Wholesale Drug Research Articles

Delphi method applicability in drug foresight

BackgroundThe aim of the current study was to assess the accuracy of expert predictions, which were derived using a Delphi panel foresight study between 2009 and 2011, on a variety of drug-related topics in Finland in 2020.MethodsThe material used to evaluate the accuracy of the predictions consists of published reports on statistics, survey results, official register data, wastewater analyses and official documents. Whenever possible, we used multiple information sources to ascertain possible changes related to the predictions.ResultsBetween 2009 and 2011, the majority – but not all – of the experts accurately predicted an increase in drug use. Indeed, more people experimented with or used drugs, and more drug residues were found in wastewater monitoring. The experts also correctly predicted an increase in population-level approval of drug use, but this development has been rather slow. Contrary to predictions, there was no marked increase in the use of new synthetic drugs. However, the misuse of buprenorphine increased during the 2010s. In the drug market, unit prices were surprisingly stable over the ten-year period. There were no changes in legislation related to the legal status of drugs, as was foreseen by the experts. However, enforcement moved in the direction foreseen by the experts: more lenient measures have been taken against users. Drug care system reforms favored a combination of mental health and addiction care units between 2009 and 2011, and 2020, as foreseen by the experts.ConclusionsIt seems to have been easier for the experts to foresee the continuation of existing trends, e.g., increasing use of drugs or widening approval of drugs, than to predict possible changes in the popularity of distinct groups of drugs such as new psychoactive substances (NPS). Even armed with the prediction that drug imports and wholesale would increasingly fall into the domain of organized crime, this undesirable development could not be stopped. Expert disagreement can also be seen as a valuable indication of uncertainty regarding the future. Foresight related to drug-related issues can produce relatively accurate and realistic views of the future at least up to ten years ahead.

Mapping drug smuggling networks in Japan: a social network analysis of trial documents

ABSTRACT This paper addresses a significant gap in drug market literature by examining high-level drug trafficking networks in Japan. We focus on three aspects: the structure of drug importation networks, the impact of transport methods on these structures, and the role of Japan’s mafia, the yakuza. Using novel statistical techniques that extend exponential random graph models (ERGMs) to multi-network samples, we analyse 573 Japanese trial documents on wholesale drug importation. We test the theory that trafficking operations with higher information-processing demands exhibit more efficiency-oriented network structures, while governance-type groups avoid expanding into trade activities. Our findings support these theories, showing that networks with higher information-processing demands are more efficiency-oriented but maintain security. Conversely, smaller networks with simpler transport methods prioritise security and concealment. Additionally, the yakuza do not organisationally engage in drug trafficking; when involved, yakuza members act as independent entrepreneurs.

Surgical Thromboprophylaxis in Patients With Head and Neck Cancer: An Economic Model.

To quantify postoperative venous thromboembolism (VTE) incidence in head and neck cancer (HNC) patients, and assess the economic implications of chemoprophylaxis. Retrospective cost-effective analysis. Fifty-threehealth care organizations. The TriNetX Research Network was queried to identify the 1-month VTE rate in HNC patients undergoing neck dissection from 2012 to 2022. A literature search provided additional postsurgical VTE rates in HNC patients. Costs of prophylactic heparin and enoxaparin were obtained from a drug wholesaler, and VTE-associated medical costs were sourced from the literature. A break-even analysis determined the absolute risk reduction (ARR) in the VTE rate necessary for a medication to break-even on cost. In TriNetX, 8193 HNC surgical patients underwent neck dissection, and an additional 1640 patients underwent neck dissection plus free flap reconstruction without chemoprophylaxis. Respective 1-month VTE rates were 1.3% (n = 103) and 2.5% (n = 41). Four additional studies of 1546 postoperative HNC patients not prescribed chemoprophylaxis reported a mean VTE rate of 3.8% (n = 59), ranging from 1.9% to 13.0%. At $8.40 per week, heparin resulted in cost savings if it decreased the VTE rate by an ARR of at least 0.05%, while enoxaparin, at $23.66 per week, needed to achieve a 0.14% ARR. Considering potential added costs from bleeding complications, heparin, and enoxaparin remained cost-effective if chemoprophylaxis did not increase bleeding complications by an absolute risk of more than 2.86% and 2.79%, respectively. Postoperative VTE rates varied in HNC patients. Despite this, achievable ARRs suggested the potential cost-effectiveness of routine chemoprophylaxis with heparin and enoxaparin.

Enhancing Security, Transparency, and Efficiency of Blockchain Technology in Pharmaceutical Supply Chain

Blockchain technology has emerged as a promising solution to address persistent challenges like lack of transparency, inefficient tracking, and counterfeiting issues in pharmaceutical supply chains. However, there are still limitations in integrating blockchain with existing legacy systems, lack of common standards, scalability concerns due to its decentralized architecture, and lack of regulatory clarity that need to be addressed before successful implementation in the pharmaceutical industry is feasible. This review explores the potential benefits and current use cases of blockchain in enabling drug traceability, establishing authenticity and integrity of data, facilitating smart contracts for seamless financial transactions, and optimizing overall supply chain operations. The current blockchain-based solutions employed by various stakeholders like drug manufacturers, wholesalers, distributors, retailers, hospitals, and regulators across the different stages of the pharmaceutical value chain are reviewed in this article. Recent research efforts to mitigate the key challenges are discussed, including technical improvements in blockchain architecture for increased security and privacy, the use of permissioned blockchains, innovative consensus protocols to improve scalability, and growing regulatory guidance. The future outlook highlights the tremendous opportunities for blockchain to enable end-to-end visibility, accountability, automation, real-time monitoring and combating counterfeiting in pharmaceutical supply chains through collaborative efforts among stakeholders.

Screening for Bacterial Vaginosis Prior to Delivery: A Cost-Effectiveness Study.

The objective of this study was to compare the cost and effectiveness of three strategies for screening and/or treating bacterial vaginosis (BV) during pregnancy prior to delivery: (1) the current standard of care was neither test nor treat for BV (Treat None); (2) test all patients for BV at 36 weeks' gestation; treat if positive (Test Treat); and (3) treat all patients undergoing cesarean delivery with intravenous metronidazole at time of surgery (Treat All Cesarean). Effectiveness was defined as avoidance of postpartum surgical site infection (SSI). A decision analytic cost-effectiveness model was designed from a third-party payer perspective using clinical and cost estimates obtained from the literature, American College of Surgeons National Surgical Quality Improvement Program participant use file (2005-2019), 2019 National Vital Statistics, Medicare costs, and wholesale drug costs. Cost estimates were inflated to 2020 U.S. dollars. For this study, effectiveness was defined as avoidance of postpartum SSIs. The base case analysis that is the current standard of care of not routinely testing and treating patients for BV (Treat None) was the most expensive and least effective strategy, with a mean cost of $59.16 and infection rate of 3.71%. Empirically treating all patients for BV without testing (Treat All Cesarean) was the most effective and the least expensive strategy, with a mean cost of $53.50 and an infection rate of 2.75%. Testing all patients for BV and treating those positive for BV (Test Treat) was also relatively inexpensive and effective, with an infection rate of 2.94% and mean cost of $57.05. Compared with Treat None, we would expect the Treat All Cesarean strategy to reduce the infection rate by 26%. These findings suggest that treating pregnant patients with intravenous metronidazole at time of cesarean delivery could be an effective and cost-saving strategy. Testing and treating for BV could also be considered a reasonable strategy, as it has the added benefit of preserving antibiotic stewardship. In no analysis was the standard of care strategy of neither testing nor treating for BV before delivery the preferred strategy. · BV colonization may increase surgical site infection risk after cesarean section.. · Treatment of BV before or during delivery may be cost-saving strategies as treatment could prevent costs associated with infection.. · Further study is needed to best balance the risk of surgical site infection with antibiotic stewardship..

Assessment of veterinary pharmaceutical warehouse management practices and its associated challenges in four selected zones and Bahir Dar city of Amhara regional state, Ethiopia.

A pharmaceutical warehouse is part of the pharmaceutical supply chain and is essential to maintaining the quality and efficacy of veterinary pharmaceuticals for successful animal health service delivery. However, poor storage conditions, improper handling, and inappropriate use and disposal constitute challenges for veterinary supplies in animal health services. Therefore, this study aimed to assess the existing practices and challenges in warehouse management in government veterinary clinics and private veterinary drug wholesalers in Ethiopia. A cross-sectional study was conducted on 37 veterinary health facilities in four selected zones (south Gondar, west Gondar, central Gondar, and west Gojam zones) and Bahir Dar administrative city. Zones were selected using a simple random sampling technique. Data was collected using a structured questionnaire, pre-defined and tested observational checklists, and semi-structured interview guides. Descriptive statistics were used to analyze the quantitative data, while qualitative data was analyzed using a thematic approach. The study revealed the presence of poor stock management practices, such as the absence of standard operating procedures for warehouse activities in ~59.5% of facilities surveyed. In none of the surveyed facilities, bin cards and system software utilization were satisfactory. The absence of disposal guidelines was detected in 83.8% of the facilities, and the practice of timely disposal of expired drugs was not satisfactory. Compared to the government veterinary clinics, private veterinary drug wholesalers had better storage practices (86.25%) following theoretical recommendations. The storage conditions in government clinics were rated poor at 48.3% (>80%, which is the limit to the acceptable rate for good storage conditions). The challenges of inadequate infrastructure, a lack of qualified staff, problems with the availability and affordability of pharmaceutical products, insufficient regulatory practice, and budget constraints were identified. A holistic approach involving related stakeholders should be followed to improve the existing challenges and the sector's efficiency.

External Factors That Affect Operational Performance: A Conceptual Model Development for Pharmaceutical Drug Wholesalers Companies in Bali, Indonesia

Pharmaceutical distributor companies or also known as PBF (Pharmaceutical Drug Wholesalers) play an important role in the distribution of pharmaceutical products in Indonesia. Without the role of PBF, the drug will not reach the patients from the manufacturer. The PBF appointed by the manufacturer to distribute the product, has operational performance targets that must be achieved. However, like other businesses, PBF operational performance is also affected by external factor, such as the Covid-19 pandemic. The purpose of this study was to analyze the impact of external factors, those are: Covid-19 pandemic, government regulations and the intensity of competition on the operational performance of PBF in Bali. This study uses the literature review method. Data analysis in the literature review involves compiling and presenting findings from various data sources that have been collected. The result of this research is a conceptual model that synergizes sales strategy and operational control as mediating and moderating variables to minimize the negative impact of external factors on operational performance. This research is expected to contribute to the field of strategic management, particularly related to the supply chain of pharmaceutical products.

Availability of Systemic Antifungals in Africa: A Comparative Study between North Africa and West Africa

Introduction. Due to the lack of systemic antifungals (SAs), many invasive fungal infections (IFIs) do not yet benefit from effective treatment in Africa. Yet, fungi are a major threat to human health. This study aimed to assess the availability of SAs and compare this availability between West Africa (WA) and North Africa (NA). Materials and methods. The information processed was obtained during the same period between February and June 2021 in Senegal, Mauritania, and Côte d’Ivoire as well as in Morocco and Tunisia. In WA, data were received from wholesale drug suppliers and private pharmacies while in NA, the data were those available on the websites of the pharmacy and drug directorates. Results. All classes of SAs were available. However, this availability was not uniform depending on location, whether in WA or NA. Fluconazole and itraconazole were the only SA available in WA. In NA, all classes of SAs have been found, particularly in Morocco, while flucytosine was the only molecule absent in Tunisia. Conclusion. NA is ahead of WA as regards the burden of IFIs both diagnostically and in the availability of SAs. Studies on the epidemiology of IFIs in Africa, particularly in WA, are limited. The partial data available highlight that IFIs are not negligible, though these may be underestimated. Thus, a network based on the directory of African pharmacy and drug directorates must be set up and run in collaboration with the national laboratory directorates for the harmonization of procedures in order to reduce morbidity and mortality related to IFIs.

ВЛИЯНИЕ ГОСУДАРСТВЕННЫХ ИНСТИТУЦИОНАЛЬНЫХ НОРМ НА УПРАВЛЕНИЕ АССОРТИМЕНТНОЙ ПОЛИТИКОЙ ОРГАНИЗАЦИЙ ОПТОВОЙ ТОРГОВЛИ ЛЕКАРСТВЕННЫМИ СРЕДСТВАМИ

Introduction. Continuous analysis of regulatory norms and their implementation is a significant factor that affects the efficiency of the wholesale segment of the pharmaceutical market in the dynamically evolving legal field. Aim. Summarize and analyze state institutional norms that affect the processes of managing the assortment policy of drug wholesalers in the modern pharmaceutical market. Material and Methods. The object of the study was the regulatory legal acts that influence the formation and management of the assortment policy in the wholesale segment of the pharmaceutical market. In the course of the work, methods of documentary observation and comparison, content analysis of legislative acts and regulatory legal documents were used. Results and discussion. It was revealed that the formation of the medicinal assortment is significantly influenced by institutional norms that determine the procedure for the circulation of medicines (state regulation of maximum selling prices, preferential provision of medicines for decreed groups of citizens, and others). It has been established that institutional norms, on the one hand, provide a guaranteed demand for pharmaceutical products of a reduced range, and on the other hand, limit profits due to state regulation of selling prices. However, the share of goods of this assortment does not exceed 15-20% in terms of the number of inventory units and 25% in terms of wholesale sales, which allows us to provide a stable, complete assortment with a high turnover and profitable commercial activity. Conclusion. Thus, state institutional norms have a significant impact on the formation of the product range of Russian pharmaceutical distributors, but this does not undermine the profitability of their economic activities and ensures the social responsibility of the business.

Analysis of Wholesale Drug Acquisition and Laboratory Assessment Costs Between Heparin Compared With Bivalirudin-Based Systemic Anticoagulation Strategies in Adult Extracorporeal Membrane Oxygenation.

To assess the wholistic costs of systemic anticoagulation delivery in heparin versus bivalirudin-based maintenance of adult patients supported on extracorporeal membrane oxygenation (ECMO). Single-center retrospective cohort study. Large academic ECMO center. Adults on ECMO receiving heparin or bivalirudin for primary maintenance systemic anticoagulation. None. Electronic data were abstracted from a database maintained by our ECMO center, which transitioned to a preferred bivalirudin-based anticoagulation management in 2017. The pretransition group consisted of 126 patients (123 heparin and three bivalirudin), whereas the posttransition group included 275 patients (82 heparin and 193 bivalirudin). Drug costs were estimated using the wholesale acquisition cost, and laboratory assays costs were estimated using reimbursement fee schedules. Cost data were normalized to the duration of the ECMO run and reported in U.S. Dollar per ECMO day. Following the practice change, bivalirudin patients were less likely to receive AT supplementation (31.0 vs 12.4%; p < 0.0001) and had fewer coagulation assays ordered (6.1 vs 5.4 per ECMO day; p = 0.0004). After the transition, there was a dramatic decrease in costs related to AT assay assessments ($11.78 [interquartile range {IQR}, $9.48-$13.09] vs $1.03 [IQR, $0-$5.75]; p < 0.0001) and AT supplementation ($0 [IQR, $0-$312.82] vs $0 [IQR, $0-$0]; p < 0.0001) per ECMO day. Unadjusted survival at 28 days was higher posttransition (64.3 vs 74.9%; p = 0.0286). Antithrombin assays and supplementation compromise a significant proportion of heparin-based anticoagulation costs in ECMO patients and is substantially reduced when a bivalirudin-based anticoagulation strategy is deployed. A favorable association exists between the aggregate cost of administration of bivalirudin compared with heparin-based systemic anticoagulation in adults supported on ECMO driven by reductions in antithrombin activity assessments and the cost of antithrombin replacement.

Determinants of operational performance of pharmaceutical wholesalers’ companies in Bali province

Pharmaceutical distribution companies or also known as Pharmaceutical Drug Wholesalers (PBF) play a significant role in the distribution of pharmaceutical products in Indonesia. Without the role of PBF, the drug will not reach the patients from the manufacturer. The PBF appointed by the manufacturer to distribute the product, has operational performance targets that must be achieved. However, like other businesses, PBF operational performance is also affected by external factors, such as the COVID-19 pandemic, government regulations and competition intensity. The impact of internal factors such as limited company resources is also investigated in this research. This research tries to explore the impact of external factors, those are: the pandemic of COVID-19, government regulations, competition intensity and internal factors that are the company's limited resources to PBF operational performance. Sales strategy is also used as mediating variables from external and internal factors to operational performance, thus operational control as moderating variable from sales strategy to operational performance respectively. Data collection was obtained by questionnaires and interviews with 44 PBF operational leaders in Bali, Indonesia. Data analyzing using SmartPLS 3.0. The COVID-19 pandemic, government regulations, competition intensity and company’s limited resources have a negative impact on the company's operational performance. Sales strategy serves as a mediating variable from external and internal factors to operational performance. Operational control plays a significant role in moderating sales strategy and the performance of operational. The theoretical implication of this research is to enhance The Contingency Theory, which claims that the business environment, strategy, and control are three major contingency elements that are linked. The findings of this study also strengthen the concept of Transaction Cost Theory, which states that the relationship between the parties in a transaction is associated with rights and obligations that are poured into a very detailed agreement. The operational performance required by the principal to PBF is also included in the agreement and PBF should strive to achieve that operational performance.

Brief Report: Financial Burden of Toxoplasmosis Encephalitis Treatment at a Safety Net Hospital.

Although the price increase of pyrimethamine in 2015 received heavy media coverage, there are little data regarding specific implications to hospitals and the total costs of treating inpatients with toxoplasmosis encephalitis (TE). Using average drug wholesale costs, we estimated the inpatient drug costs of TE drugs 3 years prepyrimethamine and postpyrimethamine price increase in August 2015. The drug regimens and total doses were determined through retrospective chart review of patients living with HIV who received treatment for TE while inpatient during this period. The 3-year pre-increase TE drug costs for 66 admissions were estimated at $50,310 compared with a total drug cost of $1,026,006 for 61 admissions postincrease. Pyrimethamine made up 98% of the drug costs postincrease, compared with 57% pre-increase. Pyrimethamine-based regimens were the most frequently used throughout the study period. The price increase of pyrimethamine in 2015 led to a substantial and unnecessary financial burden to hospitals. This required health care systems to shift valuable resources to continue to provide medications to a vulnerable patient population. There has been more focus on providing high-value care in recent years. Our study highlights the need for further examination of pharmaceutical companies' arbitrary determination of medication costs and how they contribute to patient care.

Pharmaceutical pollution: Prediction of environmental concentrations from national wholesales data.

The regulation and monitoring of pharmaceutical pollution in Europe lag behind that of more prominent groups. However, the repurposing of sales data to predict surface water environmental concentrations is a promising supplement to more commonly used market-based risk assessment and measurement approaches. The Norwegian Institute of Public Health (NIPH) has since the 1980s compiled the Drug Wholesale Statistics database - covering all sales of both human and veterinary pharmaceuticals to retailers, pharmacies, and healthcare providers. To date, most similar works have focused either on a small subset of Active Pharmaceutical Ingredients (APIs) or used only prescription data, often more readily available than wholesale data, but necessarily more limited. By using the NIPH's product wholesale records, with additional information on API concentrations per product from, we have been able to calculate sales weights per year for almost 900 human and veterinary APIs for the period 2016-2019. In this paper, we present our methodology for converting the provided NIPH data from a public health to an ecotoxicological resource. From our derived dataset, we have used an equation to calculate Predicted Environmental Concentration per API for inland surface waters, a key component of environmental risk assessment. We further describe our filtering to remove ecotoxicological-exempt and data deficient APIs. Lastly, we provide a limited comparison between our dataset and similar publicly available datasets for a subset of APIs, as a validation of our approach and a demonstration of the added value of wholesale data. This dataset will provide the best coverage yet of pharmaceutical sales weights for an entire nation. Moreover, our developed routines for processing 2016-2019 data can be expanded to older Norwegian wholesales data (1974-present). Consequently, our work with this dataset can contribute to narrowing the gap between desk-based predictions of exposure from consumption, and empirical but expensive environmental measurement.

Court tackles opioid diversion and where blame lies

Court tackles opioid diversion and where blame lies

Pharmaceutical pollution: Prediction of environmental concentrations from national wholesales data

The regulation and monitoring of pharmaceutical pollution in Europe lag behind that of more prominent groups. However, the repurposing of sales data to predict surface water environmental concentrations is a promising supplement to more commonly used market-based risk assessment and measurement approaches. The Norwegian Institute of Public Health (NIPH) has since the 1980s compiled the Drug Wholesale Statistics database - covering all sales of both human and veterinary pharmaceuticals to retailers, pharmacies, and healthcare providers. To date, most similar works have focused either on a small subset of Active Pharmaceutical Ingredients (APIs) or used only prescription data, often more readily available than wholesale data, but necessarily more limited. By using the NIPH’s product wholesale records, with additional information on API concentrations per product from, we have been able to calculate sales weights per year for almost 900 human and veterinary APIs for the period 2016–2019. In this paper, we present our methodology for converting the provided NIPH data from a public health to an ecotoxicological resource. From our derived dataset, we have used an equation to calculate Predicted Environmental Concentration per API for inland surface waters, a key component of environmental risk assessment. We further describe our filtering to remove ecotoxicological-exempt and data deficient APIs. Lastly, we provide a limited comparison between our dataset and similar publicly available datasets for a subset of APIs, as a validation of our approach and a demonstration of the added value of wholesale data. This dataset will provide the best coverage yet of pharmaceutical sales weights for an entire nation. Moreover, our developed routines for processing 2016–2019 data can be expanded to older Norwegian wholesales data (1974–present). Consequently, our work with this dataset can contribute to narrowing the gap between desk-based predictions of exposure from consumption, and empirical but expensive environmental measurement.

Budget Impact of Keytruda for the Treatment of Patients with Recurrent or Metastatic (R/M) and Locally Advanced (LA) Cutaneous Squamous Cell Carcinoma (cSCC) in the United States

<h3>Purpose/Objective(s)</h3> cSCC is a type of non-melanoma skin cancer and represents 20% of skin cancer deaths. When not cured by local therapy, cSCC is associated with mortality rates exceeding 70%. KEYTRUDA, an immuno-oncology therapy, was recently approved by the FDA for the treatment of patients with R/M and LA cSCC that is not curable by surgery or radiation. The objective of this study was to estimate the budget impact of adding KEYTRUDA to a US healthcare plan formulary as a therapy in advanced cSCC. <h3>Materials/Methods</h3> A budget impact model (3-year time horizon) was developed to compare the direct costs of treating R/M and LA cSCC patients with and without the introduction of KEYTRUDA. Comparators included commonly used systemic therapies (cemiplimab-rwlc, cetuximab, cisplatin + paclitaxel and cisplatin + 5-fluorouracilMT). Market shares were estimated from market research data for comparators, and assumed for KEYTRUDA as follows: 30%, 36%, 42% in R/M; and 13%, 15%, 18% in LA for years 1-3 respectively. Costs included drug Wholesale Acquisition Cost, administration, monitoring and Grade 3-5 adverse event management costs. A one-way sensitivity analysis and two scenario analyses (including Q6W schedule for KEYTRUDA, and equal KEYTRUDA and cemiplimab-rwlc treatment durations) were conducted. <h3>Results</h3> In a hypothetical 1 million member health plan, the number of R/M and LA cSCC patients were 60/60/61 and 52/52/53, respectively in years 1-3. Of these, 18/22/25 (R/M) and 7/8/9 (LA) patients receive KEYTRUDA in years 1-3. In R/M cSCC, KEYTRUDA was associated with cost savings of $1.967m over 3 years. In LA cSCC, KEYTRUDA resulted in a 3-year budget impact of $0.425m. In total, the adoption of KEYTRUDA in cSCC population was projected to lead to cost savings of $1.541m over 3 years (7% decrease). The cost saving was driven by the shorter treatment duration of KEYTRUDA versus cemiplimab-rwlc resulting in decreased drug acquisition, administration, and monitoring costs, and a less costly safety profile of KEYTRUDA versus chemotherapies. Sensitivity and scenario analyses indicate sensitivity to time on treatment assumptions. <h3>Conclusion</h3> The introduction of KEYTRUDA for R/M and LA cSCC patients in a hypothetical plan of 1 million members is projected to lead to budgetary savings of 7% over three years. Results are most sensitive to assumed time on treatment.

THEORETICAL BASIS OF FORMATION AND MANAGEMENT OF THE COMMODITY ASSORTMENT OF THE ORGANIZATION OF WHOLESALE TRADE OF MEDICINES

Abstract: For Russian drug wholesalers (pharmaceutical distributors), the study of the profitability of a range of goods and services is becoming increasingly important. This is due to a number of specific conditions for the functioning of the pharmaceutical market, namely, its territorial scope; high level of competition in the wholesale segment; significant influence of government regulation on pharmaceutical activities in general and assortment policy management, in particular. The purpose of the study was to analyze the scientific and methodological foundations for the formation of a product range and management of the assortment policy in the wholesale segment of the pharmaceutical market. The methods of bibliographic and content analysis, analytical, direct observation and comparison were used as the scientific apparatus of the research. From the beginning of its formation to the present time, the Russian pharmaceutical market has a range of socio-economic, geographical, logistic and other features that have led to the formation of a powerful network of pharmaceutical distributors characterized by a high level of competition. The purpose of the assortment policy is to form the optimal product assortment of the organization for solving its strategic market goals, depending on the current and future needs of the market. One of the mechanisms for the formation of a product range in a wholesale organization is the development of an assortment matrix - a complete assortment list of goods corresponding to the required width and depth of product filling. An analysis of the regulatory legal regulation of the sphere of circulation of medicines shows that the process of forming the drug assortment is significantly influenced by institutional norms, which, on the one hand, provide a guaranteed demand for medicines to provide privileged categories of citizens and a minimum pharmaceutical assortment, and on the other hand, they limit profitability, due to state regulation of selling prices, as well as the growth of costs for their logistics and maintenance in stocks.As a result of the study, it was found that the scientific and methodological foundations of assortment policy management, based on planning, organization and control, including permanent structural analysis of consumer demand, adequate inventory management and marketing analysis of the pharmaceutical market, allow to optimize the financial results of a pharmaceutical distributor in an intensely competitive environment.

Marketing and Distribution System Foster Misuse of Antibiotics in the Community: Insights from Drugs Wholesalers in India.

Antibiotic misuse is one of the major drivers of antimicrobial resistance (AMR). In India, evidence of antibiotic misuse comes largely from retailers as well as formal and informal healthcare providers (IHCPs). This paper presents the practices and perspectives of drug wholesalers, a critical link between manufacturers and last-mile dispensers. Four experienced wholesalers and an ex-State Drug Controller (ex-SDC) were interviewed in depth, using semi-structured guides in the National Capital Region of Delhi, India, between November 2020 and January 2021. Four main findings were that wholesalers (i) have limited knowledge about wholesale licensing and practice regulations, as well as a limited understanding of AMR; (ii) directly supply and sell antibiotics to IHCPs; (iii) facilitate medical representatives (MRs) of pharmaceutical companies and manufacturers in their strategies to promote antibiotics use in the community; and (iv) blame other stakeholders for unlawful sale and overuse of antibiotics. Some of the potential solutions aimed at wholesalers include having a minimum education qualification for licensing and mandatory Good Distribution Practices certification programs. Decoupling incentives by pharmaceutical companies from sales targets to improve ethical sales practices for MRs and optimize antibiotic use by IHCPs could alleviate wholesalers’ indirect actions in promoting antibiotic misuse.

Estimation of the Share of Net Expenditures on Insulin Captured by US Manufacturers, Wholesalers, Pharmacy Benefit Managers, Pharmacies, and Health Plans From 2014 to 2018

Recent US media and policy attention on insulin affordability has focused on the role of manufacturers in setting prices; however, the role of other drug distribution intermediaries in determining prices has received less attention. To estimate the share of net expenditures on insulin captured by manufacturers, wholesalers, pharmacy benefit managers, pharmacies, and health plans from 2014 to 2018. This cross-sectional study of the US insulin market was conducted in 2020 using 2014-2018 data from multiple sources, including list and estimated net prices from SSR Health for 32 insulin products, mean use weights from a commercial pharmacy claims database, mean acquisition costs and reimbursements from the Centers for Medicare & Medicaid Services, mean spread and share of rebates retained by pharmacy benefit managers from state Medicaid and drug transparency reports, and profit margins from the public filings of distribution system participant companies. Participants were insulin manufacturers, drug wholesalers, pharmacies, pharmacy benefit managers, and health plans. Mean list and net insulin prices, mean net expenditures on insulin, share of expenditures retained by each distribution system participant. Between 2014 and 2018, mean list prices of 32 insulin products increased by 40.1% (from $19.60 to $27.45), while mean net prices received by manufacturers decreased by 30.8% (from $10.53 to $7.29). Net expenditures per 100 units of insulin increased by 3.2% (from $15.11 to $15.59) while the share of a hypothetical $100 insulin expenditure accruing to manufacturers decreased by 33.0% (from $69.71 to $46.73) and the share accruing to health plans decreased by 24.7% (from $13.82 to $10.40). The share of insulin expenditures retained by pharmacy benefit managers increased by 154.6% (from $5.64 to $14.36), the share retained by pharmacies increased by 228.8% (from $6.21 to $20.42), and the share retained by wholesalers increased by 74.7% (from $4.63 to $8.09). Results of this cross-sectional study of the distribution of insulin expenditures suggest that policies to control insulin costs should consider all entities throughout the insulin distribution system. Manufacturers represented a decreasing share of insulin expenditures, and pharmacies, pharmacy benefit managers, and wholesalers accounted for a growing share; all entities play a role in increasing insulin costs.

Cost per Responder Analysis for Pegcetacoplan and Eculizumab in the Treatment of Adults with Paroxysmal Nocturnal Hemoglobinuria

Background: In the absence of clinical guidelines for paroxysmal nocturnal hemoglobinuria (PNH), the European Society for Blood and Marrow Transplantation (EBMT) developed categories for classifying hematological response to complement inhibitor treatment (per Risitano AM, et al. Front Immunol. 2019;10:1157). These categories are: complete (no transfusions, normal stable Hb, and no evidence of hemolysis); major (no transfusions, normal Hb, but evidence of residual intravascular/extravascular hemolysis); good (no transfusions, but persistent chronic mild anemia); partial (persistent chronic moderate anemia and/or occasional red blood cell transfusions); minor (3-6 transfusions every 6 months); no response (>6 transfusions every 6 months). In the phase 3 PEGASUS trial (NCT03500549), 41 and 39 patients previously treated with C5 inhibitors with Hb<10.5 were randomized for treatment with pegcetacoplan or eculizumab, respectively. In a post hoc analysis of the 16-week PEGASUS data, patients were classified by EBMT category to compare hematologic responses of each treatment (per Risitano AM, et al. Blood. 2020; 136(Suppl1):44-5).Objectives: The objective of this study was to evaluate the number needed to treat (NNT) and treatment costs of pegcetacoplan and eculizumab using EBMT response criteria.Methods: The analysis used a United States payer perspective and included drug acquisition costs and associated intravenous or subcutaneous administration costs. Drug costs were calculated using dosages for each treatment as given in the PEGASUS trial, including dosage and frequency escalations. Weekly dosages were multiplied by each drug's wholesale acquisition costs from RedBook (2020 United States dollars). We calculated the following outcomes over 16 weeks and by treatment: NNT to achieve each level of response, mean cost per treated patient, total costs, mean cost per treated patient per week, cost per complete responder, cost per good responder, and cost spent on patients with partial/minor/no response.Additional analyses were conducted to calculate outcomes for treatment-naïve patients treated with pegcetacoplan using similar post hoc analyses of combined 16-week data from the phase 1b-2a PADDOCK/PALOMINO (NCT02588833 and NCT03593200) trials.Results: Results are summarized in Table 1. Based on response rates, patients with PNH treated with pegcetacoplan had a lower NNT (1.4) to achieve good-to-complete response compared with eculizumab (19.5). NNT to achieve complete response was 2.6 for pegcetacoplan; no patients treated with eculizumab achieved complete response at 16 weeks.For the PEGASUS trial, mean cost per treated patient was $182,762 (with C5 inhibitor loading dose) and $176,504 over 16 weeks for pegcetacoplan and eculizumab, respectively. Among the 41 pegcetacoplan-treated patients, the total costs were $7,493,256 over 16 weeks. Of 41 pegcetacoplan patients, 16 achieved a complete response, and their total costs were $2.9 million over the 16-week period ($468,328 per complete responder). The total 16-week costs were $2.6 million for 14 patients with good response ($535,233 per good responder). For the 39 eculizumab-treated patients, total 16-week costs were $6,883,637. Two of 39 patients achieved a good response, and their total costs were $353,007 ($3,441,818 per good responder). Of the 39 patients, 37 achieved partial, minor, or no response or discontinued treatment, for a total cost of $6.5 million. This resulted in 95% of total treatment costs being spent on inadequate or no response in the eculizumab arm compared with 27% in the pegcetacoplan arm.For treatment-naïve patients treated with pegcetacoplan, the mean cost per complete responder ($347,339) and per good responder ($496,198) over 16 weeks were both lower than the cost per responder for patients treated with either pegcetacoplan or eculizumab after previous C5 inhibitor treatment.Conclusion: Based on the treatment response observed in PEGASUS, the NNT and cost to achieve good or good-to-complete response was lower for pegcetacoplan-treated patients than eculizumab-treated patients, according to EBMT consensus-based hematological response categories. PNH treatment with pegcetacoplan allowed more patients to achieve EBMT defined good-to-complete response and better overall response and is a more efficient use of spending with lower cost per responder in all response categories. [Display omitted] DisclosuresAnderson: Apellis: Consultancy, Research Funding. Talbird: Apellis: Consultancy, Research Funding. Fishman: Apellis: Current Employment, Current equity holder in publicly-traded company.