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Pharmacy Practice-Chapter 6
Regulatory Standards in Pharmacy Practice
Terms in this set (63)
1. A package insert is required to be given to all patients who are taking...
... steroids, analgesics, and estrogenic drugs (all of them).
2. Which of the following is considered a controlled substance?
... Demerol (CII), Morphine (CII), Valium (CIV) (all of them).
3. Regulations affecting pharmacy practice encompass...
... Federal and state statutes, states rules and regulations, CSA regulations (all of them).
4. Which of the following is NOT an approved use of tax-free alcohol?
5. Which of the following is NOT a responsability of the Food, Drug, and Cosmetic ACT (FDCA)?
Collection of adverse drug reaction reports.
6. Controlled substances are required by federal law to have appropiate safeguards with their use. Which of the following is NOT an issue?
7. Which of the following is NOT a reason to report adverse drug reactions to the FDA?
8. A Class I recall does NOT include...
... assigment of the drug recall classification by the FDA.
9. The intent of the Occupational Safety and Health Administration (OSHA) is...
To monitor job-related injuries, to develop job safety and health standards, to ensure a safe and healthy workplace (all of them).
10. Pharmacy practice standards, guidelines, and statements...
... define reasonable and prudent practices.
11.a. Durham-Humphrey Amendment
Establishes prescription versus over-the-counter drugs.
11.b. Orphan Drug Act
Creates incentives for manufactures to research and develop drugs to treat rare diseases and disorders.
11.c. Controlled Substances Act
Regulates the manufacture, sale, and distribution of drugs that have a high abuse potential.
11.d. Poison Prevention Packaging Act
Establishes requirements for child-resistant containers.
11.e. Hazard Communication Standard
Establishes the rights of employees to know the dangers of substances used in the workplace.
11.f. Health Insurance Portability and Accountability Act
Establishes guidelines to protect patient privacy.
12.a. RULES and REGULATIONS...
... are administrative enactments implemented by government agencies that meet the intent of statutory policies.
12.b. The PURE FOOD AND DRUG ACT OF 1906...
... prohibits the adulteration and misbranding of foods in interstate commerce.
12.c. The FOOD, DRUG, AND COSMETIC ACT OF 1938...
... requires that all new drugs be proven safe and effective.
12.d. Schedule " I "...
... drugs have no approved medical use in the United States.
12.e. The FDA requires distribution of...
... PATIENT PACKAGE INSERTS (PPIs) to educate patients about the proper use of and potential hazards of drugs.
Laws enacted by a legislative body that dictate the conduct of persons or organizations subject to the law.
Rules and Regulations
Promulgated by government agencies at the local, state, and federal levels.
Food and Drug Administration (FDA)
Promulgates rules, regulations, and standards; inspects drug and food facilities to ensure public safety regarding drug products.
Drug Enforcement Administration (DEA)
A federal agency established to implement the rules and regulations to enforce the Controlled Substances Act (CSA) to combat controlled substance abuse.
Recognized standards that are similar to laws.
Federal vs State Drug Control Laws
Pharmacists are equally responsible for compliance with both federal and state law and respective regulations foverning their pharmacy practice. If the federal law or regulation is more STRINGENT than the comparable state law or regulation, or vice versa, the more stringent law or regulation must be followed.
State Board of Pharmacy
Body established to ensure that the public is well served professionally by pharmacists.
Other responsabilities of the State Board of Pharmacy
Licensing and registering pharmacies.
Delaing with complaints of professional misconduct.
Carrying out disciplinary proceedings.
Developing regulations relating to filling and refilling prescriptions.
Substituting generic and therapeutic drugs.
Defining pisons and mandating records to be maintained upon retail sale.
Pure Food and Drug Act of 1906.
Food, Drug, and Cosmetic Act of 1938.
Durham-Humphrey Amendment of 1951.
Kefauver-Harris Amendment of 1962.
Medical Device Amendment of 1976.
Orphan Drug Act of 1983.
Food and Drug Administration Modernization Act of 1997.
Federal Food, Drug, and Cosmetic Act (FDCA)
Federal law through which the Food and Drug Administration promulgates its rules and regulations.
Food, Drug, and Cosmetic Act of 1938
The federal statute through which the FDA promulgates its rules and regulations.
An amendmento to the Federal Food and Cosmetic Act that required all new drugs marketed in the United States to be shown to be not only safe, but also efective.
Food and Drug Administration Modernization Act of 1997 (FDAMA)
Legislation that streamlined regulatory procedures and encouraged manufacturers to conduct reserch for new uses of drugs and perform pediatric studies of drugs.
Schedule I dugs samples:
Heroin, marijuana, LSD, peyote, mescaline, hallucinogenic substances.
Drugs with high potential for abuse, with severe psychological and/or physical dependence liability.
Schedule II drugs samples:
Alfrentanyl, amobarbital, amphetamines, cocaine, fentanyl, hydromorphone, levorphanol, meperidine, methadone, methylphenidate, morphine, methamphetamine, oxycodone, pentobarbital, phenmetrazine, secobarbital, sufentanyl, tincture of opium.
A controlled substance whose abuse may lead to moderate or low physical dependence or high psychological dependence.
Schedule III drugs samples:
Acetaminophen with codeine, anabolic steroids, butabarital, dronabinol, nalorphine, thiopental.
A controlled substance with less abuse potential and limited risk of physical and psychological dependence.
Schedule IV drugs samples:
Alprazolam (Xanax), butorphanol, chloral hydrate, chlordiazepoxide, clonazepam, diethylpropion, eszopicione (Lunesta), flurazepam, midazolam, oxazepam, pemoline, pentazocine, phenobarbital, propoxyphene, sibutramine, temazepam, triazolam.
Contains preparations with limited quantities of certain narcotic drugs.
Schedule V drugs samples:
Actifed with codeine, dimetane DC, phenergan with codeine, Robitussin A-C, Diphenoxylate with atropine.
Medication Administration Record (MAR)
A record maintained by the nursing staff containing information about the patient's medication and its frequency of administration.
Can pharmacy technicians dispense controlled substances?
Whether a pharmacy technician may engage in the dispensing of a controlled substance under the supervision of a licensed pharmacist depends on state law.
Controlled drug prescriptions must be dated on the day when written and must include:
The name and address of the patient.
The drug name, strength, and dosage form.
The quantity prescribed.
Directions for use.
The name and address and registration number of the prescriber.
A pharmacist may dispense a Schedule II drug on oral authorization of the prescriber under the following emergency circumstances:
The quantity prescribed is limited only to the amount necessary to treat the patient for the emergency.
The prescription must be immediately reduced to writing by the pharmacist.
The prescriber must deliver to the dispensing pharmacist within 7 days a written prescription for the emergency quantity prescribed. The prescription must have written on its face "Authorization for Emergency Dispensing". On receipt, the pharmacist must attach this prescription to the oral emergency prescription. Failure of the prescriber to deliver the written prescription within 7 day period requires the pharmacist to notify DEA.
Federal Hazardous Substances Act
Requires that hazardous household products bear cautionary labels to alert consumers of potential dangers and to inform them of measures to take to protect themselves.
Occupational and Safety Act of 1970
Federal law that assures every working man and woman in the nation safe and healthy working conditions; established the Occupational Safety and Health Administration (OSHA).
Omnibus Budget Reconciliation Act (OBRA)
Mandated three provisions that affect the profession of pharmacy, including the provision that drug manufacturers are required to provide their lowest prices to Medicaid patients, and the provision that pharmacists are to provide drug use review and patient counseling.
Prospective Drug Review
A review of the patient's medication profile by a pharmacist to screen for any drug problems prior to the drug being dispensed.
Protected Health Information (PHI)
Includes any individually identifiable health information, with the exclusion of employment records.
Entities which HIPAA regulations apply to: namely, health plans that provide or pay the costs of medical care, health care clearing-houses that facilitate the processing of health information from another entity, and health care providers of medical or health services.
American Pharmaceutical Association Code of Ethics for Pharmacist - Principle 2
A pharmacist is dedicated to protecting the dignity of the patient. With a caring attitude and compassionate spirit, a pharmacist focuses on seeing the patient in a private and confidential manner.
American Association of Pharmacy Technicians Code of Ethics for Pharmacy Technicians - Principe VI
A pharmacy technician respects and supports the patient's individuality, dignity, and confidentiality.
National Drug Code Number (NDC)
Number required on all over-the-counter and prescription drug labels. The NDC number assigned to new drugs has 11 digits. The first five digits identify the manufacturer or distributor, and the last six digits identify the drug name, package size, and type of drug.
Adverse Drug Reaction
Any unexpected, or unwanted change in a patient's condition that a physician suspects may be due to a drug, that occurs at doses normally used in humans, and that requires treatment, indicates decrease or cessation of therapy with the drug, or suggests that future therapy with the drug carries an unusual risk in the patient.
Drug Recalls - Class I
There is a reasonable probability that the use or exposure to a product will cause severe adverse health consequences or death.
Drug Recalls - Class II
The use of or exposure to a product may cause temporary or medically reversible adverse health consequences.
Drug Recalls - Class III
The use of or exposure to a product is not likely to cause adverse health consequences.
Bureau of Alcohol, Tobacco, and Firearms (ATF)
A department of the U.S. Treasury, which establishes regulatory standards for procuring, storing, despensing, and use of tax-free alcohol for specific clinical uses.
Not-for-profit organization whose standards are set to ensure effective quality services (e.g., optimal standards for the operation of hospitals)
Patients' bill of rights
A declaration ensuring that all patients, inpatients, outpatients, and emergency service patients are afforded their rights in a health care institution.