FDA Regulations and Drug Development
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Questions and Answers

What is the primary law governing FDA regulations?

  • Federal Food, Drug, and Cosmetic Act (FD&C Act) (correct)
  • Food and Drug Administration (FDA) Act
  • Investigational New Drug (IND) Application
  • Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)

    • What type of application is submitted to the FDA for drug approval?

  • Investigational New Drug (IND) Application
  • Abbreviated New Drug Application (ANDA)
  • Prescription Drug Labeling
  • New Drug Application (NDA) (correct)

    • What is the purpose of the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)?

  • To classify drugs into schedules
  • To allow for the approval of generic drugs (correct)
  • To ensure drug safety and efficacy
  • To regulate the price of drugs

    • What is the purpose of labeling on drug packaging?

    <p>To provide information on dosage and administration</p> Signup and view all the answers

    What is the purpose of post-marketing surveillance?

    <p>To monitor drug safety and efficacy after approval</p> Signup and view all the answers

    What is the purpose of adverse event reporting?

    <p>To report adverse events to the FDA</p> Signup and view all the answers

    What is Schedule I in the FDA drug classification?

    <p>High potential for abuse, no currently accepted medical use</p> Signup and view all the answers

    What is the purpose of an Investigational New Drug (IND) Application?

    <p>To conduct clinical trials in the US</p> Signup and view all the answers

    What is the purpose of phase I metabolism in drug metabolism?

    <p>To oxidize, reduce, and hydrolyze drugs</p> Signup and view all the answers

    What can affect the rate of drug metabolism?

    <p>Both genetic and environmental factors</p> Signup and view all the answers

    What is the consequence of altered drug metabolism on drug therapy?

    <p>Both altered efficacy and toxicity</p> Signup and view all the answers

    What is the purpose of record-keeping and reporting requirements for controlled substances?

    <p>To prevent misuse and diversion of controlled substances</p> Signup and view all the answers

    What is the significance of drug metabolism in pharmacotherapy?

    <p>It affects both drug efficacy and toxicity</p> Signup and view all the answers

    What is the primary process by which a drug enters the bloodstream?

    <p>Absorption</p> Signup and view all the answers

    Which of the following is a strategy for medication safety?

    <p>Medication reconciliation</p> Signup and view all the answers

    What is the primary reason for the regulation of controlled substances?

    <p>To prevent abuse and addiction</p> Signup and view all the answers

    What is the term for the process by which the body breaks down a drug?

    <p>Metabolism</p> Signup and view all the answers

    What is the term for the movement of a drug throughout the body?

    <p>Distribution</p> Signup and view all the answers

    What is the primary difference between Schedule II and Schedule III controlled substances?

    <p>Potential for abuse</p> Signup and view all the answers

    Which of the following Phase I reactions is responsible for converting the parent drug into a more polar metabolite?

    <p>Oxidation</p> Signup and view all the answers

    What is the primary goal of medication safety initiatives?

    <p>To reduce medication errors</p> Signup and view all the answers

    What is the primary factor that influences the rate of drug absorption?

    <p>All of the above</p> Signup and view all the answers

    Which of the following enzymes is responsible for the majority of Phase I reactions?

    <p>CYP3A4</p> Signup and view all the answers

    What is the term for the process by which a drug is removed from the body?

    <p>Elimination</p> Signup and view all the answers

    What is the primary goal of the DEA's scheduling of controlled substances?

    <p>To reduce the potential for abuse</p> Signup and view all the answers

    Which of the following is an example of a Type B adverse drug reaction?

    <p>Idiosyncratic reaction</p> Signup and view all the answers

    What is the primary purpose of prescription requirements for controlled substances?

    <p>To reduce the potential for abuse</p> Signup and view all the answers

    What is the term for the time required for the concentration of a drug in the body to decrease by 50%?

    <p>Half-life</p> Signup and view all the answers

    What is the main criterion for classifying a controlled substance as Schedule I?

    <p>High potential for abuse and no currently accepted medical use</p> Signup and view all the answers

    What is the process by which a drug is moved throughout the body?

    <p>Distribution</p> Signup and view all the answers

    What type of reaction is responsible for the biotransformation of a drug into active/inactive metabolites?

    <p>Phase I reaction</p> Signup and view all the answers

    What type of drug interaction occurs when two or more drugs affect each other's pharmacokinetics?

    <p>Pharmacokinetic interaction</p> Signup and view all the answers

    What is the primary goal of medication safety initiatives?

    <p>To promote safe medication use</p> Signup and view all the answers

    What is the term for the process by which a drug is converted into a more polar metabolite?

    <p>Oxidation</p> Signup and view all the answers

    What is the term for an immune-mediated response to a drug?

    <p>Allergic reaction</p> Signup and view all the answers

    What is the primary factor that influences the rate of drug excretion?

    <p>Kidney function</p> Signup and view all the answers

    What is the term for the study of the movement of drugs throughout the body?

    <p>Pharmacokinetics</p> Signup and view all the answers

    What is the primary goal of the DEA's scheduling of controlled substances?

    <p>To regulate access to controlled substances</p> Signup and view all the answers

    Which of the following controlled substances has a high potential for abuse and no accepted medical use?

    <p>Heroin</p> Signup and view all the answers

    What is the primary purpose of the DEA's scheduling of controlled substances?

    <p>To classify substances based on their potential for abuse and medical use</p> Signup and view all the answers

    Which of the following enzymes is responsible for the majority of Phase I reactions in drug metabolism?

    <p>CYP450</p> Signup and view all the answers

    What is the consequence of altered drug metabolism on drug therapy?

    <p>Changes in drug response and potentially adverse effects</p> Signup and view all the answers

    What is the primary goal of medication safety initiatives?

    <p>To minimize the risk of adverse events</p> Signup and view all the answers

    What is the term for the process by which a drug is converted into a more polar metabolite?

    <p>Biotransformation</p> Signup and view all the answers

    Which of the following is an example of a Phase II reaction in drug metabolism?

    <p>Glucuronidation</p> Signup and view all the answers

    What is the primary factor that influences the rate of drug absorption?

    <p>Gastrointestinal motility</p> Signup and view all the answers

    What is the term for the study of the movement of drugs throughout the body?

    <p>Pharmacokinetics</p> Signup and view all the answers

    What is the primary purpose of prescription requirements for controlled substances?

    <p>To prevent the misuse of controlled substances</p> Signup and view all the answers

    What is the primary purpose of the Controlled Substances Act (CSA)?

    <p>To categorize controlled substances based on their potential for abuse and medical use</p> Signup and view all the answers

    Which of the following controlled substances has a high potential for abuse and currently accepted medical use?

    <p>Cocaine</p> Signup and view all the answers

    What is the role of the Drug Enforcement Administration (DEA) in regards to controlled substances?

    <p>To enforce the Controlled Substances Act and regulate the distribution and possession of controlled substances</p> Signup and view all the answers

    What is the purpose of registering with the DEA for practitioners who handle controlled substances?

    <p>To comply with the CSA and legally handle controlled substances</p> Signup and view all the answers

    What is the primary difference between Schedule III and Schedule IV controlled substances?

    <p>Schedule III has a higher potential for abuse than Schedule IV</p> Signup and view all the answers

    What is the purpose of prescription requirements for controlled substances?

    <p>To ensure the safe use of controlled substances</p> Signup and view all the answers

    What is the consequence of violating controlled substance laws?

    <p>Both civil and criminal penalties</p> Signup and view all the answers

    What is the primary factor that determines the schedule of a controlled substance?

    <p>The potential for abuse and medical use</p> Signup and view all the answers

    Which of the following is an example of a Schedule V controlled substance?

    <p>Cough suppressants with codeine</p> Signup and view all the answers

    What is the purpose of the DEA's scheduling of controlled substances?

    <p>To regulate the distribution and possession of controlled substances</p> Signup and view all the answers

    What is the nurse's responsibility when a client refuses medication?

    <p>Respect the client's right to refuse and explain the sequences</p> Signup and view all the answers

    During the implementation phase of the nursing process, what should the nurse avoid during medication preparation?

    <p>Interruptions during medication preparation</p> Signup and view all the answers

    What is the primary purpose of evaluation in the nursing process?

    <p>To evaluate the client's responses to medications and document the results</p> Signup and view all the answers

    What should the nurse do when a client questions the color of their medication?

    <p>Bring the packaging and show the client their prescription</p> Signup and view all the answers

    What is the nurse's responsibility when an error occurs during medication administration?

    <p>Notify the provider and report the error</p> Signup and view all the answers

    What is the primary purpose of data collection in the nursing process?

    <p>To know the medication and its effects</p> Signup and view all the answers

    What should the nurse do when preparing a client's medication?

    <p>Prepare one client's medication at a time</p> Signup and view all the answers

    What is the purpose of reporting medication errors?

    <p>To prevent future errors and improve client safety</p> Signup and view all the answers

    What should the nurse do when a client has a question about their medication?

    <p>Educate the client on their medication and its effects</p> Signup and view all the answers

    What is the primary goal of the nursing process?

    <p>To ensure the client receives safe and effective medication therapy</p> Signup and view all the answers

    What is the primary purpose of medication reconciliation?

    <p>To compare the list of the client's current medications to the new prescriptions</p> Signup and view all the answers

    What is the primary component of a medication prescription?

    <p>All of the above</p> Signup and view all the answers

    What is the term for the process of ensuring the right client receives the right medication?

    <p>Right client</p> Signup and view all the answers

    What is the purpose of the 'right dose' in the right to safe medication administration?

    <p>To verify the dose of the medication</p> Signup and view all the answers

    What type of medication prescription is a one-time order?

    <p>Single or one-time order</p> Signup and view all the answers

    What is the primary purpose of the 'right route' in the right to safe medication administration?

    <p>To verify the route of administration</p> Signup and view all the answers

    What is the primary purpose of the FDA's drug testing?

    <p>To determine the effectiveness and safety of new drugs</p> Signup and view all the answers

    What is the term for a medication that has a potential for misuse and dependence?

    <p>Controlled substance</p> Signup and view all the answers

    What is the primary purpose of the 'right documentation' in the right to safe medication administration?

    <p>To document the medication administration immediately after administration</p> Signup and view all the answers

    What is the term for the process of ensuring the right client receives the right education on medication use?

    <p>Right client education</p> Signup and view all the answers

    Study Notes

    FDA Regulations

    Overview

    • The Food and Drug Administration (FDA) is responsible for regulating drugs in the United States.
    • The FDA ensures that drugs are safe and effective for human use.

    Key Regulations

    • Federal Food, Drug, and Cosmetic Act (FD&C Act): The primary law governing FDA regulations.
    • Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act): Allows for the approval of generic drugs.

    Drug Development and Approval Process

    • Investigational New Drug (IND) Application: Required for conducting clinical trials in the US.
    • New Drug Application (NDA): Submitted to the FDA for drug approval.
    • Abbreviated New Drug Application (ANDA): Submitted for generic drug approval.

    FDA Drug Classification

    • Schedule I: High potential for abuse, no currently accepted medical use (e.g., heroin).
    • Schedule II: High potential for abuse, currently accepted medical use (e.g., cocaine).
    • Schedule III: Moderate to low potential for abuse, currently accepted medical use (e.g., anabolic steroids).
    • Schedule IV: Low potential for abuse, currently accepted medical use (e.g., benzodiazepines).
    • Schedule V: Low potential for abuse, currently accepted medical use (e.g., cough suppressants).

    Labeling and Packaging

    • Labeling: Information on the drug's packaging, including ingredients, dosage, and warnings.
    • Prescription Drug Labeling: Includes information on dosage, administration, and warnings.
    • Over-the-Counter (OTC) Drug Labeling: Includes information on dosage, administration, and warnings for non-prescription drugs.

    Post-Marketing Surveillance

    • Adverse Event Reporting: Manufacturers and healthcare professionals report adverse events to the FDA.
    • Post-Marketing Studies: Conducted to gather additional safety and efficacy data after drug approval.

    Enforcement and Compliance

    • FDA Inspections: Regular inspections of drug manufacturing facilities to ensure compliance with regulations.
    • Warning Letters: Issued to companies that violate FDA regulations.
    • Recalls: Voluntary or mandatory removal of a drug from the market due to safety concerns.

    FDA Regulations

    Overview

    • The FDA ensures drugs are safe and effective for human use in the United States.

    Key Regulations

    • The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the primary law governing FDA regulations.
    • The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) allows for the approval of generic drugs.

    Drug Development and Approval Process

    • An Investigational New Drug (IND) Application is required for conducting clinical trials in the US.
    • A New Drug Application (NDA) is submitted to the FDA for drug approval.
    • An Abbreviated New Drug Application (ANDA) is submitted for generic drug approval.

    FDA Drug Classification

    • Schedule I drugs have high potential for abuse and no currently accepted medical use (e.g., heroin).
    • Schedule II drugs have high potential for abuse and currently accepted medical use (e.g., cocaine).
    • Schedule III drugs have moderate to low potential for abuse and currently accepted medical use (e.g., anabolic steroids).
    • Schedule IV drugs have low potential for abuse and currently accepted medical use (e.g., benzodiazepines).
    • Schedule V drugs have low potential for abuse and currently accepted medical use (e.g., cough suppressants).

    Labeling and Packaging

    • Labeling includes information on the drug's packaging, including ingredients, dosage, and warnings.
    • Prescription Drug Labeling includes information on dosage, administration, and warnings.
    • Over-the-Counter (OTC) Drug Labeling includes information on dosage, administration, and warnings for non-prescription drugs.

    Post-Marketing Surveillance

    • Adverse Event Reporting involves manufacturers and healthcare professionals reporting adverse events to the FDA.
    • Post-Marketing Studies are conducted to gather additional safety and efficacy data after drug approval.

    Enforcement and Compliance

    • FDA Inspections are regular inspections of drug manufacturing facilities to ensure compliance with regulations.
    • Warning Letters are issued to companies that violate FDA regulations.
    • Recalls involve the voluntary or mandatory removal of a drug from the market due to safety concerns.

    Pharmacokinetics

    • Study of the movement of drugs through the body, focusing on:
    • Absorption: how a drug enters the bloodstream
    • Distribution: how the drug moves throughout the body
    • Metabolism: how the body breaks down the drug
    • Excretion: how the body eliminates the drug
    • Factors affecting pharmacokinetics include:
      • Patient-related factors: age, weight, liver/kidney function
      • Drug-related factors: dosage, route of administration, formulation

    Medication Safety

    • Importance of medication safety:
      • Prevents medication errors and adverse reactions
      • Ensures optimal therapeutic outcomes
    • Strategies for medication safety:
      • Medication reconciliation: verifying patient medication lists
      • Barcode medication administration: verifying medication administration via barcode scanning
      • Medication therapy management: monitoring patients for medication-related issues
    • Medication safety risks:
      • Medication errors: wrong drug, dose, or route
      • Adverse drug reactions: allergic reactions, side effects
      • Drug interactions: interactions with other medications or foods

    Controlled Substances

    • Definition: drugs with potential for abuse and addiction, regulated by the DEA
    • Schedules of controlled substances:
      • Schedule I: high potential for abuse, no accepted medical use (e.g., heroin)
      • Schedule II: high potential for abuse, accepted medical use (e.g., opioids)
      • Schedule III: moderate potential for abuse, accepted medical use (e.g., anabolic steroids)
      • Schedule IV: low potential for abuse, accepted medical use (e.g., benzodiazepines)
      • Schedule V: low potential for abuse, accepted medical use (e.g., cough suppressants)
    • Prescribing and dispensing controlled substances:
      • Requirements for prescription and dispensing
      • Record-keeping and reporting requirements

    Drug Metabolism

    • Definition: process by which the body breaks down drugs into inactive or active metabolites
    • Types of drug metabolism:
      • Phase I metabolism: oxidation, reduction, and hydrolysis reactions
      • Phase II metabolism: conjugation reactions (e.g., glucuronidation, sulfation)
    • Factors affecting drug metabolism:
      • Genetic factors: genetic variations in metabolizing enzymes
      • Environmental factors: diet, liver function
      • Drug interactions: inhibition or induction of metabolizing enzymes
    • Importance of drug metabolism:
      • Affects drug efficacy and toxicity
      • Influences dosing and dosing intervals

    Controlled Substances

    • DEA schedules controlled substances into 5 categories based on potential for abuse, currently accepted medical use, and safety under medical supervision
    • Schedule I: High potential for abuse, no accepted medical use (e.g., heroin, LSD)
    • Schedule II: High potential for abuse, currently accepted medical use (e.g., cocaine, methamphetamine)
    • Schedule III: Moderate to low potential for abuse, currently accepted medical use (e.g., anabolic steroids, ketamine)
    • Schedule IV: Low potential for abuse, currently accepted medical use (e.g., benzodiazepines, modafinil)
    • Schedule V: Low potential for abuse, currently accepted medical use (e.g., cough suppressants, anticonvulsants)
    • Prescribers must register with the DEA and obtain a unique identifier (DEA number)
    • Prescriptions for controlled substances must include the prescriber's DEA number, patient's name and address, and the quantity and strength of the medication

    Drug Metabolism

    Phase I and II Reactions

    • Phase I Reactions: Oxidation, reduction, and hydrolysis reactions that convert the parent drug into a more polar metabolite
    • Phase II Reactions: Conjugation reactions that attach a polar group to the metabolite, increasing water solubility and facilitating excretion

    CYP450 Enzymes

    • A family of enzymes responsible for Phase I reactions
    • CYP3A4 is the most common isoenzyme involved in drug metabolism

    Enzyme Induction and Inhibition

    • Certain drugs can induce (increase) or inhibit (decrease) CYP450 enzyme activity, leading to drug interactions and altered metabolism

    Medication Safety

    Adverse Drug Reactions

    • Harmful and unintended consequences of medication use
    • Type A: Augmented effects (dose-dependent)
    • Type B: Bizarre effects (idiosyncratic)

    Medication Errors

    • Preventable events that can occur during any stage of the medication use process
    • Includes prescribing, transcribing, dispensing, and administering

    High-Alert Medications

    • Medications that can cause significant harm if used incorrectly
    • Examples: anticoagulants, opioids, and insulin

    Pharmacokinetics

    Absorption, Distribution, Elimination

    • Absorption: The process by which a drug enters the bloodstream
    • Influenced by factors such as route of administration, dosage form, and patient factors
    • Distribution: The movement of a drug throughout the body
    • Influenced by factors such as blood flow, protein binding, and tissue permeability
    • Elimination: The removal of a drug from the body
    • Primarily through metabolism and excretion

    Half-Life

    • The time required for the concentration of a drug in the body to decrease by 50%
    • Influences dosing intervals and duration of action

    Controlled Substances

    • Classification of controlled substances into five schedules (I to V) based on potential for abuse, currently accepted medical use, and safety under medical supervision
    • Schedule I substances have high potential for abuse and no currently accepted medical use
    • Examples of Schedule I substances include heroin and LSD
    • Schedule II substances have high potential for abuse, but with currently accepted medical use with severe restrictions
    • Examples of Schedule II substances include cocaine and methamphetamine
    • Schedule III substances have moderate to low potential for abuse, with currently accepted medical use
    • Examples of Schedule III substances include anabolic steroids and ketamine
    • Schedule IV substances have low potential for abuse, with currently accepted medical use
    • Examples of Schedule IV substances include Xanax and Soma
    • Schedule V substances have low potential for abuse, with currently accepted medical use
    • Examples of Schedule V substances include cough suppressants with codeine

    Pharmacokinetics

    • ADME stands for absorption, distribution, metabolism, and excretion of drugs in the body
    • Absorption is the process by which a drug enters the bloodstream
    • Examples of routes of absorption include oral, IV, and topical
    • Distribution is the movement of a drug throughout the body
    • Factors affecting distribution include blood flow and tissue binding
    • Metabolism is the biotransformation of a drug into active or inactive metabolites
    • The liver plays a key role in metabolism through enzyme activity
    • Excretion is the elimination of a drug from the body
    • Examples of routes of excretion include kidneys, liver, and lungs

    Drug Metabolism

    • Phase I reactions involve oxidation, reduction, and hydrolysis
    • Cytochrome P450 enzymes play a key role in Phase I reactions
    • Phase II reactions involve conjugation
    • Examples of Phase II reactions include glucuronidation and sulfation
    • Induction occurs when a substance increases the activity of an enzyme
    • Inhibition occurs when a substance decreases the activity of an enzyme
    • Genetic variations can affect drug metabolism
    • Examples of genetic polymorphisms affecting drug metabolism include CYP2D6 and CYP2C19

    Medication Safety

    • Adverse Drug Reactions (ADRs) are harmful or unintended effects of drugs
    • Allergic reactions are immune-mediated responses to drugs
    • Drug interactions occur when the effect of one drug is altered by another drug
    • Examples of drug interactions include pharmacokinetic and pharmacodynamic interactions
    • Medication errors are preventable mistakes in medication use
    • Examples of medication errors include overdose and wrong medication
    • Risk management strategies are used to minimize medication-related harm
    • Examples of risk management strategies include monitoring and patient education

    Controlled Substances

    • DEA schedules controlled substances into 5 categories based on potential for abuse, currently accepted medical use, and safety under medical supervision
    • Schedule I: High potential for abuse, no accepted medical use (e.g. heroin, LSD)
    • Schedule II: High potential for abuse, currently accepted medical use with severe restrictions (e.g. cocaine, methamphetamine)
    • Schedule III: Moderate to low potential for abuse, currently accepted medical use (e.g. anabolic steroids)
    • Schedule IV: Low potential for abuse, currently accepted medical use (e.g. benzodiazepines)
    • Schedule V: Low potential for abuse, currently accepted medical use (e.g. cough suppressants)
    • Prescribers must register with the DEA to prescribe controlled substances
    • Prescriptions must be written in accordance with state and federal laws

    Drug Metabolism

    • Phase I metabolism involves oxidation, reduction, and hydrolysis reactions (e.g. CYP450 enzymes)
    • Phase II metabolism involves conjugation reactions (e.g. glucuronidation, sulfation)
    • Enzyme induction or inhibition can alter drug metabolism and lead to interactions
    • Genetic variations in metabolism can affect individual responses to drugs

    Pharmacokinetics

    • ADME: Absorption, Distribution, Metabolism, Excretion of drugs
    • Bioavailability is the proportion of an administered dose that reaches the systemic circulation
    • Peak and trough levels are used to determine dosing regimens
    • Peak levels are the maximum drug concentrations
    • Trough levels are the minimum drug concentrations

    Medication Safety

    • Adverse drug reactions (ADRs) are harmful and unintended effects of medications
    • Medication errors are preventable events that can cause harm, such as dosing errors or allergic reactions
    • Medication reconciliation is the process of verifying medication lists to ensure accuracy and reduce errors
    • Patient education is crucial for medication safety, including educating patients on proper medication use, side effects, and interactions

    Controlled Substances

    Definition

    • Controlled substances are drugs or chemicals regulated by the government due to their potential for abuse or addiction.

    Schedules of Controlled Substances

    • The Controlled Substances Act categorizes controlled substances into five schedules based on their potential for abuse, medical use, and safety under medical supervision.
    • Schedule I: High abuse potential, no accepted medical use, and lack of safety under medical supervision (e.g., heroin, LSD, marijuana).
    • Schedule II: High abuse potential, accepted medical use with severe restrictions (e.g., cocaine, methamphetamine, opium).
    • Schedule III: Moderate to low abuse potential, accepted medical use, and moderate to low dependence risk (e.g., anabolic steroids, ketamine).
    • Schedule IV: Low abuse potential, accepted medical use, and low dependence risk (e.g., Xanax, Soma).
    • Schedule V: Low abuse potential, accepted medical use, and low dependence risk (e.g., cough suppressants with codeine).

    Regulation and Enforcement

    • The Drug Enforcement Administration (DEA) enforces the Controlled Substances Act and regulates controlled substances distribution and possession.
    • The DEA issues registrations to manufacturers, distributors, and practitioners handling controlled substances.
    • The CSA allows for criminal and civil penalties for violating controlled substance laws.

    Prescribing and Dispensing

    • Practitioners must register with the DEA to prescribe controlled substances.
    • Prescriptions for controlled substances must comply with CSA requirements, including written prescriptions and quantity limits.
    • Pharmacists must verify prescription authenticity and ensure CSA compliance before dispensing controlled substances.

    Medication Administration

    • Uncontrolled medications require monitoring by the provider but do not pose a risk for misuse.

    Controlled Substances

    • Have a potential for misuse and dependence
    • Have a schedule classification (e.g., Heroin is Schedule 1, morphine is Schedule 2, phenobarbital is Schedule 5)

    FDA Regulations

    • The Food and Drug Administration (FDA) tests new drugs to determine effectiveness and safety before approval

    Pregnancy Schedule

    • Categories medications based on safety during pregnancy (A, B, C, D, X)
    • X is the most dangerous category

    Types of Medication Prescriptions

    • Routine or standing order
    • Single or one-time order
    • Stat prescription
    • PRN prescription

    Components of a Medication Prescription

    • Client's full name
    • Date and time of prescription
    • Name of medication (generic or trade)
    • Strength and dose of medication
    • Route of administration
    • Time and frequency
    • Quantity to dispense
    • Signature of the prescribing provider

    Medication Reconciliation

    • Comparing the list of the client's current medications to new prescriptions
    • Process takes place during admission, transfer, and discharge

    Right to Safe Medication Administration

    • Right client (check client's name, assigned ID number, telephone number, ID band, check for allergies, use barcode)
    • Right medication (read medication label and compare it with MAR)
    • Right dose (check drug reference, have another nurse verify)
    • Right time (critical: 30 minutes before, non-critical: 20-30 minutes before or after)
    • Right route (oral is the most used)
    • Right documentation (after administration, document immediately)
    • Right client education (nurse should inform client about medication, right to refuse)
    • Right evaluation (follow up with client to verify therapeutic effects and adverse effects)

    Nursing Process

    • Data collection (know the medication, sources include provider, nurses, physicians, pharmacists, poison control center, etc.)
    • Planning (identifies client's outcomes of medication administration, set priorities)
    • Implementation (avoid interruptions during medication preparation, prepare one client's medication at a time, double-check with another nurse)
    • Evaluation (evaluate client's responses to medications, document and report)

    Error Reporting

    • Notify provider of all errors (include client's identification, name and dose of medication, time and place of incident, accurate and objective account of event)
    • Do not include incident report in client's medical record
    • Report all errors to facility to prepare and find ways to avoid errors

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