Survey of workflow and cost implications of decommissioning regarding the Falsified Medicines Directive in Hungarian hospital pharmacies

Objectives, setting and participantsIn July 2011, the EU adopted the Falsified Medicines Directive (FMD) primarily aiming to prevent the infiltration of falsified medicines into the legitimate supply chain. Our aim was to measure the cost elements of FMD implementation and operation using an internationally adaptable tool among Hungarian hospital pharmacies.DesignA 41-item questionnaire was developed to evaluate the implementation process and associated cost consequences leading up to February 2019, and the stabilisation period.ResultsOur representative data are supported by the high response rate, as 44.8% of the Hungarian hospital pharmacies have completed the survey. Human resource requirements related to decommissioning activities were measured as working hours and were expressed in full time equivalent (FTE). We have found an increased workload with extra 0.25 pharmacist and 0.75 technician FTE/institution at the end of the stabilisation period. The entire infrastructural and IT implementation costs were determined as €2173, on average (SD: €3366) and the median was €1506 (range: €0–€20 723). The total IT investment cost per institution was valued at €1410 (SD: €335). We identified a positive correlation (R=0.663) in consideration of the costs, the number of beds and the number of hospital locations with a multivariate linear regression model. At the time of our survey, 76.7% of the respondents experienced drug shortages, 58.1% reported suspected increase in drug costs regarding serialised medications, and 53.5% noticed an increase in packaging size.ConclusionsNotably, our research is the first complex study depicting FMD cost implications in the hospital pharmacy sector in Central Europe, indicating decommissioning significantly impacted workflow referencing human resources and IT.

Combatting Substandard and Falsified Medicines: Public Awareness and Identification of Counterfeit Medications

Objectives: The objective of this study was to determine the identification rate of substandard and falsified medications and its association with knowledge among public.Methods: This descriptive cross-sectional study was conducted in different geographic areas among a convenient sample of people aged 18 or older. A validated web-based electronic questionnaire was used for data collection tool. The questionnaire contained three sections assessing the following: (1) Sociodemographic data; (2) Knowledge regarding counterfeit medicines; and (3) Ability to identify counterfeit medicines, according to 12 questions rated on a five-point Likert scale. Univariate and multivariate logistic regression analyses were used to assess the association between sociodemographic factors and counterfeit medication identification rate.Results: A total of 320 people participated in the study. Only 98 participants (30.6%, 95% CI 25.6–35.7%) identified the counterfeit medications. Ability to correctly identify counterfeit medications was significantly higher in participants who were older (p = 0.016), single (p = 0.001), Asian (p = 0.001), or American (p = 0.019), as well as those who indicated that they would check the certification of the medications (p = 0.015) and report counterfeit medications to the authorities (p < 0.0001).Conclusions: These results underscore the need for greater public awareness of the hazards associated with counterfeit medicines.

Laboratory evaluation of twelve portable devices for medicine quality screening

Background Post-market surveillance is a key regulatory function to prevent substandard and falsified (SF) medicines from being consumed by patients. Field deployable technologies offer the potential for rapid objective screening for SF medicines. Methods and findings We evaluated twelve devices: three near infrared spectrometers (MicroPHAZIR RX, NIR-S-G1, Neospectra 2.5), two Raman spectrometers (Progeny, TruScan RM), one mid-infrared spectrometer (4500a), one disposable colorimetric assay (Paper Analytical Devices, PAD), one disposable immunoassay (Rapid Diagnostic Test, RDT), one portable liquid chromatograph (C-Vue), one microfluidic system (PharmaChk), one mass spectrometer (QDa), and one thin layer chromatography kit (GPHF-Minilab). Each device was tested with a series of field collected medicines (FCM) along with simulated medicines (SIM) formulated in a laboratory. The FCM and SIM ranged from samples with good quality active pharmaceutical ingredient (API) concentrations, reduced concentrations of API (80% and 50% of the API), no API, and the wrong API. All the devices had high sensitivities (91.5 to 100.0%) detecting medicines with no API or the wrong API. However, the sensitivities of each device towards samples with 50% and 80% API varied greatly, from 0% to 100%. The infrared and Raman spectrometers had variable sensitivities for detecting samples with 50% and 80% API (from 5.6% to 50.0%). The devices with the ability to quantitate API (C-Vue, PharmaChk, QDa) had sensitivities ranging from 91.7% to 100% to detect all poor quality samples. The specificity was lower for the quantitative C-Vue, PharmaChk, & QDa (50.0% to 91.7%) than for all the other devices in this study (95.5% to 100%). Conclusions The twelve devices evaluated could detect medicines with the wrong or none of the APIs, consistent with falsified medicines, with high accuracy. However, API quantitation to detect formulations similar to those commonly found in substandards proved more difficult, requiring further technological innovation.

Perspective on Criminalization of Smuggling of Goods

The article examines the perspective on criminalization of smuggling of goods arising in connection with the Draft Law of Ukraine «On Amendments to the Criminal Code of Ukraine and the Criminal Procedure Code of Ukraine on criminalization of smuggling of goods and excisable goods and inaccurate declaration of goods» (№ 5420). The Draft Law provides for the following criminal offenses: smuggling (Article 201); transporting across the customs border of Ukraine out of customs control or with concealment from customs control of timber or lumber of valuable and rare species of trees, unprocessed timber, as well as other timber prohibited for export out of the customs territory of Ukraine (Article 201-1); smuggling of goods (Articles 201-2); smuggling of excisable goods (Articles 201-3); smuggling of narcotic drugs, psychotropic substances, their analogues or precursors or falsified medicines (Article 305). They form a homogeneous group of actions, between which there must be systemic connections. It follows that the reasons for formulating the peculiar title of Article 201-1 are missing. The title of this article should be formulated as follows: «Smuggling of timber or lumber of valuable and rare species of trees, unprocessed timber, as well as other timber prohibited for export out of the customs territory of Ukraine». It was found that Article 201-2 of the Draft Law provides for the general description of a criminal offense, and the description of criminal offenses specified in Articles 201, 201-1, 201-3 and 305 of the Draft Law are peculiar. In this regard, it seems appropriate to swap the Criminal Law provisions of Articles 201 and 201-2 of the Draft Law. In Section 4 of Article 201-4 of the Draft Law, the phrase «assistance in any form by a customs official to commit such acts with the use of power or official position» is not a qualifying feature, but an independent structure. If there is a need to criminalize this act, it may be provided for in a separate article or should be specified in a separate section of Article 201-4 of the Draft Law as an independent act. It is established that on the one hand, the criminalization of smuggling of goods is an urgent need in Ukraine, on the other side the present Draft Law of Ukraine cannot effectively address this issue, as it requires additional elaboration.

Sounding out falsified medicines from genuine medicines using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

The trade in falsified medicine has increased significantly and it is estimated that global falsified sales have reached $100 billion in 2020. The EU Falsified Medicines Directive states that falsified medicines do not only reach patients through illegal routes but also via the legal supply chain. Falsified medicines can contain harmful ingredients. They can also contain too little or too much active ingredient or no active ingredient at all. BARDS (Broadband Acoustic Resonance Dissolution Spectroscopy) harnesses an acoustic phenomenon associated with the dissolution of a sample (tablet or powder). The resulting acoustic spectrum is unique and intrinsic to the sample and can be used as an identifier or signature profile. BARDS was evaluated in this study to determine whether a product is falsified or genuine in a rapid manner and at lower cost than many existing technologies. A range of genuine and falsified medicines, including falsified antimalarial tablets from south-east Asia, were tested, and compared to their counterpart genuine products. Significant differences between genuine and falsified doses were found in their acoustic signatures as they disintegrate and dissolve. Principal component analysis was employed to differentiate between the genuine and falsified medicines. This demonstrates that the tablets and capsules included here have intrinsic acoustic signatures which could be used to screen the quality of medicines.

The current state of the pharmaceutical market of Ukraine, quality assurance and falfication of medicines

The aim of our article was the study of the current state of the pharmaceutical market of Ukraine in the context of the quality assurance of medicines and preventing the spread of falsified medicines (FM), the identification of the main problems in the field of circulation of medicines and the ways to solve them. It is established that the dynamic development of the pharmaceutical market and its high profitability cause problem of drug quality, increasing threats to the spread of FM in circulation and require the implementation of effective mechanisms for regulation of quality and safety of medicines. Analysis the annual official statistics of the State Service of Ukraine on Medicines and Drug Control for the period of 2008–2019 on the number of detected FM in circulation showed a steady trend of increasing FM and insufficient implementation of effective measures to combat them. The creation of effective quality assurance system of drugs and preventing the spread of FM need to improve the organization of state control of drug quality, strengthening criminal liability for falsification of drugs and optimization of the system of their detection.

When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries

The recent growth of medicine sales online represents a major disruption to pharmacy markets, with COVID-19 encouraging this trend further. While e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in low-income and middle-income countries (LMICs). Public health concerns associated with e-pharmacy include the sale of prescription-only medicines without a prescription and the sale of substandard and falsified medicines. There are also non-health-related risks such as consumer fraud and lack of data privacy. However, e-pharmacy may also have the potential to improve access to medicines. Drawing on existing literature and a set of key informant interviews in Kenya, Nigeria and India, we examine the e-pharmacy regulatory systems in LMICs. None of the study countries had yet enacted a regulatory framework specific to e-pharmacy. Key regulatory challenges included the lack of consensus on regulatory models, lack of regulatory capacity, regulating sales across borders and risks of over-regulation. However, e-pharmacy also presents opportunities to enhance medicine regulation—through consolidation in the sector, and the traceability and transparency that online records offer. The regulatory process needs to be adapted to keep pace with this dynamic landscape and exploit these possibilities. This will require exploration of a range of innovative regulatory options, collaboration with larger, more compliant businesses, and engagement with global regulatory bodies. A key first step must be ensuring that national regulators are equipped with the necessary awareness and technical expertise to actively oversee this e-pharmacy activity.

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

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.

Elusive quality: the challenges and ethical dilemmas faced by international non-governmental organisations in sourcing quality assured medical products

Although medical products that are of sound quality are fundamental to the delivery of healthcare, so too is their availability, affordability, accessibility and acceptability. However, achieving all of these aims consistently and simultaneously may be unfeasible due to a host of barriers—no matter the country. If uncertainty, constraints and conflicting priorities also threaten their delivery, not only does the situation becomes yet more challenging, the morally just course of action becomes yet more opaque. While global health organisations, supply chains and projects are heterogenous, international non-governmental organisations (iNGOs) responding to humanitarian crises or delivering development assistance in low-income and middle-income countries are undoubtedly prone to this issue. In a novel framing of the problem of substandard and falsified medicines, this article explores some ethical dilemmas that, directly or indirectly, could result in the quality of medical products in iNGO health projects to be compromised. Drawing on a broad literature base and years of experience as a senior humanitarian pharmacist, the author reflects on the barriers, culture and system that contributes to the existence and persistence of substandard and falsified medical products in global assistance projects. The paper offers an in-depth examination of pressures that may arise in four key areas (capacity, supply chain, bureaucracy and quality assurance) and postulates on the myriad ways in which this may alter the attitudes, behaviours and decision-making of iNGOs in a manner that disincentivises the prioritisation of medical product quality. This paper does not seek to excoriate the aid sector, but rather to lend a new perspective: that such predicaments are overlooked, real-world ethical dilemmas in urgent need of greater openness, research, debate and guidance, for the benefit of moral decision-making and patient care.