Chapter 2

Drug development and ethical consideration

Drug development
The process of getting a promising pharmacological chemical from preclinical research to
regulatory approval and accessibility to patients and prescribers is known as drug development.
Various stages are involved in developing a new drug; Preclinical stage, Clinical Stages,
Obtaining Regulatory Approval throughout the Drug Development Process, Investigational New
(IND)Drug and New Drug Application (NDA).
1. Preclinical stage
This stage consists of animal studies to determine several criteria for a drug under development.
A sponsor examines the medicine's toxicological and pharmacological consequences in vitro and
in vivo laboratory animal experimentation during preclinical drug development. Geno-toxicity
testing is carried out, as well as studies on drug uptake and metabolism, the toxic effects of the
drug's metabolites, and the rate at which the pharmaceutical and its metabolic products are
eliminated from the body.
2. Clinical Stages
Phase I: Phase I investigations on healthy human volunteers in small groups of 20 to 100 people.
The goal of phase I research is to discover the metabolic and pharmacological consequences of
medication in people and the adverse effects associated with higher dosages and, if necessary, to
acquire early indications of efficacy..
Phase II: The early controlled clinical trials undertaken to acquire preliminary findings on the
efficacy of the medicine for a specific indication or implications in individuals with the disease
or condition are referred to as phase II.
Phase III: Phase 3 research includes both regulated and unregulated trials. They are carried out
after initial evidence showing the drug's efficacy has been acquired in Phase 2. Their purpose is
to gather further information regarding the effectiveness and safety required to examine the
drug's total benefit relationship..
Phase IV: besides the above three phases, once the medicine is licensed and sold, Phase IV, often
known as Postmarket Monitoring, is conducted. Besides the above three phases, once the drug is
approved and marketed, Phase IV, often known as postmarket monitoring, is undertaken..
3. Obtaining Regulatory Approval throughout the Drug Development Process
(a)Investigational New Drug (IND)
After the compound has been evaluated in animals (preclinical testing), a firm files an IND with
the FDA to obtain authorization to test the medication in people. The IND describes past
experiment findings, how, where, and by whom researchers will do the new research, the
chemical composition of the molecule, how it is thought to operate in the body, any hazardous
consequences discovered in animal experiments, and how the substance is produced.
Furthermore, the IND must be evaluated and authorized by the Review Board, where the
researcher will perform the research, and progress updates on drug testing must be provided to
the FDA regularly. IND contains the following three broad areas;
1. Animal Pharmacology and Toxicology Investigations
2. Manufacturing Drug details such as manufacturer, formulation, stability, and restrictions
3. Clinical Protocols and Data for Investigators
(b)New Drug Application (NDA)
The NDA application is the developed system by which medication sponsors request that the
FDA authorize a novel medicine for marketing and selling. The NDA aims to offer enough
material for FDA reviewers to make the following essential choices:
1. If the medication is safe and effective for the intended use(s), whether the benefits exceed
the dangers.
2. If the anticipated labeling (package insert) for the medicine is suitable, and what it should
include
3. If the production techniques and production standards are employed to keep the drug's
identity, strength, quality, and purity are enough to retain the drug's identity, strength,
quality, and purity.
.
Drug name
All drugs have three types of names;
1. Chemical names- The chemical names are the scientific nomenclature based on the drug's
molecular structure.
2. Nonproprietary (generic) names- For a number of reasons, generic names are employed.
They serve as a clear and distinctive identification for active chemical compounds,
appearing on all medication labels, advertising, and other substance-related materials.
3. Brand names- this are unique names that are used by the different companies to sell the
manufactured drugs. Drugs with the same active compounds but produced by different
companies trade under different names
Over the counter drugs
OTC medication is also known as nonprescription medicine or OTC medicine. All of these
words allude to medications that may be purchased without a prescription. They are safe and
effective when used in accordance with the recommendations on the label and as prescribed by
your health care provider.
Pain medicines such as acetaminophen (Tylenol) and ibuprofen (Advil, Motrin), cough
suppressants such as dextromethorphan (Robitussin), and antihistamines such as loratadine are
common examples (Claritin 24H). These medications are often found on the shelves of
pharmacies, grocery shops, and even petrol stations.
Ethical considerations
Ethical consideration is a set of principles and ideals that should be adhered to when conducting
human affairs. Ethical concerns ensure that nobody acts in a way that is detrimental to society or
an individual. It prevents people and institutions from engaging in heinous behavior. Ethical
considerations include;
1. Informed consent
Informed consent implies that the person taking part in the assessment is entirely knowledgeable
about the study. Volunteers must be informed of the project's goal, who or what organization is
sponsoring it, how the results will be utilized if there are any possible negative consequences to
their involvement, and who will have access to the results.
2. Voluntary participation
Voluntary participation indicates that people take part in the assessment without being coerced.
Participants have the right to withdraw at any time without affecting their participation in future
services or the current program, as well as their connections with any of the investigators or
research organizations participating.
3. Do no harm
Harm can be physical and psychological, manifesting as tension, discomfort, worry, diminished
self-esteem, or violation of privacy. The evaluation method mustn't damage participants in any
manner.
4. Confidentiality
Confidentiality implies that no identifiable information is given to or accessible by anybody
other than the program director. Confidentiality also guarantees that such personally identifiable
information is not included in any reports or public materials. Since the numbers in peer-based
programs are frequently tiny, it is critical to evaluate how statements are phrased to guarantee
that no one may be recognized even if identities are not included.
5. Anonymity
Anonymity is more stringent privacy than discretion since the person's identification is unknown
to the study team. This is far more difficult to establish than secrecy since participants in social
science research are often known to the program organizer.
6. Only consider relevant components.
Only evaluate the elements that are relevant to the program/initiative being implemented.
Potentially dangerous populations are frequently employed as guinea pigs or a public platform in
assessments to raise all types of questions relevant to those running the program/initiative but do
not apply to the program or will be to the group engaged in the project. It is critical to keep
assessments as basic as possible while staying focused on the purpose of the assessment and how
the data obtained will be used.
Nursing practice act
Every state and territory in the United States has enacted legislation to control the profession of
nursing. The Nursing Practice Act defines these laws (NPA). The NPA is then interpreted into
regulations by each state and territory nursing board, which has the ability to regulate nursing
care practice and the authority to enforce the laws. Fifty states, the District of Columbia, and four
US territories have state boards of nursing (BON) in charge of regulating their own NPA.  These
laws are enforced by the boards in accordance with the directives of their respective state or
territorial legislative authorities. The legislative body delegated authority to the board of nursing
to penalize nurses who violated nursing laws and regulations. Only the BON has the authority to
punish a nurse who may endanger the public.
Nursing considerations
Nurses are responsible for identifying patients' symptoms, administering drugs within their area
of practice, offering additional symptom relief methods, and coordinating with other profession
Patient care entails more than simply the medical element of nursing. Patients may suffer anxiety
as a result of their medical illnesses, injuries, treatments, operations, or recuperation. It is critical
for nurses to address both a patient's physical and emotional requirements. Also to improve
patients' comfort and families' knowledge and adaptability.
When nurses demonstrate empathy, they establish a collaborative connection with patients,
which can aid in the identification of causes, symptoms, or explanations, resulting in an accurate
diagnosis and suitable treatment.
Chapter 3
Pharmacokinetics and Pharmacodynamics
Pharmacokinetics
Pharmacokinetics is a drug’s journey through the body, during which it passes through four
different phases: absorption, distribution, metabolism, and excretion.
Absorption: The process by which a medication travels from the place of delivery to the site of
action. The pace and degree of medication absorption is affected by a number of factors,
including:
1. Route of administration
2. A drug's formulation and chemical characteristics
3. Interactions between drugs and foods
The route of administration of a medication (oral, intravenous and inhalation) impacts
bioavailability, which is the percentage of the active form of a drug that enters the bloodstream
and effectively reaches its target location. When a drug is administered intravenously, there is no
need for absorption, and bioavailability is 100 percent since the active form of the medicine is
instantly transferred to the systemic circulation.
Distribution: Describes the drug's travel via the bloodstream to numerous tissues throughout the
body. A medication will travel from the site of absorption to tissues throughout the body,
including brain tissue, fat, and muscle.
Metabolism: Describes the process through which the medication is broken down. Cytochrome
P450 (CYP450) enzymes are in charge of the biotransformation or metabolism of about 70-80
percent of all medicines in clinical use. The following factors affect the metabolism of drugs;
1. Genetics can influence whether a person metabolizes medicines fast or slowly.
2. Age can have an effect on liver function; the elderly have decreased liver function and may
metabolize medicines more slowly, raising the risk of intolerability, whereas neonates or babies
have immature liver function and may require specific dosage considerations.
3. Drug interactions can cause reduced drug metabolism by inhibiting enzymes or enhanced drug
metabolism by inducing enzymes.
In general, when a drug is metabolized by CYP450 enzymes, it produces inactive metabolites
that lack the pharmacologic action of the original drug. Certain medicines, such as codeine,
remain inert until they are metabolized in the body into a pharmacologically active substance.
These are generally known as prodrugs.
Excretion: The process through which a medication is removed from the body. The factors that
affect excretion are;
1. Direct renal impairment, which may cause the half-life of some medicines to be prolonged and
need dosage changes.
2. Age, which can contribute to different rates of excretion and affect drug dose.
3. Pathologies affecting renal blood flow, such as congestive heart failure and liver disease,
might impair medication excretion.
If a patient has just undergone gastric bypass surgery, is a CYP2D6 poor metabolizer, or has
renal dysfunction, an individual's features influence these four processes, which can eventually
influence drug selection.
Pharmacodynamics
Pharmacodynamics is the study of a drug's molecular, biochemical, and physiologic effects or
activities on the human body. Nurses must have a basic grasp of pharmacodynamics in order to
contribute sensibly in attaining the therapeutic goal..

Dose-response interactions
The dose-response connection (the link between the amount of an administered dosage and the
strength of the reaction generated) is a critical problem in therapeutics. Drug-receptor
interactions
Drugs aren't "magic bullets"; they're just chemicals. Because medicines are chemicals, the only
way for them to generate their effects is through interaction with other substances. Most
medicines interact with receptors, which are unique "chemicals" in the body that most
pharmaceuticals interact with to create effects.
A receptor is any functional macromolecule in a cell to which a drug binds in order to generate
its effects. Numerous biological components might be called drug receptors under this wide
definition, because medicines bind to many cellular components (e.g., enzymes, ribosomes,
tubulin) to generate their effects
Chapter 4
Pharmacogenetics
The study of how a person's genes influence how he or she reacts to medicines.
Pharmacogenetics is being used to predict what the optimal medicine or dose of a drug will be
for a person. Clinical pharmacogenetics, or the use of genetic data to guide drug therapy
decisions, is starting to be utilized for medicines frequently recommended by family doctors.
Clinical pharmacogenetics investigates whether variations in the expression of a protein or
enzyme impact drug metabolism. These effects may cause variations in the levels of active or
inactive metabolites, which may need the administration of a new medication or dosage. 1
Family doctors are typically the initial point of contact for patients with genetic issues; yet, using
pharmacogenetic data quickly and accurately in a clinical setting is difficult.
Terminologies utilized in pharmacogenetics;
Allele - Individuals inherit two alleles for each gene, one from each parent; if the two alleles are
the same (e.g., CYP2C19*1/*1), the individual is homozygous for that gene; if the alleles are
different (e.g., CYP2C19*1/*2), the individual is heterozygous for that gene.
Gene - Basic physical and functional unit of heredity
Genotype - An individual's collection of genes
Phenotype - Clinical manifestations or visible features of a person with a certain genotype
Polymorphism - Natural variation in a gene, DNA sequence, or chromosome
Single nucleotide polymorphism - Type of polymorphism involving variation of a single base
pair in the human genome
Star allele nomenclature - Gene symbol, *allele number /*allele number (e.g., CYP2C19*1/*2) is
a common format used to describe variability of a given gene.
For several genes, pharmacogenetics uses a “star allele” naming scheme in which the normal or
reference allele is referred to as wild type and given the notation *1. To distinguish it from other
variations, a variant allele is generally marked with a * followed by a number other than one. For
example, a patient with two wild-type CYP2C19 alleles would be identified as having a
CYP2C19*1/*1 genotype, which is linked with normal CYP2C19 activity (the patient's
phenotype).
This genetic diversity has clinical consequences because it alters how medicines are metabolized
or activated in the body. There is evidence to indicate a link between genetic variability and
variations in medication levels or effects for some genes and medicines. Carrying two reduced-
function (or loss-of-function) CYP2C19 alleles, such as CYP2C19*2/*2, is linked to poor
metabolization and low CYP2C19 activity. Clopidogrel is a prodrug that must be activated by
CYP2C19 before it may be used. As a result, individuals with this “poor metabolizer” phenotype
had lower active clopidogrel metabolites and greater on-treatment platelet aggregation compared
to CYP2C19*1/*1 carriers.
Chapter 5
Complementary and Alternative Therapies
Complementary treatment is the use of a nontraditional technique in addition to standard care.
The adoption of a nonmainstream method in place of traditional treatment is known as
alternative therapy.
The phrase "complementary therapy" encompasses a wide range of therapies, making it difficult
Conventional medicine and alternative treatments are frequently used in tandem. However, it is
critical to inform your doctor and complementary practitioner about any medications, therapies,
or cures you are taking or using. Misuse of alternative therapies, erroneous diagnosis, or
postponement of conventional therapy may put your health at danger. Some alternative remedies
may produce adverse effects or interfere with conventional medications. It is recommended that
you never stop taking prescription drugs or modify the dose without first consulting with your
doctor.
Some people may be adversely affected by complementary medications, including severe
allergic responses. Many complementary treatments contain active substances that most people
are unfamiliar with. Contamination has also been observed in several cases. Do not use
supplementary medicines in children or if you are pregnant, trying to get pregnant, or nursing.
Before taking any alternative therapy, consulting with your healthcare provider about its possible
advantages and drawbacks is necessary

The following are typical beliefs connected with most modern therapies:

1. Illness develops when the body is out of equilibrium.

2. If given the appropriate conditions, the body can mend itself and sustain a healthy state.

3. The entire person, not simply the sickness or symptoms, should be treated.

4. The gentlest treatments should be tried initially, followed by tougher ones.

5. There is no fast remedy since mending and restoring equilibrium take time.
6. Natural goods are preferred over synthetic items.

Most individuals use complementary treatments for two reasons:

1. To achieve and maintain excellent health, and to assist them in doing daily activities.
2. Dissatisfaction with traditional medical methods
3. Dissatisfaction with their doctor–patient relationships
4. Desire to be in control of their own health and medical concerns
5. Easy online access to consumer health information
6. Reading evidence of the advantages and safety of various alternative treatments and therapies
7. Being unhappy with the low effectiveness rates or negative side effects of prescription
medications
8. Being unhappy with the low effectiveness rates or negative side effects of prescription
medications
9. Desire to obtain treatment that addresses the complete person rather than simply their
symptoms (Note: both complementary healthcare practitioners and some conventional health
professionals actively endorse holistic care).
Chapter 6
Pediatric considerations
Medication administration to children is a unique issue that needs specific knowledge and
abilities. The age, history, and degree of physical and mental development of each kid must be
addressed, and the administration procedure must be adjusted to match their specific demands.
Furthermore, youngsters are especially prone to pharmaceutical mistakes. The nurse must also
pay particular attention to the type of drug, the dose, and the method of administration.
It is critical to remember and follow the five "rights" of pediatric medication administration:
1. The appropriate patient
2. Appropriate medication
3. The proper dosage
4. Correct path
5. Appropriate time
First, locate the appropriate patient. Infants and toddlers cannot be depended on to identify
themselves. A parent may not always be present in a hospital environment. As a result, the only
secure way to identify a child is to compare the hospital ID band to the prescription card.
Second, select the proper medication—always ensure that it is appropriate for the child's
condition.
Third, be certain that the correct dose has been prescribed. Always consult the ordering physician
if the quantity of tarring of the dosage appears odd.
Fourth, confirm the proper administration path.
Finally, be certain that the drug is given at the appropriate time. Reviewing these key procedures
with each patient will aid in the elimination of errors and guarantee effective drug delivery.
Preventing medical errors
Medication error prevention is an especially important problem in pediatrics. Most hospitals
have rules that require specific medications, including as digoxin, heparin, insulin, epinephrine,
opiates, and sedatives, to be double-checked by another nurse before being administered to a kid.
Even if it is not required at your institution, it is prudent to take such measures.
The margin for error is quite tiny since youngsters require lower dosages. For instance, a single
mistake in decimal point placement results in a tenfold or higher dose error.
By adhering to a few simple principles, you can drastically minimize the likelihood of a
pharmaceutical mistake occurring:
1. Confirm that the patient's dosage is based on his or her current weight at all times.
2. Do not shorten the names of medications.
3. Leave a gap between words and numerals at all times (10 mg-NOT lOmg).
4. Never add a 0 after a whole number (2 mg—NOT 2.0 mg).
5. For dosages less than one, always use a zero to the left of the decimal point (0.1 mg-NOT .1
mg).
6. Prescription must be legible.
Coaching children
Because many youngsters resist taking drugs, medication delivery necessitates a strong yet
encouraging approach. Above everything, be truthful. Always inform the kid that you are
administering medicine. Never tell a youngster that medicine tastes like candy, even if it does..
Intramuscular and subcutaneous injection
Injecting medicine into youngsters presents a unique set of problems. Most children are
unpredictable, and only handfuls are completely cooperative when it comes to receiving a shot.
Always prepare injections at the nurse's station or medicine cart to prevent scaring the kid. The
injection location and needle size will be determined by the child's size, weight, age, and
condition. While older children have minimal difficulties in finding a good location for
intramuscular (1M) injections, newborns have fewer options due to their tiny and undeveloped
muscles.
Oral medication administration
When giving medicines to children, the oral route is preferable whenever feasible. Many oral
medicines are available in flavored liquids, which most youngsters will drink with little or no
resistance. Even newborns will take modest amounts of liquid medicine from a syringe without a
needle.
Liquids must be measured precisely, especially when the dose is less than a teaspoon. To
guarantee accuracy, use a calibrated syringe with clearly defined measurements. Any medication
ordered in teaspoons must be measured in cubic centimeters or milliliters. The standard
measurement is 5 cc, or 5 ml, per teaspoon.
Administration of optic, ophthalmic and nasal systems
There are minimal changes between giving ear, eye, and nose medicine to toddlers and adults.
The main challenge is getting the child's cooperation. Although administering ocular,
ophthalmic, and nasal medicine is not painful, these medications might induce unpleasant
feelings. Fortunately, they may be removed using a variety of methods.
Improving and guaranteeing pediatric patients' health can be one of the most satisfying elements
of a nurse's job. Children who are sick or injured are among the most vulnerable and reliant
patient populations. As a result, nurses must do all necessary to deliver drugs safely and swiftly,
as well as to safeguard the children under their care from pharmaceutical mistakes. Remember,
as a nurse, you can make a sad child happy again.
Chapter 7
Drug therapy in older adults
The prevalence of prescription medication usage rises dramatically with age. According to
survey data from 2010–2011, almost 90% of older individuals routinely use at least one
prescription medicine, nearly 80% regularly take at least two prescription drugs, and 36%
regularly take at least five prescription drugs. It is difficult to provide safe, effective
pharmacological therapy to older individuals for a variety of reasons, including:
1. They consume more medications than any other age group, raising the risk of side effects and
drug interactions and complicating adherence.
2. They are more prone to have chronic diseases that may be exacerbated or affected by the
medication.
3. Their physiologic reserves are typically depleted, which can be exacerbated by acute and
chronic illnesses.
4. Ageing can affect medication pharmacodynamics and pharmacokinetics.
5. They may have a more difficult time obtaining or affording medicines.
There are two ways to optimizing medication treatment in the elderly:
1. Use suitable medicines as directed while maximizing cost-effectiveness
2. Avoiding harmful drug effects by assuring proper drug dosing, eliminating unneeded
medications, and avoiding drug-drug and drug-disease interactions
Overprescribing (polypharmacy) has been identified as a serious concern for older individuals
due to the increased risk of harmful medication effects. Underprescribing suitable and
therapeutically helpful medicines, on the other hand, must be avoided.
Certain medication classes (for example, analgesics, anticoagulants, antihypertensives,
antiparkinsonian medicines, diuretics, hypoglycemic agents, and psychotropic drugs) offer
unique hazards to older individuals. Some medicines, while suitable for use in younger
individuals, are so dangerous that they should be avoided in older adults.
Drugs that;
All older individuals may find the following potentially inappropriate: If at all possible, avoid
because of the possibility of drug-disease and drug-syndrome interactions: To be avoided in
elderly people who have specific illnesses or syndromes. To be used with extreme caution: In
certain cases, the benefit may outweigh the danger.
Chapter 8
Drugs in substance use disorder
Drug addiction, also known as substance use disorder, is a condition that affects the brain and
behavior of a person, resulting in an inability to regulate the use of a legal or illicit drug or
medicine. Substances like alcohol, marijuana, and nicotine are also classified as drugs. When
you are addicted to a substance, you may continue to use it despite the harm it causes
Substance addiction can begin with the occasional use of a recreational drug in social
circumstances, and for some people, the drug usage progresses to more frequent use. Others,
particularly those addicted to opioids, develop a drug addiction after being exposed to
prescription drugs or getting medications from a friend or relative who has been given the
medication
The danger of addiction and the rate at which you get hooked differs depending on the drug.
Some medications, such as opioid pain relievers, have a higher risk of addiction and induce it
more quickly than others. As time goes on, you may require more dosages of the medication to
become high. Soon, you may require the medication simply to feel good. As your drug usage
progresses, you may find it increasingly difficult to abstain from the substance. Attempts to quit
using drugs may result in severe cravings and make you physically unwell (withdrawal
symptoms)
The most frequent forms of SUDs in the United States include the use of one or more of the
substances listed below.
1. Alcohol - Excessive alcohol use raises the risk of major health disorders such as heart
disease, brain and liver damage, and hypertension, as well as health problems connected
to intoxication and withdrawal. Inability to manage alcohol consumption, tolerance
development, and/or withdrawal symptoms are all diagnostic criteria.
2.  Opioids — The usage of opioids, which are drugs used to treat pain in healthcare
settings, has skyrocketed in the United States in recent years. Opioids function by
attaching to pain receptors in the brain or body to block pain signals from reaching the
brain. Opioids include prescription medications such as hydrocodone (Vicodin®),
oxycodone (OxyContin®, Percocet®), codeine, morphine, and illicit narcotics such as
heroin. Opioid abuse can result in physical dependency, severe respiratory depression,
and even death.
3. Stimulants - Stimulants include amphetamines, methamphetamines, and cocaine.
Stimulants raise alertness, breathing rate, blood pressure, and heart rate. Misuse can cause
hyperthermia, seizures, and heart failure, as well as psychological symptoms such as
anger and psychosis.
4. Hallucinogens - Hallucinogens are drugs that create hallucinations by distorting
perceptions of reality. Chemically manufactured drugs such as MDMA (also known as
Ecstasy), phencyclidine (PCP), and lysergic acid diethylamide (LSD), as well as naturally
occurring chemicals such as psilocybin mushrooms, peyote, or mescaline, are examples
of hallucinogenic substances.
5. Cannabis — Excessive use of cannabis, often known as marijuana, can cause memory,
learning, and perceptual difficulties, as well as loss of motor coordination and trouble
thinking and problem-solving abilities. Excessive cannabis usage in adolescents can also
raise the risk of cognitive problems and mental disorders.
6. Tobacco is a leafy plant that contains the addictive chemical nicotine and is commonly
smoked in the form of cigarettes, cigars, and pipes. Tobacco smoking is the biggest
avoidable cause of disease and death in the United States, increasing one's risk of cancer,
coronary heart disease, and chronic obstructive pulmonary disease (COPD). Smoking
during pregnant can cause baby tissue and lung damage, as well as an increased risk of
preterm birth, low birth weight, and Sudden Infant Death Syndrome (SIDS).
The greatest method to avoid becoming addicted to a substance is to avoid using it at all. If your
doctor prescribes a medicine that has the potential for addiction, exercise caution when taking it
and follow your doctor's recommendations.

Chapter 9
Safety and Quality
Drug safety
Drug safety is the science of detecting, assessing, analyzing, and preventing side effects, which
helps us to learn more about a medicine's dangers and benefits. Drug safety experts collect and
analyze information from patients and healthcare professionals in order to discover new
information regarding the usage of medications and any adverse effects that patients may
encounter.
Drug safety monitoring is a continuous process that occurs throughout clinical trials when
medicines are created, once medicines are released (also known as "licensed"), and during the
full period that a medicine is accessible for patients to use. Medicines are often used by huge
numbers of individuals, and uncommon adverse effects are occasionally identified only after a
medicine has been promoted. Individual individuals and healthcare professionals are urged to
report any adverse effects they encounter through the Medicines and Healthcare Products
Regulatory Agency's (MHRA) Yellow Card reporting program or directly to the manufacturer of
the medication.
The approaches used to assess drug safety range from individual case report inquiry to data
mining in big datasets and epidemiology. This information is used to guarantee the safe use of
medications and to protect patients from damage, and it frequently results in an update of the
adverse effects for a medicine mentioned in the leaflet.
1. Individual case report reporting to regulatory agencies
2. Preparation of product safety reports at certain periods
3. Preparation of risk management plans that include measures (such as epidemiological
research) to further characterize hazards associated with medications and ensure that procedures
are in place to mitigate risks once they are identified.
Some firms hire pharmacovigilance specialists to guarantee that medication safety is closely
monitored and considered, but in others, the function is integrated with medical information
teams.
Drug quality
The total of all measures done to verify the identification and purity of a certain medication is
referred to as quality control. The pharmaceutical business relies heavily on quality control.
Drugs must be promoted as safe and therapeutically active formulations with consistent and
predictable performance. It not only protects the producer against compensation claims, but it
also ensures the patient receives a safe and effective product. QC measures primarily comprise
drug formulation stability testing, dissolution testing, and examination of raw ingredients and
synthesis products.
The World Health Organization (WHO) has been concerned about pharmaceutical quality since
its founding. The establishment of global standards is required in Article 2 of the WHO
Constitution, which lists one of the Organization's duties as "developing, establishing, and
promoting worldwide standards with regard to food, biological, pharmaceutical, and similar
goods." At the International Conference on Primary Health Care in Alma-Ata in 1978, one of the
conditions for the delivery of health care was the availability of high-quality necessary
medications. Similarly, the Nairobi Conference of Experts on the Rational Use of Drugs, held in
1985, and WHO's Revised Drug Strategy, endorsed by the World Health Assembly in May 1986,
highlighted efficient national drug regulatory and control systems as the sole way to ensure the
safety and quality of medicines.
Side effects from the use of drugs are the major cause of drug-related injuries, adverse events,
and deaths. Some side effects can be avoided, while others are unavoidable. Side effects that can
be avoided include recognized drug–drug or drug–food interactions, contraindications, poor
compliance, and so on. In many situations, medication therapy necessitates a personalized
pharmacological treatment strategy as well as vigilant patient monitoring. Some recognized
adverse effects occur even with the finest medical care and when the medication is taken
correctly. Antibiotics can cause nausea, while chemotherapy can cause bone marrow
suppression.
Another essential factor to consider is the quality of the drug. The appropriateness of a drug
substance or drug product for its intended use is recognized and specified in ICH (Worldwide
Conference on Harmonization, which provides for international standards of new drug product
quality; see below). This word encompasses characteristics such as individuality, strength, and
purity. Defects in medication product quality are a significant source of risk that affect drug
product performance and can have an impact on patient safety and therapeutic efficacy. The
strength and purity of the drug substance, the manufacturing method of the drug product, and the
monitoring of the manufacturing process all contribute to product quality.
Pharmaceutical producers must adhere to current Good Manufacturing Practices (cGMP) to
guarantee that their products are continuously of high quality.

Chapter 10
Drug administration
Nurses are largely responsible for drug delivery in a variety of situations. Nurses can also help
with medicine administration and preparation (similar to pharmacists), such as breaking tablets
and drawing out a specified quantity for injections.
Drugs are introduced into the body by several routes. They may be;
Oral route
Many medications can be taken orally as liquids, capsules, pills, or chewable tablets. The oral
route is the most commonly utilized since it is the most convenient, safest, and least costly. It
does, however, have limits due to the way a medication generally travels through the digestive
tract. Absorption of medicines given orally may begin in the mouth and stomach. Most
medicines, however, are typically absorbed through the small intestine.
Injection routes
Injection administration (parenteral administration) encompasses the following routes:
1. Subcutaneous (under the skin)
A needle is injected into fatty tissue immediately under the skin for the subcutaneous route. After
an injection, the medication enters tiny blood vessels (capillaries) and is transported away by the
circulation.
2. Intramuscular injection (in a muscle)
When greater quantities of a medicinal product are required, the intramuscular method is
recommended over the subcutaneous approach. A longer needle is required since the muscles are
located beneath the epidermis and fatty tissues. Drugs are often injected into the upper arm,
thigh, or buttock muscle..
3. Venous intravenous (in a vein)
For the intravenous method, a needle is injected straight into a vein. A drug-containing fluid can
be administered as a single dosage or as a continuous infusion. For infusion, the solution is
transported by gravity (from a collapsible plastic bag) or, more often, by an infusion pump
through thin flexible tubing to a tube (catheter) placed in a vein, generally in the forearm.
Intravenous administration is the most effective technique to give a precise dosage rapidly and in
a well-controlled manner throughout the body. It is also utilized for irritant solutions that would
induce discomfort and tissue damage if injected subcutaneously or intramuscularly.
4. Intrathecal (around the spinal cord)
A needle is placed between two vertebrae in the lower spine and into the area around the spinal
cord for the intrathecal route. After that, the medication is administered into the spinal canal. To
numb the injection site, a tiny quantity of local anesthetic is frequently utilized. This method is
used when a medication must have immediate or local effects on the brain, spinal cord, or the
layers of tissue that surround them (meninges), such as when treating infections in these tissues.
Anesthesia and analgesics (such as morphine) are occasionally administered in this manner.
The buccal and sublingual routes
A few medicines are put under the tongue (sublingually) or between the gums and teeth
(buccally) to dissolve and be absorbed directly into the tiny blood veins beneath the tongue.
These medications are not taken orally. The sublingual route is particularly beneficial for
nitroglycerin, which is used to treat angina, because absorption is fast and the medication reaches
the circulation directly without first passing through the intestinal wall and liver. Most
medicines, however, cannot be taken in this manner because they may be absorbed in an
incomplete or irregular manner.
The rectal route
Many medicines that are taken orally can also be taken rectally as a suppository. A medication is
combined with a waxy material that melts or liquefies after being injected into the rectum in this
form. The medication is easily absorbed since the rectum's wall is thin and its blood supply is
plentiful.
The vaginal route
Some medicines can be given to women vaginally as a solution, pill, cream, gel, suppository, or
ring. The medication is absorbed gradually via the vaginal wall. This method is frequently used
to provide estrogen to women experiencing menopause in order to alleviate vaginal symptoms
such as dryness, pain, and redness.
The ocular pathway
Drugs used to treat eye diseases (such as glaucoma, conjunctivitis, and injuries) can be combined
with inert ingredients to form a liquid, gel, or ointment that can be administered to the eye.
Liquid eye drops are generally simple to administer, but they may run off the eye too fast to be
effectively absorbed. Gel and ointment formulations maintain the medication in touch with the
eye surface for a longer period of time, although they may cause blurred vision. Solid inserts,
which deliver the medication constantly and gradually, are also available, although they may be
difficult to implant and maintain in place.
The otic pathway
Ear inflammation and infection can be treated with drugs that can be applied directly to the
afflicted ears. Typically, ear drops comprising solutions or suspensions are only administered to
the outer ear canal. Before using ear drops, patients should thoroughly clean and wipe their ears
with a damp towel.
The nasal route
A medication must be converted into small droplets in air before it can be breathed in and
absorbed via the thin mucous membrane that coats the nasal passages (atomized). The
medication enters the circulation once it has been absorbed.
Inhalation method
Drugs inhaled via the mouth must be atomized into smaller droplets than those inhaled through
the nose in order to pass down the windpipe (trachea) and into the lungs. The size of the droplets
determines how far into the lungs they travel. Smaller droplets penetrate deeper, increasing the
quantity of medication taken. They are taken into the bloodstream inside the lungs.
.
Route of nebulization
Drugs administered through nebulization, like those administered via inhalation, must be
aerosolized into tiny particles in order to reach the lungs. Nebulization necessitates the use of
specialized equipment, most notably ultrasonic or jet nebulizer systems..
Cutaneous path
Drugs applied to the skin are often utilized for local effects, and are thus most generally used to
treat superficial skin problems such as psoriasis, eczema, skin infections (viral, bacterial, and
fungal), itching, and dry skin. The medication is combined with inactive ingredients. The
formulation may be an ointment, cream, lotion, solution, powder, or gel, depending on the
viscosity of the inactive components
 Transdermal route
Some medicines are administered throughout the body via a patch applied to the skin. These
medicines are occasionally combined with a substance (such as alcohol) that improves
penetration through the skin into the bloodstream without the need for an injection. The
medication can be administered slowly and constantly through a patch for many hours, days, or
even weeks. As a consequence, medication levels in the blood may be kept reasonably stable.

Chapter 11
Drug calculation
Determining the units in which your medicine is measured (units/hour, mg/hour, or
mcg/kg/minute) is the first step in drug calculation. If your computation is weight-based, know
the patient's weight in kilograms. To calculate mcg/kg/minute, use the universal formula below
and then divide the final result by the patient's weight in kg.
The capacity of the practitioner to calculate medicines accurately and in a timely way is critical
to patient safety. Dimensional Analysis, Ratio Proportion, and Formula or Desired Over Have
Method are the three major ways for determining medicine doses.
Desired Over Have or Formula Method
Desired rather than Have or Formula Method, like ratio proportion, is a formula or equation used
to solve for an unknown number (x). Conversion factors are used in drug calculations, such as
when converting pounds to kilograms or liters to milliliters. This approach, while simple in
design, allows us to work with different units of measurement, converting factors to obtain our
solution. It is useful for double- or triple-checking the correctness of the various calculating
techniques listed above.
1. A fundamental formula for solving for x assists us in constructing an equation:
2. D/H x Q = x, i.e. desired dosage (quantity) = ordered Dose amount/amount on hand multiplied
by quantity
For example, a clinician may order lorazepam 4 mg IV push for a patient who is experiencing
acute alcohol withdrawal. The doctor has vials containing 2 mg/mL on hand. To give the desired
dose, how many milliliters should he or she draw up in a syringe?
3. Amount desired to be given = Dose ordered (4 mg) x Quantity (1 mL)/Have (2 mg) (2 mL)
Units of measurement must match, for example, milliliters and milliliters, or conversion to
comparable units of measurement is required. In the above example, the requested dose was in
milligrams, and the have dose was in milligrams, which balance out, leaving milliliters (response
called for milliliters), thus no additional conversion is necessary.
Dimensional Analysis Technique
If a clinician orders lorazepam 4 mg IV PUSH with a CIWA score of 25 or above, follow the
CAGE Protocol for following doses depending on CIWA scoring.
1. The automated dispensing unit has 2 mg/mL vials for the clinician.
2. How many milliliters are required to get the desired dose?
3. Place the required dose over 1 remember, (x mL) = 4 mg/1 x 1 mL/2 mg x (4)(1)/2 x 4/2 x 2/1
= 2 mL, continue multiplying/dividing until the desired quantity is obtained, 2 mL in our case.
4. Note that the fraction was designed with milligrams and milligrams intentionally positioned to
cancel each other out, making the equation easier to calculate for the required unit or milliliters.
Work is completed because the answer makes sense.
Zeros, like other units, can be cancelled out. As an example:
5.1000/500 x 10/5 = 2, the two zeros in 1000 and two zeros in 500 may be crossed off because
they are in the same unit, leaving 10/5, a lot easier fraction to calculate, and the result makes
sense.
We've covered zeros, now let's move on to one.
6. When a number is multiplied by a 1, the result is the same.
7. However, if you multiply a number by zero, the result is zero.
8. The following are some examples: 18 x 0 equals 0 or 20 x 1 equals 20
Ratio and Proportion Method
The Ratio and Proportion Method has been used in medication computations for many years and
is one of the oldest techniques (as mentioned in Boyer, 2002)[Lindow, 2004]. The concepts of
addition are a problem-solving method that has no impact on this connection. To solve a ratio
and proportion issue, only multiplication and division are required, not addition. A better
understanding will be provided by the following example, which uses a fraction or a colon
format:
Lorazepam 4 mg IV is prescribed by a doctor. Now is the time to aim for a CIWA score of 25.
There are 2 mg/mL vials available. How many milliliters are needed to administer the prescribed
dose?
1. Have on hand / Quantity you have = Desired Amount / x
2. 2mg/1 mL = 4 mg/x
3. 2x/2 = 4/2
4. x = 2 mL 

One would use H:V::D:X and multiply means DV and Extremes HX in colon format

5. Hx = DV, x = DV/H, 2:1::4:x, 2x = (4)(1), x = 4/2, x = 2 mL

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