case studies in clinical pharmacy and therapeutics

Pharmacy Case Studies for Pharmacists & Medical Sciences Students

Pharmacists and healthcare practitioners are required to demonstrate knowledge and understanding of the application of therapeutics in clinical practice. Pharmacists must ensure patient safety and achieve desired health outcomes through effective decision-making. The idea of designing these case studies is to meet the needs and challenges of a modern pharmacy undergraduate curriculum. Case studies are increasingly used in pharmacy undergraduate as well as postgraduate education.

Each chapter contains five case studies, increasing in complexity from those we would expect first-year students to complete (Level 1) through to cases designed for fourth-year/pre-registration students (Level M). The chapters have been designed to follow approximately the British National Formulary chapters for ease of use. Case study scenarios include both community and hospital pharmacy situations as suited to the disease and pharmaceutical care provision.

This section is only for Bangladeshi Pharmacy/Medical Students & Professionals !

Cardiovascular case studies by Narinder Bhalla

Case study level 1 – Angina Case study level 2 – Hypertension Case study level 3 – Atrial ﬁbrillation Case study level Ma – Heart failure Case study level Mb – Myocardial infarction

Respiratory system case studies by Soraya Dhillon and Andrzej Kostrzewski

Case study level 1 – Asthma – community Case study level 2 – Asthma – acute on chronic Case study level 3 – Chronic obstructive pulmonary disease (COPD) with co-morbidity Case study level Ma – COPD Case study level Mb – Brittle asthma

Obstetrics, gynaecology and UTI case studies by Alka Mistry

Case study level 1 – Primary dysmenorrhoea Case study level 2 – Urinary tract infections in pregnancy Case study level 3 – Pelvic inﬂammatory disease Case study level Ma – Endometriosis management in secondary care Case study level Mb – Management of severe pre-eclampsia/ eclampsia

Liver disease case studies by Caron Weeks and Mark Tomlin

Case study level 1 – Alcoholic cirrhosis; alcohol withdrawal Case study level 2 – Alcoholic cirrhosis; management of bleeding risk and treatment for the maintenance of alcohol abstinence Case study level 3 – Hepatic encephalopathy and ascites Case study level Ma – Pulmonary tuberculosis Case study level Mb – Liver failure

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Liver disease case studies: Case study level 1 – Alcoholic cirrhosis; alcohol withdrawal

Cardiovascular case studies: case study level mb – myocardial infarction, cardiovascular case studies : case study level 3 – atrial fibrillation.

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Pharmacy Case Studies

Dhillon, soraya; raymond, rebekah, first edition.

Edited by Soraya Dhillon - Head, The School of Pharmacy, University of Hertfordshire and Rebekah Raymond - Teacher Practitioner

Understand the application of therapeutics in clinical practice with Pharmacy Case Studies . This book helps you to integrate and demonstrate the knowledge gained during your undergraduate and pre-registration study.

Case studies of increasing complexity tie in strands of learning from across the pharmacy curriculum. Scenarios include both community and hospital pharmacy situations, as suited to the disease and pharmaceutical care provision.

Each chapter contains five case studies with questions and answers increasing in complexity from those for first year students through to cases designed for fourth year/pre-registration level.

Primarily aimed at pharmacy students and pre-registration pharmacists, this book will also be useful for qualified pharmacists as well as medical students, nurses and others with a professional interest in therapeutics.

7. Obstetrics, Gynaecology and UTI

8. Malignant Disease

9. Nutrition and Blood

10. Musculoskeletal and Joint

14. Immunological/vaccines

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Our Pharmacy Blog

Mastering pharmacy case studies.

Introduction

If you are training to become a pharmacist, you will have had experience with pharmacy case studies. But why are pharmacy case studies so important?

As a qualifying pharmacist, case studies bring together the threads of study over the past four years. This includes your study of subjects such as:

Pharmacology
Pharmaceutical chemistry
Pharmaceutics
Clinical pharmacy practice

In practice, pharmacists are expected to draw on this knowledge and clinically apply it where necessary. These subjects feed into one another where knowledge of one subject became necessary to advance in a second subject and so forth. University staff overseeing the course structure put that structure together with these factors in mind. Pharmacy case studies are an important component, often toward the end of your pharmacy degree, that aim to establish the most relevant details that play a role in the career of a qualified pharmacist.

Case studies give pharmacy students an opportunity to test their understanding of a specialist topic. This may be anything from the formulation and dosing of medicines; to a drug’s mechanism of action, drug interactions, and clinical appropriateness for a medicine in a given scenario for a patient with specific factors to keep in mind. Evidently, this takes practice. There are many possible case study scenarios to consider. It can be difficult to always get things right.

Case studies are, then, a special kind of barometer through which we measure the professional competency of pharmacy students .

That is why pharmacy case studies are popular in degree programs – forcing students to think critically about a given topic – whether it be blood diagnostics, epidemiology, treatment options, or drug monitoring – tying together their past year’s study and how to apply this knowledge to (potentially) real-life situations.

Below, we’ve put together an introductory case study to provide you with a clear example of what kinds of questions can be asked and how best you should approach each question. With enough practice, clinical case studies become that much easier. And with time, students learn to enjoy case studies – as they are often your first direct experience of learning real and relevant facts that have an impact on your long-term professional career.

Pharmacy Case Study – Osteoporosis

A 49-year old woman with osteoporosis has been taking Fosamax for 6-months. She visits her GP complaining of acid reflux and pain radiating down her esophagus.

What is the active ingredient of Fosamax?
What is the mechanism of action of this medicine?
Suggest a reason why this patient is taking Fosamax.
How should the GP respond to the patient’s symptoms?
What foods and/or medicines should the patient avoid?

Explanation

The questions ask more about the medicine – how it works, what it’s indicated for, how the GP should respond to patient symptoms and what interactions, from both food and drug sources, the prescriber and pharmacist must consider.

A – The active ingredient of Fosamax is alendronate; a bisphosphonate drug.

B – Alendronate works by inhibiting osteoclast-mediated bone resorption (the process whereby bone is broken down and minerals are released into the blood).

C – As a 49-year old woman, the patient is likely post-menopausal. Bisphosphonates are routinely prescribed to prevent osteoporosis in these patients.

D – The patient may be improperly administering the medicine. Patients who do not follow the correct protocol of administering bisphosphonates are likely to experience specific symptoms, particularly relating to the esophagus and GI tract. Patients should be counseled to take the medicine in the morning on an empty stomach, whilst remaining upright, and taken with a full glass of water. This eases the bisphosphonate through the digestive tract without irritating the esophageal wall. Patients should avoid taking and food or medicines, both before and for at least 30-minutes after taking the bisphosphonate.

E – Two groups of medicines should be avoided. First, NSAIDs should be avoided; as they increase the risk of gastrointestinal side effects. Second, patients should avoid foods or supplements that contain multivalent ions such as magnesium, aluminum, or calcium. This category includes dairy products and antacids. As we learned above, bisphosphonates should be avoided with these medicines/foods for at least 30-minutes after the bisphosphonate has been taken (on an empty stomach).

Practice More Pharmacy Case Studies

The more pharmacy case studies you practice , the better prepared you are for the needs and demands that present during the licensing end of your pharmacy program. Pharmacy case studies help guide students through the must-know clinical facts about drugs and medicines; both theoretical and practical knowledge.

Clinical case studies are one of the ways in which students make the transition between an experienced, knowledgeable student and a clinical professional whose expertise can be trusted in the real world. Case studies bring pharmacy students to the next level. The more practice you put in, the better results you can expect as you progress through the licensing stage of your nascent career. That, in the end, is what matters.

That’s about it for our discussion of case studies! Check back to our pharmacy blog soon for more exclusive content to help you master the science of drugs and medicines and build your long-term career.

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Don't stop learning now, you may also like, corticosteroids pharmacology, fluoroquinolones pharmacology, ssris pharmacology.

A, Post–COVID-19 condition (PCC), death, hospitalization, and composite outcome of death or hospitalization. B, Individual post–acute sequelae (components of PCC). Outcomes were ascertained 30 days after the SARS-CoV-2 positive test result until the end of follow-up. The nirmatrelvir group consisted of 35 717 patients, and the control group consisted of 246 076 patients. Adjusted hazard ratios and 95% CIs are presented. Absolute risk reduction of nirmatrelvir compared with the control group per 100 persons at 180 days and associated 95% CIs were estimated based on the difference of survival probability in the nirmatrelvir group compared with the control group. Statistically significant results are presented in light blue, and results that lacked statistical significance are presented in orange.

A, Post–COVID-19 condition (PCC). B, Death. C, Hospitalization. D, Composite outcome of death or hospitalization. Outcomes were ascertained 30 days after the SARS-CoV-2 positive test until the end of follow-up. Event rates in percentage presented for the nirmatrelvir group (blue, n = 35 717) and the control group (orange, n = 246 076). Shaded areas are 95% CIs.

A, By demographic and disease subgroups included age (≤60 years, >60 years to ≤70 years, and >70 years), race (White and Black), sex, smoking status (current smoker, former smoker, and never smoker), cancer, cardiovascular disease, chronic kidney disease, chronic lung disease, diabetes, immune dysfunction, and hypertension. B, By number of baseline risk factors (1 to 2, 3 to 4, ≥5), vaccination status (unvaccinated, 1 to 2 doses of vaccine, and boosted), and SARS-CoV-2 infection status (with primary SARS-CoV-2 infection and reinfection). Baseline risk factors of progression to severe acute COVID-19 illness included age of older than 60 years, body mass index of more than 25 (calculated as weight in kilograms divided by height in meters squared), current smoker, cancer, cardiovascular disease, kidney disease, chronic lung disease, diabetes, immune dysfunction, and hypertension. Outcomes were ascertained 30 days after the SARS-CoV-2 positive test until the end of follow-up.

eFigure 1. Cohort flow

eFigure 2. Cohort timeline

eTable 1. Demographic and health characteristics of the overall cohort, the nirmatrelvir group, and the control group before weighting

eTable 2. Unadjusted event rates in nirmatrelvir and control groups

eTable 3. Hazard ratio and absolute risk reduction of nirmatrelvir on post-acute sequelae of COVID-19, death, hospitalization, and composite outcome of death or hospitalization compared to control group

eTable 4. Hazard ratio of nirmatrelvir on Long Covid compared to control group by subgroups

eTable 5. Sensitivity analyses

Data sharing statement

Waiting for an RCT of Nirmatrelvir for Prevention of Post–COVID-19 Condition Editor's Note June 1, 2023 Mitchell H. Katz, MD

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Xie Y , Choi T , Al-Aly Z. Association of Treatment With Nirmatrelvir and the Risk of Post–COVID-19 Condition. JAMA Intern Med. 2023;183(6):554–564. doi:10.1001/jamainternmed.2023.0743

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Association of Treatment With Nirmatrelvir and the Risk of Post–COVID-19 Condition

Question Is treatment with nirmatrelvir in the acute phase of SARS-CoV-2 infection associated with a lower risk of post–COVID-19 condition (PCC)?

Findings In this cohort study of 281 793 people with SARS-CoV-2 infection who had at least 1 risk factor for progression to severe COVID-19 illness, compared with 246 076 who had no treatment, nirmatrelvir use in the acute phase (n = 35 717) was associated with reduced risk of PCC, including reduced risk of 10 of 13 post–acute sequelae in various organ systems, as well as reduced risk of post–acute death and post–acute hospitalization. Nirmatrelvir was associated with reduced risk of PCC in people who were unvaccinated, vaccinated, and boosted, and in people with primary SARS-CoV-2 infection and reinfection.

Meaning In people with SARS-CoV-2 infection and at least 1 risk factor for progression to severe COVID-19 illness, treatment with nirmatrelvir during the acute phase of COVID-19 was associated with reduced risk of PCC.

Importance Post–COVID-19 condition (PCC), also known as long COVID, affects many individuals. Prevention of PCC is an urgent public health priority.

Objective To examine whether treatment with nirmatrelvir in the acute phase of COVID-19 is associated with reduced risk of PCC.

Design, Setting, and Participants This cohort study used the health care databases of the US Department of Veterans Affairs (VA) to identify patients who had a SARS-CoV-2 positive test result between January 3, 2022, and December 31, 2022, who were not hospitalized on the day of the positive test result, who had at least 1 risk factor for progression to severe COVID-19 illness, and who had survived the first 30 days after SARS-CoV-2 diagnosis. Those who were treated with oral nirmatrelvir within 5 days after the positive test (n = 35 717) and those who received no COVID-19 antiviral or antibody treatment during the acute phase of SARS-CoV-2 infection (control group, n = 246 076) were identified.

Exposures Treatment with nirmatrelvir or receipt of no COVID-19 antiviral or antibody treatment based on prescription records.

Main Outcomes and Measures Inverse probability weighted survival models were used to estimate the association of nirmatrelvir (vs control) with post–acute death, post–acute hospitalization, and a prespecified panel of 13 post–acute COVID-19 sequelae (components of PCC) and reported in relative scale as relative risk (RR) or hazard ratio (HR) and in absolute scale as absolute risk reduction in percentage at 180 days (ARR).

Results A total of 281 793 patients (mean [SD] age, 61.99 [14.96]; 242 383 [86.01%] male) who had a positive SARS-CoV-2 test result and had at least 1 risk factor for progression to severe COVID-19 illness were studied. Among them, 246 076 received no COVID-19 antiviral or antibody treatment during the acute phase of SARS-CoV-2 infection, and 35 717 received oral nirmatrelvir within 5 days after the positive SARS-CoV-2 test result. Compared with the control group, nirmatrelvir was associated with reduced risk of PCC (RR, 0.74; 95% CI, 0.72-0.77; ARR, 4.51%; 95% CI, 4.01-4.99), including reduced risk of 10 of 13 post–acute sequelae (components of PCC) in the cardiovascular system (dysrhythmia and ischemic heart disease), coagulation and hematologic disorders (pulmonary embolism and deep vein thrombosis), fatigue and malaise, acute kidney disease, muscle pain, neurologic system (neurocognitive impairment and dysautonomia), and shortness of breath. Nirmatrelvir was also associated with reduced risk of post–acute death (HR, 0.53; 95% CI, 0.46-0.61); ARR, 0.65%; 95% CI, 0.54-0.77), and post–acute hospitalization (HR, 0.76; 95% CI, 0.73-0.80; ARR, 1.72%; 95% CI, 1.42-2.01). Nirmatrelvir was associated with reduced risk of PCC in people who were unvaccinated, vaccinated, and boosted, and in people with primary SARS-CoV-2 infection and reinfection.

Conclusions and Relevance This cohort study found that in people with SARS-CoV-2 infection who had at least 1 risk factor for progression to severe disease, treatment with nirmatrelvir within 5 days of a positive SARS-CoV-2 test result was associated with reduced risk of PCC across the risk spectrum in this cohort and regardless of vaccination status and history of prior infection; the totality of findings suggests that treatment with nirmatrelvir during the acute phase of COVID-19 may reduce the risk of post–acute adverse health outcomes.

Post–COVID-19 condition (PCC), also known as long COVID , is the disease encompassing the post–acute sequelae of SARS-CoV-2 infection, and it affects millions of people around the world. 1 - 3 Despite PCC affecting a substantial portion of the patient population, there is no approved medication for the prevention or treatment of PCC. Several hypotheses have been proposed to explain the underlying mechanisms of PCC including persistence of the virus (or its fragments) or intensity of the inflammation during the acute phase of the disease. 4 The antiviral nirmatrelvir (in combination with ritonavir, marketed under the name Paxlovid) that has been shown to reduce the risk of progression to severe acute COVID-19 has been suggested as a candidate drug that may reduce the risk of developing PCC. 5 , 6 In December 2021, oral nirmatrelvir was approved in the US for the treatment of acute SARS-CoV-2 infection (typically within 5 days of symptom onset) in nonhospitalized people at risk of progression to severe COVID-19 illness. Millions of people in the US have since received treatment with nirmatrelvir. Urgent calls have been made to evaluate whether treatment with nirmatrelvir in the acute phase of COVID-19 reduces the risk of PCC—but data have thus far been lacking. 5 Addressing this question will guide treatment approaches of SARS-CoV-2 infections and will inform the effort to develop and optimize prevention and treatment strategies for PCC.

In this cohort study, we used the health care databases of the US Department of Veterans Affairs (VA) to identify patients who had a SARS-CoV-2 positive test result between January 3, 2022, and December 31, 2022, who were not hospitalized on the day of the positive test, who had at least 1 risk factor for progression to severe COVID-19 illness, and who had survived the first 30 days after SARS-CoV-2 diagnosis. We identified those who were prescribed oral nirmatrelvir within 5 days after the positive test and did not receive other outpatient COVID-19 antiviral or antibody treatment within 30 days after the positive test (nirmatrelvir group, n = 35 717) and those who received no outpatient COVID-19 antiviral or antibody treatment within 30 days after the positive test (control group, n = 246 076). We then used the inverse probability weighting approach to balance the characteristics of the groups and evaluate whether treatment with oral nirmatrelvir vs the control was associated with reduced risk of post–acute outcomes, including PCC (from a set of 13 prespecified post–acute sequelae of SARS-CoV-2 infection), post–acute death, post–acute hospitalization, and each individual post–acute sequela.

The VA operates the largest integrated health care system in the US; the system comprises 1283 health care facilities (including 171 VA medical centers and 1112 outpatient sites) located across the US. The VA provides comprehensive health care to discharged veterans of the US armed forces including preventative and health maintenance, outpatient care, inpatient hospital care, prescriptions, mental health care, home health care, primary care, specialty care, geriatric and extended care, medical equipment, and prosthetics.

The cohort study was conducted using the VA health care databases. The VA health care data are updated daily and include individual-level demographic information and data on health care encounters, comorbidities, procedures, and surgeries. Data domains included outpatient encounters, inpatient encounters, inpatient and outpatient medications, laboratory results and non-VA care program integrity tools were used. The VA COVID-19 Shared Data Resource was used to collect information on patients with COVID-19 and vaccination status. The Area Deprivation Index (ADI)—which is a composite measure of income, education, employment, and housing—was used as a summary measure of contextual disadvantage at participants’ residential locations. 7

A flowchart and a timeline of cohort construction are provided in eFigures 1 and 2 in Supplement 1 , respectively. There were 332 256 participants who had a positive SARS-CoV-2 test result between January 3, 2022, and December 31, 2022, when their first date of positive test was set to be T 0 . A total of 37 466 participants prescribed nirmatrelvir within 5 days of T 0 were selected into the nirmatrelvir group. We then selected 36 641 participants with at least 1 risk factor of progression to severe acute COVID-19 illness, which included being older than 60 years, a body mass index (BMI) of greater than 25 (calculated as weight in kilograms divided by height in meters squared), current smoker, cancer, cardiovascular disease, kidney disease, chronic lung disease, diabetes, immune dysfunction, and hypertension. We also excluded participants with liver disease, end-stage kidney disease, estimated glomerular filtration rate (eGFR; a measure of kidney function) of less than 30 mL/min/1.73m 2 (to convert to mL/s/m 2 , multiply by 0.0167), and/or prescription fill of a medication that precluded them from receiving nirmatrelvir (n = 35 815). Participants who did not use other outpatient COVID-19 antiviral or antibody treatments within 30 days after T 0 were selected (n = 35 776). To examine the post–acute events, only participants alive 30 days after T 0 were included in the nirmatrelvir group (final n = 35 717).

A control group of participants was constructed from the 332 256 participants who had a positive SARS-CoV-2 test result between January 3, 2022, and December 31, 2022, when their first date positive test was set to be T 0 . From those who were not prescribed nirmatrelvir within 5 days of T 0 (n = 294 790), we selected 278 965 participants with at least 1 risk factor of progression to severe acute COVID-19 illness, and excluded participants with liver disease, end stage kidney disease, eGFR of less than 30 mL/min/1.73m 2 , and/or prescription fill of a medication that precluded them from receiving nirmatrelvir (n = 260 093). Participants who did not use any outpatient COVID-19 antiviral or antibody treatments within 30 days after T 0 (n = 249 443) were further selected. To examine the post–acute events, only participants alive 30 days after T 0 were included in the control group (final n = 246 076).

The final cohort consisted of 281 793 participants, of which 35 717 were in the nirmatrelvir group and 246 076 in the control group. The cohort was followed-up until February 2, 2023.

We defined exposure as a filled nirmatrelvir prescription within 5 days of SARS-CoV-2 positive test result. We examined the risk of post–acute death and hospitalization and a composite outcome of death or hospitalization. We also studied individual post–acute sequelae—which were selected based on prior evidence 1 , 2 , 8 - 23 —including ischemic heart disease, dysrhythmia, deep vein thrombosis, pulmonary embolism, fatigue and malaise, liver disease, acute kidney injury, muscle pain, diabetes, neurocognitive impairment, dysautonomia, and shortness of breath and cough. Individual sequelae were defined based on inpatient and outpatient International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnosis codes and laboratory results; death was defined based on vital status data; and hospitalization was defined based on inpatient encounter data. The PCC score was built by assigning weights to each individual sequela following the methods of the Global Burden of Disease Long COVID Collaborators (weights provided at https://github.com/yxie618/Nirmatrelvir_PASC ) 24 ; we then constructed the PCC score for each participant as the sum of weights of all the incident sequelae in that participant during follow up. 25 Incident outcomes were assessed within those without history of the related outcome within 3 years before T 0 . All outcomes were ascertained 30 days after T 0 .

We identified baseline characteristics that may be associated with the use of treatment and the occurrence or assessment of outcomes based on literature review and prior knowledge. 1 , 19 , 25 , 26 All covariates were assessed within 3 years before study enrollment unless otherwise specified. Predefined covariates included age, race (White, Black, and other), ethnicity (Hispanic and non-Hispanic), sex, ADI, BMI, smoking status (current, former, and never), history of SARS-CoV-2 infection, use of steroids, use of long-term care, eGFR, systolic and diastolic blood pressure, cancer, chronic lung disease, dementia, diabetes, hyperlipidemia, and immune dysfunction. We adjusted for medications that would have drug-drug interaction with nirmatrelvir-ritonavir based on 3 levels (require temporary hold of concomitant medication; require adjustment of concomitant medication dosing; and require monitoring for adverse effects). We also considered health care utilization parameters including number of outpatient and inpatient encounters, number of laboratory encounters and number of outpatient medications received within 1 year before study enrollment and influenza vaccination status. Continuous variables were transformed into restricted cubic spline functions to account for potential nonlinear associations.

Baseline characteristics were reported as mean and standard deviation or frequency and percentage. Covariate balance between groups was evaluated by the absolute standardized differences where an absolute standardized difference of less than 0.1 was considered evidence of good balance.

To examine the risk of incident outcomes, for each outcome besides death or hospitalization, we conducted analysis on a subcohort of participants without the history of the outcome within 3 years before T 0 . An inverse probability weighting method was used to balance the differences in baseline characteristics between the nirmatrelvir and control groups. Logistic regression was built to estimate the probability of receiving nirmatrelvir given covariates. The probability was then used as the propensity score. We then constructed the inverse probability weights as a value of 1 for those in the nirmatrelvir group and as propensity score divided by (1−propensity score) for those in the control group to estimate the association within population with same baseline characteristics as the nirmatrelvir group. Weights larger than 10 would be truncated at 10 to reduce the influence of extreme weights (in the present study, no weights were larger than 10, and none were truncated). The inverse probability weights were then applied to a Cox survival model in order to estimate the association of nirmatrelvir with individual outcomes. Hazard ratio (HR) and survival probability for both groups at 180 days were estimated. Absolute risk reduction (ARR) at 180 days was computed as the difference of survival probability in the nirmatrelvir group compared with the control group. To estimate the association of nirmatrelvir with PCC score, the inverse probability weighted zero inflated Poisson regression was used, and the relative risk (RR) and ARR in percentage at 180 days were estimated.

The association of nirmatrelvir with the risk of PCC was further examined within prespecified subgroups by age (≤60 years, >60 years to ≤70 years, and >70 years), race (White and Black), sex, smoking status (current smoker, former smoker and never smoker), cancer, cardiovascular disease, chronic kidney disease, chronic lung disease, diabetes, immune dysfunction, and hypertension. We also examined the association within populations with different vaccination status (unvaccinated, 1-2 doses of vaccine, and boosted) and infection status (with primary SARS-CoV-2 infection and reinfection). To examine the association within populations with different baseline risks, we also defined subgroups based on the number of baseline risk factors (1-2, 3-4, or ≥5) of progression to severe acute COVID-19 illness, where risk factors included age of older than 60 years, BMI greater than 25, current smoker, cancer, cardiovascular disease, kidney disease, chronic lung disease, diabetes, immune dysfunction, and hypertension.

Analyses were performed with SAS Enterprise Guide, version 8.2 (SAS Institute). Data visualizations were performed in R 4.0.4 (R Project for Statistical Computing). The robust sandwich variance estimator was used to estimate variance in weighted analyses. Risk on relative scale with a 95% CI that does not cross 1 and risk on absolute scale with a 95% CI that does not cross 0 was considered statistically significant. The study was approved by the VA St Louis Health Care System institutional review board, which granted a waiver of informed consent because of the retrospective nature of the study. The study followed the Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) reporting guideline.

The cohort included 281 793 participants; 35 717 were in the nirmatrelvir group, and 246 076 were in the control group that received no COVID-19 antiviral or antibody treatment within the first 30 days after infection. The demographic and health characteristics before weighting are provided in eTable 1 in Supplement 1 ; characteristics after weighting are provided in Table 1 . Absolute standardized mean differences between the the nirmatrelvir group and the control group after application of inverse probability weighting were all below 0.1—suggesting good balance ( Table 1 ). The unadjusted event rates are presented in eTable 2 in Supplement 1 .

In this study, measurements of risk are provided on both relative and absolute scale: (1) RR or HR of nirmatrelvir in comparison to the control group and (2) ARR in percentage at 180 days; the latter represents the event rate reduction in the nirmatrelvir group compared with the control group at 180 days.

Compared with the control group, nirmatrelvir was associated with reduced risk of PCC (RR, 0.74; 95% CI, 0.72-0.77); the event rate was 12.99% (95% CI, 12.52-13.49) and 17.51% (95% CI, 17.08-17.94) at 180 days in the nirmatrelvir and the control groups, respectively. This corresponded to an ARR of 4.51% (95% CI, 4.01-4.99) at 180 days ( Figures 1 A and 2 A; eTable 3 in Supplement 1 ).

Compared with the control group, nirmatrelvir was associated with reduced risk of post–acute death (HR, 0.53; 95% CI, 0.46-0.61; ARR, 0.65%; 95% CI, 0.54-0.77), post–acute hospitalization (HR, 0.76; 95% CI, 0.73-0.80; ARR, 1.72%; 95% CI, 1.42-2.01), and the composite outcome of post–acute death or hospitalization (HR, 0.74; 95% CI, 0.70-0.77; ARR, 2.15%; 95% CI, 1.85-2.46) ( Figures 1 A and 2 B, 2 C, and 2 D; eTable 3 in Supplement 1 ).

Compared with the control group, nirmatrelvir was associated with reduced risk of 10 of the 13 prespecified post–acute sequelae evaluated in this analysis. Nirmatrelvir was associated with reduced risk of sequelae in the cardiovascular system (dysrhythmia and ischemic heart disease), coagulation and hematologic disorders (pulmonary embolism and deep vein thrombosis), fatigue and malaise, liver disease, acute kidney disease, muscle pain, neurologic system (neurocognitive impairment and dysautonomia), and shortness of breath ( Figure 1 B, Table 2 ). There was lack of a statistically significant association between nirmatrelvir and other post–acute sequelae, including new-onset diabetes, liver disease, and cough ( Figure 1 B, Table 2 ).

Compared with the control group, people treated with nirmatrelvir exhibited reduced risk of PCC in subgroups based on age, race, sex, smoking, cancer, cardiovascular disease, chronic kidney disease, chronic lung disease, diabetes, immune dysfunction and hypertension ( Figure 3 A; eTable 4 in Supplement 1 ).

Because nirmatrelvir is prescribed to people with at least 1 baseline risk factor for progression to severe acute COVID-19 illness, and to better understand the association between nirmatrelvir and the risk of PCC in people with different baseline risk strata, the association between nirmatrelvir and the risk of PCC was tested according to the number of baseline risk factors for progression to severe acute COVID-19 illness. Nirmatrelvir was associated with reduced risk of PCC in people with 1 to 2, 3 to 4, and 5 or more baseline risk factors ( Figure 3 B; eTable 4 in Supplement 1 ).

Examination of the association between nirmatrelvir and risk of PCC by vaccine status suggested that nirmatrelvir was associated with reduced risk of PCC in people who were unvaccinated, vaccinated, and those who received a booster vaccine ( Figure 3 B; eTable 4 in Supplement 1 ). Nirmatrelvir was associated with reduced risk of PCC in people with primary SARS-CoV-2 infection and in people with reinfection ( Figure 3 B; eTable 4 in Supplement 1 ).

In this cohort study of 281 793 people with SARS-CoV-2 infection who had at least 1 risk factor for progression to severe COVID-19 illness, compared with the control group of people who did not receive antiviral or antibody treatment during the acute phase of SARS-CoV-2 infection, treatment with nirmatrelvir within 5 days of a positive SARS-CoV-2 test was associated with reduced risk of PCC, including reduced risk of 10 of 13 post–acute sequelae examined. Nirmatrelvir was also associated with reduced risk of post–acute death and hospitalization at 180 days. Nirmatrelvir was associated with reduced risk of PCC in subgroups based on age, race, sex, smoking, cancer, cardiovascular disease, chronic kidney disease, chronic lung disease, diabetes, immune dysfunction, and hypertension. Nirmatrelvir was associated with reduced risk of PCC across strata of baseline risk, and in people who were unvaccinated, vaccinated, and boosted, and in people with primary SARS-CoV-2 infection and reinfection. Altogether, the findings suggest that treatment with nirmatrelvir during the acute phase reduces the risk of post–acute adverse health outcomes.

These results show that the salutary effect of nirmatrelvir may extend to the post–acute phase of COVID-19; nirmatrelvir was associated with reduced risk of PCC in the overall cohort and in various subgroups, including those across risk strata, vaccination status, and prior history of COVID-19. These findings are coupled with the observation that among 281 793 people with acute SARS-CoV-2 infection who had at least 1 risk factor for progression to severe disease who would be eligible for treatment with nirmatrelvir, 35 717 (12.67%) patients were treated with nirmatrelvir, and 246 076 (87.33%) patients received no antiviral treatment. The totality of evidence suggests that improving the uptake and use of nirmatrelvir in the acute phase as a means of not only preventing progression to severe acute disease but also reducing the risk of post–acute adverse health outcomes may be beneficial.

Nirmatrelvir was associated with 26% less risk of PCC, 47% less risk of post–acute death, and 24% less risk of post–acute hospitalization; the magnitude of risk reduction on the absolute scale is also substantial amounting to 4.51, 0.65, and 1.72 less cases of PCC, post–acute death, and post–acute hospitalization for every 100 treated persons between 30 to 180 days of infection. These findings should be contextualized within the broader body of evidence showing effectiveness of nirmatrelvir in also reducing risk of hospitalization or death in the acute phase. 6 The clinical decision to initiate treatment with nirmatrelvir should consider its overall effectiveness in reducing burden of death and disease in both the acute and post–acute phases of COVID-19.

Nirmatrelvir was approved in the US for the treatment of acute COVID-19 illness in people with 1 or more risk factors for progression to severe disease. Whether the salutary benefit of nirmatrelvir extends to people without risk factors for progression to severe disease (who would not qualify for nirmatrelvir prescription under the current US Food and Drug Administration emergency use authorization and were not included in the present study’s analyses) remains to be tested in future randomized clinical trials.

We note that the present results suggested risk reduction for some but not all the prespecified post–acute sequelae in this analysis. It is possible that various sequelae are mediated by various mechanisms including some that may be affected by the receipt of antivirals and others that may not. Participants in the current study were treated in the acute phase with a 5-day course of nirmatrelvir; it remains unclear whether longer duration of treatment, a higher treatment dose, or both may have resulted in more reduced risk of post–acute sequelae. It is also unclear whether initiation of treatment in the post–acute phase of COVID-19 reduces the risk of PCC.

While we examined nirmatrelvir in this work, other antivirals that have also been shown to have efficacy and effectiveness in the acute phase (eg, molnupiravir) should also be tested to understand whether the association reported here extends to other antivirals. 27 This approach will help expand clinicians’ armamentarium and reduce reliance on a single agent—especially with a rising risk of antiviral resistance. 28 - 30

This study has several strengths. The VA operates the largest integrated health care system in the US, and the vast and rich national health care databases of the VA—with a large number of treated and untreated patients followed longitudinally over time—allows the evaluation of outcomes that were not assessed in randomized clinical trials. The VA data contain comprehensive information about participants, including COVID-19 testing results, medication use, vaccination records, hospitalization records, death records, and other attributes, which allows the comprehensive capture of covariates from different domains, such as demographics, diagnoses, laboratory test results, medications, vital signs, health care utilization, and contextual factors. We tested robustness of the present findings in multiple sensitivity analyses that yielded consistent results.

This study has several limitations. The demographic composition of the cohort (majority older, White, male adults) and accessibility to VA health care may limit generalizability of study findings. We used the electronic health care databases of the VA to conduct this study, and although we took care to adjust the analyses for a large set of predefined variables, we cannot completely rule out misclassification bias and residual confounding. We relied on filled prescription records to assign exposure, and filling of nirmatrelvir prescription does not necessarily guarantee use. We did not capture nirmatrelvir use outside the VA system; if a large number of people in the control group used nirmatrelvir outside the VA, this may bias the results toward the null. These data do not capture hospitalization and diagnoses which may have occurred outside the VA. We focused the present analyses on a prespecified set of 13 sequelae and did not examine all possible components of PCC. We examined the association of nirmatrelvir with PCC at 180 days after infection, and randomized clinical trials with longer follow-up would help further support the findings. Finally, as the virus continues to mutate, new variants emerge, and vaccine uptake improves, it is possible that the effectiveness of nirmatrelvir may also change over time.

This cohort study found that in people with SARS-CoV-2 infection who had at least 1 risk factor for progression to severe disease, treatment with nirmatrelvir within 5 days of a positive SARS-CoV-2 test was associated with a reduced risk of PCC across the risk spectrum in this cohort and regardless of vaccination status and history of prior infection. These findings suggest that the salutary benefit of nirmatrelvir may extend to the post–acute phase of COVID-19.

Accepted for Publication: February 22, 2022.

Published Online: March 23, 2023. doi: 10.1001/jamainternmed.2023.0743

Corresponding Author : Ziyad Al-Aly, MD, Clinical Epidemiology Center, Research and Development Service, VA St Louis Health Care System, 501 North Grand, St Louis, MO 63106 ( [email protected] ).

Author Contributions: Dr Al-Aly had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Xie, Al-Aly.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Xie, Al-Aly.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: All authors.

Obtained funding: Al-Aly.

Administrative, technical, or material support: Al-Aly.

Supervision: Al-Aly.

Conflict of Interest Disclosures: Dr Al-Aly reported receiving consultation fees from Gilead Sciences and Tonix Pharmaceuticals and consulting (uncompensated) for Pfizer.

Funding/Support: This study used data from the US Department of Veterans Affairs (VA) COVID-19 Shared Data Resource. This research was funded by the VA (Z.A.A.).

Role of the Funder/Sponsor: The VA had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The contents do not represent the views of the VA or the US government.

Data Sharing Statement: See Supplement 2 .

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Pharmacy Case Study Assignment of Clinical Pharmacotherapy Case Solution & Answer

Home » Case Study Analysis Solutions » Pharmacy Case Study Assignment of Clinical Pharmacotherapy

PHAR 2204 Clinical Pharmacotherapy 1 – Clinical Case Study Assignment

Main Potential and Actual Medication Problems

A 58 year old patient with 170/95 BP, that is considered a high blood pressure, the BMI falls within normal weight range. High blood pressure leads to increased risks of heart disease and severe complications, death and stroke.Additionally, she has been diagnosed with left ventricular dysfunction which indicates the presence of high risk factors such has diabetes, coronary artery disease and high blood pressure. She also has been suffering from atrial fibrillationi.e. often rapid or irregular heart rate, which can increase the risk of heart failure,stroke and other heart-related complications. Presently, she has been spotted with Peptic Ulcer Disease because she most frequently drinks alcohol. Further, the laboratory test shows the Urea 10 H mmol/L which is significantly high, also GGT 450 H U/L is high which correlates with the risk factor such as damaged liver.

Antibiotic-Induced Skin Eruption

A care plan will be developed for the medical conditions of the patient being managed with pharmacotherapy and treatment strategies. It would includeintervention, therapy goalsas well as schedules for next follow ups for the evaluation. One of theside effects with antibiotics includes skin rash.

The most distinctive feature of the skin eruption is the pattern of papules and macules. As Nandra has been suffering with skin rash, it is recommended to not stop the antibiotic treatment without the approval of the healthcare provider, however, it is critically suggested to finish all medications. Stopping antibiotics may allow infection to worsen and it would further leads to antibiotic resistance, which would make antibiotic less effective. Mild allergic reactions also results in skin rash, therefore, severe allergic reaction is referred to anaphylaxisthat most probably requires immediate medical attention.

The clinical assessment and management of the antibiotic allergyessentially requires a detailed medical history of the patient. Information related to the specific symptoms, time interval between allergicevaluation and clinical symptoms, time interval between appearance of symptoms and antibiotic administration and other medications which have been applied on or used by the patient. The assessment of Nandra comprises a systematicalphysical examination that would most likely be implicated in the clinical manifestations. The treatment of maculopapular rash highly depends upon the cause, as Nandra has been suffering from itchy rashes which have covered her legs, arms and trunk.It should be the duty of thepharmacistto notify that for the purpose of relieving the itches, the doctor should prescribe topical steroids or antihistamines (Thong, Update on the Management of Antibiotic Allergy, 2010). The over-the-counter drugs may also be prescribed to her such as Benadryl or Hydrocortisone creams. She is recommended to have non-pharmacological treatment at home by using medication i.e. skin creams or ointments and antihistamines. It is also suggested for her to use insect repellant and also to take appropriate measuresfor the purpose of eradicating mosquitos in her house and around her neighborhood(Thong, 2010 ).

Webster et al. has proposed a phenomenon in the vivo and in vitro investigation intended to critically evaluate the evidence of cell-mediated and humoral immune responsesto ampicillin in the patients who has been developingskin rashes, followsantibiotic therapy(BM, 1967). In addition to this, hydration, rest and pain killers are the effective way to treat Nandra with maculopapular rash (A, 1995 ).

Subsequent Management of Peptic Ulcer Disease

A peptic ulcer is one of the defect and sore in the duodenal or gastric wall, the management of the patient with peptic ulcer disease is most likely based on the ulcer characteristics, etiology, and anticipated natural history.

The objectives of treatment includes; the promotion ofulcer healing, the reduction of gastric acid secretion,relief frompain, elimination ofH Pylori if it is present and to prevent reoccurrenceof the deadly disease i.e. ulcer.

The non-pharmacological treatment of ulcer includes:

Avoiding the alcohol intake and smoking.
Avoiding the food intake that can aggravate pain.
Allay stress and anxiety.

On the other extremes, the objectives of pharma other a py are to reduce the morbidity, eradicate H pylori infection and prevention of several emerging complications in Nandra with ulcer disease. The following are some recommended test and treatment of Peptic Ulcer Disease:

Antibiotic medication in order to kill H. pylori : If Nandra is diagnosed withH. pylori, the doctor would recommend an antibiotics combination to kill the bacterium. It mayinclude Clarithromyc in (Biaxin),Amoxicillin (Amoxil), Tinidazole (Tindamax),Metronidazole (Flagyl),Levofloxacin (Levaquin) and Tetracycline (Tetracycline HCL). These tests would be determined with existing antibiotic resistance rate. The antibiotics are recommended to her for the period of 2 weeks, not only this,she would also need additional medication which would reduce stomach acid (NIH Consensus Development Panel on Helicobacter pylori in Peptic Ulcer Disease, 1994).
Medication promote healing and block acid production: The stomach acid would be reduced by Proton Pump Inhibitors by blocking the actions of the cell parts producing acid.These drugs includes over-the-counter medication and prescription omeprazole (Prilosec),Rabeprazole (Aciphex),lansoprazole (Prevacid),Pantoprazole (Protonix) and Esomeprazole (Nexium).
Medications reducing production of acid : Histamine blockers also called acid blockers will reduce the stomach acid amount released into Nandraâ€™s digestive track which would then relieve ulcer pain and it would also encourage healing. It is available by over-the-counter medication and prescription, acid blockers comprisemedications Famotidine (Pepcid),Ranitidine (Zantac),Nizatidine (Axid AR) and Cimetidine (Tagamet HB).
Antacids neutralize stomach acid :
Antacid will be included in Nandra drug regimen. It will neutralized current stomach acid, not only this, it will also relief the ulcer pain. The constipation and diarrhea are the side effects. Antacids will provide symptom relief.
Medications protect the stomach lining and small intestine:
Cytoprotective agents are medications which will be prescribed by the doctors that would help in protecting the issues that lines the small intestine and stomach (Clearinghouse, 2002).

Follow-up after initial treatment

The medication for the ulcer would most likely be successful which would lead to healing of ulcer disease. Since, Nandra has been suffering from severe symptoms, her doctor would recommend endoscopy for the purpose of ruling out most appropriate causes of the disease symptoms. During endoscopy if ulcer would be detected, her doctor would suggest endoscopy in order to ensure that the ulcer is healed……

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