Professional Documents
Culture Documents
Pharmacy Law
Table of Contents
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4. Drug Recalls
A. FDA-Requested Recalls (p 16)
B. Sample Questions (p 17)
6. Prescription Fraud
A. Types of Fraudulent Prescriptions (p 21)
B. Scrutinizing Prescriptions (p 21)
C. Patterns of Possible Diversion (p 21)
D. Preventing Diversion (p 22)
E. Sample Questions (p 23)
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1. Important Pharmacy Laws
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1984 Hatch-Waxman Act Provides up to five years extension on a
patent once the patent on a brand-name
drug expires.
1987 Prescription Drug Marketing Act Amendment to the FD&C Act to reduce
the potential health risks that may result
from the diversion of prescription drugs
from legitimate commercial channels.
1990 Omnibus Budget Reconciliation Required Pharmacists to counsel
Act (OBRA) Medicaid patients on their medications.
1997 FDA Modernization Act Changed the legend requirements to Rx
Only.
1996 Health Insurance Portability and The first-ever federal privacy standards to
Accountability Act (HIPAA) protect patients medical records and
other health information provided by
health plans, doctors, hospitals,
pharmacies and other health care
providers. Took effect on April 14, 2003.
2002 Public Health Security and To improve the ability of the United
Bioterrorism Preparedness and States to prevent, prepare for, and
Response Act respond to bioterrorists and other public
health emergencies.
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B. Federal Controlled Substances Act of 1970
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ii. Controlled Substances Act Requirements
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C. Federal Laws Regulating Controlled Substances
iii. Recordkeeping
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D. Health Insurance Portability and Accountability Act of 1996
(HIPAA)
Federal standards began on April 14, 2003 for patient privacy protection.
The new privacy regulations ensure a national floor of privacy protections
for patients by limiting the ways that health plans, pharmacies, hospitals and
other covered entities can us patients personal medical information. The
regulations protect medical records and other individually identifiable health
information, whether it is on paper, in computers, or communicated orally.
i. HIPAA Provisions
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E. State Laws
Such regulations may reside in different departments of the state, such as the
Board of Pharmacy, the Department of Health, or Consumer Affairs.
Legal liability means you could be prosecuted for misconduct. This does not
mean you intended to do wrong, however the failure to do something you
should have done is called negligence.
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G. Sample Questions
1. What act requires that all hazardous materials be handled cautiously and
are disposed of in a well-recognized container?
a. Food and Drug Act
b. Harrison Narcotic Act
c. Medical Device Act
d. Federal Hazardous Substance Act
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6. What controlled substance schedule has the highest potential for abuse?
a. C-V
b. C-IV
c. C-III
d. C-II
9. When theft or significant loss of a drug occurs, the pharmacist must report
this immediately to the Board of Pharmacy and file what type of form?
a. DEA form 222
b. DEA form 106b
c. DEA form 221
d. DEA form 22-b
10. All C-I and C-II scheduled drugs need to be ordered on what form?
a. DEA form 222
b. DEA form 106b
c. DEA form 221
d. DEA form 22-b
11. Under HIPAA, criminal penalties can range from $50,000 to $250,000
and up to how many years in prison?
a. 1
b. 5
c. 10
d. 20
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12. A pharmacy technician could be prosecuted for
a. Misconduct
b. Negligence
c. Giving out medical advice
d. All of the above
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2. Drug Development Process
FDA review/approval.
A. Marketing Drugs
This process can take up to 17 years or longer. Once approved by the FDA, a
new brand drug is entered into the market. Once all of the research is paid
back for the development, a generic drug can be marketed by other
companies. All generic drugs have to be pharmaceutically and
therapeutically equivalent to the brand drug listed in the Orange Book with
the active ingredient, dosage form, route of administration, and strength.
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B. Investigational Drugs
OTC drugs have to be approved by the FDA. Proper labeling of OTC drugs
includes all active ingredients, amount of contents, warnings, direction for
use, expiration date, and lot number.
Federal law requires that containers do not look like another drug container.
However, some drugs look alike and sound alike.
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3. The National Drug Code Number
Example: 34468-2322-02
Sometimes manufacturers will use 4 digits for the first set of numbers, or 3
digits for the second set of numbers. If you need to order this drug, you
would put a 0 (zero) in front of the 1st or 2nd sets of numbers before it can be
translated in the computer system. Always use 5 digits, 4 digits, 2 digits.
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4. Drug Recalls
A drug recall is the action taken to remove a drug from the market
and return it to the manufacturer.
A. FDA-Requested Recalls
If the FDA requests a recall, the following steps would apply depending on
the class:
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B. Sample Questions
2. Approximately how many years does the drug development process take
before a drug can be marketed?
a. 10
b. 12
c. 15
d. 17
4. What is the safest way to verify that a drug is the correct medication
before it is dispensed?
a. Generic name
b. NDC number
c. Manufacturers name
d. Ask another technician if this is the correct drug
5. What does the second group of numbers mean in the National Drug Code?
a. Package size
b. Manufacturer
c. Cost
d. Medication strength and dosage form
6. What is the most serious class of recall for a drug that can cause death?
a. Class I
b. Class II
c. Class III
d. Class IV
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5. Drug Enforcement Agency (DEA) Number
DEA numbers are required by federal law but are administered by the
states.
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B. DEA FORM 222
DEA Forms 222 are to be kept in a separate file from other invoices.
C-III through C-V drugs do not require DEA Form 222 to be filled out,
although recordkeeping is required for all controlled substances.
PT 3:5
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C. Sample Questions
3. How many copies of DEA form 222 are submitted to different entities?
a. 4
b. 3
c. 2
d. 1
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6. Prescription Fraud
How to Stop Drug Diversion and Protect Your Pharmacy.
B. Scrutinizing Prescriptions
21
D. Preventing Diversion
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E. Sample Questions
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7. Healthcare Standard-Making Organizations
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A. Sample Question
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8. Pharmacy Resources
Martindale
This reference book is used internationally with the best source of
information on drugs, with monographs that provide information on actions
and uses of drugs.
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American Drug Index
This index is a cross reference of drugs by generic, brand and chemical
names with indications and manufacturers.
Orange Book
This is the common name used for the FDAs Approved Drug Products
Publication which provides abbreviations that are made up of 2 letter codes.
Codes beginning with A signify that the product is deemed therapeutically
equivalent to the reference product for the category. Codes beginning with
B indicate that bioequivalence has not been confirmed. In some instances,
a number is added to the end of the AB code to make it a three-character
code (ex. AB3).
Remington
The science and practice of pharmacy. Published every 5 years and used to
cover all aspects of pharmacy for students, practitioners and researchers.
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MedWatch Form
A voluntary reporting system in which health professionals can report
adverse events and product problems. This is the FDA medical products
reporting program.
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A. Sample Questions
3. Which book is published every 5 years and is used to cover all aspects of
pharmacy for students, practitioners and researchers?
a. American Drug Index
b. United States Pharmacopoeia Drug Information
c. Goodman and Gilman
d. Remington
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9. Answer Key for Sample Questions
1. G. 4. B. 5. C. 6. E. 7. A. 8. A.
1. d 1. c 1. d 1. b 1. c 1. c
2. b 2. d 2. c 2. d 2. b 2. a
3. c 3. c 3. b 3. d
4. a 4. b 4. d
5. a 5. d 5. a
6. d 6. a
7. c
8. a
9. b
10. a
11. c
12. d
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