Pharmacy Technician Certification And Implementation Quiz

The 1906 Federal Food and Drug Act aimed to protect consumers by prohibiting the sale of adulterated or mislabeled food, drinks, and drugs, ensuring they meet certain safety and quality standards.

The Harrison Narcotic Act of 1914 aimed to control the distribution and use of opiates, specifically opium and coca leaves. It did not legalize opium for recreational use, but instead restricted its transport and required a prescription for purchase. The act was a response to the rising concern over addiction and abuse of these substances.

The 1951 Durham Humphrey Amendment was a landmark legislation that brought about crucial distinctions between legend drugs and over the counter drugs, requiring specific labeling requirements and physician supervision for legend drugs. The incorrect answers provided do not accurately represent the provisions of the amendment.

The Kefauver-Harris Amendment of 1962 had a significant impact on drug regulation in the United States by requiring drugs to be proven safe and effective, increasing oversight on advertising, and implementing stricter approval and reporting requirements for manufacturers.

The 1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act - CSA) was significant as it led to the formation of the Drug Enforcement Agency (DEA) and placed controlled substances into different schedules based on their abuse potential, ranging from Schedule I (highest abuse potential) to Schedule V (lowest abuse potential). This helped establish regulations for the manufacturing, distribution, and dispensing of various drugs.

The 1970 Poison Prevention Packaging Act primarily focused on childproof packaging for drugs and certain exemptions were in place for emergency drugs and small quantities unlikely to harm young children.

The 1983 Orphan Drug Act specifically focuses on promoting research and marketing of drugs for rare diseases, rather than regulating generic drugs, overseeing all clinical trials, or setting pricing regulations.

The 1988 Food and Drug Administration Act played a key role in establishing the FDA as an agency under the Department of Health and Human Services and emphasizing the importance of reporting adverse drug reactions to the FDA for regulation and monitoring purposes.

The Prescription Drug Marketing Act of 1988 specifically banned the sale, trade, or purchase of drug samples to ensure proper regulation and control over prescription medications.

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 primarily focuses on increasing the privacy and security of patient health information, providing limitations on who can access and share this information, making health insurance portable for individuals changing jobs, and mandating standardized electronic submissions of claim information to make healthcare processing more efficient and cost-effective.

The 2006 Combat Methamphetamine Epidemic Act (CMEA) restricts the purchase of pseudophedrine (pse) products to 3.6g of pse per day or 9g per 30 days in order to combat the production of methamphetamine.

A Class I Recall is the most serious type of recall and is issued when there is a reasonable probability that the use of the drug will cause serious adverse health consequences or death. Patients must be notified immediately to prevent harm.

Class II recalls are classified as such when there is a low probability of serious harm and the effects are usually temporary or reversible. The recalls are typically due to consistency of potency issues and do not reach the customer level.

Class III recalls are considered to be the least severe type of recall as they are not likely to cause serious adverse effects and do not reach the level of the customer.

OTC labeling must contain a comprehensive list of information including product name, manufacturer address, net contents, all ingredients, habit-forming drugs, caution/warning labels, and directions for use.

The Food, Drug, and Cosmetic Act specifies the necessary information that should be present on prescription drugs to ensure safe dispensing and usage.

Package inserts provide critical information about the drug including its description, clinical pharmacology, indications, contraindications, warnings, dosage, and the most recent label revision date. Other information such as drug pricing, side effects only, marketing slogans, or brand name only would not provide a comprehensive overview of the drug.

Package inserts are required for drug classes where detailed information is necessary for safe and effective use. While antibiotics, antihistamines, and vitamins may also require information, the specified drug classes have specific risks and precautions that necessitate the distribution of package inserts.

The National Drug Code (NDC) uniquely identifies each medication and is composed of three sets of numbers to identify the manufacturer, drug, and pack size. It is not used to identify patient information, track medication usage by pharmacies, or composed of two sets of numbers.

The first set of NDC numbers typically indicate the manufacturer of the medication. This helps identify the company that produced the drug.

The correct answer is 'Specific drug - each drug has its own number.' The NDC second set/middle set of four numbers represent a specific drug, with each drug having its unique identifier within the National Drug Code system.

The NDC last two numbers indicate the package size of the medication. For example, if the last two numbers are 01, it could represent a package size of 100 tablets, while 05 could indicate a package size of 500 tablets.

Schedule I drugs are classified as substances with no accepted medical use in the United States and have the highest potential for abuse according to the Drug Enforcement Administration (DEA).

Schedule II drugs are tightly controlled substances due to their high potential for abuse and dependence. They can NOT be refilled, require specific forms for ordering and returning, and have strict regulations surrounding their use.

Schedule III drugs are classified as such because they have a moderate to low potential for physical and psychological dependence. They can be refilled up to 5 times within a six month period, unlike Schedule I and II drugs which have stricter refill limitations.

Schedule IV drugs have specific regulations regarding refills and are considered to have lower potential for abuse compared to other schedules.

Schedule V drugs are classified as substances with the least potential for abuse among prescription medications, which is why they are subject to the least strict regulations compared to other schedules.