Kevin L.

Villarante BSN-II
NUR104 Pharmacology II

1. Outline the steps involved in developing and approving a new drug.

The United States Food and Drugs Administration has a total of five steps involve in
the development and approval of new drugs. The first one is the Pre-clinical Trials, where the
drug is tested on an animal to confirm its therapeutic effect and to rule out if there is any
adverse effect. After Pre-clinical Trial, if the drug has a confirmed therapeutic effect it will
go to the next step which is the “Phase I,” in this step the drug is tested on healthy human
volunteers preferably men because the drug under development may hinder the child bearing
capacity of a woman. If the drug under development will exhibit a therapeutic effect with
little to no adverse effect it will now go to the next step which is the “Phase 2,” in this step
the drug will be tested on patients with the disease that the drug is designed to treat, its
number of volunteers is larger than the Phase I. If the drug is proven effective and has no or
little adverse or toxic effect or its benefit outweigh its risk then it will now proceed to the
next step which is the “Phase III,” in this step the drug will be tested on a vast clinical market
where prescribers are informed of the known reaction of the drug and precaution required for
its safe use, they also observe their patient closely for any undesirable effect. Drugs that
finish Phase III studies are evaluated by the FDA and only those that receive its committee
approval may be marketed. The last phase which is the “Phase IV,” where drug after its
approval is continually evaluated and prescribers are obligated to report any unexpected
effects of the drugs that are not seen until wide distribution occurs, the information is also
continually evaluated by the FDA.

2. Differentiate between generic and brand-name drugs, over-the-counter and

prescription drugs.
Generic Name is the original designation that a drug is given when the drug company
that developed it applies for the approval process of the FDA (Karch, 2016). On the other
hand, Brand Name is the name given to a drug by the pharmaceutical company that develop
it; it is also called trade name or proprietary name (Karch, 2016).

Over-the-counter or OTC drugs are drugs that are available without a prescription for
self-treatment of a variety of complaints and is deemed to be safe when used as directed,
while prescription drugs are the opposite of OTC drugs, they cannot be obtain without a
prescription and are monitored for when overused and not utilized as directed it my harm the
patient

3. Explain the benefits and risk associated with the use of over-the-counter drugs.
OTC drugs are readily accessible and have been shown to be safe when used as
directed and properly, so if you're sick, you can buy them and use them without a
prescription. However, these drugs may mask the signs and symptoms of underlying disease,
making diagnosis difficult, for example a simple headache may indicate something big
however taking an OTC drug for headache may eliminate that symptom making it difficult
for doctors to diagnose the disease. Taking them with prescription medications may cause
drug interactions and interfere with drug therapy, since there are drug-drug interactions that
decrease the effect of the other drug. If not used as directed, may result in serious drug
overdose.

4. Describe how the body cells respond to the presence of drugs that are capable of
altering their function.
Typically, drugs function in one of four ways:
1. To replace or function as alternatives for substances that are no longer available
2. to boost or promote specific biological functions
3. to suppress or slow cellular activity
4. To cause cell death by interfering with the function of foreign cells, such as invading
microorganisms or neoplasms (drugs that act in this way are called chemotherapeutic agents)

5. Explain the meaning of half-life of a drug and calculate the half-life of given drugs.
The half-life of a drug is the time it takes for the amount of drug in the body to
decrease to one half of the peak level it previously achieved. For instance, if a patient takes
40 mg of a drug with a half-life of 2 hours, 20 mg of the drug will remain 2 hours after
administration. Two hours later, 10 mg will be left (one half of the previous level); in 2 more
hours, only 5 mg will remain.

6. List at least six factors that can influence the actual effectiveness of drug in the
body.
1. Weight
2. Age
 3. Gender
4.Physiological
5.Factors
6.Pathological Factors

7. Define drug-drug, drug-alternative therapy, drug-food, and drug-laboratory test

interaction.
Drug-drug: occur with drugs that have small margins of safety. If there is very little
difference between a therapeutic dose and a toxic dose of the drug, interference with the
drug's pharmacokinetics or pharmacodynamics can produce serious problems, at the site of
absorption, during distribution, biotransformation, or excretion and at the site of action. May
also affect the amount between the therapeutic and toxic affect

Drug-alternative therapy: Adverse effects are undesired effects that may be unpleasant or
even dangerous. Alternative therapies, such as herbal products, act as drugs in the body and
can cause an interaction to occur, causing unanticipated effects in the body.

Drug-food: a drug-food interaction occurs when the drug and the food are in direct contact in
the stomach. Some foods increase acid production, speeding the breakdown of the drug
molecule and preventing absorption and distribution of the drug. Some foods chemically
react with certain drugs and prevent their absorption into the body.

Drug-laboratory test: caused by the drug being given and not necessarily by a change in the
body's responses or actions. can get a positive preggo test, when not really. Increase of
hormones

8. Define the term adverse drug reaction and explain the clinical significance of this
reaction.
An adverse drug reaction or ADR is defined as ‘an appreciably harmful or unpleasant
reaction resulting from an intervention related to the use of a medicinal product;
determination of such effect is clinically important as it usually predict hazard from future
administration and warrant prevention, or specific treatment, or alter the dosage regimen, or
withdraw of the drug.
9. List the responsibilities of the nurse in drug therapy.
Because nursing obligations include the following, the nurse is in a unique position
when it comes to drug therapy:
1. Administering drug
2. Assessing drug effects
3. Intervening to make the drug regimen more tolerable
4. Providing patient teaching about drugs and drug regimen
5. Monitoring the overall patient care plan to prevent medical errors.

10. Explain what is involved in each steps of the nursing process as it relates to drug
therapy.
Assessment
Because a patient's past experiences and illness can influence a drug's effect, the patient's
history is an important part of drug therapy assessment. The following are significant features
of the patient's medical history that are directly connected to medication therapy:
A. Chronic Conditions- may affect pharmacokinetics and pharmacodynamics.
B. Drug Use- prescription and OTC drugs, street drugs, alcohol, nicotine, alternative
therapies, and caffeine use may have an impact on a drugs effect.
C. Allergies- patient’s history of allergies can affect drug therapy.
D. Level of Education and Understanding- this information is a base line from which the
nurse can determine the appropriate types of teaching information to use with the patient.
E. Social Support- patient that are discharged may need continuing needs and support.
F. Financial Support- health care is high cost, it is to be considered when initiating drug
therapy and promoting patient compliance.
G. Pattern of Health Care- how patient seeks health care provides the nurse with valuable
information to include when preparing the patient’s teaching plan.
H. Weight- help determine whether the recommended drug dose is appropriate.
I. Age- children and older adults often require dose adjustments based on the functional level
of the liver and kidneys and the responsiveness of other organs.
J. Physical Parameters Related to Disease or Drug Effects- specific parameters that need to be
assessed depend on the disease process being treated and on the expected therapeutic and
adverse effects of the drug therapy.

Nursing Diagnosis
Based on the clinical presentation, a nursing diagnosis demonstrates existing or probable
changes in patient function. Because drug therapy is only a minor component of a patient's
entire situation, nursing diagnoses linked to drug therapy must be included in a patient's
overall picture. Nursing diagnoses for drug therapy are those that represent a possible change
in function of the body based only on the therapeutic or unfavorable effects of a medicine,
with no regard for environmental or disease-related factors.

Planning
Setting goals and intended patient outcomes will be part of this approach to ensure safe and
successful pharmacological therapy. Typically, these aims include ensuring a good response
to pharmacological therapy, reducing side effects, and comprehending the drug regimen.

Implementation
Involves nursing interventions with the purpose of accomplishing the results set out in the
planning phase. In medication therapy, three types of nursing interventions are typically used:
1. Proper Drug Administration- nurse should consider the seven points or “rights,” to ensure
safe and effective drug administration.
2. Comfort Measures- nurses are in a unique position to help the patient cope with the effects
of drug therapy since patient are more likely to comply when the effects of the therapy are
not too uncomfortable.
3. Patient and Family Education- Patients are becoming more responsible for their own
treatment, so it's critical that they have all of the information they need at home to ensure safe
and effective medication therapy.

11. Describe essential elements of a medication error.

A set of checks are built into the medication regimen process, which includes
prescribing, distributing, and giving a drug to a patient, to help spot problems before they
happen. These individuals include the physician or nurse practitioner who writes the
prescription, the pharmacist who fills the prescription, and the nurse who administers the
medication. Each is a system check to identify mistakes such as the incorrect medicine, the
wrong patient, the wrong dose, the wrong route, the wrong time, the improper storage, or the
wrong paperwork. Because the nurse is the one who delivers the medicine and is responsible
for patient education before the patient is sent to home, the nurse is frequently the final check
in the process.
12. Outline the important points that must be assessed and considered before
administering a drug.
1. Right patient. It is always important to make sure that you are giving the drug to the
correct patient. Checking the patient’s wrist band and asking the patient to repeat his/her
name and often birth-date are good policies to make sure it is the patient you think it is.
2. Right drug. To prevent medication errors, always check to make sure the drug you are
going to administer is the one that was prescribed. Many drugs may look alike and or have
sound-alike names.
3. Right storage. Be aware that some drugs require specific storage environments (e.g.,
refrigeration, protection from light).
4. Right route. Determine the best route of administration; this is frequently established by
the formulation of the drug.
5. Right dose. Always double-check calculations, and always do the calculations if the drug
is not available in the dose ordered.
6. Right preparation. Know the specific preparation required before administering any drug.
7. Right time. When drugs are studied and evaluated, a suggested timing of administration is
established.
8. Right recording. Always document drug administration. If it isn’t written, it didn’t
happen.

13. Describe the role of the nurse and the patient in preventing medication errors.

Nurse’s Role

The huge challenge of maintaining drug safety while dealing with all of the possible
complications that may arise for the patient is best accomplished by following the "rights" of
medication administration regularly. The following are these rights:

1. Right patient.

2. Right drug.

3. Right storage.

4. Right route.

5. Right dose.
6. Right preparation.

7. Right time.

8. Right recording.

Patient’s Role

With so many patients managing their medication regimens at home, there is another vital
check in the system: the patient. Only the patient knows what is being taken and when it is
being taken, and only the patient can report the actual medication regimen being followed
rather than the recommended drug regimen. Medication mistake prevention relies heavily on
patient and family education. Encourage patients to speak out and ask questions so that they
may be their own advocates. This helps to avoid pharmaceutical mistakes. In the home
environment, the following educational ideas can assist to decrease the likelihood of
medication errors:

1. Keep a written list of all medications you are taking, including prescription, OTC, and

herbal medications.

2. Know what each of your drugs is being used to treat.

3. Read the labels, and follow the directions.

4. Store drugs in a dry place, away from children and pets.

5. Speak up.

Children have special hurdles when it comes to drug mistakes. Children are frequently unable
to talk for themselves and must rely on a caregiver or carers to provide their medication.
Because children's bodies are still growing and respond to many medications differently than
adults', the risk of major adverse effects is higher. When dealing with a youngster, the margin
of safety for many medications is relatively narrow. Include the following advice when
informing parents about their children's medicine regimens:

1. Keep a list of all medications you are giving your child, including prescription, OTC, and

herbal medications.

2. Never use adult medications to treat a child.

3. Read all labels before giving your child a drug.

4. Measure liquid medications using appropriate measuring devices.

5. Call your health care provider immediately if your child seems to get worse or seems to be

having trouble with a drug.

6. When in doubt, do not hesitate to ask questions.

References:

Karch, A. (2016). Focus on Nursing Pharmacology 7th Edition. Wolters Kluwer.

McCuiston, L.E., DiMaggio, K., Winton, M.B., Yeager, J.J. (2021). Pharmacology: A
Patient-Centered Nursing Process Approach 10th Edition. Elsevier Inc.