Federal Law Flashcards
1
Q
CMS
A
Centers for Medicare and Medicaid Services
2
Q
CMS Responsibility/Oversight
A
Responsible for reimbursement policies and procedures for pharmacies and other healthcare providers participating in the Medicare and Medicaid Programs
3
Q
FDA
A
Food and Drug Administration
4
Q
FDA REsponsibilities
A
Administers the Federal Food, Drug and Cosmetic Act
5
Q
FTC
A
Federal Trade Commission
6
Q
FTC Responsibility
A
Administers the Federal Trade Commission Act, which enforces unfair business practices and antitrust violations
7
Q
DEA
A
Drug Enforcement Agency
8
Q
DEA Responsibility
A
Administers the Federal Controlled Substances Act
9
Q
Three legal tests a regulation must meet to be valid
A
- The regulation must be within the scope of the agency’s authority
- The regulation must be based on a statue that gives the agency the authority to promulgate the regulation
- The regulation must bear a reasonable relationship to the public health, safety, and welfare
10
Q
Shortcomings of the Pure Food and Drug Act of 1906
A
- US V. Johnson: Johnson claimed on the label of a drug that it was effective against cancer, knowing this representation was false. –> Court ruled that the misbranding provision in the law prevented false statements only to the drug’s identity
- The act failed to regulate cosmetics and devices
11
Q
Intents and Requirements imposed by the Federal Food, Drug, and Cosmetic Act.
A
- No new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA.
- Expanded on the definitions of mislabeling and adulteration used in the earlier act- labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs
- The law applies to cosmetics and devices as well
- The act exempted drugs marketed before 1938 from the requirement that new drugs proven safe before being marketed.
12
Q
What two drugs marketed before 1938 received amendments to ensure uniform potency?
A
Insulin (amendment made in 1941)
Penicillin (amendment made in 1945)
13
Q
Two medications resulting in tragedy that were major catalysts for major legislation
A
- Sulfanilamide elixir
- Thalidomide
14
Q
Durham-Humphrey Amendment of 1951
A
- Established 2 classes of drugs: Prescription and Over the Counter
- Provided that the labels of prescription drugs need not contain: “adequate directions for use” so long as they contain the legend, “Caution: Federal law prohibits dispensing without prescription”
- Authorizes oral prescriptions and refills of prescription drugs
15
Q
Alternate name for Durham-Humphrey Amendment of 1951
A
Prescription Drug Amendment
16
Q
The purpose of the Delaney Clause
A
to prohibit the approval of any food additive that might cause cancer
17
Q
Two amendments that contain the Delaney Clause
A
- Food Additives Amendment of 1958
- Color Additives Amendment of 1960
18
Q
Alternate name of the Kefauver- Harris Amendment of 1962
A
Drug Efficacy Amendment
19
Q
Major outcome(s) of the Kefauver-Harris Amendment of 1962
A
1.Strengthened the new drug approval process by requiring that drugs be proved not only safe, but effective. (was made retroactive to all drugs marketed between 1938 and 1962)
2. Transferred jurisdiction of prescription drug advertising from the Federal Trade Commission to the FDA
3. Established the Good Manufacturing Practices requirements
4. Added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug effects.
20
Q
good manufacturing practice (GMP)
A
guidelines for how manufacturers must make their drugs
21
Q
Requirements of the Medical Device Amendment of 1976
A
- Classification of devices according to function
- Premarket approval
- Establishment of performance standards
- Conformance with GMP regulations
- Adherence to record and reporting requirements
22
Q
Intent of the Orphan Drug Act of 1983
A
Incentivize the development of drugs for orphan diseases (diseases that affect relatively few people)
23
Q
How did the Orphan Drug Act of 1983 incentivize its intent
A
provided tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologics for the treatment of “rare diseases and conditions”
24
Q
Alternate name for the Drug Price Competition and Patent Terms Restoration Act of 1984
A
Waxman-Hatch Amendment
25
Intent of the Drug Price Competition and Patent Terms Restoration Act of 1984
Streamline the generic drug process while giving patient extensions, in certain cases, to innovator drugs. (Making generic drugs more readily available to the public and provide incentives for manufacturers to develop new drugs.)
26
Requirements of the Prescription Drug Marketing Act of 1987
1. Establishes sales restrictions and record keeping requirements for prescription drug samples
2. Prohibits hospitals and other healthcare entities from reselling their pharmaceutical purchases to other healthcare entities.
3. Requires state licensing of drug wholesalers
27
Dietary Supplement Health and Education Act of 1994
1. Defines dietary supplements and permits manufacturers to make certain claims that would otherwise be illegal under the FDCA.
2. Forced FDA to regulate dietary supplements more are food than as drugs
28
Major intended impacts of the food and Drug Administration Modernization Act of 1997
a.To eliminate backlogs in the approval process and ensure the timely review of applications.
b.Creates fast track approval process for drugs intended for serious or life-threatening diseases
c.Establishes databank of information on clinical investigations.
d.Authorizes scientific panels to review clinical investigations.
e.Expands the rights of manufacturers to disseminate unlabeled use information
f.Expands the FDA’s authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients.
g.Priority review for breakthrough technologies in medical devices and allowing the FDA to contract with outside scientific experts for review of medical device applications.
29
Key aspects of the Food and Drug Administration Amendments Act of 2007
a.Allows FDA broader use of the fees generated from PDUFA, while substantially increasing the fees.
b.Provides FDA with significantly enhanced responsibilities and authorization to regulate drug safety, including the authority to mandate labeling changes related to safety, require clinical trial data reporting and registries, require post market clinical studies to assess risks, and require companies to implement risk evaluation and migration strategies.
30
Purposes of the FDA Safety and Innovation Act of 2012
a.Primary purpose: reauthorize PDUFA, allows the FDA to continue to collect use fees from manufacturers seeking NDAs or medical device approvals.
b.Adds new user fees to generic drugs and biosimilars
c.Reducing drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages, enhancing the exchange of prescription drug diversion information across state lines.
d.Enables the FDA to inspect foreign drug manufacturers more regularly and requires the agencies to target problematic manufacturing sites in the US or otherwise.
31
Identify Two Titles of the Drug Quality and Security Act of 2013
Title I: Also known as the Compound Quality Act; clarifies and strengthens FDA oversight over pharmacies engaged in the large scale compounding and shipping of sterile products to other licensed entities
Title II: Also known as the Drug Supply Chain Security Act; adds track and trace requirements for all entities in the chain of distribution of pharmaceutical products. Also mandates an electronic, interoperable product tracing system by 2023, strengthens wholesaler and third party logistics licensure requirements and requires manufacturers to serialize drugs by 2017
32
Impact in the 21st Century Cures Act of 2016
Goal is to streamline and add flexibility and innovation to the drug development and approval processes, primarily by creating new clinical trial design options and by accelerating the pathways to market for drugs intended to treat certain serious or life-threatening diseases
33
Risk inherent in the 21st Century Cures Act of 2016
Speeding up drug approval in this manner amounts to shortcuts that will endanger public safety.
34
Acts that are Direct Regulation
1. FDCA
2. Durham-Humphrey
3. Kefauver-Harris
35
Acts that are Indirect Regulation
1. Pure Food and Drug Act
2. FDCA
36
Act that requires companies to implement REMS
Food and Drug Administration Amendments of 2007
37
Agency that enforces the FDCA and the source of authority
Vested in the FDA (a component of the Department of Health and Human Services)
38
Two major components of the definition of a drug
1. Articles recognized in the official US Pharmacopoeia, official Homeopathic Pharmacopoeia of the US, or National Formulary, or any supplement to any of them.
2. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
39
Food
article used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.
40
Special Dietary Foods
includes, but not limited to those supplying need that exists by reason of physical, physiological, pathological, or other condition (e.g. pregnancy, allergic hypersensitivity, overweight, etc.)
41
Medical Foods
food formulated for oral or enteral use under the supervision of a physician.
42
Drug
Articles recognized in the USP or NF. Used to diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
43
Dietary Supplement
product intended for ingestion, intended to supplement the diet, and contains any one or more of the following:
i. A vitamin
ii. A mineral
iii. An herb or botanical
iv. An amino acid
v. A dietary substance for use by humans to supplement the diet by increasing the total dietary intake.
vi. A concentrate, metabolite, constituent, extract, or combination of the previous.
44
Device
instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.
45
Cosmetics
articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.
46
Label
a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
47
Labeling
all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.
48
10 Acts Prohibited by Section 301 of the FDCA
a.The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.
b.The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.
c.The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
d.The introduction or delivery for introduction into interstate commerce of any article in violation of section 404 or 505.
e.The refusal to permit access to or copying of any record as required … or the failure to establish or maintain any record, or make any report, required… or the refusal to permit access to or verification or copying of any such required record.
f.The refusal to permit entry or inspection as authorized by section 704
g.The manufacture within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded.
h.The doing of any act which causes a drug to be a counterfeit drug, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit drug.
i.The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.
j.The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 413 of this title.
49
Adulteration
1. Consists in while or in part of any filthy, putrid, or decomposed substance
2. Purports to be a drug the name of which is recognized in an official compendium and its strength differs from, or its quality or purity falls below the standards set forth in the compendium
3. its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
4.If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefore
50
Misbranding
Focusing on the representation made by the manufacturer on the label or labeling.
1. False or Misleading Labeling
2. Habit-Forming Drugs
3. Established Name Drugs
4. Adequate Directions for Use
5. Adequate Information for Use
6. Imitation Drugs
7. Batch Certification
51
Four means for the FDA to enforce the FDCA
a.Under 302, the FDA can bring an injunctive action against the violator to cause it to cease its illegal activity.
b.Under 303, the FDA can institute criminal proceedings against violators, resulting in fines, imprisonment, or both.
c.Under 304, the FDA can seize any adulterated or misbranded food, drug, or cosmetic in interstate commerce.
d.Congress added 309 (because of the strict liability nature of 302 and the realization that minor violations of the act should not be subject to criminal prosecution or seizure actions) which allows the FDA to send a warning letter to the violator as a first step when such an action would adequately serve the public interest.
52
Three Types of Recalls
a.Class I: issued when there is a reasonable probability that the product will cause serious adverse health consequences or death.
b.Class II: occur when the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote.
c.Class III: apply to products that are not likely to cause adverse health consequences.
53
Traditional Pregnancy Warnings
Categories A, B, C, D, X
54
Three Subsections of Pregnancy Warnings
Pregnancy, Lactation, and Females and Males of Reproductive Potential
55
First Segment of NDC
Assigned by the FDA and identifies the manufacturer or distributor
56
Second Segment of NDC
Identifies a specific strength, dosage form, and formulation
57
Third Segment of NDC
Identifies Package Size and Types
58
Components that must be included in the new drug application
a. Full reports of investigations showing the drug’s safety and efficacy
b. The drug’s components and composition
c. The methods, facilities, and controls used in manufacturing, processing, and packaging the drug.
d. Samples of the drug and its components
e. The proposed labeling of the drug
59
GRASE
Generally recognized as safe and effective
60
S-NDA
Supplemental New Drug Application
61
Three Procedural Categories of S-NDA
1. Prior Approval: Changes in any part of the production, ranging from the synthesis of the drug to the manufacturing processes of the drug to most of the labeling of the drug
2. Change Being Effected: For certain types of labeling changes, those that strengthen warnings or dosage or administration information or certain changes in manufacturing methods, facilities, and controls
3. Very Minor Changes: editorial changes in labeling or changes in container size (merely need to be reported in the annual report)
62
IND
Investigational New Drug Application
63
ANDA
Abbreviated New Drug Application
64
Phase 1 Trials
Involves a small number of subjects --> determine the safety and detect adverse effects, not for efficacy
65
Phase 2 Trials
Tested on a limited number of patients who have the disease --> determine the efficacy of the drug and the dosages at which the efficacy occurs
66
Phase 3 Trials
Tested in 100-1000s of patient (typically in actual clinical settings) --> Looking at efficacy and safety
67
Phase 4 Trials
Postmarket clinical studies help in determining new uses or abuses for a drug or to obtain additional safety or efficacy data for labeled indications.
68
REMS
Risk Evaluation and Mitigation Strategies
69
ETASU
Elements to Assure Safe USe
70
PDUFA
Prescription Drug User Fee Act
71
FDAAA
Food and Drug Administration Amendments Act
72
DESI
Drug Efficacy Study Implementation
73
Definition of biologics
products derived from living organisms
74
Examples of Biologics
Viruses, therapeutic serums, toxins, antitoxins, vaccines, blood and blood components, and derivatives applicable to the prevention, treatment, or cure of a disease or condition of humans.
75
Legislative Acts the regulate biologics
1. Public Health Service Act
2. FDCA
76
Amendment of the Constitution that Guarantees the rights to free speech
The First Amendment
77
Four factors primarily considered when evaluating the governmental regulation of commercial speech
a. The speech must not be misleading or related to an unlawful activity.
b. The government interest in the regulation must be substantial.
c. The regulation must directly advance the government interest asserted.
d. The restriction of speech cannot be more extensive than necessary to serve that interest.
78
Statute potentially violated when not complying with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers
Federal Anti-Kickback Statute
79
Factors the FDA will consider in evaluating whether an activity is independent
a.The degree of control the company has over the content of the program.
b.Whether there was adequate disclosure during the program of the company’s funding support
c.The company’s relationship to the presenters
d.Whether any unapproved uses will be discussed.
e.Whether the focus of the program is on educational content and free from commercial influence or bias
f.Whether the audience was selected by the company (as a reward to high prescribers, dispensers, or decision makers)
g.Whether there are promotional activities such as presentations or exhibits in the meeting room
80
Impacts of the FDASIA of 2012 on social media promotion
a.The first draft guidance addressed interactive promotional media (Defined as technologies that often allow for real-time communications and interactions such as some websites, Twitter, Facebook, live podcasts, and firm blogs. --> States that the FDA’s regulatory authority extends both to product promotional communications carried out by the company as well as conducted by someone else on the company’s behalf.
b.The second provides guidance on using social media platforms with space limitations such as Twitter. --> The clear message is that any communication must have fair balance conveying both benefits and risks in a balanced manner, even though space limitations may pose challenges.
c.The third guidance focuses on how manufacturers should respond, if they choose to do so, to correct third-party misinformation about their product on the Internet and through social media, regardless of whether it appears on the company’s or a third party’s site
81
Prohibitions in PhRMA's Code on Interactions with HCPs
a. Prohibits companies from what used to be a common practice of providing entertainment and recreational activities to healthcare professionals, either separate from or in conjunction with an informational or educational program.
b. Prohibits providing healthcare professionals, either directly or at programs, with items, even of minimal value, such as pens, note pads, mugs, or even stethoscopes that do not advance education.
82
Characteristics of prescription drugs which the FDA has authority to categorize as prescription drugs
a. Unsafe for use except under the supervision of a practitioner because of the toxicity, the method of use, or the collateral measures necessary to use the drug.
b. Subject to the new drug application approval process.
83
Federal Labeling Requirements
i. The name and address of the dispenser
ii. The serial number and date of the prescription or its filling
iii. The name of the prescriber
iv. The name of the patient
v. The directions for us and cautionary statements
84
Most states labeling requirements
i. The name, initials, or license number of the dispensing pharmacist
ii. The expiration date or beyond-use date of the drug
iii. The drug’s name, strength, and quantity dispensed.
iv. The address of the patient
v. The name of the manufacturer or distributor
vi. The lot or control number
85
Two key elements of USP guidance regarding BUDs
1. the expiration date on the manufacturer's container
2. 1 year from the date the drug is dispensed
86
Which Amendment is the source of prescriptive authority?
Durham-Humphrey Amendment
87
Does the Durham-Humphrey Amendment prohibit pharmacists from prescribing
No
88
Collaborative Practice Agreement
Allows pharmacists to initiate or adjust drug therapies in collaboration with a physician
89
Mandatory substitution states
Pharmacists must substitute a less expensive generic drug for the brand name drug, unless the prescriber writes “dispense as written”, “brand necessary”, or a similar notation on the prescription.
90
Permissive substitution states
Pharmacists may choose to substitute if the prescriber issues the prescription in a way that permits substitution.
91
Published Book entitled "Approved Drug Products with Therapeutic Equivalence Equations"
Orange book
92
AA
drugs that are available in conventional dosage forms and have no bioequivalence problems
93
AB
Drugs identified by the FDA as having actual or potential bioequivalence problems, but which have been resolved by adequate scientific evidence
94
AN
bioequivalent solutions and powders for aerosolization
95
AO
Bioequivalent injectable oil solutions
96
AP
Bioequivalent injectable aqueous solutions and some intravenous nonaqueous solutions
97
AT
Bioequivalent topical drug with no known bioequivalence problems
98
BC
Drugs in extended-release dosage forms with bioequivalence issues
99
BD
Active ingredients and dosage forms with documented bioequivalence problems
100
BE
delayed-release oral dosage forms with potential bioequivalence problems
101
BN
Products in aerosol nebulizer drug delivery systems, unless proven bioequivalent
102
BP
Active ingredients and dosage forms with potential bioequivalence problems
103
BR
Suppositories or enemas that deliver drugs for systemic absorption unless proven bioequivalent
104
BS
Products having drug standard deficiencies
105
BT
Topical drug products with bioequivalence issues
106
BX
Products for which the data are insufficient to determine therapeutic equivalence
107
Narrow Therapeutic Index
Drugs where there is less than a two-fold difference between the median lethal dose and the median effective dose or where there is less than a two-fold difference between the minimum toxic concentrations and the minimum effective concentrations in the blood
108
Significance in dispensing NTDs
Pharmacists should exercise professional judgement when switching NTI drugs, inform patients of the switch, and alert patients to contact them if they notice any physiological changes.
i.B-rated NTI drugs should not be switched without notifying the prescriber and informing the patient.
ii.Pharmacists must also be aware of state laws that may restrict the substitution of some of these products.
109
Amendments to the FDCA created by the Prescription Drug Marketing Act
a.Require states to license wholesale distributors of prescription drugs.
b.Ban the reimportation of prescription drugs, except by the manufacturer or for emergency use.
c.Ban the sale, trade, or purchase of drug samples.
d.Mandate storage, handling, and record-keeping requirements for drug samples.
e.Ban the trafficking in or counterfeiting of drug coupons.
f.Prohibit the resale of prescription drugs purchased by hospitals or healthcare facilities, with certain exceptions.
110
Pedigree
a record that identifies each prior sale, purchase, or trade of the drugs they receive and distribute.
111
UPI
unique product identifier
112
SNI
standardized numerical identifiers
113
3PLs
Third party logistics providers
114
Exceptions to DSCSA product tracing requirements
a. Transfer from one pharmacy to another to fulfill a specific patient need such as filling a prescription.
b. Distribution in a minimal quantity by a pharmacy to a practitioner for office use.
c. Distribution pursuant to a sale or merger of a pharmacy.
d. Distribution of drug/device combination products.
e. Distribution for emergency medical reasons.
f. Product returns.
115
Is reimportation allowed from canada?
Yes, if it is from the original manufacturer or for emergency use
116
Agency responsible for the enforcement of the PPPA
Consumer Product Safety Commission
117
Individuals who may request/receive non-PPPA-compliant containers
a. Drugs dispensed pursuant to prescription from the packaging requirement if either the physician prescribing the drug or the patient receiving the drug requests noncompliant containers.
b. Patients may make blanket requests that all their medications be dispensed in noncompliant packaging; prescribers may not.
c. The PPPA allows manufacturers to market one size of an OTC product for elderly or handicapped individuals in noncompliant packaging.
d. Drugs dispensed to institutionalized patients are exempt from the act if they are to be administered by the employees of the institutions
118
Exempt legend/ Controlled Substance Drugs
i. Sublingual dosage forms of nitroglycerin Sublingual and chewable forms of isosorbide dinitrate in strengths of 10 mg or less
ii. Sodium fluoride products containing not more than 264 mg of sodium fluoride per package
iii. Anhydrous cholestyramine in powder form
iv. Methylprednisolone tablets containing not more than 84 mg of the drug per package
v. Mebendazole tablets containing not more than 600 mg of the drug per package
vi. Betamethasone tablets containing not more than 12.6 mg of the drug per package
vii. Potassium supplements in unit-dose forms, including effervescent tablets, unit-dose vials of liquid potassium, and powdered potassium in unit-dose packets containing not more than 50 mEq per unit dose
viii. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8 g of the equivalent of erythromycin
ix. Colestipol in powder form up to 5 g in a packet
x. Erythromycin ethylsuccinate tablets in packages containing no more than 16 g of the drug
xi. Preparations in aerosol containers intended for inhalation therapy
xii. Pancrelipase preparations
xiii. Prednisone tablets containing not more than 105 mg per package
xiv. Cyclically administered oral contraceptives, conjugated estrogens, and norethindrone acetate tablets in manufacturer’s memory-aid (mnemonic) dispenser packages
xv. Medroxyprogesterone acetate tablets
xvi. Sucrase preparations in a solution of glycerol and water
xvii. Oral dosage form products containing aspirin and acetaminophen must comply with the act’s pack- aging requirements, except:
1. Effervescent tablets containing aspirin or acetaminophen other than those intended for pediatric use. The dry tablet must contain less than 15% of aspirin or acetaminophen, the tablet must have an oral LD50 in rates of greater than 5 g/kg body weight, and the tab- let placed in water must release at least 85 ml of carbon dioxide per grain in the dry tablet when measured stoichiometrically at standard conditions.
2. Unflavored aspirin- or acetaminophen- containing preparations in powder form not intended for pediatric use that are packaged in unit doses providing not more than 15.4 grains of aspirin or 13 grains of acetaminophen per unit dose and that contain no other substances subject to the provisions of the Act.
119
Compounding pharmacies that are exempt from registering as manufacturers
If they do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail.
120
Actions a pharmacy cold take that would require registration as a manufacturer
a. Pharmacies that repackage OTC products or in any way change the container, wrapper, or labeling of these products for resale.
121
Impetus for the Drug Quality and Security Act of 2013
A Massachusetts pharmacy (New England Compounding Center) compounded and shipped large batches of contaminated sterile injectables to hospital pharmacies, physicians’ offices, and other licensed entities. --> The products killed 64 people and injured more than 700 others and highlighted the lack of clarity in the law regarding the FDA’s authority over large batch compounders.
122
USP Chapters that govern Compounding
795 (non-sterile), 797 (sterile), 800 (hazardous drugs)
123
Minimum requirements of USP 800
a. A list of hazardous drugs
b. Proper facility and engineering controls
c. Competent personnel
d. Safe work practices
e. Proper use of appropriate Personal Protective Equipment
f. Policies for HD waste segregation and disposal
124
OSHA
Occupational Safety and Health Administration
125
NIOSH
National Institute for Occupational Safety and Health
126
HIPAA
Health Insurance Portability and Accountability Act
127
Goal of HIPAA
overall goal of improving efficiency and effectiveness in the healthcare system; Seeks to improve portability and continuity of health insurance coverage and prohibit discrimination; Regulates privacy and security health info; Authorizes DHHS to enact regulations
128
Four Aspects of health information under HIPAA
a. Transaction and code sets
b. National provider identities
c. Security
d. Privacy
129
Who is covered and must comply with HIPAA
Any health plans, clearinghouses, and HCP that conduct financial or administrative transactions electronically must comply; aka “covered entities.” Also business associates of covered entities
130
Define PHI
Protected health information- all health info that relates to past, present, or future physical/mental state and can identify the patient.
131
TPO
Treatment, Payment, and Operations- privacy rule allows pharmacies to use and disclose PHI for TPO.
132
HITECH
Health Information Technology for Economic and Clinical Health (HITECH)
133
Implications for pharmacist
if a covered entity uses EMR, they are required to account for all disclosures, including those of TPO within 3 years prior to date of request.
134
Identifiable PHI
a. Names
b. Geographic subdivisions
c. Dates (birth, admission, discharge, death, age)
d. Phone numbers, fax, email
e. SSN, certificates, license numbers
f. Medial record numbers
g. Health plan beneficiary numbers
h. Account numbers
i. Vehicle identifiers, serial numbers, license plates
j. Device identifiers and serial numbers
k. Web universal resource locators
l. Internet protocol address numbers
m. Biometric identifiers
n. Full face photo images or comparable images
o. Anything else unique
135
Breaches of PHI that require patient notification
If it’s a breach, pharmacy must notify affected individuals by first-class mail or electronically within 60 days of discovery. --> If more than 500 were effected, must also notify DHHS
136
Appropriate methods for disposal of PHI
a. Anything reasonable to dispose completely, such as shredding or burning records. Using opaque bags for pickup and clearing electronic media too.
b. Deidentification- removing identifying factors
137
OBRA '90
Omnibus Budget Reconciliation Act of 1990
138
Primary goal of OBRA '90
Save money; ensures taxpayer dollar are spent properly, improve quality of drug therapy and can reduce cost of healthcare
139
Source of OBRA '90 authority
a. Establishment of national policy pharmacy practice standards requires indirect approach because only states can regulate professional practice.
b. States don’t have to enact standards, but if they don’t, then they don’t receive funding for Medicaid.
c. Some states have a Board of Pharmacy to promulgate regulations, others leave responsibility for Medicaid.
140
Retrospective DUR
DUR recognizes “ideal” drug therapy and determines whether actual medication use conforms to that idea. This is done by comparing current medication use of a given amount of time with past criteria from that medication determined by DUR.
141
Prospective DUR
lets pharmacists consider prescribed drug therapy and apply their knowledge on proper medication use; Generates new data with dispensing meds, which can then be used to represent the most up-to-date patterns of actual medication use.
142
Authority for the closed system of controlled substance distribution
Only those registered with DEA, part of Dept. of Justice, can legally manufacture, distribute, and dispense controlled substances.
143
Can states regulate controlled substances?
State can regulate controlled substances under its powers unless it conflicts with federal law; state cannot be less strict than federal otherwise it’s invalid. Pharmacists must comply with stricter law.
144
Schedules of Controlled substances
I, II, III, IV, V
145
Schedule I
high potential for abuse, no currently accepted medical use in tx of disease, lack accepted info on safety of their uses.
146
Schedule II
high potential for abuse, have an accepted medical use with/without severe restrictions; abuse can lead to physical or psychological dependence.
147
Schedule III
Potential for abuse, has accepted medical use, may lead to moderate/low physical dependence or high psychological dependence when abused.
148
Schedule IV
low potential for abuse, may lead to limited physical or psychological dependence.
149
Schedule V
low potential for abuse, abuse may lead to dependence
150
Pharmacist's legal capacity to possess or use marijuana
a schedule I under federal law, thus it cannot be possessed or used by pharmacists. They can only dispense if it’s in a non-traditional pharmacy.
151
Identify medications listed under the statutory definition of narcotics and contrast with the accepted definition of narcotics.
Narcotics via statute- natural or synthetic opium or derivative or cocoa leaves.
Medically accepted are those for narcolepsy
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Schedule of drugs with no currently accepted medical use in treatment in the US
Schedule I
153
Who schedules medications
Attorney general
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Exemptions to controlled substances registration requirements
a. Agent/employee of any registered manufacturer, distributor, or dispenser of any controlled substance if that agent/employee is acting in the usual course of their business.
i. Pharmacists do not need to individually register at an already registered pharmacy.
b. A common or contract carrier or warehouseman or employee whose possession of controlled substances is within normal business.
c. Ultimate user who possesses substances for a lawful purpose.
d. Those in armed services, public health services, prisons, and law enforcement officials can all prescribe, dispense, or administer, but they cannot purchase
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Requirements for distributing controlled substances and limitations on distributions without a distributor registration
a. Practitioner to whom the drug is distributed is registered to dispense.
b. Distribution is recorded with proper info by distributing and receiving practitioners.
c. Triplicate federal order form is executed if drug is a C-I or II
d. Total number of dosage units distributed does not exceed 5% of the total units of controlled substances distributed and dispensed in one year.
156
Practitioner limitations on controlled substance distribution
licensed and registered person in which he practices/researches to distribute, dispense, research with respect to administer or teach a controlled substance in a professional practice or research.
157
Dispenser limitations on controlled substance distribution
practitioner who delivers substance to an ultimate user research subject
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DEA Form 106
theft or significant loss of any controlled substance within one business day of delivery
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DEA Form 222
required to distribute schedule I or II drugs
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DEA Form 224
used by any person wanting to obtain registration as a dispenser; encourage to complete online and takes about 4-6 weeks.
161
DEA Form 225
completed by manufacturers, distributors, and NTP to obtain registration with the DEA as a dispenser.
162
Two methods by which schedule II-V controlled substances may be secured
a. Store in securely locked cabinet or dispensed throughout stock of non-controlled substances in a way that will obstruct theft.
b. All those except a small amount of schedule I and II substances should be stored in a safe weighing more than 750 pound and be cemented to the floor if MANUFACTURER
163
Requirements of an individual practitioner that a pharmacist might use to determine if they can prescribe a controlled substance
a. Authorized to prescribe in that state they are licensed to practice in.
b. Registered or exempt from registration under the CSA
c. No state allows true general prescriptive authority to pharmacists, since they depend on collaboration
164
Who may fill a controlled substance prescription under federal law
a. Only a pharmacist acting in their normal business who is registered.
b. Pharmacy techs control/dispensing is STATE LAW.
c. Pharmacy intern can dispense under the supervision of a pharmacist.
165
Controlled prescription requirements
a. must have the date of issuance, full name and address of the patient, name, address, registration number of practitioner, drug name, strength, dosage form quantity prescribed, and directions for use.
b. May also need to have physician’s DEA if Rx is issued pursuant to Drug Addiction Treatment Act (DATA) or it can have written notice that the physician is acting in good faith while waiting for ID number to be issued.
c. Rx for gamma-hydrobutyric acid must include medical need written on Rx.
d. Rx must be signed on day of issuance.
e. Written in ink or typed, but signed manually when oral orders are not permitted. Pharmacist may write in the name of prescriber when oral orders are taken. Computer prescriptions that are printed out or faxed must be manually signed.
f. If filled in pharmacy, Rx must have written name/initials of the pharmacist dispensing the drug, date dispensed or number of units of volume dispensed.
h. Individual practitioners exempt from registration must include on the Rx the number of the hospital/institution at which they practice and the special internal code number assigned to them.
166
Illegitimate opioid prescription orders
i. Forged Rx written by people not authorized to issue orders
ii. Rx for office use.
iii. For fictitious patients.
iv. Patients not on the Rx or no medical reason,
v. Narcotic rx to maintain addiction or detoxify an addict
vi. Written outside practitioner’s usual scope.
167
Suspicious opioid prescription orders
i. Written for large numbers on Rx compared to others
ii. Writes for antagonistic drugs (depressants and stimulants)
iii. Patients returning too frequently for refills
iv. Patients presenting Rx orders written in names of other people
v. Number of people appear within short time with similar orders from the same prescriber.
vi. Numerous strangers show up with Rx from the same physician
168
Red flags for opioid prescriptions
Multiple customers filling Rx by same prescriber for same drug in the same quantities, customers with same last name/street address with similar Rx on close together days, two short-acting opiates together, patient’s traveling long distances to fill Rx, drug cocktails, payment with cash, larger quantities.
169
Emergency filling of C2s
the pharmacist can dispense schedule II drugs on oral authorizations of an individual practitioner if: Quantity prescribed and dispensed is limited to necessary amount to treat the patient for the emergency period; Rx must be immediately reduced to writing by the pharmacist and must contain all the information, except the signature of the prescriber; Use good faith effort, usually call prescriber with number on director; Within 7 days after authorizing Rx, prescriber must deliver to the dispensing pharmacist a written Rx for the emergency quantity prescribed. Delivered in person or mail in 7 days. Rx must have “Authorization for Emergency Dispensing” and the date of the oral order.
170
Partial filling of C2s
i. Partial fills for CII must be requested by the patient or prescriber and the total quantity dispensed in all partial fills cannot exceed the total quantity prescribed. State laws can be stricter.
ii. May be allowed when pharmacist receives oral Rx in emergencies, in which the remainder of the Rx must be provided to the patient within 72 hours, if it is not, then no further dispensing is allowed.
iii. For LTCF or patients with a medical dx documenting a terminal illness. May be partially filled to allow for dispensing of individual dosage units, but for no more than 60 days from the date of issuance and the Rx must state “LTCF” or “terminally ill.”
171
Partial fills for C3-5
recorded appropriately, the total quantity doesn’t exceed total prescribed, and no dispensing 6 months after date of issuance.
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Refills in C3-4
Schedule III or IV cannot be refilled more than 6 months after date of issuance or more than 5 times, whichever is first.
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PDMP
all states have electronic PDMPs, which require pharmacists and prescribers to electronically transmit to the state a record of each controlled substance Rx dispensed.
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Records that must be stored at the pharmacy
a. Records on inventory
b. Records of drugs received
c. Records of drugs dispersed
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Inventory of Controlled Substances
If substances is a I or II, registrant must make an exact count or measure of the substance for the inventory. If it’s a III, IV, or V, then an estimated count is allowed unless it holds more than 1,000 tablets.
176
Records of Receipt
i. Invoices are acceptable for schedule III, IV, and V; if the invoice has noncontrolled substances, the controls must be distinguished.
ii. DEA form is allowed for schedule I and II.
iii. When receiving orders, the date must be written on invoice or form 222 and be filed appropriately.
iv. Records must include name of substance, dosage form, strength of substance, number of units, number of containers, date of receipt, and supplier information
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Record of dispersal
any documents for removal of drugs including Rx, record books, DEA 222, invoices, institutional records, records of disposal, and records of theft/loss.
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Filing options
i. In 3 separate files: one for schedule II, second for III, IV, and V, and a third for noncontrol.
ii. In 2 separate files: one for schedule II and a second for III, IV, V, and noncontrols. Scheduled drugs should make a red “C”
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When can Schedule V drugs be sold without a prescription
i. Dispensing is only done by a pharmacist
ii. No more than 240mL (8oz) or 48 dosage units of any controlled substance that contains opium nor more than 120mL (4oz) or 24 dosage units of any other control may be dispensed at retail to the same purchaser in 48 hours.
iii. Purchaser is 18 years old with ID.
iv. Pharmacist maintains record book with info.
v. Federal, state, or local law does not require a Rx to dispense the control.
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DEA Form 41
Used by registrants to request authority to dispose of controlled substances in their inventory. Record of controlled substances destroyed.
181
Transferring of C3-5 to another registrant
Must be recorded by an invoice that contains: Name of substance, dosage form, strength, dosage units, containers, date distributed, name/address/registration number of a person to whom containers were distributed.
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Transferring of C2 to another registrant
Form 222 must be completed first; Total number of dosage units distributed to another must not exceed 5% of the total units of controlled substances distributed and dispensed in 1 year or the pharmacy may have to register.
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Form 222 requirements for documentation
a. To submit forms, registrant must submit an order form requisition, which is part of the application. Once approved, the order forms are supplied.
b. Purchaser prepares and executes 3 copies of each form either written or typed.
c. Each order form as 10 numbered lines where one item can be entered for each line; multiple units of the same item can be ordered on the same line.
d. The number of the last line completed must be noted on each form
e. If one order form is insufficient for all the items, an additional may be used.
f. Order forms for carfentanil, etorphine HCl, and diprenorphine must contain only orders for those substances.
g. For each item, the form must show: name of the substance, finished form, number of units/volume in each container, and the number of commercial containers ordered.
h. NDC if it’s an option.
i. Supplier can substitute identical products in packaging sizes different from those ordered.
j. Purchaser must include the name and address of the supplier.
k. Order forms must be signed and dated by authorized individual. If it is someone that’s not the purchaser, the purchaser’s name must be included.
l. Keeping the copy: purchaser keeps copy 3 for their files
m. Only registrants are required to obtain 222 copies from DEA by submitting an order for registration.
n. Each request for order forms must have the name, address, and registration number along with the number of envelopes desired.
o. Requisition must be signed and dated by the same person who signed recent application or is authorized to do so.
p. Order forms are issued in mailing envelopes with multiple forms
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What is CSOS
Controlled Substance Ordering System (electronic equivalent to Form 222)
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Penalties a pharmacist can encounter in the normal course of doing business
1. Drug Trafficking Offenses- unlawful to intentionally manufacture, distribute, dispense, or own with intent to do any of those for a controlled substance or a counterfeit. --> penalties include imprisonment to fines
2. Distributing/Dispensing in Violation of Controlled Substances Act- unlawful to distribute/dispense a control other than as prescribed. --> up to 1 year in prison, a fine, or both
3. Order form 222 Violation- distribute I or II knowingly and intentionally without 222. --> a fine and up to 4 years in prison
4. Illegal possession- knowingly owning a control, unless it’s for a prescription or order issued by practitioner in usual practice. --> penalty up to 1 year in prison and/or fine
5. State board Discipline- if persecuted under CSA, people can also be subject to disciplinary action by the state board resulting in license revoke, suspension, and/or a fine.
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Restrictions/requirements for DEA agent inspections under the CSA
a. Preregistration and cyclic inspections are common.
b. DEA may enter and inspect any place where control records are kept or people are registered under the CSA.
c. DEA inspector can examine/copy all reports, inspect premises within reasonable limits, and take inventory of controlled substances.
d. Inspector cannot inspect financial data unless the owner has written consent.
e. Prior to investigation, investigator must state their purpose, credentials, and written notice of inspection
187
Restrictions/Requirements for Administrative Inspection Warrants
a. AIW is an alternative to a search warrant basically.
b. AIW probable cause is defined as a valid public interest, thus it’s fairly easy to obtain. Valid public interest could be large purchases of controlled substances or a need to ensure compliance.
c. AIW must include: name and address of premises to be inspected, statement of statutory authority for the warrant, statement of nature/extent of inspection, statement that has the premises either have not been previously inspected or were last inspected on a certain date, may only be served during business hours and completed in a reasonable manner
188
Requirements for selling C5 Codeine cough syrup without a prescription
i. Dispensing is only done by a pharmacist
ii. No more than 240mL (8oz) or 48 dosage units of any controlled substance that contains opium nor more than 120mL (4oz) or 24 dosage units of any other control may be dispensed at retail to the same purchaser in 48 hours.
iii. Purchaser is 18 years old with ID.
iv. Pharmacist maintains record book with info.
v. Federal, state, or local law does not require a Rx to dispense the control.
189
Requirements for a physician to dispense methadone for detox and addiction treatment
a. Methadone is a schedule II narcotic analgesic used for tx of severe pain and detoxification/maintenance of addicts.
b. Any licensed, registered pharmacy may dispense methadone, but only for it’s analgesic indication. It may not be legally prescribed/dispensed for antitussive effects.
c. Cannot be prescribed/dispensed for maintenance or detoxification of addicts in the regular course of medical practice.
d. Requirements include certification through board, reaccredited and recertified every 3 years. Must keep records. Pharmacy can’t dispense for anything but pain.
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Requirements to treat addiction under DATA
b. Drug Addiction Tx Act (DATA)-provides office-based tx of opioid dependent patients by allowing physicians to prescribe and dispense schedule III, IV, and V that are FDA approved.
c. Qualifying physicians can treat 30 patients in first year, then up to 100 a year later, then 275 after that.
d. Prescribing privileges go out to qualifying physicians, ARNP, and PA who meet all requirements and is allowed under state law.
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CMEA daily sales limit of ephedrine/ pseudoephedrine/ phenylpropanolamine
3.6 grams
192
CMEA monthly limit of ephedrine/ pseudoephedrine/ phenylpropanolamine
9 grams within 30 days (7.5 g within 30 days if by mail)
193
Four groups covered by Medicare
a. 65 years and older
b. Permanent disability
c. End-stage renal disease
d. Exposed to environmental health hazards from living in areas subject to an emergency declaration and have developed certain health issues as a result.
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Four parts of Medicare
Part A: hospitalization insurance without a monthly premium for most eligible beneficiaries, like workers and dependents who receive SS checks or railroad retirement
Part B: outpatient medical services
Part C: AKA Medicare Advantage- gives beneficiaries the option to choose a managed care plan- combines benefits offered under original medicare
Paart D: Prescription benefit
195
What two parts of Medicare that pay for prescription drugs
Parts B and D
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Doughnut Hole
Part D has to create plans that are at least as good as the standard benefit plan. Under the standard benefit, beneficiaries pay annual deductible of $405 and then a 25% coinsurance of drug expenditures between $405-3750. Once the $3750 is incurred, the patient enters the “Doughnut Hole” aka the Coverage Gap.
197
Requirements and restrictions for waiver of Medicare co-payments
Low-income usually pay less with no premium or deductible plus a fixed co-payment
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Medications that fall on the excluded list
a. OTC drugs
b. Weight loss/gain drugs
c. Fertility promotion drugs
d. ED for sexual dysfunction
e. Drugs for cosmetics/ hair growth
f. Cough and cold
g. Vitamins and minerals outside prenatals, niacin, fluoride, and some Vitamin D
h. Outpatient drugs for which the manufacturer requires testing or monitoring
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Any willing provider
any pharmacy can participate in the plan that meets the terms and conditions of the plan
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Conditions of Participation of Medicare
a. Pharmacist must supervise the compounding, packaging, and dispensing of drugs.
b. Drugs and biological must be kept in a locked storage area.
c. Outdated products must be made unavailable by putting them in a special area where they pharmacists cannot retrieve them.
d. When a pharmacist isn’t available, only designated personnel may remove drugs from the pharmacy.
e. There must be a stop order policy for drugs that are prescribed without a specified duration of therapy.
f. Drug administration errors, adverse reactions, and incompatibilities must be reported immediately to attending and to the hospital-wide assurance program.
g. Abuses and losses of controls must be reported
h. Info relating to all aspects of drug therapy must be available to staff
i. A formulary system must be established by the medical staff to ensure the availability of quality pharmaceuticals at reasonable cost.
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Patients covered by Medicaid
Blind, disabled, aged, and members of families with dependent children; eligibility is determined by income
202
Two sources of funding for Medicaid
1. state funding
2. federal government reimbursing the state government for a % of its Medicaid expenditures
203
Ways pharmacies might violate the Anti-Kickback Statute
i. Offering any remuneration to a prescriber to refer patients to the pharmacy
ii. Referring patients to the Part D plans with which the pharmacy contracts
iii. Offering patients gifts, coupons, or cash for Rx transfers
204
SNF
Skilled Nursing Facility
205
ICF
Intermediate Care Facility
206
LTCF
Long Term Care Facilities
207
Dispensing cycle standard for LTCF
no more than a 14 day cycle (exceptions include solid, oral abx)
208
Minimum frequency requirement for drug regimen review by a pharmacist for a LTCF resident
Review at least once a month to promote positive outcomes
209
Labeling requirements for LTCF dispensations
a. Must comply with currently accepted principles, including deferral and state requirements.
b. Must include medication name, prescribed dose, strength, expiration date, resident’s name, and route of administration
c. Should also be labeled with instructions and precautions
d. Include name and volume of solution, infusion rate, name/quantity of additive, date of preparation, initials of compounder, date/time administration, and BUD if it’s prepared or compounded for IV infusion.
e. OTC should be labeled with OG manufacturer’s or pharmacy applied label with the drug name, strength, quantity, accessory instructions, lot number, and expiration date.
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Section 1 of the Sherman Antitrust Act
makes unlawful every contract, combination, or conspiracy in restraint of trade
211
Section 2 of the Sherman Antitrust Act
prohibits monopolies, attempts to monopolize, or conspiracies to monopolize
212
Robinson- Patman Act
unlawful for sellers to discriminate in price between purchasers of like products when the effect of discrimination may substantially injure competition, unless the discrimination is cost justified.
213
Per Se antitrust violations
Price fixing, boycotting, typing arrangements, Third parties, Rx benefit managers, exclusive contracts, joint ventures, preferred provider organizations, purchasing cooperatives, efforts to influence Gov’t action.
214
Beneficiaries of 340B
a. 340B requires drug manufacturers provide outpatient drugs at special reduced prices to designated covered entities serving underserved and uninsured populations. Covered entities include federally qualified health centers, disproportionate share or safety net hospitals, family planning projects, and state-operated AIDS drug assistance programs and similar types of clinics, facilities, and hospitals. Also children’s hospitals and free-standing cancer hospitals that are excluded from Medicare.
215
PSQIA
Patient Safety and Quality Improvement Act of 2005
216
Impact of PSQIA of 2005
a voluntary program that HCP can share information related to patient safety events called patient safety work product with patient safety organizations.
217
Tech-check-Tech program
If the pharmacist is unavailable, techs may check other techs, but pharmacists are still liable for anything that happens.
218
Three objectives of licensure
a. Increase quality of healthcare
b. Reduce cost of healthcare
c. Inhibit the criminal abuse of drugs
219
Structure and Function of the NABP
national organization that brings together individual state boards- Oversees administration of standardized exams that states use for licensure; Also serves as a forum for development of policies and standards; Develops model legislation and regulations for use by member boards, supervises licensure transfers regarding discipline.
220
Structure and function of state boards of pharmacy
administrative agency for regulating the proactive of pharmacy: Purpose is to protect the public health, safety, and welfare. They protect the public, not the profession; Members are mostly practicing pharmacists, but sometimes have consumer members and other HCP; mostly independent community practitioners
221
Requirements for pharmacist licensure
a. Graduation from accredited pharmacy school
b. Completion of specified internship requirements
c. Attainment of a specified age
d. Passing score on one or more license exams (NAPLEX)
e. Demonstration of good moral character
222
Requirements for pharmacy licensure
a. Meet established standards relating to structural matters, library, and assurance of pharmacist supervision.
b. Some states have laws restricting ownership to pharmacists, others to physicians, but rarely just physicians
c. Them pharmacy owner should designate a particular phatmacist as the pharmacist-in-charge (PIC), who has the responsibility to ensure everyone complies with laws and regulations
223
Options for pharmacists who have been found to be impaired because of alcohol/dug use
a. Pharmacist can voluntarily enter into rehab with or without the board of pharmacy involvement or knowledge.
b. Pursue a board of pharmacy disciplinary hearing
c. Often, if a pharmacist successfully meets program expectations, they can resume practice
d. Some states require pharmacies to have written policies and procedures for taking action to protect the public when a pharmacist is impaired, which could involve reporting to the state board.
224
MAC
Maximum Allowable Cost
225
FUL
Federal Upper Limit
226
EAC
Estimated Acquisition Cost
227
AWP
Average Wholesale Price
228
AAC
Actual Acquisition Cost
229
Current FUL
pharmacists reimbursement varies according to whether the drug is a multiple source drug, for which CMS has established a specific upper limit or another drug
230
Current AWP
manufacturer’s suggested price for wholesalers to sell to pharmacies
231
Current AAC
actual acquisition cost relative to AWP
232
Current EAC
The cost the pharmacy gets reimbursed if a specific brand name is requested.
233
ERISA
Employee Retirement Income Security Act- federal law that works to protect employees from losing the benefits accrued through service to their employers by setting minimum standards for plan reporting and disclosure, vesting, funding, and fiduciary responsibilities
234
Pharmacy Practice Act
Collection of state laws and regulations directed at pharmacies and pharmacists in a particular state
235
Pros of Pharmacy Take-Back Programs
Intent is to allow unused drugs to be recycled. Generally allows hospitals, LTCF, pharmacies, manufacturers, and wholesalers to donate sealed, unexpired medications to be distributed to the indigent (some states include CS, but federal law says that isn't lawful)
236
Cons of Pharmacy Take-Back Programs
Concerns of adulteration that may affect safety and efficacy because they might not be stored properly or drugs that require a restricted distribution program.
237
Elements for a legal cause of action for negligence
a. Duty owned
b. Breach of duty
c. Causation
d. damages
238
Actual causation
difficulty proving in drug-related cases because the drug has already been ingested and eliminated by the time an investigation can be conducted; jury must resolve based on expert testimony
239
Proximate Causation
related to limiting the liability of a defendant whose conduct has been shown to be the actual cause of harm; Most cases address the liability of a defendant who breached a duty of care when the defendant’s negligent conduct had an unforeseeable result.
240
Actual damage
purpose is compensation; goal is to get the patient to the position they would have been in if the pharmacist was not negligent
241
Punitive damage
recovery for damages in an amount greater than the necessary to compensate the plaintiff for harm actually suffered
242
Statute of limitations
a plaintiff has to bring in a claim within a specific amount of time after the cause of action accrues.
243
Statue of limitations for general negligence
2 years
244
Statute of limitations for medical malpractice
1 year
245
Discovery
specifies that a cause of action foes not accrue until the date on which the plaintiff discovers the injury, even if it’s years later
246
Statute of Response
limits the length of response after the defendant’s alleged negligent action during which the discovery rule can postpone the accrual of the statute of limitations. Without this, drugs that cause latent problems could give litigations decades after.
247
Vicarious liability
places liability upon the employer without regard to any negligence on the part of the employer
248
Risk Management
Business activities designed to reduce the incidence of errors, in order to prevent the negative fallout that adversely affects a business at which the errors have occurred.
249
Wantonly
Reckless disregard for the health and safety of others.
250
Rules for effective risk management
a. Be correct
b. Be complete
c. Be concise
d. Be consistent
e. Be cautious
251
Category of defect most commonly associated with drug product liability
Warning defect
