Chapt 6 Flashcards
Practicing pharmacists and technicians equally responsible for compliance
True
Food and Drug Administration enforces rules and regulations
(FDA)
Pure Food and Drug Act of 1906
Prohibited adulteration and misbranding of foods and drugs in interstate commerce
Durham-Humphrey Amendment (DHA)
Established two classes of drugs:Prescription and OTC
Prescription: No requirement for labels to provide “adequate directions for use”
Pharmacist uses directions from prescriber
OTC:Labels required
FDA Modernization Act of 1997
Streamlined regulatory procedures by encouraging manufacturers to:
Research new uses of drugs
Conduct pediatric studies of drugs
Some hospitals and health care facilities authorized to
purchase, possess, and use controlled substances
Maintenance of Controlled Substances
Must keep many records, including:
Order from person authorized to prescribe.
Separate record at main point of supply for controlled substance
Record of authorized requisitions for such drugs
Documentation of each substock (amount on nursing unit)
Entry on patient’s MAR upon each administration
Controlled Substances Act (CSA) of 1970
Important federal law regulating manufacture, distribution, and sale of drugs with potential for abuse and dependence
Controlled Substances Act (CSA) of 1970
Classifications:
Schedule I
No current approved medical use in U.S.
Abuse potential
Schedule II
High abuse and dependency potential
Required to be affixed with orange label and caution statement
Schedule III
Less abuse and dependency potential
Schedule IV
Minimal abuse and dependency potential
Schedule V
Contain limited quantities of narcotics
Ordering Controlled Substances
CSA requirements:
Triplicate order forms when ordering substances in Schedules I and II
Federal registration of all people in chain of purchase to distribute/dispense
Anyone who manufactures, distributes, gives instructions about, imports, exports, or administers must register with Drug Enforcement Administration (DEA)
Lost/Stolen Controlled Substances or Order Forms
Must be immediately reported to:
DEA Diversion Field Office
Local police
Destruction of Controlled Substances
Pharmacy must contact Bureau of Controlled Substances and/or DEA to dispose of excess
Necessary forms provided to pharmacy
Issuing Prescriptions
Only issued by authorized, licensed individual
Licensed in practicing state
Employee (nurse or secretary) can communicate prescription issued from practitioner to pharmacist
Only pharmacist can fill prescription
Dispensing Controlled Substances
Only if state law allows, pharmacy technician can dispense under supervision of pharmacist
Prescriptions must have name of prescriber and signature of physician
Dispensing Controlled Substances
Only if state law allows, pharmacy technician can dispense under supervision of pharmacist
Prescriptions must have name of prescriber and signature of physician
Pharmacist may dispense on oral authorization, but must follow series of steps in accordance with law
Recordkeeping Requirements
All records must be kept for at least two years at place of registration
State law may require longer :
-E.g., New York requires five years
-Must adhere to higher standard
Omnibus Budget Reconciliation Act (OBRA) of 1990
Ensures higher level of patient care and professional service
Three mandated provisions that affect pharmacy:
-Drug manufacturers required to provide lowest prices to Medicaid patients
- Drug use review
- Patient counseling
Health Insurance Portability and Accountability Act (HIPAA)
- Aimed at improving efficiency and effectiveness of American health care system by adopting national standards for electronic health care transactions
- Requires protection of personal health care information
Health Insurance Portability and Accountability Act (HIPAA)
Title I
Insurance reform protects health insurance coverage for workers and their families when they lose their job
Title II
Simplify administrative functions by standardizing health care transactions
Patient Package Inserts (PPIs)
- Necessary labeling of medication important for both professional and patient information
- Required for safe and appropriate prescription use of medication
- Educate patient on medication
Labeling
- Prescription drugs labeled for health care professional rather than patient
- Unit dose packaging used when single dosage of drug is packed for administration
- Regulated by FDA
National Drug Code (NDC)
-Required on all OTC and prescription drugs
- Ten numbers
- First five digits identify manufacturer
- Last five digits identify drug name, package size, and type of drug
-FDA mandates pharmaceutical bar coding to help reduce medication errors
Clinical Studies
Three phases
All three must be completed
If successful, researchers can complete New Drug Application
Phase I
- Drug introduced to humans for first time
- Control group receives both placebo and drug
- Researcher and patient usually unaware of which drug given
Phase II
- Emphasis on establishing activity of new drug in patients
- Research may be abandoned if unfavorable outcome
Phase III
- Provides proof of efficacy
- Establishes acceptable use of drug
Preclinical Studies
- Identify drug’s biological and toxicological characteristics
- Use animals to determine how drug is absorbed, distributed, metabolized, and eliminated
- Once results determined, researchers find suitable human dosage regimens
Informed Consent
- FDCA requires investigators to obtain from patients during all clinical phases
- Must outline and explain all possible risks and benefits of drug
- Institutional Review Board (IRB) ensures patients receive
- Risks to patients minimized
Handling Investigational Drugs
Hospital pharmacy responsible for:
- Distribution and control of investigational drugs
- Clinical services
- Research
- Clinical study management
Adverse Drug Reactions
- Researchers and hospital must report to FDA
- FDA maintains voluntary program
- Drug Quality Reporting System (DQRS)
Drug Recalls
- All are voluntary
- Classified as Class I, Class II, and Class III
- Pharmacist or pharmacy technician immediately retrieves all lot numbers of recalled med’s and destroys or returns them
The Joint Commission
- Formed in 1951
- Mission is to address quality of patient care and safety
- Establishes optimal standards for health care providers
- Evaluates organizations for compliance with standards through unannounced survey
- Accredits organizations
