Laws & Regulations
Which law required drugs to be safe and effective. It was enacted as a result of the thalidomide tragedy. In other words, does it require manufacturers to prove the effectiveness of drug products before they go into the market, and afterwards report any serious side effects?
Kefauver-Harris Amendment of 1962
What is the classification of Zestril?
ACE Inhibitor
What is the agency responsible for regulating and safeguarding of medications
Food and Drug administration (FDA)
What is a contraindication for taking Lipitor (Atorvastatin)?
Pregnancy
What class medication recall is being recalled due to a product having a strong chance of serious adverse effect or death?
Class I
Which act offers financial incentive to organizations that develop and market drugs previously unavailable in the U.S, includes drugs that affect fewer than 200,000 people, offers tax breaks, and offers 7 years monopoly on sales. Incentivizes pharmaceutical companies to develop drugs for rare diseases by offering market exclusivity and tax credit?
Orphan Drug Act of 1983
What is the classification of Vicodin?
Narcotic Analgesic CII
Which of the following should a pharmacy technician identify as the primary purpose of medwatch?
To allow voluntary reporting of adverse effects
How does food affect the absorption of Ambien (Zolpidem)?
Food delays the absorption of Ambien, postponing the onset of sleep.
What class medication recall is being recalled because of a problem that is not likely to cause adverse effects?
Class III
Which act clarifies the regulatory framework applicable to nutritional supplements and to create specific labeling requirements?
Dietary Supplements Health and Education Act of 1994
What is the classification of Tylenol?
Analgesics and antipyretics (can say either)
A pharmacy technician should identify that which of the following information applies to a prescription for Isotretinoin(Accutane)?
IPLEDGE
What types of drugs interfere with oral contraceptives? (3)
Antibiotics, anticonvulsants, antifungals
What class medication recall is being recalled because there is a temporary (but reversible) chance of adverse effect or little chance of serious adverse effect?
Class II
This law is intended to stop recreational use of opium, narcotic becoming prescription drug, required registration of providers. Also required narcotic manufacturers, sellers, and distributors to register with the Bureau of Internal Revenue under the U.S. Treasury Department.
1914 Harrison Narcotic Act
What is the classification of dextromethorphan?
antitussive
Personnel who are authorized to enter the sterile compounding room should receive training in accordance with which of the following organizations?
United States Pharmacopeia (USP)
What happens if Synthroid (Levothyroxine) is taken with an iron or calcium supplement?
There is less absorption of Synthroid.
What program do we obtain information about adverse effects?
MedWatch
This act requires manufacturers to register and list their medical products, to follow good manufacturing practices, and report device failures. In other words it was intended to provide reasonable assurance of the safety and efficacy of medical devices.
Medical Device Amendments of 1976
What is the classification of bupropion?
Norepinephrine dopamine reuptake inhibitors
A pharmacy technician discovers that a medication was dispensed to the wrong patient. After reporting the error to the pharmacist to which of the following organizations should the error be reported?
Medication Error Reporting Program (MERP)
What are the precautions for taking Evista (Raloxifene)?
Hypertension and atrial fibrillation
What organization can issue a medication recall?
FDA