Clinical Case Studies on Medication Safety 0323988024, 9780323988025

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Clinical Case Studies on Medication Safety

Clinical Case Studies on Medication Safety Edited by

Yaser Mohammed Al-Worafi Clinical Pharmacy, College of Pharmacy, University of Science and Technology of Fujairah, Fujairah, United Arab Emirates; College of Medical Sciences, Azal University for Human Development, Sana’a, Yemen

Academic Press is an imprint of Elsevier 125 London Wall, London EC2Y 5AS, United Kingdom 525 B Street, Suite 1650, San Diego, CA 92101, United States 50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom Copyright © 2023 Elsevier Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions. This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein). Notices Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary. Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility. To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. ISBN: 978-0-323-98802-5 For information on all Academic Press publications visit our website at https://www.elsevier.com/books-and-journals

Publisher: Stacy Masucci Acquisitions Editor: Andre G. Wolff Editorial Project Manager: Susan E. Ikeda Production Project Manager: Swapna Srinivasan Cover Designer: Miles Hitchen Typeset by STRAIVE, India

Dedication

To My mothers Anisah Ali Othman Shoieb (Late) Rada Ali Othman Shoieb

Contributors

Ghulam Abbas Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Government College University, Faisalabad, Pakistan Faisal Mohammad Ali Abdalla School of Pharmacy, Memorial University, St. John’s, NL, Canada Fahad Ezzi Obaid Abrah School of Pharmacy, Universiti Sains Malaysia (USM), George Town, Malaysia Tawseef Ahmad Department of Pharmacy, COMSATS University Islamabad, Abbottabad, Pakistan Issa Saad Al-Moraya Clinical Toxicology Department, College of Medicine Umm Al-Qura University, Mecca; Forensic Medicine & Toxicology Center, Aseer, Saudi Arabia Mayudh Saleh Mohsen Alnefaie Diabetes Center, King Abdulaziz Specialist Hospital, Taif, Saudi Arabia Hussien Abdullah M. Alqahtani Forensic Medicine & Toxicology Center, Aseer, Saudi Arabia Sami Alshakhshir College of Pharmacy, Aqba University of Technology, Aqba, Jordan Abdulkareem Mohammed Al-Shami Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Pahang; Faculty of Pharmacy, PICOMS International University College, Kuala Lumpur, Malaysia Ali Salman Al-Shami Karnataka College of Pharmacy, Bangalore, Karnataka, India Qusai Al-Share Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan Yaser Mohammed Al-Worafi College of Pharmacy, University of Science and Technology of Fujairah, Fujairah, United Arab Emirates; College of Medical Sciences, Azal University for Human Development, Sana’a, Yemen

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Contributors

Abdullah Ahmed Dhabali Faculty of Pharmacy, Sana’a University; School of Clinical Pharmacy, Lebanese International University, Sana’a, Yemen Yu Fang Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy; Center for Drug Safety and Policy Research, Xi’an Jiaotong University; Shaanxi Center for Health Reform and Development Research; Research Institute for Drug Safety and Monitoring, Institute of Pharmaceutical Science and Technology, Western China Science & Technology Innovation Harbor, Xi’an, China Nafis Haider Prince Sultan Military College of Health Sciences, Dhahran, Saudi Arabia Muhammad Hanif Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan, Pakistan Kainat Ilyas Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Government College University, Faisalabad, Pakistan Ammar Ali Saleh Jaber Dubai Pharmacy College for Girls, Dubai, United Arab Emirates Asad Khan Department of Pharmacy Practice, Faculty of Pharmacy and Health Sciences, University of Balochistan, Quetta, Pakistan Faiz Ullah Khan Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy; Center for Drug Safety and Policy Research, Xi’an Jiaotong University; Shaanxi Center for Health Reform and Development Research; Research Institute for Drug Safety and Monitoring, Institute of Pharmaceutical Science and Technology, Western China Science & Technology Innovation Harbor, Xi’an, China Hafeez Ullah Khan Department of Pharmaceutics, College of Pharmacy, University of Sargodha, Sargodha, Pakistan Yusra Habib Khan Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka, Saudi Arabia Tauqeer Hussain Mallhi Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka, Saudi Arabia Albaraa M. Marran Department of Pharmaceutical Care, Prince Mohammed Bin Nasser Hospital, Jizan, Saudi Arabia

Contributors

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Faizan Mazhar Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden Long Chiau Ming PAP Rashidah Sa’adatul Bolkiah Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei Darussalam Gouri Nair Department of Pharmacology, Faculty of Pharmacy, Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India Mohamed Rashrash Department of Pharmaceutical and Administrative Sciences, School of Pharmacy, University of Charleston, Charleston, WV, United States Akhtar Rasul Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Government College University, Faisalabad, Pakistan Malik Saadullah Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, Government College University, Faisalabad, Pakistan Suhila Sawesi Health Informatics and Bioinformatics Graduate Program, School of Computing, Grand Valley State University, Grand Rapids, MI, United States Shelley Schliesser Department of Pharmacy Practice, School of Pharmacy, University of Charleston, Charleston, WV, United States Muhammad Abid Shah Aga Khan University Hospital, Karachi, Pakistan Shahid Shah Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Government College University, Faisalabad, Pakistan Aina M. Shaju Department of Pharmacy Practice, Faculty of Pharmacy, Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India Aymen Shatnawi Department of Drug Discovery and Biomedical Sciences, College of Pharmacy, Medical University of South Carolina, Charleston, SC, United States Abubakar Siddique Uniazah College of Pharmacy, Qassim University, Buraydah, Saudi Arabia Viswam Subeesh Department of Pharmacy Practice, Faculty of Pharmacy, Ramaiah University of Applied Sciences, Bengaluru; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Udupi, Karnataka, India Syed Azhar Syed Sulaiman Advanced Medical and Dental Institute, Universiti Sains Malaysia (USM), George Town, Penang, Malaysia

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Contributors

Beulah Elsa Thomas Sparsh Hospital, Bengaluru, Karnataka, India Wasim Ullah Department of Pharmacy Practice, Faculty of Pharmaceutical and Allied Health Sciences, Shifa Tameer-e-Millat University, Islamabad, Pakistan Farman Ullah Khan Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy; Center for Drug Safety and Policy Research, Xi’an Jiaotong University; Shaanxi Center for Health Reform and Development Research; Research Institute for Drug Safety and Monitoring, Institute of Pharmaceutical Science and Technology, Western China Science & Technology Innovation Harbor, Xi’an, China

Preface

Adverse drug reactions (ADRs), medication errors, drug-related problems (DRPs), drug abuse and misuse, and inappropriate use of antibiotics are examples of medication safety issues, which affect patients, families, and ministries of health worldwide. They lead to not achieving the treatment outcomes, increase the length of hospitalization, increase the morbidity and mortality, affect quality of life, and increase the cost of illness and health expenditure. Healthcare professionals are the cornerstones in improving medication safety practices in developed and developing countries. It is very important and highly recommended to equip future healthcare professionals with all competencies during their studies including training. Real-time and simulation case studies are effective teaching strategies to achieve the learning outcomes of medical and health sciences programs and develop competent healthcare professionals with the necessary knowledge and skills. Clinical Case Studies on Medication Safety provides real and simulated scenarios about safety issues related to medication safety such as ADRs, medication errors, DRPs, among others. With over 150 case studies, this book will help medical and health sciences educators, students, healthcare professionals, and others to apply their knowledge and skills to solve cases related to medication safety issues for better patient care. Yaser Mohammed Al-Worafi

Acknowledgments

It would have been difficult to write such a book without the help of: My wife, who provided me the time and support to work on the book, even though it meant spending less time with the family. Susan Ikeda and Kristi Anderson, who provided valuable guidance and advice during the writing of this book.

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

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Yaser Mohammed Al-Worafia,b a College of Pharmacy, University of Science and Technology of Fujairah, Fujairah, United Arab Emirates, bCollege of Medical Sciences, Azal University for Human Development, Sana’a, Yemen

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 Clinical Case Studies on Medication Safety. https://doi.org/10.1016/B978-0-323-98802-5.00004-2 Copyright © 2023 Elsevier Inc. All rights reserved.

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Clinical Case Studies on Medication Safety

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.

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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

Introduction to the medication safety and clinical case studies

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22. Antibiotics Safety Case Studies: Hospitals 23. Vaccines Safety Case Studies

References Al-Worafi, Y. M. (Ed.). (2020a). Drug safety in developing countries: Achievements and challenges Academic Press. Al-Worafi, Y. M. (2020b). Drug safety in developing versus developed countries. In Drug safety in developing countries (pp. 613–615). Academic Press. The Institute for Safe Medication Practices Canada. (2007). https://www.ismp-canada.org/. World Health Organization. (2002). The importance of pharmacovigilance. World Health Organization. (2004). Pharmacovigilance: Ensuring the safe use of medicines (No. WHO/EDM/2004.8). Geneva: World Health Organization.

Adverse drug reactions (ADRs) case studies: Mild ADRs

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Yaser Mohammed Al-Worafia,b, Long Chiau Mingc, Abdullah Ahmed Dhabalid,e, Abdulkareem Mohammed Al-Shamif,g, and Ammar Ali Saleh Jaberh a College of Pharmacy, University of Science and Technology of Fujairah, Fujairah, United Arab Emirates, bCollege of Medical Sciences, Azal University for Human Development, Sana’a, Yemen, cPAP Rashidah Sa’adatul Bolkiah Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei Darussalam, dFaculty of Pharmacy, Sana’a University, Sana’a, Yemen, eSchool of Clinical Pharmacy, Lebanese International University, Sana’a, Yemen, fKulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Pahang, Malaysia, gFaculty of Pharmacy, PICOMS International University College, Kuala Lumpur, Malaysia, hDubai Pharmacy College for Girls, Dubai, United Arab Emirates

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). Clinical Case Studies on Medication Safety. https://doi.org/10.1016/B978-0-323-98802-5.00008-X Copyright © 2023 Elsevier Inc. All rights reserved.

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Clinical Case Studies on Medication Safety

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,

Adverse drug reactions (ADRs) case studies: Mild ADRs

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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

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Clinical Case Studies on Medication Safety

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: l

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“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

Adverse drug reactions (ADRs) case studies: Mild ADRs

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▪ 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. l

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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

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Clinical Case Studies on Medication Safety

Social History l

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Married with four children Primary school teacher Smoker X 20 years Exercise once to twice monthly

Allergies NKDA Physical Examination Vital signs General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared generally well 145/90 mmHg 101 bpm Not measured °C 37 (Normal) NA NA NA NA NA NA NA NA

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.

Adverse drug reactions (ADRs) case studies: Mild ADRs

Medication safety name Medication safety potential causes Management

Literature review

Recommendations

11

Mild adverse drug reactions Metformin There are many approaches to prevent/minimize this adverse drug reaction such as: Take the metformin during meals or immediately after meals. Start metformin with a low dose and increase it gradually. Change dosage form to a metformin extended-release formulation Type 2 diabetes mellitus is a common disease worldwide, management of type 2 diabetes mellitus requires nonpharmacological and pharmacological interventions. Metformin is a first-line pharmacological treatment for patients with type 2 diabetes mellitus; however, there are many potential adverse reactions/effects including nausea. Nausea may limit metformin use in some patients. Extended-release metformin improves GI tolerability ( Jabbour & Ziring, 2011). Pharmacists play/can play an important role in medication safety including improving adherence to nonpharmacological and pharmacological interventions, preventing/minimizing the potential drug-related problems including adverse drug reactions and treating the actual drug-related problems including adverse drug reactions. Appropriate and effective patient education and counseling by pharmacists is the key to achieving the desired outcomes for treating patients including the clinical, economical and humanistic outcomes. Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due to any reason, pharmacists can manage them such as in this case: there are many approaches to manage the adverse reaction such as change the dosage form. There are many drug-related problems in this case such as patient blood pressure still high, pharmacists can conduct medication review & medication therapy management and contribute effectively to suggest a pharmacist care plan which helps patient to achieve the desired outcome.

Case 2. Case of vomiting—Amoxicillin/clavulanate Patient data Age: 8 years. Gender: Male. Weight: 25 kg Chief Complaint Vomiting

Height: 1.23 m

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Clinical Case Studies on Medication Safety

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 General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared Tired-looking and uncomfortable NA NA Not measured °C 38 NA NA NA NA NA NA NA NA

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

Adverse drug reactions (ADRs) case studies: Mild ADRs

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Case discussion and medication safety issue analysis The patient was diagnosed with otitis media. He had vomiting occurred after taking amoxicillin-clavulanate. Medication safety name Medication safety potential causes Management

Literature review

Recommendations

Mild adverse drug reactions amoxicillin-clavulanate. Stop amoxicillin-clavulanate. Change amoxicillin-clavulanate to ceftriaxone intramuscular injection. Children with acute otitis media usually present with symptoms such as ear pain, rubbing of the ear, fever, irritability, crying, poor feeding, restlessness at night, cough, or rhinorrhea. Symptoms usually resolve within 3–7 days without antibacterial drugs. However, antibiotics can be prescribed for children with otitis media if the child is systemically very unwell, has signs or symptoms of a more serious illness, or is at high risk of complications. Amoxicillin-clavulanate dose for otitis media is depending on the weight and it is usually very high, which could affect the adherence (Lieberthal et al., 2013) Vomiting is among the reasons that affect adherence to the prescribed regimens, pharmacists play/can play an important role in medication safety including improving adherence to nonpharmacological and pharmacological interventions, preventing/minimizing the potential drug-related problems including adverse drug reactions and treating the actual drugrelated problems including adverse drug reactions. Appropriate and effective patient education and counseling by pharmacists is the key to achieving the desired outcomes for treating patients including the clinical, economical and humanistic outcomes. Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due to any reason, pharmacists can manage them such as in this case by stopping the medication and changing it to another medication will not cause vomiting.

Case 3. Case of ankle edema—Amlodipine Patient data Age: 53 years. Gender: Male. Weight: 84 kg, Chief Complaint Ankle edema

Height: 1.68 m

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Clinical Case Studies on Medication Safety

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 l

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Married with three children Lecturer Lack of exercise Smoker X 30 years

Allergies NKDA Physical Examination General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared generally well 147/85 mmHg 103 bpm 20 bpm °C 37 Normal, intact, warm, and dry Normal Normal Normal Normal Normal Ankle edema No problem was reported by patient

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%

Adverse drug reactions (ADRs) case studies: Mild ADRs

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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.

Medication safety name Medication safety potential causes Management

Literature review

Recommendations

Mild adverse drug reactions Amlodipine There are many approaches to prevent/minimize this adverse drug reaction such as: Decrease the dose of medication. Change the medication to another medication Hypertension is a common disease worldwide, management of hypertension requires nonpharmacological and pharmacological interventions. Amlodipine is a calcium channel blocker medication and can be prescribed for treating hypertension either alone or with other medications. Calcium channel blockers induced edema is caused by “increased capillary hydrostatic pressure that results from preferential dilation of precapillary vessels” (De la Sierra, 2009). Decreasing the dose of Calcium channel blockers could solve the problem, treat patients with hypertension with a low dose then increase it gradually can solve the problem. Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) cause postcapillary dilation and normalize hydrostatic pressure, and are thus ideally suited for the prevention/reversal of CCB-induced edema (De la Sierra, 2009). Selecting the appropriate medications for treating patients with hypertension is very important, moreover, monitoring the efficacy and safety of medications, especially at the beginning of treatment is very important and the key to achieving the desired outcomes. Appropriate and effective patient education and counseling is the key to achieving the desired outcomes for treating patients with hypertension including the clinical, economical and humanistic outcomes. Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due for any reason, therefore, identifying the potential causes is the key of manage them. There are many approaches for managing adverse drug reactions including stopping the medication, decreasing the dose and others, selecting the appropriate intervention can be different from one patient to another.

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Clinical Case Studies on Medication Safety

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 l

l

l

l

Married Accountant Exercise weekly for 1 h Nonsmoker

Allergies NKDA Physical Examination General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared generally well 128/80 mmHg 87 bpm Not measured °C 37 Normal Normal Normal Normal Normal Normal Normal No problem was reported by the patient

Laboratory findings Complete blood count NA Kidney function and electrolyte tests NA

Adverse drug reactions (ADRs) case studies: Mild ADRs

17

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.

Medication safety name Medication safety potential causes Management Literature review

Recommendations

Mild adverse drug reactions sildenafil Paracetamol 500 mg (One or two tablets) could relieve the headache. About 25% of patients who are prescribed sildenafil, the phosphodiesterase type 5 (PDE-5) inhibitor, for erectile dysfunction (ED) experience headaches (Moreira et al., 2000). Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due for any reason, therefore, identifying the potential causes is the key of manage them. There are many approaches for managing adverse drug reactions including stopping the medication, decreasing the dose and others, selecting the appropriate intervention can be different from one patient to another. In this case, dispensing analgesics is the option to relieve the adverse effect of medication. The rationality of sildenafil for this patient was not assessed, the patient sildenafil based on his friend’s suggestion, which could not be a rationale for him. Assessing the patient’s needs at the time of prescribing and medication dispensing is very important to ensure that there is a rationality for taking medications.

Case 5. Case of constipation—Iron Patient data Age: 28 years. Gender: Female.

Weight: 58 kg,

Height: 1.59 m

18

Clinical Case Studies on Medication Safety

Chief Complaint Constipation History of Present Illness A 28-year-old woman presented to the community pharmacy with constipation. She stated that constipation started after taking iron and folic acid supplementations for her anemia. She was diagnosed with anemia 1 month ago. Past Medical History Anemia Past Medications History Folic acid (The dose was not reported) Iron supplementation (The dose was not reported) Family History Not significant for any disease Social History l

l

Married School teacher

Allergies NKDA Physical Examination

General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared generally well 118/80 mmHg 85 bpm Not measured °C 37 Normal Normal Normal Normal Normal Normal Normal No problem was reported by the patient

Laboratory findings Complete blood count Significant for low hemoglobin and hematocrit. Kidney function and electrolyte tests NA Liver function tests NA Lipid profile NA Cardio enzymes tests NA

Adverse drug reactions (ADRs) case studies: Mild ADRs

19

Endocrine tests Within normal limits Other investigations None. Case discussion and medication safety issue analysis The patient was diagnosed with anemia. She was suffering from constipation. There are many potential causes of constipation; however, the patient reported that her constipation occurred after taking anemia medications.

Medication safety name Medication safety potential causes Management

Literature review

Recommendations

Mild adverse drug reactions Iron supplementation There are many approaches to prevent/minimize this adverse drug reaction such as: Decrease the dose of medication. Change the dosage form to intravenous iron preparations Take laxative preparations such as lactulose oral solution or glycerin suppositories. Iron deficiency anemia (IDA) is a worldwide healthcare problem affecting approximately 25% of the global population. The most common IDA treatment is oral iron supplementation, which has been associated with gastrointestinal (GI) side effects such as constipation and bloating. These can result in treatment nonadherence and the persistence of IDA. Intravenous iron does not cause GI side effects, which may be due to the lack of exposure to the intestinal lumen (Bloor, Schutte, & Hobson, 2021). Selecting the appropriate dose and dosage form medications for treating patients with anemia is very important, moreover, monitoring the efficacy and safety of medications, especially at the beginning of treatment is very important and the key to achieving the desired outcomes. Appropriate and effective patient education and counseling is the key to achieving the desired outcomes for treating patients with anemia including the clinical, economical and humanistic outcomes. Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due for any reason, therefore, identifying the potential causes is the key of manage them. There are many approaches for managing adverse drug reactions including stopping the medication, decreasing the dose and others, selecting the appropriate intervention can be different from one patient to another.

20

Clinical Case Studies on Medication Safety

Case 6. Case of diarrhea—Amoxicillin Case summary Patient data Age: 22 years. Gender: Female. Weight: 68 kg, Height: 1.61 m Chief Complaint Diarrhea History of Present Illness A 22-year-old woman suffered from diarrhea. She stated that diarrhea started after taking amoxicillin for her respiratory infection. Past Medical History Not significant for any disease Past Medications History NA Family History Father with diabetes mellitus and hypertension Social History l

l

Single Student

Allergies NKDA Physical Examination General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared generally well 120/80 mmHg 87 bpm Not measured °C 37 Normal Normal Normal Normal Normal Normal Normal No problem was reported by the patient

Laboratory findings Complete blood count Significant for increasing white blood cells Kidney function and electrolyte tests Within normal limits Liver function tests NA Lipid profile NA

Adverse drug reactions (ADRs) case studies: Mild ADRs

21

Cardio enzymes tests NA Endocrine tests Within normal limits Other investigations None. Case discussion and medication safety issue analysis The patient was diagnosed with a respiratory infection. She was suffering from diarrhea. There are many potential causes of diarrhea; however, the patient reported that her diarrhea occurred after taking amoxicillin. Medication safety name Medication safety potential causes Management

Literature review

Recommendations

Mild adverse drug reactions amoxicillin There are many approaches to prevent/minimize this adverse drug reaction such as: Change the medication to amoxicillin-clavulanate Drink enough fluids Consider drinking oral rehydration solution Antidiarrheal medications such as loperamide Diarrhea is a common adverse effect of antibiotic treatments. Antibiotic-associated diarrhea occurs in about 5%–30% of patients either early during antibiotic therapy or up to 2 months after the end of the treatment. The frequency of antibioticassociated diarrhea depends on the definition of diarrhea, the inciting antimicrobial agents, and host factors. Almost all antibiotics, particularly those that act on anaerobes, can cause diarrhea, but the risk is higher with aminopenicillins, a combination of aminopenicillins and clavulanate, cephalosporins, and clindamycin. Selecting the appropriate dose and dosage form medications for treating patients with anemia is very important, moreover, monitoring the efficacy and safety of medications, especially at the beginning of treatment is very important and the key to achieving the desired outcomes. Appropriate and effective patient education and counseling is the key to achieving the desired outcomes for treating patients with anemia including the clinical, economical and humanistic outcomes. Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due for any reason, therefore, identifying the potential causes is the key of manage them. There are many approaches for managing adverse drug reactions including stopping the medication, decreasing the dose and others, selecting the appropriate intervention can be different from one patient to another.

22

Clinical Case Studies on Medication Safety

Case 7. Case of stomach pain—Ibuprofen Patient data Age: 61 years. Gender: Male. Weight: 83 kg, Height: 1.75 m Chief Complaint Stomach pain History of Present Illness A 61-year-old man presented to the emergency department with a 2-day history of stomach pain. He stated that his pain started 2 days ago. He was diagnosed with chronic lower back pain 3 months ago and took ibuprofen for his pain. Past Medical History Hypertension for 10 years Diabetes mellitus for 10 years Dyslipidemia for 10 years Lower back pain 3 months ago Past Medications History Metformin 1000 mg twice daily Glibenclamide 5 mg once daily Simvastatin 20 mg daily Perindopril/indapamide (Dose not reported) Ibuprofen 400 mg three times daily Family History Father and mother with diabetes mellitus and hypertension. He has one son and two daughters, and they are in good health, and they don’t have any significant diseases. Social History l

l

l

Married Businessman Smoker X 35 years

Allergies NKDA Physical Examination Vital signs General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared generally well 138/85 mmHg 95 bpm 25 bpm °C 37 (Normal) Normal Normal Normal Normal Stomach pain Normal Normal Normal

Adverse drug reactions (ADRs) case studies: Mild ADRs

23

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 Within normal limits. Other investigations None. Case discussion and medication safety issue analysis The patient was diagnosed with lower back pain. He had stomach pain. There are many potential causes of stomach pain. Medication safety name Medication safety potential causes Management

Literature review

Recommendations

Mild adverse drug reactions Ibuprofen There are many approaches to prevent/minimize this adverse drug reaction such as: Take the ibuprofen during meals or immediately after meals. Proton pump inhibitors such as omeprazole or esomeprazole can relieve stomach pain. Changing it to another pain killer can help also. Try another analgesic with a different dosage form such as gels, creams, etc. Ibuprofen is one of the most common over-the-counter (OTC) medications used to treat pain, Ibuprofen risks for developing adverse drug reactions is low and affected by many factors such as patient age, dose, duration and other factors (Rainsford, 2009). Pharmacists play/can play an important role in medication safety including improving adherence to nonpharmacological and pharmacological interventions, preventing/minimizing the potential drug-related problems including adverse drug reactions and treating the actual drug-related problems including adverse drug reactions. Appropriate and effective patient education and counseling by pharmacists is the key to achieving the desired outcomes for treating patients including the clinical, economical and humanistic outcomes. Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize Continued

24

Clinical Case Studies on Medication Safety

them or prevent them. However, if they occur due to any reason, pharmacists can manage them such as in this case: there are many approaches to manage the adverse reaction such as changing the dosage form, add another medication to treat the ADR and other interventions.

Case 8. Case of skin burning and reddened—Salicylic acid Patient data Age: 31 years. Gender: Male. Weight: 83 kg, Height: 1.81 m Chief Complaint Skin burning and reddened History of Present Illness A 31-year-old man presented at the community pharmacy looking for medication for the burning and reddened. He stated that he used the salicylic acid solution for his finger’s warts. Past Medical History Not significant for any diseases. Past Medications History NA Family History Parents are in good health, and they don’t have any significant diseases. Social History l

l

l

l

Married Lawyer Swim for 2–3 h weekly Nonsmoker

Allergies NKDA Physical Examination General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared generally well 125/80 mmHg 70 bpm Not measured °C 37 Normal Normal Normal Normal Normal Normal Normal No problem was reported by the patient

Adverse drug reactions (ADRs) case studies: Mild ADRs

25

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 skin burning and reddened. He reported that his fingers were affected after applying the salicylic acid solution to his warts.

Medication safety name Medication safety potential causes Management

Recommendations

Mild adverse drug reactions salicylic acid solution Ask the patients about he was using this solution for his warts and educate him about the correct use. Change the dosage form to another dosage form. Treat the skin burning and reddened with antihistamine, corticosteroid and other treatments depends on the case. Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due for any reason, therefore, identifying the potential causes is the key of manage them. There are many approaches for managing adverse drug reactions including stopping the medication, decreasing the dose and others, selecting the appropriate intervention can be different from one patient to another. In this case, treat the ADR is very important, educate the patient about the appropriate use of his medication and change the dosage form can prevent it in the future.

Case 9. Case of muscle pain—Statin Patient data Age: 66 years. Gender: Male. Weight: 71 kg,

Height: 1.75 m

26

Clinical Case Studies on Medication Safety

Chief Complaint Muscle pain History of Present Illness A 66-year-old man visited the family physician complaining of muscle pain. He stated that the muscle pain started within 1 month after starting the new medication (statin) and continues to worsen. He was diagnosed with hyperlipidemia 4 months ago. Past Medical History Hypertension for 15 years Diabetes mellitus for 10 years Hyperlipidemia for 4 months Past Medications History Captopril 25 mg twice daily Metformin 750 mg twice daily Atorvastatin 20 mg once daily Family History Father with diabetes mellitus, hypertension, and hyperlipidemia Mother with hypertension and diabetes mellitus Five children, healthy and not significant for any disease Social History l

l

l

l

Married with five children Engineer Lack of exercise Smoker X 40 years

Allergies NKDA Physical Examination General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared generally well 135/87 mmHg 96 bpm 25 bpm °C 37 Normal and dry Normal Normal Normal Normal Normal Normal Normal

Laboratory findings Complete blood count Within normal limits Kidney function and electrolyte tests Within normal limits

Adverse drug reactions (ADRs) case studies: Mild ADRs

27

Liver function tests Within normal limits Lipid profile Within normal limits Cardio enzymes tests Within normal limits Endocrine tests Within normal limits except for HbA1c Other investigations None. Case discussion and medication safety issue analysis The patient was diagnosed with hyperlipidemia. He was suffering from muscle pain. There are many potential causes of muscle pain; however, the patient reported that the muscle pain started within 1 month after starting the new medication (statin) and continues to worsen. He was diagnosed with hyperlipidemia 4 months ago.

Medication safety name Medication safety potential causes Management

Literature review

Recommendations

Mild adverse drug reactions Atorvastatin There are many approaches to prevent/minimize this adverse drug reaction such as: Decrease the dose of medication and increase it after few months if needed. Try another type of statin Educate the patient about the appropriate time of taking statin (bedtime) can reduce the mild muscle pain Exercise regularly before taking statins are less likely to experience muscle pain Check if the patient has a low blood level of vitamin D, restoring it to normal with a supplement may help reduce muscle pain. Statins remain among the most frequently prescribed drugs and constitute a cornerstone in the prevention of cardiovascular disease. However, muscle symptoms are often reported from patients on statins. Muscle symptoms are frequently reported as adverse events associated with statin therapy (Pergolizzi et al., 2020). Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due for any reason, therefore, identifying the potential causes is the key of manage them. There are many approaches for managing adverse drug reactions including stopping the medication, decreasing the Continued

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Clinical Case Studies on Medication Safety

dose and others, selecting the appropriate intervention can be different from one patient to another. In this case, treat the ADR is very important, educate the patient about the appropriate time to use of his medication can prevent it in the future. Decrease the dose of medication and increase it after few months if needed can prevent this ADR in the future

Case 10. Case of skin dryness—Isotretinoin Case summary Patient data Age: 18 years. Gender: Female. Weight: 64 kg, Height: 1.65 m Chief Complaint skin dryness History of Present Illness An 18-year-old woman suffered from skin dryness. She stated that this occurs after taking isotretinoin tablets for her acne. Past Medical History Not significant for any disease Past Medications History NA Family History Father with hypertension Social History l

l

Single Student

Allergies NKDA Physical Examination

General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

The patient appeared generally well 122/80 mmHg 80 bpm Not measured °C 37 Dryness Normal Normal Normal Normal Normal Normal No problem was reported by the patient

Adverse drug reactions (ADRs) case studies: Mild ADRs

29

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 diagnosed with acne. She was suffering from skin dryness. There are many potential causes of skin dryness; however, the patient reported that the skin dryness occurred after taking acne medication. Medication safety name Medication safety potential causes Management

Literature review

Recommendations

Mild adverse drug reactions Isotretinoin Use moisturizers Check the appropriateness of the dose, decrease it if needed is another option. Isotretinoin is an oral prescription medication that affects sebaceous glands and is used to treat severe acne. The drug was approved by the US Food and Drug Administration (FDA) in 1982 to treat severe, resistant, nodular acne that is unresponsive to conventional therapy, including systemic antibiotics. However, there are many adverse effects could happen as a result of taking this medication such as skin dryness (McLane, 2001) Adverse drug reactions (ADRs), especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due for any reason, therefore, identifying the potential causes is the key of manage them. There are many approaches for managing adverse drug reactions including stopping the medication, decreasing the dose, treat the adverse reactions and others, selecting the appropriate intervention can be different from one patient to another. In this case, treat the adverse effect, which was skin dryness is an option. Check the appropriateness of the dose, decrease it if needed is another option.

30

3.

Clinical Case Studies on Medication Safety

Conclusion

This chapter has discussed the ADRs, mild ADRs and provided real cases about the mild ADRs with its management and recommendations. ADRs, especially mild ADRs can be prevented/minimized at the time of dispensing medications by educating patients about them and how they can minimize them or prevent them. However, if they occur due to any reason, therefore, identifying the potential causes is the key to manage them. There are many approaches for managing adverse drug reactions including stopping the medication, decreasing the dose, treating the adverse reactions and others, selecting the appropriate intervention can be different from one patient to another.

4.

Educational resources

Schwinghammer, T. L., and Koehler, J. (2009). Pharmacotherapy casebook: A Patient-Focused Approach, 7e McGraw-Hill Professional Publishing. Al-Worafi, Y. M. (Ed.). (2020). Drug Safety in Developing Countries: Achievements and Challenges. Academic Press. Pharmacotherapy: A Pathophysiologic Approach, 11 ed. Joseph T. DiPiro, Gary C. Yee, L. Michael Posey, Stuart T. Haines, Thomas D. Nolin, Vicki Ellingrod

Abbreviations Abd BP BPM CV Gen Genit/Rect HEENT HR Ht MS/Ext Neuro RR T VS Wt

abdomen blood pressure breaths per minute cardiovascular general appearance genitalia/rectal head, eyes, ears, nose, and throat heart rate height musculoskeletal and extremities neurologic respiratory rate temperature vital signs—blood pressure, pulse, respiratory rate, and temperature. weight

References Alomar, M. J. (2014). Factors affecting the development of adverse drug reactions. Saudi Pharmaceutical Journal, 22(2), 83–94. Al-Worafi, Y. M. (Ed.). (2020a). Drug safety in developing countries: Achievements and challenges Academic Press.

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Al-Worafi, Y. M. (2020b). Drug safety in developing versus developed countries. In Drug safety in developing countries (pp. 613–615). Academic Press. Al-Worafi, Y. M. (2020c). Medications safety-related terminology. In Drug safety in developing countries (pp. 7–19). Academic Press. Al-Worafi, Y. M. (2020d). Adverse drug reactions. In Drug safety in developing countries (pp. 39–57). Academic Press. American Society of Health-System Pharmacists. (1995). ASHP guidelines on adverse drug reaction monitoring and reporting. American Society of Hospital Pharmacy. American Journal of Health-System Pharmacy, 52(4), 417–419. Bates, D. W., Cullen, D. J., Laird, N., Petersen, L. A., Small, S. D., Servi, D., et al. (1995). Incidence of adverse drug events and potential adverse drug events: Implications for prevention. JAMA, 274(1), 29–34. Bloor, S. R., Schutte, R., & Hobson, A. R. (2021). Oral iron supplementation—Gastrointestinal side effects and the impact on the gut microbiota. Microbiology Research, 12(2), 491–502. Cobert, B. L., & Biron, P. (2001). Pharmaco-vigilance from A to Z: Adverse drug event surveillance. Wiley-Blackwell. De la Sierra, A. (2009). Mitigation of calcium channel blocker-related oedema in hypertension by antagonists of the renin–angiotensin system. Journal of Human Hypertension, 23(8), 503–511. Edwards, I. R., & Aronson, J. K. (2000). Adverse drug reactions: Definitions, diagnosis, and management. The Lancet, 356(9237), 1255–1259. Jabbour, S., & Ziring, B. (2011). Advantages of extended-release metformin in patients with type 2 diabetes mellitus. Postgraduate Medicine, 123(1), 15–23. Lieberthal, A. S., Carroll, A. E., Chonmaitree, T., Ganiats, T. G., Hoberman, A., Jackson, M. A., et al. (2013). The diagnosis and management of acute otitis media. Pediatrics, 131(3), e964–e999. McLane, J. (2001). Analysis of common side effects of isotretinoin. Journal of the American Academy of Dermatology, 45(5), S188–S194. Moreira, S. G., Jr., Brannigan, R. E., Spitz, A., Orejuela, F. J., Lipshultz, L. I., & Kim, E. D. (2000). Side-effect profile of sildenafil citrate (Viagra) in clinical practice. Urology, 56(3), 474–476. MSD. (2019). https://www.msdmanuals.com/home/drugs/adverse-drug-reactions/severity-ofadverse-drug-reactions. Nebeker, J. R., Barach, P., & Samore, M. H. (2004). Clarifying adverse drug events: A clinician’s guide to terminology, documentation, and reporting. Annals of Internal Medicine, 140(10), 795–801. Pergolizzi, J. V., Jr., Coluzzi, F., Colucci, R. D., Olsson, H., LeQuang, J. A., Al-Saadi, J., et al. (2020). Statins and muscle pain. Expert Review of Clinical Pharmacology, 13(3), 299–310. Rainsford, K. D. (2009). Ibuprofen: Pharmacology, efficacy and safety. Inflammopharmacology, 17(6), 275–342. Schwinghammer, T. L., & Koehler, J. (2009). Pharmacotherapy casebook: A patient-focused approach (7th ed.). McGraw-Hill Professional Publishing. World Health Organization. (1969). International drug monitoring: The role of the hospital: Report of a WHO meeting. WHO. World Health Organization (WHO). (2002). The importance of pharmacovigilance. World Health Organization (WHO). (2007). Session 4. Assessing and managing medicine safety. http://origin.who.int/medicines/technical_briefing/tbs/04-PG_Dug-Safety_final08.pdf.

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Further Reading Barbut, F., & Meynard, J. L. (2002). Managing antibiotic associated diarrhoea: Probiotics may help in prevention. BMJ, 324(7350), 1345–1346. Vervloet, D., & Durham, S. (1998). Adverse reactions to drugs. BMJ, 316(7143), 1511–1514.

Adverse drug reactions (ADRs) case studies: Moderate ADRs

3

Mohamed Rashrasha, Shelley Schliesserb, Aymen Shatnawic, Suhila Sawesid, and Qusai Al-Sharee a Department of Pharmaceutical and Administrative Sciences, School of Pharmacy, University of Charleston, Charleston, WV, United States, bDepartment of Pharmacy Practice, School of Pharmacy, University of Charleston, Charleston, WV, United States, cDepartment of Drug Discovery and Biomedical Sciences, College of Pharmacy, Medical University of South Carolina, Charleston, SC, United States, dHealth Informatics and Bioinformatics Graduate Program, School of Computing, Grand Valley State University, Grand Rapids, MI, United States, eDepartment of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan

1.

Background

The World Health Organization (WHO) defines an adverse drug reaction (ADR) as “A noxious and unintended reaction that occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or the modification of physiological function.” (World Health Organization, 1969). Adverse drug events are considered among the major burdens in the healthcare system as they are major reasons for hospital admissions. About 3%–5% of all hospital admissions are due to adverse drug events (Einarson, 1993; Moore, Lecointre, Noblet, & Mabille, 1998). Approximately 5%–8% of patients in hospitals could suffer from serious ADRs, and about one-tenth of in-hospital costs are attributed to ADRs (Lazarou, Pomeranz, & Corey, 1998; Moore et al., 1998). People at high risk of ADRs are those who are very young, old, female, those who have a history of ADRs, those who do not take their medication as prescribed, those who take multiple medications, those who have comorbidities, those who suffer from chronic diseases such as asthma, diabetes, anemia, congestive heart failure, those who have genetic factors relative to deficiency of enzymes, and those who have changes in organ functions such as renal and hepatic dysfunctions (Leape et al., 1991). The most frequent classes of drugs responsible for ADRs include antibiotics, antitumor agents, anticoagulants, cardiovascular agents, anticonvulsants, hypoglycemic agents, antihypertensive, analgesics, antiasthma agents, sedative hypnotics, antidepressants, and antipsychotics. The least frequent class involves antiulcer agents (Leape et al., 1991).

Clinical Case Studies on Medication Safety. https://doi.org/10.1016/B978-0-323-98802-5.00005-4 Copyright © 2023 Elsevier Inc. All rights reserved.

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Clinical Case Studies on Medication Safety

Common causes of medicine-related deaths include gastrointestinal (GI) hemorrhage or ulceration caused by corticosteroids, aspirin, nonsteroidal antiinflammatory diseases (NSAIDs), and anticoagulants. Warfarin and cytotoxic drugs can cause other types of lethal hemorrhages. Aplastic anemia is caused by chloramphenicol, gold, tricyclic antidepressants (TCAs), sulfonamides, and cytotoxic drugs. Hepatic damage can be caused by chlorpromazine, isoniazid, flucloxacillin, and amoxicillin/ clavulanate. Renal failure can be caused by analgesics, amino glycosides, cephalosporin, angiotensin-converting enzyme (ACE) inhibitors. Certain kinds of infections can be caused by corticosteroids, cytotoxic, and immunosuppressive agents. Pseudo membranous colitis can be caused by most antibiotics, particularly lincosamides, cephalosporin (Leape et al., 1991; Pirmohamed et al., 2004). Medicine-disease interactions include arrhythmias that interact with phenothiazines, TCAs, cisapride, fluoroquinolone antibiotics, erythromycin, and clarithromycin. Asthma can interact with beta-blockers, aspirin, and other NSAIDs. Mature onset diabetes might interact with corticosteroids, thiazides, beta-blockers. Peptic ulcer disease can interact with aspirin, NSAIDs, corticosteroids, potassium chloride. Finally, anticholinergics and TCAs may interact with glaucoma (Abhinav Kant, 2013; Leape et al., 1991; Lindblad et al., 2006; Lynch, 2019). Common adverse effects caused by medications may include all the following: Confusion may be caused by anti-Parkinson agents, benzodiazepines, cimetidine, diuretics, hypoglycemic, opioids, phenothiazines, and TCAs. Constipation can be caused by antacids (aluminum (Al), calcium (Ca)), anticholinergics, opioids, phenothiazines, TCAs, and verapamil. Falls can be caused by anticonvulsants, antihypertensive, antiParkinson agents, TCAs, benzodiazepines, and fluoroquinolone antibiotics. Shortness of breath for heart failure patients may be caused by beta-blockers, calcium-channel blockers, digoxin, ACE inhibitors, and excessive sodium intake (Leape et al., 1991; Woo et al., 2020). Long duration of therapy can also increase the risk of ADRs such as the use of antibiotics for more than 30 days (bacterial resistance), Urinary alkalizer for more than 60 days can lead to hypernatremia and systemic alkalosis. Benzodiazepines use for more than 30 days can cause dependence, withdrawal effect, memory impairment, and risk of falls in older persons. Antiemetics use for more than 28 days, such as prochlorperazine, can lead to tardive dyskinesia (TD) and parkinsonism, while metoclopramide can cause extra pyramidal effects and TD. Eventually, major tranquilizers use for more than 90 days can cause depression, personality disorders, or the risk of TD (Abhinav Kant, 2013; Hacker, 2009; Leape et al., 1991).

Classifications of adverse drug reactions Adverse drug reaction can be classified based on the frequency of incidence, probability of occurrence, and the severity of the reactions.

Moderate ADRs case studies

35

Frequency of incidence, in which the ADR can be very common when the frequency is more than or equal to 1/10; common (frequent) when the frequency is less than 1/10 but more than or equal 1/100; uncommon (infrequent) when the frequency is less than 1/100 but more than or equal to 1/1000; rare when the frequency is less than 1/1000 but more than or equal to 1/10,000; and very rare when the frequency is less than 1/10,000 (Neubert et al., 2013). Probability of happening, in which the ADR assessed based on Naranjo Score (LiverTox, 2012). Definite ADR, when the reaction scores more than or equal to 9, probable ADR, when the score is between 5 and 8, possible ADR, when the score range from 1 to 4, and doubtful ADR, when the score is less than or equal to 0 (LiverTox, 2012). Severity of reactions—“the main focus of this chapter,” in which the adverse reaction can be mild, which means the ADR can be bothersome but requires no change in therapy, moderate reaction when it requires a change in treatment, additional treatment, hospitalization, or serious ADR, which includes any untoward effect that at any dose results in death, is life-threatening, requires inpatient hospitalization, and needs prolongation of existing hospitalization, results in persistent or significant disability, or results in a congenital abnormality. This chapter focuses on moderate ADRs only (Edwards, 2012).

Management of adverse drug reactions Management of ADRs can be done according to the type of reaction. For example, dose-related reactions can be managed by decreasing the dose and therapeutic monitoring to adjust the drug dose if needed, such as lithium, theophylline, digoxin, warfarin, or even stopping the drug. Nondose-related reactions such as hypersensitivity reactions and autoimmune reactions can be managed by stopping the drug and establishing a drug avoid list to prevent the recurrence of the ADR (Leape et al., 1991; Schlienger., 2000).

Cases presentations In this chapter, we discuss the moderate adverse reaction in detail using real-case scenarios to demonstrate the types of ADRs that can be encountered when drugs are administered as well as factors that may affect the incidence or severity of a given ADR. Such real-case representations will improve pharmacy students and healthcare professionals’ knowledge and their application in practice, resulting in improved patient outcomes. The last two cases are related to pharmacogenomics and are presented to specialized professionals and graduate students.

2.

Case studies

Case of drug allergies, antibiotics, penicillin

Case Summary Patient Data Chief Complaint History of Present Illness

Past Medical History

Age: 50-year Gender: Female Wt in kg: 80 Ht m: 1.52 The patient was admitted to ER with symptoms of rash, hypotension, angioedema, mild shortness of breath, nausea The patient was outside, pulling weeds and cleaning around the outside house for the past 2 days. Rash appeared last night but precipitated into a full reaction this AM. Of note, cloudy for the past 2 days outside. Patient-reported wearing hat, gloves, and full sleeve shirt during gardening Two days ago went to the ambulatory clinic for treatment of sinusitis/allergies Migraine Type II diabetes Hypertension Hyperlipidemia l

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Past Medications History

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Atorvastatin 20 mg daily Furosemide 20 mg daily Lisinopril 5 mg daily Glyburide 5 mg daily Metformin 500 mg twice daily Amitriptyline 10 mg daily

New Medication l

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Family History

Diphenhydramine every 6 h as needed for sinusitis Amoxicillin/clavulanate potassium 875 mg every 12 h.

NA Continued

Social History

Married, Two grown children, Occupation school teacher, amateur gardener Reports no alcohol or drug abuse NKDA

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Allergies Physical Exam Vital signs Skin HEENT Chest, Abd, Genit/Rect, Ext, Neuro Heart

BP: 100/72 HR: 120 RR: 25 T °C 37 Red raised rash on the trunk, no apparent signs of a sting, no blistering or dry patches Slightly swollen throat WNL Tachycardia

Laboratory findings Sodium: 135–145 mmol/L

140

Hemoglobin: 12–17 g/dL

15

Potassium: 3.5–5 mmol/L Chloride: 95–105 mmol/L Glucose: 65–110 mg/dL

3.5

Hematocrit 40%–52% Mean Corpuscular Volume (MCV): 80–100 fL Red Blood Cell Distribution Width (RDW): 11.5%–14.5%

45

Creatinine: 0.8–1.3 mg/dL Blood Urea Nitrogen (BUN): 8–21 mg/dL Bicarbonate (HCO3): 18–22 mmol/L Oxygen Saturation: 96%–100%

100 120

1 14 20

90 12

White blood cells (WBC): 4–10
109/L Neutrophils: 2–8
109/L Bands: > Give 4 Units
In 6:50 p.m.: RBS ¼ 300 mg/dL >> we give 4 units of insulin HR “state”

Day 6

Assessment Stable

Subjective Conscious and oriented No New Events Not in Pain Objective Not Documented

Plan - Continue the same Therapy (Complete Blood count Today)

Day 7 Subjective No New Events Not in Pain Objective Conscious and oriented Not Documented

Assessment Stable Plan - To be Discharged Discharge Medications: 1-Enalapril 10 mg 2-Simvastatin 20 mg PO OD 3-Salbutamol 100 μg inhaler PO OD 4-Aspirin 81 mg PO OD 5-Gliclazide 80 mg (2
2) two tablets BID 6-Acyclovir Ophthalmic ointment 3% TID

Case discussion and Medication safety issue analysis Medication safety name Discussion

Drug-Related Problems There are many drug-related problems in this case such as the following: Potential interaction between statin and clarithromycin Uncontrolled conditions such as blood pressure, high blood glucose. Continued

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Recommendations

Healthcare professionals should be aware about the actual and potential drug-related problems and how they can manage it if occurs, prevent it. Communication and collaboration between the healthcare professionals are the key to success in the patient care.

Case 4 Patient data Age: 37 years. Gender: Female. Weight: 44 kg Chief compliant Breathing difficulties, fever, and cough History of Present Illness: Breathing difficulties, fever, and cough for 2 days Past Medical History Breast cancer Hypertension Medications History Enalapril 10 mg PO OD. Salbutamol 200 mg PRN. Capecitabine 1 m bid, 2 weeks lapatinib 1 g OD/2 weeks Family history Not significant for any disease Social History Married Allergies NKDA Physical Examination General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

Height: 1.62 m

The patient appeared well 124/77 100 20 °C 38 Normal Normal She has B/L coarse expiratory crackles mainly in the right middle zone and rhonchi all over the chest Normal Normal Normal Normal Normal

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Laboratory findings Day Test

Normal range

1

2

WBC RBC Hb Hct MCV PLT Neutrophil absolute Creatinine serum Urea serum Uric acid Albumin T. protein T. bilirubin ALT AST Na K Ca Mg

4.5–11 mmol/L 3.8–5.8 mmol/L 12.6–17 0.4 g/dL 37%–51% 80–100 fL 150–440 1.8–7.7 36–124 μmol/L 1.7–8.1 mmol/L 150–428 mmol/L 38–53 g/L 66–87 g/L 0–18 μmol/L 0–65 unit/L 0–35 U/L 135–145 mmol/L 3.5–5.3 mmol/L 2.2–2.6 mmol/L 0.8–1.1 mmol/L

12.14 3.52 10.2 33.1 94 257 1.2 68 3.4 153 31 64 4.7 23 28 135 2.7 2.05 0.66

16.87 3.89 9.8 36.8 94.6 224 1.4 68 3.6 122 23 36

3

4 15.6 3.84 9.3 39 95 248 1 62 3.3 120 28.2 76 4.8 28 41 136 4.8 2.19 0.76

136 4 2.08 0.7

Management plan Subjective/objective

Assessment/plan

Day 1 Subjective

Fever, productive cough and shortness of breath

Assessment

Objective

Temp: 38.4°C BP: 142/86 mmHg Pulse: 98/min O2 Sat: 95% R.R: 22 Zero pain score

Plan

Breast cancer. Hypertension Exacerbation of chest infection On xeloda/ lapatinib CBC, CXR. Medication: Ventolin 5 mg Neb. 6 h Artovent 500 μg neb. TID Pulumicort 1 mg Neb. BID Continued

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Subjective/objective

Assessment/plan Dexamethasone 4 mg IV BID Omeprazole 20 mg PO BID Moxifloxacin 400 mg IV OD Enalapril 10 mg PO OD

Day 2 S

Still shortness of breath but less than before and she can walk few step.

A

Metastatic Breast cancer Improving for chest symptoms Continue the same medications

O

Afebrile, hemodynamically stable. Chest B/L wheezes Temp: 37.6°C BP: 138/74 mmHg Pulse: 96/min O2 sat: 96% R.R: 21

P

Generalized body ache Sore throat Chest rhonchi without pain Temp: 36.7°C BP: 128/68 mmHg Pulse: 91/min O2 sat: 96% R.R: 23 Chest clear Abdomen: soft, lax, and no tenderness

A

Stable

P

Add Fevadol plus 1 g q 6 h PO

Stable even better than before Continue same treatment For possible discharge.

Day 3 S

O

Day 4 S

Patient complains of S.O.B Pt. conscious, oriented

A

O

T: 37°C BP: 120/70 RR 20 Pulse: 98 SpO2: 98% Pt. had B/L crackles and rhonchi Hemodynamically stable

P

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Case discussion and Medication safety issue analysis Medication safety name Discussion

Recommendations

Drug-Related Problems There are many drug-related problems in this case such as the following: Needs additional dug therapy for treating patient pneumonia. Untreated conditions such as: hypoalbuminemia, low hemoglobin, and hypomagnesemia Healthcare professionals should be aware about the actual and potential drug-related problems and how they can manage it if occurs, prevent it. Communication and collaboration between the healthcare professionals are the key to success in the patient care.

Case 5 Patient data Age: 27 years. Gender: Male. Weight: 55 kg Chief Complaint Ataxia, nystagmus, and diplopia History of Present Illness Ataxia, nystagmus, and diplopia for 3 days Past Medical History Epilepsy for 5 years Past Medications History Phenytoin 200 mg om and 160 mg on Valproic acid 800 mg to 1000 mg tablet Family History Not significant for any disease Social History Single Nonsmoker Allergies NKDA Physical Examination General BP HR RR Temperature Skin HEENT

Height: 1.71 m

The patient appeared well 104/83 97 Not reported °C 37 Normal Normal Continued

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Chest Heart Abd Genit/Rect Ext Neuro

Normal Normal Normal Normal Normal Nystagmus, ataxia, and diplopia.

Laboratory findings Day 1

Normal range

WBC HGB HCT MCV PLT Sodium Potassium Urea Sr Cr Cl Cr Chloride Total protein Albumin Globulin Total bilirubin ALT ALP

4.5 15 45 91 332 140 4.3 3.6 80 85 103 61 44 17 8 29 39

PT INR aPTT

11 1.2 27.3

5.2–12.4
103/UL 12.0–16.0 g/dL 37.0%–47.0% 81–99 fL 130–400 136–145 mmol/L 3.5–5.0 mmol/L 3.5–7.2 mmol/L (>50 years) 53–115 μmol/L 70–140 mmol/min 98–107 66–87 g/L 35–50 g/L 20–36 g/L 3–21 μmol/L 0–55 u/L 40–150 (>15 YRS) expected conc?

Concomitant use of traditional medicine or presence of other interfering substances. Inhibition of PHT metabolism by food. Therapeutic Drug Monitoring has a role to play in detecting medication error and preventing further harm done to patient.

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Pharmacists have a role to play in detecting and preventing medication error, which will adversely affect patient care.

Conclusion

This chapter has discussed the DRPs and provided real cases about it. To manage the actual DRPs and prevent the potential DRPs, healthcare professionals should develop and improve their skills in order to identify the DRPs, solve the actual DRPs.

4.

Educational resources

DiPiro, J. T., Talbert, R. L., Yee, G. C., Matzke, G. R., Wells, B. G., & Posey, L. (2017). Pharmacotherapy A Pathophysiologic Approach, 10e. Pharmacotherapy: A Pathophysiologic Approach. 10e. New York: McGraw-Hill Education, 255-8. Al-Worafi, Y. M. (Ed.). (2020). Drug Safety in Developing Countries: Achievements and Challenges. Academic Press.

Abbreviations Abd BP BPM CV Gen Genit/Rect HEENT HR Ht MS/Ext Neuro RR T VS Wt

abdomen blood pressure breaths per minute cardiovascular general appearance genitalia/rectal head, eyes, ears, nose, and throat heart rate height musculoskeletal and extremities neurologic respiratory rate temperature vital signs—blood pressure, pulse, respiratory rate, and temperature weight

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References Al-Worafi, Y. M. (Ed.), (2020). Drug safety in developing countries: Achievements and challenges. Academic Press. Al-Worafi, Y. M. (2020b). Drug safety in developing versus developed countries. In Drug safety in developing countries (pp. 613–615). Academic Press. Al-Worafi, Y. M. (2020c). Medication errors. In Drug safety in developing countries (pp. 59–71). Academic Press. Al-Worafi, Y. M. (2020d). Drug-related problems. In Drug safety in developing countries (pp. 105–117). Academic Press. Al-Worafi, Y. M. (2020e). Medications safety-related terminology. In Drug safety in developing countries (pp. 7–19). Academic Press. American Society of Hospital Pharmacists (ASHP) (1993). ASHP statement on pharmaceutical care. American Journal of Hospital Pharmacy, 50, 1720–1723. Cipolle, R. J., Strand, L. M., & Morley, P. C. (2012). Pharmaceutical care practice: The patientcentered approach to medication management: (pp. 435–644). New York, NY: McGrawHill Medical. Cipolle, R. J., Strand, L., Morley, P. C., & Morley, P. (2004). Pharmaceutical care practice: The clinician’s guide. McGraw-Hill Medical. DiPiro, J. T., Talbert, R. L., Yee, G. C., Matzke, G. R., Wells, B. G., & Posey, L. (2017). Pharmacotherapy: A pathophysiologic approach: (pp. 255–258) (10th ed.). New York: McGraw-Hill Education. Hepler, C. D., & Strand, L. M. (1990). Opportunities and responsibilities in pharmaceutical care. American Journal of Hospital Pharmacy, 47(3), 533–543. Kr€ahenb€uhl-Melcher, A., Schlienger, R., Lampert, M., Haschke, M., Drewe, J., & Kr€ahenb€uhl, S. (2007). Drug-related problems in hospitals. Drug Safety, 30(5), 379–407. Masnoon, N., Shakib, S., Kalisch-Ellett, L., & Caughey, G. E. (2017). What is polypharmacy? A systematic review of definitions. BMC Geriatrics, 17(1), 1–10. Schwinghammer, T. L., & Koehler, J. (2009). Pharmacotherapy casebook: A patient-focused approach (7th ed.). McGraw-Hill Professional Publishing. Segal, R. (1997). Therapeutic outcomes monitoring: A method for implementing pharmaceutical care. Journal of Research in Pharmaceutical Economics, 8, 193–198. Strand, L. M., Morley, P. C., Cipolle, R. J., Ramsey, R., & Lamsam, G. D. (1990). Drug-related problems: Their structure and function. DICP, 24(11), 1093–1097. van den Bemt, P. M., Egberts, T. C., de Jong-van den Berg, L., & Brouwers, J. R. (2000). Drugrelated problems in hospitalised patients. Drug Safety, 22(4), 321–333. van Mil, F. (1999). International working conference on outcomes measurements in pharmaceutical care. Pharmaceutical care network Europe (PCNE). Hilleroed, Denmark, 1999 January 26–29. .

Drug-related problems case studies: Part II

12

Yaser Mohammed Al-Worafia,b a College of Pharmacy, University of Science and Technology of Fujairah, Fujairah, United Arab Emirates, bCollege of Medical Sciences, Azal University for Human Development, Sana’a, Yemen

1.

Background

Drug-Related Problems (DRPs) can be defined as “an undesirable patient experience that involves drug therapy and that actually or potentially interferes with a desired patient outcome” (Strand, Morley, Cipolle, Ramsey, & Lamsam, 1990). DRPs are common in developing countries as well as developed countries; it is common in all healthcare settings and affects patients, their families, healthcare providers, and the whole healthcare system. DRPs are associated with failure in the achieving the treating desired outcomes, increase morbidity and mortality, increase the length of hospitalization, increase the cost of treating diseases, and decrease the quality of patient’s life’s and make the people dissatisfied with their treatment as well as healthcare system (Al-Worafi, 2020a, 2020b, 2020c, 2020d; DiPiro et al., 2017).

2.

Cases

Case 1 Patient data Age: 37 years. Gender: Male. Weight: 74 kg Height: 1.51 m Chief compliant Aggressive behavior History of Present Illness: in hospital by the police and her brother after she became aggressive and broke the door of her house. Past Medical History Schizophrenia for years

Clinical Case Studies on Medication Safety. https://doi.org/10.1016/B978-0-323-98802-5.00013-3 Copyright © 2023 Elsevier Inc. All rights reserved.

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Medications History Medication

Dose

Dosage form

Chlorpromazine Benzhexol Fluphenazine decanoate Sulpiride Haloperidol Benzhexol Valproic acid Fluphenazine deconate

100 mg OM, 200 mg ON 2 mg TDS 50 mg monthly 150 mg BID 10 mg TDS 2 mg TDS 400 mg TDS 50 mg monthly

Tablet Tablet IM Tablet Tablet Tablet Tablet IM

Family history Not significant for any disease Social History Single, unemployed, stays with her brother Nonsmoker Allergies NKDA Physical Examination General

BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

Alert and conscious. Ø fairly kempt and poor eye contactirrelevant and incomprehensible speech. restricted and blunted affect.unable to assess as patient shouting in obscene words.insight and judgment and rapport. 120/84 81 – °C 37 Normal Normal Normal Normal Normal Normal Normal Normal

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Laboratory findings Lab tests

Results

Normal range

WBC HGB HCT PLT Sodium Potassium Urea Sr Cr Cl Cr Chloride Total cholesterol LDL HDL Triglycerides Total protein Albumin Globulin A/G ratio Total bilirubin ALT ALP

5.7 12.3 45 361 132 3.8 3.4 61 130.39 99 7.0 mmol/L repeat FBG if FBG still >7.0 mmol confirm diabetes) DRP#2Recommendation: Repeat FBG if still >7.0 mmol/L confirm diabetes. Metformin should be included in the therapy for all type 2 DM patients, if tolerated and not contraindicated, as it is the only oral antihyperglycemic medication proven to reduce the risk of total mortality and cardiovascular death, according to the United Kingdom Prospective Diabetes Study. LDL increased above normal range DRP#3Recommendation: lifestyle changes with restricted intake of total and saturated fat and cholesterol and a modest increase in polyunsaturated fat intake, along with a program of regular exercise and weight reduction if needed. If the target not achieved during 3 months, start statin therapy. Healthcare professionals should be aware about the actual and potential drug-related problems and how they can manage it if occurs, prevent it. Communication and collaboration between the healthcare professionals are the key to success in the patient care. l

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Case 2 Patient data Age: 69 years. Gender: Male. Weight: 50 kg Height: 1.63 m Chief Complaint Vomiting and abdominal pain History of Present Illness Vomiting and abdominal pain 1 day before the admission to the hospital, became worse last hours before the admission. Past Medical History Hypertension for 9 years

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Diabetes mellitus for 9 years Psychotic disorder for 5 years Past Medications History Metformin 500 mg twice daily Metoprolol 50 mg TDS Clonazepam 2 mg once daily Valproic acid 400 mg once daily Family History Not significant for any disease Social History Married Smoker Allergies NKDA Physical Examination

General BP HR RR Temperature Skin HEENT Chest Heart Abd Genit/Rect Ext Neuro

Alert and conscious. Chest pain, SOB, palpitation and giddiness. 72/53 64 25 °C 37.5 Pale Normal Chest pain Normal – Normal Normal Normal

Laboratory findings

Test

Day 1

Day 7

Normal range

Sodium Potassium Urea Sr Cr Cl Cr Chloride Total protein Albumin Globulin

137 3.5 5.3 64 68.47 105 74 28 46

139 3.5 5.4 64 68.47 105 70 29 47

136–145 mmol/L 3.5–5.0 mmol/L 3.5–7.2 mmol/L (>50 Years) 53–115 μmol/L 70–140 mmol/minute 98–107 66–87 g/L 35–50 g/L 20–36 g/L Continued

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Test

Day 1

Day 7

Normal range

Total bilirubin ALT ALP

8 13 142

8 12 137

3–21 μmol/L 0–55 u/L 40–150 (>15 YRS)