Implementing pharmaceutical track-and-trace systems: a realist review

Abstract

IntroductionOne way to prevent falsified medical products from entering the regulated pharmaceutical supply chain is to implement a pharmaceutical track-and-trace system (PTTS). Such systems in the most extensive versions generally mandate a scan at every point of contact with the medical product: from the point of entry to dispensation. There have been several attempts to implement such systems; for example, a ‘full’ PTTS in Turkey and the more pared-down version offered by the European Union’s Falsified Medicines Directive and Delegated Act. This study aims to identify facilitators and barriers to implementing (elements of) a PTTS, with the Turkish system used as a benchmark.MethodsWe conducted a ‘realist’ review, which synthesises literature and aims to establish how a specific technology works, for whom, under which circumstances. We searched Embase, Medline Ovid, Web of Science, Cochrane Central and Google Scholar databases, yielding 2,790 scholarly articles. We selected 21 for review.ResultsImplementation of PTTS elements has been attempted in different compositions in several primarily high-income and middle-income countries. Factors that affected implementation included stakeholders like the government and supply chain actors, the coordination between them, and their awareness, knowledge, and skills, as well as regulation and legislation, monetary investments, and technical and digital requirements.ConclusionThe interplay between contextual factors is crucial for successful PTTS implementation. Specifically, the findings indicate that aligning the incentives for all actors and allowing for adjustments in a continuous implementation process will likely facilitate implementation.

The challenges associated with the prevention of smuggling and counterfeiting health goods in Iran

“…Pharmaceutical tracking and tracing system (PTTS) is used for the security of pharmaceutical supply chains by some countries [ 36 ]. Factors influencing the effective implementation of PTTS include stakeholders such as the government and supply chain actors; their awareness, knowledge, and skills; rules and regulations; financial investment; and technical and digital requirements [ 36 ].…”

“…Pharmaceutical tracking and tracing system (PTTS) is used for the security of pharmaceutical supply chains by some countries [ 36 ]. Factors influencing the effective implementation of PTTS include stakeholders such as the government and supply chain actors; their awareness, knowledge, and skills; rules and regulations; financial investment; and technical and digital requirements [ 36 ]. In Iran, The electronic system for Tracing, Tracking and Authentication Control (TTAC) has been launched since 2013 to manage the currency allocated to medicines, create a suitable platform for gathering information, management of medicine and medical equipment shortages and financial resources, and prevent wastage and misuse of financial support, and control the targeted payment of insurers.…”

Pharmacists' views on the impact of the Falsified Medicines Directive on community pharmacies: A cross-sectional survey

“…Several mechanisms exist internationally to help detect falsified medicines, including pharmacovigilance reporting systems, drug quality screening, training programmes for pharmacists, mobile phone applications for medicine authentication, and pharmaceutical track-and-trace systems (PTTSs). 2 , 5 In 2011, the Falsified Medicines Directive (FMD) was published by the European Commission with the goal to implement such a PTTS to minimise the circulation of falsified medicines across the European Union by tracking medicines from production to their dispensing to patients. 6 The FMD requires that most prescription-only medicines, as well as some over-the-counter products which have been falsified previously, must be protected with an anti-tamper seal and have a unique identifier (achieved with a 2D barcode).…”

“…Previous evidence shows that PTTSs can require significant investment and can be challenging to implement. 5 Thus, it will be particularly important to investigate how the FMD has affected the key stakeholders involved in implementing the directive's procedures across Europe – particularly community pharmacists, who are responsible for the final step in the supply chain. From reviewing the literature, the FMD has been primarily framed as an important measure in further safeguarding patients, but was also predicted to be quite disruptive to community pharmacists' dispensing process (e.g.…”

Uncertainties about the quality of medical products globally: lessons from multidisciplinary research

“…Hasnida et al presented an investigation of the political and economic determinants of SF medicines in Indonesia: the political pressure to reduce prices and certain healthcare provider incentives can drive markets for SF medicines, and policy-makers should carefully consider the potential impact of rules governing health financing, procurement, taxation and industry, on medicines quality 14. Kootstra and Kleinhout-Vliek presented a realist review of pharmaceutical track-and-trace systems, with the Turkish system used as a benchmark; their findings emphasise the interplay between technical solutions, contextual factors, and the need to align incentives for all actors in a continuous implementation process 15. Finally, Hamill et al looked at the ‘on the ground’ effectiveness of the WHO Global Surveillance and Monitoring System for SF medicines in Tanzania; they provided important insights into how the theorised mechanism between technical reporting and a reduction in undesirable behaviours plays out in a low-income setting, and revealed hidden assumptions about regulator behaviour and motivations 16…”