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PHAR 1010 Ch 4

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Sarah Inman

on 21 February 2013

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Transcript of PHAR 1010 Ch 4

Pharmacy Law and Ethics Constitutional Law Statues & Regulations Criminal Law Civil Law CMS regulates the administration of Medicare, Medicaid, State Children's Health Insurance Program, Health Insurance Portability Act, & several other health-related programs--conduct inspections to make sure guidelines are being followed. State & Federal Functions Federal government determines the extent of medical practice regulations are consistent throughout the 50 states. The Food, Drug, & Cosmetic Act
of 1938 FDCA Purpose: limit trade (interstate commerce) in drugs to only drugs that are safe and effective. The Poison Prevention Packaging Act of 1970 I. A pharmacy technician’s first consideration is to ensure the health and safety of the patient, and to use knowledge and skills to the best of his/her ability in serving patients II. A pharmacy technician supports and promotes honesty and integrity in the profession, which includes a duty to observe the law, maintain the highest moral and ethical conduct at all times and uphold the ethical principles of the profession. III. A pharmacy technician assists and supports the pharmacists in the safe and efficacious and cost effective distribution of health services and healthcare resources. IV. A pharmacy technician respects and values the abilities of pharmacists, colleagues and other healthcare professionals. V. A pharmacy technician maintains competency in his/her practice and continually enhances his/her professional knowledge and expertise. VI. A pharmacy technician respects and supports the patient’s individuality, dignity, and confidentiality. VII. A pharmacy technician respects the confidentiality of a patient’s records and discloses pertinent information only with proper authorization. VIII. A pharmacy technician never assists in dispensing, promoting or distribution of medication or medical devices that are not of good quality or do not meet the standards required by law. IX. A pharmacy technician does not engage in any activity that will discredit the profession, and will expose, without fear or favor, illegal or unethical conduct of the profession. X. A pharmacy technician associates with and engages in the support of organizations, which promote the profession of pharmacy through the utilization and enhancement of pharmacy technicians. The Pharmacy Technician Code of Ethics Overview of Law All laws passed must adhere to the principles and rights set forth in the U.S. Constitution Statues are laws that are passed by federal, state, or local legislatures. Regulations clarify and explain statues (laws) State Law & Regulations Statues passed by the state must meet federal and state constitutions, be consistent with United States Code & Code of Federal Regulations. May not take away rights established by federal law. Legislative Intent Criminal, Civil, & Administrative Law homicide, illegal drugs, theft, etc. Criminal laws are enforced by state agencies against specific persons or corporations. Victim cannot prosecute criminal personal injuries, medical malpractice, business disputes, land deals, slander, etc. Civil law: lawyer hired by an injured party (plaintiff) against alleged wrongdoer (defendant) Administrative Law Administrative agencies (IRS, Centers for Medicare and Medicaid Services, Social Security Administration) that work with the federal government to enforce laws. State Agencies: State Board of Pharmacy: operate only through the state. Also, refine laws with regulations to leave little room for interpretation (federal agencies)
State agency (SBOP) legislation is more vague giving the agency the authority to determine the details of the regulations. Violations of the Law Misdemeanor: an offense or infraction that is less serious than a felony.
(community service, fine, parole, imprisonment < 12 months) Felony: a serious crime, murder
(typically imprisonment > 12 months) Regulatory Agencies Work with both federal & state levels, oversee pharmacy practices. Centers for Medicare and Medicaid Services Drug Enforcement Agency DEA regulates the legal trade in narcotic and dangerous drugs, manages a national narcotic intelligence system, and works with other agencies to prevent illegal drug trafficking. Food and Drug Administration FDA protects public health by ensuring safe, efficient, security of drugs, biological products, food, cosmetics, and medical devices. Also, reviews & approves new drugs, generics, or new therapeutic indications for existing medications. Regulatory Agencies Joint Commission on Accreditation of Healthcare Organizations JCAHO established and enforces standards that improve the safety & quality of care given by healthcare organizations. Evaluates and accredits hospitals, hospice facilities, nursing homes, etc.. Occupational Safety and Health Administration OSHA oversees the Occupational Safety & Health Act in all 50 states. Enforces protective standards in the work place and provides assistance to workers and employers through technical assistance & consultation programs. State Board of Pharmacy Overview of Pharmacy Law States usually have their own agency to enforce federal laws, but also allows each state to add restrictions to the federal laws. Ex: State license pharmacies and pharmacy professionals determine the standards that pharmacists practice. The Pure Food &
Drug Act of 1906 June 1906, Congress passed a law required federal inspection of meat products, forbid the manufacture, sale, or transport of altered food products or poisonous patent medicines. As time passed, the law became inadequate because it did not: cover cosmetics; require labeling to identify contents of a product; prohibit manufactures making false statements about medications; or give the federal gov't authority to ban unsafe medications. manufactures required to provide evidence that new drugs were safe before they were allowed to sell the drug to the public.
all drugs had to have warnings & directions for use
clinical testing was required of new drugs before sold to the public
diagnostic drugs, therapeutic devices, and cosmetics were regulated for the 1st time. FDCA established an agency within the U.S. Department of Health and Human Services: Food & Drug Administration (FDA) FDCA Many labeling requirements were established by the FDCA: all labels, graphics, package inserts, & other packaging Regulated who can prescribe legend drugs (Rx drugs)
prescriber does not have to be licensed in the state where the Rx is filled (Rx must be valid in that state)
prescriber can authorize an individual to transmit a prescription (nurse call in a new Rx to a pharmacy)
prescriber cannot allow for other individuals to write a new Rx or authorize refills (patient cannot ask nurse for a BP med & the nurse write it for the patient; a refill must be authorized by the physician before a nurse can give the okay) Legend Drugs physicians, surgeons, veterinarians, dentists, physician assistants, nurse practitioners Labeling requirements for dispensed prescriptions:
Pharmacy name & address
Rx #
Date of fill Expiration date
Prescriber's name
Patient's name
Directions
Auxiliary labels Label of a legend drug (from manufacturer)
Established name & strength of active ingredient
Quantity of package
Usual dose
Federal legend (Rx Only)
Route of administration
Federal warning (habit forming) Inactive Ingredients (Rx other than for
oral use) Lot or control #
Expiration date
Type of dispensing container
Name & place of manufacturer, packer, or distributor Package Insert Description (Chemical Structure)
Clinical pharmacology
Indications & usage
Contraindications (when drug shouldn't be used)
Precautions
Warnings of side effects & potential safety hazards
Adverse reactions
Drug abuse and dependence
Dosage
How drug is supplied (tabs, caps, cream, inj, etc)
Date of most resent revision of labeling OTC Label Product name
Quantity of contents Directions for use
Required warnings or cautions Established name of all active ingredients
& qty of certain (active or inactive) ingredients Name & address of the manufacturer, distributor, repackager, & others in chain of commerce Name of any habit forming drug contained in the OTC medication The Durham-Humphrey Amendment
of 1951 (Prescription Drug Amendment) "Caution: Federal Law prohibits dispensing without a prescription" The Kefauver-Harris Amendment of 1962 Drug manufacturers' accountability for efficacy & effectiveness of drugs. Good manufacturing processes
Manufacturers' required to prove safety & effectiveness of drug before marketing new drugs
FDA took control of supervising the advertising of Rx's
Procedures for new & investigative drugs was established Schedule I Schedule V Controlled Drug Schedule Schedule II Schedule IV Schedule III The Comprehensive Drug Abuse
Prevention and Control Act
(1970) Established the DEA Combined all federal laws: narcotics, stimulants, depressants, & abused designer drugs commonly called: Controlled Substance Act (CSA) Highest potential for abuse
No current accepted medical use (U.S.)
OR no current accepted safety standard LSD Marijuana Heroin High potential for abuse
May lead to severe dependence
Current accepted medical use (U.S.) morphine Percocet Adderall XR Concerta Tylox Methadone Duragesic C-II C-I Less abuse potential than C-I, C-II
Moderate physical dependence
OR high psychological dependence
Refill limit to 5; filled within 6 months of the original date C-III Vicodin Lortab Tylenol #3 Testosterone Low potential for abuse
Limited dependence
5 refills; filled within 6 months from written date Valium Klonopin Ambien Xanax Temazepam Low abuse potential
Limited dependence
Refills for 1 year C-IV C-V Lomotil Robitussin AC Promethazine/Codeine Tussionex Lyrica CSA created five classes (schedules) for controlled drugs Prescribing and Dispensing Prescriptions for controlled drugs:
Full name & address of patient
Name, address, phone #, Dr. DEA
Date Issued
Physical signature (no electronically generated)
written in ink, typewriter, or indelible ink Additional Requirements for C-II in GA
Security paper
Each Rx will have a lot number
Additional # that tells which paper it was in the Rx pad C-III & C-IV: have to have original fill date & refill date In GA, C-II Rx's expire 6 months from the written date. In most states C-II Rx's expire within 7 days. CSA continued Registration DEA registration is required to participate in the following: Manufacturing controlled substances
Distributing controlled substances
Dispensing controlled substances
Conducting research with controlled substances
Conducting instructional activities w/ controlled substances
Conducting narcotic treatment programs
Conducting chemical analysis w/ controlled substances
Importing or exporting controlled substances
Compound controlled substances Initial registration is granted for a period of 28 to 39 months; then must be renewed every 36 months. A DEA number is given to each registrant (used within the DEA's closed system) Ordering To Order C-I & C-II drugs:
Triplicate DEA Form 222
OR submit a request online using the DEA Controlled Substance Ordering System *pharmacy technicians may not order C-I or C-II drugs Record Keeping "on-hand" inventory of controlled substances
Twice yearly inventory of controlled substances Exact quantities are required to be kept for C-I & C-II's 3 different Rx filing methods:
One: 3 drawers; C-II; C-III, C-IV, CV; all other Rx's
Two: 2 drawers; C-II, C-III, C-IV, C-V; all other Rx's
C-III, C-IV, C-V must have red C stamped in lower right corner
Three: 2 drawers; C-II; C-III, C-IV, C-V, all other Rx's Reporting Theft of controlled substances must be reported to the DEA & local police. Disposal of controlled substances must be reported to the DEA using DEA Form 41 Inspections All reports, forms, prescriptions, physical inventories, containers, labels, and equipment pertaining to controlled substances DEA can also take inventory of all controlled substances or inspect security systems. (& large discrepancies (5%) is missing) Statutory & regulatory laws are based on the legislators intention & meaning of a law. In case law, the meaning of a section or particular wording is studied and discussed to determine how to appropriately enforce the intent. (Justices & Judges) SBOP registers and regulates pharmacists, pharmacy technicians, and pharmacy facilities. Each state is required to establish and maintain a state pharmacy practice act that regulates the practice of pharmacy within that state. SBOP also has the ability to revoke or fine pharmacists, pharmacy technicians, and pharmacy facilities for not following the regulations. http://rules.sos.state.ga.us/pages/GEORGIA_STATE_BOARD_OF_PHARMACY/PHARMACY_TECHNICIANS_AND_OTHER_PHARMACY_PERSONNEL/index.html PPPA states that all prescription (legend) and controlled drugs must be dispensed in childproof packaging. Patients that prefer non-childproof packaging must sign a written request to the pharmacy stating such.

**exceptions sublingual nitroglycerin, birth control, medications dispensed to admitted patients in the hospital The Omnibus Budget Reconciliation Act of 1990 The Anabolic Steroid Control Act of 1990 The Dietary Supplement Health and Education Act of 1994 The Prescription Drug Marketing Act of 1987 The Drug Price Competition and Patent Term Restoration Act
of 1984 The Orphan Drug Act
of 1983 The Acts Continue The Occupational Safety and Health Act of 1970 The Drug Listings Act of 1972 The Medical Device Amendment
of 1976 The Health Insurance Portability and Accountability Act
of 1996 The Combat Methamphetamine Epidemic Act of 2005 A drug or device that is in a physical condition other than the one intended from the manufacturer. misrepresentations made from the manufacturer about the medication or device OR fraudulent labeling Adulteration Versus Misbranding Ethics & the Pharmacy Technician OSHA makes sure that employers provide its workers with a safe and healthy environment to work in--free from toxic chemicals, unsanitary conditions, mechanical dangers, etc OSHA created the National Institute for Occupational Safety and Health (NIOSH) to research and establish standards for workplace safety and health. This act added and improved the FDCA of 1938 to require that all manufacturers, repackagers, and distributers:
to register their products
list all commercially marketed drug products with the FDA
This applies to human & veterinary drugs, and medicated animal feed premixes. Each drug is assigned a National Drug Code (NDC) Requires that the safety and effectiveness of life-sustaining
& life-supporting devices have premarket approval from the FDA. *respirator, dialysis machine, pacemakers Offered incentives to stimulate the development of drugs for rare diseases (< or equal to 200,000 affected people).
7 year market exclusive to sponsors of approved orphan products
50% tax credit of the cost of human clinical trails
federal research grants for clinical testing of new therapies to treat/diagnosis of rare diseases. *In 1997, exemption from the standard drug application or user fees charged by the FDA was given to companies developing orphan products. cystic fibrosis, snake venom poisoning Modern system of generic drugs approval. Generic drug manufacturers can file Abbreviated New Drug Application (ANDAs) to obtain FDA approval for generic alternative for a brand-name medication whose patent will expire soon. Brand-name companies can apply for up to 5 years of a patent extension. --Plavix placed anabolic steroids (Depo-testosterone, Androgel, Axiron, Fortesta, Testim) on the C-III list of the CSA.

Anabolic steroid: any drug or hormonal substance that is chemically & pharmacologically related to testosterone that promotes muscle growth (excluding estrogens, progestins, and corticosteroids) Established legal safeguards to make sure that the distributed prescription medications were safe and effective.
misbranded
adulterated
expired Rx drugs
counterfeit OBRA focused on Federal Funding for Medicare & Medicaid programs. Mandated that pharmacists perform Drug Utilization Reviews (DURs) & provide counseling to patients created a higher need for pharmacy technicians Defines dietary supplements & ingredients
Establishing an outline for safety
Outlines guidelines for information displayed where supplements are sold
Requiring ingredient & nutrition labeling
Provide use for claims & nutritional support statements
FDA has control to create good manufacturing practice regulations establishes an executive level Commission on Dietary Supplements, Office of Dietary Supplements in the National Institutes of Health HIPAA gives patients the right to:
view his/her medical records
have to consent before transferring medical records
patient consent before oral, electronic, and/or written communication to be sent to third parties PHI:
any information received or created by the pharmacy
info. relating to patient's past, present, or future mental or physical health
info. that could identify a patient Regulates the daily & monthly retail sale limits of ephedrine, pseudoephedrine, & phenylpropanolamine products.
(photo id & log book (written or electronic) is required for purchase)
Products are displayed behind the pharmacy counter. phenylpropanolamine: no longer OTC due to side effects made, stored, packaged, held, or packed in unsanitary conditions
GMP's not followed
contains unsafe color additive
in a container that is made from a poisonous, harmful, or unsafe materials
OTC drugs that are not in taper-resistant packaging Adulteration Misbranded endanger a person's health by taking as directed per the medication package
drug that deteriorates at a more rapid pace (NTG) without proper labeling or precautions letting the consumer know
required information is not placed correctly
Rx: advertisements do not state--side effects, warnings, contradictions, effectiveness, available strengths New Drugs: approval according to the FDCA--have to exempt under the 1963 amendments or approved by the FDA through a new drug application or investigational new drug application. Samples: FDA allows samples of drugs to be given to the prescriber from the manufacturers & distributers by written request from the prescriber. Drug sample: a drug that is restricted to investigational use or has the federal legend; not intended to be sold; any drug that is habit forming Medical Devices: an instrument or machine that is recognized by the National Formulary or U.S. Pharmacopedia. Intended uses: cure, diagnosis, reducing the seriousness of a condition or disease, prevention of disease, affected the structure or any function of the body in an animal or human. Class I: low potential to cause harm--scissors, needles
Class II: thermometers, hearing aids, catheters
Class III: life-support systems Package Inserts (monographs) Description Clinical Pharmacology Indications & Usage Warnings Contradictions Precautions Dosage Drug Abuse and Dependence Adverse Reactions How Supplied Ethical decisions are often made under a professional code of ethics. These decisions are based upon the understanding of moral principles both personal and professional. Medical Ethics: principles & moral values of proper medical care. Moral philosophy: individual set of values or a value system. It leads to a moral reasoning process to help decide right or wrong with regard to conduct. Practicing Ethics Beneficence: to benefit others; bring about good; being kind or charitable Fidelity: faithful to duties and obligations; keeping a promise Veracity: truthfulness; being truthful Justice: acting with fairness or equality; principle of moral rightness Autonomy: self-reliance; being or acting independently Ethical Theories Social Contracts: understood agreement between individual members of society (pharmacist to patient; pharmacist to pharmacy tech) Consequentialism: purpose of all actions is to bring about greatest good to the greatest number (value of an action is based solely upon the value of the consequence) Nonconsequentialism: study of the actions themselves without looking at the outcome (certain actions, in and of themselves, are wrong) The Ethics of Care: decision-maker focuses more on basic moral skills kindness, sensitivity, attentiveness, patience, tact, and reliability (ER refill) Rights-Based Ethics: understanding of human rights--each person has certain moral rights as well as legal rights. Principle-Based Ethics: moral principles are general (rather follow laws or clear cut guidelines) Virtue-Based Ethics: use of virtues, or idealized specific morals to make a decision; right reason for making a decision Law: laws and ethics are closely related and often overlap. The law can create difficulty when trying to make "right decisions" when the decision technically goes against the law. *written by technicians for technicians **American Association of Pharmacy Technicians
and National Pharmacy Technician Association
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