module 3 tuts p8

CLINICAL TRIALS

Has 2 groups:

• Staff:

  • Pharmacist

  • Nurses

  • Physicians

  • Researchers

  • Administrators

  • Other members of the healthcare team

• Subjects:

  • Healthy individuals/volunteers

  • Patients

Investigational New Drugs

(IND) is a substance being tested for safety and effectiveness in human clinical trials that has not yet been approved by regulatory bodies like the Food and Drug Administration (FDA)

Placebo

• To please

• a "dummy" treatment or inactive substance with no therapeutic effect, used to establish a control group for comparison with a group receiving an active drug or treatment

• Act as negative control

Single blinded study

only the participants are unaware of which treatment they are receiving

Double blinded study

both the participants and the researchers/experimenters are unaware of the treatment allocation.

PHASE 1 CLINICAL TRIAL

• Subjects: Healthy individuals/Healthy volunteers

• Importance: Test for SAFETY, determine the DOSAGE AND SIDE EFFECTS

• Adults and children but with consent

PHASE 2 CLINICAL TRIAL

• Subjects: Patients (affected individuals)

• Importance: Test for EFFICACY AND SIDE EFFECTS

PHASE 3 CLINICAL TRIAL

• Subjects: Patients (wider demographics) >1000 participants

• Importance: Test for long-term effectiveness and comparisons with other medications

  • Bioequivalence studies

CLINICAL TRIALS: FDA Approval

• Treatment determined effective and safe for public use

PHASE 4 CLINICAL TRIAL

• Subjects: Patients (wider demographics)

• Importance:

  • Post-marketing surveillance - ADR (pharmacovigilance)

  • Continue testing for effectiveness and safety

  • Drug can be taken off the market if necessary

    • Thalidomide - phocomelia

    • Rofecoxib (Vioxx®) - severe cardiovascular effects

    • Varenicline - contaminated with nitrosoamines (carcinogens)

True

• Drug taken off the market

  • Thalidomide - phocomelia

  • Rofecoxib (Vioxx®) - severe cardiovascular effects

  • Varenicline - contaminated with nitrosoamines (carcinogens)

STUDY DESIGNS

• Cross-sectional Study

• Cohort or Prospective Study

• Retrospective Study

• Randomized Controlled Trials (RCTs)

• Meta-analysis

Cross-sectional Study

• Both the exposure and the outcome are determined simultaneously

• Prevalence of the disease or condition is determined

• 100 px with DM (regroup)

  • 21 - non obese

  • 79 - obese

  • Obesity is related to DM

Cohort or Prospective Study

• The researcher selects a group of exposed and another group of unexposed individuals

• Followed over time to determine whether a particular outcome of interest will occur

Cohort or Prospective Study

Ex:

• One group is exposed to smoking while the other is unexposed

• Follow up → Both groups are then followed over a long period. Researchers periodically collect data on new lung cancer diagnoses and track the participants' health

• Group A exposed got lung cancer

• Group B not exposed no lung cancer

• Establish relationship

Retrospective Study

The outcome of interest is already determined at the time the study is initiated

Retrospective Study / Case Control Study

Ex:

• Participant A: Lung cancer

• Participant B: No lung cancer (controls)

• Babalikan ang exposure ←

• Participant A: Smokers

• Participant B: Non-smokers

• Establish the relationship

Randomized Controlled Trials (RCTs)

• Randomized: Researchers decide randomly which participants receive the new treatment and which receive a placebo

• Controlled: Uses a control group for comparison (placebo or reference treatment)

Randomized Controlled Trials (RCTs)

Gold standard for clinically testing treatments and drugs

Meta-analysis

A statistical analysis that summarizes results of multiple scientific studies

Meta-analysis

Ex.

• Gingko biloba → memory enhancer

• Find clinical papers with similar topics → summarize

• Treated statistically - common conclusion = publish as your own

B. Randomized controlled study

Which of the following study designs would be most appropriate in determining the efficacy of the drug?

A. Cross-sectional study

B. Randomized controlled study

C. Cohort study

D. Case-control study

C. I, II and III

Which of the following is/are TRUE when conducting clinical trials?

I. Serious Adverse Drug Reaction can happen.

II. Children can be test subjects.

III. Placebo can be used for comparison.

A. I and III

B. II and III

C. I, II and III

D. I

C. Phase 1

Which of the following phases of clinical trials would usually involve healthy human subject?

A. Phase 4

B. Phase 2

C. Phase 1

D. Phase 3

A. Meta-analysis

The hospital pharmacist has reviewed several clinical papers concerning the benefits of a new formulary drug and is preparing summary comparing the findings for publication. Which term is used to describe this type of review?

A. Meta-analysis

B. Double blind study

C. Peer review

D. Dimensional analysis

C. Retrospective

A study was approved that aims to determine the relationship between a newly approved formulary drug and ulcer. Record of patients diagnosed with peptic ulcer disease versus controls over the period from July 2009- July 2019 was used. This is an example of a _______ study?

A. Cross-sectional

B. Cohort

C. Retrospective

D. Prospective

Hospital

PaWER

• Patient care

• Wellness

• Education

• Research

A. Provides rooms and services for outpatients (inpatients)

The following are functions of a hospital, except:

A. Provides rooms and services for outpatients

B. Medical Research

C. Patient Care

D. Promotes wellness of the community

B. American Society of Health-System Pharmacists

ASHP means

A. American Society of Health Pharmacists

B. American Society of Health-System Pharmacists

C. American Society of Hospital Pharmacists

D. American Society of Health Care Pharmacists

A. Honorary Staff

Retired Medical Practitioners fall under:

A. Honorary Staff

B. Attending Staff

C. Courtesy Staff

D. Residents

Clinical Staff of Hospital

• Courtesy Medical Staff (Open)

  • Not regular staff → occasional practice

• Associate Medical Staff (Closed)

  • Junior staff → supervised by attending physicians

• Resident Medical Staff (Closed)

  • Render full fime services = training (residency)

• ATTENDING MEDICAL STAFF

  • POST-RESIDENCY + DELIVERY of MEDICAL CARE

  • + SUPERVISE residents & associates

• CONSULTANT (specialist)

  • Specialized knowledge/ability

• Honorary

  • Former or retired practitioners

B. Pull System

Which of the following refers to the drug distribution system in which each peripheral facility determine the drug quantities to be requisitioned from the procurement unit or warehouse?

A. Unit dose distribution system

B. Pull System

C. Direct purchase from suppliers

D. Push System

PULL SYSTEM

• Pharmaceutical distribution system in which each peripheral facility determines the medicine quantities to be requisitioned from the procurement unit or warehouse

• Facility dictates the supply given by the supplier

PUSH SYSTEM

• Pharmaceutical distribution system in which the procurement unit or warehouse determines what medicine quantities are to be issued to peripheral facilities.

• Supplier dictates the supply given to the facility

Pharmacoeconomics

• COST vs FEATURES of a drug

• A discipline within health economics that evaluates the costs and consequences of pharmaceutical products and services

PHARMACY AND THERAPEUTIC COMMITTEE (PTC)

Pharmacist - secretary

• Formulate and update Drug formulary

• Prescription & treatment guidelines

• Rational use of drugs

• Reports for ADE / ADR / Medication Errors

• Perform DRUG USE EVALUATION (DUE) or

• DRUG UTILIZATION REVIEW (DUR)

Pharmacoeconomic Evaluation

• Cost of Illness

• Cost-Benefit

• Cost-Minimization

• Cost-Effectiveness

• Cost-Utility

Pharmacoeconomic Evaluation

• Cost of Illness

  • ALL costs related to the illness

• Cost-Benefit

  • Cost: SAME

  • Benefit: DIFFERENT

  • “Mas sulit”

• Cost-Minimization

  • Cost: DIFFERENT

  • Benefit: SAME

  • “Mas mura”

• Cost-Effectiveness

  • Cost to Effectiveness = Cost/Outcome ⭐

• Cost-Utility

  • COST vs QALY (quality-adjusted life year)

B. Pharmacoeconomics

Which of the following refers to the science that evaluates the value of a pharmaceutical product or drug therapy compared to its effects?

A. Pharmacogenetics

B. Pharmacoeconomics

C. Pharmapreneurship

D. Pharmacogenomics

B. Intangible cost

When choosing medicines for inclusion in the formulary, evaluation would involve looking at the complete cost of using the drug. What type of cost would quality of life belong?

A. Indirect cost

B. Intangible cost

C. Direct cost

D. Direct, Indirect and Intangible cost

Types of cost of Illness

• Direct Cost of Illness

  • DIRECTLY related to the illness

  • Medical = HEALTHCARE & MEDICATION

  • Nonmedical = FOOD, TRANSPORTATION

• Indirect Cost of Illness

  • INDIRECTLY related to the illness

  • Productivity cost

• Intangible Cost of Illness

  • IDENTIFIED, but CANNOT be quantified

  • Emotional reactions

DIRECT COST

Cost incurred as a result of medical management of the disease or condition

INDIRECT COST

Cost attributable to loss of productivity of patients

INTANGIBLE COST

Cost that cannot be easily quantified or measured in monetary terms

Code carts/Crash Carts

availability of critical medications and supplies to respond to emergencies

EMERGENCY DRUGS

List of Emergency Drugs:

• Adenosine

• Atropine

• Calcium gluconate

• Dextrose (10%)

• Dopamine

• Epinephrine

• Fentanyl

• Hydralazine

• Lorazepam

• Morphine

• Naloxone

• Phenobarbital

• Sodium bicarbonate

• Vecuronium

• Volume Expanders (RBC’s and Normal Saline)

Adenosine

Used for Tachycardia (↑ heart rate)

Atropine

Used for Bradycardia (↓ heart rate)

Calcium gluconate

• Used in cases of cardiac arrest

• Used also in the treatment of cardiotoxicity, secondary to Hyperkalemia & Hypermagnesemia

Dextrose (10%)

D-Glucose

• Used in cases of hypoglycemia

Dopamine

• Adrenergic agonist

• Used in hypotension

• Used in the treatment of cardiac arrest

Epinephrine

Adrenaline

• Treatment for anaphylaxis

Fentanyl

Opioid

• Used as analgesic

• Maintain anesthesia

Hydralazine

• Treat hypertensive emergency

Lorazepam

Benzodiazepines

• Used as anticonvulsant

Morphine

• It is a narcotic analgesic

Naloxone

• Antidote for opioid toxicity

Phenobarbital

Barbiturates

• Used as anticonvulsant

• Used in px with alcohol withdrawal symptoms

Sodium bicarbonate

• Treatment of metabolic acidosis

Vecuronium

Curare derivative

• Used as muscle relaxant

Volume Expanders (RBC’s and Normal Saline)

• Used to treat hypotension secondary to hypovolemia

A. Availability of critical medications and supplies to respond to emergencies

Code carts located at nursing units and clinics are used primarily for what purpose?

A. Availability of critical medications and supplies to respond to emergencies

B. Securing all controlled substances available at the units

C. Securing PRN medications available for patients

D. Availability of unit dose for 24-hour medications for individual patients

TOTAL PARENTERAL NUTRITION

• Administered via: Subclavian Vein

• Prepared under a Laminar Flow Hood

• Must be administered within 24 hours after reconstitution

Macronutrients

Sources of calories or kiloCalories

• Carbohydrates (Dextrose)

  • D-glucose is a monosaccharide

• Proteins (Amino acid)

  • Like glycine, building blocks of proteins

• Fats (Triglycerides)

Micronutrients

Add-ons

• Electrolytes

  • Major: Na, K, Cl, Ca

• Trace Minerals

  • Iron, copper, zinc

• Vitamins

B. Carbohydrates, Proteins and Fats

Which of the following are macronutrients found in Total Parenteral nutrition?

A. Fats, Vitamins, Carbohydrates, Trace Elements

B. Carbohydrates, Proteins and Fats

C. Carbohydrates, Proteins, Vitamins

D. Proteins, Fats and Electrolytes

D. I

Which of the following components of parenteral nutrition is/are micronutrients?

I. Electrolytes

II. Dextrose

III. Triglycerides

A. III

B. I, II and III

C. II and III

D. I

D. 5% Dextrose in water

The IV fluid D5W means?

A. 0.5% Dextrose in water

B. 0.05% Dextrose in water

C. 50% Dextrose in water

D. 5% Dextrose in water

D. II and III

Which of the following deficiencies is/are the most common cause/s of megaloblastic anemia?

I. Iron Deficiency - microcytic

II. Vitamin B12 Deficiency

III. Folic acid Deficiency

A. I

B. I, II and III

C. III

D. II and III