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A Preliminary Evaluation of the Efficacy, Safety, and Costs Associated
with the Treatment of Chronic Pain with Medical Marijuana in the Elderly
Terrance J. Bellnier, RPh, MPA, FASCP 1,2, Geoff Brown, PharmD cand.1,2,Tulio Ortega, MD2, Robert Insull, PhD2 1. SUNY University at Buffalo, 2. GPI Clinical Research
Abstracts
Introduction
Age 71 + 7 (65-86) years
Gender 9-male, 27-female
Ethnicity 100% - Caucasian
Duration of Chronic Pain Diagnosis 18 + 7 years
Primary Diagnosis Cancer-8%, Parkinson’s-3%, Neuropathies-28%,
Chronic pain-50%, IBS/Crohn’s-11%
Subjects:
Results: PQAS
Discussion:
0
2
4
6
8
10
Baseline 3 Months
Presented at ASCP 2017 Annual Meeting:
November 2-5, Kissimmee , Florida
Objective/Purpose: To evaluate the efficacy and safety of medical marijuana (MM) as a
treatment for chronic pain in community-dwelling elderly.
Method: Institution Review Board approval was given to conduct this retrospective chart review.
All patients meeting inclusion criteria were included and served as their own controls. The EQ-
5D quality of life, Pain Quality Assessment Scale (PQAS) factor analysis, GAD-7 Anxiety and
PHQ-9 Depression were used to measure clinical outcomes. Records were reviewed for 3
months prior to MM initiation (Pre) and 3 months post exposure to MM use (Post). Kruskal-Wallis
for analysis of variance and Wilcoxon-signed rank test for significance were used.
Results: 36 ambulatory patients were identified with a diagnosis of chronic pain. Patient
demographics included: age 71+/- 7(65-86), 100% Caucasian, 27 females, 9 males, duration of
illness 18 +/- 7 years. Clinical outcome: EQ-5D (Pre 31 – Post 62, P<.0001), PQAS Paroxysmal
(Pre 7.72 – Post 2.04, P<.0001), Surface (Pre 5.20 – Post 1.59, P<.0001), Deep (Pre 6.87 –
Post 3.03, P<.0001), Unpleasant (Pre “miserable” – Post “annoying”, P<.0001), GAD-7
Anxiety.(Pre 4.81-Post 2.83, P<.0001), and PHQ-9 Depression (Pre 3.97-Post 3.57, P<.001)
Service utilization: pain medication cost (Pre $363.90– Post $238.40, P<.05). Safety: morphine
equivalents (Pre 69.94– Post 18.65, P<.05). Adverse effects were reported in 9% of subjects.
Conclusion: The present study provides evidence that medical marijuana in community-
dwelling elderly is effective, well tolerated and cost effective for chronic pain. A randomized
placebo controlled clinical trial is warranted to further evaluate the role of medical marijuana in
the treatment of chronic pain in the elderly.
Pain Quality Baseline 3 months P value
Intense 7.28 + 1.2 3.17 + 0.9 <.0001
Sharp 7.13 3.21 + 2.3 <.0001
Hot 7.97 + 3.07 2.29 + 1.92 <.0001
Dull 4.38 + 3.21 2.06 + 1.86 <.0001
Cold 1.93 + 3.1 0.36 + 1.19 <.0001
Sensitive 4.63 + 3.4 1.63 + 1.11 <.0001
Tender 5.69 + 3.65 1.65 + 1.59 <.0001
Itchy 1.93 + 2.05 0.21 + 0.59 <.0001
Shooting 7.65 + 2.59 2.12 + 1.65 <.0001
Numb 7.31 + 3.09 2.93 + 1.52 <.0001
Electrical 7.11 + 3.06 1.69 + 1.36 <.0001
Tingling 5.97 + 3.37 2.12 + 1.59 <.0001
Cramping 6.76 + 3.03 2.26 + 1.64 <.0001
Radiating 6.68 + 3.69 2.49 + 1.64 <.0001
Throbbing 6.99 + 3.49 1.98 + 1.69 <.0001
Aching 7.31 + 2.47 2.48 + 1.52 <.0001
Heavy 5.42 + 3.79 1.69 + 2.11 <.0001
Results: PQAS factor analysis
How unpleasant your pain feels
intolerable
miserable
bothersome
annoying
0
50
100
150
200
250
300
350
400
Baseline 3	Months
Morphine equivalents (mg/day) Medication Costs ($/month)
Results: Service utilization
References:
1.Ferrell, B.A., B.R. Ferrell, and D. Osterweil, Pain in the nursing home. Journal of the American geriatrics Society, 1990.
38(4): p. 409-414.
2.Miller, M., et al., Opioid Analgesics and the Risk of Fractures Among Older Adults with Arthritis. Journal of the American
Geriatrics Society, 2011. 59(3): p. 430-438.
3.State Medical Marijuana Laws. 2017; Available from: http://www.ncsl.org/research/health/state-medical-marijuana-
laws.aspx
4.Medical Use of Marijuana, in 6357-E, Title V-A N.Y.S. Assembly, Editor. 2013: United States.
5.Lee, M.C., et al., Amygdala activity contributes to the dissociative effect of cannabis on pain perception. Pain, 2013.
154(1): p. 124-134.
6.Abrams, D.I. and M. Guzman, Cannabis in cancer care. Clin Pharmacol Ther, 2015. 97(6): p. 575-86.
7.Bachhuber, M.A., et al., Medical cannabis laws and opioid analgesic overdose mortality in the United States, 1999-2010.
JAMA Intern Med, 2014. 174(10): p. 1668-73.
The lack of safe and effective treatment options for chronic pain leaves both
patients and clinicians without options. Opiates have been responsible for
more than 183,000 lives over the past 15 years. A safe and effective option
for the treatment of chronic pain is needed. The present study provides
evidence that medical marijuana as adjunctive or monotherapy for chronic
pain regardless of the etiology is an effective, well tolerated and cost effective
treatment for community-dwelling elderly. Few patients experienced side
effects (9%) and all were transient and short lived. New York State provides a
unique environment to evaluate this treatment. The quality and consistency
of the product, along with the required monitoring of controlled substances
affords investigators the means to help determine the value of medical
marijuana as a alternative to opiates. Our goals are to develop evidenced
based treatment guidelines to aide clinicians in recommending medical
marijuana as a alternative to opiates in the treatment of chronic pain. Due to
the limitations of our retrospective evaluation these results may not be
applicable to the general population. A controlled clinical trial is warranted to
further evaluate the role of medical marijuana in the treatment of chronic pain
in community-dwelling and institutional-dwelling elderly..
Results: Quality of Life
Results: Depression and Anxiety
Persistent pain is a debilitating and widespread problem in the elderly population. More than
50% of community-dwelling elderly and more than 80% of nursing home residents suffer from
chronic pain [1]. The management of pain in older adults presents substantial challenges to
clinicians. Inadequate pain management in these patients can lead to further disability and
significant deterioration in quality of life. As a last-ditch effort to relieve patients of pain, they
are often placed on opioid analgesics. Opioids develop rapid tolerance, have been linked to
hip fractures, and lead to side effects that often require additional therapy [2].
Evidence supporting MM’s effectiveness as an analgesic is growing and is attracting attention
from the medical community and general public. As of November 2016, a total of 28 states and
3 US districts have legalized the use of medical marijuana or its extracts for pain management
[3]. In some states, MM is not entirely divided from recreational marijuana nor is it regulated
like a pharmaceutical. In New York State (NYS), the Department of Health’s (DOH) program
aims to keep the “medical” in MM by enacting stringent legislation with strict oversight. MM is
only to be dispensed by a registered pharmacist, who must dispense a pharmaceutical grade
smokeless dosage form [4]. In March of this year, the NYS DOH added chronic pain to the list
of qualifying conditions for the state’s medical marijuana program. The expansion aims to
improve patient access to MM, but also reduce inappropriate and dangerous use of opioids in
chronic settings.
Chronic pain often involves both nociceptive and neuropathic pain components. The mixed
picture of chronic pain adds complexity to an already difficult clinical scenario, especially in
older adults whom often have multiple comorbidities and take a higher number of prescription
drugs. In neuropathic pain, the brain experiences an inappropriate perception of pain rather
than pain from real or potential tissue damage. MM offers a unique mechanism in the
approach to treating chronic pain syndromes. By altering the brain’s perception of brain, MM
can potentially relieve chronic pain refractory to conventional therapies [5].
Two compounds present in MM, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
are responsible for a majority of the drug’s pharmacologic effects [6]. The primary receptors
acted on, are cannabinoid receptors, one (CB1) and two (CB2). CB1 is found in high
concentrations in the brain in areas that modulate nociceptive pain. CB2 is more widespread in
the periphery and is associated with cells of the immune system. MM may exert its analgesic
effect through a combination of activity at both of these receptors. Altering the perception of
pain at CB1, and acting through an anti-inflammatory mechanism at CB2 to reduce mast-cell
release.
Given the regulatory landscape present in NYS, evidence supporting MM’s analgesic effects, and fact that
opioid overdose deaths are reduced in states with public MM programs, we investigated MM’s utility in the
treatment of chronic pain [7].
0
1
2
3
4
5
6
7
8
9
Paroxysmal Surface Deep
Baseline 3 Months
0 1 2 3 4 5 6
Baseline
3 Months
PHQ-9 Depression GAD-7 Anxiety

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Medical Marijuana in the Elderly

  • 1. A Preliminary Evaluation of the Efficacy, Safety, and Costs Associated with the Treatment of Chronic Pain with Medical Marijuana in the Elderly Terrance J. Bellnier, RPh, MPA, FASCP 1,2, Geoff Brown, PharmD cand.1,2,Tulio Ortega, MD2, Robert Insull, PhD2 1. SUNY University at Buffalo, 2. GPI Clinical Research Abstracts Introduction Age 71 + 7 (65-86) years Gender 9-male, 27-female Ethnicity 100% - Caucasian Duration of Chronic Pain Diagnosis 18 + 7 years Primary Diagnosis Cancer-8%, Parkinson’s-3%, Neuropathies-28%, Chronic pain-50%, IBS/Crohn’s-11% Subjects: Results: PQAS Discussion: 0 2 4 6 8 10 Baseline 3 Months Presented at ASCP 2017 Annual Meeting: November 2-5, Kissimmee , Florida Objective/Purpose: To evaluate the efficacy and safety of medical marijuana (MM) as a treatment for chronic pain in community-dwelling elderly. Method: Institution Review Board approval was given to conduct this retrospective chart review. All patients meeting inclusion criteria were included and served as their own controls. The EQ- 5D quality of life, Pain Quality Assessment Scale (PQAS) factor analysis, GAD-7 Anxiety and PHQ-9 Depression were used to measure clinical outcomes. Records were reviewed for 3 months prior to MM initiation (Pre) and 3 months post exposure to MM use (Post). Kruskal-Wallis for analysis of variance and Wilcoxon-signed rank test for significance were used. Results: 36 ambulatory patients were identified with a diagnosis of chronic pain. Patient demographics included: age 71+/- 7(65-86), 100% Caucasian, 27 females, 9 males, duration of illness 18 +/- 7 years. Clinical outcome: EQ-5D (Pre 31 – Post 62, P<.0001), PQAS Paroxysmal (Pre 7.72 – Post 2.04, P<.0001), Surface (Pre 5.20 – Post 1.59, P<.0001), Deep (Pre 6.87 – Post 3.03, P<.0001), Unpleasant (Pre “miserable” – Post “annoying”, P<.0001), GAD-7 Anxiety.(Pre 4.81-Post 2.83, P<.0001), and PHQ-9 Depression (Pre 3.97-Post 3.57, P<.001) Service utilization: pain medication cost (Pre $363.90– Post $238.40, P<.05). Safety: morphine equivalents (Pre 69.94– Post 18.65, P<.05). Adverse effects were reported in 9% of subjects. Conclusion: The present study provides evidence that medical marijuana in community- dwelling elderly is effective, well tolerated and cost effective for chronic pain. A randomized placebo controlled clinical trial is warranted to further evaluate the role of medical marijuana in the treatment of chronic pain in the elderly. Pain Quality Baseline 3 months P value Intense 7.28 + 1.2 3.17 + 0.9 <.0001 Sharp 7.13 3.21 + 2.3 <.0001 Hot 7.97 + 3.07 2.29 + 1.92 <.0001 Dull 4.38 + 3.21 2.06 + 1.86 <.0001 Cold 1.93 + 3.1 0.36 + 1.19 <.0001 Sensitive 4.63 + 3.4 1.63 + 1.11 <.0001 Tender 5.69 + 3.65 1.65 + 1.59 <.0001 Itchy 1.93 + 2.05 0.21 + 0.59 <.0001 Shooting 7.65 + 2.59 2.12 + 1.65 <.0001 Numb 7.31 + 3.09 2.93 + 1.52 <.0001 Electrical 7.11 + 3.06 1.69 + 1.36 <.0001 Tingling 5.97 + 3.37 2.12 + 1.59 <.0001 Cramping 6.76 + 3.03 2.26 + 1.64 <.0001 Radiating 6.68 + 3.69 2.49 + 1.64 <.0001 Throbbing 6.99 + 3.49 1.98 + 1.69 <.0001 Aching 7.31 + 2.47 2.48 + 1.52 <.0001 Heavy 5.42 + 3.79 1.69 + 2.11 <.0001 Results: PQAS factor analysis How unpleasant your pain feels intolerable miserable bothersome annoying 0 50 100 150 200 250 300 350 400 Baseline 3 Months Morphine equivalents (mg/day) Medication Costs ($/month) Results: Service utilization References: 1.Ferrell, B.A., B.R. Ferrell, and D. Osterweil, Pain in the nursing home. Journal of the American geriatrics Society, 1990. 38(4): p. 409-414. 2.Miller, M., et al., Opioid Analgesics and the Risk of Fractures Among Older Adults with Arthritis. Journal of the American Geriatrics Society, 2011. 59(3): p. 430-438. 3.State Medical Marijuana Laws. 2017; Available from: http://www.ncsl.org/research/health/state-medical-marijuana- laws.aspx 4.Medical Use of Marijuana, in 6357-E, Title V-A N.Y.S. Assembly, Editor. 2013: United States. 5.Lee, M.C., et al., Amygdala activity contributes to the dissociative effect of cannabis on pain perception. Pain, 2013. 154(1): p. 124-134. 6.Abrams, D.I. and M. Guzman, Cannabis in cancer care. Clin Pharmacol Ther, 2015. 97(6): p. 575-86. 7.Bachhuber, M.A., et al., Medical cannabis laws and opioid analgesic overdose mortality in the United States, 1999-2010. JAMA Intern Med, 2014. 174(10): p. 1668-73. The lack of safe and effective treatment options for chronic pain leaves both patients and clinicians without options. Opiates have been responsible for more than 183,000 lives over the past 15 years. A safe and effective option for the treatment of chronic pain is needed. The present study provides evidence that medical marijuana as adjunctive or monotherapy for chronic pain regardless of the etiology is an effective, well tolerated and cost effective treatment for community-dwelling elderly. Few patients experienced side effects (9%) and all were transient and short lived. New York State provides a unique environment to evaluate this treatment. The quality and consistency of the product, along with the required monitoring of controlled substances affords investigators the means to help determine the value of medical marijuana as a alternative to opiates. Our goals are to develop evidenced based treatment guidelines to aide clinicians in recommending medical marijuana as a alternative to opiates in the treatment of chronic pain. Due to the limitations of our retrospective evaluation these results may not be applicable to the general population. A controlled clinical trial is warranted to further evaluate the role of medical marijuana in the treatment of chronic pain in community-dwelling and institutional-dwelling elderly.. Results: Quality of Life Results: Depression and Anxiety Persistent pain is a debilitating and widespread problem in the elderly population. More than 50% of community-dwelling elderly and more than 80% of nursing home residents suffer from chronic pain [1]. The management of pain in older adults presents substantial challenges to clinicians. Inadequate pain management in these patients can lead to further disability and significant deterioration in quality of life. As a last-ditch effort to relieve patients of pain, they are often placed on opioid analgesics. Opioids develop rapid tolerance, have been linked to hip fractures, and lead to side effects that often require additional therapy [2]. Evidence supporting MM’s effectiveness as an analgesic is growing and is attracting attention from the medical community and general public. As of November 2016, a total of 28 states and 3 US districts have legalized the use of medical marijuana or its extracts for pain management [3]. In some states, MM is not entirely divided from recreational marijuana nor is it regulated like a pharmaceutical. In New York State (NYS), the Department of Health’s (DOH) program aims to keep the “medical” in MM by enacting stringent legislation with strict oversight. MM is only to be dispensed by a registered pharmacist, who must dispense a pharmaceutical grade smokeless dosage form [4]. In March of this year, the NYS DOH added chronic pain to the list of qualifying conditions for the state’s medical marijuana program. The expansion aims to improve patient access to MM, but also reduce inappropriate and dangerous use of opioids in chronic settings. Chronic pain often involves both nociceptive and neuropathic pain components. The mixed picture of chronic pain adds complexity to an already difficult clinical scenario, especially in older adults whom often have multiple comorbidities and take a higher number of prescription drugs. In neuropathic pain, the brain experiences an inappropriate perception of pain rather than pain from real or potential tissue damage. MM offers a unique mechanism in the approach to treating chronic pain syndromes. By altering the brain’s perception of brain, MM can potentially relieve chronic pain refractory to conventional therapies [5]. Two compounds present in MM, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are responsible for a majority of the drug’s pharmacologic effects [6]. The primary receptors acted on, are cannabinoid receptors, one (CB1) and two (CB2). CB1 is found in high concentrations in the brain in areas that modulate nociceptive pain. CB2 is more widespread in the periphery and is associated with cells of the immune system. MM may exert its analgesic effect through a combination of activity at both of these receptors. Altering the perception of pain at CB1, and acting through an anti-inflammatory mechanism at CB2 to reduce mast-cell release. Given the regulatory landscape present in NYS, evidence supporting MM’s analgesic effects, and fact that opioid overdose deaths are reduced in states with public MM programs, we investigated MM’s utility in the treatment of chronic pain [7]. 0 1 2 3 4 5 6 7 8 9 Paroxysmal Surface Deep Baseline 3 Months 0 1 2 3 4 5 6 Baseline 3 Months PHQ-9 Depression GAD-7 Anxiety