CAMCD s Medical Cannabis Dispensary Certification Pilot Program. Baseline Data Summary Report

Transcription

1 CAMCD s Medical Cannabis Dispensary Certification Pilot Program Baseline Data Summary Report Prepared by : Rielle Capler, Kim Crosby, Zach Walsh on behalf of the SEED Project November, 2014 Contact: rielle.capler@ubc.ca or zachary.walsh@ubc.ca 1

2 CAMCD S Medical Cannabis Dispensary Certification Pilot Program Baseline Data Summary Background CAMCD Certification Program The Canadian Association of Medical Cannabis Dispensaries (CAMCD) is a not-for-profit corporation, established in 2011 to promote a regulated community-based approach to medical cannabis access, and to support medical cannabis dispensaries in the provision of high quality patient care across Canada. Accreditation is considered one of the most effective ways for health service organizations to regularly examine and improve the quality of their services, and also to assure patients and other stakeholders that these organizations are reputable and adhere to stringent protocols. CAMCD has been working with researchers from the University of British Columbia and patient advocacy organization Canadians for Safe Access as part of the Medical Cannabis Standards, Engagement, Evaluation, Dissemination (SEED) Project to develop, implement and evaluate a certification program for medical cannabis dispensaries in Canada. The overall goal of the certification program is to create a regulated community-based approach to medical cannabis distribution and to support medical cannabis dispensaries to provide the highest quality of patient care. The development of the CAMCD Certification Program has been an intensive process drawing on guidelines for best practices already developed by dispensaries 1 as well as consultations with patients, dispensary representatives and community stakeholders including policy-makers from the medical community, relevant NGOs, all levels of governments, and law enforcement. Modeled on other established accreditation programs for health care services in Canada, the certification program quantifies dispensary services in a rigorous external evaluation process. The program is based on adherence to the CAMCD Certification Standards, which represent the foundational policies and practices of dispensary operations. Seventy-four standards are organized into 7 key areas: Patient Eligibility; Patient Intake; Products and Services; Dispensing; Supply; Safety, Security and Privacy; and Effective Organization. Dispensaries participating in the CAMCD Certification Program first complete a self-assessment followed by an on-site survey. Achievement of full certification requires a dispensary to meet a minimum of 90% of the CAMCD Certification Standards during an onsite survey, including all 18 Required Organizational Practices (ROPs). Full certification is valid for 3 years. A preliminary certification, valid for 1 year, is awarded with a minimum of 50% of the standards met, including all 1 Guidelines for the Distribution of Medical Cannabis in Canada. N. Rielle Capler and Philippe Lucas. BC Compassion Club Society and Vancouver Island Compassion Society (2006). 2

3 ROPs. More information about the CAMCD Certification Program and the CAMCD Certification Standards can be found here: Program Evaluation: Baseline Survey In June 2013, CAMCD launched a pilot certification program with the goal of assessing and improving the CAMCD Certification Program. Nine dispensaries enrolled in the pilot certification program. To assess current practices and progress toward adoption of the CAMCD Certification Standards, participants completed a baseline survey before progressing to the self-assessment and onsite survey stages of the program. Participants self-reported their level of compliance with 73 of the 74 standards (one was not queried about due to an oversight) by indicating if they Always, Sometimes or Never adhere to them. Some standards were assessed by one survey question, while others had several corresponding questions to assess different aspects of the standard. Altogether, there were 138 questions. Participants also were asked to indicate if they have documented polices and procedures related to each of 138 questions. All nine participating dispensaries answered all the survey questions. The results of the baseline survey are presented below. First we present a summary of baseline responses, including overall rates of compliance for each section, as well as for the ROPs and policies in each key area of the standards. Next, we review the levels of compliance with the standards within each key area, including responses for each related question. We also provide individual dispensary compliance rates for each key area. Finally, we provide overall rates of compliance for the individual participating dispensaries, identified by a code. For the summaries, we considered standards to be fully complied with if all corresponding questions were responded to as Always ; we considered noncompliance to a standard if all corresponding questions were responded to as Never ; compliance was considered to be partial if corresponding questions were responded to as Sometimes or had mixed responses. Results I. Summary of Baseline Responses Table 1, below, provides a summary of compliance with standards in each section across dispensaries and an overall summary of baseline compliance with all the standards. Overall compliance to standards was 77%. All sections had above 50% full compliance, however only Section 1 (Patient Eligibility) achieved over 90% full compliance. 3

4 Table 1: Overall Section Section: Noncompliance Partial Full 1. Patient Eligibility 1.2% 8.6% 90.1% 2. Patient Intake 0.0% 11.1% 88.9% 3. Products and Services 2.6% 29.1% 68.4% 4. Dispensing 0.0% 13.3% 86.7% 5. Supply 11.1% 23.6% 65.3% 6. Safety, Security and Privacy 6.0% 19.6% 74.3% 7. Effective Organization 7.4% 25.2% 67.4% OVERALL 4.0% 18.7% 77.3% Table 2 (below) provides a summary of compliance with the ROPs in each section. The overall full compliance rate for ROPs was similar to the overall full compliance rate for all standards, at 76%. Of note, there was the requisite 100% compliance rate with the ROPs in section 1 (Patient Eligibility) only. Noncompliance was reported for some of the ROPs in Section 6 (Safety, Security and Privacy). Table 2: Overall ROP Number of Section: ROPs Noncompliance Partial Full 1. Patient Eligibility 5 0.0% 6.7% 93.3% 2. Patient Intake 1 0.0% 0.0% 100.0% 3. Products and Services 0 N/A N/A N/A 4. Dispensing 3 0.0% 18.5% 81.5% 5. Supply 1 0.0% 44.4% 55.6% 6. Safety, Security and Privacy 7 6.3% 25.7% 68.3% 7. Effective Organization 1 0.0% 44.4% 55.6% OVERALL % 23.3% 75.7% 4

5 Table 3 (below) demonstrates that the rate of dispensaries having documented polices and procedures for standards in each section is quite low, overall at under 50%. Table 3: Overall Policies and Procedures Section: No Policies Partial Policies Complete Policies 1. Patient Eligibility 37.0% 1.2% 61.7% 2. Patient Intake 25.0% 8.3% 66.7% 3. Products and Services 38.5% 6.8% 54.7% 4. Dispensing 33.3% 13.3% 53.3% 5. Supply 59.7% 9.7% 30.6% 6. Safety, Security and Privacy 57.4% 6.0% 36.5% 7. Effective Organization 51.9% 12.6% 35.6% OVERALL 43.3% 8.3% 48.4% II. within Key Areas 1. Patient Eligibility Nine standards were assessed by 13 survey questions in Section 1, including 5 of the 18 ROPs. This section had the highest compliance rate, with 90% full compliance, 9% partial compliance and 1% noncompliance (Table 1). There was 93% full compliance rate with the ROPs in this section (Table 2) and documented policies and procedures were 62% complete across dispensaries (Table 3). Five standards, including 3 ROPs, were fully complied with by all dispensaries. There was one case of noncompliance with one standard (Table 4). Four dispensaries reported full compliance with all standards in this section, the rest were at over 50% full compliance. Only one dispensary demonstrated non-compliance to a standard in this section (Table 5). 5

6 Table 4: Patient Eligibility Across Dispensaries Never Sometimes Always Has Policy 1.1. Age of Patient * Verifies age 9 7 Obtains consent Medical Conditions and Symptoms 1.2.a. Diagnosis and Recommendation for Use * b. Special Considerations * Documentation 1.3.a. Healthcare Practitioners* 9 6 (1.3.b Required Information) No data 1.3.c. Date of Documentation c.i Expiry of Documentation c.ii. Renewal of Documentation d. Document Verification * Verifies application content 9 7 Verifies validity of HCP license e. Types of Documentation Outlines acceptable types 9 6 Informs patients of acceptable types Ineligible Applications Note: * = ROP Table 5. Patient Eligibility per Dispensary Dispensary ID: Noncompliance Partial Full % 0.0% 100.0% % 11.1% 88.9% % 22.2% 77.8% % 0.0% 100.0% % 0.0% 88.9% % 0.0% 100.0% % 0.0% 100.0% % 22.2% 77.8% % 22.2% 77.8% 6

7 2. Patient Intake There are 8 standards in this section assessed by 14 survey questions. This section had the second highest compliance, at 89% full compliance, 11% partial compliance and 0% noncompliance (Table 1). Dispensaries documented policies and procedures related to these standards at an average rate of 67% (Table 3). Four standards, including the one ROP, were fully complied with by all dispensaries (Table 6). Four dispensaries fully complied with all standards in this section, all dispensaries were above 50% full compliance, and none demonstrated noncompliance to any standard (Table 7). Table 6: Patient Intake Across Dispensaries Never Sometimes Always Has Policy 2.1. Applications 2.1.a. Processing Applications Transparent procedure 9 6 Informs patients of status b. Critical and Terminal Stage of Illness Registration 2.2.a. Patient information and verification * Collects patient info 9 7 Verifies patient identity b. Patient rights and responsibilities c. Consent Consent to designate dispensary Accepting legal risk d. Dispensary Identification Confirms registration 9 7 Confirms registration to third parties Patient Education and Individual Plans 2.3.a. Patient Education Provides patient education Updates information b. Individual Plans and Monitoring Protocols Develops individual plans Develops monitoring protocols Note: * = ROP 7

8 Table 7. Patient Intake per Dispensary Dispensary ID: Noncompliance Partial Full % 0.0% 100.0% % 25.0% 75.0% % 0.0% 100.0% % 0.0% 100.0% % 12.5% 87.5% % 12.5% 87.5% % 37.5% 62.5% % 0.0% 100.0% % 12.5% 87.5% 3. Products and Services There are 13 standards in Section 3 surveyed by 20 questions. There are no ROPs in this section. Overall compliance for Section 3 was the second lowest, at 68% full compliance, 29% partial and 3% noncompliance (Table 1). There is a low level of documented policies and procedures in this section, at 55% (Table 3). Four standards were fully complied with by all nine dispensaries, and there was noncompliance with 3 standards (Table 8). None of the nine dispensaries fully complied with all of the standards in this section. One dispensary failed to achieve over 50% full compliance with standards in this section, and one was above 90%. One dispensary was responsible for all the non-compliance to standards in this section (Table 9). 8

9 Table 8: Products and Services Across Dispensaries Never Sometimes Always Has Policy 3.1. Access 3.1.a. Hours of Operation Has regular hours 9 7 Informs patients of hours b. Visiting Patients Provides access Verifies documentation c. Accessible Services Complies with legislation Enables patients to communicate concerns Cannabis Strains and Products 3.2.a. Cannabis Strains b. Cannabis Products c. Devices for Administration d. Other Products Products approved for sale in Canada Has appropriate retail license Prohibits the sale of alcohol, tobacco, or schedules substances Support and Monitoring 3.3.a. Strain and Product Information b. Tracking Efficacy and Side Effects Tracks patient reports Provides tools to patients to track c. Individualized Consultations d. Specialized Support and Monitoring Ancillary Services 3.4.a. Healthcare and Community Resources b. Advocacy Provides access to advocacy Logs advocacy activities

10 Table 9. Products and Services per Dispensary Dispensary ID: Noncompliance Partial Full % 30.8% 69.2% % 46.2% 53.8% % 23.1% 76.9% % 15.4% 84.6% % 15.4% 61.5% % 46.2% 53.8% % 53.8% 46.2% % 7.7% 92.3% % 23.1% 76.9% 4. Dispensing The 10 standards in Section 4, including 3 ROPs, were surveyed by 23 questions. Overall compliance for Section 4 was third highest, at 87% full compliance, 13% partial and 0% noncompliance (Table 1). The ROP full compliance rate was 81.5% (Table 2). Documented policies and procedures for the standards in this section were at 53% (Table 3). There was full compliance by all nine dispensaries for 5 standards, including one ROP, and no cases of noncompliance with any of the standards in this section (Table 10). All dispensaries were above 50% full compliance, with 5 reporting 90% full compliance or greater with all of the standards in this section (Table 11). 10

11 Table 10: Dispensing Across Dispensaries Never Sometimes Always Has Policy 4.1. Options and Requirements 4.1.a. Dispensing Options Outlines procedures 9 6 Confirms receipt by patient Protects safety/security of personnel b. Verification of Identification * Verifies a patient's identity Ensures personnel verify identity Restrictions 4.2.a. Quantity Restrictions Sets restrictions Has equivalency formulas Ensures limits are followed b. Right to Refuse Service Outlines circumstances 9 7 Informs patients of refusal 9 7 Records all instances of refusal Dispensing Practices 4.3.a. Dispensing Area* Complies with food handling regulations Clean dispensing area b. Handling * Outlines acceptable methods 9 5 Ensures personnel adhere to methods Accuracy and Transparency 4.4.a. Weighing Accurate scales 9 4 Accurate/consistent measurement 9 4 Ensures personnel adheres to practices b. Labeling Labels all products 9 5 Ensures personnel label products c. Packaging Outlines acceptable methods 9 4 Ensures personal package appropriately d. Sales Records 9 7 Note: * = ROP 11

12 Table 11. Dispensing per Dispensary Dispensary ID: Noncompliance Partial Full % 30.0% 70.0% % 0.0% 100.0% % 30.0% 70.0% % 10.0% 90.0% % 0.0% 100.0% % 0.0% 100.0% % 20.0% 80.0% % 20.0% 80.0% % 10.0% 90.0% 5. Supply There are 8 standards in Section 5 assessed by 16 survey questions. Overall this section had a 65% full compliance rates, with 24% partial compliance. It had the highest noncompliance rate of all sections at 11%, (Table 1). Full compliance with the one ROP in this section was also low at 56%, although there were no cases of noncompliance (Table 2). This section had the lowest rate of documented policies and procedures, at 31% (Table 3). There was full compliance by all dispensaries with 3 standards in this section, and 3 standards were not complied with by one or more dispensary (Table 12). None of the 9 dispensaries reached 90% compliance rate for the standards in this section, however they were all at 50% or greater full compliance. Five dispensaries reported noncompliance with standards in this section (Table 13). 12

13 Table 12: Supply Across Dispensaries Never Sometimes Always Has Policy 5.1. Product Quality 5.1.a. Quality Control * Monitors quality control Responds to adverse effects b. Production Methods Documents production requirements Reviews/approves production methods Ensures adherence to requirements c. Storage and Packaging Develops storage methods 9 3 Stores according to developed method Inventory Management 5.2.a. Product Variety and Quality b. Product Tracking Supply Accountability 5.3.a. Eligible Recipients b. Contracts Enters into contracts with suppliers Contracts stipulate quantity/quality/safety standards Policies for entering into contracts are implemented c. Reporting Responsibilities Contracts stipulate reporting requirements Implements reporting requirements Documents reporting requirements Note: * = ROP 13

14 Table 13. Supply per Dispensary Dispensary ID: Noncompliance Partial Full % 37.5% 50.0% % 25.0% 75.0% % 12.5% 87.5% % 25.0% 75.0% % 0.0% 75.0% % 37.5% 50.0% % 50.0% 50.0% % 12.5% 50.0% % 12.5% 75.0% 6. Safety, Security and Privacy There are 10 standards for Section 6, measured by 16 questions. Seven of the 18 ROPs are found in this section. This section had 74% full compliance, 20% partial compliance, and 6% noncompliance (Table 1). Full compliance with ROPs was at 68% (Table 2). Only 37% of the policies were completed for this section across dispensaries (Table 3). Five standards were not complied with in this section, including 3 ROPs, and one standard was fully complied with by all dispensaries (Table 14). All dispensaries, except one, were above 50% full compliance with standards in this section, and none were above 90%. Two dispensaries reported noncompliance with at least one standard in this section (Table 15). 14

15 Table 14: Safety, Security and Privacy Across Dispensaries Never Sometimes Always Has Policy 6.1. Healthy Environment 6.1.a. Infection Control * b. Emergency Preparedness* c. Restroom Facilities Provides clean facilities Ensures staff/patient awareness of locations d. On-Site Medication Use** e. Health and Safety Regulations * Documents regulations Adheres to regulations Safe Conduct 6.2.a. Incident Management * Transparent process Ensures staff is aware of process b. Consequences for Infractions Security and Privacy Measures 6.3.a. Security Systems* Enacts appropriate infrastructure Informs patients of security measures Monitors security regularly b. Management of Sensitive Information * c. Privacy and Confidentiality* Protects privacy/confidentiality 9 4 Communicates policies to patients Note: * = ROP; ** = Only valid for dispensaries that allow on-site medication. 15

16 Table 15: Safety, Security and Privacy per Dispensary Partial Dispensary ID: Noncompliance Full % 30.0% 70.0% % 33.3% 66.7% % 10.0% 80.0% % 11.1% 88.9% % 11.1% 88.9% % 20.0% 80.0% % 30.0% 70.0% % 11.1% 44.4% % 20.0% 80.0% 7. Effective Organization There are 15 standards, including 1 ROP in Section 7, assessed by 36 survey questions. This section had the lowest overall compliance at 67% full compliance, 25% partial compliance and 7% noncompliance (Table 1). There was 56% full compliance with the one ROP in this section, with no cases of noncompliance (Table 2). Policies and procedures were fully documented for only 35.6% of the standards in this section across dispensaries (Table 3). There was noncompliance with 3 standards in this section, and full compliance by all dispensaries to 5 standards (Table 16). One dispensary was below 50% full compliance, and none were above 90% full compliance with standards in this section. Five dispensaries reported noncompliance with at least one standard in this section (Table 17). 16

17 Table 16: Effective Organization Across Dispensaries Never Sometimes Always Has Policy 7.1. Governance and Management 7.1.a. Governance b. Record Keeping c. Financial Management and Reporting Prepares budgets Disseminates budgets Establishes accounting practices 9 5 Implements accounting practices d. Insurance and Risk Management Has a risk plan Reviews risks and adjusts plan Implements risk plan e. Performance Management Has performance indicators Assesses progress on an ongoing basis Legal and Regulatory 7.2.a. Federal, Provincial, and Municipal Regulations* Demonstrates knowledge of regulations Complies with regulations b. Applicable Taxes Accountability to Patients 7.3.a. Rights of Patients Communicates rights to patients 9 6 Ensures rights are available for review b. Patient Engagement Seeks patient input 9 4 Analyzes/responds to input c. Complaints Process Reviews/addresses patient complaints 9 6 Communicates complaints process Maintains a physical location Personnel and Employment Practices 7.4.a. Qualifications and Training Outlines necessary qualifications 9 6 Verifies backgrounds/credentials Evaluates staff competency

18 Table 16: continued Ensures adequate training b. Employment Practices Has transparent practices 9 5 Policies accessible to employees 9 5 Adheres to employment laws c. Personnel Support and Engagement Obtains input from personnel 9 4 Addresses complaints 9 4 Addresses work-related health/legal impacts Community Contributions and Regulations 7.5.a. Community Contribution Contributes to community Documents activities b. Community and Stakeholder Relations Maintains clean/safe storefront 9 5 Positive communication with neighbours 9 2 Obtains input from community/stakeholders 5 4 Note: * = ROP 18

19 Table 17: Effective Organization per Dispensary Dispensary ID: Noncompliance Partial Full % 40.0% 60.0% % 40.0% 60.0% % 13.3% 86.7% % 13.3% 80.0% % 13.3% 73.3% % 20.0% 80.0% % 20.0% 60.0% % 26.7% 60.0% % 40.1% 46.6% III. Individual Dispensaries None of the nine dispensaries complied with all Certification Standards. While none were above 90% full compliance, all were above the 50% full compliance required for preliminary certification. Eight of the nine dispensaries reported some level of noncompliance, with two accounting for the majority of the overall noncompliance found across dispensaries (Table 18). None of the dispensaries were in full compliance with all ROPs, as required for certification. Full compliance rates ranged from 59% to 98%. The range for policies is larger, from 0%-86% (Table 19). 19

20 Table 18: Overall Individual Dispensary Partial Dispensary ID: Noncompliance Full % 24.0% 74.2% % 25.8% 74.2% % 15.9% 82.7% % 10.7% 88.4% % 7.5% 82.2% % 19.5% 78.8% % 30.2% 67.0% % 14.3% 72.1% % 20.1% 76.3% OVERALL 4.0% 18.7% 77.3% Table 19:Individual Dispensary with ROPs and Policies Dispensary ID: ROPs Policies % 9.9% % 23.8% % 78.5% % 54.9% % 57.5% % 80.0% % 0% % 45.4% % 85.9% OVERALL 75.7% 48.4% 20

21 Discussion Dispensaries demonstrated a high level of cooperation with this baseline survey. All participating dispensaries responded to all the survey questions, and variation in responses was demonstrated within individual dispensary responses, including indicating that they never or only sometimes adhered to the practices. Variation was also seen across dispensaries. All dispensaries were above the 50% full compliance rate required for preliminary certification. While none had achieved the 90% full compliance rate necessary for full certification, partial compliance rates indicate they are on the right track, either needing to demonstrate more consistent practice or have improvements to make on some aspects of the standard. Despite overall decent compliance rates at baseline, no dispensaries would have achieved neither preliminary nor full certification since none were in compliance with all ROPs. There was a very low rate for having documented policies and procedures related to all standards, which will be required for demonstrating compliance. This will also be an area of for dispensaries to focus on prior to certification. Data from individual dispensaries show that one dispensary is responsible for all the noncompliance in some sections (e.g. Sections 1 and 3). In other sections noncompliance it is more diffuse. Some dispensaries are noncompliant with standards in only one section, while others are noncompliant with standards in several sections. Overall, dispensaries were excelling at standards related to patient eligibility (Section 1). This section represents a fundamental premise of dispensaries, ensuring dispensaries are providing services to those in medical need while supporting patient access. High compliance was also found for standards related to intake (Section 2) and dispensing (Section 4). These sections are some of the core areas of dispensary practices, with the goals of ensuring the patient intake process is transparent and contributes to high quality care, and o dispensing cannabis and cannabis products in a safe, timely and accountable manner. Dispensaries were doing a fair job with safety, security and privacy standards (Section 6). This section is focused on dispensaries maintaining adequate safety and security measures to protect the welfare of patients, personnel, and the community. Dispensaries were struggling with some of the standards related to products and services (Section 3), supply (Section 5), and effective organization (Section 7). Section 3 standards aim to ensure products and services that meet patient needs are consistently accessible. Within this section, dispensaries excelled at the core practices, however were less consistent with related value-added practices such as supporting patients to track efficacy and side effects, and providing and logging ancillary services such as advocacy and referrals to heath and social services. Additionally, not all dispensaries had licenses to sell other products which they provided (i.e. paraphernalia). The goal of Section 5 is to ensure a high quality and accountable supply of medical cannabis is consistently available. Some challenges were presented by standards requiring oversight and a level of control over producers and production methods. Finally, Section 7 is focused on effective, efficient and ethical governance and leadership, and positive outcomes for patients, personnel and the community. Dispensaries are excelling at some of the standards in this section, such as good accounting practices and record 21

22 keeping, but are lacking in regards to higher level management practices, such as preparing budgets, insurance, risk and performance management, as well as community contributions and relations. While some areas of difficulties encountered apply to any type of business (e.g. those in Section 7 related to effective organization), others are unique to dispensaries. These may be indicative of the current regulatory framework for medical cannabis distribution in Canada, which does not include dispensaries. For example, dispensaries may be presented with obstacles to obtaining business licenses, which precludes them from obtaining licenses for selling paraphernalia to support patients to safely utilize their medicine. In addition, concerns regarding the privacy and security of producers may be inhibiting some dispensaries from obtaining contracts and performing oversight. It may be worthwhile for CAMCD to review the distribution of standards and number of questions in each section, and that they reflect priorities, since the more questions there are, the more opportunities there are for noncompliance. For example, section 1 (eligibility) had 9 standards assessed by 13 questions, whereas section 7 (effective organization) has 13 standards assessed by 36 questions. This baseline data will provide useful information for CAMCD in developing their certification program. It will also enable them to see where dispensaries need support and to determine what kind of support they need. 22