Unit 1 Review Flashcards
To gain a strong understanding of Unit 1 of Pharmacy Tech
1
Q
What does DAW 0 mean?
A
That the prescriber has no preferred medication. You can substitute with generic.
2
Q
What does DAW 1 mean?
A
Substitution not allowed by prescriber. Prescriber wants patient to receive brand-name product.
3
Q
What does DAW 2 mean?
A
Substitution not allowed by patient.
4
Q
What does DAW 3 mean?
A
Substitution not allowed by pharmacist.
5
Q
What does DAW 4 mean?
A
Substitution not allowed because the generic drug is not in stock.
6
Q
What does DAW 5 mean and when is it used?
A
Brand name is dispensed as the generic. Usually use if brand dispensing is more cost effective
7
Q
What does DAW 6 mean?
A
Override is required. Rarely Used
8
Q
What does DAW 7 mean?
A
Substitution not allowed by the state/law.
9
Q
What does DAW 8 mean and when does it happen?
A
Substitution not allowed because the generic is not available in the marketplace. Happens when the drug isn’t manufactured/distributed or is temporarily unavailable.
10
Q
What does DAW 9 mean?
A
Other/Reserved and currently not in use
11
Q
Who can prescribe controlled substances?
A
Physician, Dentist, Podiatrists, Veterinarians. In some states Physician Assistant, Nurse practitioner, optometrists.
12
Q
For the first letter of a DEA number, what are the possible options?
A
A, B, F, M, and X
13
Q
What decides the second letter of a DEA number?
A
The first letter of the persons last name.
14
Q
How do you verify a correct DEA number?
A
Last Digit((1d + 3d + 5d) + 2(2d+ 4d + 6d)) = 7d
15
Q
What must be included on a prescription for a controlled RX?
A
Date of issue, Patient full name and address, Prescribers full name address & DEA number, Drug Name, Drug Strength, Dosage form, Quantity to be prescribed, directions for use, number of refills if any. If written prescribers signature. If electronic id linked to prescriber.
16
Q
What way can a CII’s be sent?
A
Written or Electronic with verbals allowed in only in emergency situations. If verbal hardcopy must be received in 7 days. For community Pharmacys fax is only acceptable for data entry. Must receive original RX before dispensing. Longterm care facilities have exceptions and can recieve faxes. Also some hospice patients can.
17
Q
What way can CIII - V be sent?
A
Faxed, Written, Verbal, or electronic
18
Q
What are the refills options for class drugs?
A
Class II = No refills, Class III & IV = Upto 5 in 6 months, Class V = No restrictions
19
Q
When do Class II drugs expire?
A
Federally it has no time limit. States may have stricter rules.
20
Q
When do Class V drugs expire?
A
Federally it has no time limit. States may have stricter rules. Washington is 6 months 5 refills
21
Q
When do Class III drugs expire?
A
Good for 6 months
22
Q
When do Class IV drugs expire?
A
Good for 6 months
23
Q
Can class II be partially filled and if so what are the restrictions?
A
Must be fully filled in 72H/3D
24
Q
Can class III and highers be partially filled? and if so what are the restriction?
A
Yes they can. No restrictions on how soon it needs to be filled after partial.
25
What must the label for a prescription list?
Pharmacy's name and address, RX number, PA name, Prescriber name, Directions for use, Date filled. Also if Class II-IV warning prohibiting drug diversion.
26
What form is used for ordering CII? and what must be listed?
DEA form 222. Triplicated if paper. Date and amount received.
27
How long must records be kept on CII orders?
2 years
28
How often does federal law require an inventory of class drugs?
Every 2 years (biennially) from initial inventory date.
29
How long are records kept for Class inventories by federal law?
2 years
30
How many times can a schedule drug be transferred?
1 unless there is an electronic system.
31
What form is required to transfer a CII?
DEA form 222
32
What form is required to send CII to reverse distributor?
DEA form 222
33
What form is required for destruction of CII meds at a pharmacy?
DEA 41 form
34
What type of pharmacy doesn't require preapproval to destroy Class medication?
Hospital Pharmacy
35
What form is used to report a theft and loss of Class medication to the DEA?
DEA form 106
36
How soon after a loss of class drugs does the DEA need to be notified?
1 day
37
What class of drug requires both an exact count and perpetual inventory?
Schedule II
38
What are the active count requirements for schedule III, IV, V drugs?
Estimated count on containers with less than 1000 dosage units. Exact count for containers that have 1000 or more dosage units.
39
How frequently are controlled inventorys required federally?
2 years(biennially)
40
How long are inventory records to be kept?
2 year(biennially)
41
Are Class II order forms allowed to be placed with other pharmacy records?
No
42
What program is used to monitor when a patient picked up a controlled substance?
PDMPs/PMPs Prescription Drug Monitoring Programs
43
What are package inserts?
Package inserts are manefacturer supplied information sheets intended for use by healthcare professionals?
44
What are black box/Boxed warnings?
The most serious safety alerts
45
On package inserts what is the highlight section for?
Contains the prescribing info about risk and benefits of using drug. Helps find information quickly. Contains boxed warnings.
46
What is contained of the table on contents on a package insert?
A reference area for the location of sections on the package insert.
47
What is contained in the Indication and Usage section of a package insert?
List disease states/conditions that medication is approved to treat.
48
What is contained in the Dosage and administration section of the package insert?
Recommended doses, dosing schedules, and administration requirements.
49
What is contained in the Contraindication section of the package insert?
List situations when a drug should not be used. Disease states, interacting drugs, allergic reactions
50
What is contained in the Warning and Precaution section of the package insert?
List situations that requires caution while taking the medication, boxed warnings, lab tests that can affect the drug.
51
What is contained in the Adverse Reactions section of the package insert?
Lists reported side effects from the drug's testing phases and post marketing experience.
52
What is contained in the Drug Interaction section of the package insert?
Lists the most significant drug-drug interactions for the drug and labs that can affect the drug.
53
What is contained in the Specific Populations section of the package insert?
List safety concerns when using the drug during pregnancy, during labor and delivery, while breastfeeding, in children, and in the eldery.
54
What is contained in the Drug Abuse and Dependence section of the package insert?
List the medications controlled substance classification. List the abuse and tolerance potential of drug.
55
What is contained in the Overdosage section of the package insert?
List the signs, symptoms, and treatment options during an overdose siuation.
56
What is contained in the Product description section of the package insert?
Chemical Name, Structural formula, Active ingredients, inactive ingredients(dyes, fillers, flavorings)
57
What is contained in the Clinical Pharmacology section of the package insert?
Used mostly by pharmacist and prescribers. Contains how medication works(mechanism of action)
Explains how medication is absorbed, metabolized, and eliminated from the body.
Gives explanations of the studies performed with the medication in different populations
58
What is contained in the How Supplied section of the package insert?
Lists the medication's
Dosage forms, color, Markings, Special storage and handling instructions, and sometimes shape of medication.
59
What is contained in the Nonclinical Toxicology section of the package insert?
Lists any cancer and fertility risks from using the medication. mainly used by pharmacists and prescribers.
60
What is contained in the Clinical studies section of the package inserts?
Provides information from the clinical studies showing how well the drug works for its approved indication.
61
What is contained in the Patient counseling information section of the package inserts?
Highlights the most important counseling points about the medication for the pharmacist or prescriber.
62
What is the weakness of packages inserts?
Takes a long time to updates since wording must be approved by fda. May not have upto date information.
63
What is found on the orange book website?
informs which generics are equivalent to which brand name drugs. Helps determine if substitution is allowed.
64
What is the definition of Therapeutically Equivalent?
Generic product identical in active ingredients, strength, and dosage form to brand name.
Must also absorb and release identically in the body. Expected to have same safety protocol and chemical effect.
65
How many letters are there in a rating code?
2
66
In a rating code what is the meaning of "A" and "B" on the first letter?
A = Therapeutically Equivalent | B = Not Therapeutically equivalent
67
What are the options for the second letter of orange book and their meanings?
A = oral dosage form, "B" = Bioequivalence, "N" = product for aerosolization, "P" = parenteral/injectable product, "T" = Topical dosage form
68
What is the Facts and Comparisons eAnswers?
An online drug reference allowing side by side comparison of drugs. Contains a drug identification tool. Can search for product availability and generic alternatives.
69
What is Prescribers Digital Reference (PDR)?
Contains same info as package inserts as well as FDA safety updates
70
What is the United States Pharmacopeia National Formulary?
Defines the standards for medications. Dosage form, drug substances, Excipients or inactive ingredients.
Contains official title of medication, standard for strengths and purity, procedure for proper handling and storage.
Contains formula for manufacture and preparation and recipes for specific informationfor the materials used when compounding
71
What is the handbook on Injectable drugs?
Provides information about parenteral meds. Similar to USP-NF with some info on interactions, prep, stability and administration requirements.
72
What is natural medicines?
Provides up-to-date information on dietary supplements, vitamins, minerals and other natural remedies. Has a drug-herb interaction checker and product rating.
73
What are the stages for approving a new drug?
Preclinical -> Submit IND -> Clinical -> Submit NDA or BLA -> Postmarket
74
What is the first phase of clinical testing?
Phase 1 - First time a drug is given to human. Goal is to determine if drug is safe in humans with minimal adverse effects. Subjects are healthy subjects who do not have the disease being studied about less than 100 subjects
75
What is the preclinical testing phase for a drug?
New drug compound is given to animals for testing. identifies risk and benefits of drugs and appropriate doses that might be safe for humans.
76
What is the IND application?
Investigational New Drug application - Filed to FDA for approval to test drug or biologic in humans
77
What is the second phase of clinical testing?
Goal is to determine drug's effective dose, best method of delivery, dosing intervals and continue safety evalution. Subjects have disease drug is intended to treat. 50-300 subjects
78
What is the third phase of clinical testing?
Goal is to establish acceptable use or uses of the drug. About 3000 people Subjects have disease
79
What is the NDA in drug testing?
New Drug Application. Submitted after all of phases testing have proven its safe and effective. Drug goes to market once approved by FDA
80
What is the BLA in drug testing?
Biologics License Application. Submitted after all of phases testing have proven its safe and effective. Drug goes to market once approved by FDA
81
What is the other name for Phase 4 in drug testing?
Postmarket testing
82
What is the IRB?
Institutional Review Board. Reviews and approves research involving human subjects for their institution. Also approves protocols and materials used by researchers in hospitals. Also approves patient consent forms and brochures.
83
What is the FDA?
Food and Drug Administration. Governing body over medications sold in U.S. Branch of U.S Department of Health and Human Services
84
What is the CDC?
Center for Disease control and Prevention. Provides regulation for infection control
85
What is the DEA?
Drug Enforcement Administration. Enforces the laws and regulations surrounding controlled and illegal substances. Also sets the requirements for dispensing and refilling controlled substances.
86
What is the The Pure Food and Drug Act of 1906?
First law to regulate to medications. Prohibits falsely labelling Pharmaceutical products (Misbranding). Prohibits sale of contaminated products or those with unknown contents (adulteration)
87
What is the Food, Drug, and Cosmetic Act of 1938?
Added to the Pure Food and Drug Act of 1906. Expanded role of FDA in approving new drugs. Requires drug manufactures to prove a drugs purity, strength and safety before it can be sold.
88
What is the Durham-Humphrey Ammendment of 1951?
Created 2 classes of medication. Prescription (Legend), Nonprescription (OTC). Prescription medications will state "RX only" on medication labelling.
89
What does legend mean in medication?
Prescription Drug
90
What does OTC mean in medication?
Nonprescription
91
What is misbranding?
falsely labelling Pharmaceutical products (Misbranding)
92
What is Adulteration?
Prohibits sale of contaminated products or those with unknown contents (adulteration)
93
What is the Poison Prevention Packaging Act of 1970?
Standard for packaging to protect children from taking harmful medications.
94
Who authorized the Poison Prevention Packaging Act of 1970?
CPSC (Consumer Product Safety Commission)
95
What is the standard for child resistant packaging?
Cannot be opened by 80% of children younger than 5. Can be opened by 90% of adults.
96
What medications don't require Child-Resistant Packaging?
Sublingual nitroglycerin, Oral contraceptives in memory-aid packaging, Inhalers, Inpatient meds, some otc meds, Vitamin and supplements.
97
What medications require a Patient Package insert?
Oral Contraceptives, Estrogen-containing medications.
98
What are the differences in patient package insert requirement of Outpatient vs Inpatient pharmacies?
Outpatient pharmacy must dispense patient package inserts every time including refills. Inpatient must dispense it for the first dose and once every 30 days thereafter as long as therapy continues.
99
What is the drug listing act of 1972?
Requires each new drug to have a unique and permanent product code. Called an National Drug code (NDC)
100
What does NDC stand for?
National Drug Code
101
What are the sections of a NDC code?
First Section - Manufacture or distributor, Middle Section - identifies drug details, Last segment - Identifies package size and type
102
How many numbers in an NDC code?
Usually 10 some systems use an 11 digit system
103
What is the Drug Price Competition and Patient Term Restoration Act of 1984?
Allows manufactures to submit abbreviated new drug applications (ANDA) to market generic products. Done so generic meds don't have to go thru the entire approval process. (Hatch-Waxman Act)
104
What is the other name for the Drug Price Competition and Patient Term Restoration Act of 1984?
Hatch-Waxman Act
105
What is the Omnibus Budget Reconcilation Act of 1990?
OBRA '90. Requires a pharmacist to discuss information about new and refill prescriptions with patients. Only basic federal requires on pharmacist counseling. State laws go more specific.
106
What is the Dietary Supplement Health and Education Act of 1994
(DSHEA) requires supplements (vitamins, minerals and herbals) to be treated more like tahn drugs than food. Labels must list intended purpose and can't say they can treat, prevent or cure a specific disease or condition.
107
What is the Health Insurance Portabililty and Accountability ACT of 1996 (HIPAA)?
Sets standards for ensuring patient information is protected and safe.
108
What is the TIRF program?
Transmucosal immediate release fentanyl - Program to control the abuse of transmucosa immediate release fentanyl products. Prescriber and pharmacy must be enrolled.
109
What is the Lotronex rems program?
Pertains to lotronex and it’s generic alosetron. Ensures prescribers and patients are informed about serious gi effects of from alsoetron.
110
What is the clozapine Rems program?
Refers to clozaril and it’s generic clozapine used to schizophrenia.
Pharmacies and prescriber must be enrolled. Prescriber must order anc to be done.
111
What is MERP?
Medication Errors Reporting Program. Operated by ISMP and USP. individual healthcare providers and consumers may report medication errors confidentially.
112
What is MedWatch?
Operated by FDA. individual healthcare providers and consumers may report medication errors.
113
What is MedMARx?
Used in the hospital setting to monitor error prevention strategies and share with other institutions.
114
What is CSA?
Controlled subtance act. Dictates specifics for manufacturing, prescribing, and dispensing controlled substances.
115
What must be included on a prescription label?
Pharmacy's name and address, Prescription number, Patients name, Prescriber's name, Directions for use, Date of filling. On Schedule II-IV a warning against diversion
116
What is a Class I Recall?
Involves product that are likely to cause serious adverse events or death in people that take the drug.
117
What is a Class II Recall?
Involves product that could cause temporary but reversible side effects.
118
What is a Class III Recall?
Involves product or specific batches that are unlikely to cause adverse event in people who take drug.
