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The prevalence and incidence of medicinal cannabis on prescription in The Netherlands

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Background: A growing number of countries are providing pharmaceutical grade cannabis to chronically ill patients. However, little published data is known about the extent of medicinal cannabis use and the characteristics of patients using cannabis on doctor's prescription. This study describes a retrospective database study of The Netherlands. Methods: Complete dispensing histories were obtained of all patients with at least one medicinal cannabis prescription gathered at pharmacies in The Netherlands in the period 2003-2010. Data revealed prevalence and incidence of use of prescription cannabis as well as characteristics of patients using different cannabis varieties. Results: Five thousand five hundred forty patients were identified. After an initial incidence of about 6/100,000 inhabitants/year in 2003 and 2004, the incidence remained stable at 3/100,000/year in 2005-2010. The prevalence rate ranged from 5 to 8 per 100,000 inhabitants. Virtually all patients used some form of prescription medication in the 6 months preceding start of cannabis use, most particularly psycholeptics (45.5 %), analgesics (44.3 %), anti-ulcer agents (35.9 %) and NSAIDs (30.7 %). We found no significant association between use of medication of common indications for cannabis (pain, HIV/AIDS, cancer, nausea, glaucoma) and variety of cannabis used. Conclusions: This is the first nationwide study into the extent of prescription of medicinal cannabis. Although the cannabis varieties studied are believed to possess different therapeutic effects based on their different content of tetrahydrocannabinol (THC) and cannabidiol (CBD), no differences in choice of variety was found associated with indication.
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PHARMACOEPIDEMIOLOGY AND PRESCRIPTION
The prevalence and incidence of medicinal cannabis
on prescription in The Netherlands
Arno Hazekamp &Eibert R. Heerdink
Received: 26 October 2012 /Accepted: 28 December 2012
#Springer-Verlag Berlin Heidelberg 2013
Abstract
Background A growing number of countries are providing
pharmaceutical grade cannabis to chronically ill patients.
However, little published data is known about the extent
of medicinal cannabis use and the characteristics of patients
using cannabis on doctors prescription. This study de-
scribes a retrospective database study of The Netherlands.
Methods Complete dispensing histories were obtained of all
patients with at least one medicinal cannabis prescription
gathered at pharmacies in The Netherlands in the period
20032010. Data revealed prevalence and incidence of use
of prescription cannabis as well as characteristics of patients
using different cannabis varieties.
Results Five thousand five hundred forty patients were
identified. After an initial incidence of about 6/100,000
inhabitants/year in 2003 and 2004, the incidence remained
stable at 3/100,000/year in 20052010. The prevalence rate
ranged from 5 to 8 per 100,000 inhabitants. Virtually all
patients used some form of prescription medication in the
6 months preceding start of cannabis use, most particularly
psycholeptics (45.5 %), analgesics (44.3 %), anti-ulcer
agents (35.9 %) and NSAIDs (30.7 %). We found no sig-
nificant association between use of medication of common
indications for cannabis (pain, HIV/AIDS, cancer, nausea,
glaucoma) and variety of cannabis used.
Conclusions This is the first nationwide study into the extent
of prescription of medicinal cannabis. Although the cannabis
varieties studied are believed to possess different therapeutic
effects based on their different content of tetrahydrocannabi-
nol (THC) and cannabidiol (CBD), no differences in choice of
variety was found associated with indication.
Keywords Cannabis .Therapeutic use .Prevalence .
Incidence .The Netherlands
Introduction
As the medicinal properties of the cannabis plant are increas-
ingly being unraveled, the number of countries that provide an
official source of cannabis to chronically ill patients is grow-
ing. Canada (since 2001) and The Netherlands (since 2003)
have had a government-run program for the last decade, sup-
plying quality-controlled herbal cannabis grown by specialized
companies [1,2]. Several countries are now following this
WHAT THIS PAPER ADDS
What is already known on this subject
As clinical support for the therapeutic use of cannabis or its isolated
components such as THC is mounting, several countries are now providing
herbal cannabis of pharmaceutical grade to chronically ill patients.
Many other patients obtain cannabis from illicit sources and experiment
with self-medication, without the supervision of a medical professional.
Other than surveys based on self-selected participation, not much is
known about characteristics or preferences of medicinal cannabis users,
What this study adds
This study is the first one using objective data to study national medicinal
cannabis consumption patterns, providing accurate data on the incidence,
prevalence and characteristics of users of prescribed medicinal cannabis in
The Netherlands.
Understanding the background and preferences of cannabis patients may
help medical professionals to decide about the role of medicinal cannabis in
their own practice.
A. Hazekamp
Department of Plant Metabolomics, Faculty of Science,
Leiden University, Leiden, The Netherlands
E. R. Heerdink
Department of Pharmacoepidemiology and Clinical
Pharmacology, Utrecht Institute for Pharmaceutical Sciences,
Faculty of Science, Utrecht University, PO Box 80082,
3508 TB Utrecht, The Netherlands
E. R. Heerdink
Department of Clinical Pharmacy, Division of Laboratory
Medicine & Pharmacy, University Medical Center,
Utrecht, The Netherlands
A. Hazekamp (*)
Gorlaeus Laboratory, Einsteinweg 55,
2333 CC Leiden, The Netherlands
e-mail: ahazekamp@rocketmail.com
Eur J Clin Pharmacol
DOI 10.1007/s00228-013-1503-y
example, either by setting up their own program (Israel, Czech
Republic) or by importing products from The Netherlands
(Italy, Finland, Germany). In the United States, the number
of states that have introduced laws to permit the medical use of
marijuana has now grown to 17 plus the District of Columbia
(DC), even though this development is not endorsed by the US
federal government [3]. In contrast to these developments, little
published data is known about the extent of medicinal cannabis
use and the characteristics of patients using cannabis on doc-
tors prescription, other than survey data relying on self-
selected participation and self-reports [49].
The medicinal cannabis program of The Netherlands,
supervised by the Office of Medicinal Cannabis (OMC) of
the Dutch Health Department, provides an opportunity to
study such questions. The program offers pharmaceutical
grade cannabis on prescription to chronically ill patients
suffering from multiple sclerosis, cancer, HIV/AIDS, chronic
pain, therapy-resistant glaucoma, and Tourettes syndrome
[1]. The product is cultivated by contracted company
Bedrocan BV, and dispensed through pharmacies in the form
of dried female flowers (Cannabis Flos) packaged in 5 g
containers. Patients are advised to administer medicinal can-
nabis by using a cannabis vaporizer or by preparing it as a tea
[10,11]. In a growing number of cases, costs are reimbursed
by health insurance companies [12].
Patients in The Netherlands typically utilise only a single
pharmacy for obtaining all their prescription medicine, mak-
ing it possible to track patients over time and construct
complete medication histories including both GP and spe-
cialist prescriptions [13]. Therefore, using the Dutch canna-
bis program as a well-documented source of data, this study
aims to analyse the incidence and prevalence of prescription
medicinal cannabis use, as well as the demographics and
characteristics of patients using cannabis on prescription.
Methods
The data collection covered the period of September 2003
(when medicinal cannabis first became officially available
on prescription in The Netherlands) to the end of December
2010. Data on dispensing was collected from two sources. The
main source was the Dutch Foundation for Pharmaceutical
Statistics (Stichting Farmaceutische Kengetallen; SFK); an
independent organization collecting data from community
pharmacies in The Netherlands for policy and research
purposes. Medication dispensed through hospital pharma-
cies and nursing homes for in-house patients are not regis-
tered in the SFK database and are therefore not covered in
our study. The second source of data was the only Dutch
pharmacy specialized in dispensing of medicinal cannabis
(Hanzeplein pharmacy, Groningen). Since 2007 this phar-
macy has been active in dispensing the same medicinal
cannabis for a reduced price (as a result of cheaper packag-
ing, distribution and labour cost) through mail-order to
patients located all over The Netherlands.
Data collected from both sources included date of dispens-
ing, variety and amount of medicinal cannabis dispensed, and
patient characteristics (age, gender, and geographical location
by zip code). Complete comedication dispensed through the
pharmacy was collected for SFK data only from 6 months
preceding the first medicinal cannabis dispensing until the end
of medicinal cannabis use. Comedication was coded
according to the WHO ATC/DDD methodology and grouped
accordingly [14]. All data were anonymized and patients were
not financially or otherwise compensated.
In the period covered by this study (20032010), four dif-
ferent varieties of cannabis were available to patients, each
containing a standardized amount of the known active ingredi-
ents tetrahydrocannabinol (THC) or cannabidiol (CBD) [15].
These varieties were: Bedrocan® (ca. 19 % THC; introduced
2003); Bedrobinol® (ca. 12 % THC; introduced 2005); and
Bediol® (ca. 6 % THC, 7.5 % CBD; introduced 2007). Variety
SIMM18 (ca. 11 % THC; introduced 2003) was only available
until 2006, after which it was replaced by Bedrobinol®.
Incident use of medicinal cannabis was defined as the
first dispensing date available in the database. Since the
database covers the complete period of availability of me-
dicinal cannabis in The Netherlands, this refers to actual
new users. Year-by-year prevalence was determined by
counting the number of patients with at least one dispensing
of a medicinal cannabis preparation in a calendar year. Total
duration of cannabis use was defined as the time difference
between the first and last dispensing of medicinal cannabis,
supplemented with the number of days needed to consume
the last dispensed amount (assuming an average daily use as
shown in Table 1). Average dosage of cannabis per day per
patient was calculated by dividing the total dispensed dose
(in grams) of each individual, by the total duration of use
(in days) calculated for that same individual.
Results
Demographics
Table 1shows demographic data of the study population.
Over the 20032010 study period, 5,540 individual patients
were identified receiving a combined total of approximately
35,000 medicinal cannabis dispensations. The majority of
patients (5,255; 94.9 %) received their product through regular
community pharmacies, the remaining patients (285; 5.1 %)
had their prescription filled in by the specialized cannabis
pharmacy. More females (56.8 %) compared to males
(42.7 %) used medicinal cannabis on prescription. The mean
(median) age of the study population was 55.6 (55) years, with
Eur J Clin Pharmacol
a range of 14 to 93 years. The zip code information available
for each patient indicated that medicinal cannabis users were
fairly equally distributed, without noticeable agglomeration in
specific geographical locations (data not shown).
Average cannabis use and duration
Data on cannabis use are also shown in Table 1.Patients
received on average 6.4 prescriptions of medicinal cannabis
with a median of 10 g dispensed per prescription. Overall,
medicinal cannabis was prescribed for an average duration of
251days.Patientshadanaveragedailydoseof0.68gperday
dispensed. Male patients (0.71 g) were found to consume slight-
ly more medicinal cannabis daily than female patients (0.65 g).
Despite the differences in composition of active ingredients, no
clear differences in average daily dose were observed between
the four cannabis varieties offered (data not shown).
Incidence and prevalence
After an initial incidence of about 1,000 new users per year
at the start of the cannabis program in 2003 and 2004
(equalling 6 per 100,000 persons per year), the number of
new users stabilized somewhat lower around 500 per year,
(3 per 100,000 per year). The number of patients receiving
at least one prescription of medicinal cannabis per year
ranged from 800 to 1,300 per year, which translates into a
yearly prevalence rate of 58 per 100,000 persons as shown
in more detail in Fig. 1.
Comedication and correlation with cannabis varieties
Virtually all patients used at least some form of prescription
medication, other than cannabis, in the 6 months preceding
the first cannabis prescription. Comedication observed most
often were psycholeptics (ATC code N05; used by 45.5 % of
study population), analgesics (N02; 44.3 %), anti-ulcer
agents (A02B; 35.9 %) and NSAIDs (M01; 30.7 %).
Because the Dutch program provides multiple cannabis
varieties, each with different content of THC and CBD, this
may (tentatively) allow us to identify correlations between these
pharmaceutically active components and particular symptoms
under treatment, by studying the comedication used in the
period before start of cannabis treatment. We therefore selected
those indications that are specifically mentioned by the Office
of Medicinal Cannabis, and that can be fairly unambiguously
recognized by the (co)medication used. These included severe
pain (as identified by use of opioid and non-opioid pain med-
ication), cancer (oncolytics), HIV/AIDS (HIV-medication),
nausea (anti-nausea medication) and glaucoma (eye drops).
Other indications, such as MS or Tourette syndrome, were not
investigated here because there is no specific comedication that
unambiguously indicates these conditions.
As shown in Table 2(which includes the 5,250 patients
from the SFK database only), pain medication was used by
53.6 % of all cannabis users, which was further broken
down into non-opioids (40.5 % of cannabis users), and weak
(21.8 %) or strong opioids (21.2 %). Although cancer and
HIV/AIDS are often mentioned in popular media in relation
to medicinal cannabis use, oncolytics (2.7 %) and HIV
medication (0.9 %) were only used by a small proportion
of cannabis users. Glaucoma medication was seen in 2.2 %
of users. In contrast, medication prescribed to treat nausea
was used by 15.5 % of all cannabis users.
The results in Table 2were further broken down for the
different cannabis varieties available. Varieties Bedrobinol
and SIMM18 were combined because of their similar THC
content. For ease of interpretation, only data of patients who
had used one single cannabis variety is shown, which covered
4,507 (85.8 %) of all subjects. Of the remaining subjects, 682
(13.0 %) patients had used 2 different varieties, while 98
(1.9 %) had used 3 or 4 varieties. Although some minor
differences between varieties are visible, there seemed to be
no clear correlation between content of THC/CBD and any of
the comedication we studied.
Discussion & conclusion
This first nationwide study into the extent of prescription of
medicinal cannabis provides us with a characterization of
patients using medicinal cannabis on prescription in The
Netherlands, including demographics, average use and infor-
mation on varieties and indications. A strength of this study is
the virtual nationwide coverage of the data-collection, with the
SFK data statistically covering about 85 % of the total Dutch
population [Dutch Foundation for Pharmaceutical Statistics,
personal communication]. Before conclusions may be drawn,
Table 1 Demographics and medicinal cannabis use in the study pop-
ulation from 2003 to 2010
N=(%) Average
duration
of use (days)
Average
number of
dispensations
Average
daily use
(grams)
Study
population
5,540 (100) 251 6.43 0.68
Sex
Male 2,366 (42.7) 244 6.70 0.71
Female 3,149 (56.8) 258 6.26 0.65
Age
20 93 (1.7) 181 5.57 0.82
2140 846 (15.3) 316 8.73 0.72
4160 2,551 (46.0) 304 7.44 0.66
6180 1,722 (31.1) 174 4.51 0.67
>80 303 (5.5) 99 3.01 0.74
Eur J Clin Pharmacol
however, the potential limitations of the study must be clearly
addressed. Our study was performed based on the assumption
that Dutch patients receive all their medication from one
pharmacy only. Although this is generally considered to be
typical for the Dutch pharmacy system, we cannot exclude
that at least a proportion of patients visited multiple pharma-
cies over the study period. When a patient visits a new
pharmacy, the person is entered into the database under a
new identifier, which in our study would have been interpreted
as a new user. Also, it should be noted that obtaining cannabis
from the Dutch outlets known as coffee shops remains a
(pseudo-legal) option for patients [16]. A recent large-scale
international survey among 953 patients performed by the
International Association for Cannabinoid Medicines
(AICM) indicated that the street market (including coffee
shops), as well as growing your own cannabis, remain widely
popular even among those patients who have access to can-
nabis on prescription [4].
Despite these limitations, we believe this was the first
time objective data was used to study national medicinal
cannabis consumption patterns, in contrast to surveys based
on self-selected participation. Indeed, the differences be-
tween these two approaches can be significant. For example,
the average daily use determined in our study was 0.68 g. In
contrast, the international IACM survey found an average
daily use ranging from 2.4 to 3.8 g per day, depending on
the administration form used [4]. Unfortunately, in our cur-
rent study the administration form of the cannabis was not
known; although patients are advised to inhale their cannabis
by using an vaporizer or to prepare tea [1], we cannot be certain
they follow these instructions. We also noticed a significant
difference in age of subjects between the IACM survey (mean
40.7 years) and our own study (mean 55.6 years). Other
surveys have found similar results for higher daily consump-
tion [7,17] or younger mean age, compared to the database
approach described here [1820]. Such differences may indi-
cate that surveys based on self-selected medicinal cannabis
users, at least to some extent, inadvertently attract younger
patients who have an above-average interest in herbal canna-
bis, and use more liberal amounts of cannabis on a daily base.
Because the SFK database did not cover the entire Dutch
general population (totaling 16.6 million inhabitants in 2010),
Fig. 1 Prevalence (vertical
bars) and prevalence rate
(secondary horizontal axis) of
medicinal cannabis use in The
Netherlands, 20032010
Table 2 Use of comedication
categorized per cannabis variety.
Results are expressed as per-
centage of total users in each
category
a
All users for which comedication
information was available (SFK
database patients only)
b
For exact THC and CBD
content, see Methods
All users
a
Users of high
THC:
b
Bedrocan
Users of low THC:
b
Bedrobinol/SIMM
Users of THC+CBD
b
Bediol
Total (N=) 5,250 2,136 1,933 438
Associated comedication (%)
Pain medication 2,801 (53.4) 1,119 (52.4) 1,072 (55.5) 220 (50.2)
-Non-opioid 2,125 (40.5) 814 (38.1) 841 (43.5) 168 (38.4)
-Weak opioid 1,147 (21.8) 470 (22.0) 423 (21.9) 99 (22.6)
-Strong opioid 1,114 (21.2) 476 (22.3) 430 (22.2) 95 (21.7)
HIV medication 48 (0.9) 24 (1.1) 9 (0.5) 4 (0.9)
Oncolytics 139 (2.6) 66 (3.1) 50 (2.6) 9 (2.1)
Nausea medication 806 (15.4) 337 (15.8) 335 (17.3) 68 (15.5)
Glaucoma medication 116 (2.2) 49 (2.3) 40 (2.1) 10 (2.3)
Eur J Clin Pharmacol
and at least a proportion of patients is believed to con-
sume cannabis obtained from non-official sources, our
calculated prevalence rate of 58 per 100,000 should be
considered a very conservative estimate. By comparison,
prevalence rates (unofficially) reported in some other
countries where medicinal cannabis use is registered by
national authorities are 35 (per 100,000) for Canada and
80 for Israel, while in some US states prevalence rates of
over 100 are claimed [21]. However, these numbers likely
include significant numbers of pseudo-patients who, other
that Dutch consumers, do not have the opportunity to
obtain cannabis from legal street sources like the Dutch
coffee shops. Importantly, the low average daily dose
(0.68 g) found in our study points to a low potential of
misuse, and a seeming absence of widespread develop-
ment of tolerance. By comparison, an average Dutch
cannabis cigarette used for recreational purposes contains
about 0.26 g of cannabis mixed with tobacco [22]. The
slightly higher daily consumption by male patients com-
pared to females may be explained by differences in
average body weight between both sexes.
By studying the comedication prescribed in the period right
before first onset of cannabis use, we identified pain and nausea
as common medical indications correlated with cannabis use.
This may not be surprising given the fact that nausea (together
with vomiting and lack of appetite) is a clinically proven
indication for THC, e.g. in the form of Marinol®, while prep-
arations containing THC and/or CBD were shown to be clini-
cally effective for several pain indications, including severe
chronic noncancer pain [23], various neuropathic pains [24],
postoperative pain [25]andMS[26]. Surprisingly, the differ-
ences between varieties, in terms of average daily consumption
or associated comedication, were found to be minimal.
Although the cannabis varieties are believed to possess different
therapeutic effects based on their different content of THC and
CBD, only a minority of patients (14.9 %) had tried more than
one single variety. It is unknown whether this means that the
first choice of variety was already sufficiently effective in most
patients, or that patients were generally not interested in trying
another variety of cannabis in case the first variety failed to
provide proper relief. Alternatively, doctors may have lacked
sufficient information to make an informed decision, or may
have refused to write another prescription after the first variety
was found to be ineffective.
The Dutch program is currently unique in the world for
providing a choice of standardized and quality controlled
cannabis varieties to patients. Nevertheless, based on our
study it should be concluded that the differences between
these varieties are still insufficiently recognized. In contrast, it
is important to realize that although our data accurately show
what (how much, how often, what variety) doctors have
prescribed, it cannot reveal whether the prescribed products
were actually effective or not in treating the intended
symptoms. Large population-based surveys, preferably
among the same well-documented Dutch patient population,
are needed to further describe the intentions and experiences
of medicinal cannabis patients. Eventually, properly designed
clinical trials are needed to provide a better understanding of
the link between specific combinations of cannabinoids and
medical indications. In the meantime, an increased effort to
educate medical users as well as prescribers about the medic-
inal use of cannabis may further strengthen the Dutch model
of providing pharmaceutical-grade cannabis to chronically ill
patients.
Acknowledgments AH is Head of R&D at Bedrocan BV, The Neth-
erlands. The Dutch Association for Legal Cannabis and its Constitu-
ents as Medicine (NCSM foundation, Oegstgeest, The Netherlands) is
gratefully acknowledged for providing the funds to collect data from
the SFK database and providing the data to the authors. No additional
funding was received for conducting this study.
References
1. Office of Medicinal Cannabis (OMC), Department of Health,
official website http://www.cannabisbureau.nl (accessed Sep 2012)
2. Health Canada: Canadian department of Health, Marijuana Medi-
cal Access Program:http://hc-sc.gc.ca/dhp-mps/marihuana/index-
eng.php (accessed Sep 2012)
3. Americans for Safe Access (ASA). Connecticut Becomes 17th Med-
ical Marijuana State in the Face of Ongoing Federal Intimidation.
Press release of 01 June 2012. http://www.safeaccessnow.org/
article.php?id=7174 (accessed Sep 2012)
4. Hazekamp A, Mueller-Vahl K, Ware M et al The medicinal use of
cannabis and cannabinoids; an international cross-sectional survey
on methods of intake. J Psychoactive Drugs. in press
5. Reiman AE (2007) Medical cannabis patients: patient profiles and
health care utilization patterns. Complement Heal Pract Rev
12(1):3150
6. OConnell TJ, Bou-Matar CB (2007) Long term marijuana users
seeking medical cannabis in California (20012007): demo-
graphics, social characteristics, patterns of cannabis and other drug
use of 4117 applicants. Harm Reduct J 4:16
7. Ware MA, Adams H, Guy GW (2005) The medicinal use of
cannabis in the UK: results of a nationwide Survey. Int J Clin
Pract 59(3):291295
8. Page SA, Verhoef MJ, Stebbins RA et al (2003) Cannabis use as
described by people with multiple sclerosis. Can J Neurol Sci
30(3):201205
9. Ogborne AC, Smart RG, Adlaf EM (2000) Self-reported medical
use of marijuana: a survey of the general population. CMAJ
162(12):16851686
10. Hazekamp A, Ruhaak R, Zuurman L et al (2006) Evaluation of a
vaporizing device (Volcano) for the pulmonary delivery of tetra-
hydrocannabinol. J Pharm Sci 95(6):13081317
11. Hazekamp A, Bastola K, Rashidi H et al (2007) Cannabis tea
revisited: a systematic evaluation of the cannabinoid composition
of cannabis tea. J Ethnopharm 113:8590
12. NCSM: Dutch foundation for legal cannabis and its constituents as
medicine. Survey among major health insurance companies [report in
Dutch]. 2012 http://www.ncsm.nl/cfsystem/userData/pdf/
1342695429__document__ncsm-vergoeding-medicinale-cannabis-
2012.pdf (accessed Sep 2012)
Eur J Clin Pharmacol
13. Buurma H, Bouvy ML, De Smet PA et al (2008) Prevalence and
determinants of pharmacy shopping behaviour. J Clin Pharm Ther
33(1):1723
14. WHO: World Health Organization Collaborating Centre for Drug
Statistics Methodology. http://www.whocc.no/atc_ddd_index/
(accessed Sep 2012)
15. Bedrocan BV Supplier of medicinal cannabis, official website:
http://www.bedrocan.nl (accessed Sep 2012)
16. Hazekamp A (2006) An evaluation of medicinal grade cannabis in
The Netherlands. Cannabinoids 1(1):19
17. Lynch ME, Young J, Clark AJ (2006) A case series of patients
using medicinal marihuana for management of chronic pain under
the Canadian Marihuana Medical Access Regulations. J Pain
Symptom Manag 32(5):497501
18. Anichek JL, Reiman A (2012) Clinical service desires of medical
cannabis patients. Harm Reduct J 9:1217
19. Woolridge E, Barton S, Samuel J et al (2005) Cannabis use in HIV
for pain and other medical symptoms. J Pain Symptom Manag
29(4):358367
20. Braitstein P, Kendall T, Chan K et al (2001) Mary-Jane and her
patients: sociodemographic and clinical characteristics of HIVpositive
individuals using medical marijuana and antiretroviral agents. AIDS
15(4):532533
21. International Association for Cannabinoid Medicine
(IACM). Increasing numbers of patients use cannabis for
medicinal purposes. Electronic newsletter of 08 April 2012.
http://blog.norml.org/2012/04/11/estimate-worldwide-popula
tion-of-lawful-medical-marijuana-patients/ (accessed Sep
2012)
22. Van der Pol P, Liebregts N, De graaf R et al (2013) Validation of
self-reported cannabis dose and potency: an ecological study.
Addiction, submitted
23. Narang S, Gibson D, Wasan AD et al (2008) Efficacy of
dronabinol as an adjuvant treatment for chronic pain patients on
opioid therapy. J Pain 9(3):254264
24. Wilsey B, Marcotte T, Tsodikov A et al (2008) A randomized,
placebo-controlled, crossover trial of cannabis cigarettes in neuro-
pathic pain. J Pain 9(6):506521
25. Holdcroft A, Maze M, Doré C et al (2006) A multicenter dose-
escalation study of the analgesic and adverse effects of an oral
cannabis extract (Cannador) for postoperative pain management.
Anesthesiology 104(5):10401046
26. Zajicek JP, Hobart JC, Slade A et al (2012) Multiple sclerosis and
extract of cannabis: results of the MUSEC trial. J Neurol
Neurosurg Psychiatry. Published online first: 12 July 2012.
doi:10.1136/jnnp-2012-302468
Eur J Clin Pharmacol
... Among all included studies, only two examined the prevalence of cannabis use exclusively among patients suffering from CMP (Ste-Marie et al., 2016). Most of the studies focused on mixed samples that included patients with CMP (between 2 and 91% of participants) (31 studies) (Swift et al., 2005;Aggarwal et al., 2009;Ilgen et al., 2013;Aggarwal et al., 2013a;Aggarwal et al., 2013b;Belle-Isle et al., 2014;Bottorff et al., 2011;Bruce et al., 2018;Coomber et al., 2003;Degenhardt et al., 2015;Erkens et al., 2005;Gorter et al., 2005;Haroutounian et al., 2016;Harris et al., 2000;Hoffman et al., 2017;Kilcher et al., 2017;Lucas & Walsh, 2017;Lynch et al., 2006;Nunberg et al., 2011;Ogborne et al., 2000;Pedersen & Sandberg, 2013;Piper et al., 2017;Reinarman et al., 2011;Schnelle et al., 1999;Sexton et al., 2016;Shiplo et al., 2016;Ste-Marie et al., 2012;Troutt & DiDonato, 2015;Walsh et al., 2013;Ware et al., 2003) or experiencing unspecified chronic non-cancer pain (between 24 and 97% of participants) (17 studies) (Boehnke et al., 2016;Perron et al., 2015;Alexandre, 2011;Bonn-Miller et al., 2014;Brunt et al., 2014;Corroon Jr. et al., 2017;Cranford et al., 2016;Crowell, 2017;Fanelli et al., 2017;Grella et al., 2014;Grotenhermen & Schnelle, 2003;Hazekamp & Heerdink, 2013; Reiman, 2009;Reiman et al., 2017;Shah et al., 2017;Webb & Webb, 2014;Zaller et al., 2015). ...
... The conditions permitting to be registered as a MC user as well as access to MC vary between countries, states, and over time. For example, MC can be obtained from pharmacies in the Netherlands (Erkens et al., 2005;Brunt et al., 2014;Hazekamp & Heerdink, 2013), from special dispensaries in some states of the USA (Aggarwal Aggarwal et al., 2013a;Piper et al., 2017;Troutt & DiDonato, 2015;Bonn-Miller et al., 2014;Grella et al., 2014;Zaller et al., 2015), and since 2013 from registered producers in Canada (Ste-Marie et al., 2016;Lucas & Walsh, 2017;Shiplo et al., 2016), as reflected in the included studies with participants recruited at dispensaries, registration clinics, or through online advertisement. ...
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Background Chronic musculoskeletal pain (CMP) may lead to reduced physical function and is the most common cause of chronic non-cancer pain. Currently, the pharmacotherapeutic options against CMP are limited and frequently consist of pain management with non-steroidal anti-inflammatories, gabapentinoids, or opioids, which carry major adverse effects. Although the effectiveness of medical cannabis (MC) for CMP still lacks solid evidence, several patients suffering from it are exploring this therapeutic option with their physicians. Objectives Little is known about patients’ perceptions of their MC treatment for CMP. We aimed to increase this knowledge, useful for healthcare professionals and patients considering this treatment, by conducting a scoping literature review, following guidance by Arksey and O’Malley, to describe the views and perceptions of adult patients who had consumed MC to relieve chronic CMP. Methods Databases (PUBMED, EMBASE, Web of Science) and websites were searched using combinations of controlled and free vocabulary. All studies and study designs reporting on patients’ perceptions regarding MC against CMP were considered. Studies had to include adult patients reporting qualitatively or quantitatively, i.e., through questionnaires, on MC use to treat CMP or other non-cancer pain, since studies reporting exclusively on perceptions regarding CMP were very rare. Study characteristics were extracted and limitations of the study quality were assessed. The review includes patients’ demographic characteristics, patterns of MC use, perceived positive and negative effects, use of alcohol or other drugs, reported barriers to CM use, and funding sources of the studies. Results Participants of the 49 included studies reported that MC use helped them to reduce CMP and other chronic non-cancer pain, with only minor adverse effects, and some reported improved psychological well-being. In the included studies, men represent between 18 and 88% of the subjects. The mean age of participants in these studies (42/49) varied between 28.4 and 62.8 years old. The most common route of administration is inhalation. Conclusion MC users suffering from CMP or other chronic non-cancer pain perceived more benefits than harms. However, the information from these studies has several methodological limitations and results are exploratory. These user-reported experiences must thus be examined by well-designed and methodologically sound clinical or observational studies, particularly regarding CMP, where reports are very scarce.
... The cannabis plant (Cannabis sativa L.) has been used worldwide both for recreational and medicinal purposes for thousands of years. With a fast-growing aging population, its medicinal use has also caught up and is growing in the elderly [1][2][3]. ...
... (2) studied effects of cannabinoids for recreational purposes or failed to provide the dosage of cannabinoids; and (3) were not reported in English language. Here, we focus on results from RCTs. ...
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Background Cannabinoid-based medicines (CBMs) are being used widely in the elderly. However, their safety and tolerability in older adults remains unclear. We aimed to conduct a systematic review and meta-analysis of safety and tolerability of CBMs in adults of age ≥50 years. Methods and findings A systematic search was performed using MEDLINE, PubMed, EMBASE, CINAHL PsychInfo, Cochrane Library, and ClinicalTrials.gov (1 January 1990 to 3 October 2020). Randomised clinical trials (RCTs) of CBMs in those with mean age of ≥50 years for all indications, evaluating the safety/tolerability of CBMs where adverse events have been quantified, were included. Study quality was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria and Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. Two reviewers conducted all review stages independently. Where possible, data were pooled using random-effects meta-analysis. Effect sizes were calculated as incident rate ratio (IRR) for outcome data such as adverse events (AEs), serious AEs (SAEs), and death and risk ratio (RR) for withdrawal from study and reported separately for studies using tetrahydrocannabinol (THC), THC:cannabidiol (CBD) combination, and CBD. A total of 46 RCTs were identified as suitable for inclusion of which 31 (67%) were conducted in the United Kingdom and Europe. There were 6,216 patients (mean age 58.6 ± 7.5 years; 51% male) included in the analysis, with 3,469 receiving CBMs. Compared with controls, delta-9-tetrahydrocannabinol (THC)-containing CBMs significantly increased the incidence of all-cause and treatment-related AEs: THC alone (IRR: 1.42 [95% CI, 1.12 to 1.78]) and (IRR: 1.60 [95% CI, 1.26 to 2.04]); THC:CBD combination (IRR: 1.58 [95% CI,1.26 to 1.98]) and (IRR: 1.70 [95% CI,1.24 to 2.33]), respectively. IRRs of SAEs and deaths were not significantly greater under CBMs containing THC with or without CBD. THC:CBD combination (RR: 1.40 [95% CI, 1.08 to 1.80]) but not THC alone (RR: 1.18 [95% CI, 0.89 to 1.57]) significantly increased risk of AE-related withdrawals. CBD alone did not increase the incidence of all-cause AEs (IRR: 1.02 [95% CI, 0.90 to 1.16]) or other outcomes as per qualitative synthesis. AE-related withdrawals were significantly associated with THC dose in THC only [QM (df = 1) = 4.696, p = 0.03] and THC:CBD combination treatment ([QM (df = 1) = 4.554, p = 0.033]. THC-containing CBMs significantly increased incidence of dry mouth, dizziness/light-headedness, and somnolence/drowsiness. Study limitations include inability to fully exclude data from those <50 years of age in our primary analyses as well as limitations related to weaknesses in the included trials particularly incomplete reporting of outcomes and heterogeneity in included studies. Conclusions This pooled analysis, using data from RCTs with mean participant age ≥50 years, suggests that although THC-containing CBMs are associated with side effects, CBMs in general are safe and acceptable in older adults. However, THC:CBD combinations may be less acceptable in the dose ranges used and their tolerability may be different in adults over 65 or 75 years of age.
... The use of medical cannabis in recent years is growing rapidly [1][2][3], frequently based on limited knowledge regarding safety and efficacy in varied indications such as: chronic pain, chemotherapy-induced nausea and vomiting, multiple sclerosis, Parkinson's disease, epilepsy and more [4][5][6]. Older adults have become the fastest growing group of medical cannabis users [7][8][9], ranging from approximately 7% to more than one third, depending on the country [10][11][12]. ...
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Background: Medical cannabis use is increasing rapidly in the past several years, with older adults being the fastest growing group. Nevertheless, the evidence for cardiovascular safety of cannabis use is scarce. The aim of this study was to assess the effect of cannabis on blood pressure, heart rate, and metabolic parameters in older adults with hypertension. Methods: We conducted a prospective study of patients aged 60 years or more with hypertension and a new prescription of cannabis. We have performed the following assessments: 24-hours ambulatory blood pressure monitoring, ECG, blood tests, and anthropometric measurements prior to the initiation of cannabis therapy and 3 months afterward. The primary outcome was change in mean 24-h blood pressure at 3 months. Results: Twenty-six patients with a mean age of 70.42 ± 5.37 years, 53.8% females completed the study. At 3 months follow-up, the mean 24-hours systolic and diastolic blood pressures were reduced by 5.0 mmHg and 4.5 mmHg, respectively (p<0.001 for both). The nadir for the blood pressure and heart rate was achieved at 3 hours post-administration. The proportion of normal dippers changed from 27.3% before treatment to 45.5% afterward. No significant changes were seen in the different metabolic parameters assessed by blood tests, anthropometric measurements, or ECG exam. Conclusion: amongst older adults with hypertension, cannabis treatment for 3 months was associated with a reduction in 24-hours systolic and diastolic blood pressure values with a nadir at 3 hours after cannabis administration.
... The number of countries that have legalized therapeutic cannabis use (medical cannabis) has grown in recent years. In the Netherlands, the drastic increase in the prevalence of medical cannabis prescriptions can be explained by the emergence of new formulations, especially cannabis oils [15], which have become the preferred option for therapeutic use [16]. ...
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Background and objective: Changes in cannabis legalization regimes in several countries have influenced the diversification of cannabis use. There is an ever-increasing number of cannabis forms available, which are gaining popularity for both recreational and therapeutic use. From a therapeutic perspective, oral cannabis containing Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) is a promising route of administration but there is still little information about its pharmacokinetics (PK) effects in humans. The purpose of this systematic review is to provide a general overview of the available PK data on cannabis and THC after oral administration. Methods: A search of the published literature was conducted using the PubMed database to collect available articles describing the PK data of THC after oral administration in humans. Results: The literature search yielded 363 results, 26 of which met our inclusion criteria. The PK of oral THC has been studied using capsules (including oil content), tablets, baked goods (brownies and cookies), and oil and tea (decoctions). Capsules and tablets, which mainly correspond to pharmaceutical forms, were found to be the oral formulations most commonly studied. Overall, the results reflect the high variability in the THC absorption of oral formulations, with delayed peak plasma concentrations compared to other routes of administration. Conclusions: Oral THC has a highly variable PK profile that differs between formulations, with seemingly higher variability in baked goods and oil forms. Overall, there is limited information available in this field. Therefore, further investigations are required to unravel the unpredictability of oral THC administration to increase the effectiveness and safety of oral formulations in medicinal use.
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Background Reinforcement models identify negative affect (NA) and positive affect (PA) to be important momentary determinants and outcomes of cannabis use. Sensitization and allostatic models further suggest that these mood-cannabis associations are stronger among individuals with more cannabis-related problems. Despite this theoretical background and the fact that cannabis is commonly used for its mood-enhancing effects among college students, surprisingly, little is known about the momentary associations between mood and cannabis use in this population. Aims To examine the associations between (a) momentary within-person variations in NA (worried, stressed, nervous) and PA (happy, enthusiastic, proud, excited) and intention to use cannabis within the next hour, (b) the within-person variations in time elapsed since last cannabis use, amount used and momentary NA and PA, and (c) to test whether cannabis-related problems moderate the stated associations. Method Eighty, more-than-weekly, cannabis using students at the University of Amsterdam reported on cannabis use, NA and PA three times daily for 14 consecutive days. Mixed-effects models were performed to analyze the dataset. Results Within-persons, relatively high PA and low NA were associated with a higher likelihood of intending to use cannabis. Within-persons, more recent and greater amounts of cannabis use were associated with relatively high PA. More recent cannabis use was associated with relatively low NA. Cannabis-related problems did not moderate the associations. Conclusions While recent cannabis use related to higher PA and lower NA, high PA but low NA preceded use, supporting positive reinforcement rather than negative reinforcement in this college sample of regular cannabis users
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According to the National Cancer Institute in 2020 there will be an estimated 21,750 new ovarian cancer cases and 276,480 new breast cancer cases. Both breast and ovarian cancer are hormone dependent cancers, meaning they cannot grow without the presence of hormones. The two most studied hormones in these two cancers are estrogen and progesterone, which are also involved in the modulation of pain. The incidence of pain in breast and ovarian cancer is very high. Research about mechanisms involved in modulation of pain by hormones are still being debated, as some studies find estrogen to be anti-nociceptive and others pro-nociceptive in pain studies. Moreover, analgesic treatments for breast and ovarian cancer-associated pain are limited and often ineffective. In this review, we will focus on estrogen and progesterone mechanisms of action in modulation of pain and cancer. We will also discuss new treatment options for these types of cancer and associated-pain.
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Introduction: Different countries have employed a variety of methods for their populace to access medical cannabis. Objectives: The purpose of this literature review was to assess the international literature on pharmacists' beliefs and attitudes towards medical cannabis. Methodology: This literature review summarized the various countries that utilize pharmacies and pharmacists to dispense medical cannabis. The countries included in this review were: Australia, Canada, Denmark, Finland, Germany, Israel, Italy, Netherlands, Poland, Serbia, Switzerland, USA, and Uruguay. Discussion: The pharmacist perspective has been of key importance within the medical landscape, as they are the ones who not only dispense medication but also counsel and monitor patients and it is this perspective that is lacking. Conclusion: Overall, this review found that even though pharmacists are generally comfortable with dispensing medical cannabis; they still require further education to do so as safely and effectively as possible.
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Objectives Older adults with cancer are increasingly inquiring about and using cannabis. Despite this, few studies have examined cannabis use in patients with cancer aged 65 years and older as a separate group and identified characteristics associated with use. The current study sought to determine the rate of cannabis use in older adult patients with cancer and to identify demographic and clinical correlates of use. Methods We conducted a retrospective review of patients with cancer referred for specialised symptom management between January 2014 and May 2017 who underwent routine urine drug testing for tetrahydrocannabinol as part of their initial clinic visit. Results Approximately 8% (n=24) of patients with cancer aged 65 years and older tested positive for tetrahydrocannabinol compared with 30% (n=51) of young adults and 21% (n=154) of adults. At the univariate level, more cannabis users had lower performance status than non-users (p=0.02, Fisher’s exact test). There were no other demographic and clinical characteristics significantly associated with cannabis use in older adults. Conclusions Older adult patients made up nearly 25% (n=301) of the total sample and had a rate of cannabis use of 8%. As one of the first studies to assess cannabis use via objective testing rather than self-report, this study adds significantly to the emerging literature on cannabis use in people aged 65 years and older. Findings suggest the rate of use in older adults living with cancer is higher than that among older adults in the general population.
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This review proposes the hypothesis that the effectiveness of irinotecan chemotherapy might be impaired by high doses of concomitantly administered Δ9-tetrahydrocannabinol (THC). The most important features shared by irinotecan and THC, which might represent sources of potentially harmful interactions are: first pass hepatic metabolism mediated by cytochrome P-450 (CYP) enzyme CYP3A4; glucuronidation mediated by uridine diphosphate glycosyltransferase (UGT) enzymes, isoforms 1A1 and 1A9; transport of parent compounds and their metabolites via canalicular ATP-binding cassette (ABC) transporters ABCB1 and ABCG2; enterohepatic recirculation of both parent compounds which leads to an extended duration of their pharmacological effects; possible competition for binding to albumin; butyrylcholinesterase (BChE) inhibition by THC which might impair the conversion of parent irinotecan into the SN-38 metabolite; mutual effects on mitochondrial dysfunction and induction of oxidative stress; potentiation of hepatotoxicity; potentiation of genotoxicity and cytogenetic effects leading to genome instability; possible neurotoxicity; and effects on bilirubin. The controversies associated with the use of highly concentrated THC preparations with irinotecan chemotherapy are also discussed. Despite all of the limitations, the body of evidence provided here could be considered relevant for human risk assessments and calls for concern in cases when irinotecan chemotherapy is accompanied by preparations rich in THC.
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Cannabinoids, including tetrahydrocannabinol and cannabidiol, are the most important active constituents of the cannabis plant. Over recent years, cannabinoid-based medicines (CBMs) have become increasingly available to patients in many countries, both as pharmaceutical products and as herbal cannabis (marijuana). While there seems to be a demand for multiple cannabinoid-based therapeutic products, specifically for symptomatic amelioration in chronic diseases, therapeutic effects of different CBMs have only been directly compared in a few clinical studies. The survey presented here was performed by the International Association for Cannabinoid Medicines (IACM), and is meant to contribute to the understanding of cannabinoid-based medicine by asking patients who used cannabis or cannabinoids detailed questions about their experiences with different methods of intake. The survey was completed by 953 participants from 31 countries, making this the largest international survey on a wide variety of users of cannabinoid-based medicine performed so far. In general, herbal non-pharmaceutical CBMs received higher appreciation scores by participants than pharmaceutical products containing cannabinoids. However, the number of patients who reported experience with pharmaceutical products was low, limiting conclusions on preferences. Nevertheless, the reported data may be useful for further development of safe and effective medications based on cannabis and single cannabinoids.
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The possible medicinal uses of cannabis are growing, yet research on how patients use medical cannabis facility services remains scarce. This article reports on the Cannabis Care Study, in which 130 medical cannabis patients at seven facilities in the San Francisco Bay Area were surveyed to gather information about demographics, personal health practices, health outcomes, service use, and satisfaction with medical cannabis facilities. The study was modeled after Andersen's Behavioral Model of Health Services Use. Results show that patients tend to be males older than 35, identify with multiple ethnicities, and report variable symptom duration and current health status. Nearly half the sample reported substituting cannabis for alcohol and illegal drugs; 74% reported substituting it for prescription drugs. Satisfaction did not differ across study sites and was significantly higher than nationally reported satisfaction with health care. Implications for the medical cannabis community and the greater system of health and social care are discussed.
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Since 2003 medicinal grade cannabis is provided in the Netherlands on prescription through phar- macies. Growing, processing and packaging of the plant material are performed according to pharmaceutical standards and are supervised by the official Office of Medicinal Cannabis (OMC). The quality is guaranteed through regular testing by certified laboratories. However, in the Nether- lands a tolerated illicit cannabis market exists in the form of so-called 'coffeeshops', which offers a wide variety of cannabis to the general public as well as to medicinal users of cannabis. Since cannabis has been available in the pharmacies, many patients have started to compare the price and quality of OMC and coffeeshop cannabis. As a result, the public debate on the success and neces- sity of the OMC program has been based more on personal experiences, rather than scientific data. The general opinion of consumers is that OMC cannabis is more expensive, without any clear dif- ference in the quality. This study was performed in order to show any differences in quality that might exist between the official and illicit sources of cannabis for medicinal use. Cannabis samples obtained from ran- domly selected coffeeshops were compared to medicinal grade cannabis obtained from the OMC in a variety of validated tests. Many coffeeshop samples were found to contain less weight than expected, and all were contaminated with bacteria and fungi. No obvious differences were found in either cannabinoid- or water-content of the samples. The obtained results show that medicinal cannabis offered through the pharmacies is more reliable and safer for the health of medical users of cannabis.
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Aims: To assess the reliability and validity of self-reported cannabis dose and potency measures. Design: Cross-sectional study comparing self-reports with objective measures of amount of cannabis and delta-9-tetrahydrocannabinol (THC) concentration. Setting: Ecological study with assessments at participants' homes or in a coffee shop. Participants: Young adult frequent cannabis users (n = 106) from the Dutch Cannabis Dependence (CanDep) study. Measurements: The objectively measured amount of cannabis per joint (dose in grams) was compared with self-reported estimates using a prompt card and average number of joints made from 1 g of cannabis. In addition, objectively assessed THC concentration in the participant's cannabis was compared with self-reported level of intoxication, subjective estimate of cannabis potency and price per gram of cannabis. Findings: Objective estimates of doses per joint (0.07-0.88 g/joint) and cannabis potency (1.1-24.7%) varied widely. Self-reported measures of dose were imprecise, but at group level, average dose per joint was estimated accurately with the number of joints made from 1 g [limit of agreement (LOA) = -0.02 g, 95% confidence interval (CI) = -0.29; 0.26], whereas the prompt card resulted in serious underestimation (LOA = 0.14 g, 95% CI = -0.10; 0.37). THC concentration in cannabis was associated with subjective potency ['average' 3.77% (P = 0.002) and '(very) strong' 5.13% more THC (P < 0.001) than '(very) mild' cannabis] and with cannabis price (about 1% increase in THC concentration per euro spent on 1 g of cannabis, P < 0.001), but not with level of intoxication. Conclusions: Self-report measures relating to cannabis use appear at best to be associated weakly with objective measures. Of the self-report measures, number of joints per gram, cannabis price and subjective potency have at least some validity.
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Objective Multiple sclerosis (MS) is associated with chronic symptoms, including muscle stiffness, spasms, pain and insomnia. Here we report the results of the Multiple Sclerosis and Extract of Cannabis (MUSEC) study that aimed to substantiate the patient based findings of previous studies. Patients and methods Patients with stable MS at 22 UK centres were randomised to oral cannabis extract (CE) (N=144) or placebo (N=135), stratified by centre, walking ability and use of antispastic medication. This double blind, placebo controlled, phase III study had a screening period, a 2 week dose titration phase from 5 mg to a maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase. The primary outcome measure was a category rating scale (CRS) measuring patient reported change in muscle stiffness from baseline. Further CRSs assessed body pain, spasms and sleep quality. Three validated MS specific patient reported outcome measures assessed aspects of spasticity, physical and psychological impact, and walking ability. Results The rate of relief from muscle stiffness after 12 weeks was almost twice as high with CE than with placebo (29.4% vs 15.7%; OR 2.26; 95% CI 1.24 to 4.13; p=0.004, one sided). Similar results were found after 4 weeks and 8 weeks, and also for all further CRSs. Results from the MS scales supported these findings. Conclusion The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS. This was supported by results for secondary efficacy variables. Adverse events in participants treated with CE were consistent with the known side effects of cannabinoids. No new safety concerns were observed. Trial registration number NCT00552604.
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Medical cannabis dispensaries following the social or hybrid model offer supplementary holistic services in addition to dispensing medical cannabis. Historically, alternative physical health services have been the norm for these dispensaries, including services such as yoga, acupuncture, or chiropractor visits. A clinical service dearth remains for medical cannabis patients seeking substance use, misuse, dependence, and mental health services. This study examined patient desires for various clinical services and level of willingness to participate in specific clinical services. Anonymous survey data (N = 303) were collected at Harborside Health Center (HHC), a medical cannabis dispensary in Oakland, CA. The sample was 70% male, 48% Caucasian and 21% African American. The mean male age was 38 years old and female mean age was 30. Sixty two percent of the male participants and 44% of the female participants are single. Sixteen percent of the population reported having a domestic partner. Forty six percent of the participants are employed full time, 41% have completed at least some college, and 49% make less than $40,000 a year. A significant portion of the sample, 62%, indicated a desire to participate in free clinical services at HHC, 34% would like more information about substances and use, and 41% want to learn more about reducing harms from substance use. About one quarter of the participants marked "would" or "likely would" participate in individual services such as consultation. Approximately 20% indicated "would" or "likely would" participate in psycho-educational forums, harm reduction information sharing sessions, online support groups, and coping, life, and social skills group. There was little interest in traditional NA/AA 12-step groups or adapted 12-step groups. Desired clinical services can be qualified as a combination of harm reduction, educational, skills-based, peer support and therapeutic individual and group services. Results suggest that medical cannabis patients seek more information about various substances, including cannabis. Dispensaries can help to decrease gaps in substance education and clinical services and fulfill unmet clinical desires. More research is necessary in additional medical cannabis dispensaries in different geographic settings with different service delivery models.
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Background and objective: Discontinuity of care bears the risk of medication errors and poor clinical outcomes. Little is known about the continuity of care related to pharmacies. Therefore, we studied the prevalence and determinants of pharmacy shopping behaviour in the Netherlands. Methods: Beneficiaries from a Dutch pharmacy claims database who had visited two or more pharmacies in 2001 were indicated as 'shoppers' (n = 45 805). A random sample was taken from all the other beneficiaries who had received at least one prescription: 'non-shoppers' (n = 45 805). Shoppers were classified as light (all patients who visited more than one pharmacy at least once in 2001, except for patients defined as heavy or moderate shoppers), moderate (visited 3 or 4 pharmacies and had proportion of prescriptions elsewhere >10% and number of prescriptions elsewhere >10) or heavy (visited 5 or more pharmacies and had proportion of prescriptions elsewhere >10% and number of prescriptions elsewhere >10). Determinants of shopping behaviour were investigated as well as the association between any dispensing of Anatomical Therapeutic Chemical (ATC) classes of drugs and this behaviour. Results: 10.8% beneficiaries were identified as shoppers: 98.8%'light shoppers', 1.0%'moderate shoppers' and 0.2%'heavy shoppers'. Female gender [odds ratio (OR)(adj) 1.2; 95% confidence interval (CI) 1.1-1.2], younger age (OR(adj) 1.7; 95%CI 1.7-1.8), the use of > or =3 drugs (OR(adj) 2.9; 95%CI 2.8-3.0) and visiting different kind of prescribers (OR(adj) 2.4; 95%CI 2.4-2.5) were associated with shopping behaviour. Shoppers more frequently received at least one prescription for systemic anti-infectives (51.7% vs. 30.8%; OR 2.4; 95%Cl 2.3-2.5) and for nervous system drugs (46.2% vs. 29.3%; OR 2.1; 95%Cl 2.0-2.1). Conclusions: Pharmacy shopping behaviour is limited in the Netherlands. However, it may put the patient at risk for unintentional problems, such as drug-drug interactions with anti-infectives. A small proportion of patients exhibit possibly intentional shopping behaviour with psychotropic drugs.