Innovative Clinical-Organizational Model to Ensure Appropriateness and Quality in the Management of Medical Cannabis: An Italian Regional Case
Abstract
:1. Introduction
2. Materials and Methods
2.1. Working Groups
- drawing up a strategic technical document aimed at assisting in the attainment of an updated daily working tool, capable of fostering transparency in the relationships between services, operators and patients, as well as being easily appliable at different operating realities.
- setting the rules, applicable by the Regional Health Service (SSR), for the delivery of galenic preparations, based on cannabinoids for medical use,
- ensuring the correct and safe use of these magistral galenic preparations.
2.2. Regutalory Issues
2.3. Drafting of Documents
2.4. Dissemination of Results and Diffusion of Information
2.5. Data Collection and Monitoring
3. Results and Discussion
3.1. Acquired Data from Regional Monitoring (after the Entry into Force of the Regional Protocol)
3.2. Adherence and Coherence of Regional Data in Comparison with National Data from the ISS Portal
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
A.Li.Sa | Ligurian Healthcare Company |
AIFA | Italian drug agency |
ASL | Local Health Authority |
CB1 | Cannabinoid receptors |
CB2 | Cannabinoid receptors |
CBD | Cannabidiol |
CBDA | Cannabidiolic acid |
CBN | Cannabinol |
CNS | Central Nervous System |
DIFAR | Department of Pharmacy |
DM | Ministerial Decree |
DPR | Presidential Decree |
IIS | Italian Institute of Health |
FU | Italian Official Pharmacopoeia |
NBP | Good preparation standards |
NHS | National Health Service |
SCFM | Military Pharmaceutical Chemical Industry |
SIFAP | Italian Society of Preparatory Pharmacists |
SIFO | Italian Society of Hospital Pharmacists |
SRR | Regional Health Service |
THC | Delta-9-tetrahydrocannabinol |
THCA | Delta-9-tetrahydrocannabinolic acid |
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Producer | Name | CBD/THC Content |
---|---|---|
Bedrocan BV (The Netherlands) | Bedrocan | 22% THC and CBD < 1% |
Bedrobinol | 13.5% THC and CBD < 1% | |
Bediol | 6% THC and 8% CBD | |
Bedrolite | THC < 0.4% and 9% CBD | |
Bedica | 14% THC and CBD < 1% | |
Pedanios/Aurora (Canada) | Pedanios 22/1 | 22% THC and CBD < 1% |
Pedanios 8/8 | 8% THC and 8% CBD | |
Pedanios 1/9 | THC < 1% and 9% CBD | |
SCFM (Italy) | FM2 | 5–8% THC and 7.5–12% CBD |
FM1 | 13–20% THC and CBD < 1% |
2018 | 2019 | 2020 | |||||||
---|---|---|---|---|---|---|---|---|---|
Health Facility | I Sem | II Sem | I Quarter | II Quarter | III Quarter | IV Quarter | I Quarter | II Quarter | III Quarter |
San Martino * | 27 | 55 | 40 | 46 | 48 | 66 | 85 | 95 | 88 |
Galliera * | 6 | 24 | 28 | 21 | 21 | 17 | 17 | 19 | 19 |
Gaslini * | 69 | 48 | 16 | 17 | 13 | 13 | 11 | 9 | 10 |
ASL1 ** | 57 | 75 | 75 | 88 | 82 | 85 | 95 | 88 | 79 |
ASL2 ** | 672 | 684 | 570 | 605 | 598 | 538 | 533 | 465 | 466 |
ASL3 ** | 65 | 59 | 56 | 41 | 71 | 91 | 101 | 109 | 106 |
ASL4 ** | 169 | 138 | 133 | 140 | 121 | 134 | 134 | 150 | 190 |
ASL5 ** | 105 | 82 | 76 | 80 | 83 | 83 | 95 | 129 | 104 |
Total | 1170 | 1165 | 994 | 1038 | 1037 | 1027 | 1071 | 1064 | 1062 |
Period | N. of Patients Registered on ISS Platform | N. of Patients (Data Provided by Regional Health Facility) | DELTA of Patients Number (ISS—Regional) | % Adherence to the ISS Portal |
---|---|---|---|---|
I quarter 2019 | 625 | 994 | −369 | 63% |
II quarter 2019 | 820 | 1038 | −218 | 79% |
III quarter 2019 | 815 | 1037 | −222 | 78% |
IV quarter 2019 | 707 | 1056 | −349 | 67% |
I quarter 2020 | 717 | 1071 | −354 | 67% |
II t quarter 2020 | 671 | 1064 | −393 | 63% |
III quarter 2020 | 671 | 1062 | −391 | 63% |
Period | Number of Medical Prescriptions | Number of Prescriptions on ISS Portal | Number of Patients on ISS Portal | Average Value Prescriptions/ Patient |
---|---|---|---|---|
I quarter 2019 | 22 | 1174 | 625 | 1.9 |
II quarter 2019 | 20 | 1231 | 820 | 1.5 |
III quarter 2019 | 21 | 1364 | 815 | 1.7 |
IV quarter 2019 | 20 | 1390 | 707 | 2.0 |
I quarter 2020 | 21 | 1414 | 717 | 2.0 |
II quarter 2020 | 21 | 1412 | 671 | 2.1 |
III quarter 2020 | 19 | 1412 | 671 | 2.1 |
Total | 22 | 9397 | 5026 | 1.9 |
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Russo, E.; Cannas, C.; Rivetti, M.S.; Villa, C.; Rebesco, B. Innovative Clinical-Organizational Model to Ensure Appropriateness and Quality in the Management of Medical Cannabis: An Italian Regional Case. Healthcare 2021, 9, 1425. https://doi.org/10.3390/healthcare9111425
Russo E, Cannas C, Rivetti MS, Villa C, Rebesco B. Innovative Clinical-Organizational Model to Ensure Appropriateness and Quality in the Management of Medical Cannabis: An Italian Regional Case. Healthcare. 2021; 9(11):1425. https://doi.org/10.3390/healthcare9111425
Chicago/Turabian StyleRusso, Eleonora, Clara Cannas, Maria Susanna Rivetti, Carla Villa, and Barbara Rebesco. 2021. "Innovative Clinical-Organizational Model to Ensure Appropriateness and Quality in the Management of Medical Cannabis: An Italian Regional Case" Healthcare 9, no. 11: 1425. https://doi.org/10.3390/healthcare9111425