Men s Health Concerns: Widely Experienced, Widely Misunderstood Date: March 6, 2016
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1 Men s Health Concerns: Widely Experienced, Widely Misunderstood Date: March 6, 2016 Sunny Linnebur, Pharm.D., BCPS, CGP Associate Professor, University of Colorado Skaggs School of Pharmacy Clinical Pharmacist University of Colorado Hospital Seniors Clinic J. Mark Ruscin, Pharm.D. FCCP, BCPS Professor and Chair, Department of Pharmacy Practice Southern Illinois University Edwardsville School of Pharmacy Learning Objectives: At the completion of this application-based activity, participants will be able to: 1. Evaluate and manage drug-induced causes of benign prostatic hyperplasia (BPH), urinary incontinence, and erectile dysfunction in adult men. 2. Compare new medications with traditional therapy options for men s health-related conditions. 3. Construct a care plan for men with benign prostatic hyperplasia, addressing concerns regarding implementing therapy, adverse events, and patient education. 4. Compare the safety, efficacy, and routes of administration of available testosterone replacement products. 5. Explain screening recommendations for prostate cancer prevention and provide appropriate education to men in the community setting. Format: Today s session will be a highly interactive discussion of the attached case studies. Based on the data available in the case study, the facilitators and audience will discuss practical management strategies and the scientific rationale that supports these strategies. Premise: You (audience members) are a pharmacist who works in an ambulatory-based setting in collaboration with a group of physicians. You have access to patient s electronic medication records. You are responsible for evaluating and monitoring the patient s therapy. You are responsible for providing comprehensive patient management and education. Page 1
2 CASE #1 Part 1 Date: Mar 2016 Initials BM DOB/Age 72 yo Sex M Race/Ethnicity Caucasian Source Patient and medical records CC/HPI (including sx analysis for CC): This having to use the bathroom at night is getting old Patient presented to his primary care physician this morning with complaints of worsening urinary symptoms. The patient has had some minor urinary symptoms in the past related to BPH, but his physician has not initiated him on medical treatment up to this point. Today, he describes symptoms of weak stream, hesitancy, and dribbling. He also states that over the past few months, it has been more common that he has to get up 2-3 times at night to urinate. Prior to that, he typically only had to get up one time, occasionally two times at night. He has not had any episodes of incontinence. He states that he has noticed the symptoms have become more problematic over the last few months. He also noticed that his night time symptoms are worse when he has coffee in the evening after dinner or if he drinks any alcohol in the evening, so he has quit drinking coffee and alcoholic beverages in the evening. His wife assists with medication taking. Patient has difficulty on occasion remembering to take his medications. Wife sets up pill box every week to help them both remember. The physician ordered routine labs, PSA, and took a urine sample for urinalysis. Past Medical History (major illnesses and surgeries) From Medical Record HTN x 25+ years Hypothyroidism x 14 years BPH s/p TIA (2011) no residual deficits Osteoarthritis of the knees 15+ years Mild cognitive impairment (MMSE Score = 26) Current Prescription/OTC Medications Start Date Drug Name/Strength/Regimen Indication 9/2014 Amlodipine 5mg daily HTN 4/2013 Losartan 50mg ½ tablet daily HTN 10/2012 Hydrochlotothiazide 12.5mg daily HTN 7/2011 Aspirin 81mg daily Stroke prevention 7/2011 Levothyroxine 0.1mg daily Hypothyroidism 2/2010 Acetaminophen 500mg 1-2 tablets BID prn Osteoarthritis Vaccinations: Influenza vaccine fall 2015; pneumococcal vaccine 2008 RX Payment: Medicare Part D ($3/$12/$45 copay) Pharmacy(ies) Used: Neighborhood Pharmacy Meds Admin by: Self Page 2
3 Drug Allergies/Adverse Effects: NKDA Family Medical History: Sister (71) DM Type 2 and heart problems ; Father died of stroke in his seventies; Mother died of colon cancer in her seventies. Social History Residence: lives at home w/ wife Smoking: Previously smoked 1PPD; quit 25 years ago Illicit Drugs: Never Occupation: Retired school teacher/coach EtOH: Drinks 1-2 beers or glasses of wine occasionally/socially Diet: Tries to eat healthy; does not add salt to food; wife cooks all his meals Education: college degree Family/Social Environment: Lives with wife; 3 grown children who live in the area; 2 grandchildren Objective Data (observations/vital signs/physical examination/labs) General: pleasant elderly male in NAD BP= 136/68 mmhg Pulse= 72 bpm regular Height = 5 11 Weight = 195 lbs BMI =27.2 kg/m 2 Laboratory Tests (measured this morning) FASTING Glucose = 110 mg/dl Na = 141 mg/dl K = 4.8 mg/dl Cl = 101 mg/dl CO3 = 24 mg/dl BUN = 13 mg/dl SCr = 1.1 mg/dl egfr > 60 ml/min/1.73m 2 Alb = 4.0 mg/dl AST = 22 ALT = 34 TSH = 2.96 Urinalysis: ph 7.05; Sp Gr 1.015; gluc (-), blood (-), epi (0-2), wbc (0-2), rbc (0-2), bact (none) DRE: smooth, rubbery prostate estimated size gm Post Void Residual: 100 ml (estimated via bladder scan) AUA-SI Score = 12 (0=not at all; 1=less than 1 in 5 times; 2=less than ½ of the time; 3= ½ of the time; 4=more than ½ of the time; 5=almost always; *=number per night) 1. Incomplete emptying: 1 2. Frequency: 0 3. Intermittency: 4 4. Urgency: 0 5. Weak stream: 3 6. Straining: 1 7. Nocturia*: 3 Severity of symptoms (total score): 0-7=mild; 8-19=moderate; 20-35=severe Page 3
4 Question #1 Which of the following medications could be contributing to BM s symptoms? a) Amlodipine b) Hydrochlorothiazide c) Losartan d) Levothyroxine Question #2 Based on BM s described symtptoms, AUS-SI score and his PVR, would you classify his LUTS as obstructive, irritative, or a combination of obstructive and irritative? a) Obstructive b) Irritative c) Combination of obstructive and irritative Question #3 The medication identified in Question #1 is discontinued. Six weeks later, the patient presents to clinic with similar complaints and his AUA-SI score has not changed substantially, as it is now His BP reading today is 138/72 mmhg. Which of the following would be the best option to consider for treating his BPH symptoms? a) Finasteride b) Dutasteride c) Terazosin d) Tamsulosin Question #4 What monitoring would be recommended for BM with regard to implementation of this new treatment to evaluate efficacy and safety? a) AUA-SI b) PVR c) Adverse Effects d) All the above Page 4
5 Question #5 Three months after beginning his new treatment, BM is scheduled to have cataract surgery. What would be recommended for him in this situation? a) BPH treatment should be discontinued for 1 month b) Cataract surgery should be cancelled c) Change treatment to a non-selective alpha blocker d) Ensure the ophthalmologist is aware of alpha blocker use Page 5
6 CASE #1 Part 2 Date: 7 years later Initials BM DOB/Age 79 yo Sex M Race/Ethnicity Caucasian Source Patient and medical records CC/HPI (including sx analysis for CC): The patient presents to his primary care physician for follow-up, two weeks after having been seen in the ER for an episode of acute urinary retention (AUR) requiring catheterization. This is the first episode of AUR that BM has experienced. He has experienced occasional episodes of urinary incontinence, but states that this occurs maybe once per month, if he has difficulty getting to the bathroom in time. Past Medical History (major illnesses and surgeries) From Medical Record HTN x 30+ years Hypothyroidism x 20+ years BPH (medically treated) s/p TIA x 2 (2011 and 2016) History of Falls (x 2, w/o injury) Cognitive impairment/dementia (MMSE Score = 22) Current Prescription/OTC Medications Start Date Drug Name/Strength/Regimen Indication 2 mo Acetaminophen PM daily HS Sleep 3 yrs Donepezil 10mg daily Cognitive impairment 4 yrs Tamsulosin 0.8 mg daily Stroke prevention 7 yrs Clopidogrel 75mg daily BPH 10 yrs Losartan 50mg daily HTN 11 yrs Hyrdrochlorothiazide 25mg daily HTN 12 yrs Levothyroxine 0.1mg daily Hypothyroidism 14 yrs Acetaminophen 500mg 1-2 tablets BID Osteoarthritis Objective Data (observations/vital signs/physical examination/labs) General: pleasant male in NAD; A&0 x 3 BP= 132/70 mmhg Pulse= 72, bpm, regular Height = 5 11 Weight = 183 lbs BMI =25.5 kg/m 2 Laboratory Tests (measured in ER, non-fasting) Glucose = 126 mg/dl Na = 141 mg/dl K = 4.4 mg/dl Cl = 100 mg/dl CO3 = 23 mg/dl BUN = 14 mg/dl SCr = 1.2 mg/dl egfr = 60 ml/min/1.73m 2 Urinalysis: ph 6.95; Sp Gr 1.018; gluc (-), blood (+), epi (0-2), wbc (5-10), rbc (5-10), bact (rare); culture (-) at 48 hours Transrectal ultrasound (ER) = estimated prostate size 45 gm Page 6
7 Post Void Residual: 150 ml (estimated via bladder scan today) AUA-SI Score: 21 (today) 1. Incomplete emptying: 3 2. Frequency: 1 3. Intermittency: 5 4. Urgency: 1 5. Weak stream: 4 8. Straining: 4 9. Nocturia*: 3 Question #6 What was the most likely cause of BM s recent AUR episode? a) BPH clinical progression b) Drug-induced effect c) Acute illness d) Impossible to determine Question #7 Which of the following recommendations would most likely reduce the risk of future BPH-related complications in BM? a) Initiate tolterodine b) Switch tamsulosin to terazosin c) Initiate finasteride d) Switch tamsulosin to alfuzosin Question #8 Which of the following would be important for educating BM? a) Risk of adverse effects b) Timeframe for expected improvement c) Avoid medications that can exacerbate symptoms d) All the above Page 7
8 Question #9 If BM was taking tamsulosin and he had complaints of bothersome symptoms with the following: AUA-SI = 14 (frequency=5; urgency=5; nocturia=4), PVR=45ml, prostate size 35ml, which treatment option would be most effective for treating his urinary symptoms in this scenario? a) Finasteride b) Dutasteride c) Tolterodine d) Doxazosin Page 8
9 CASE #2 Part 1 Initials BB American Pharmacists Association Annual Meeting 2016 March 2016 DOB/Age 55 Sex M Race/Ethnicity African American Source Patient and Medical Records CC/HPI (including sx analysis for CC): I m having problems with sexual function. Patient presents to his primary care physician for an annual wellness exam, but has also brought up his sexual function concerns. He has no other symptoms that are bothering him. His medication list was updated and he is taking a new supplement. He does not know the name of it, but he says it is not helping him. He does not really exercise much other than taking his dog for a walk once a week. He usually walks for 1 mile and it takes him about 30 minutes. He is a salesman and is either in the car traveling or meeting with clients. He eats at restaurants every day during the week for lunch, but eats at home for his other meals. He still smokes ½ ppd and has attempted to quit twice in the past few years. The last attempt, he quit cold turkey and was successful for 1 month. He is open to quitting. His physician ordered the following labs: metabolic panel, A1c, fasting lipids; the patient states he was fasting for over 12 hrs when the blood was drawn. Past Medical History (major illnesses and surgeries) From Medical Record Hypertension Dyslipidemia Osteoarthritis of knee Obesity Depression Current Prescription/OTC Medications Start Date Drug Name/Strength/Regimen Indication 1/2015 Naproxen 500 mg BID Osteoarthritis 2010 HCTZ 50 mg daily Hypertension 2010 Simvastatin 40mg daily Dyslipidemia 2010 Amlodipine 10 mg daily Hypertension 11/2015 Spironolactone 25 mg daily Hypertension 10/2015 Sertraline 50 mg daily Depression 1/2016 Virility supplement (patient does not know exact name) Erectile health Vaccinations: Influenza vaccine fall 2015; Tdap 2 years ago Pharmacy Used: Neighborhood Pharmacy Rx Payment: Commercial insurance ($0/$20/$50 copay) Meds Admin by: Self Drug Allergies/Adverse Effects: Sulfonamides, lisinopril (cough) Family Medical History: 1 sibling, with HTN and T2DM; father and mother still alive and in their 70s Social History Residence: lives at home with wife Occupation: salesman Page 9
10 Smoking: ½ ppd X 20 years EtOH: 1-2 beers on weekends and rarely during the week Illicit Drugs: Marijuana in the past (college years) Diet: His wife cooks most meals and he eats whatever she makes; struggles at work with snacking on salty foods and eats out most lunches Education: college graduate Family/Social Environment: Lives with wife; 2 grown children Sexual Health Inventory for Men Over the Past 6 Months: 1. How do you rate your confidence that you could get and keep an erection? 2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration (entering your partner)? 3. During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner? 4. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? 5. When you attempted sexual intercourse, how often was it satisfactory for you? NO SEXUAL ACTIVITY DID NOT ATTEMPT VERY LOW LOW MODERATE HIGH VERY HIGH ALMOST NEVER OR NEVER A FEW TIMES (MUCH LESS THAN HALF THE TIME) SOMETIMES (ABOUT HALF THE TIME) MOST TIMES (MUCH MORE THAN, HALF THE TIME) ALMOST ALWAYS OR ALWAYS INTERCOURSE DID NOT ATTEMPT ALMOST NEVER OR NEVER A FEW TIMES (MUCH LESS THAN HALF THE TIME) SOMETIMES (ABOUT HALF THE TIME) MOST TIMES (MUCH MORE THAN, HALF THE TIME) ALMOST ALWAYS OR ALWAYS INTERCOURSE DID NOT EXTREMELY DIFFICULT VERY DIFFICULT DIFFICULT SLIGHTLY DIFFICULT NOT DIFFICULT ATTEMPT INTERCOURSE ALMOST NEVER OR NEVER A FEW TIMES (MUCH LESS THAN HALF THE TIME) SOMETIMES (ABOUT HALF THE TIME) MOST TIMES (MUCH MORE THAN, HALF THE TIME) ALMOST ALWAYS OR ALWAYS Add the numbers corresponding to questions 1-5. TOTAL: 14 The Sexual Health Inventory for Men further classifies ED severity with the following breakpoints: 1-7 Severe ED 8-11 Moderate ED Mild to Moderate ED Mild ED Page 10
11 Objective Data (observations/vital signs/physical examination/labs) Blood Pressure: 145/77 mmhg Pulse: 80 Height: 72 inches Weight: 235 lbs BMI: 31.9 kg/m 2 Laboratory Tests (measured this morning) - FASTING A1c = 6.0% Na = 138 mg/dl K = 4.0 mg/dl Cl = 99 mg/dl CO2 = 24 mg/dl BUN = 12 mg/dl SCr = 1.0 mg/dl egfr = ml/min/1.73m 2 Alb = 4.2 mg/dl AST = 20 ALT = 17 Total Cholesterol = 167 mg/dl LDL = 98 mg/dl HDL = 48 mg/dl TG = 105 mg/dl Question #10 Which of the following medications may be contributing to BB s symptoms of erectile dysfunction (ED)? a) HCTZ b) Sertraline c) Spironolactone d) All of the above Question #11 Which of the following comorbidities could be contributing to BB s symptoms of ED? a) HTN b) Obesity c) Depression d) All of the above Question #12 Which of the following lifestyle factors is most likely contributing to BB s symptoms of ED? a) Smoking b) Alcohol intake c) Eating salty foods d) All of the above Page 11
12 Question #13 Which of the following additional screening tests would be the most important to discuss with BB at this time? a) PSA b) Serum testosterone c) Exercise ability/treadmill test d) Colorectal cancer screening test Question #14 Which of the following therapeutic plans would be most appropriate for BB s erectile and overall health? a) Add sildenafil b) Discontinue naproxen c) Reduce dose of sertraline d) Change spironolactone to losartan Page 12
13 e) CASE #2 Part 2 Date: 5 years later Initials BB DOB/Age 60 years Sex M Race/Ethnicity African American Source Patient and Medical Records CC/HPI (including sx analysis for CC): The patient presents to his primary care physician this morning for a follow-up ambulatory visit. His erectile dysfunction has been treated for the past several years with tadalafil as needed, and he really likes the flexibility of how long-acting it is, along with it is covered by his prescription plan. He sometimes gets back pain when he takes it, but he takes acetaminophen for that pain. However, he describes that he has less sexual desire than in the past and decreased morning erections. Four years ago, he made significant improvements in his diet and exercise and he lost 30 pounds. He swims for about 30 minutes almost daily, along with short walks with his dog, and weight lifting three times weekly. He rarely takes naproxen, but does take acetaminophen daily. He also quit smoking and has maintained that for the past 3 years. Recently, he was diagnosed with angina, but he has not had chest pain symptoms since the initial diagnosis, which was made in the Emergency Department. He also describes some hot flushes and loss of body hair. Past Medical History (major illnesses and surgeries) From Medical Record Hypertension Dyslipidemia Osteoarthritis of knee Overweight Depression Chronic stable angina Insomnia Current Prescription/OTC Medications Start Date Drug Name/Strength/Regimen Indication 5 yrs ago Naproxen 500 mg BID prn Osteoarthritis 10 yrs ago HCTZ 12.5 mg daily Hypertension Last month Atorvastatin 40mg daily Dyslipidemia 10 yrs ago Amlodipine 10 mg daily Hypertension 5 yrs ago Losartan 50 mg daily Hypertension 5 yrs ago Bupropion ER 300 mg daily Depression Within 1 yr Aspirin 81 mg daily Cardiovascular health 12 yrs ago Acetaminophen mg 4 times daily prn Osteoarthritis Last month Nitroglycerin 0.4 mg SL prn chest pain Chronic stable angina 2 yrs ago Zolpidem 5 mg daily Insomnia Page 13
14 SHIM test: 20 points Objective Data (observations/vital signs/physical examination/labs) Blood Pressure: 122/72 mmhg Pulse: 76 Height: 72 in Weight: 202 lbs BMI: 27.4 kg/m 2 Laboratory Tests (In Office) A1c = 5.5% Na = 139 mg/dl K = 4.6 mg/dl Cl = 99 mg/dl CO2 = 24 mg/dl BUN = 12 mg/dl SCr = 1.1 mg/dl egfr = 91.8 ml/min/1.73m 2 Hgb = 15.3 g/dl HCT = 47.9% PLT = /L PSA = 2.3 ng/ml AST = 24 ALT = 32 Total testosterone = 200 ng/dl Free testosterone = 6.0 ng/dl FSH = 22.0 miu/ml LH = 15.8 miu/ml Question #15 Which of the following medications is inappropriate for BB at this time? a) Zolpidem b) Tadalafil c) Naproxen d) Amlodipine Question #16 Based upon BB s laboratory work-up, new medical conditions, and new medications, which of the following treatments would be appropriate for his ED? a) Continue tadalafil and add testosterone replacement b) Continue tadalafil without testosterone replacement c) Discontinue tadalafil and add testosterone replacement d) Discontinue tadalafil without testosterone replacement Question #17 Which of the following laboratory measurements would be important to monitor for if BB elects to use testosterone replacement in the future? a) FSH b) LH c) Hemoglobin/hematocrit d) Evening testosterone concentrations Page 14
15 References : Answer Key: Q1 a Q2 a Q3 - d Q4 - d Q5 - d Q6 - b Q7 - c Q8 - d Q9 - c Q10 - d Q11 - d Q12 a Q13 c Q14 d Q15 b Q16 c Q17 c Page 15
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