Why Scheduled Medicines Require Evidence-Based Community Care and Real-Time Monitoring

The Case for Evidence-Based, Structured Prescribing

Medical Cannabis, Ketamine, Psychedelics, Peptides like BPC-157, and even GLP-1 receptor agonists are being prescribed to patients around the world. Yet the gap between clinical trial efficacy and real-world persistence is staggering. This gap exposes a critical infrastructure problem: most healthcare systems weren't built to monitor scheduled medicines at scale with rigorous, participant-reported outcomes.

This is community care for scheduled medicines informed by real data. This moves beyond a start low, go slow, and see how you go approach. This is rigorous, data-centred, compliance-first medicine.

The Real-World Persistence Crisis

Let's begin with a sobering fact about medications that work in trials but fail in communities.

GLP-1 receptor agonists (semaglutide, tirzepatide, liraglutide) produce substantial weight loss in clinical trials. Yet real-world persistence tells a different story: only 46.3% of patients remain on therapy at 6 months, and just 32.3% persist at 1 year. Among these patients, only 27% achieved adherence rates above 80%, defined as the proportion of days covered (PDC) at or above therapeutic thresholds. Two-thirds of commercially insured patients initiating GLP-1 therapy discontinue within the first year because of cost, side effects, perceived lack of effect, or simply lose motivation without structured monitoring. [1]

This pattern repeats across classes. For cannabis prescriptions in primary care, guideline adherence is lacking: 87.1% of cannabis prescriptions failed to meet evidence-based prescribing guidelines and there is a major need to build on data from sources like OnTracka that provides data on medical cannabis prescriptions for mental health, as outlined in the From Data to Decision-Making White Paper.

Shared care agreements (SCAs) for scheduled medications show 32.3% of prescribed medications lack up-to-date monitoring data, with attention-deficit/hyperactivity disorder medications showing the highest non-compliance.

The pattern is clear: access isn't the barrier anymore. Compliance is. And compliance happens in the community, in the structured space between prescription and patient action.

OnTracka's Data: From 1.2 Million Data Points to Clinical Anchor Points

Over the past 4 years, OnTracka has captured and analysed real-world data from participants using medical cannabis, with rigorous ethics approval and participant consent published in a white paper called “From Data to Decision Making”. This dataset comprises over 1.2 million data points, making it one of the largest standardised collections of participant-reported outcomes for medical cannabis in community settings.

The findings are clear: structured prescribing works.

Psychedelics, Ketamine, and the Emergence of Scheduled Medicine in Mental Health

Scheduled medicines for mental health are transitioning from research to clinical practice faster than regulatory and training frameworks can accommodate.

Psilocybin-assisted therapy showed remarkable efficacy in landmark randomised controlled trials of major depression: achieved clinically significant response at week 1 post-treatment (≥50% reduction in depression score), with 58% meeting remission criteria. Depression scores dropped from 16.7 (baseline) to 6.3 (day 1 post-session), a Cohen d of 2.6, with effects sustained at week 4 follow-up. [2]

MDMA-assisted therapy for post-traumatic stress disorder achieved response rates of 86.5% versus 69.0% placebo at 18 weeks, with remission rates of 46.2% versus 21.4%.[3]

Ketamine-assisted psychotherapy for methamphetamine use disorder is now moving into feasibility trials, with protocols defining subanaesthetic doses (0.75-0.9 mg/kg) paired with cognitive behavioural therapy delivered in community settings.

But here's the critical gap: these results come from highly controlled settings with intensive monitoring, structured therapy protocols, and enrolled populations unlikely to represent actual community practice. The question isn't whether psychedelics work. It's whether they work when prescribed by non-specialist doctors, taken by diverse patient populations, monitored through fragmented systems, and sustained without clinical anchor points to guide dose or frequency adjustments.

OnTracka's approach to scheduled medicines is to build the infrastructure that specialist trials already have into community-based prescribing from the start.

OnTracka's research on medical cannabis prescribing tells a different narrative than guideline non-adherence alone.

In our dataset, we tracked participant-reported outcomes across diverse symptom domains (pain, fatigue, nausea, depression) across different product formulations and routes of administration. Rather than identifying failure, we identified structure.

Participants whose care included:

• Clear baseline symptom documentation

• Dose escalation tied to specific symptom improvement thresholds

• Structured monitoring at dose 10, dose 20-40, and beyond

• Documented adverse effect resolution or formulation switching

...showed markedly different adherence and symptom response patterns than those managed through ad hoc prescribing.

The lesson: compliance isn't about access. It's about structure. Build monitoring into prescribing protocols from the start, and adherence follows.

The Four Clinical Anchors in Evidence-Based Scheduling for Scheduled Medicines

For cannabis, ketamine, psychedelics, peptides, and other emerging scheduled medicines, evidence-based prescribing in community care requires four clinical anchor points:

1. Baseline Risk Stratification and Contraindication Screening

Before any scheduled medicine is prescribed, systematic screening for absolute contraindications must occur. For cannabis: cardiovascular or respiratory disease, active alcohol use disorder, age under 25, psychosis risk. For psychedelics: uncontrolled hypertension, recent myocardial infarction, severe psychiatric instability.

For GLP-1s: pancreatitis history, medullary thyroid carcinoma, retinopathy.

This screening must be documented systematically. The failure to do so has led to 65.7% of cannabis prescriptions proceeding despite contraindications. Digital health systems must enforce screening protocols before prescribing is possible, not as an afterthought.

2. Dose Escalation Protocols with Measurable Clinical Endpoints

Start low and go slow is descriptive, not prescriptive. Effective prescribing requires defined dose escalation tied to specific clinical endpoints.

OnTracka's PresicionDose Tool is evidence that this works. When pain is the target, define baseline pain score, target pain reduction (e.g. 30% from baseline), maximum tolerable dose, and scheduled review points. For psychedelics in mental health, define baseline depression or anxiety score, expected improvement trajectory, and criteria for continuing versus discontinuing.

Real-world evidence from GLP-1s shows that most patients use suboptimal doses. Without clear dose escalation protocols linked to measurable endpoints, prescribers err on the side of under-dosing, reducing efficacy.

3. Structured Monitoring Intervals with Biomarkers and Patient-Reported Outcomes

OnTracka's infrastructure is dynamic to capture both participant-reported outcomes and clinical endpoints at structured intervals. While it is not applicable or necessary for all projects, the capacity to integrate blood pressure, heart rate, liver function, and symptom scores at weeks 2, 4, and 8 changes safety monitoring for complex or high-risk patients. For psychedelics: depression/anxiety scales at defined intervals post-treatment. For peptides: weight, blood glucose, gastrointestinal symptoms at specified time points.

While this is not where the market is. This is a blueprint for how we ensure medicine moves beyond the system we currently have. By including clinical anchor points that guide dose adjustment or discontinuation, OnTracka's data shows that clinical decisions become data-driven rather than intuition-based.

4. Safety Monitoring with Real-Time Alerts and Wearable Integration

Wearable devices and digital touchpoints integrated into OnTracka's platform can flag potential safety signals before they become adverse events.

Heart rate elevation during psychedelic therapy? Alert to clinician. Elevated blood pressure on peptide therapy? Automated notification triggering review. Psychological distress after consuming an edible/pastille? Digital assessment prompt.

The justification for these technologies is straightforward: they provide the real-time parameters necessary for the four anchors above. They're not spectacles. They are part of the clinical infrastructure and essential self-monitoring capabilities to bring patients into the experience.

Real-World Evidence: From Dose to Decision Making

OnTracka's whitepaper, "From Data to Decision-Making," answers a fundamental question: what does structured data tell prescribers when a patient doesn't improve or tolerates poorly?

In traditional prescribing, the answer is often: wait, or switch drugs entirely. In OnTracka's evidence-based model, the answer is data-driven decision-making anchored to specific decision thresholds.

Example from cannabis: a participant prescribed for chronic pain shows a baseline pain score of 7/10. After dosing at the escalation point A, pain remains 6.5/10 (minimal response, below R20 threshold). Decision threshold triggers: either signal a script adjustment, escalate dose or explore alternative options. Data, not guesswork, drives the decision.

This is what real-world evidence actually means. It's decision-making infrastructure built into prescribing protocols from the start.

Building Compliance into Patient Experience

OnTracka's retention data showing >85% engagement in real-world datasets and clinical trials isn't accidental. It reflects compliance infrastructure embedded in participant experience.

From participant's perspective, compliance happens through:

Friction Reduction: Dosing reminders, easy refill processes, integrated pharmacy systems. Every friction point is a potential drop-off. OnTracka's platform removes these barriers systematically.

Feedback Loops: Participants seeing their own data. Pain score trending down? Show them the graph. Sleep quality improving? Visualise it. The moment a participant sees personal evidence of efficacy, compliance skyrockets. OnTracka's dashboard makes this transparent.

Wearable Integration: Not for spectacles. They are part of the clinical infrastructure and essential self-monitoring capabilities to bring patients into the experience.

Transparent Protocols: Participants knowing the dose escalation logic, monitoring plan, and decision criteria in advance increases perceived legitimacy and compliance. Hidden rules breed mistrust. OnTracka's framework makes protocols explicit.

Structured Clinician Time: Brief interventions by trained staff, pharmacists, nurses, and social workers between doctor visits. Adherence support isn't a 60-minute therapy session. It's targeted, intelligent, and clinically meaningful interactions tied to decision points. OnTracka's data flagging system prioritises these touchpoints.

The future of scheduled medicine prescribing in primary care depends on rigorous infrastructure: baseline screening, dose escalation protocols tied to measurable endpoints, structured monitoring intervals, and real-time safety alerts. Ontracka's data-driven approach transforms scheduled medicine prescribing from intuition-based to evidence-based, making compliance routine across community care settings.

References

[1] Gleason, P.P., et al. (2024). Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists for weight management. PMC11616284​

[2] JAMA Psychiatry randomised clinical trial by Davis et al. (2021) on psilocybin-assisted therapy for major depressive disorder. Jama Network​

[3]Phase 3 trial of MDMA‑assisted therapy (MDMA‑AT) for moderate to severe PTSD led by Mitchell et al., Nature​

[4] Fletcher, K., et al. (2025). Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy. PIB​

[5] Elias, D.A., et al. (2019). Adherence to prescription guidelines for medical cannabis. PMC3514853