pharmacy case study examples

5 Interesting Medication Case Reports - Part 5

This article highlights 5 published case reports that document accidental administrations of medications following pharmacy or nursing errors.

This article is part 5 of a 6-part series on interesting and unusual medication-related case reports. For part 4 click here .

Case reports are defined as the scientific documentation of an individual patient. These reports are often written to document an unusual clinical presentation, treatment approach, side effect, or response to treatment. Most experts see case reports as the first line of evidence in health care, which can sometimes lead to future higher-level studies.

Case reports can be a great learning opportunity for both pharmacists and pharmacy students to understand a case progression and the unconventional response and effects of medications.

1. Patient harm following Norvasc error 1

Norvasc (amlodipine) is a dihydropyridine calcium channel blocker indicated for the treatment of hypertension and coronary artery disease. A case report was published in 2016 detailing an alarming and overlooked medication error involving a prescription for Norvasc.

The case report involves a recently widowed 71-year-old female who was hospitalized for uncontrolled hypertension and acute kidney injury. During the hospital stay she received temporary hemodialysis, her blood pressure medications were adjusted, and she subsequently improved clinically. Upon discharge her prescription medications included Norvasc 10 mg twice daily, metoprolol 50 mg twice daily, doxazosin 2 mg daily, and torsemide 30 mg daily.

Over the next several months, she began experiencing worsening fatigue, slow movements, personality changes, and uncontrolled blood pressure. During this time, she was hospitalized once for chest pain and had several visits to her outpatient family physician where she was diagnosed with anxiety and depression; for these she was prescribed citalopram and alprazolam. Soon after, she was rehospitalized following a fall due to light-headedness.

An admission medication reconciliation revealed that the patient was actually taking Navane (thiothixene), an antipsychotic, instead of the Norvasc. Upon further review, it was revealed the pharmacy had accidently dispensed the wrong medication despite the written prescription being fully legible. After the thiothixene was discontinued, the patient’s clinical status improvement. The authors explain how this example shows the ‘Swiss Cheese Model’ of how medication errors can occur despite interacting with multiple areas of the health care system.

2. Rythmol prescription error 2

Rythmol (propafenone) is a class 1C antiarrhythmic drug that was FDA approved in 1989. In 2010, a case report was published documenting a medication error involving a handwritten prescription for Rythmol.

The case tells the story a 73-year-old man with a history of cardiac arrhythmia who presented to the clinic for a routine follow-up visit. After being evaluated by his physician, the patient received a handwritten prescription for Rythmol 150 mg, which he had been taking for the previous 3 years. He filled this prescription with the clinic pharmacy and subsequently started to experience nausea, sweating, and an irregular heartbeat. After 2 weeks of symptoms, he called his physician for an appointment, noting that his Rythmol tablets looked different than last time.

Upon evaluation, the physician discovered that the patient incorrectly received Synthroid (levothyroxine) 150 mcg from the pharmacy instead of the prescribed Rythmol 150 mg. The pharmacist who filled the prescription attributed the error to unclear handwriting on the prescription copy. The patient’s symptoms were believed to be caused by both abrupt discontinuation of Rythmol and unnecessary use of Synthroid at a high initial dose. Once the error was corrected, the patient’s symptoms gradually resolved.

The authors explain that this error demonstrates the importance of pharmacists clarifying with physicians on prescriptions with sloppy or illegible handwriting and appropriately counseling patients on new medication therapy.

3. Accidental administration of epinephrine instead of midazolam 3

Medication errors within the inpatient setting can have severe consequences on patient harm and prolonging length of stay. This 2016 case report details a 50-year-old women who was accidentally administered epinephrine instead of midazolam during colonoscopy prep.

The patient originally presented to the hospital with a history of abdominal pain and altered bowel habits. A colonoscopy was scheduled following administration of what was believed to be midazolam 5 mg. She then started to complain of chest tightness, difficulty breathing, and generalized tremors. It was soon discovered that a medication error occurred and the patient was instead administration 0.25 mg of epinephrine instead of midazolam. The procedure was postponed for several days until the patient recovered.

A root cause of the error revealed that the epinephrine ampule was mistakenly placed in the box with the midazolam in the pharmacy following an instance where a previous patient did not require the medication. Ampules of both medications were similar in size, shape, and color. As a result, the hospital initiated new procedures to ensure regular reviews of drug containers and their contents and double checking medication names before administration.

4. Unintentional administration of insulin instead of influenza vaccine 4

In 2016, researchers published the results of an investigation where a cluster of 5 adult patients unintentionally received insulin instead of the influenza vaccine. The mix-up occurred at a public school clinic in Missouri and was discovered following an investigation from the Saint Louis County Department of Public Health. Officials learned that a school nurse inadvertently administered Humalog U-100 insulin instead of the influenza vaccine. Acute hypoglycemia was reported in all 5 patients who received the insulin with varying degrees of symptoms.

After the first 2 patients complained of sweating and lightheadedness, the nurse reported the incidents to the supervising nurse, but did not stop administering vaccines. Two later patients would require hospitalization for their symptoms, one of which was documented to have a blood glucose level of 23 mg/dL. The investigation revealed that the influenza vaccine vial was kept in the nurse’s office refrigerator along with a 10 mL vial of Humaog U-100 insulin; they were found to not be stored in separate, labeled containers or bins. The manufacturer of the influenza vaccine conducted its own analysis but found no deviations or manufacturing incidents that would suggest a quality control problem.

The study authors state this incident was likely a result of ‘confirmation bias’ where a healthcare worker may rely on familiar cues, such as the shape, colors, and markings on a vial to confirm preconceptions, which may lead to reduced vigilance and an increased risk of medication errors.

5. Warfarin and Xarelto duplication 5

Coumadin (warfarin) and Xarelto (rivaroxaban) are anticoagulants used to reduce the risk of stroke and embolism in patients with atrial fibrillation and for prophylaxis of deep vein thrombosis (DVT). A case report was recently published documenting a patient who unintentionally received both medications concurrently.

The case involves a 62-year-old man who was referred to a pharmacist-managed anticoagulation clinic for follow-up post bilateral pulmonary embolism. The patient was advised to continue on the warfarin he initiated in the hospital at a dose of 5 mg daily and return the following week for a repeat INR test. At next visit, his INR was revealed to be over 8.0. He denied taking any extra warfarin doses, recent alcohol intake, or new prescription medications. No symptoms of bruising or bleeding were noted. Upon further questioning, the patient reported starting a new medication 5 days earlier from his retail pharmacy which the clinic determined to be Xarelto 20 mg.

Investigation into the issue revealed that a prescription for Xarelto had been sent to his retail pharmacy to inquire about the cost of the medication with his insurance plan. The retail pharmacy then placed the medication on hold rather than discontinue the order entirely like the clinic staff had requested. When he visited his retail pharmacy the next day, they filled and dispensed the medication. The patient had not been counseled and assumed it was a new medication for his neuropathy. The Xarelto was subsequently discontinued and the warfarin dose was gradually reduced until the INR was within range. The case shows the importance of counseling patients on new medications and inquiring about potential duplicate therapies.

References:

• Da Silva B, Krishnamurthy M. The alarming reality of medication error: a patient case and review of Pennsylvania and National data. J Community Hosp Intern Med Perspect . 2016;6(4):10.3402/jchimp.v6.31758. doi:10.3402/jchimp.v6.31758.
• Devine B. Bad Writing, Wrong Medication. AHRQ. April 2010. Available at: https://psnet.ahrq.gov/webmm/case/215/bad-writing-wrong-medication
• Gado A, Ebeid B, Axon A. Accidental IV administration of epinephrine instead of midazolam at colonoscopy. Alexandria J of Med . 2016;62(1). doi:10.1016/j.ajme.2014.11.003.
• Clogston J, Hudanick L, Suragh TA, et al. Unintentional administration of insulin instead of influenza vaccine: a case study and review of reports to US vaccine and drug safety monitoring systems. Drugs Ther Perspect . 2016. 32: 439. doi:10.1007/s40267-016-0333-2.
• Fusco JA, Paulus EJ, Shubat AR, Miah S. Warfarin and Rivaroxaban Duplication: A Case Report and Medication Error Analysis . Drug Saf Case Rep . 2015 Dec;2(1):5.

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How to answer pharmacy case studies.

How to Answer Pharmacy Case Studies

Whether you’re a student of pharmacy, medicine or nursing – you cannot underestimate the value of case studies.

Case studies bring together the essential strands of your professional study. They are the means through which you analyse a patient, their condition, the medicines they are taking and the impact that additional medicines have on their circumstances.

Studying subjects separately – whether it be pharmacology, pharmaceutical chemistry, pharmaceutics or clinical pharmacy – has value, but it’s though practicing case studies that bring the essential, relevant facts into sharp relief.

Reaching the next level

Case studies are what elevate your status from general student into prospective clinical professional. The more case studies you review, the more rounded your knowledge becomes. Your critical thinking skills become more refined and more focussed.

The link between chemistry, how it translates into a meaningful pharmacological impact, and how these twin forces inform your real-life clinical judgement, suddenly begins to make sense.

To begin with, case studies are challenging, difficult and can dampen your confidence. In time, case studies become enjoyable, insightful and a positive force that serves to nourish clinical judgement.

It’s through persistence and hard work that you reap the long-term benefits of case studies. Knowing how to approach case studies , then, is important. With the wrong approach and an improper mindset, you’ll never extract the value that case studies bring.

How to approach case studies

When faced with a case study, approach it with the following points in mind:

Review the case study more than once . Never rush into a case study, picking and choosing facts you understand. Instead, approach the case study with an open mind. Be prepared to accept that you might not know the answer straight-off. The study may require some careful consideration, time and reflection.

Evaluate the clinical significance of each statement . If told that the patient’s blood pressure is 148/90, relate this fact to every other detail in the question. Is hypertension a side effect of any of the patient’s medicines? Does the presence of hypertension mean that the patient’s dosing is incorrect? Is hypertension a cause of a drug-drug interaction?

Perhaps hypertension is not caused by any medicine but is instead related to the patient’s lifestyle. In other words, you need to approach each statement from a multi-dimensional perspective – reviewing every possible angle and dismissing those angles that cannot possibly be true.

Take the patient’s age into consideration . Knowing the patient’s age is extremely important. When informed of the patient’s age, think about:

• Whether the patient is a child. Dosing is lower in children. Many medicines cannot be administered to children (think of aspirin and tetracyclines, for example).
• Older patients are more likely to experience side effects. For example – CNS effects, such as drowsiness or dizziness, are invariably worse. Older patients are more susceptible to infection, too. The risk of bleeding increases too, a factor that should inform your judgement of anticoagulants, such as warfarin.
• Age and the onset of biological change. Female patients over the typical menopausal age may be taking bisphosphonates to ward off (or treat) the onset of osteoporosis. Male patients over of the age of 40 produce less antidiuretic hormone, meaning they urinate more.
• How senescence impacts drug metabolism. Older patients metabolise drugs at a slower rate than younger patients, impacting their adverse effect profile.

Of course, these are just some of the factors you should consider. At this point, we must appreciate why age is, when evaluating case studies, is an important consideration.

How their medical history informs the debate . An older patient may be admitted to the hospital with an acute bacterial infection. Five years ago, they patient may have been treated for deep vein thrombosis. As a result, anticoagulant therapy should be considered. There are three reasons:

• First, the patient is older meaning that risk of recurring DVT increases
• The patient has a history of DVT
• The patient will be relatively immobile during hospital admission, increasing risk

The relationship between past disease and current treatment is important.

Understand diagnostic parameters . As a prospective clinical professional, you must understand the various diagnostic factors at play.

For example – sodium, potassium, white blood cell and cholesterol ranges; what is normal, what are considered low values and what high values mean? Understand the relationship between these factors, the medicines the patient is taking and the how their underlying disease impacts both factors.

For example – proton-pump inhibitors reduce gastric acid levels. Because ketoconazole is best absorbed in acidic conditions, proton-pump inhibitors impact absorption and therapeutic efficacy. High gastric pH also reduces metabolism of essential nutrients, such as vitamin B 12 .

Know side effects and drug interactions . It’s challenging to learn the major side effects and drug interactions. It doesn’t come overnight – it takes time. That’s why studying pharmacy case studies is important; they give you the opportunity to apply the learning you’ve done so far and extract the detail that you have yet to learn. Take two minutes to revise our compilation of major side effects .

Build your knowledge of side effects over time. Often, knowing the drug’s mechanism of action is enough to inform your judgement of either potential side effects or drug interactions.

For example – knowing that opioids, such as buprenorphine, causes respiratory depression should trigger alarm bells if the patient is co-prescribed another medicine, such as alprazolam; a benzodiazepine which itself causes respiratory depression.

Practice, practice, practice!

Knowing how to answer pharmacy case studies effectively is invariably down to practice, too. The more practice, the more knowledge gaps are plugged and the greater the degree of context you construct around specific clinical topics.

At PharmaFactz, we have developed over pharmacy case studies for you to practice . These case studies cover just about every aspect of clinical pharmacy – major organ systems, diagnostics, blood test results, side effects and drug interactions, and the essential clinical facts you need to know – helping you acquire the knowledge and expertise you need to excel at pharmacy case studies.

• Anticancer Pharmacology
• Antimicrobial Drugs
• Cardiovascular Pharmacology
• Clinical Case Study
• Clinical Pharmacy
• General Pharmacology
• GI Pharmacology
• Immune System Pharmacology
• Nervous System Pharmacology
• Respiratory Pharmacology
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Don't stop learning now, you may also like, common terms in pharmacology, fluoroquinolones pharmacology.

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Chapter Eight:  Case Reports and Case Series in Pharmacy

Katie E. Barber; Jamie L. Wagner

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Introduction, case reports and case series.

• COMMON RESEARCH QUESTIONS IN CASE REPORTS AND CASE SERIES
• PRACTICAL AND TECHNICAL CONSIDERATIONS FOR CASE REPORTS AND CASE SERIES
• EXPERTISE NEEDED FOR CONDUCTING CASE REPORTS AND CASE SERIES
• EXEMPLARS OF LEARNER-INVOLVED PUBLISHED CASE REPORTS OR CASE SERIES
• DISSEMINATION CONSIDERATIONS AND FRAMEWORKS
• SUMMARY AND CONCLUSIONS
• KEY POINTS AND ADVICE
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Define case reports and case series in pharmacy settings

Discuss various sources for case reports and case series in pharmacy settings

Identity common research questions in case reports and case series

Understand the practical and technical considerations for case reports and case series

Discuss the strategies for harnessing the expertise needed for conducting case reports and case series

Describe an example of learner-involved case reports or case series project

Understand the dissemination framework for case reports and case series

Case reports, case series

Case reports and case series are used primarily to convey unique or interesting clinical scenarios that help the medical community identify new diseases, recognize rare disease manifestations, utilize new diagnostic approaches, discover the pathophysiology of a disease process, detect new side effects of medications, or prescribe alternative therapeutic treatments. 1 These studies can help identify observations that would normally be missed or overlooked in larger clinical trials. The Food and Drug Administration encourages reporting of these observations to aid in documenting post-marketing experiences using the FDA MedWatch Portal. 2 Therefore, case reports and case series should be educational and provide useful, practical, and easy-to-follow instructions for others to accurately identify the scenario described.

The use of case reports and case studies in pharmacy literature is abundant. A simple search in Pubmed/MEDLINE with the terms “case report” or “case series” and “pharmacy” returns over 150,000 articles published in peer-reviewed journals. Unfortunately, case reports and case series are not always highly valued based on their low level in the research design hierarchy. 3,4 However, Murad et al. described an adapted hierarchy that suggests the divide between study design types is not as strict and can vary based on the information and bias contained within the report. 4 This chapter will provide a guide to understanding common research questions in case reports and case series within pharmacy practice, sources for case reports and case series, practical and technical considerations, expertise needed, and examples of learner-led reports.

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Pharmacy Case Study

• Read the following article: Pharmacist-led interventions to improve medication adherence in older adults: A meta-analysis
• Use the CASP Systematic Review Checklist to assess the quality of the review.

For an accessible version of this activity, please refer to our document Step 3: Appraise – 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.

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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How to read all case studies?

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Press Release: 4 Symposiums at BioPharma Asia Convention 2013, Singapore

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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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