Chapter 3: Pharmacy Law, Regulations & Ethics

Front 1

Patient Protection & Affordable Care Act (Healthcare Reform/Obamacare)

Back 1

• Year: 2010
• Goal of improving patient care quality and outcomes whiles also reducing cost.

Front 2

Food & Drug Act

Back 2

• Year: 1906
• Prohibits interstate commerce in adulterated or misbranded food drinks and drugs.
• Government pre-approval required for drugs

Front 3

Food Drug and Insecticide Administration

Back 3

• Year: 1927
• Law enforcement agency is formed and was renamed in 1930 as the food and Drug Administration.

Front 4

Omnibus Budget Reconciliation Act (OBRA)

Back 4

• Year: 1990
• Requires pharmacist to offer counseling to Medicaid patients

Front 5

Drug Price Competition & Patent Term Restoration Act(Hatch-Waxman)

Back 5

• Year: 1984
• Allows for both the extension of drug patent terms and quicker introduction of lower cost generic drugs.

Front 6

Prescription Drug Marketing Act

Back 6

• Year: 1987
• Restricts distribution of prescription drugs to legitimate commercial channels requires drug wholesalers to be licensed by the states.

Front 7

Health Information Technology for Economic & Clinical Health Act (HITECH)

Back 7

• year: 2009
• Promotes expanded health and technology while improving privacy and security provisions of HIPPA.

Front 8

Harrison Narcotics Tax Act

Back 8

• Year: 1914
• Established that manufacturers pharmacists importers and physicians prescribing narcotics should be licensed and required to pay a tax.

Front 9

Controlled Substance Act (CSA)

Back 9

• Year: 1970
• Classifies five levels of controlled substances that have potential for abuse.
• Establishes the Drug Enforcement Administration (DEA) as a Division of the justice Department.

Front 10

Poison Prevention Packaging Act

Back 10

• Year: 1970
• Requires child proof packaging on all controlled and most prescription drugs dispensed by pharmacies.
• Exempt only by patient or prescriber request.

Front 11

Combat Methamphetamine Epidemic Act

Back 11

• Year: 2005
• Established strict sales of pseudoephedrine ephedrine and phenylpropanolamine.

Front 12

Medical Device Amendment

Back 12

• Year: 1976
• Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices.

Front 13

Fair Packaging & Labeling Act

Back 13

• Year: 1966
• Requires all consumer products in interstate commerce be honestly and informatively labeled.

Front 14

Health Insurance Portability and Accountability Act (HIPPA)

Back 14

• Year: 1996
• A federal act that protects the privacy of individuals and the sharing of protected health information.

Front 15

Kefauver-Harris Amendment

Back 15

• Year: 1962
• An amendment to the FDA Act.
• Requires that all drugs marketed in the U.S. must first be shown to be safe and effective.
• Regulates prescription drug advertising. Requires “informed consent” by research subjects and established the Good Manufacturing Practices (GMP).

Front 16

Drug Quality & Security

Back 16

• Year: 2013
• Expands the authority of the FDA for compounded drugs.

Front 17

FDA Amendments Act

Back 17

• Year: 2007
• Establishes Risk Evaluation and Mitigation Strategy (REMS) requirements for manufacturers of drugs and biologicals.

Front 18

Social Security Act

Back 18

• Year: 1965
• Established the Medicare program.

Front 19

Orphan Drug Act

Back 19

• Year: 1983
• Provides incentives to promote research approval and marketing of drugs needed for the treatment of rare diseases.

Front 20

Food Drug and Cosmetic (FDC) Act

Back 20

• Year: 1938
• This law requires that before any new drug can be marketed it must be proven safe when used per directions on its label.

Front 21

Durham-Humphrey Amendment

Back 21

• Year: 1951
• This amendment established two classes of drugs

Front 22

legend drugs and OTC drugs.
• Also

Back 22

allows for the provision of telephoned prescriptions and refills.

Front 23

FDA Safety & Innovation Act

Back 23

• Year: 2012
• Establishes user fees to enhance access to medications and medical devices and made provisions for addressing drug product shortages in the U.S.

Front 24

Anabolic Steroid Control Act

Back 24

• Year: 1990
• Passed to “address the abuse of steroids by athletes and especially youngsters and teenagers.

Front 25

Alberty Food Products V. U.S.

Back 25

• Year: 1950
• Court of appeal ruled that the purpose for which a drug is to be used must be included on its label.

Front 26

Medicare Modernization Act

Back 26

• Year: 2003
• Establishes optional Medicare part D to provide coverage for prescription drugs and medication therapy management (MTM).

Front 27

Recall Class III

Back 27

Where a product is not likely to cause adverse effects.

Front 28

Controlled Substances Schedule V

Back 28

• Low potential abuse than IV
• Medical use in U.S.
• Limited physical or psychological dependency
• Examples: Compounds containing limited amounts of narcotics such as codeine.

Front 29

Refills for Class III/IV/V

Back 29

5 refills within 6 months

Front 30

Testing Phase 2

Back 30

• # of Patients: up to several hundred patients
• Time: several months up to 2 years
• Purpose: Short-term safety but MAINLY effectiveness

Front 31

DEA Form 224

Back 31

• Application for new registration
• Retail hospital clinic practitioner teaching institute and mid-level practitioners.
• Business activity drug schedules state license number state controlled substance number (required)

Front 32

Refills for Class II

Back 32

No refills

Front 33

Testing Phase 3

Back 33

• # of Patients: several hundred up to several thousand
• Time: 1 to 4 years
• Purpose: Safety dosage and effectiveness

Front 34

DEA Form 510

Back 34

Application for Registration – for chemical Registration

Front 35

DEA Form 363a

Back 35

Narcotic Treatment Program Renewal Registration
Controlled Substances Schedule II
• High potential of abuse
• Medical use in U.S.
• Lead to physical or psychological dependency
• Examples: Opium cocaine methadone various opiates

Front 36

DEA Form 363

Back 36

Narcotic Treatment Program

Front 37

Controlled Substances Schedule I

Back 37

• High potential of abuse
• No medical use in U.S.
• May not be prescribed
• EX. Heroin various opium derivatives hallucinogenics

Front 38

Testing Phase I

Back 38

• # of patients: 20-100 patients
• Time: several months
• Purpose: mainly safety

Front 39

DEA Number

Back 39

All prescribers of controlled substances must be authorized by DEA. They are assigned a DEA # which must be used on all controlled drug prescriptions.

Front 40

Two main divisions of Judicial law?

Back 40

• Criminal Law
• Civil Law

Front 41

CMEA Daily & Monthly Restrictions

Back 41

• 3.6grams/daily
• 9.0grams/monthly
• 7.5grams/delivery
**ID + 2 years of recording keeping after purchase

Front 42

How long must signed “Acknowledgements” be kept?

Back 42

6 years from the last date of service

Front 43

Dispensed Prescription Drug Labels Requires?

Back 43

• Name and address of dispenser
• Prescription serial number
• Date filled
• Name of prescriber
• Name of patient
• Directions for use
• Cautionary statements

Front 44

Recall Class I

Back 44

Where there is a strong likelihood that the product will cause serious death or serious adverse effects.

Front 45

DEA Form 106

Back 45

Report of theft or Loss of controlled substance

Front 46

Recall Class II

Back 46

Where a product may cause temporary but reversible adverse effects or in which there is little likelihood of serious adverse effect.

Front 47

DEA Form 41

Back 47

Registrants Inventory of Drugs Surrendered:
*Requests info such as mailing address DEA# name of drug or preparation # of containers contents and controlled substance content in each unit.

Front 48

DEA Form222

Back 48

Is used to order class-I and class-II substances.

Front 49

Controlled Substances Schedule III

Back 49

• Less potential for abuse than I & II
• Medical use in U.S.
• Moderate or low physical dependency
• High psychological dependency
• Example: anabolic steroids various compounds with narcotics.

Front 50

Exempt Narcotics

Back 50

Medications with habit-forming ingredients that could be dispensed by a pharmacist without a prescription to persons at least 18 years of age.

Front 51

Controlled Substances Schedule IV

Back 51

• Low potential abuse than III
• Medical use in U.S.
• Limited physical or psychological dependency
• Examples: phenobarbital sedative chloral hydrate and anesthetic methohexital.

Front 52

6 Basic Values of Ethical Consideration

Back 52

• Autonomy
• Beneficence
• Dignity
• Non-maleficence
• Justice
• Truthfulness
• Honesty

Front 53

DEA Form 224a

Back 53

Renewal Application for Registration

Front 54

Ways a technician can be found guilty of misconduct?

Back 54

• Incorrectly labeling the prescription
• Failing to maintain patient confidentiality
• Failing to recognize expired drugs
• Calculation errors
• Dispense wrong medication
• Incorrect handling of Controlled Substances
• Inaccurate record keeping

Front 55

Recall Process

Back 55

Report of adverse effect
Manufacturer agrees to recall
Customers contacted
Recalls listed publicly

Front 56

Reports of Adverse Effects

Back 56

FDA receives enough reports of adverse effects or misbranding that it decides the product is a threat to public health. They contact manufacturers and recommend a recall.

Front 57

Manufacturer Agrees to Recall

Back 57

If manufacturer agrees to a recall they must establish a recall strategy with the FDA addressing the depth of the recall the extent of public warnings and a means for checking effectiveness of the recall.

Front 58

Customers Contacted

Back 58

Customers are contacted by manufacturer by telegram mailgram or first class letter with following information:
• Product name size lot number code or serial number and any other important identifying information.
• Reason for recall and the hazard involved
• Instructions on what to do with product beginning with ceasing distribution.

Front 59

Recalls Listed Weekly

Back 59

Recalls are listed in the weekly FDA Enforcement Report.

Front 60

Controlled Substances

Back 60

Five groups of drugs identified by the 1970 Controlled Substance Act (CSA) as having the potential for abuse and whose distribution is therefore strictly controlled by 5 controlled schedules.

Front 61

Schedule II Record Keeping

Back 61

• Schedule II records must be kept for 7 years and all other records for 2 years.
• Schedule II prescription records must be kept separate from noncontrolled records.

Front 62

Legend Drug

Back 62

Any drug that requires a prescription and either has the legend: “Caution: Federal law prohibits dispensing without a prescription” or “RX Only”

Front 63

Placebo

Back 63

An inactive substance given in place of medication.

Front 64

Patient Package Inserts (PPI)

Back 64

Required by the FDA for some potentially dangerous drugs and have information for patients on how to safely use the drug/medication.

Front 65

Medication Guides (MedGuides)

Back 65

A patient handout provided for many prescriptions to provide FDA-approved information to help patients avoid serious adverse events required for certain drugs.

Front 66

Pharmaceutical Equivalent

Back 66

Drug products that contain identical amounts of the same active ingredients in the same dosage.

Front 67

Therapeutic Equivalent

Back 67

Pharmaceutical equivalents that produce the same effects in patients.

Front 68

National Drug Code (NDC) Number

Front 69

Dual Marketing

Back 69

The classification of a medicine as both prescription and Over the counter (OTC).

Front 70

Adverse Effect

Back 70

An unintended side effect of a medication that is negative or in some way injurious to a patient’s health.

Front 71

Civil Law

Back 71

Laws pertaining to wrongs to an individual.

Front 72

Criminal Law

Back 72

Laws pertaining to a wrong to society.

Front 73

Torts

Back 73

Civil wrongs that have duties associates with them.

Front 74

Negligence

Back 74

Failing to do something that should or must be done.

Front 75

Injunction

Back 75

A court order preventing a specific action such as the distribution of a potentially dangerous drug.

Front 76

Recall

Back 76

The action taken to remove a drug from the market and have it returned to the manufacturer.

Front 77

Protected Health Information (PHI)

Back 77

Any personal information that could be used to identify an individual to their health industry.

Front 78

Malpractice

Back 78

A type of negligence lawsuit brought against a person with a professional license.

Front 79

Liability

Back 79

Legal responsibility for costs or damages arising from misconduct or negligence.

Front 80

Contracts

Back 80

Legal agreements that have duties associated with them.

Front 81

Ethics

Back 81

A branch of philosophy that helps determine what should be done in a principled sense.

Front 82

6 Basic in Ethical Considerations:Autonomy

Back 82

Patients have the right to choose their own treatment.

Front 83

6 Basic in Ethical Consideration:Beneficence

Back 83

The actions of the healthcare provider should be in the best interest of the patient.

Front 84

6 Basic in Ethical Considerations:Dignity

Back 84

The healthcare provider should treat the patient with dignity and respect.

Front 85

6 Basic in Ethical Considerations:Non-Maleficence

Back 85

The healthcare provider should do no harm in providing care to the patient.

Front 86

6 Basic in Ethical Consideration:Justice

Back 86

Fairness and equality should be applied when providing care to the patient.

Front 87

6 Basic in Ethical Considerations: Truthfulness & Honesty

Back 87

Healthcare providers should be truthful and honest when providing care to patients.

Front 88

CMEA Rules:

Back 88

• the pharmacy or store cannot exceed the daily or monthly limits per customer for OTC sale of ephedrine and pseudoephedrine.
• Store or pharmacy must maintain written or electronic records for 2 years containing product name quantity sold name and address of purchaser date and time of sale proof of I.D signature of the purchaser.

Front 89

Exempt Narcotics: Rules

Back 89

• Must be done by pharmacist
• Cashier can complete transaction once pharmacy approves and completes the appropriate documentation.
• Limits for number of dosage in 48-hour period are followed.
• Purchaser is 18 with suitable I.D.
• Bound record book is kept containing name and address of the purchaser name and quantity of exempt narcotic purchased date of each purchase and the name or initials of the pharmacist who dispensed the substance.

Front 90

Investigational New Drug (IND)

Back 90

• Is a proposed new drug during trial phase?
• Only available within trial groups unless granted a special “treatment” status

Front 91

NATO Stock Number (NSN)

Back 91

An NSN number is an identification number used to identify material items of supply and is recognized in all NATO countries.

Front 92

United States Pharmaceutical Convention (USP)

Back 92

• Sets standards for the manufacturer and distributor of drugs and related products in the U.S.
• Published in the “State Pharmacopeia and the National Formulary”

Front 93

American Society of Health-System Pharmacist (ASHP)

Back 93

• 30000-member association of pharmacists practicing in hospitals HMOs long-term care home-care and other healthcare systems.
• The accreditation organization pharmacy residency and tech training programs.

Front 94

The Joint Commission (TJC)

Back 94

• Establishes standards and monitors compliance for nearly 20000 healthcare programs in the U.S.
• TJC accredited programs include hospitals healthcare networks HMOs and nursing homes among others.

Front 95

The American Society for Consultant Pharmacists (ASCP)

Back 95

Sets standard for practice for pharmacists who provide medication distribution and consultant services to nursing homes.

Front 96

The Accreditation Commission for Healthcare (ACHC)

Back 96

• Sets standards for pharmacies that provide the following services infusion specialty community retail and long-term pharmacy.
• They also administer the (PCAB) Pharmacy compounding Accreditation Board accreditation.

Front 97

A Code of Ethics Principles

Back 97

The application and support of the moral obligations that guide the pharmacy profession.

Front 98

C-II Prescription Information

Back 98

• DEA number must appear on the form and patients address.
• No P.O. Box allowed for address.

Front 99

DEA Form 224b

Back 99

Retail Pharmacy Registration Affidavit for Chain Renewal

Front 100

Code of Ethics Principles: Health & Safety

Back 100

Ensure health and safety of patient and use knowledge and skills to the best of his/her ability in serving patients.

Front 101

Code of Ethics Principles: Honesty and Integrity

Back 101

Promotes honesty and integrity in the profession which includes a duty to observe the law maintain the highest moral and ethical conduct always.

Front 102

Code of Ethics Principles: Assist and Support

Back 102

Assists and supports the pharmacists in safe and efficacious and cost effective distribution of health services and health-care resources.

Front 103

Code of Ethics Principles: Respect and Value

Back 103

• Technician respects and values the abilities of the pharmacists colleagues and other health-care professionals.
• Maintains competency in his/her practice and continually enhances his/her professional knowledge and expertise.

Front 104

Code of Ethics Principles: Respect and Support

Back 104

Technician respects and supports the patient’s individuality dignity and confidentiality.

Front 105

Code of Ethics Principles: Confidentiality

Back 105

Technicians respect the confidentiality of a patient’s pertinent information only with proper authorization.

Front 106

Code of Ethics Principles: Never Assists

Back 106

Technician assists in dispensing promoting or distributing of medications or medical devices that are not of good quality or do not meet the standards required by law.

Front 107

Code of Ethics Principles: Does Not Engage

Back 107

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.

Front 108

Code of Ethics Principles: Associates and Engages

Back 108

Technician associates with and engages in the support of organizations which promote the profession of pharmacy through the utilization and enhancement of pharmacy technician.