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Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
Chapter 3 drug regulation and control
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Chapter 3 drug regulation and control

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  • Chemical name-chemical structure Generic name-common name of the active drug In the orange book in terms of active ingredient and dosage forms as well as route of administration and strength—2 letter code Trade or brand name-original drug FDA requires the same stipulations for generic drugs as for brand-name drugs Requires the drug data is bioequivalent to the one used in original safety and efficacy testing FDA reviews the active and inactive ingredients, tests the actual drug product, reviews the labeling, periodically inspects the manufacturing plant, monitors drug quality after approval. Cost savings of 30-50 percent less than the brand
  • Chemical name-chemical structure Generic name-common name of the active drug In the orange book in terms of active ingredient and dosage forms as well as route of administration and strength—2 letter code Trade or brand name-original drug FDA requires the same stipulations for generic drugs as for brand-name drugs Requires the drug data is bioequivalent to the one used in original safety and efficacy testing FDA reviews the active and inactive ingredients, tests the actual drug product, reviews the labeling, periodically inspects the manufacturing plant, monitors drug quality after approval. Cost savings of 30-50 percent less than the brand
  • Give some examples: celexa - celebrex
  • Show students a OTC package
  • For controlled II 3 copies Total list
  • Class I-causes serious adverse effects or death Class II-causes temporary adverse reactions Class III-not likely to cause adverse effects Show student a recall documentation for a manufacturer or wholesaler Recalls-action taken to remove a drug from the market and return it to the manufacturer.
  • Transcript

    • 1. The PharmacyTechnician 4E Chapter 3Drug Regulation and Control
    • 2. Chapter Outline Drug Regulation New Drug Approval Marketed Drugs Behind-the-counter Medications Sample Labels Controlled Substances DEA forms Public Safety Law and the Technician
    • 3. Brief History of Statutory Pharmacy Law In the 19th century, drugs in the United States were unregulated.  Medicines did not require proof that they were either safe or effective.  Most agents contained a high content of alcohol.  Some caused injury or death. To combat abuses in both formulation and labeling, in 1906 the U.S. Congress passed the first of a series of landmark 20th century laws to regulate drugs.
    • 4. Pure Food and Drug Act of 1906 The purpose of the Pure Food & Drug Act was to prohibit the interstate transportation or sale of adulterated and misbranded food and drugs.  Adulterated is impure by adding extraneous, improper, or inferior ingredients.  Misbranded to brand or label misleadingly or fraudulently. Did not require drugs to be labeled, but required that drug labels not contain false information about the drugs’ strength and purity. Proved unenforceable and new legislation was required.
    • 5. Harrison Tax Act 1914 Established that manufacturers, pharmacists, importer, and physicians prescribing narcotics should be Licensed and required to pay a tax. The law enacted in response to growing opiates and cocaine-containing medications.
    • 6. Food, Drug, and Cosmetic (FDC) Act of 1938 Sulfa poisoning caused the death of 107 people, primarily children.  Due to untested sulfanilamide concoction.  In response to this event, FDC was introduced. FDC is the most important piece of legislation in pharmaceutical history. Required only that drugs be SAFE for human consumption before marketing.
    • 7. Food, Drug, and Cosmetic (FDC) Act of 1938 Gave FDA the power to conduct inspections of manufacturing plants to ensure compliance. Act applied to interstate transactions, as well as to intrastate transactions. FDA required pharmaceutical manufacturers to file a new drug application (NDA) with each new drug before marketing.
    • 8. Durham-Humphrey Amendment of 1951• States that drug containers do not have to include “adequate directions for use” as long as they include • “Caution: Federal Law Prohibits Dispensing Without Prescription.” • Now, “Rx Only.”• Distinguished between • Legend (prescription) drugs. • Over-the-counter (OTC) (non-prescription) drugs.• Authorized • Verbal prescriptions. • Prescription refills.
    • 9. Kefauver-Harris Amendment of 1962 In 1962 a new sleeping pill containing the drug THALIDOMIDE was found to cause severe birth defects when used during pregnancy (Europe). Extended the FDC Act of 1938 to require that  Drugs not only be safe for humans but also be EFFECTIVE. Requires drug manufacturers to file  An investigational new drug application (INDA) with the FDA before initiating a clinical trial in humans.  Once proven safe and effective, manufacturer may submit an NDA seeking approval to market the product.
    • 10. Poison Prevention Packaging Act of 1970 Passed to prevent accidental childhood poisonings from prescription and nonprescription products. Enforced by the Consumer Product Safety Commission. Requires most over-the-counter (OTC) and legend drugs to be packaged in child-resistant containers.  Cannot be opened by 80% of children under five.  Can be opened by 90% of adults. Older patients or people with a disability may request a non-child-resistant container; other exceptions are provided for by law.
    • 11. Comprehensive Drug Abuse Prevention and Control Act of 1970 Commonly referred to as the Controlled Substances Act (CSA). Created to combat and control drug abuse and to supersede previous federal drug abuse laws. Created the Drug Enforcement Administration (DEA), an arm of the Department of Justice.  Charged with enforcement and prevention related to the abuse of controlled substances like many narcotic pain medications.
    • 12. Comprehensive Drug Abuse Prevention and Control Act of 1970 Classified drugs with potential for abuse as controlled substances. Ranked controlled substances into five categories, or schedules.  Ranging from those with great potential for abuse (Schedule I) to those with little potential (Schedule V).  Narcotics are highly regulated.
    • 13. Comprehensive Drug Abuse Prevention and Control Act of 1970Schedule Medical Use Examples I For research only – not Heroin, LSD approved for human use II Dispensing severely restricted Morphine, oxycodone, meperidine III Prescriptions can be refilled Codeine with aspirin, up to 5 times in 6 months anabolic steroids IV Same as for Schedule III Benzodiazepines, meprobamate V Some sold w/o a prescription; Liquid codeine must be 18 combination preps.
    • 14. Drug Listing Act of 1972 Gives the FDA the authority to compile a list of currently marketed drugs. Each drug is assigned a unique and permanent product code  Known as a National Drug Code (NDC).  Ten characters that identify manufacturer or distributor, drug formulation, size and type of packaging. FDA requests, but does not require, that the NDC appear on all drug labels.
    • 15. 1976 Medical Device Amendment The Medical Device Amendment requires pre-market approval of safety and effectiveness of life sustaining and life supporting medical devices.
    • 16. Orphan Drug Act of 1983 An orphan drug is intended for use in a few patients with a rare disease or condition.  Developing such a drug would be prohibitively expensive, given the small market. The Orphan Drug Act encourages the development of orphan drugs by:  Providing tax incentives.  Granting manufacturers exclusive license. Over 250 orphan drugs have been approved by the FDA.
    • 17. Drug Price Competition and Patent-Term Restoration Act of 1984 Also called Hatch-Waxman Act. Allows substation of generic drugs with the same chemical composition as brand name products. Once the original patent expires, any manufacturer may market a generic drug.  Usually is less costly than the brand name. A given drug typically has several names.  Generic name is a common name given to a drug regardless of brand name.  One or more brand names under which the manufacturer markets a drug.
    • 18. Prescription Drug Marketing Act of 1987 PROHIBITS  Re-importation of a drug into the United States.  United States seniors getting prescription medication from Canada, Mexico, or other countries. PROHIBITS  Sale or trading of drug samples. PROHIBITS  Distribution of samples in response to prescription drug samples being illegally diverted and distributed.  To persons other than those licensed to prescribe them except by mail or by common carrier.
    • 19. Omnibus Budget Reconciliation Act of 1990 (OBRA-90) Requires states to establish standards for Drug Use Review (DUR) by the pharmacist. Requires pharmacists to offer counseling to Medicaid patients. Requires a manufacturers rebate to state Medicaid program between the manufacturer’s best price for a drug (typically the wholesale price) and the average billed price.
    • 20. Health Insurance Portability and Accountability Act (HIPAA) of 1996 Defines the scope of health information that may or may not be shared among health care providers without patient consent. Provided for broad and stringent regulation to respect “Patient’s right to privacy.” Affects the confidentiality of patient medical records.  Placed safeguards to protect patient confidentiality.  Requires healthcare facilities to provide information to the patient on how they protect the patient’s health information.
    • 21. Health Insurance Portability and Accountability Act (HIPAA) of 1996In pharmacy, HIPAA requirements include : Restrictions on transmission of prescription data. Provision of a private area for counseling. A training program for employees about confidentiality.For pharmacy technicians, HIPAA means : Must not reveal any information on any patient outside the pharmacy.  Violations would be grounds for immediate termination and legal action.
    • 22. Food & Drug Administration Modernization Act Authorizes fees to be added to a new drug application (NDA) process to accelerate the review and approval process for new drugs. Updates the labeling on prescription medications .  Products labeled “legend” are to be changed to read “Only.”  LEGEND is the term that has been used to indicate whether a drug was available by prescription or over-the-counter (OTC).  New labeling requirements were implemented in 2004.
    • 23. The FDA’s Center for Drug Evaluation & Research Provides an Index to Drug-Specific Information with patient, consumer and healthcare professional information sheets, including FDA Alerts. Works with drug manufacturers to develop risk management programs for drugs with FDA.  Alerts, such as the iPLEDGE program for Accutane. Health care professionals, wholesalers, pharmacies and patients must register in the iPLEDGE program to prescribe , distribute, fill prescriptions, or use Accutane.
    • 24. New Drug Approval All new drugs (domestic or imported) require FDA approval before they can be marketed in the US. Before approval, new drugs must be shown to be SAFE and EFFECTIVE and its benefits OUTWEIGH its risks. Drug manufacturers and not the FDA is responsible for proof. The testing process currently takes about 8.5 years. Discovery : 2-10 years. Preclinical testing : laboratory and animal testing. Phase I: 20-80 healthy volunteers. Phase II: 100-300 patient volunteers. Phase III : 1,000-5,000 patients volunteers. FDA review/approval Approved by FDA: 17 years. Post-marketing testing Five year extension on patent (Hatch-Waxman Act of 1984).
    • 25. New Drug Approval Process Placebo  Inactive substance: not real medicine administrated  Gives the impression that they’re receiving the real medicine.  Used to compare against patients with the test drugs Investigational New Drug Application (INDA)  An application submitted to FDA by the manufacturer before initiating a clinical trial in humans. New Drug Application (NDA)  Once proven safe and effective, manufacturer may submit an NDA seeking approval to market the product.
    • 26. Testing Phases Begins in the laboratory for chemical analysis. Animal testing (preclinical testing)  Use animals and treat them as humanly as possible.  Test using different species.  Only a fraction of the drugs tested on animals reach clinical trials stage. Clinical trials with humans  INFORMED CONSENT is required for each patient before enrolling into clinical trials.  Requires for the patient to be told all the risks and other treatment options in a language they understand.  Patients should also be free to leave the trial at any time.
    • 27. Clinical Trial Testing Phase I  20-100 patients.  Several months.  The main purpose is to study SAFETY.  Only about 25% of drugs tested in phase 1 successfully reach the market. Phase II  Up to several hundred patients.  Several months to two years.  The main purpose is short-term SAFETY AND EFFECTIVENESS.
    • 28. Clinical Trial Testing Cont. Phase III  Several hundred to several thousands patients.  1-4 years.  The main purpose is safety, dosage, and effectiveness. Phase IV  Begs after the drug is approved.  Life time of the drug.  The main purpose is for safety.
    • 29. Clinical Trials Special “Treatment Status”  Permission given to administer drugs in patients outside the clinical trials for relief to a critically ill patient without a better proven drug.  E.g. AZT for AIDS in early 1990’s. Controlled Trial  Group of patients (with similar condition or disease) who are given a placebo (or no drug) and used to compare the effect of the test drug.  Groups are placed on controlled or treatment arm randomly. Blind Trial  The patient or the doctor who is treating the patient does not know which arm of the study a particular patient is on.
    • 30. Marketed DrugsPatent is a right given to a manufacturer to exclusively market a new product for a specific period of time under a brand name. A patent is good for 17 years.Hatch-Waxman Act of 1984 Extends patient up to 5 years to compensate for lost time in research before going to market. While the drug is under patent, a generic drug will NOT be marketed by other companies.
    • 31. Marketed Drugs Medical devices and biological products such as insulin and vaccines must also meet FDA testing and approval requirements. The Center for Devices and Radiological Health (CDRH) is responsible for devices. The Center for Biologics Evaluation and Research (CBER) is responsible for biological products made from living organisms.
    • 32. Marketed DrugsGeneric drugs are Pharmaceutically Equivalent is identical to the brand-name product listed in the orange book (FDA’s Approved Drugs Products publication) in terms of Active ingredient. Dosage form. Route of administration and strength.Therapeutically equivalent is the body uses of the drug is the same.
    • 33. Look Alike and Sound Alike Drugs Federal laws require containers NOT to look like another drug, however some drugs look alike and sound alike. Safe ways to check the correct drug being dispensed is to check the NDC number on the container against the NDC number on the prescription label.
    • 34. Over-the-Counter (OTC) Drugs OTC drugs have to be approved by the FDA . Can be used upon the judgment of the consumer without a prescription from a physician. There are over 100,000 OTC drugs in 80 therapeutic categories. The manufacturer has to follow a format called drug monograph to be able to market with proper label including: • Active ingredient • Direction for use • Amount of content • Warnings • Expiration date
    • 35. Sample OTC Label
    • 36. Behind-The-Counter OTC Medications Medications sold without a prescription, but with RESTRICTION on their sales. Kept behind the pharmacy counter. Limitation: 3.6 grams per day and 7.5 gram per month. E.g. Pseudoephedrine and Ephedrine containing products.
    • 37. Combat Methamphetamine Epidemic Act Requires that cold and allergy medicine containing these ingredients be kept behind the counter. Set daily and monthly amount restrictions. A sales record (written or electronic) must be kept for a period of 2 years. The record should contain:  Drug name  Quantity  Name and address of purchaser  Date and time of the sale  Proof of ID  Signature of the purchaser.
    • 38. Exempt Narcotics Sold by a pharmacist without a prescription.  E.g. Cough syrups that contain a small amount of codeine. Only pharmacists can approve their dispensing. Purchasers have to:  Be at least 18 years old.  Provide identification Document the sale in a bound record book (name and address of the purchaser, drug name and quantity, date, name or initial of the pharmacist.)
    • 39. Emergency Contraceptives Plan B®  Has a dual marketing status (both Rx and OTC).  Prescription >17 years old.  OTC < 17 years old. Exception  Pharmacists in some states have authority to prescribe and dispense under protocol to patients under 17 years old.
    • 40. Manufacturing Label brand & generic names NDC number Manufacturer’s name & address Dispensing StoragerequirementsLot Number& Exp Date Legend statement controlled substances mark PT 3:3
    • 41. Product Labeling Package Inset – is prescription information which comes with a document on the drug product. Includes:  Clinical pharmacology,  Indications,  Contraindications,  Warnings,  Adverse reaction, and  Other related information. Intended for health care professionals who prescribe or dispense the product Is contained in a reference book called Physician Desk Reference (PDR).
    • 42. National Drug Code (NDC Number) NDC 01234-5678-90 Identification number assigned by the manufacturer to a drug product. Has 3 sets of numbers.  1st five digits - manufacturer.  2nd four digits - medication strength and dosage form.  3rd two digits - package size.
    • 43. Prescription Bottle
    • 44. F A C D K E I H J BA: Rx number H: Number of refills remainingB: Prescribing physician I: Manufacturer of the drugC: Date J: Expiration dateD: Patient Name K: Direction for useE: Drug Name, strength, dosage formF: Pharmacy Name, Address, and phone numberG: Quantity
    • 45. Controlled Substances Drugs that have an abuse potential. Enacted in 1970 by Controlled Substance Act (CSA) . Five groups (or schedules) of such drugs and put a strict guideline on their distribution. Requires to register with the Drug Enforcement Administration (DEA) of the Justice Department.
    • 46. DEA Registration Each pharmacy registers.  Pharmacy employees are not required to register.  Registration varies from 1 to 3 years in length. Laws vary from state to state.  some state laws are more stringent than the federal CSA.  the most stringent of the laws will be followed  If federal law is more stringent, it is followed.  If state law is more stringent, it is followed.
    • 47. Drug Enforcement Administration (DEA)  Issues licenses  To medical practitioners to write prescriptions for scheduled drugs.  To pharmacies to order scheduled drugs from wholesalers.  Distributors to distribute controlled substances.  Inspects medical facilities, including pharmacies.  Tracks narcotics from manufacturer to warehouse to pharmacy.
    • 48. DEA Regulations Manufacturers must label controlled drugs using the letter “C.”  e.g. C-II, C-III, etc. Record keeping  Schedule II – 7 years  Others – 2 years Storage  Schedule II – should be kept separately in a locked, and tamper-proof narcotic cabinet secured to the floor or wall.  Schedule III-V can be stored on the shelf with other prescription drugs.
    • 49. Dispensing of Schedule II Drugs Prescriptions for Schedule II substances must be hand- signed by the prescriber except in emergencies.  To minimize fraudulent use.  To maintain a record-tracking system. An emergency supply of a Schedule II drug (72 hours supply) can be provided to a patient without a written prescription in most states.
    • 50. DEA Form 222 Used to order C-I and C-II. Must be signed by a registered person. Three copies:  Copy 1: Blue copy is retained by the supplier.  Copy 2: Green copy is sent to the DEA.  Copy 3: Brown copy is kept for your records. Must be kept in a separate file from other invoices. Note that C-III - C-V does not require federal order forms. Form has its own unique serial number. Form can be requested online.
    • 51. DEA Form 222 PT 3:5
    • 52. DEA Numbers Assigned to prescribers for controlled drugs. Two letters and seven digits . First letter is a code identifying the type of registrant. Second letter is the initial of the registrants last name. Seventh digit is a “checksum" that is calculated.
    • 53. DEA Numbers Example: AR4342793  Add 1st +3rd +5th number = ___.  Add 2nd+4th +6th number = ___ multiply by 2 =__.  Then add ____+____=____. The total should be a number whose last digit is the same as the last digit of the DEA number. AR4342793  (4+4+7=15 3+2+9=14 14x2=28 then 15+28=43).
    • 54. Drug Enforcement Administration (DEA) Branch of the U.S. Justice Department responsible for regulating sale and use of drugs with abuse potential.  Responsible for enforcing laws regarding both legal and illegal addictive substances.  Directs most of its efforts toward illegal drug trafficking.  Supervises legal use of narcotics and other controlled substances.
    • 55. Controlled Substance Prescriptions The DEA number must appear on the form and the patient’s full name and full street address must be entered. NO REFILL is allowed on Schedule II prescriptions. When filling the prescription, the pharmacist draws a line across the prescription indicating it has been filled.
    • 56. Federal LawsA prescription for a controlled substance must meetthe following requirements. Patient’s full name and address. Practitioner’s name, address, and DEA#. Drug name, strength, dosage form, quantity, directions, and refills. Must be written in ink or typewritten and signed by prescriber. Controlled substance must be dated on the date of issuance.
    • 57. Federal LawsSchedule III, IV, and V Prescriptions May be verbal, written, or faxed and may be refilled if authorized by the prescriber. Schedule III and IV may be refilled up to 5 times within 6 months. Schedule V may be refilled as directed by the prescriber. Schedule II requires a written prescription by the prescriber that is signed and is not refilled.
    • 58. Food and Drug Administration (FDA) Primary responsibility and authority is to enforce the law and create regulations to assist in providing the public with safe drug products. Requires all manufacturers to file applications for investigation studies and approval of new drugs. Oversees the recall of dangerous products. Has no legal authority over the practice of pharmacy in each state (is a responsibility of the BOARD OF PHARMACY).
    • 59. Public Safety FDA approval process is quite thorough, but it is impossible to fully prove that a drug is safe for use. The FDA has several options if it determines that a marketed drug presents a risk of illness, injury, or gross consumer deceptions. Requests healthcare professionals and the public to report any adverse effects of drugs once they are marketed. FDA seizes the drug, stops distribution, or may issue a recall of the drug.
    • 60. MedWatch Allows any healthcare professional to report a serious adverse event that is suspected of being associated with the use of an FDA-regulated product.  Includes product problem, or medication error. A voluntary program. Designed to detect side effects not identified from research studies. Manufacturers must file a report if an adverse drug reaction is reported. Reports can be made.  Phone 1-800-FDA-0178, by mail, or online.
    • 61. Public Safety Adverse Effect  Unintended side effect of a medication that is negative or in some way injurious to a patient’s health. Injection  Court order preventing a specific action.  E.g. the distribution of potentially dangerous drugs.
    • 62. Recalls Removal of a drug from the market based on report .  Can be prescription or over-the-counter from the market.  Can be from the public or healthcare professionals  Adverse drug effect can be reported to the Manufacturer or to the FDA. Steps 1. FDA will contact the manufacturer. 2. Manufactures contact wholesalers, retailers, and all consumer levels. 3. Personal phone calls are made or letters are sent to customers. 4. Recalls are listed publicly. 5. Listed in the weekly FDA enforcement report.
    • 63. Types of RecallsClass I: Serious adverse effects or death.Class II: Cause temporary but reversible effects.Class III: Not likely to cause adverse effects.
    • 64. Vaccine Adverse Event Reporting System (VAERS) Vaccine Adverse Event Reporting Systems (VAERS)  MedWatch does not monitor vaccines.  Performed by VAERS.  Post-marketing surveillance system operated by the FDA and the Centers for Disease Control (CDC). Report  (1-800-822-7967), online, or submitted by mail on a downloaded form.
    • 65. Law and the Technician Federal laws provide foundation for the state laws which governs pharmacy practice.
    • 66. State Laws Responsible for licensing of all prescribers and dispensers. Each state enacts laws governing the manufacturer, distribution, prescription, and dispensing of prescription drugs. Pharmacists must comply with both federal regulations and regulations in the state(s) in which they practice. Such regulations may reside in different departments of the state, such as the board of pharmacy, the department of health, or consumer affairs.
    • 67. State Boards of Pharmacy Composed of leaders from the pharmacy community and the public. Activities vary from state to state .  Can suspend or revoke pharmacy/pharmacist license or registration.  Provide regulations regarding the practice of pharmacy.
    • 68. State Boards of Pharmacy &Legal Duties of Pharmacy Personnel No statutory federal definition of the role of the pharmacy technician exists.  No uniform definition of role and duties of pharmacy technicians from state to state.  Roles and duties of pharmacy technicians are changing. Requirements for pharmacy technicians vary by state.  Some states require licensure or registration with the board.  Some states require passing national certification exams.  Technicians duties in all states must be carried out under the direct supervision of a licensed pharmacist.
    • 69. Law and the Technician Legal liability means you can be prosecuted for misconduct or negligence. Misconduct means a wrongful, improper, or unlawful conduct motivated by premeditated or intentional purpose. Negligence is the most common form of misconduct.  Refers to failure to do something that should or must be done.  Incorrect labeling, failure to maintain patient confidentiality.  Failure to recognize expired drugs.  Calculation errors.  Dispensing wrong medication.  Incorrect handling of controlled substance.  Inaccurate record keeping. Compliance is doing what is required.
    • 70. American Society of Health-System Pharmacists (ASHP) One of the various professional bodies and associations which set and maintain pharmacy standards. Over 30,000 members primarily practice in hospitals. Serves as an accrediting organization for pharmacy residency and pharmacy technician training programs.
    • 71. Drug and Professional Standards United States Pharmacopeia (USP)  Independent scientific not-for-profit organization.  Sets quality standards for prescription drugs, OTC drugs, and dietary supplements. United States Pharmacopeia  Official publication of USP.  Develops authoritative, unbiased information on drug use.
    • 72. JACHO Joint Commission on Accreditation of Health Care Organizations. Independent non-profit organization. Establishes standards and monitors compliance Monitors over 20,000 health care programs. Covers hospital, health care networks, HMOs, and nursing homes.
    • 73. National Association of Boards of Pharmacy (NABP) The NABP represents all 50 state boards of pharmacy.  Assists in developing, implementing, and enforcing uniform standards.  Develops licensing exams for pharmacists. Coordinates reciprocation of pharmacist licenses from one state to another. Meets regularly to discuss national trends and issues in pharmacy law.
    • 74. National Association of Boards of Pharmacy (NABP) Verifies the licensure of online pharmacies.  Internet VIPPS® program (Verified Internet Pharmacy Practice Sites). NO regulatory authority, unlike the FDA or DEA. Coordinates issuance of “NCPDP Provider ID.”  Assigned a unique number to pharmacies in the United States and territories of the United States.  Identifies your pharmacy to health plan claims processors and third party contractors. Developed the Model State Pharmacy Practice Act (MSPPA).
    • 75. Others Basic criminal and civil laws apply to pharmacy technicians. Crimes like theft, discrimination, sexual harassment, fraud, etc. are punishable just as they would be outside of your job.
    • 76. Terms to Remember1. Adverse effect 10. Liability2. Combat methamphetamine 11. NDC (national drug code) epidemic act (CMEA) 12. Negligence3. Compliance 13. Pediatric4. Controlled substance mark 14. Pharmaceutical equivalent5. Controlled substances 15. Placebo6. Dual marketing 16. Product labeling7. Exempt narcotics 17. Protocol8. Injunction 18. Recall9. Legend drug 19. Therapeutic equivalent
    • 77. Terms to Remember20. Pure Food and Drug Act of 190621. Food, Drug, and Cosmetic (FDC) Act of 193822. Durham-Humphrey Amendment of 195123. Kefauver-Harris Amendment of 196224. Comprehensive Drug Abuse Prevention and Control Act of 197025. Poison Prevention Packaging Act of 197026. Drug Listing Act of 197227. Orphan Drug Act of 198328. Drug Price Competition and Patent-Term Restoration Act of 198429. Prescription Drug Marketing Act of 198730. Omnibus Budget Reconciliation Act of 1990 (OBRA-90)31. Health Insurance Portability and Accountability Act (HIPAA) of 199632. Medicare Prescription Drug, Improvement, and

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