardsPrivacy and confidentiality standards
45 Health Insurance Portability and Accountability Act of 1996 (HIPAA) Enacted to ensure patient confidentiality and privacyGave patients the right to review their medical recordsEstablished the requirement of patient consent for the transfer of medical records
46 Mike Gallitelli / Pearson Education / PH College Figure The electronic transmission and storage of medical records is protected by the Health Insurance Portability And Accountability Act.
47 FDA Modernization Act of 1997 This act focused on safe pharmacy compounding, user fees, food safety, and medical devices.It gave patients increased access to experimental drugs and devices.It also gave extension to manufacturers developing new pediatric drugs.
48 Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.) Defines protected health information (PHI) as:Any information created or received by the pharmacyInformation relating to a patient’s health—mental or physical; past, present, or futureInformation that may identify a patient
49 Medicare Modernization Act of 2003 This act created new “Advantage” plans providing better patient care.It partially privatized Medicare.Medicare Part D was established to cover FDA-approved drugs, and is a voluntary program with varied plans and co-payment amounts.
50 Combat Methamphetamine Epidemic Act of 2005 This act was designed to stop illegal use of methamphetamine and regulated trafficking of this drug and others, when these activities are used to finance terrorism.Ingredients used to manufacture methamphetamine are now limited for sale, and buyers must be registered with the U.S. Attorney General.
51 Federal AgenciesFood and Drug Administration (FDA): part of U.S. Department of Health and Human Services; controls all drugs for legal useDrug Enforcement Administration (DEA): part of the Federal Bureau of Investigation (FBI); enforces controlled substance laws
52 Federal AgenciesCenters for Disease Control and Prevention (CDC): ensures infection control regulations and provides statistics and information to health professionals about disease treatment
53 Food and Drug Administration (FDA) Reviews/approves new drugs, generic equivalents, and therapeutic indications for existing medications
54 Food and Drug Administration (FDA) (cont.) Responsible for protecting public healthAssures safety, efficacy, and security of:DrugsBiological productsMedical devicesFoodCosmetics
55 Drug Enforcement Administration (DEA) Regulates legal trade in narcotic and dangerous drugsManages national narcotics intelligence systemWorks with other agencies to support drug traffic preventionShares jurisdiction over drug offenses with Federal Bureau of Investigation (FBI)
56 Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Evaluates and accredits nearly 15,000 healthcare organizations and programsEstablishes and enforces standards that improve quality and safety of healthcare organizations
57 Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (cont.) Evaluates and accredits:HospitalsHospice facilitiesNursing homesLong term care facilitiesRehabilitation centersOther healthcare organizations
58 State LawThe states are the main regulators of laws governing pharmacy practice.No one may practice pharmacy without a state license except those exempted by state legislation.Certificates of registration are granted for 1 or 2 years in most states.
59 State Board of Pharmacy (SBOP) State agency that registers and regulates:Pharmacy facilitiesPharmacistsPharmacy techniciansResponsible for the actual practice of pharmacy within state domainGranted the authority to monitor, reprimand, and revoke licensures
60 Ethics and Pharmacology Ethics: standards of behavior that encompass the concepts of right and wrong beyond a given situation’s legal considerationsConfidentiality: health professionals must maintain strict confidentiality
61 Ethics and Pharmacology Health-care workers must know laws of state in which they work, including rules that apply to phoning prescriptions to pharmacists.
62 EthicsThe considered reflection and systematic analysis of the morality of certain behavior when required actions are unclear
63 Ethics Derived from the Greek word ethos, referring to one’s character Discipline of evaluating the merits, risks, and social concernsCommonly defined as considered reflection or systematic analysis when required actions are unclear
64 Ethics (cont.)Based on certain universal principles such as justice, doing no harm, etc.Ethics are not morals, but can be influenced by personal morals
65 Ethical DecisionsNot clear-cut, either/or, correct or incorrect (binary) decisionsRequire a balance between a professional code of ethics and personal moralsAre not emotional reactions, but courses of conduct that have been weighed and measured carefully
66 Pharmacy Technician Code of Ethics, Part 1 Health and safetyEnsure the health and safety of the patientNever assist in dispensing or distributing medications or devices that are not of good quality or do not meet the standards required by law
67 Pharmacy Technician Code of Ethics, Part 1 (cont.) Respect and integritySupport and promote honesty and integrity in the professionRespect and value the abilities of other healthcare professionalsRespect and support the patient’s individuality, dignity, and confidentialityRespect the confidentiality of the patient’s records
68 Pharmacy Technician Code of Ethics, Part 2 Professional developmentUse knowledge and skills to serve othersMaintain competency and continually enhance professional expertiseDo not engage in any activity that will discredit the professionAssociate with organizations that promote the profession of pharmacy
69 Reasonable Standards of Care Always maintain reasonable standards of patient care regarding medication management duties.
70 Ensuring Clarity of Orders Ensure that orders and prescriptions clearly include in writing the drug’s:NameDosageRouteFrequency of administrationEnsure that prescriber signed the order
71 Ensuring Specificity of Orders An order or prescription must clearly state the specific circumstances and conditions under which the drug must be given.Do not accept nonspecific orders, such as “if needed,” “if indicated,” or “as warranted.”
72 Label vs. Labeling The Label of a Drug A display of written, printed, or graphic matter upon the immediate container; the information on the outer portion of the packageThe Labeling of a DrugAll labels and other written, printed, or graphic matter either upon or accompanying the drugBroader in scope – includes the package insert
73 Labeling Requirements – Dispensed Prescriptions Pharmacy name and addressSerial (Rx) numberDate of fillExpiration datePrescriber’s namePatient’s nameDirections for useCautionary statements (if needed)
75 Label Requirements – Legend Drugs Established name and quantity of each active ingredientStatement of new quantityStatement of usual dosageFederal legendRoute of administrationIn the case of habit-forming drugs – the federal warningName of all inactive ingredients (if not oral)Unique lot/control numberStatement specifying the type of container to be used in dispensingName/address of manufacturer/distributorExpiration date, if applicable
76 Labeling Requirements – Legend Drugs Description (chemical structure)Clinical pharmacologyIndications and usageContraindicationsWarningsPrecautionsAdverse reactionsDrug abuse and dependenceDosageStatement as to how suppliedDate of the most recent revision to the labeling(in addition to the label requirements)
77 Monographs Commonly known as package inserts A necessary component of drug labelingProvides all the clinical information required by the FDA
78 Figure 4.4Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)
79 Figure 4.4 (continued)Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)
80 Figure 4.4 (continued)Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)
81 Figure 4.4 (continued)Sample package insert, or monograph, for Keppra® injection. (Courtesy of UCB, Inc.)
82 Labeling Requirements – OTC Drugs Product nameName/address of manufacturer/distributorEstablished name of all active ingredients and the quantity of certain ingredientsNet contentsRequired warnings/cautionsThe name of any habit-forming drug contained in the formulaAdequate directions for use