When Medicines Run Out, Patient Safety Is At Stake
Ermelinda Marques
Master’s Student in Health Law, Faculty of Law, Universitas Gadjah Mada
Medicines are not merely good stored in the warehouses of hospital or health centres. For patients, they are an essential part of recovery, disease control and health protectection, when someone comes to a health faliticies for treatment, care cannot be delivered optimally if the medicines they need are not available. Medicine stock-outs should therefore not be viewed solely as an inventory problem. They also concern continuity of treatment, the economic burden on patiens, the quality of health care and the responsability of the instituitions that deliver public services.
In Timor-Leste the issue drew renewed attention thoughout 2026. Stock of sodiim valproate, an anti-seizure medicine, briefly ran out at Hospital Nacional Guido Valadare (HNGV) in March. In july, the central warehouse ran out of ferrous sulphate an iron suplement for pregnant women. In august, HNGV acknowledged that stocks of several medicines and consumables were running low.
Public attention grew further when on october 2026, Committee of National Parliament and the Instituto Nacional de Farmácia e Produtos Médicos (INFPM) reported different stock-out figures. Committee F cited 43% of around 1,450 items, while INFPM reported 16% for vital, essential and consumable items. INFPM also explained that some newly arrived goods had not yet been entered into the inventory system. This disrepancy does not itself prove that either party is at fault. It does however, raise an important question : do the government and the oversight body use the same definitions and calculation methods to asses medicine avaivility? The question matter because clear data are the foundation of decission-making, oversight and patient protection.
Definig Stock-outs
In pharmaceutical management, the terms shortage and stock-out are related but not identical. A shortage describes a situation in which ihe supply of essential medicines is insufficient to meet public health and patient need, whereas a stock-out refers to the absence of a medicine at the point of service when it is needed (WHO,2017).
The distinction matters. A medicine may still be available at the central warehouse but not yet have reacched health facilities. Conversely, a medicine may be recorded in the system but not be physically available when a patient needs it. Goods may also have arrived but not yet been recorded or cleared for distribution. Through resolution WHA69.25, the World Health Assembly emphasised the need for technical definitions and notification systems for medicine stock-outs (WHA, 2016). More recent evidence shows that this problem persists. Definitions of shortages still differ across countries, making data incomplete and difficult to compare (Shukar et al., 2021; European Court of Auditors, 2025), while building an effective reporting system must begin with a clear definition of what constitutes a shortage (Vann Yaroson et al., 2024). Without consistent measurement standards, inventory figures are difficult to compare and the effectiveness of policy is difficult to evaluate.
Yet the most fundamental issue is not simply what percentage of medicines is out of stock. The more important question are which medicines are unavalable, how long the stock-out lasts, which facilities are affected, and how many patients do not receive the medicines they need. A stock-out an anti-seizure medicine, for example carries clinical implications different from those of a product with adequate alternatives. Likewise, delays in providing iron to pregrant women must be assessed in light of the patient’s condition, the duration of stock-out and the availability of alternative therapy.
Patient safaty and medicine availability
Patient safety is the foundation of quality health care. WHO defines patient safety as the absence of preventable harm to a patient and the reduction of the risk of unnecessary harm associated with health care to an acceptable minimum. WHO estimates that around one in ten patients is harmed while receiving health care, and that half of all preventable harm is related to medicines (WHO, 2023). Given the large role medicines play in preventable harm, WHO has made medication safety a global patient safety challenge through its Medication Without Harm initiative (WHO, 2017).
In the context of medicine availability, patient safaty requires more than medicines of good quality that are correctly dosed and properly used. It also requires continuity of treatment, clear information for patients and safe clinical decissions when a prescribed medicine is unvailable. A stock-out becomes a patient safety issue when it interrupts treatment, delays care, or leads to substitution without adequate clinical assessment.
The international literature show why this matter. Phuong and colleagues, 2019, found that medicine stortages can have clinical, economic and phychosocial consequences for patients. A systematic review by Olaniran and colleagues (2022) of community level health services in low and middle-income contries found that stock-outs of essential medicines increase patients out of pocket spending, reduce adherence to treatment and lower the use of health services.
These finding do not prove that all such effects have occurred for every patient in Timor-Leste. They do, however explain why medicine stock-outs should be treated as a patient safety issue rather than a purely adminitrative matter.
Medicine availability within the health system
Medicine availability cannot be understood in isolation from the health system as a whole. WHO views a health system as six interdependent building blocks: service delivery, health workforce, health information systems, access to essential medical products, financing, and leadership and governance (WHO, 2007). Within this framework, acces to medicines is one of the core building blocks, but its success depends on the others. Medicines cannot be made available on a sustained basis without adequate financing, accurate data, a components of the system, rather than simly the failure of a single unit.
At the operational level, Management Sciences for Health (MSH, 2012) describes medicine management as a cycle of selection, procurement, distribution and use. These four stages are supported by management functions, namely organisation, financing, information systems and human resources, and take place within the applicable policy and legal framework. The cycle is continuous: data on use inform the next roud of selection and planning, so a weakness at one stage affects the others. This framework helps trace the stage at which a stock-out originates, whether in planning, procurement, receipt and recording or distribuition to serviice facilities.
A recurring problem riquires a system level evaluation
Medicine stock-out are not new in Timor-Leste. A study by camnahas and colleagues (2021), based on interviewa with 46 health workes, documented that stock-out have disrupted health services since 2005 and identified barriers in coordination, forecasting, budgeting and logistics information system. The 2025 National Medicines and Health Products Policy also acknowledges frequent episodes of stock-outs and inadequate stock management and record keeping (Ministério da Saúde & WHO, 2025). These finding show that challenges in medicine availability have persisted for years. However, earlier reseach cannot be used directly to determine the cause of each event in 2026. Specific causes must still be examined on the basis of data and evidence from the relavant period.
Medicine management is a chain of interdependent processes, from selection, needs planning and budgeting to procurement, storage, record keeping and distribution to health facilities (MSH, 2012). Weakness at one stage affets the next. Planning that is not based on comsumption data and desease patterns risks orders that do not match needs. Lengthy procurement can deplete stocks before the next delivery arrives: according to INFPM, a regular tender can take up to six months, plus around three months production overseas. Outdated records obscure the true stock position, while administrative obstacles can hold back medicines that have already arrived, as occured at Tibar Port in january 2026.
Resolving the problem therefore requires more than looking for someone to blame once medicines have run out. Reason (2000) distinguishes the person approach, which seeks those at fault, from the system approach, which examines the conditions under which failures occur. The system approach does not remove individual or institutional responsibility. Rather, it helps determine responsibility on the basis of mandate, obligation, evidence and the actions actually taken.
Each instituition must understand its role. INFPM is responsible for procuring , quality controlling, storing and distribuiting pharmaceutical products for the National Health Service. The Ministery of Health is responsible for health policy and the oparation of health system, while health facilities must ensure that available stocks are managed well and that patients needs are handled safate. This division of tasks must not become a reason for each instituition to work in isolation. The ultimate goal is the same: the medicines patients need must be available at the right time and in the right place.
Medicine availability from a health law prespective
From health law perspective, the availability of medicine is closely linked to the rigth to health. Article 57 of the Constitution of the Democratic Republic of Timor-Leste recognises everyone’s right to health and to medical and sanitary assistance, and provides for the establishment of a universal and general national health service that is, as far as possible, free of charge. This framework is further developed in Law No. 10/2004 on the Health System, as amended. The constituition guarantee must be realised though actual service delivery. Health care is not simply a matter of providing building, health workers and medical consultations. Patients also need medicines that match their clinical indications and that are available through a safe system of care.
At the international level, Article 9 of the Constitution provides that the norms of ratified international agreements apply within the national legal order. The International Covenant on Economic, Social and Cultural Rights recognises the right of everyone to the highest attainable standard of physical and mental health (United Nations, 1966). General Comment No. 14 explains that the right to health comprises four elements, namely availability, accessibility, acceptability and quality, and identifies the provision of essential drugs as a core obligation of the State (CESCR, 2000, paras. 12, 43). These principles provide a framework for assessing whether the health system has fulfilled its obligation to ensure access to medicines.
Nevertheless, stock -out does not automatically prove a violation of the law. Legal assessment must be conducted carefully by examining the aplicable provisions, the mandates and obligations of the institutions concerned, the causes of the stock-out, and the steps taken to prevent and resolve it. General Comment No. 14 distinguishes between a State that is unable and one that is un willing to meet its obligations; where resource constraints are invoked, the State must demonstrate the maximum effort it has made (CESCR, 2000, para. 47).
Resource constraints should therefore be assessed on the basis of facts and actual efforts. Were medicines need planned reasonably? Did procurement begin at the right time? Are there mechanisms to deal with supply delays? Are safe therapeutic alternatives available? Do patients receive information and appropriate care when prescribed medicine is unvailable?
These questions help distinguish stock-out that occur despite reasonable measures from those that may be linked to a failure to fulfil obligations. In this way, legal analysis neither turns into accusation without evidencenor allows problem to recur without evaluation. Within the accoutability framework of the rigth to health, this process links monitoring, review mechanisms and remedial action. The rigth to healt should therefore be understood as a basis for improving services and clarifying responsibility, not merely as a norm cited in policy documents.
Patients must not beat the burden of system failure alone
When medicines are unvailable, patients are in the weakest position. Services in public health facilities are free of charge, yet some patient are asked to buy their medicines at private pharmacies. For patients who live far from facilities or have limited income, the cost of medicices, transport and repeat visits becomes and additional burden, contrary to the aim of the 2025 National Medicines policy to reduce patients out of pocket spending (Ministério da Saúde & WHO, 2025). Patients also risk stopping treatment, reducing doses or using substitute medicines without adequate assessment.
Patient are therefore entitled to honest information about the stock situation and the options available, while any substitution or change in therapy must be decided by an authorised health professional on clinical grounds. The principle is simple: supply problems must not leave patients without protection in health care.
What needs to be done?
First, establish a stock-out reporting system with consistent definitions and calculatiion methods. Each report should specify the type of medicines, its priority category under the vital, essential and non-essential (VEN) classification, the location of measurement, the period, the duration of the stock-out and the status of good that have arrived but have not yet been recorded or cleared for distribuition.
Second, stengthen planning and procurement on the basis of consumption data, disease patterns, procurement lead times and the needs of each facility. For vital medicines, safety stocks and continuous procurement mechanisms should be considered, such as the framework agreements ( agordo -quadro) intoduced by the publuc procurement and contracts code in force since 1 january 2026. An early warning system is also needed so that potential stock-out are identified before supplies are fully depleted.
Trird, adopt patient protection protocols in health facilities. These should cover the provision of information, assessment of therapeutic alternatives by authorised health professionals, and the recording of unment patient needs.
Fourth, strengthen inter-institutional coordination. The Ministery of Health, INFPM, Health Facilities and other relelvant authorities, including customs, need clear communication mechanisms and a clear division of responsilibities. Inventory data should be updated and reconciled with physical stock, and pharmacist should be involved in needs planning and in monitoring medicine use.
The success of policy should not be measured only by the quantity of medicines purchased or dispatched. What must be assessed is whether those medicines actually reach the facilities that need them and can be obtained by patients when required.
Medicine Availability is a Share Resposability
The discrepancy in stock-out figures reported in october 2026 should be an opportunity to improve the reporting system, not merely a debate about which figure is most accurate. The figures of 43% and 16% need to be explained in terms of their respective scope and calculation methods so that the public can understand the stock situation accurately.
At the same time, the problem cannot be solved throughh better data alone. Needs planning, procurement, starage, record keeping, distribuition and coordination must be examined as a single system. When problems arise, the instituition concerned should explain the corrective actions taken and how those actions will prevent recurrence.
From a health law perspective, Article 57 of the Constituition provides an important basis for plancing patients at the centre of health service delivery. Realising this right, however, requires a system that can ensure the availability of medicines, provide adequate information, maintain continuity of treatment and offer protection when supplies are disrupted. Donabedian’s quality framework assesses health care thoough three interrelated dimentions. Structure referes to the resources and setting in which care is delivered, such as facilities, health workers and medicine. Process refers to the activities involved in delivering care, including the management and dispensing of medicines. Outcome refers to the effects of care on patient’s health and safety (Robby et.al 2025). Within this framework, medicine availability is part of structure, inventory management is part of process and patient safety is the outcome to be achieved. The Lancet Global Health Commission on High Quality Health systems likewise places medicines among the foundations of a health system, while stressing that health system should ultimately be judged by their impact on people’s health and confidence.
Ultimately, the success of medicine management is not deternined by number of items recorded in a werehouse. It is reflected in patients obtaining the medicines they need, receiving accurate explanations, and being able to continue their treatment safety.
Conclusion
Base on the discussion above, medicine stock-out in Timor-Leste should understood as a patient safaty issue, not merely an inventory problem. Their impact depends on the type of medicine, the patient’s condition, the duration of the stock-out and availabilitly of therapeutic alternatives. The literatures shows that stock-out can distrup continuity of treatment, add to patient’s economic burder and reduce the use of health service.
The problem is also recurred and systemic. Medicine stock-outs have been documented for years and are acknowledged in oficial government policy. The descrepancy between the figures of 43% and 16% in October 2026 shows that unifom definitions, calculations methods and reporting mechanisms are not yet in place. Improvements must therefore cover the entire medicine management chain, from planning to distribuition and be grounded in evidence.
From a health law perspective, the availability of medicines is part of the fulfilment of the right to health. Article 57 of Constituition and General Comment No. 14 place essential medicines within the obligations of the state. A stock-out does not automatically constitute a violation of the law, but recurring stock-out demand open explanation, measurable corrective action and protection for the patients affected,
Acordingly, the success of medicine management should de measured not by the quatity of goods in the werehouse, but by whether the right medicines reach the patients who need them, at the right time and in a safety manner.
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