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Module 01: Introduction to Pharmacology (Lecture) Flashcards

1
Q

This is known as the study of drugs and their interaction with living systems. This encompasses the physical and chemical properties drugs including their biochemical and physiologic properties.

A

Pharmacology

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2
Q

This is any chemical (liquid or gas) that can affect living processes.

A

Drugs

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3
Q

This is known as the study of drugs in human including the study of drugs in sick patients as well as healthy individuals or volunteers during new drug development.

A

Clinical Pharmacology

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4
Q

This is characterized as the use of drugs to diagnose, prevent or treat disease. This is also known as the medical use of drugs.

A

Therapeutics (pharmacotherapeutics)

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5
Q

This source of drugs is characterized be the oldest source and most of the drugs in ancient times were derived from this.

A

Plant Sources

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6
Q

This source of drugs is characterized as one of the major sources of drugs which utilizes specific body parts, organs, blood, and even bodily secretions.

A

Animal Sources

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7
Q

This source of drugs can be characterized as metallic (gold, zinc, iodine, iron, or silver) or nonmetallic (fluorine, selenium, petroleum, etc.)

A

Mineral Sources

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8
Q

This source of drugs is known to be derived from microbes or bacteria and their compositions, byproducts or secretions, fungi, etc.

A

Microbiological Sources

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9
Q

This source of drugs are known as chemicals produced that are derived from natural sources wherein their chemical structure is manipulated.

A

Synthetic or semi-synthetic drugs

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10
Q

This source of drugs involves a cleavage of DNA material, insertion of genetic materials into the bacterial cultures.

A

Recombinant DNA

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11
Q

This pertains to how well a particular drugs elicits the desired response it was intended for. The law requires that all drugs be proven this prior to their release to the market.

A

Effectiveness

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12
Q

This pertains to at which a particular drug cannot produce any harmful effects regardless of the dose and duration of treatment.

A

Safety (There is no safe drug)

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12
Q

This pertains to a drug only eliciting the desired response it was prescribed for. This type of drug will not result to any side effects.

A

Selectivity (All medications cause side effects)

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13
Q

Under the Philippine Regulatory Classification, these are listed in the Comprehensive Dangerous Drugs Act of 2002 and is supplied only on special DOH Prescription Form (Yellow rx) by a licensed PDEA prescribing physician.

A

Dangerous Drugs (DD, Rx)

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14
Q

Under the Philippine Regulatory Classification, these are medications containing any amount of prohibited or regulated drugs. This is supplied on ordinary prescription forms with 5-2 licensed number by a licensed PDEA prescribing physician.

A

Controlled Drugs (EDD, Rx)

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15
Q

Under the Philippine Regulatory Classification, these are medications that can only be obtained with a valid prescription and the must only be taken by the person for whom they are prescribed for.

A

Prescription Medication (Rx)

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15
Q

Under the Philippine Regulatory Classification, these are medications which can be purchased from any licensed retailer, such as a supermarket. They are also known as general sales drugs.

A

Non-Prescription Medication (Non-Rx)

There are still some controls in terms of the quantity that can be purchased, the strength of the medication, and the age limits of the purchase.

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16
Q

Under the Philippine Regulatory Classification, these medications do not require a prescription but can only be sold by a pharmacist. They may be stronger preparations of certain prescription medications, contraceptives, etc.

A

Pharmacy Only Medications

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17
Q

This refers to the amount of the drug (usually expressed in mg, g, mEqs, IU, mmol, etc.) needed to produce an effect, such as relief of pain or reduction of blood pressure.

A

Potency (strength)

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18
Q

When can a drug be classified as more or less potent?

A

A drug that requires a large to dose to produce the desired effect is said to be less potent.

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19
Q

Drug potency depends on what?

A

(1) The affinity of a drug for the receptor (tendency for the drug to bind to the receptor)
(2) Efficacy (the ability to produce an effect)

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20
Q

This is considered as the parameter that measures the degree of beneficial effect under the “real world” or in clinical settings.

A

Effectiveness

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20
Q

This is known as the measure as to whether an intervention produces the expected result under ideal circumstances.

A

Efficacy

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21
Q

What are the factors that determine the intensity of drug response?

A

(1) Administration
(A) Medication errors
(B) Patient Adherence

(2) Pharmacokinetics
(A) Absorption
(B) Distribution
(C) Metabolism
(D) Excretion

(3) Pharmacodynamics
(A) Drug receptor interaction
(B) Patient’s functional state
(C) Placebo Effects

What are the sources of individual variation?
(1) Pharmacokinetics
(2) Pharmacodynamics

can affect…
(A) Physiological variables
(B) Pathological variables
(C) Genetic variables
(D) Drug interactions

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22
This is known as the degree to which a patient follows a treatment regimen.
Adherence to Drug Regimen
23
What are the most common reasons for non-adherence?
(1) Frequent dosing (2) Denial of illness (3) Poor comprehension of the benefits of taking the drug (4) Cost
24
Who are less likely classified than adults to adhere to a treatment regimen?
Children
25
Why are children less likely to adhere to a treatment when compared to adults?
(1) Adherence in worst chronic disorders requiring complex, long term treatment (e.g. juvenile diabetes and asthma) (2) Parents may not clearly understand prescription instruction, and within 15 minutes, forget about half the information given by the physician.
26
What are the different reasons of non adherence that can be drawn from the patient itself?
(1) Apathy (2) Concern about taking drugs (adverse effects or addiction) (3) Denial of the disorder or its significance (4) Financial concerns (5) Forgetfulness and misunderstanding of prescribing instructions (6) No faith on the drug's efficacy (7) Physical difficulties (with swallowing tablets or capsules, opening bottles or obtaining prescriptions) (8) Reduction, fluctuation or disappearance of symptoms
27
What are the reasons of non adherence which can be drawn from the drug itself?
(1) Adverse effects (real or imagined) (2) Complex regimen (frequent dosing, many drugs) (3) Inconvenient or restrictive precautions (no alcohol or cheese) (4) Similar appearance of drugs (5) Unpleasant taste or smell
28
This is characterized as the changes in a drug's effects.
Drug interactions
29
Drug interactions are characterized as the changes in a drug's effects due to what:
(1) Recent or concurrent use of another drug or drugs (drug to drug interactions) (2) Ingestion of food (drug-nutrient interactions) (3) Ingestion of dietary supplements (dietary supplements-drug interactions)
30
Drug interactions are characterized to what?
Increase or decrease the effects of one or both drugs
31
This occurs when there are two drugs with similar properties or one drug taken for different indications taken at the same time or separately may have additive effects.
Therapeutic Duplication (leads to toxicity)
32
Drug interactions involve what:
(1) Pharmacodynamic interactions (2) Pharmacokinetic interactions
33
This type of drug interaction occurs when one drug alters the sensitivity or responsiveness of tissues to another drug by having the same (agonistic) or a blocking (antagonistic) effect.
Pharmacodynamic interactions (usually occur at the receptor level but may occur intracellularly)
34
This type of drug interaction occurs when a drug usually alters absorption, distribution, protein binding, metabolism or excretion of another drug.
Pharmacokinetic interactions (the amount and persistence of available drug at receptor site might change)
35
This involves variations in drug response due to the individual's genetic makeup.
Pharmacogenetics
36
This is characterized as the decrease in response to a drug that is used repeatedly.
Tolerance
37
This is known as the development of the ability to withstand its previously destructive effect of a drug by a microorganism or tumor cells.
Resistance
38
This type of resistance occurs when strains of microorganisms are no longer killed or inhibited by a previously effective antimicrobial drugs. A genetic change from this results from a mutation or gene acquisition.
Antibiotic resistance
39
What happens to resistant and nonresistant organisms during antibiotic resistance?
The previously effective antimicrobial drug preferentially eliminates nonresistant organisms, the resistant organism become the predominant species.
40
What are some examples of antibiotic resistance?
(1) Methicillin resistant Staphylococcus aureus (MRSA) (2) Vancomycin-resistant Enterococcus (VRE) (3) Multi-drug resistant Mycobacterium tuberculosis (MDR-TB) (4) Carbapenem-resistant Enterobacterales (CRE)
41
When can tumors become resistant?
If a mutation develops that confers resistant to an anticancer drug and that anticancer drug is used repeatedly, preferentially eliminating non resistant tumor cells. (Many patients with chronic myeloid leukemia become resistant to tyrosine kinase inhibitor imantinib because of the presence of the T315l mutation)
42
This type of resistance is known to affect the treatment of a number of disorders such as asthma or inflammatory bowel disease.
Corticosteroid Resistance
43
The mechanism of Corticosteroid Resistance is not fully understood but may involve a number of different factors such as:
(1) Infection, oxidative stress, allergen exposure, inflammation (2) Deficient of vitamin D3 (3) Genetic mutations or variations
44
Under drug development and evaluation process, how much participants does phase 1 include?
It includes between 20 and 100 participants (can be healthy or have the disease or condition being studied).
45
This phase of drug development and evaluation process gathers information of the drug's adverse effects, mechanism of drug metabolism and excretion.
Phase 1 (The researchers observe the participants very closely and check to see how the medicine or therapy works in a human body. They may also change the dose (amount) they give of the medicine or therapy to understand what amount is best)
46
How long does phase 1 last?
Several months
47
How many participants does phase 2 include under the drug development and evaluation process.
Includes 300 people who have the disease or condition being studied
48
Under this phase during drug development and evaluation process, the researchers obtain preliminary data on the effectivity of the drug. There is more information about how safe the medicine or therapy is; continuous evalaution on short term adverse effects.
Phase II
49
How long does phase II last?
Phase 2 usually lasts from few months up to two years
50
How many participants does phase III include?
Phase 3 includes 300 to 3,000 volunteers who have the disease or condition being studied.
51
This phase under drug development and evaluation process occurs when the researchers check whether the medicine or therapy actually works to prevent, diagnose, or treat the disease or health condition it was made for.
Phase III (researchers learn more about the possible side effects of the medicine or therapy because more people are involved)
52
If phase III trial is successful, what will happen?
The sponsor then applies for New Drug.
53
Explain the process of the application to the FDA.
The process includes a review of the proposed professional labeling and inspection of the manufacturing. If the review, is favorable, the FDA may approve the drug for marketing.
54
How many people does phase IV include under drug development and evaluation process?
Phase 4 includes thousands of people who have the disease or condition being studied.
55
This phase occurs when the medicine or therapy has been approved by the food and drug administration (FDA) to be given to the public. Under this, the researchers continue to look at the new medicine or therapy's benefits and risks (side effects) and at the way to best use it.
Phase IV
55
What does phase IV include?
information on the medication's long term safety, effectiveness, and any other benefits (identifying off label effects)
56
This is categorized based on the source of the decision to recall.
Product Recall
57
This type of product recall is done by manufacturers, traders, and distributors of health products when they decided to and or have withdrawn their product from any of the stages of the supply chain due to any safety and or quality reason.
Marketing Authorization Voluntary Recall (MAH) Initiated or Voluntary Recall
58
This type of product recall is done when the evaluation by the PRC shows that there is reason to believe that a health product can be imminently injurious, unsafe, defective, ineffective and or grossly deceptive, and when the MAH fails to initiate a recall.
FDA ordered or Mandatory Recall
59
This pregnancy category of drugs pertains to when adequate and well controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Category A
60
This pregnancy category of drugs pertains to when animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women.
Category B
61
This pregnancy category pertains to when animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant the use of the drug in pregnant women despite potential risks.
Category C
62
This pregnancy category of drugs pertains to when there is a positive evidence of human fetal risk based on the adverse reaction date from investigational or marketing experience or studies in humans, but potential benefits may warrant the use of the drug in pregnant women despite potential risks.
Category D
63
This pregnancy category of drugs pertains to when studies in animals or humans have demonstrated abnormalities and or there is positive evidence of human fetal risk based on the adverse reaction from investigational or marketing experience and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Category X
64
This is a sedative or anti anxiety drug that was created in Germany by the Grunenthal group.
Thalidomide (Contergan) in 1953
65
The thalidomide was first licensed for use where?
In the UK (Distaval) as a safe sedative, even prescribed for flu, morning sickness and insomnia associated with pregnancy (1958).
66
This Australian doctor wrote to the Lancet noticing an increase in the number of deformed babies born at his hospital, all to mothers who had taken thalidomide.
William Mcbride (1961) - The drug was withdrawn later the same year.
67
They reached a compensation settlement after a legal battle with the families of those affected.
UK manufacturer Distillers Biochemicals Ltd (now Diageo) (1968)
68
What article did the Sunday Times publish during 1972?
The Sunday Times published a front page lead under the banner "Our thalidomide children, a cause for national shame," part of a long running campaign for further compensation.
69
How much money was paid out by Diageo during the 1970s?
28 million euros
70
What happened in 2004 during the Thalidomide Tragedy: Timeline?
Thalidomide was made available on a named patient basis, meaning doctors can give it to patients only on a case to case basis at their own discretion, under strict controls.
71
What research was published during 2007?
(1) A study showed that thalidomide can significantly improve the survival chances of bone-marrow cancer patients. (2) Researchers said that adding thalidomide to standard treatment extended the livers of elderly patients with multiple myeloma by an average of 18 months.
72
When was the drug approved for the treatment of multiple myeloma by the European Medicines Agency?
2008
73
What was discovered in 2009 during the Thalidomide Tragedy: Timeline?
(1) Scientists at the University of Aberdeen claimed that they have solved a 50 year puzzle after discovering how Thalidomide caused limb defects. (2) They found that a component of the drug prevented the growth of new blood vessels in developing embryos, stunting limb growth.
74
How much money was granted by the government as a Thalidomide Trust over three yeas?
20 million euros
75
During 2010, he made a formal apology to the thalidomide victims, expressing "sincere regret and deep sympathy" on behalf of the government.
UK Health Minister Mike O Brien (The apology got mixed responses from victims, with some describing it as too little and too late)
76
What was the compensation conferred during 2010?
Eighteen Northern Irish Thalidomide survivors received a formal apology and 1 million compensation
77
What was released during 2012 based on the Thalidomide Tragedy Timeline?
The inventor of thalidomide, the Grunenthal Group released a statement saying "It regrets the consequences of the drug."
78
She is an FDA inspector who prevented the drug's approval within the United States despite pressure from the pharmaceutical company and FDA supervisors.
Dr. Frances Oldham Kelsey (July of 1962 her work was recognized by Pres. John F Kennedy)
79
How did Kelsey reject the application for thalidomide?
Kelsey insisted that the application for thalidomide contained incomplete and insufficient data on its safety and effectiveness as there was a lack of data whether the drug could cross the placental barrier.
80
Where was the world pharmacokinetics drawn from?
from the word pharmaco which means drug and kinesis which pertains to the word motion

PHARMACOLOGY (9 decks)

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