Clinical Case Studies on Medication Safety

Clinical Case Studies on Medication Safety provides real and simulated scenarios about safety issues related to medication, including Adverse Drug Reactions (ADRs), medication errors, and Drug Related Problems (DRPs). The book explains real-life case management, including details about adverse drug reactions, mistakes during drug administration, drug avoidance, and drug-drug interactions with a goal of improving patient care. With over 150 case studies, including cases from alternative medicine and traditional medicine, this book will help medical and health sciences educators, students, healthcare professionals, and other readers apply their knowledge and skills to solve cases for better patient care.

• Includes real and simulated case studies about drug safety issues
• Aids medical students and practitioners to improve their case solving skills
• Contains more than 150 case studies with questions and key answers

• Language: English
• Publisher: Academic Press
• Release date: Jan 19, 2023
• ISBN: 9780323972697

Book preview

1: Introduction to the medication safety and the importance of clinical case studies

Yaser Mohammed Al-Worafia,b    a College of Pharmacy, University of Science and Technology of Fujairah, Fujairah, United Arab Emirates

b College of Medical Sciences, Azal University for Human Development, Sana’a, Yemen

Abstract

Clinical case studies on medication safety provide real and simulated scenarios about safety issues related to medication, including adverse drug reactions (ADRs), medication errors, and drug-related problems (DRPs). The book explains real-life case management, including details about ADRs, mistakes during drug administration, drug avoidance, and drug-drug interactions with the goal of improving patient care. With over 150 case studies, including cases from alternative medicine and traditional medicine, this book will help medical and health sciences educators, students, healthcare professionals, and other readers apply their knowledge and skills to solve cases for better patient care.

Keywords

Medication safety; Clinical case studies; Adverse drug reactions (ADRs); Medication errors; Drug-related problems (DRPs)

1: Background

The Institute for Safe Medication Practices Canada defined medication safety as freedom from preventable harm with medication use (ISMP Canada, 2007). Drug safety (also known as pharmacovigilance) is the science of detection, assessment, understanding, and prevention of side effects, which allows us to understand more about the risks and benefits of a medicine (WHO, 2002). Taking medications and herbal medications has been increased more than any time in history due to many reasons such as an increase in morbidity worldwide, lifestyle change, and other contributing factors. However, medications are like a double-edged sword; in one edge, it provides its efficacy to treat diseases and conditions as well as prevent diseases and conditions, while in the other edge, it could lead to medication-related problems (Al-Worafi, 2020a, 2020b). Medication safety issues are affecting the patients, their families, the healthcare system, and the whole country in developing countries and developed countries (Al-Worafi, 2020a). Preparing the future healthcare professionals with the necessary competencies related to the medication-safety-related issues is the key to success in medication safety practice in the future; however, improving the current healthcare professionals’ medication safety competencies is very important in order to improve the patients’ treating outcomes in terms of efficacy and safety. Medication-safety-related issues such as: pharmacovigilance and adverse drug reactions (ADRs) and its reporting; medication errors Prescribing & prescription writing errors, transcribing errors, dispensing errors, administration errors and diagnostic errors; self-medication and self-medication with antibiotics; antibiotics resistance; drug-related problems (DRPs); counterfeit and substandard medications; medications abuse and misuse; storage of medications; disposal of medications; safety of medications for geriatrics; safety of medications for pediatrics; safety of medications during pregnancy; safety of medications during lactation; safety of herbal medications; safety of vaccines nowadays affecting people and their families, drug authorities and ministries of health and the whole countries worldwide. Healthcare professionals, as well as patients, expect that the prescribed and recommended medications treat their diseases effectively and safely but unfortunately, no medications without actual or potential DRPs, therefore monitoring the safety of medications is very important like the monitoring the efficacy of medications to achieve the desired outcomes as well as avoid or minimize the toxicity of medications (Al-Worafi, 2020a, 2020b; WHO, 2002, 2004).

2: The scope of the present textbook

Clinical case studies on medication safety provide real and simulated scenarios about safety issues related to medication, including ADRs, medication errors, and DRPs. The book explains real-life case management, including details about adverse drug reactions, mistakes during drug administration, drug avoidance, and drug–drug interactions with the goal of improving patient care. With over 150 case studies, including cases from alternative medicine and traditional medicine, this book will help medical and health sciences educators, students, healthcare professionals, and other readers apply their knowledge and skills to solve cases for better patient care.

3: Key features

•Includes real and simulated case studies about drug safety issues

•Aids medical students and practitioners to improve their case-solving skills

•This book contains more than 20 chapters and will be a good source for medication safety cases as the following:

1.Introduction to the Medication Safety and the Importance of Clinical Case Studies

2.Adverse Drug Reactions (ADRs) Case Studies: Mild ADRs

3.Adverse Drug Reactions (ADRs) Case Studies: Moderate ADRs

4.Adverse Drug Reactions (ADRs) Case Studies: Severe ADRs

5.Medication Errors Case Studies: Prescribing, Transcribing, and Prescriptions/Orders Writing Errors

6.Medication Errors Case Studies: Dispensing and Administration Errors

7.Medication Errors Case Studies: Monitoring and Counseling Errors

8.Medication Errors Case Studies: Medication Reconciliation Errors

9.Drug Interactions Case Studies

10.Adherence, Compliance, and Persistence Case Studies

11.Drug-Related Problems Case Studies: Part I

12.Drug-Related Problems Case Studies: Part II

13.Counterfeit and Substandard Medications Case Studies

14.Medications Misuse and Abuse Case Studies

15.Medications Safety for Special Population Case Studies: Geriatrics

16.Medications Safety for Special Population Case Studies: Pediatrics

17.Medications Safety for Special Population Case Studies: Pregnancy

18.Medications Safety for Special Population Case Studies: Lactation

19.Herbal Medicines Case Studies: Part I

20.Herbal Medicines Case Studies: Part II

21.Antibiotics Case Studies: Community Pharmacies and Primary Care and Public

22.Antibiotics Safety Case Studies: Hospitals

23.Vaccines Safety Case Studies

References

Al-Worafi, 2020a Al-Worafi Y.M., ed. Drug safety in developing countries: Achievements and challenges. Academic Press; 2020a.

Al-Worafi Y.M. Drug safety in developing versus developed countries. In: Drug safety in developing countries. Academic Press; 2020:613–615.

The Institute for Safe Medication Practices Canada. https://www.ismp-canada.org/. 2007.

World Health Organization. The importance of pharmacovigilance. 2002.

World Health Organization. Pharmacovigilance: Ensuring the safe use of medicines (No. WHO/EDM/2004.8). Geneva: World Health Organization; 2004.

2: Adverse drug reactions (ADRs) case studies: Mild ADRs

Yaser Mohammed Al-Worafia,b; Long Chiau Mingc; Abdullah Ahmed Dhabalid,e; Abdulkareem Mohammed Al-Shamif,g; Ammar Ali Saleh Jaberh    a College of Pharmacy, University of Science and Technology of Fujairah, Fujairah, United Arab Emirates

b College of Medical Sciences, Azal University for Human Development, Sana’a, Yemen

c PAP Rashidah Sa’adatul Bolkiah Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei Darussalam

d Faculty of Pharmacy, Sana'a University, Sana’a, Yemen

e School of Clinical Pharmacy, Lebanese International University, Sana’a, Yemen

f Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Pahang, Malaysia

g Faculty of Pharmacy, PICOMS International University College, Kuala Lumpur, Malaysia

h Dubai Pharmacy College for Girls, Dubai, United Arab Emirates

Abstract

Adverse drug reactions (ADRs) can be defined as: Any unexpected, unintended, undesired, or excessive response to a drug that requires discontinuing the drug (therapeutic or diagnostic), requires changing the drug therapy, requires modifying the dose (except for minor dosage adjustments), necessitates admission to a hospital, prolongs stay in a health care facility, necessitates supportive treatment, significantly complicates diagnosis, negatively affects prognosis, or results in temporary or permanent harm, disability, or death. ADRs are one type of the potential as well as actual medication-related problems, which can affect the treating clinical, economical, and humanistic outcomes. ADRs increase the admission rate to hospitals, increase the morbidity and mortality, increase the cost of therapy, affect the quality of life, and affect the patient satisfaction toward health care. This chapter aims to discuss the real cases of mild-ADRs, moreover, suggest the management and recommendations for each case. ADRs cases will help medical and health sciences educators and students and healthcare professionals to deal with the cases of ADRs in their practice, teaching, and learning.

Keywords

Adverse drug reactions; Mild ADRs; Causes; Management and cases

Abbreviations

Abd abdomen

BP blood pressure

BPM breaths per minute

CV cardiovascular

Gen general appearance

Genit/Rect genitalia/rectal

HEENT head, eyes, ears, nose, and throat

HR heart rate

Ht height

MS/Ext musculoskeletal and extremities

Neuro neurologic

RR respiratory rate

T temperature

VS vital signs—blood pressure, pulse, respiratory rate, and temperature.

Wt weight

1: Background

Taking medications and herbal medications has increased more than at any time in history due to many reasons such as an increase in morbidity worldwide, lifestyle change, and other contributing factors. However, medications are like a double-edged sword; on one edge, it provides their efficacy to treat diseases and conditions as well as prevents diseases and conditions, while on the other edge, they could lead to medication-related problems; adverse drug reactions (ADRs) are one type of the potential as well as actual medication-related problems, which can affect the treating clinical, economical, and humanistic outcomes (Al-Worafi, 2020a, 2020b).

Terminologies

Adverse Drug Reactions (ADRs)

There are many definitions for ADRs as the following (Al-Worafi, 2020c, 2020d):

Edwards and Aronson (2000) defined ADRs as: An appreciably harmful or unpleasant reaction, caused by an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product (Edwards & Aronson, 2000).

World Health Organization (WHO) in 1996 defined ADRs as: A response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or for modification of physiological function (WHO, 1969).

American Society of Health-System Pharmacists (ASHP), 1995, defined ADRs as: Any unexpected, unintended, undesired, or excessive response to a drug that requires discontinuing the drug (therapeutic or diagnostic), requires changing the drug therapy, requires modifying the dose (except for minor dosage adjustments), necessitates admission to a hospital, prolongs stay in a health care facility, necessitates supportive treatment, significantly complicates diagnosis, negatively affects prognosis, or results in temporary or permanent harm, disability, or death (ASHP, 1995).

Unexpected adverse reaction

An adverse reaction, the nature, or severity of which is not consistent with domestic labeling or market authorization, or expected from characteristics of the drug (WHO, 2002).

Adverse event

Harm in a patient administered a drug but not necessarily caused by a drug (Edwards & Aronson, 2000).

Adverse drug event

Harm caused by a drug or the inappropriate use of a drug (Bates et al., 1995; Nebeker, Barach, & Samore, 2004).

Side effect

Any unintended effect of a pharmaceutical product occurring at a dose normally used in humans, which is related to the pharmacological properties of the drug (WHO, 2002).

Side effect

A usually predictable or dose-dependent effect of a drug that is not the principal effect for which the drug was chosen; the side effect may be desirable, undesirable, or inconsequential (Cobert & Biron, 2001).

Drug allergy

An immunologically mediated reaction, characterized by specificity, transferability by antibodies or lymphocytes, and recurrence on re-exposure

Chief complaint (CC)

The chief complaint is a brief statement of the reason why the patient consulted the physician, stated in the patient’s own words (Schwinghammer & Koehler, 2009).

History of present illness (HPI)

The history of present illness is a more complete description of the patient’s symptom(s) (Schwinghammer & Koehler, 2009).

Past medical history

The past medical history includes serious illnesses, surgical procedures, and injuries the patient has experienced previously (Schwinghammer & Koehler, 2009).

Past medications history

The medication history should include an accurate record of the patient’s current use of prescription medications, nonprescription products, and dietary supplements (Schwinghammer & Koehler, 2009).

Family history

The family history includes the age and health of parents, siblings, and children. For deceased relatives, the age and cause of death are recorded. In particular, heritable diseases and those with a hereditary tendency are noted (e.g., diabetes mellitus, cardiovascular disease, malignancy, rheumatoid arthritis, obesity) (Schwinghammer & Koehler, 2009).

Social history

The social history includes the social characteristics of the patient as well as the environmental factors and behaviors that may contribute to the development of disease. Items that may be listed are the patient’s marital status; number of children; educational background; occupation; physical activity; hobbies; dietary habits; and use of tobacco, alcohol, or other drugs (Schwinghammer & Koehler, 2009).

Allergies

Allergies to drugs, food, pets, and environmental factors (e.g., grass, dust, pollen) are recorded. An accurate description of the reaction that occurred should also be included. Care should be taken to distinguish adverse drug effects (upset stomach) from true allergies (hives) (Schwinghammer & Koehler, 2009).

Physical examination

The exact procedures performed during the physical examination vary depending upon the chief complaint and the patient’s medical history. In some practice settings, only a limited and focused physical examination is performed. In psychiatric practice, greater emphasis is usually placed on the type and severity of the patient’s symptoms than on physical findings (Schwinghammer & Koehler, 2009).

Mild adverse drug reactions: Characteristics

Mild reactions usually described as of minor significance include

Digestive disturbances (such as nausea, constipation, diarrhea)

Headaches

Fatigue

Vague muscle aches

Malaise (a general feeling of illness or discomfort)

Changes in sleep patterns

However, such reactions can be very distressing to people who experience them. As a result, people may be less willing to take their drug as instructed, and the goals of treatment may not be achieved (MSD, 2019).

Factors affecting the development of adverse drug reactions (ADRs)

Alomar, 2014, conducted a systematic review between 1991 and 2012 and reported the following factors of developing adverse drug reactions (Alomar, 2014):

"Patient related factors

Age

Gender

Maternity status

Fetal development

Creatinine clearance category

Allergy

Body weight and fat distribution

Social factors

Alcohol drinking

Race and ethnicity factors

Smoking

Drug related factors

Polypharmacy

Drug dose and frequency

Disease related factors (accompanied diseases)" (Alomar, 2014).

Prevention of adverse drug reactions (ADRs) prevention and management

Prevention

WHO recommended the following in the prevention of ADRs (WHO, 2007):

Prescribers and healthcare professionals can prevent the potential ADRs by:

•"Is this medicine the correct one for the patient’s clinical condition?

•Are the dose, route, and interval correct?

•Does the patient have any medical or physical conditions that would affect the pharmacokinetic aspects of the medicine?

•Does the patient have an allergy to this medication or a chemically similar medicine?

•Is the patient on another medicine (or herbal product) that would cause a significant medicine interaction?

•What is the patient’s compliance with the medication?

•Is the medicine being prescribed a medicine that is at high risk for producing ADRs (e.g., aminoglycosides, digoxin, warfarin, heparin, and antineoplastics)? Special precautions are necessary when using these high-risk medicines.

•Is the medicine being prescribed of high quality (i.e., reputable manufacturer, not expired, no deterioration)?

•Is the medicine being administered correctly (e.g., sterile needle or syringe for injectable medicines or with food for gastrointestinal irritants)?"

Adverse drug reactions (ADRs) management

Pharmacists and healthcare professionals play an important role in the management of ADRs. Successful management requires early identification of the suspected ADRs; therefore, pharmacists and healthcare professionals should be educated and trained to be able to diagnose and manage the suspected ADRs (WHO, 2007). WHO recommended the following steps in the management of ADRs (WHO, 2007):

"Step 1. Evaluate the nature of the event.

▪Obtain a detailed history of the patient.

▪Identify and document the clinical reaction. Look up suspected medicines and known ADRs in the literature and match them with the reactions described by the patient

▪Classify the severity of the reaction.

▪Severe—fatal or life threatening

▪Moderate—requires antidote, medical procedure, or hospitalization

▪Mild—symptoms require discontinuation of therapy

▪Incidental—mild symptoms; patient can choose whether to discontinue treatment or not.

Step 2. Establish the cause.

•Use the Naranjo algorithm (or other system) to assess the patient’s reaction.

•Evaluate the quality of the medicine.

•Check for a medication error.

Step 3. Take corrective and follow-up action.

Corrective action will depend on cause and severity

▪Severe ADRs

▪Educate and monitor prescribers.

▪Change the formulary or standard treatment guideline if necessary to substitute a medicine that is safer or that is easier to use by staff.

▪Modify patient monitoring procedures.

▪Notify drug regulatory authorities and manufacturers.

▪All ADRs

▪Educate and warn patients, to reduce the possibility of ADR recurrence." (WHO, Session 4. Assessing and Managing Medicine Safety).

2: Cases

Case 1. Case of nausea—Metformin

Patient data

Age: 48 years.    Gender: Male.    Weight: 94 kg,    Height: 1.76 m

Chief Complaint

Nausea

History of Present Illness

A 48-year-old man presented to the community pharmacy with a 5-day history of nausea. He stated that nausea started within the first day of the first dose of metformin and continues to worsen. He was diagnosed with diabetes mellitus type 2, 3 months ago, and started metformin about 5 days ago.

Past Medical History

Hypertension for 5 years

Diabetes mellitus (Recently diagnosed for 3 months)

Dyslipidemia (Recently diagnosed for 3 months)

Past Medications History

Telmisartan 40 mg once daily

Metformin 1000 mg twice daily

Atorvastatin (the dose not reported)

Family History

Father with diabetes mellitus and hypertension

Social History

•Married with four children

•Primary school teacher

•Smoker X 20 years

•Exercise once to twice monthly

Allergies

NKDA

Physical Examination

Vital signs

Laboratory findings

Complete blood count

Not measured recently; however, the patient reported that it was normal a few months ago

Kidney function and electrolyte tests

Not measured recently; however, the patient reported that it was normal a few months ago

Liver function tests

Not measured recently; however, the patient reported that it was normal a few months ago

Lipid profile

Significant for high total cholesterol and low-density lipoprotein.

Cardio enzymes tests

NA

Endocrine tests

Significant for high fasting blood glucose level and HbA1c.

Other investigations

None.

Case discussion and medication safety issue analysis

The patient was diagnosed with diabetes mellitus type 2, hypertension, and dyslipidemia. He had nausea. There are many potential causes of nausea; however, the patient reported that his nausea occurred after using metformin.

Case 2. Case of vomiting—Amoxicillin/clavulanate

Patient data

Age: 8 years.    Gender: Male.    Weight: 25 kg    Height: 1.23 m

Chief Complaint

Vomiting

History of Present Illness

An 8-year-old boy presented with his father to the community pharmacy with a 1-day history of vomiting. He stated that the vomiting started after taking amoxicillin/clavulanate suspension for his otitis media. He reported that his child couldn’t drink the medicine and vomit it.

Past Medical History

Respiratory Tract Infection a few years ago.

Past Medications History

Antibiotics (The parent could not remember the name of antibiotics)

Family History

Father: NA

Mother: NA

Social History

Both parents are in good health. He is living with three brothers, and they are in good health.

Allergies

NKDA

Physical Examination

Laboratory findings

Complete blood count

Significant for high white blood cells.

Kidney function and electrolyte tests

NA

Liver function tests

NA

Lipid profile

NA

Cardio enzymes tests

NA

Endocrine tests

NA

Other investigations

NA

Case discussion and medication safety issue analysis

The patient was diagnosed with otitis media. He had vomiting occurred after taking amoxicillin-clavulanate.

Case 3. Case of ankle edema—Amlodipine

Patient data

Age: 53 years.    Gender: Male.    Weight: 84 kg,    Height: 1.68 m

Chief Complaint

Ankle edema

History of Present Illness

A 53-year-old man visited the cardiovascular physician with a history of ankle edema. He stated that the edema started within the first month after starting his new medications and continues to worsen. He was diagnosed with hypertension few months ago.

Past Medical History

Hypertension for 4 months

Past Medications History

Amlodipine 10 mg once daily

Family History

Father with diabetes mellitus and hypertension

Mother with hypertension

Social History

•Married with three children

•Lecturer

•Lack of exercise

•Smoker X 30 years

Allergies

NKDA

Physical Examination

Laboratory findings

Complete blood count

Within normal limits

Kidney function and electrolyte tests

Within normal limits

Liver function tests

Within normal limits

Lipid profile

Within normal limits

Cardio enzymes tests

NA

Endocrine tests

Significant for HbA1c, HbA1c is 6.2%

Other investigations

None.

Case discussion and medication safety issue analysis

The patient was diagnosed with hypertension. He was suffering from ankle edema. There are many potential causes of ankle edema; however, the patient reported that the ankle edema occurred after taking hypertension medication.

Case 4. Case of headache—Sildenafil

Patient data

Age: 25 years.    Gender: Male.    Weight: 91 kg,    Height: 1.79 m

Chief Complaint

Headache

History of Present Illness

A 25-year-old man presented at the community pharmacy looking for medication for his headache. He stated that he got married recently and one of his friends advised him to take Viagra. However, he bought Viagra from a community pharmacy and took one tablet. He did not remember the dose (either 25, 50, or 100 mg tablet).

Past Medical History

Nil

Past Medications History

Nil

Family History

Father with hypertension

Social History

•Married

•Accountant

•Exercise weekly for 1 h

•Nonsmoker

Allergies

NKDA

Physical Examination

Laboratory findings

Complete blood count

NA

Kidney function and electrolyte tests

NA

Liver function tests

NA

Lipid profile

NA

Cardio enzymes tests

NA

Endocrine tests

NA

Other investigations

None.

Case discussion and medication safety issue analysis

The patient was suffering from a headache. There are many potential causes of headache; however, the patient reported that the headache occurred after taking a sildenafil tablet.