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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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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  

• Case study for pharmacist
• Pharmacy case study

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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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Case Presentation

Suggested readings, case study: a patient with type 2 diabetes working with an advanced practice pharmacist to address interacting comorbidities.

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Peggy Yarborough; Case Study: A Patient With Type 2 Diabetes Working With an Advanced Practice Pharmacist to Address Interacting Comorbidities. Diabetes Spectr 1 January 2003; 16 (1): 41–48. https://doi.org/10.2337/diaspect.16.1.41

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Advanced practice pharmacists in the field of diabetes work collaboratively with patients’ medical providers, often in primary care settings or in close proximity to the providers’ practices. They help to integrate the pharmaceutical, medical, education/ counseling, and direct patient care activities necessary to meet patients’ individual self-management and diabetes care needs.

Patient education and self-management behavioral change are underpinnings of pharmaceutical care, and not only as they directly relate to the use of medications. Pharmacists, especially those who are certified diabetes educators (CDEs), frequently provide diabetes patients with education not only on medications, but also on the overall disease state, nutrition, physical activity, decision-making skills, psychosocial adaptation, complication prevention, goal setting, barrier resolution, and cost issues.

In addition to these substantial education responsibilities, advanced practice pharmacists who are Board Certified–Advanced Diabetes Managers (BC-ADMs) play an expanded role that encompasses disease state management. This includes performing clinical assessments and limited physical examinations; recognizing the need for additional care; making referrals as needed; ordering and interpreting specific laboratory tests; integrating their pharmacy patient care plans into patients’ total medical care plans; and entering notes on patient charts or carrying out other forms of written communication with patients’ medical care providers. Depending on state regulations and physician-based protocols, some advanced practice pharmacists can prescribe and adjust medications independently or after consultation with prescribing clinicians.

The clinical activities of BC-ADM pharmacists are not carried out independent of referring, collaborative practitioners. Rather, they are complementary to and serve to enhance the diagnostic, complex physical assessment, and management skills of medical providers.

The following case study illustrates the pharmacotherapeutic challenges of diabetes with other comorbidities, which can lead to potential drug-drug and drug-disease interactions. Although it does not offer detailed solutions to such problems, this case does describe the process of patient care and problem resolution as approached by advanced practice pharmacists.

B.L. is a 58-year-old white woman who has been referred to the pharmacist clinician for pharmacotherapy assessment and diabetes management. Her multiple medical conditions include type 2 diabetes diagnosed in 1995, hypertension, hyperlipidemia, asthma, coronary artery disease, persistent peripheral edema, and longstanding musculoskeletal pain secondary to a motor vehicle accident. Her medical history includes atrial fibrillation with cardioversion, anemia, knee replacement, and multiple emergency room (ER) admissions for asthma.

B.L.’s diabetes is currently being treated with a premixed preparation of 75% insulin lispro protamine suspension with 25% insulin lispro preparation (Humalog 75/25), 33 units before breakfast and 23 units before supper. She says she occasionally “takes a little more” insulin when she notes high blood glucose readings, but she has not been instructed on the use of an insulin adjustment algorithm.

Her other routine medications include the fluticasone metered dose inhaler (Flovent MDI), two puffs twice a day; salmeterol MDI (Serevent MDI), two puffs twice a day; naproxen (Naprosyn), 375 mg twice a day; enteric-coated aspirin, 325 mg daily; rosiglitazone (Avandia), 4 mg daily; furosemide (Lasix), 80 mg every morning; diltiazem (Cardizem CD), 180 mg daily (per cardiologist consult); lanoxin (Digoxin), 0.25 mg daily (per cardiologist consult); potassium chloride, 20 mEq daily; and fluvastatin (Lescol), 20 mg at bedtime. Medications she has been prescribed to take “as needed” include sublingual nitroglycerin for chest pain (has not been needed in the past month); furosemide, additional 40 mg later in the day if needed for swelling (on most days the additional dose is needed); and albuterol MDI (Proventil, Ventolin), two to four puffs every 4–6 hours for shortness of breath. She denies use of nicotine, alcohol, or recreational drugs; has no known drug allergies; and is up to date on her immunizations.

B.L.’s chief complaint now is increasing exacerbations of asthma and the need for prednisone tapers. She reports that during her last round of prednisone therapy, her blood glucose readings increased to the range of 300–400 mg/dl despite large decreases in her carbohydrate intake. She reports that she increases the frequency of her fluticasone MDI, salmeterol MDI, and albuterol MDI to four to five times/day when she has a flare-up. However, her husband has been out of work for more than a year, and their only source of income is her Social Security check. Therefore, she has been unable to purchase the fluticasone or salmeterol and so has only been taking prednisone and albuterol for recent acute asthma exacerbations.

B.L. reports eating three meals a day with a snack between supper and bedtime. Her largest meal is supper. She states that she counts her carbohydrate servings at each meal and is “watching what she eats.” She has not been able to exercise routinely for several weeks because of bad weather and her asthma.

The memory printout from her blood glucose meter for the past 30 days shows a total of 53 tests with a mean blood glucose of 241 mg/dl (SD 74). With a premeal glucose target set at 70–140 mg/dl, there were no readings below target, 8% within target, and 91% above target. By comparison, her results from the same month 1 year ago averaged 112 mg/dl, with a high of 146 mg/dl and a low of 78 mg/dl.

Physical Exam

B.L. is well-appearing but obese and is in no acute distress. A limited physical exam reveals:

Weight: 302 lb; height 5′1″

Blood pressure: 130/78 mmHg using a large adult cuff

Pulse 88 bpm; respirations 22 per minute

Lungs: clear to auscultation bilaterally without wheezing, rales, or rhonchi

Lower extremities +1 pitting edema bilaterally; pulses good

B.L. reports that on the days her feet swell the most, she is active and in an upright position throughout the day. Swelling worsens throughout the day, but by the next morning they are “skinny again.” She states that she makes the decision to take an extra furosemide tablet if her swelling is excessive and painful around lunch time; taking the diuretic later in the day prevents her from sleeping because of nocturnal urination.

Lab Results

For the sake of brevity, only abnormal or relevant labs within the past year are listed below.

Hemoglobin A 1c (A1C) measured 6 months ago: 7.0% (normal range: <5.9%; target: <7%)

Creatinine: 0.7 mg/dl (normal range: 0.7–1.4 mg/dl)

Blood urea nitrogen: 16 mg/dl (normal range: 7–21 mg/dl)

Sodium: 140 mEq/l (normal range: 135–145 mEq/l)

Potassium: 3.4 mg/dl (normal range: 3.5–5.3 mg/dl)

Calcium: 8.2 mg/dl (normal range: 8.3–10.2 mg/dl)

Lipid panel

    • Total cholesterol: 211 mg/dl (normal range <200 mg/dl)

    • HDL cholesterol: 52 mg/dl (normal range: 35–86 mg/dl; target: >55 mg/dl, female)

    • LDL cholesterol (calculated): 128 mg/dl (normal range: <130 mg/dl; target: <100 mg/dl) Initial LDL was 164 mg/dl.

    • Triglycerides: 154 mg/dl (normal range: <150 mg/dl; target: <150 mg/dl)

Liver function panel: within normal limits

Urinary albumin: <30 μg/mg (normal range: <30 μg/mg)

Poorly controlled, severe, persistent asthma

Diabetes; control recently worsened by asthma exacerbations and treatment

Dyslipidemia, elevated LDL cholesterol despite statin therapy

Persistent lower-extremity edema despite diuretic therapy

Hypokalemia, most likely drug-induced

Hypertension JNC-VI Risk Group C, blood pressure within target and stable

Coronary artery disease, stable

Obesity, stable

Chronic pain secondary to previous injury, stable

Status post–atrial fibrillation with cardioversion

Status post–knee replacement

Financial constraints affecting medication behaviors

Insufficient patient education regarding purposes and role of specific medications

Wellness, preventive, and routine monitoring issues: calcium/vitamin D supplement, magnesium supplement, depression screening, osteoporosis screening, dosage for daily aspirin

Strand et al. 1 proposed a systematic method for evaluation of and intervention for a patient’s pharmacotherapy, using a process called the Pharmacist’s Work-Up of Drug Therapy (PWDT). The PWDT has been modified by subsequent authors, 2 – 4 but the process remains grounded in the following five questions:

What are reasonable outcomes for this patient?

Based on current guidelines and literature, pharmacology, and pathophysiology, what therapeutic endpoints would be needed to achieve these outcomes?

Are there potential medication-related problems that prevent these endpoints from being achieved?

What patient self-care behaviors and medication changes are needed to address the medication-related problems? What patient education interventions are needed to enhance achievement of these changes?

What monitoring parameters are needed to verify achievement of goals and detect side effects and toxicity, and how often should these parameters be monitored?

Outcomes and Endpoints

Clinical outcomes are distinctly different from therapeutic or interventional endpoints. The former refers to the impact of treatment on patients’ overall medical status and quality of life and should emphasize patient-oriented evidence that matters (POEMs) rather than disease-oriented evidence (DOEs).

Therapeutic endpoints include the anticipated and desired clinical effects from drug therapy that are expected, ultimately, to achieve the desired outcome(s). As such, therapeutic endpoints are used as surrogate markers for achievement of outcomes. Commonly, more than one endpoint will be needed to achieve an outcome. For example, near-normal glycemic control and normalization of blood pressure (endpoints) would be necessary to significantly reduce the risk of end-stage renal disease (outcome).

Therapeutic endpoints should be specific, measurable, and achievable within a short period of time. Achievement of clinical outcomes usually cannot be determined except by long-term observation or retrospective analysis.

Outcomes and endpoints for any given patient should be determined collaboratively between patient and provider before selecting or initiating pharmacotherapy or nonpharmacological interventions. Taking the time to identify these components up front (and periodically revise them later on) helps ensure that subsequent medications or strategies are appropriately directed. It further ensures a common vision and commitment for ongoing patient care and self-management among the care team (including the patient), thus maximizing the potential for optimal disease control and patient satisfaction.

The outcomes and endpoints for a patient such as B.L. are numerous and obviously would not be addressed or attained in a single session. Therefore, after desired outcomes and endpoints are determined, they should be prioritized according to medical urgency and patient preference. Implementation and goal setting related to these priorities can then be undertaken, thus establishing a treatment plan for the eventual attainment of the full list.

During ongoing and follow-up visits, this care plan should be reviewed and modified as indicated by changes in patient status, preferences, and medical findings. Examples of desired outcomes and endpoints for B.L. are given in Tables 1 and 2 . For the sake of brevity, these tables are not intended to be inclusive.

Medication-Related Problems and Proposed Interventions

With agreement between patient and clinician concerning desired outcomes and endpoints, the next logical step is to evaluate whether the current treatment plan is likely to achieve those goals, or, if treatment is to be initiated, which therapies or interventions should be selected.

According to Strand et al., 1 a medication-related problem is any aspect of a patient’s drug therapy that is interfering with a desired, positive patient (therapeutic) outcome or endpoint. The PWDT proposes a systematic and comprehensive method to identify, resolve, or prevent medication-related problems based on the following major categories:

No indication for a current drug

Indication for a drug (or device or intervention) but none prescribed

Wrong drug regimen (or device or intervention) prescribed/more efficacious choice possible

Too much of the correct drug

Too little of the correct drug

Adverse drug reaction/drug allergy

Drug-drug, drug-disease, drug-food interactions

Patient not receiving a prescribed drug

Routine monitoring (labs, screenings, exams) missing

Other problems, such as potential for overlap of adverse effects

Once problems are identified, resolutions must be developed, prioritized, and implemented. Patient or caregiver input is especially helpful at this stage because the individual can describe subjective as well as objective data, expectations or concerns that may be affecting drug therapy, and deficits in drug knowledge, understanding, or administration.

Resolutions may result from numerous strategies, including dose alteration, addition or discontinuation of medication, adjunct medications, regimen adjustment, complementary therapies, instruction on medication administration or devices, disease or medication education, development of “cues” as compliance reminders (e.g., pill boxes), and identification of ways to avoid, detect, or manage side effects or toxicities. Needless to say, the involvement of patients and family or caregivers is critical for successful implementation of most resolution strategies and for optimal disease management.

Because of the extent of B.L.’s medication-related problems and potential interventions ( Tables 3 and 4 ), it was agreed to tackle first her asthma exacerbations and high blood glucose levels. To this end, B.L. was counseled about the role of maintenance asthma medications versus rescue drugs. The root of her confusion between these agents was easy to understand—because the prednisone and fluticasone were both called steroids, it seemed likely that the tablets were a cheaper and easier way to take the medicine. Likewise, since albuterol and salmeterol were both called bronchodilators, it seemed that the albuterol was the cheaper way to take the medicine.

Having grasped the concept of asthma prevention, she was willing to convert to a product combining fluticasone and salmeterol (Advair Diskus) for maintenance/prevention and to reserve the albuterol for quick relief of acute symptoms. Free samples of the new product were dispensed, and B.L. was enrolled in the manufacturer’s indigent drug program for subsequent supplies.

She was further instructed on the use of a peak flow meter and advised to monitor her readings and symptoms. At the next visit, these data will be used to determine her maximal expiratory effort (“personal best”) and to construct an asthma action plan.

B.L.’s insulin was changed to a basal-based regimen utilizing bedtime glargine (Lantus) insulin and premeal lispro (Humalog) insulin. Education was provided on this dosing concept. She and the pharmacist discussed how this regimen can give greater flexibility in dosing, especially for responding to changes in diet, exercise, and disease exacerbations or medications. She was also given an initial supplementary adjustment algorithm (sliding scale) to correct for any temporary elevation of blood glucose. She agreed to test four times daily and to record her blood glucose results, carbohydrate intake, and insulin doses. At the next visit, these data will be used to modify the adjustment algorithm and to construct a prospective algorithm for matching premeal bolus insulin to the anticipated carbohydrate intake (insulin-to-carbohydrate ratio).

The final interventions for this visit were to increase the dose of potassium chloride and change the fluvastatin to atorvastatin (Lipitor) to further reduce B.L.’s LDL cholesterol. Medication education for atorvastatin was provided, and patient questions were answered.

Other medication-related problems and interventions identified for B.L. are listed and briefly discussed in Tables 3 and 4 . For the sake of brevity, these lists are not inclusive nor are all pharmacotherapy issues discussed.

Monitoring for Effectiveness, Side Effects, and Toxicity

The last step in the PWDT process is to develop a plan to evaluate the patient’s progress in attaining desired outcomes, therapeutic endpoints, and behavior changes; to assess effectiveness of pharmacotherapy; and to identify side effects, drug interactions, or toxicity issues that need to be addressed.

The monitoring/follow-up component is the most tedious aspect of the PWDT. For each medication or intervention, key parameters must be identified as markers for effectiveness, for side effects, for drug interactions, and for toxicity. In addition, the time frame and process for assessing those parameters must be determined. Finally, the desired range for the parameter must be listed or a “decision point” must be identified to signal that additional action will be required.

It should be noted that only a limited number of parameters are selected for a given patient. For example, it is not necessary to list and monitor for every possible side effect with equal intensity and frequency. Selection of the monitoring parameters is based on the positive effects (efficacy) that are most important to the care of that patient, as well as the adverse effects (side effects, toxicity, or drug interactions) that are most important to avoid for the safety of that patient or to which that patient is most prone.

Because the monitoring component is usually extensive, examples listed for B.L. in Table 5 have been limited to three of the medication or regimen changes that were made at the first pharmacist visit: switching from fluvastatin to atorvastatin; switching from two shots of premixed 75/25 lispro to bedtime glargine with premeal lispro; and substituting the combination inhaler product for her fluticasone and salmeterol MDI prescriptions. Because atorvastatin and fluvastatin differ chemically, the monitoring parameters for this change are similar to those for initiation of a new medication. Monitoring for the new insulin regimen (basal insulin with premeal bolus) focuses primarily on glycemic control patterns and hypoglycemic episodes. Because B.L. has previously used the two ingredients of her new inhaler product (fluticasone and salmeterol) without adverse effect, monitoring of her new asthma therapy is focused on effectiveness, tolerance of inhalation of its dry powder formula, and use of the administration device.

Diabetes patients with multiple co-morbidities have concerns about all of their problems, not just the diabetes; therefore, BC-ADM pharmacists must comprehensively explore all the ramifications of comorbidities as well as patients’ feelings, expectations, and concerns for total health. B.L. is a good example of this; even though her referral was for “diabetes management,” her greatest concern at this visit was her asthma exacerbations.

As can be seen in this case, each coexisting disease or coprescribed drug has a domino effect, affecting other diseases or drugs and ultimately affecting quality of life. With input from B.L., the pharmacist clinician was able to develop a PWDT that addresses her diabetes as well as her other health care needs.

B.L. was able to leave the health center with a few achievable self-care goals and medication changes that address her acute concerns and with the knowledge and confidence that, at each subsequent visit, additional progress will be made toward her personalized health status goals.

Examples of B.L.’s Desired Outcomes

Examples of B.L.’s Therapeutic Endpoints

Examples of B.L.’s Medication-Related Problems

Examples of B.L.’s Interventions (Prioritized and to be Implemented Accordingly)

Examples of B.L.’s Monitoring Plans

Peggy Yarborough, PharmD, MS, BC-ADM, CDE, FAPP, FASHP, NAP, is a professor at Campbell University School of Pharmacy in Buies Creek, N.C., and a pharmacist clinician at Wilson Community Health Center in Wilson, N.C.

For information concerning POEMs and DOEs: a multitude of literature on this topic is available through Internet sources. Search for “patient oriented evidence that matters” using a medical topic browser.

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Pharmacotherapy Casebook: A Patient-Focused Approach 12th Edition

Author(s): Terry L. Schwinghammer; Julia M. Koehler; Douglas Slain; Jill S. Borchert; Sharon K. Park

Principles of Patient-Focused Therapy

• 11 Chemical Threat Agent Exposure
• 9 Clinical Toxicology: Acetaminophen Toxicity
• 10 Cyanide Exposure
• 7 Geriatrics
• 8 Palliative Care
• 6 Pediatrics

Cardiovascular Disorders

• 16 Acute Coronary Syndrome: ST-Elevation Myocardial Infarction
• 20 Acutely Decompensated Heart Failure
• 26 Atrial Fibrillation
• 27 Cardiac Arrest
• 23 Chronic Anticoagulation
• 21 Deep Vein Thrombosis
• 14 Dyslipidemia
• 19 Heart Failure with Preserved Ejection Fraction
• 18 Heart Failure with Reduced Ejection Fraction
• 12 Hypertension
• 13 Hypertensive Crisis
• 28 Hypovolemic Shock
• 17 Peripheral Arterial Disease
• 22 Pulmonary Embolism
• 15 Stable Ischemic Heart Disease
• 25 Ventricular Arrhythmia

Respiratory Disorders

• 29 Acute Asthma
• 30 Chronic Asthma
• 31 Chronic Obstructive Pulmonary Disease
• 33 Cystic Fibrosis
• 32 Pulmonary Artery Hypertension

Gastrointestinal Disorders

• 48 Acute Pancreatitis
• 45 Ascites Management in Portal Hypertension and Cirrhosis
• 49 Chronic Pancreatitis
• 42 Constipation
• 38 Crohn Disease
• 41 Diarrhea
• 46 Esophageal Varices
• 34 Gastroesophageal Reflux Disease
• 47 Hepatic Encephalopathy
• 43 Irritable Bowel Syndrome
• 40 Nausea and Vomiting
• 36 NSAID-Induced Ulcer Disease
• 44 Pediatric Gastroenteritis
• 35 Peptic Ulcer Disease
• 37 Stress Ulcer Prophylaxis
• 39 Ulcerative Colitis
• 50 Viral Hepatitis A
• 51 Viral Hepatitis B
• 52 Viral Hepatitis C

Renal Disorders

• 54 Acute Kidney Injury
• 53 Drug-Induced Acute Kidney Injury
• 58 Electrolyte Abnormalities in Chronic Kidney Disease
• 56 End-Stage Kidney Disease
• 59 Hypercalcemia of Malignancy
• 60 Hypokalemia and Hypomagnesemia
• 61 Metabolic Acidosis
• 62 Metabolic Alkalosis
• 55 Progressive Kidney Disease
• 57 Syndrome of Inappropriate Antidiuretic Hormone Release

Neurologic Disorders

• 68 Acute Management of the Traumatic Brain Injury Patient
• 71 Acute Pain Management
• 63 Alzheimer Disease
• 70 Chronic Pain Management
• 65 Complex Partial Seizures
• 66 Generalized Tonic–Clonic Seizures
• 73 Migraine Headache
• 64 Multiple Sclerosis
• 72 Pain, Agitation, and Delirium in Critical Care
• 69 Parkinson Disease
• 67 Status Epilepticus

Psychiatric Disorders

• 77 Alcohol Withdrawal
• 74 Attention-Deficit Hyperactivity Disorder
• 81 Bipolar Disorder
• 75 Bulimia Nervosa
• 82 Generalized Anxiety Disorder
• 84 Insomnia
• 80 Major Depression
• 78 Nicotine Dependence
• 83 Obsessive–Compulsive Disorder
• 76 Opioid Use Disorder
• 79 Schizophrenia

Endocrinologic Disorders

• 91 Addison Disease
• 90 Cushing Syndrome
• 92 Hyperprolactinemia
• 88 Hyperthyroidism: Graves Disease
• 89 Hypothyroidism
• 85 Type 1 Diabetes Mellitus and Ketoacidosis
• 87 Type 2 Diabetes Mellitus: Existing Disease
• 86 Type 2 Diabetes Mellitus: New Onset

Urologic Disorders

• 100 Benign Prostatic Hyperplasia
• 99 Erectile Dysfunction
• 101 Urinary Incontinence

Immunologic Disorders

• 103 Allergic Drug Reaction
• 104 Solid Organ Transplantation
• 102 Systemic Lupus Erythematosus

Bone and Joint Disorders

• 108 Gout and Hyperuricemia
• 105 Osteoarthritis
• 107 Osteoporosis
• 106 Rheumatoid Arthritis

Dermatologic Disorders

• 111 Acne Vulgaris
• 113 Atopic Dermatitis
• 114 Dermatologic Drug Reaction
• 112 Psoriasis

Hematologic Disorders

• 117 Folic Acid Deficiency
• 115 Iron Deficiency Anemia
• 118 Sickle Cell Anemia
• 116 Vitamin B12 Deficiency

Infectious Diseases

• 123 Acute Bronchitis
• 126 Acute Pharyngitis
• 149 Adult Immunization
• 147 Antimicrobial Prophylaxis for Surgery
• 120 Bacterial Meningitis
• 143 Bacterial Vaginosis
• 144 Candida Vaginitis
• 133 Clostridioides Difficile Infection
• 121 Community-Acquired Pneumonia
• 128 Coronavirus Vaccination and Treatment
• 142 Dermatophytosis
• 130 Diabetic Foot Infection
• 139 Genital Herpes, Gonococcal, and Chlamydial Infections
• 150 HIV Infection
• 122 Hospital-Acquired Pneumonia
• 146 Infection in an Immunocompromised Patient
• 131 Infective Endocarditis
• 127 Influenza
• 134 Intra-Abdominal Infection
• 145 Invasive Fungal Infections
• 135 Lower Urinary Tract Infection
• 140 Osteomyelitis and Septic Arthritis
• 124 Otitis Media
• 148 Pediatric Immunization
• 137 Pelvic Inflammatory Disease and Other Sexually Transmitted Infections
• 136 Pyelonephritis
• 125 Rhinosinusitis
• 129 Skin and Soft Tissue Infection
• 138 Syphilis
• 132 Tuberculosis
• 119 Using Laboratory Tests in Infectious Diseases

Oncologic Disorders

• 158 Acute Lymphocytic Leukemia
• 151 Breast Cancer
• 159 Chronic Myeloid Leukemia
• 153 Colon Cancer
• 156 Hodgkin Lymphoma
• 160 Kidney Cancer
• 161 Melanoma
• 155 Non-Hodgkin Lymphoma
• 152 Non–Small Cell Lung Cancer
• 157 Ovarian Cancer
• 154 Prostate Cancer
• 162 Stem Cell Transplantation

Nutrition and Nutritional Disorders

• 164 Adult Enteral Nutrition
• 165 Obesity
• 163 Parenteral Nutrition

Gynecologic and Obstetric Disorders

• 94 Contraception
• 95 Emergency Contraception
• 97 Endometriosis
• 98 Managing Menopausal Symptoms
• 93 Pregnancy and Lactation
• 96 Premenstrual Dysphoric Disorder

Eyes, Ears, Nose, and Throat Disorders

• 110 Allergic Rhinitis
• 109 Glaucoma

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Pharmacy Case Study

Your team is faced with the challenge of thinking of ways to improve the medication adherence among elderly patients. These elderly patients are particularly challenging because of polypharmacy and potential age-related impairments. They often use several medications often prescribed by multiple providers.

You believe that incorporating a PharmD on the health care team can improve the management of chronic diseases for these patients as pharmacists are highly accessible healthcare providers and pharmacist services can improve medication adherence for the population. The health system has limited resources and wants to verify what pharmacist-led interventions are most effective before developing a plan.

For accessible versions of these activities, please refer to our document Step 1: Ask – Accessible Case Studies .

Evidence-Based Practice Copyright © by Various Authors - See Each Chapter Attribution is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

Case-based learning: recognising sepsis

Sepsis can lead to organ failure and death. However, early diagnosis and recognition may help prevent these potentially fatal consequences.

JL / Science Photo Library / Shutterstock.com

Several personal stories of sepsis survivors and deaths from sepsis have been published in the media, highlighting the importance of sepsis as a major cause of preventable deaths in the UK. This article will provide an overview of sepsis with particular focus on the role of pharmacy professionals in recognition and referral.

Pathophysiology

Sepsis is characterised by a systemic inflammatory response to an invasive infection that has become unregulated [1] . White blood cells and pro-inflammatory cytokines are released causing widespread vasodilation and an increase in capillary permeability, resulting in the loss of fluid from circulation. This results in hypovolaemia and a fall in systemic vascular resistance, which in turn leads to a fall in blood pressure and a decrease in organ perfusion, culminating in tissue hypoxia and organ failure [1] .

There are around 250,000 cases of sepsis annually in the UK, 20% of which are fatal [1], [2] . The UK Sepsis Trust estimates that early diagnosis of sepsis and the application of evidence-based treatment could save 14,000 lives per year [2] . Therefore, the timely identification of sepsis can lead to rapid treatment and potential mortality reduction.

Initial recognition of sepsis relies on identifying symptoms, which presents challenges for healthcare professionals as the common symptoms are not specific to sepsis and could be caused by non-infective pathology (e.g. trauma, pancreatitis, burns ) [3] .

The inflammatory-response-induced hypovolaemia affects the brain and can cause confusion, slurred speech and loss of consciousness. Similarly, as the kidneys are affected, there is a reduction in glomerular filtration resulting in a drop in urine output and development of acute kidney injury [1] , [3] .

Gas exchange across the alveoli is compromised as fluid and proteins leak into the lungs, causing a drop in systemic oxygen saturation and a rise in carbon dioxide levels. The body attempts to compensate by increasing its respiratory rate, but the problem is ultimately compounded as the drop in organ perfusion affects the lungs, meaning that even if oxygen-rich air is present, there is little blood flow with which gas exchange can take place [1] , [3] .

Initially, the heart rate increases in an attempt to compensate for the drop in blood pressure. However, the reduction in circulating volume and the fall in systemic vascular resistance ultimately undermine this action. This is because a reduction in venous return prevents the ventricles from properly filling before they contract, reducing the cardiac output [1] .

The typical signs and symptoms of sepsis may vary across different age groups, be general or may not all be present. Examples of moderate- and high-risk symptoms include:

• Reduced urine output (e.g. dry nappies in babies and toddlers);
• Feeling cold with shivering or chills;
• Rapid breathing (increased resting breaths per minute);
• Rapid heart rate (increased resting heart rate per minute);
• Mottled (see Photoguide A) or ashen appearance;
• Cyanosis (blue tint) of skin, lips or tongue (see Photoguide B);
• Non-blanching rash (see Photoguide C) [1] , [4] , [5] .

Additional signs in babies and young children (aged under five years)

• Not responding normally to social cues (e.g. does not smile);
• Visibly unwell (e.g. floppy or overly passive);
• Wakes only with prolonged stimulation or, if roused, does not stay awake;
• Weak high-pitched or continuous cry;
• Parent or carer is concerned that the child is behaving differently from normal;
• Has a seizure or convulsion;
• Pallor of the skin, lips or tongue;
• Cold extremities, but head and torso may be hot to the touch;
• Change in temperature (e.g. red flag temperatures are over 38 o C in those aged under 3 months, 39 o C in those aged 3–6 months and less than 36 o C for any age) [1] , [4] , [5] .

Additional signs that can affect patients aged over five years

• Evidence of new-onset confusion (history may be from a parent, carer, relative or friend);
• Slurred speech;
• Signs of potential infection (e.g. redness, swelling or discharge at surgical site, breakdown of the wound);
• Tympanic temperature less than 36 o C;
• New onset arrhythmia [1] , [4] , [5] .

If sepsis is suspected, the patient should be immediately referred for emergency medical assessment. 

Photoguide: symptoms of sepsis

Source: Science Photo Library / Shutterstock.com

At-risk groups

Sepsis can affect anyone, but there are some patient groups that should be considered to be more susceptible to the development of sepsis, including:

• Very young children (aged under 1 year);
• Frail or older people (aged over 75 years);
• Immunocompromised people (e.g. those being treated for cancer with or without chemotherapy, post-splenectomy, taking long-term steroids or other immunosuppressant drugs);
• People who have had surgery or other invasive procedures in the past six weeks;
• People with any breach of skin integrity (e.g. cuts, burns, blisters or skin infections);
• People who misuse drugs intravenously;
• People with indwelling lines or catheters;
• Pregnant women;
• Women who have given birth or who have had a termination of pregnancy or miscarriage in the past six weeks [4] .

Understanding the patient risk factors may help improve timely diagnosis of suspected sepsis.

Sepsis can occur in response to a wide range of infections, but is most commonly associated with bacterial infection of the lungs, urinary tract, abdomen, central nervous system, or skin and soft tissues [1] . It is primarily diagnosed by a clinical assessment. Any number or combination of signs and symptoms may be present on diagnosis.

The National Institute of Health and Care Excellence (NICE) and the UK Sepsis Trust have published risk stratification tools to facilitate appropriate recognition of sepsis and the level of risk to the patient. Most NHS organisations use these tools or a locally approved variation of them [1] , [4] . These tools cater to a wide range of patients of different ages and the recommended action differs depending on whether patients’ symptoms are recognised in the primary or secondary care setting.

Patients who meet the high-risk criteria (see Box for the criteria for children aged under five years) should be sent urgently for emergency care (at a setting with resuscitation facilities). These patients should receive intravenous antibiotics with an appropriate level of cover within one hour of recognition of sepsis, along with other treatments and investigations [1] , [4] .

Box: high-risk criteria for children aged under five years outside of the hospital setting

• No response to social cues;
• Appears ill to a healthcare professional;
• Does not wake, or if roused, does not stay awake;
• Weak high-pitched or continuous cry.
• Aged under one year: 160 beats per minute or more;
• Aged one to two years: 150 beats per minute or more;
• Aged three to four years: 140 beats per minute or more;
• Heart rate less than 60 beats per minute at any age.

Respiratory rate

• Aged under one year: 60 breaths per minute or more;
• Aged one to two years: 50 breaths per minute or more;
• Aged three to four years: 40 breaths per minute or more;
• Oxygen saturation of less than 90% in air or increased oxygen requirement over baseline.

Temperature

• Aged under three months: 38°C or more;
• Any age: less than 36°C.

To see examples of mottled skin or ashen appearance, non-blanching rash of the skin, and cyanosis of the skin, lips or tongue, see the Photoguide.

Source: National Institute for Health and Care Excellence [8]

Initial blood tests should be requested to aid diagnosis and further inform on the likelihood of infection and prognosis. These should include:

• C-reactive protein — to detect inflammatory response;
• Full blood count — to detect immune response;
• Lactate — to detect tissue hypoxia.

Other investigations, such as a chest X-ray or lumbar puncture, may also be indicated depending on the likely focus of the suspected infection.

Point-of-care testing and future diagnostics

In the future, point-of-care testing facilities for key biomarkers may have a greater role in both primary care and hospital emergency departments, aiding healthcare professionals in diagnosing infection and sepsis. Recently published research into the use of sensor technologies designed to rapidly report on raised levels of biomarkers closely associated with sepsis (notably interleukin-6) may have the potential to aid sepsis diagnosis in the future [6] , [7] .

Case studies

Case study 1: a 12-month-old baby with suspected sepsis.

A mother brings her 12-month-old daughter Alice* into the pharmacy and asks to speak to the pharmacist. The mother clearly appears concerned and expresses that Alice seems very poorly and is not her usual self.

Consultation

The mother explains that her daughter attended nursery today and the nursery staff phoned in the afternoon to report that Alice was not feeling well. As she had a temperature of 39 o C, they administered a dose of paracetamol. The nursery staff also said that Alice had not been eating or drinking well and her nappies were dry all day.

Alice takes no regular medicine and has no ongoing health problems. She seems withdrawn and is not smiling or engaging with anyone, which the mother insists is unusual behaviour.

When assessing the patient, Alice’s hands feel cold despite her body and head feeling hot. During the interaction with Alice, she is noticeably very passive and inactive, and seems floppy in her mother’s arms. Alice does not appear to have a rash, though her skin appears pale.

Alice’s breathing appears very rapid.

Information given in the consultation suggests that Alice may have sepsis. Use the  National Institute for Health and Care Excellence ‘Sepsis risk stratification tool’ for children aged under five years out of hospital and compare it to the information obtained during the consultation [8] . By doing so, it is apparent that the following moderate-to-high risk criteria were demonstrated by the patient:

• Behaviour: parent or carer concern that the child is behaving differently than usual; not responding normally to social cues; no smile; and decreased activity;
• Cold hands or feet;
• Reduced urine output;
• Between 40 and 49 breaths per minute (normal resting respiratory rate for a 12-month-old is typically 20–40 breaths per minute);
• Pallor of skin, lips or tongue.

Although her temperature was high (39 o C), this would only be a moderate-risk criterion if Alice was aged between 3–6 months of age outside the hospital setting.

Advice and recommendations

Alice’s symptoms clearly indicate moderate-to-high risk of sepsis. According to the risk stratification tool, Alice should be referred either for a definitive diagnosis for treatment outside the hospital (i.e. to the patient’s GP), or to hospital for further review.

Considering the risk of sepsis and the importance of timely management, referral to hospital is the best choice for this patient. Calmly and clearly explain to the mother that Alice may have a serious infection and that the best course is for her to go to the hospital immediately.

Case study 2: an 11-year-old child with a viral infection

An 11-year-old boy called Liam* is brought into the pharmacy by his parents. They explain that he has not been feeling well for the past few days. The parents want to know if Liam’s symptoms can be treated with an over-the-counter (OTC) product or whether they should take him to the GP.

Liam has been unwell for the past three or four days and his condition does not seem to be improving. He has not yet taken any medicine for this illness. His temperature was 37.8 o C when most recently checked using an ear thermometer at home.

Liam says that he has a sore throat, a cough and a blocked nose. Liam describes the severity of his throat pain as three out of ten. Liam has been eating and drinking normally, has no long-term medical conditions and takes no regular medicine.

Liam and his parents agree that his behaviour and function are normal and he appears alert and coherent through the consultation. Liam’s breathing rate does not appear to be raised and his skin and lips appear normal, with no signs of a rash.

Liam may have an infection, which is likely to be viral, but does not require medical attention at present. However, to rule out sepsis, use the  National Institute for Health and Care Excellence ‘Sepsis risk stratification tool’ for children aged 5–11 years out of hospital and compare this to the information obtained during the consultation [8] . By doing so, it is apparent that no moderate-to-high risk criteria were demonstrated by the patient.

Liam can be treated with OTC analgesics to alleviate his throat pain and his raised temperature. Liam’s parents should ensure he is taking plenty of fluids and continue to monitor his temperature. If they become concerned about his condition, his behaviour or general functional ability, they should return to or call the pharmacy. Particular symptoms you advise them to look out for include development of a rash, if his skin becomes pale or mottled, his urine output drops, his breathing rate increases, or any general concern that mental state or activity is not normal.

Case study 3: an adult with red flag sepsis

Rahul*, a 28-year-old man, comes into the pharmacy and asks to see the pharmacist as he has begun to feel very unwell.

Rahul works as a driver, and he fell and scraped his leg while getting out of his van the previous day. Rahul explains that at the time he did not think much about the cut, so he did not clean or dress the wound and has not yet taken any medicine for it. Although the wound began to swell and weep overnight, Rahul went into work this morning, but left when he suddenly started to feel seriously unwell — around an hour ago.

Rahul says the wound now looks much worse than it previously did. On examination you find the wound is very red and swollen, the tissue around the wound is blistering and weeping, and there are red track marks extending further up Rahul’s leg. It is clear that this wound is infected.

Rahul uses inhalers for mild asthma, but otherwise takes no regular medicine.

Rahul says he is feeling hot and sluggish, and is clearly struggling to maintain his train of thought. His condition appears to be worsening by the minute. He needs to be referred for further help, but more information is required to decide whether he is referred to his GP or to a hospital emergency department. 

Rahul’s temperature is 35.8 o C. His breathing appears to be rapid. His blood pressure is 92/58mmHg and his heart rate is 140 beats per minute. Rahul does not appear to have a skin rash, although his lips seem to have a blue tint.

Rahul is likely to have a serious infection, which requires urgent attention. Use the National Institute for Health and Care Excellence ‘Sepsis risk stratification tool’ for people aged 18 years and over outside of the hospital setting and compare this to the information obtained during the consultation [8] . The patient has moderate- to high-risk criteria, such as tympanic temperature less than 36 o C and signs of potential infection. He also has several high-risk criteria that require urgent referral to emergency care:

• Altered behaviour or mental state;
• Respiratory rate over 25 breaths per minute;
• Heart rate more than 130 beats per minute;
• Cyanosis of skin, lips or tongue.

Tell Rahul that it is likely that he has a serious infection, and ask him to sit and wait in the pharmacy while an ambulance is called. It is not safe for him to drive to hospital. Share his information with the 999 operator and make another note of the details gathered during the consultation to hand over to the ambulance team upon arrival.

*All cases are fictional

Useful additional resources

• The UK Sepsis Trust. The Sepsis Manual. 2017–2018: Available at:  https://sepsistrust.org/wp-content/uploads/2018/06/Sepsis_Manual_2017_web_download.pdf
• National Institute for Health and Care Excellence. Sepsis: risk stratification tools. Available at:  https://www.nice.org.uk/guidance/ng51/resources/algorithms-and-risk-stratification-tables-compiled-version-2551488301
• For patients who are interested in finding out more about sepsis you can direct them to the NHS website. Available at:  https://www.nhs.uk/conditions/sepsis/

[1] The UK Sepsis Trust. The Sepsis Manual. 2017–2018. 2017. Available at: https://sepsistrust.org/wp-content/uploads/2018/06/Sepsis_Manual_2017_web_download.pdf (accessed October 2019)

[2] The UK Sepsis Trust. Professional Resources. Available at: https://sepsistrust.org/professional-resources/ (accessed October 2019)

[3] Gotts JE & Matthay MA. Sepsis: pathophysiology and clinical management. BMJ 2016;353:i1585.  doi: 10.1136/bmj.i1585

[4] National Institute for Health and Care Excellence. Sepsis: recognition, diagnosis and early management. NICE guideline [NG51]. 2016. Available at: https://www.nice.org.uk/Guidance/NG51 (accessed October 2019)

[5] National Health Service: Overview — Sepsis. 2019. Available at: https://www.nhs.uk/conditions/sepsis/ (accessed October 2019)

[6] Russell C, Ward AC, Vezza V et al . Development of a needle shaped microelectrode for electrochemical detection of the sepsis biomarker interleukin-6 (IL-6) in real time. Biosens Bioelectron 2019;126:806–814. doi: 10.1016/j.bios.2018.11.053

[7] Dolin H, Papadimos T, Stepkowski S et al. A novel combination of biomarkers to herald the onset of sepsis prior to the manifestation of symptoms. Shock 2018;49(4):364–370. doi: 10.1097/SHK.0000000000001010

[8] National Institute for Health and Care Excellence. Sepsis: Risk stratification tools. 2017. Available at: https://www.nice.org.uk/guidance/ng51/resources/algorithms-and-risk-stratification-tables-compiled-version-2551488301 (accessed October 2019)

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Taxpayers Were Overcharged for Patient Meds. Then Came the Lawyers.

A group of politically connected lawyers teamed up to go after insurers and made millions from one of the largest Medicaid settlements in history.

By Shalina Chatlani

Shalina Chatlani examined the health care system in Mississippi as a part of The Times’s Local Investigations Fellowship .

In 2018, when Mike DeWine was Ohio’s attorney general, he began investigating an obscure corner of the health care industry.

He believed that insurers were inflating prescription drug prices through management companies that operated as middlemen in the drug supply chain. There were concerns that these companies, known as pharmacy benefit managers, or P.B.M.s, were fleecing agencies like Medicaid, the government-run health insurance program for the poor.

Three years later, after Mr. DeWine became governor of Ohio, the state announced an $88 million settlement with one of the nation’s largest insurance companies, Centene.

The case led to a nationwide reckoning for the company, as attorneys general in one state after another followed Ohio’s lead, announcing multimillion-dollar settlements and claiming credit for forcing Centene to reform its billing practices.

On the surface, it appeared that these settlements, which now total nearly $1 billion, were driven by state governments cracking down on a company that had ripped off taxpayers.

But a New York Times investigation, drawing on thousands of pages of court documents, emails and other public records in multiple states, reveals that the case against Centene was conceived and executed by a group of powerful private lawyers who used their political connections to go after millions of dollars in contingency fees.

The lawyers were first hired in Ohio, without competitive bidding. Then, they gathered evidence against Centene of questionable billing practices across the country.

Using information they acquired from Centene and other sources, they negotiated with the company to set the basic framework of an agreement that could be applied in other states. With that in hand, they approached attorneys general in multiple states and made a compelling offer: hire them, at no direct cost to taxpayers, and recoup millions of dollars Centene had already set aside.

So far, the lawyers have been awarded at least $108 million in fees.

The Centene case is just one example in a thriving industry that allows private lawyers to partner with elected attorneys general and temporarily gain powers usually reserved for the government. Under the banner of their state partners, these lawyers sue corporations and help set public policy while collecting millions of dollars in fees, usually based on a percentage of whatever money they recoup. The practice has become standard fare in the oversight of major industries, shifting the work of accountability away from legislators and regulators to the opaque world of private litigation.

Private lawyers do not have to publicly defend the deals they make or prove how aggressively they went after a company accused of wrongdoing. Nearly all their work happens in secret, especially if companies settle before the stage of a lawsuit when evidence is filed with the court.

The lawyers do not even have to disclose who worked on a case or who was paid, so the public may be left unable to monitor potential conflicts of interest even as the lawyers pursue litigation on behalf of the people.

The Centene case was organized by the Mississippi-based law firm Liston & Deas along with at least three other firms, several with close ties to former Gov. Haley Barbour of Mississippi, who was once considered one of the most influential Republican power brokers in the nation.

The lawyers included Paul Hurst, who served as Mr. Barbour’s chief of staff when he was governor and who married into Mr. Barbour’s family, and David H. Nutt, one of the richest men in Mississippi, who amassed a fortune funding state lawsuits against tobacco companies. Cohen Milstein, a huge national law firm with deep experience in contingency work for state attorneys general, was also part of the venture.

Though he is not listed in any government contracts as a lawyer of record, Mr. Barbour himself was a member of the legal team when Liston & Deas vied for the contract in Ohio.

At the time, Mr. Barbour also worked for Centene as a federal lobbyist .

Even now, close to three years after Centene signed its first settlements, no one has fully explained Mr. Barbour’s role in the case for the company. There is no way for the public to know whether he influenced the outcome or to measure whether Centene paid its full share, because the data used to calculate what Centene overcharged remains hidden from the public under provisions designed to protect attorney work product.

Mr. Barbour and other lawyers said that the former governor worked on the case for less than a year when the group was examining several insurance companies, and that he cut ties when Centene emerged as the primary target. Mr. Barbour said he informed Centene and his colleagues about the development and was never involved in negotiations or legal matters. He continued representing Centene as a lobbyist, he said, but his role in the case on behalf of the company was as “more of an observer.”

The lawyers said that Mr. Barbour was never paid for his work and that the settlement was not influenced by Mr. Barbour’s connections to Centene or to the lawyers who remained. They said each state attorney general reviewed Centene’s billing practices when deciding whether to enter a settlement agreement.

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In recent years, P.B.M.s have been widely criticized , including by members of Congress, who have held multiple hearings and proposed legislation. The Centene settlements stand as the most successful attempt to hold a company operating in the industry accountable.

Liston & Deas and its partner law firms uncovered that Centene had arranged discounts with CVS Caremark on certain drugs and then pocketed the savings instead of passing them on to Medicaid. In some states, they revealed that Centene layered on unnecessary management fees that it had not disclosed. Although Centene settled without admitting guilt, the company agreed to be more transparent in how it sets reimbursement rates.

The lawyers noted that they spent several years investigating Centene and negotiating with the company at their own risk, saving states the cost of building a case.

Mr. Nutt, one of the lawyers who pursued the case, said states were happy with the terms of the settlements.

“Almost every one of those states audited to determine if our damage model was fair,” Mr. Nutt said.

“The formula was based on a triple damages model that we developed. And everybody was quite satisfied with it, because it was three times what anybody could have proven in court.”

Hiring Outside Counsel

For most of their history, state attorneys general were largely focused on advising state officials on legal matters and representing local agencies in court.

That changed drastically almost 30 years ago, when states came together to sue tobacco companies and won a $206 billion settlement to cover the cost of medical care related to smoking. The lawsuit helped redefine the role of the attorney general as one of the most powerful positions in state government and a natural place to start a political career.

Through high-profile lawsuits against corporations, an attorney general could directly affect policy and build a reputation as a champion of the people.

But complex litigation against large companies can require years of investigation and legal work, with no guarantee of success. Increasingly, states have turned to private lawyers willing to work on contingency as a way to stretch limited resources.

The rise of contingency fee cases kicked off a new wave of lobbying across the nation. Law firms looking for contracts have poured money into attorney general election campaigns and sponsored conferences at high-priced resorts, where private lawyers mingle with attorneys general and pitch their latest ideas for lawsuits.

Many states have capped how much lawyers can be paid in contingency fees and have increased oversight of private firms working for the government. But there remains concern about undue political influence and potential conflicts of interest.

“In theory, there’s an incentive to have the settlement be as big as possible, and of course that’s great for the state,” said Paul Nolette, a professor at Marquette University who has studied how the role of attorneys general has changed over time.

But in reality, lawyers have an incentive to recover the largest amount of money in the shortest amount of time, which could pressure them to water down settlements and compromise on punitive measures, Dr. Nolette said.

“I think that does raise some questions about how forcefully A.G.s and private attorneys are prosecuting a particular case,” he said.

Several experts said that contingency cases had recouped billions of dollars on behalf of the public and had become a critical way to regulate the behavior of powerful industries and large corporations.

But inviting private lawyers to help set public policy has inherent risks, they said.

Private lawyers may be more likely to have conflicts of interest because they generally represent many businesses and individuals, not just the citizens of a state.

And unlike most attorneys general, private lawyers are not elected officials. They are not generally governed by open records laws or subject to public pressure, as from legislators setting their budgets.

In the Centene case, Mr. Barbour’s associations with both Centene and the private lawyers raise “important questions” about who controlled the case to make sure it was pursued in the best interests of states that settled, said Kathleen Clark, a professor of legal ethics at Washington University in St. Louis.

“Did state A.G.s proactively pursue these cases, or did they passively accept the ‘free money’ or ‘easy money’ of the proposed settlements that the law firms had already negotiated with Centene?” Ms. Clark asked.

Christina Saler, a partner at Cohen Milstein, said Mr. Barbour’s early association with the legal team was not a conflict of interest because Mr. Barbour withdrew from the case before lawyers started investigating Centene.

“After Mr. Barbour’s disassociation, we had no further contact with Mr. Barbour on this matter,” she said.

A Well-Connected Team

Mr. Barbour’s involvement in the Ohio case against P.B.M.s illustrates the potential for favoritism when states hire private lawyers.

Mr. Hurst noted the involvement of Mr. Barbour when seeking the contract in Ohio, according to emails acquired from the Ohio attorney general’s office through a public records request.

In a June 22, 2018, email exchange, just a few days before the state hired Liston & Deas, Mr. Hurst recalled meeting with the attorney general’s staff in Ohio.

Mr. Hurst went on to note that members of his team had worked with Governor Barbour while he was in office and that they all “continue to work together now.”

In an email a week later, an assistant attorney general shared Mr. Barbour’s cell number with Mr. DeWine, saying that Mr. Barbour had shared it so he could “call him about this case anytime.”

Mr. Barbour, who had served two terms as governor of Mississippi, was a former chairman of the Republican Governors Association and a former chairman of the Republican National Committee. Known as a prolific fund-raiser , he was credited with bringing in hundreds of millions of dollars to support Republican candidates across the nation.

In 1991, Mr. Barbour co-founded BGR Group, a lobbying firm that quickly became one of the most influential in Washington.

Mr. Barbour had known Mr. DeWine since he was first elected to the Senate in 1995.

Two decades later, when Mr. DeWine was in the midst of a hard-fought campaign for governor, Mr. Barbour’s close associates solicited him for the legal work on the Centene case. In October 2018, less than three months after Mr. DeWine hired Liston & Deas, he traveled to Washington to visit Mr. Barbour’s lobbying firm for several hours, according to calendar records.

At the time, Mr. Barbour and others at BGR were registered lobbyists for Centene.

Mr. Barbour has never been named in state contracts as one of the private lawyers on the case in Ohio or anywhere else. His involvement has rarely, if ever, been publicly reported.

Ms. Saler, of Cohen Milstein, said there was no need to inform state officials because Mr. Barbour had not been involved in the Centene portion of the case and had exited the venture several years before states hired the lawyers.

At least four law firms were involved in the case in two or more states, according to retainer agreements and financial records showing broadly how settlement funds were disbursed.

According to Max Littman, a former data analyst with HealthPlan Data Solutions, the analytics firm that helped identify Centene’s overcharges in Ohio, one important role for many of the lawyers was to use their connections as they presented the overcharges to various states.

Mr. Littman, who said he worked closely with the legal team, described the dynamic: Liston & Deas, with roots in a deeply red state, would approach Republican attorneys general, and Cohen Milstein, “who were our Democrats,” would focus on Democratic states.

When The Times asked for records showing Liston & Deas’s qualifications to be hired to represent the State of Ohio, the attorney general’s office said no records existed. Cohen Milstein and other law firms had submitted such documentation in the past when seeking contracts in Ohio.

Settling With States

In June 2021, nearly three years after Ohio hired its outside counsel, two states announced the first settlements with Centene on the same day: Ohio would get $88 million, Mississippi $55 million.

After that, Centene settled in one state after another, often with just months between announcements.

In fact, Centene had already set aside $1.1 billion to handle all subsequent cases. The company estimated the amount after early discussions with the private lawyers that did not involve the state attorneys general who would later work with them.

With a settlement in hand and an estimate of how much each state could collect, the private lawyers had a powerful pitch. The team also had the option to file whistle-blower lawsuits, which can advance without a state attorney general’s having to hire outside counsel.

The team pursued whistle-blower lawsuits in Texas, California and Washington.

In Texas, the whistle-blower lawsuit came with a benefit for Attorney General Ken Paxton: Under Texas law , his office is allowed to recoup “reasonable attorney’s fees” for work associated with such cases. It collected nearly $25 million in legal fees on the Centene case while spending just 561 hours on it, financial records show. That comes out to more than $44,000 per hour of work. The Texas attorney general’s office declined to comment.

Ms. Saler said all the state attorneys general decided their own strategies in reaching settlements with Centene based on the best interest of taxpayers in their states.

In states that hired the lawyers on contingency, the attorney general closely reviewed Centene’s billing practices. But no state has revealed whether its own overcharge calculations matched those of the private lawyers.

State officials who hired Liston & Deas and the other firms knew that the lawyers had previously negotiated with Centene. But in a vast majority of states, officials did not explicitly address that fact when talking publicly about the settlements.

In addition, Liston & Deas and most of the states the firm worked for have not revealed exactly how much Centene overcharged for drugs or how settlement amounts were calculated. A few states have offered sparse descriptions, which vary widely.

The New Hampshire attorney general’s office wrote in its settlement announcement that Centene’s activities had a “$2.4 million negative financial impact.” Centene agreed to pay the state nearly 10 times that amount.

The attorney general’s office in Washington, one of the few states where officials agreed to discuss basic details about the settlement with The Times, said the $33 million it recovered amounted to treble damages.

A news release from the California attorney general’s office said the state recovered double its damages, for a total settlement of more than $215 million.

As of last month, Centene had settled in at least 19 states. The Liston & Deas website says Centene will ultimately pay about $1.25 billion to 22 states.

A Sweetheart Deal?

Some observers believe Centene would have faced stricter penalties if the federal government had taken up the case instead of private lawyers hopscotching from one state to the next.

Several experts in health care fraud litigation and whistle-blower cases said the best way to recoup money for taxpayers would have been to file a federal whistle-blower case, similar to what the lawyers did in state court in Texas and California.

A federal case could have triggered the involvement of the Justice Department, which might have investigated Centene more thoroughly. And a federal case probably would have gotten more attention and media coverage, required more transparency and taken longer to complete, the experts said.

Mr. Hurst and other lawyers in the case said they had not filed any type of federal action against Centene.

A spokesperson for the Justice Department confirmed that it had inquired about the P.B.M. and Centene cases in Ohio, but no further federal action was taken. The department declined further comment.

Mary Inman, a lawyer at Whistleblower Partners L.L.P. with decades of experience, said one of the reasons Liston & Deas wound up in state court might have been that its case relied on whistle-blowers the federal government was unlikely to approve.

The whistle-blower in Texas was Mr. Hurst. In California, the whistle-blower was Matthew McDonald, a lawyer at David Nutt & Associates and the son of Bryan McDonald, who worked in Mr. Barbour’s administration when he was governor.

Ms. Inman said whistle-blowers are typically insiders with firsthand knowledge of wrongdoing who share information at some risk to themselves, not lawyers who gain information while on the job.

“It’s very unusual,” Ms. Inman said. “And it’s something that I, as a longtime lawyer in this space, I would not want to do because atmospherically and reputationally it doesn’t look great.”

Mr. Barbour said he believes everyone walked away from the settlements happy — including executives at Centene. As evidence, he cited the company’s stock performance.

“I can’t speak for them, but if I had agreed to pay a big settlement and my stock went up after the first day, I would think it was a pretty good settlement,” Mr. Barbour said.

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Case Studies in Pharmacy Ethics (3 edn)

Professor of Medical Ethics Emeritus and Senior Research Scholar

Director, Center for Health Policy and Ethics and Dr. C.C. and Mabel L. Criss Endowed Chair in Health Sciences

Medical Safety Clinical Pharmacist

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The third edition of Case Studies in Pharmacy Ethics presents a comprehensive series of cases faced by pharmacists that raise ethical issues, with chapters arranged in a manner that simultaneously presents the topics that would be covered in a course on ethical theory. After an introduction, the book is divided into three parts. The introduction takes up four basic issues in ethical theory: the source, meaning, and justification of ethical claims; the two major ways of determining if acts are morally right; how moral rules apply to specific situations; and what ought to be done in specific cases. Part I deals with conceptual issues. Chapter 1 presents a five-step model the pharmacist can use for ethical problem solving. Chapter 2 addresses identification of value judgments in pharmacy and separation of ethical from nonethical value judgments. Chapter 3 looks at where the pharmacist should turn to find the source of ethical judgments. Part II presents cases organized around the major principles of ethics: beneficence and nonmaleficence, justice and the allocation of resources, autonomy, veracity (dealing honestly with patients), fidelity (including confidentiality), and avoidance of killing. Part III presents cases organized around topics that present ethical controversy: abortion, sterilization, and contraception; genetics and birth technologies; and mental health and behavior control. The remaining chapters cover drug formularies and drug distribution systems; health insurance, health system planning, and rationing; pharmaceutical research; consent to drug therapies; and terminally ill patients. The book includes links to professional codes of ethics and a glossary.

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• Get help with access

Access to content on Oxford Academic is often provided through institutional subscriptions and purchases. If you are a member of an institution with an active account, you may be able to access content in one of the following ways:

IP based access

Typically, access is provided across an institutional network to a range of IP addresses. This authentication occurs automatically, and it is not possible to sign out of an IP authenticated account.

Sign in through your institution

Choose this option to get remote access when outside your institution. Shibboleth/Open Athens technology is used to provide single sign-on between your institution’s website and Oxford Academic.

• Click Sign in through your institution.
• Select your institution from the list provided, which will take you to your institution's website to sign in.
• When on the institution site, please use the credentials provided by your institution. Do not use an Oxford Academic personal account.
• Following successful sign in, you will be returned to Oxford Academic.

If your institution is not listed or you cannot sign in to your institution’s website, please contact your librarian or administrator.

Sign in with a library card

Enter your library card number to sign in. If you cannot sign in, please contact your librarian.

Society Members

Society member access to a journal is achieved in one of the following ways:

Sign in through society site

Many societies offer single sign-on between the society website and Oxford Academic. If you see ‘Sign in through society site’ in the sign in pane within a journal:

• Click Sign in through society site.
• When on the society site, please use the credentials provided by that society. Do not use an Oxford Academic personal account.

If you do not have a society account or have forgotten your username or password, please contact your society.

Sign in using a personal account

Some societies use Oxford Academic personal accounts to provide access to their members. See below.

A personal account can be used to get email alerts, save searches, purchase content, and activate subscriptions.

Some societies use Oxford Academic personal accounts to provide access to their members.

Viewing your signed in accounts

Click the account icon in the top right to:

• View your signed in personal account and access account management features.
• View the institutional accounts that are providing access.

Signed in but can't access content

Oxford Academic is home to a wide variety of products. The institutional subscription may not cover the content that you are trying to access. If you believe you should have access to that content, please contact your librarian.

For librarians and administrators, your personal account also provides access to institutional account management. Here you will find options to view and activate subscriptions, manage institutional settings and access options, access usage statistics, and more.

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