Pharmacology small group facilitator notes - 1

Johnston

Facilitator Notes

Pharmacology in Older Adults

Small Group Session

Created by Bree Johnston, Anna Chang, and Helen Chen

UCSF Division of Geriatrics

LEARNING OBJECTIVES

Case #1:

1. Recognize medication nonadherence as a possible explanation of lack of therapeutic benefit

2. List common sources of non-adherence

3. Discuss effective methods for exploring nonadherence with a patient

4. Discuss the importance of drug prices as a potential cause of non-adherence, and list strategies for dealing with this issue

5. (Optional: discuss policy issues surrounding drug marketing and pricing, the physicians’ role, and Medicare Part D)

Case #2:

1. List physiologic changes in elders that impact pharmacokinetics of commonly used drugs

2. Use the MDRD to calculate the decline in renal function with aging, and describe its advantages over the Cockroft-Gault equation

3. Use the “Cockroft-Gault” equation to estimate the decline in renal function with aging and describe advantages and limitations of this tool

4. Recognize symptoms of digoxin toxicity

5. Gain an awareness of the range of costs of medications, appreciating how much cheaper “older” and generic drugs can be than newer brand name drugs

Case #3:

1. Define polypharmacy in the context of appropriate drug prescribing

2. Describe adverse consequences of polypharmacy, including drug-drug interactions, side effects, and a “prescribing cascade”

3. Discuss the importance of exploring medications as a potential cause of new or unexplained symptoms

Online Drug Pricing

Online Drug Interaction Facts

Online GFR Calculator

Medicare D

Rough Time Outline for 2 hour session:

15 minutes Introduction to session

30 minutes Case 1

30 minutesCase 2

30 minutesCase 3

15 minutesWrap up and review of learning objectives

NOTE TO FACILITATOR:

FACILIATOR INSTRUCTIONS

There are a few different ways to do this exercise:

  1. Have students look up drug prices and compare Medicare Part D plans prior to class, and come in prepared to discuss them. You can break up the group and give assignments to different groups of students, such as:

▪A-H: Look up regimen prices on PDA or another source

▪I-Q: Assign one –two Medicare Part D plans in your area

▪R-Z: Assign another Medicare Part D plan in your area

  1. Or have an internet connection in the room and do the exercises together, or if you have multiple computer connections, you can do the assignments in small groups and come back together.

Students should be instructed to bring a calculator, a pharmacology textbook or a PDA based pharm program such as Epocrates.

Case #1 Learning objectives:

1. Recognize medication nonadherence as a possible explanation of lack of therapeutic benefit

2. List common sources of non-adherence

3. Discuss effective methods for exploring nonadherence with a patient

4. Discuss the importance of drug prices as a potential cause of non-adherence, and list strategies for dealing with this issue

5. (Optional: discuss policy issues surrounding drug marketing and pricing, Medicare part D, and related issues).

Case #1:

Mrs. BJ is an 80 year old woman with CAD, status post non - ST segment elevation myocardial infarction 6 months ago. She also has Type 2 diabetes, hypertension, COPD, osteoarthritis, and hypercholesterolemia. Following her MI, a persantine thallium test showed a fixed perfusion defect inferiorly but no other abnormalities, and she continued on medical management. Two months ago she was found to have severe osteoporosis, and treatment was begun for that.

You see her in you continuity clinic, and she says she is doing well. You note that her blood pressure is 160/88, Pulse 80 R 18 and glycosylated hemoglobin level is 9.0%.

She is retired, widowed, and lives alone. Her children live far away. She is still at home, but is having more difficulty getting around and paying bills. Somebody comes in to clean her house once a week.

Her Current medications are:

Fluticasone Inhaled twice daily

Albuterol/iprratropium (Combivent) Inhaler four times a day

Alendronate 70mg weekly

Metformin 500mg PO twice daily

Amlodipine 5mg daily

Glynase prestabs 6mg PO every morning

Celecoxib 200mg po daily

Simvastatin 20mg po daily

ASA 325mg po daily

Metoprolol 100mg twice daily

Fosinopril 10 mg po daily

Calcium carbonate 500mg po twice daily and Multivitamins one daily

You decide to increase her metformin from 500mg PO twice daily BID to 500mg PO three times daily and her amlodipine from 5mg to 10mg QD. Her other medications are continued.

Three months later her blood pressure is 166/92, Pulse 78 and glycosylated hemoglobin is 9.2%.

She denies any acute health problems but says she is having a harder time walking and getting around, and has given up driving after a scary episode where she ran a red light. She is having more financial troubles because of all the help she is hiring to manage at home. She now has to take taxis to get around, hires a woman to help her 3 times a week, and is having her groceries delivered.

Case #1 Questions:

1. What are possible explanations for her lack of response to blood pressure and anti-hypertensive therapies?

2. How would you explore this further?

3. How much would this medication regimen cost? What resources would help you determine the cost of medications?

4. What steps could you take to try to improve her blood pressure and glucose control?

CASE #1 ANSWERS AND DISCUSSION

1. What are possible explanations for her lack of response to blood pressure and anti-hypertensive therapies?

Students should be able to list:

Worsening disease (DM and hypertension)

She might have gained weight

Dietary indiscretion could increase blood pressure and increase glucose levels

She could have secondary hypertension (renal artery stenosis, sleep apnea, pheochromocytoma - try to emphasize that common things are common)

Drug nonadherence

NSAIDs, including COX-2 inhibitors, can sometimes raise blood pressure

How do NSAIDs cause hypertension?

Both diastolic and systolic BP are increased by 6-8 mmHg, most often noted in patients who are already hypertensive.

NSAIDs inhibit cyclooxygenease, the enzyme which converts arachidonic acid to prostaglandins (PGE).

  • PGE2 inhibits sodium chloride reabsorption in the thick ascending loop of Henle and collecting tubule. As a result, inhibiting prostaglandin synthesis would increase salt and water retention.
  • Prostaglandins also cause vasodilation. Inhibiting prostaglandin synthesis can increase peripheral vasoconstriction.

*The above mechanisms probably augment hypertension. However, the exact cause of the increase in BP is not known.

2. Explore barriers to adherence, including:

memory problems

conscious nonadherence (due to side effects, nonbelief in drugs, other assumptions)

costs/lack of prescription coverage

inability to get drugs (might be a factor for this woman who has to take the taxi everywhere)

poor health literacy or numeracy - not understanding how to take drugs

has osteoarthritis and lives alone, could she have difficulty opening the bottle or picking up the pills?

It is worthwhile spending some time talking about ways to explore adherence, including taking a nonjudgmental history. “Many people have a hard time remembering to take all of their drugs, is this ever a problem for you?” “Are there things you do to help yourself remember to take your drugs (e.g. putting them next to the toothbrush, in a pill box, etc)?” “Do you ever have trouble getting or paying for your drugs?” Other ways to explore adherence would include having the patient bring in drugs and describe how they take them, looking at refill patterns, setting up a mediset with pharmacy or visiting nurse, doing a home visit.

3. How much would this medication regimen cost?

Medication Costs (for one month of medication)

Fluticasone Inhaled BID$94/inhaler

Albuterol/ipratropium (Combivent) Inhaler QID$74/inhaler

Alendronate 70mg weekly$67

Metformin 500mg PO BID $63

Amlodipine 5mg QD$44.

Glynase prestabs 6mg PO QAM$40

Celecoxib 200mg po QD$80

Simvastatin 20mg po QD$136

ASA 325mg po QD$5 (not covered by MC-D)

Metoprolol 100mg BID$14

Fosinopril 10 mg po QD$60

Calcium carbonate 500mg po BID and Multivitamins QD$10 (not covered by MC-D)

TOTAL$687/month

$8244/year

What resources would help you determine the cost of medications? Epocrates for handheld devices, , multiple other web sites (see cover sheet)

4. How could you help this woman with a less expensive regimen?

Are there cheaper alternatives (yes, many):

  • HCTZ or atenolol rather than amlodipine?
  • With mild osteoarthritis, it is quite possible that acetaminophen and/or glucosamine might be cheaper, safer, and equally effective
  • Glynase prestabs TM are a very expensive alternative to glyburide….generic glipizide or glyburide would be much cheaper (~$10) with no evidence of different outcomes

Does she qualify for Medi-Cal or other insurance?

Can she get drug samples? (there are some politics here that you may or may not want to explore)

Can you get higher dose pills (sometimes the same price) and split them in half?

Can she shop at cheaper pharmacies?

Other?

What about Medicare D?

Medicare D: The Basics

  1. Total the patient’s annual costs. In 2006, the break even point for potential Medicare D enrollees is about $775. Patients whose annual costs are less are unlikely to benefit from Medicare D, although they may wish to sign up for a low premium plan to avoid the non-enrollment penalty (1%/month for life, i.e. a delay in enrollment of 24 months would mean that the patient will pay a penalty of 24% over the monthly premium.
  2. Calculate the out of pocket costs: On the basic plan, the patient is liable for the first $250 of actual drug costs and then 25% of the next $2000 in actual drug costs for a total out of pocket cost of $750.
  3. Coverage gap or “donut hole”: the patient is liable for the next $2850 in actual (not the co-pays) drug costs or a ‘True Out Of Pocket’ (TROOP) expense of $3600. TROOP is calculated based on the retail cost of the medications, so patients may benefit from shopping around at discount pharmacies or using plan-based mail order services. Some more expensive Prescription Drug Plans (PDPs) may provide coverage in the donut hole. While co-pays and the 25% coinsurance count towards TROOP, costs that do NOT count towards TROOP include:
  4. Premiums. Patients must continue to pay premiums even if they are paying full price for medications.
  5. Medications purchased from overseas/Canada
  6. Medications purchased outside the plan (therefore, paying for cheaper medications out of pocket while in the gap may not be wise)
  7. Costs incurred for non-formulary medications
  8. Medications obtained through drug company sponsored prescription assistance plans.
  9. Most over the counter meds, benzodiazepines, and barbiturates
  10. Catastrophic coverage. Once the patient has reached $3600 in TROOP, Medicare will resume coverage and will pay for 95% of drug costs. On most PDPs, what this translates to is that the patient will resume paying the usual co-payment.

In practice, each plan is a little different and it can be very challenging to select a plan. Medicare.gov has a PDP comparison tool which can be helpful to patients/families who are computer literate. In fact, plans that are cheaper up front may result in patients spending a longer time in the “donut hole” (see comparison chart)

Reprinted with permission

Mrs. J’s monthly actual drug cost is $672 (not including her OTC meds). Her annual cost for OTC meds is $180. Her current annual drug cost is $8244.

Basic Medicare D plan:

  • $250 deductible
  • $32/month average premium
  • No coverage for OTCs
  • No coverage in donut hole: pt is liable for all of drug costs up to maximum of $3600 in TROOP

Blue Cross Medicare RX Gold plan:

  • Monthly Premium $34
  • No Deductible
  • No coverage for OTCs ($15/month)
  • No coverage in donut hole
  • Tiered monthly co-payments for Mrs. BJ’s meds:
  • 6 tier 1 drugs$10 co-pay x 6$60
  • 3 tier 2 drugs$3 co-pay x 3$9
  • 1 tier 3 drugs$60 co-pay x1$60

$129/ mo, not including premiums

AARP Medicare RX plan:

  • Monthly premium:$9.80 mo
  • Deductible: $250
  • No coverage for OTCs
  • No coverage in donut hole
  • Tiered monthly co-payments for Mrs. BJ’s meds:
  • 6 tier 1 drugs$5 co-pay x 6$30
  • 3 tier 2 drugs$28 co-pay x 2$56
  • 1 tier 3 drug$55 co-pay x 1$55

$136/mo, not including premiums

Plan / A: Deductible? / B: Premiums / C. Pre-coverage gap co-pays or coinsurance (25% on basic plan) / TROOP pre-donut hole:
A+C / D: Cost in donut hole / Time in donut hole (until
TROOP = $3600, ie
A + C + D) / Time in catastrophic coverage / E: Post-donut hole costs / Total costs#: A+B+C+D+E / Potential annual savings
Basic / $250 / $384
(32 x 12) / $500
Time pre-donut hole:
3.34 months / $750 / $2850 / 4.24 months
(2850/672) / 4.42 months / $148.51 / $4132.51 / $3931.49
Blue Cross Medicare Rx Gold / None / $408 / Time pre-donut hole: 3.34 months
129 x 3.34:
$430.86 / $430.86 / $3169.14 / 4.71 months
(3169.14/672) / 3.95
months / $509.55
(monthly co-pay x 3.95) / $4517.55 / $3546.45
AARP Medicare Rx / $250 / $117.60 / $136 x 3.34: 420.84 / $670.84 / $2929.16 / 4.35 months (2929.16/672) / 4.31 months / $586.16 / $4303.76 / $3760.24

*Costs are only estimates as plans handle months with partial coverage differently—some plans may elect to finish out the month of coverage even if the beneficiary technically would be in or out of the coverage gap.

#Does not include the out of pocket costs for her OTC meds, which are the same under each plan.

BOTTOM LINE: WIth any MEdICARE D PLAN SHE SPENDS ABOUT $4000-4500/year on prescription drugs, so she saves $3500-3900. the cheapest plans may not be those with the lowest premiums or no deductibles.

How much you want to get into Medicare Part D is up to you.

Review the learning objectives of Case #1 with students

Case #1 Learning objectives:

1. Recognize medication nonadherence as a possible explanation of lack of therapeutic benefit

2. List common sources of non-adherence

3. Discuss effective methods for exploring nonadherence with a patient

4. Discuss the importance of drug prices as a potential cause of non-adherence, and list strategies for dealing with this issue

5. (Optional: discuss the larger policy issues surrounding pharmaceutical industry drug pricing, extending patents, marketing, and Medicare D).

CASE #2

Learning objectives

1. List physiologic changes in elders that impact pharmacokinetics of commonly used drugs

2. Use the MDRD to calculate the decline in renal function with aging, and describe its advantages over the Cockroft-Gault equation

3. Use the “Cockroft-Gault” equation to estimate the decline in renal function with aging and describe advantages and limitations of this tool

3. Recognize symptoms of digoxin toxicity

Case #2

A70-year-old (white) man with coronary artery disease and congestive heart failure comes in for a regular appointment. He has been having gradually increasing nausea, anorexia, fatigue, and inactivity over a few months. He reports no shortness of breath or chest pain. He has been on the same medical regimen for ten years:

Digoxin .125 mg PO QD

Furosemide 40 mg PO QD

Lisinopril 40 mg PO QD

Atenolol 50 mg PO QD

ASA 325 mg PO QD

His weight has declined over the past year from 70kg to 60kg. His creatinine level had been stable over the past ten years at 1.4, but is 1.8 today. His last digoxin level two years ago was normal at 1.0.

10 years agoToday

Wt. 70 kg60 kg

Cr1.41.8

BUN 2032

Alb4.03.8

Today he appears somewhat thin. BP 140/80, HR 60 and regular, remainder of examination is normal.

Case 2 Questions

  1. What changes in pharmacokinetics can you expect to see with aging?
  2. Based on the MDRD equation, what was his estimated glomerular filtration rate 10 years ago and what today?
  3. Based on the Cockroft-Gault equation, what was his estimated creatinine clearance 10 years ago and what is it today?
  4. Are there any important drug interactions in his regimen?
  5. What are possible explanations for his symptoms?
  6. How would you adjust his medications?
  7. (optional) About how much does he pay for his medications every month?

CASE 2 ANSWERS AND DISCUSSION

Question A: What changes in pharmacokinetics can you expect to see with aging?

Elderly people often experience changes in physiology and body composition over time that result in changes in the pharmacokinetics of specific drugs. Sometimes those changes can result in new problems, even when a patient has been on the same medications for years.

Students should be able to list some of the changes with aging that might alter pharmacokinetics. First, they should be able to state that muscle and lean body mass tend to decrease with aging, which results in a smaller volume of distribution (and higher serum levels) of water soluble drugs such as digoxin. Conversely, fat soluble drugs such as diazepam have a larger volume of distribution due to increased relative body fat. The most important consequence of this is that fat soluble drugs have a longer half life in older persons.

In addition, renal function tends to decline with aging. This is not universal. On average, about a third of elders have no significant decline in renal function with aging. Equations such as the Cockroft and Gault equation can help “guestimate” creatinine clearance based on age, weight, and serum creatinine, but are not reliable in individual cases.

Changes in hepatic metabolism of drugs are variable. Cytochrome P450 enzyme activity tends to decline with age, although this is extremely complex, and depends on gender, genetics, the specific enzyme involved, etc. Conjugation/glucoronidation tends to be less impacted by aging. Hepatic blood flow is extremely variable and depends in large part of comorbidities.

Question B. The MDRD is a pretty complicated equation, though more accurate than Cockroft-Gault (though it is only valid only for adults between ages 18 and 70 and includes a modifier for white vs black race). So it is the best equation to use if you have access to it or a calculator; in the absence of a calculator, the Cockroft-Gault equation is much easier to perform, though less accurate. I use an online version of it (there is a brief and extended version of it online).

REF: AS Levey et al. Annals of Internal Medicine 1999; 130: 461-70.

MDRD

10 years agoTODAY

(simple version) 55.6/ml/min/1.73m232.4/ml/min/1.73m2

(extended version)54.9/ml/min/1.73m2 39.8/ml/min/1.73m2

Question C: Based on the Cockroft-Gault equation, what was his estimated creatinine clearance 10 years ago and what is it today?

10 years ago: (140 – 60) x 70 = 55.5

72 x 1.4

Today (140 – 70) x 60 = 32.4