Dear Editor,
Substance use is a major challenge for healthcare, judicial, and social systems in Iran, significantly contributing to the national burden of disease (1). Notably, Iran’s disability adjusted life years (DALY) and years lived with disability (YLD) indices attributable to substance use are 698 per 100,000 and 11.1, respectively — well above global averages (200 and 4 per 100,000, respectively) (2). Over the past two decades, Iran has developed one of the world’s largest networks for methadone maintenance therapy (MMT), currently encompassing approximately 7,000 clinics and serving around 700,000 patients nationwide (2).
Methadone provision in Iran follows a physician-led model, in which the same clinician is responsible for both prescribing and directly dispensing methadone within MMT centers. While this model is consistent with Iran’s regulatory obligations under national and international law — including the United Nations Single Convention on Narcotic Drugs (1961) — and is intended to ensure strict medical supervision over a controlled substance, it also presents important ethical, clinical, and operational challenges (3, 4).
It is important to clarify that physician involvement in dispensing methadone is not inherently unethical; rather, it reflects the current regulatory framework for controlled substances in Iran and many other countries. Nevertheless, the dual role of prescribing and dispensing can blur boundaries between clinical care and drug distribution, potentially leading to operational inefficiencies and conflicts of interest (5). Recent Iranian studies have reported patient dissatisfaction with the lack of individualized psychotherapy and social support, as well as concerns about overreliance on medication, limited privacy, and stigmatization (4). Additionally, there is documented evidence of methadone diversion and non-medical use, which has been linked to regulatory gaps and insufficient oversight in the current system (6).
Internationally, best practices advocate separating the roles of assessment/prescribing (by physicians) and dispensing (by pharmacists in regulated community pharmacies), which can reduce conflict of interest, enhance accountability, and leverage the expertise of pharmacists in managing controlled substances. Countries such as Australia and the United Kingdom have achieved improvements in access, patient satisfaction, and diversion control by transitioning to pharmacy-based dispensing models, supported by clear protocols and multidisciplinary teams (7).
A central limitation of the Iranian system is the insufficient integration of psychosocial interventions (1). Addiction is a biopsychosocial disorder, and comprehensive care — including psychological counseling, vocational support, and social reintegration — is key to improving retention and outcomes (8). The heavy focus on pharmacotherapy alone contributes to high relapse rates and persistent stigma, as reported by Iranian patients and families (4).
Reforming the current model would require a phased transition to pharmacy-based dispensing, regulatory reforms to clarify professional roles, and substantial investment in pharmacist training, infrastructure, and digital health systems (7, 9). Stakeholder engagement — including patients, families, clinicians, and pharmacists — is essential for successful implementation and for ensuring that changes do not disrupt access to opioid agonist therapy (OAT). Pilot programs, robust monitoring, and continuous evaluation are recommended to manage risks and guide scaling up (10).
Any reform must also prioritize the integration of robust psychosocial interventions through multidisciplinary teams — drawing on the demonstrated effectiveness of such approaches in both Iran and comparable settings (1, 8). Resource allocation and outcome measurement should be reoriented toward comprehensive, patient-centered care.
In summary, while Iran’s physician-led model for methadone provision is rooted in regulatory necessity, evolving toward a pharmacy-based, multidisciplinary system — with separated roles, expanded psychosocial services, and enhanced oversight — can address current shortcomings and align with international best practices (Table 1). With phased implementation, stakeholder engagement, and ongoing evaluation, Iran has the opportunity to modernize its addiction treatment infrastructure, safeguard public health, and better support recovery for people with substance use disorders.
Table 1.Comparison of Current and Proposed Methadone Distribution Models in Iran
| Component | Current Iranian Model | International Best Practice/Proposed Model | Key Actions for Transition |
|---|---|---|---|
| Methadone prescribing and dispensing | Both prescribing and dispensing by physicians in MMT centers (combined role) | Prescribing by physicians; dispensing by regulated community pharmacies (separated roles) | Establish legal/regulatory framework separating roles; accredit pharmacies; Pilot programs |
| Psychosocial services | Limited; Focus on medication only | Multidisciplinary team approach (psychologists, social workers, peer support, vocational/family support) | Mandate integration of psychosocial interventions; Allocate resources; Outcome measurement |
| Regulatory oversight | Limited oversight; Risk of diversion | Strict protocols for pharmacies, ongoing monitoring | Develop inspection, reporting, and monitoring systems; Digital health platforms |
| Provider training | Minimal pharmacist involvement; Limited addiction training | Pharmacists trained in addiction medicine, counseling, harm reduction | Develop and mandate training/certification programs for pharmacists and all staff |
| Stakeholder engagement | Minimal involvement of patients, families, and pharmacists | Continuous engagement (patients, families, physicians, pharmacists) | Involve stakeholders in design/implementation; Conduct surveys; Qualitative research |
| Implementation approach | Centralized, static system | Phased, incremental reform: Pilot programs, scaling up, ongoing evaluation | Start pilots in urban centers; Monitor diversion and outcomes; Adapt as needed |
| Resource allocation | Primarily medication-focused | Balanced: Medication+psychosocial services Balanced: Medication+psychosocial services Balanced: Medication+psychosocial services | Redirect funding to comprehensive care; Invest in infrastructure and human resources |
| Patient experience | Limited autonomy, confidentiality, and respect | Improved transparency; Patient autonomy; Confidential, respectful environments | Set patient-centered guidelines; Regular feedback and satisfaction measurement |
