Project Details
Description
Background
In recent years, there has been a debate worldwide whether certain patients should have the opportunity to be treated with medicinal cannabis (MC). There are differing views across the continents, but a growing number of countries in North America, South America, Europe and Australia have legalized MC to patients with certain medical conditions, such as chronic pain, anxiety and epilepsy. Nevertheless, by late 2020 around 150 countries still that have strict rules and prohibition laws against medicinal use of cannabis. Presently, there is limited information available on patients attitudes, knowledge, health-related quality of life (HRQoL) and experience with use of MC including persistence and substitution with other medicines such as opioids. This is a barrier for MC to be properly assessed and evaluated for its therapeutic potential.
Few scientific studies have tried to identify patients’ attitudes, knowledge and experiences with use of MC. A recent mixed-methods systematic review studied values and preferences towards MC among people living with chronic pain. Among 15 included studies, they found that improvement of symptoms and reduction of other prescription medications, were important factors that positively influenced patients’ decision to use MC. Factors such as negative social consequences, concern about addiction, losing control and risk of acting strangely negatively influenced their willingness to use MC. Legal status, accessibility and cost also had an influence on use. Other studies have found that MC enhanced patients’ quality of life and significantly relieved symptoms or the disease itself in more than half of the investigated indications. Both users and non-users believed it should be more widely available and would consider using it if their doctor prescribed it to them.
Some studies have assessed the ability of MC to act as a substitute for opioids. A systematic review reported a 64-75% reduction in opioid dosage when used in combination with MC. The use of MC for opioid substitution, defined as an outright stoppage of opioids, was reported by 32-59% of patients with chronic non-cancer pain. Although the authors argued that the design of the included studies, provided a limited basis on which to make a rational, evidence-based recommendation. Another recent systematic review and meta-analysis did not find any significant reduction in opioid use from randomized controlled studies (RCTs) among patients living with chronic cancer pain.
However, observational studies raised the possibility that adding MC to chronic non-cancer pain treatment may reduce the use of opioids among patients. The authors concluded that the opioid- sparring effects of MC for chronic pain remain uncertain.
Hence, evidence is still sparse about patients’ attitudes, knowledge, and experiences with use of MC, as well as the influence of HRQoL. Conclusive evidence is also lacking about how MC use develops over time and to what extent it is substituted with opioids.
The Danish setting in 2022
The Danish parliament launched the Danish medicinal cannabis experiment at January 1st 2018 for a four-year period, due to an increased public debate and demand from patients, a period that was recently extended until 2026. The program makes it possible for all physicians to prescribe a broader selection of cannabis medicines, unapproved in Denmark, to a selected group of patients with indications recommended by the Danish Medicines Agency. These are Painful spasms caused by multiple sclerosis, Painful spasms caused by spinal cord damage, nausea after chemotherapy, neuropathic pain, i.e. pain due to a disease of the brain, spinal cord or nerves. By early 2022, Denmark have four available MC-products on the Danish market as part of the MC experiment. These are the herbal teas Bedrocan, Bediol, Bedica and the inhaled dried cannabis flower Billinol, containg either THC or a mixture of THC and CBD as active substances. Earlier in the Danish experiment, there were three MC oil products and a capsule product, CBD DROPS, 1:1 DROPS, THC DROPS and Sedemen, containing THC, CBD or a combination of the two substances. They are no longer available on the market. Each product has its own product number. These are 686770- 686775 and 686777-686780 given upon market entry. They all share the same ATC-code, N02BG102.
Objectives
The aim with this PhD project is to investigate patients’ attitudes, knowledge, and experiences with MC as well as their actual use of MC.
In recent years, there has been a debate worldwide whether certain patients should have the opportunity to be treated with medicinal cannabis (MC). There are differing views across the continents, but a growing number of countries in North America, South America, Europe and Australia have legalized MC to patients with certain medical conditions, such as chronic pain, anxiety and epilepsy. Nevertheless, by late 2020 around 150 countries still that have strict rules and prohibition laws against medicinal use of cannabis. Presently, there is limited information available on patients attitudes, knowledge, health-related quality of life (HRQoL) and experience with use of MC including persistence and substitution with other medicines such as opioids. This is a barrier for MC to be properly assessed and evaluated for its therapeutic potential.
Few scientific studies have tried to identify patients’ attitudes, knowledge and experiences with use of MC. A recent mixed-methods systematic review studied values and preferences towards MC among people living with chronic pain. Among 15 included studies, they found that improvement of symptoms and reduction of other prescription medications, were important factors that positively influenced patients’ decision to use MC. Factors such as negative social consequences, concern about addiction, losing control and risk of acting strangely negatively influenced their willingness to use MC. Legal status, accessibility and cost also had an influence on use. Other studies have found that MC enhanced patients’ quality of life and significantly relieved symptoms or the disease itself in more than half of the investigated indications. Both users and non-users believed it should be more widely available and would consider using it if their doctor prescribed it to them.
Some studies have assessed the ability of MC to act as a substitute for opioids. A systematic review reported a 64-75% reduction in opioid dosage when used in combination with MC. The use of MC for opioid substitution, defined as an outright stoppage of opioids, was reported by 32-59% of patients with chronic non-cancer pain. Although the authors argued that the design of the included studies, provided a limited basis on which to make a rational, evidence-based recommendation. Another recent systematic review and meta-analysis did not find any significant reduction in opioid use from randomized controlled studies (RCTs) among patients living with chronic cancer pain.
However, observational studies raised the possibility that adding MC to chronic non-cancer pain treatment may reduce the use of opioids among patients. The authors concluded that the opioid- sparring effects of MC for chronic pain remain uncertain.
Hence, evidence is still sparse about patients’ attitudes, knowledge, and experiences with use of MC, as well as the influence of HRQoL. Conclusive evidence is also lacking about how MC use develops over time and to what extent it is substituted with opioids.
The Danish setting in 2022
The Danish parliament launched the Danish medicinal cannabis experiment at January 1st 2018 for a four-year period, due to an increased public debate and demand from patients, a period that was recently extended until 2026. The program makes it possible for all physicians to prescribe a broader selection of cannabis medicines, unapproved in Denmark, to a selected group of patients with indications recommended by the Danish Medicines Agency. These are Painful spasms caused by multiple sclerosis, Painful spasms caused by spinal cord damage, nausea after chemotherapy, neuropathic pain, i.e. pain due to a disease of the brain, spinal cord or nerves. By early 2022, Denmark have four available MC-products on the Danish market as part of the MC experiment. These are the herbal teas Bedrocan, Bediol, Bedica and the inhaled dried cannabis flower Billinol, containg either THC or a mixture of THC and CBD as active substances. Earlier in the Danish experiment, there were three MC oil products and a capsule product, CBD DROPS, 1:1 DROPS, THC DROPS and Sedemen, containing THC, CBD or a combination of the two substances. They are no longer available on the market. Each product has its own product number. These are 686770- 686775 and 686777-686780 given upon market entry. They all share the same ATC-code, N02BG102.
Objectives
The aim with this PhD project is to investigate patients’ attitudes, knowledge, and experiences with MC as well as their actual use of MC.
More specifically, I plan to:
1. Investigate patients’ HRQoL, attitudes, knowledge and experiences with MC.
2. Investigate patients’ redemption of MC prescriptions, including persistence of prescription renewal and substitution with opioids.
Layman's description
Baggrund
I løbet af det seneste årti, har der været en tiltagende debat verden rundt, i forhold til om visse patientgrupper skulle have mulighed for at blive behandlet med medicinsk cannabis (MC). MC defineres som tørrede plantedele eller ekstrakter af plantedele, i form af eksempelvis olier, fra stamplanten Cannabis Sativa. Der er forskellige holdninger til hvorvidt og i hvilken grad man bør legalisere MC, men et stigende antal af lande i særligt Nordamerika, Sydamerika, Europa og Australien har legaliseret MC til patienter med blandt andet kroniske smerter, angst og epilepsi. Ikke desto mindre er der pr. ultimo 2020 stadig i omegnen af 150 lande, der har stramme regler og forbud mod medicinsk brug af cannabis. For nuværende findes der kun begrænset information om patienters holdninger, viden, helbredsrelaterede livskvalitet og erfaringer med brug af MC, inklusiv graden af (gen)indløste recepter og erstatning af anden medicin som for eksempel opioider med MC. Foruden klinisk evidens, mangler dette for at kunne lave en tilbundsgående evaluering af MC’s muligheder for at blive et lægemiddel i fremtiden.
Enkelte medicinske studier har prøvet at identificere patienters holdninger, viden og erfaringer med brug af MC. Et nyere systematisk review har undersøgt værdier og præferencer for MC blandt patienter, der til dagligt lever med kroniske smerter. Blandt 15 inkluderede studier fandt de, at forbedring af symptomer og reduktion af anden receptpligtig medicin havde en positiv indflydelse på deres beslutning om at bruge MC. På den anden side havde negative sociale konsekvenser, bekymringer omkring afhængighed, tab af kontrol, risiko for at opføre sig underligt og medicinpriser en negativ indflydelse på deres beslutning om at bruge MC. Andre studier har fundet at MC øgede patienters livskvalitet og gav en mærkbar lindring af symptomer, eller selve den sygdom de var diagnosticeret med. Både brugere og ikke-bruger mente at MC burde være mere tilgængeligt og ikke-brugere ville overveje at bruge det, hvis de kunne få det udskrevet af deres læge.
Andre studier har undersøgt MCs muligheder for at fungere som alternativ til opioider. Et systematisk review fandt en reduktion i patienters opioidforbrug på 64-75%, når de samtidig tog MC. Blandt patienter med kroniske smerter, der ikke var relateret til kræft, fandt forfatterne at 32-59% stoppede med at bruge deres opioidmedicin til fordel for MC. Dog kunne forfatterne ikke drage nogle endelige konklusioner på baggrund af de inkluderede studier grundet begrænsninger i deres designs.
Den eksisterende evidens er derfor stadig sparsom omkring patienters holdninger, viden, erfaringer og helbredsrelaterede livskvalitet i forbindelse med brug af MC. Der mangler også yderligere evidens om hvordan brug af MC udvikler sig over tid og i hvilken grad opioider bliver med erstattet med MC.
Den danske setting
I Danmark vedtog folketinget den danske forsøgsordning med MC pr. 1. januar 2018 for en fireårig periode, grundet en øget offentlig debat og et stigende pres fra patienter. Denne periode er pr. 1. januar 2022 forlænget yderligere fire år til 2026. Forsøgsordningen gør det muligt for alle læger at ordinere et bredere udvalg af cannabismedicin, der ikke er godkendt i Danmark, til en udvalgt gruppe patienter med indikationer anbefalet af Lægemiddelstyrelsen. Disse er 1) smertefulde spasmer forårsaget af multipel sklerose, 2) smertefulde spasmer forårsaget af rygmarvsskade, 3) kvalme efter kemoterapi og 4) neuropatiske smerter, det vil sige smerter som følge af en sygdom i hjernen, rygmarven eller nerverne. Pr. medio 2023 findes der seks tilgængelige MC-produkter på det danske marked som led i forsøgsordningen. Det er urteteerne Bedrocan, Bediol, Bedica, CBD-olie og THC-olie. Urteteerne består af topskud fra cannabisplanten og indeholder en bred vifte af cannabinoider, blandt andet CBD og THC, som aktive stoffer. Olieprodukterne består af henholdsvis ren CBD og ren THC. Tidligere i det danske forsøg fandtes der yderligere et olieprodukt og et kapselprodukt, 1:1 DROPS og Sedemen, der indeholdt en kombination af CBD og THC. De er ikke længere tilgængelige på markedet.
Formål
Formålet med ph.d.-projektet er at undersøge danske patienters holdninger, viden og erfaringer med MC samt deres forbrug af MC.
Mere specifikt planlægger jeg at:
1. Undersøge patienters helbredsrelaterede livskvalitet, holdninger, viden og erfaringer i relation til MC.
2. Undersøge patienters indløsning af MC-recepter, herunder graden af receptfornyelse og udskiftning af opioider.
I løbet af det seneste årti, har der været en tiltagende debat verden rundt, i forhold til om visse patientgrupper skulle have mulighed for at blive behandlet med medicinsk cannabis (MC). MC defineres som tørrede plantedele eller ekstrakter af plantedele, i form af eksempelvis olier, fra stamplanten Cannabis Sativa. Der er forskellige holdninger til hvorvidt og i hvilken grad man bør legalisere MC, men et stigende antal af lande i særligt Nordamerika, Sydamerika, Europa og Australien har legaliseret MC til patienter med blandt andet kroniske smerter, angst og epilepsi. Ikke desto mindre er der pr. ultimo 2020 stadig i omegnen af 150 lande, der har stramme regler og forbud mod medicinsk brug af cannabis. For nuværende findes der kun begrænset information om patienters holdninger, viden, helbredsrelaterede livskvalitet og erfaringer med brug af MC, inklusiv graden af (gen)indløste recepter og erstatning af anden medicin som for eksempel opioider med MC. Foruden klinisk evidens, mangler dette for at kunne lave en tilbundsgående evaluering af MC’s muligheder for at blive et lægemiddel i fremtiden.
Enkelte medicinske studier har prøvet at identificere patienters holdninger, viden og erfaringer med brug af MC. Et nyere systematisk review har undersøgt værdier og præferencer for MC blandt patienter, der til dagligt lever med kroniske smerter. Blandt 15 inkluderede studier fandt de, at forbedring af symptomer og reduktion af anden receptpligtig medicin havde en positiv indflydelse på deres beslutning om at bruge MC. På den anden side havde negative sociale konsekvenser, bekymringer omkring afhængighed, tab af kontrol, risiko for at opføre sig underligt og medicinpriser en negativ indflydelse på deres beslutning om at bruge MC. Andre studier har fundet at MC øgede patienters livskvalitet og gav en mærkbar lindring af symptomer, eller selve den sygdom de var diagnosticeret med. Både brugere og ikke-bruger mente at MC burde være mere tilgængeligt og ikke-brugere ville overveje at bruge det, hvis de kunne få det udskrevet af deres læge.
Andre studier har undersøgt MCs muligheder for at fungere som alternativ til opioider. Et systematisk review fandt en reduktion i patienters opioidforbrug på 64-75%, når de samtidig tog MC. Blandt patienter med kroniske smerter, der ikke var relateret til kræft, fandt forfatterne at 32-59% stoppede med at bruge deres opioidmedicin til fordel for MC. Dog kunne forfatterne ikke drage nogle endelige konklusioner på baggrund af de inkluderede studier grundet begrænsninger i deres designs.
Den eksisterende evidens er derfor stadig sparsom omkring patienters holdninger, viden, erfaringer og helbredsrelaterede livskvalitet i forbindelse med brug af MC. Der mangler også yderligere evidens om hvordan brug af MC udvikler sig over tid og i hvilken grad opioider bliver med erstattet med MC.
Den danske setting
I Danmark vedtog folketinget den danske forsøgsordning med MC pr. 1. januar 2018 for en fireårig periode, grundet en øget offentlig debat og et stigende pres fra patienter. Denne periode er pr. 1. januar 2022 forlænget yderligere fire år til 2026. Forsøgsordningen gør det muligt for alle læger at ordinere et bredere udvalg af cannabismedicin, der ikke er godkendt i Danmark, til en udvalgt gruppe patienter med indikationer anbefalet af Lægemiddelstyrelsen. Disse er 1) smertefulde spasmer forårsaget af multipel sklerose, 2) smertefulde spasmer forårsaget af rygmarvsskade, 3) kvalme efter kemoterapi og 4) neuropatiske smerter, det vil sige smerter som følge af en sygdom i hjernen, rygmarven eller nerverne. Pr. medio 2023 findes der seks tilgængelige MC-produkter på det danske marked som led i forsøgsordningen. Det er urteteerne Bedrocan, Bediol, Bedica, CBD-olie og THC-olie. Urteteerne består af topskud fra cannabisplanten og indeholder en bred vifte af cannabinoider, blandt andet CBD og THC, som aktive stoffer. Olieprodukterne består af henholdsvis ren CBD og ren THC. Tidligere i det danske forsøg fandtes der yderligere et olieprodukt og et kapselprodukt, 1:1 DROPS og Sedemen, der indeholdt en kombination af CBD og THC. De er ikke længere tilgængelige på markedet.
Formål
Formålet med ph.d.-projektet er at undersøge danske patienters holdninger, viden og erfaringer med MC samt deres forbrug af MC.
Mere specifikt planlægger jeg at:
1. Undersøge patienters helbredsrelaterede livskvalitet, holdninger, viden og erfaringer i relation til MC.
2. Undersøge patienters indløsning af MC-recepter, herunder graden af receptfornyelse og udskiftning af opioider.
Status | Active |
---|---|
Effective start/end date | 01/08/2022 → 31/07/2025 |
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