FDA Amendments Quiz

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30 Questions

Which source describes drugs that are made from inorganic crystal substances found naturally on earth?

Minerals

What is an example of a drug that comes from a plant and is used to treat congestive heart failure and cardiac arrhythmias?

Digitalis

Which source provides drugs containing hormones reclaimed from mare urine?

Animals

What type of drug is used to regulate blood sugar levels in patients with diabetes mellitus?

Insulin

Patients lacking an adequate level of what may take specific mineral-based drugs?

Minerals

Which source describes drugs that are made from plants with medicinal qualities and have been used for centuries as natural remedies?

Plants

What is the therapeutic effect of a drug?

The intended physiological effect

Which of the following best describes a side effect of a drug?

A physiologic effect that is not the intended action

Why should healthcare providers identify all known side effects of a drug before administering it?

To weigh any adverse effects with the therapeutic effect

What should female patients do when taking a broad-spectrum antibiotic to counter a possible vaginal yeast infection?

Drink buttermilk and eat yogurt

Why should female patients use additional forms of birth control when taking certain medications?

Because antibiotics lower the effectiveness of birth control pills

What is a common reason why patients may discontinue the use of a medication?

Because the side effects are so unpleasant

What did the Durham-Humphrey amendment specify in relation to certain drugs?

They could only be purchased with a prescription.

What was the main focus of the Kefauver-Harris Amendment in 1962?

Standard labeling of drug containers.

How does the Comprehensive Drug Abuse Prevent and Control Act of 1970 categorize controlled substances?

Based on their potential for abuse.

What category of drugs under the Comprehensive Drug Abuse Prevent and Control Act has the highest abuse potential but also accepted medicinal use?

Schedule II

What is unique about Schedule IV and V drugs according to the act?

They have lower abuse potential with accepted medicinal uses.

What misconception is highlighted in the text regarding the source of drugs?

Drugs can be found in everyday stores like grocery stores.

What should healthcare providers ensure before administering a medication that is taken orally?

The patient can swallow

Why should caution be exercised when administering intravenous medications?

The body quickly absorbs these drugs

Which route of drug administration involves placing medication under the tongue?

Buccal

What should be avoided with enteric-coated or time-release medications?

Crushing or mixing them

Where should medication be inserted for rectal administration?

Insertion (rectal)

When is it important for the patient to take Digoxin in the morning?

It ensures proper absorption

What method of administering medication involves the nurse giving the patient a packet of medications with instructions?

Self-administration of medication

Which patient groups are mentioned to commonly use self-administration of medication?

Oncology (cancer) patients and maternity patients

What is the common method of administering intravenous pain medication mentioned in the text?

Patient controlled analgesia

What right does a mentally competent patient have in regards to medication administration?

Right to refuse medication

What should be advised to patients who refuse to take medication?

The consequences of refusal, such as worsening of the condition

What right does the patient have in relation to being informed about medication?

Right to be informed about the administered medication

Study Notes

Self-Administration of Medication (SAM)

  • Normal practice for patients in the home and workplace
  • Also used in some acute and long-term care institutional settings
  • Patients take medication according to instructions and advise the nurse when done

Patient Controlled Analgesia (PCA)

  • Common method of administering intravenous pain medication
  • Will be discussed further in a subsequent chapter

Right to Refuse Medication

  • Mentally competent patient has the right to refuse medication
  • Refusal is documented on the patient record
  • Patients should be advised of the consequences of refusal

Right to Education

  • Patient has the right to be told about the medication being administered
  • Patients should be informed about expected side effects and provided instructions on how to manage adverse side effects

Sources of Drugs

  • Plants: medicinal qualities, used for centuries as natural remedies, e.g. digitalis from foxglove plant
  • Animals: byproducts, e.g. Premarin from mare urine, insulin from humans using DNA technology
  • Minerals: inorganic crystal substances, e.g. trace elements for homeostasis

Therapeutic Effect and Side Effects

  • Therapeutic effect: intended physiological effect of a drug
  • Side effects: physiologic effects that are not the intended action, e.g. nausea, vomiting, skin rash
  • Healthcare providers must identify all known side effects and weigh adverse effects with therapeutic effect

History of Drug Regulation

  • 1938: Food, Drug and Cosmetic Act
  • 1962: Kefauver-Harris Amendment, tightened controls on drug safety, standard labeling of drug containers
  • 1970: Comprehensive Drug Abuse Prevent and Control Act, categorized controlled substances according to schedule based on potential for abuse

Routes of Medication Administration

  • Oral (by mouth): liquid, elixir, suspension, pill, tablet, and capsule
  • Sublingual (under tongue): pill, tablet, and capsule
  • Buccal (between gum and cheek): pill, tablet, and capsule
  • Topical (applied to skin): cream, ointment, and patch
  • Inhalation (aerosol sprays): liquid
  • Instillation (nose, eye, ear): liquid, cream, and ointment
  • Insertion (rectal, vaginal): suppository
  • Intradermal (beneath skin): injection
  • Subcutaneous (beneath skin): injection
  • Intramuscular (in muscle): injection
  • Intravenous (in vein): injection
  • Nasogastric and gastronomy tubes: liquid
  • Transdermal: patches

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