Gluten-Free Product Recalls and Their Impact on Consumer Trust.

The range of gluten-free food products available to consumers is steadily expanding. In recent years, recalls of food products have highlighted the importance of accurate labeling of food products for the presence of wheat, other gluten-containing cereals, or gluten itself as refined ingredient. The purpose of this study was to gain more insights into recent food recalls related to undeclared gluten/wheat contamination and consumer experiences with these recalls. Recalls of products triggered by gluten contamination are relatively scarce and are not often triggered by a consumer complaint. The impact of these recalls on consumer trust was evaluated through an online survey that was distributed among supporters of Celiac Canada (CCA) and covered (i) strategies to adhere to a gluten-free diet, (ii) experiences with gluten-free recalls and their impact on consumer trust, and (iii) demographic information. Consumer concern regarding gluten-free product recalls is significant, but the concern regarding recalls is not heightened after experiencing a recall. Companies pursuing transparency in the process, identification of the source of contamination, and mitigation strategies going forward are likely to retain consumer trust in their product and brand. Based on the survey results, further efforts focusing on consumer education regarding interpreting nutrient labels, identifying sources of information on product recalls, and understanding procedures to follow upon suspected gluten contamination of a gluten-free product are recommended.

Stock market reaction to product-harm crisis response strategies.

Product-harm crises have detrimental effects on firm's sales, reputation, and financial value, requiring crisis managers to promptly adopt appropriate response strategies to mitigate these impacts. Situational Crisis Communication Theory (SCCT) guides managers to align responsibility attribution with response strategies. Using Chinese listed firms' product-harm crises sample from 2015 to 2021, this study analyzes the stock market's reaction to different response strategies. The event study method reveals that a passive strategy is more effective during the disclosure stage, and accept+no recall and deny+recall are conforming strategies during the initial response stage. Additionally, firms with a crisis history should assume greater responsibility when developing response strategies for product-harm crises, as crisis history amplifies negative effects. The results provide recommendations to help managers formulate appropriate strategies.

Evaluating the impact of single exit pricing (SEP) on medicine product withdrawal from the private healthcare market in South Africa.

BACKGROUND: The introduction of medicine pricing policies in South Africa (SA) in the form of single exit pricing (SEP) provided a mechanism to improve medicine price transparency and reduce the medicine price and inflation. However, regulation of medicine prices may have further unforeseen effects on the availability of medicine. This research presents the impact of SEP on discontinuation of medicine products on the private healthcare market in SA. OBJECTIVES: To evaluate the impact of SEP legislation on the availability of medicines in the SA private health sector in terms of withdrawal of medicines from the market. METHODS: A descriptive, quantitative analysis of all registered medicines on the SA market by stock-keeping units (SKUs) was done to establish medicine products that were withdrawn from the market by SKUs during a 14-year period (2001 - 2014). RESULTS: A total of 152 manufacturers discontinued 3 691 SKUs between 2001 and 2014. The mean number of discontinuations per generic manufacturer was 22.34 (standard deviation (SD) 58.11), while innovator manufacturers discontinued a mean of 27.61 (41.89). The largest number of SKUs were commercially withdrawn in 2002 (n=603), followed by discontinuations in 2003 (n=463) and 2004 (n=407). There was a negative correlation between number of discontinued SKUs per year and SEP increase (Pearson's correlation coefficient r ‒0.414; p=0.14). The results showed that SEP and a transparent pricing policy may have had an impact on SKU withdrawal from the market prior to SEP implementation. CONCLUSIONS: The result of reduced product availability on the market and its impact on the cost and quality of healthcare to the patient need to be regularly monitored and evaluated to ascertain if direct price regulations achieve the intended outcomes. Other intended or unintended effects on pharmaceutical market dynamics should also be evaluated.

Impact of angiotensin receptor blocker product recalls on antihypertensive prescribing in Germany.

In Germany, ~8 million patients take angiotensin receptor blockers (ARBs) and 2.25 million of them valsartan. In 2018, contamination of generic ARBs with probable carcinogenic nitrosamines resulted in more than 30 recalls. The impact of such a huge recall has never been explored in Europe. We analyzed the utilization of valsartan, all ARBs, and other alternative antihypertensive drugs in Germany. We used our database of anonymized dispensing data from >80% of community pharmacies at the expense of the statutory health insurance (SHI) funds from January 2017 to December 2019. We analyzed 290.8 million prescriptions, including all oral mono- and fixed-dose combinations of ARBs and plausible alternatives, i.e. ACE inhibitors (ACEi), beta-blockers (BB), and calcium channel blockers (CCB). Utilization was calculated by defined daily doses per 1000 SHI-insured persons per day (DID). Valsartan use decreased substantially after the recalls in July 2018 from 39.0 to 14.2 DID (-64%) in the second quarter of 2019 and to 16.9 DID (-57%) in the fourth quarter of 2019. Simultaneously, the use of alternative ARBs increased from 77.7 DID in the second quarter of 2018 to 121.9 DID (+57%) in the fourth quarter of 2019, mainly due to an increase of candesartan dispensing to 99.8 DID (+73%). There were no changes in the utilization of ACEi, BB, or CCB. The majority of recalled generic valsartan products were replaced by other ARBs, predominantly candesartan, despite documented drug shortages. In contrast to previous safety warnings/recalls, our data do not suggest an under-prescription of antihypertensives during this period.

Inferences and Legal Considerations Following a Blood Collection Tube Recall.

In mid-2019, medical, forensic and legal communities were notified that a certain shipment of evacuated blood sampling tubes were recalled by the manufacturer. This recall order described that the preservative sodium fluoride (100 mg) and anticoagulant potassium oxalate (20 mg) were missing from a small batch of 10-mL evacuated tubes. This gave cause for concern for possible implications in criminal justice (e.g., in drink-driving offenses) when blood-alcohol concentrations are interpreted. In reality, the lack of an anticoagulant would have been immediately obvious during sample preparation, owing to the formation of a large clot in the tube when received. Certain impairing drugs (e.g., cocaine and 6-acetylmorphine) are unstable in blood and tend to degrade without an enzyme inhibitor, such as sodium fluoride, present. In reviewing available literature related to current practices and the stability of ethanol in stored blood samples, there does not appear to be a clear consensus regarding the amount of sodium fluoride preservative necessary, if any at all, when blood is taken from living subjects under sterile conditions for typical forensic ethanol analysis.

Management of Blood Product Market Withdrawals - A Single Institution's Process and Experience.

OBJECTIVE: While lookback investigations follow specific Food and Drug Administration (FDA) requirements, the management of blood product market withdrawals from suppliers varies widely. Follow-up data are limited, prompting this analysis of the types and reasons for recipient notification and their outcomes. METHODS: A single institution retrospective review of market withdrawal and lookback files from 2012-2015 included product type, reason, FDA category, notification, and turnaround time. Descriptive statistics and chi-square analysis were performed. RESULTS: Over 4 years, 796/229,549 (0.35%) blood components were implicated in supplier notifications, including market withdrawals (84.3%) and lookbacks (15.7%). Seventy-nine cases resulted in patient notification. 97% of patient notifications were achieved within 3 months. Plasma with human leukocyte antigen antibodies was the most common reason for withdrawal (20.5%). Category 1 notifications were the most commonly reported by this transfusion service, apart from in 2015 when category 4 notifications were highest. Over four years, the proportion of notifications by category remained relatively stable. CONCLUSIONS: Market withdrawal investigations involve significant effort to review, document, and appropriately notify. Standardized management and centralized reporting of recipient notification of market withdrawals may improve this process.

Bretylium, a Class III Antiarrhythmic, Returns to the Market.

Bretylium, with an extensive pharmacologic and medicinal history, was approved by the United States Food and Drug Administration in 1986 for "short-term prevention and treatment of ventricular fibrillation (VF) and treatment of life-threatening ventricular arrhythmias and ventricular tachycardia (VT) unresponsive to adequate doses of a first-line antiarrhythmic agent, such as lidocaine." The NDA sponsor withdrew bretylium from the market in 2011, largely due to unavailability of raw materials required for its production; prior to this, bretylium was removed from the 2000 ACLS Guidelines algorithm for VF/pulseless VT given the challenges obtaining raw materials for drug manufacture. Recently, bretylium has been reintroduced into the US market by a generic pharmaceutical company with the same indications as before. This article provides a history of the salient trials evaluating the efficacy and safety of bretylium and looks to the future as bretylium finds its place in the modern day management of ventricular arrhythmia.

Associations between recalled use of legal UK youth gambling products and adult disordered gambling.

BACKGROUND AND AIMS: The UK allows a number of gambling products to be legally used by people under the age of 18. The aim of this study was to explore associations between recalled legal usage of five youth gambling products and adult disordered gambling. METHODS: A retrospective cross-sectional study of 1,057 adult UK gamblers, aged 18-40. Recalled legal use of five youth gambling products (category D fruit machines, coin push machines, crane grab machines, the National Lottery, and National Lottery scratchcards) was correlated with adult disordered gambling symptoms as measured by the Problem Gambling Severity Index (PGSI). RESULTS: Recalled rates of legal engagement with each product ranged from 50.9% for Category D fruit machines to 96.6% for coin push machines. For category D fruit machines, the National Lottery, and National Lottery scratchcards, merely having legally engaged with these products as a child was associated with adult disordered gambling. Furthermore, higher levels of recalled legal youth usage with each of the five products was also associated with adult disordered gambling. DISCUSSION AND CONCLUSIONS: These results relate to recent government proposals to increase the National Lottery scratchcard legal age to 18, and add to a wider literature on youth gambling and subsequent gambling-related harm.

[Is there life after teduglutide?] / ¿Hay vida después de teduglutida?

INTRODUCTION: Intestinal failure (IF) is defined as a reduction in intestinal function below the minimum necessary for the absorption of nutrients, requiring intravenous supplementation to maintain health and/or growth. The most common cause is short bowel syndrome (SBS). Approximately 50% of patients with SBS have IF and require parenteral support. Teduglutide is a human glucagon-like peptide-2 analogue (GLP-2) approved for the treatment of patients with SBS. Clinical trial results have proven its efficacy by reducing volume and days of administration of parenteral nutrition and fluid therapy. Few publications evaluate the effects on long-term bowel function in respondent patients after teduglutide suspension. A patient with type I SBS (terminal jejunostomy) due to multiple surgeries for Crohn's disease, who was treated with liraglutide for one year and sequential teduglutide for 21 months, is described. With the former, a reduction in the need for contribution and debit by jejunostomy was observed. The GLP-2 analogue achieved a greater reduction in the hydric disbalance that allowed the suspension of the nocturnal suerotherapy, with weight gain and maintenance of nutritional parameters; situation maintained two years after its suspension.

INTRODUCCIÓN: El fallo intestinal se define como una reducción de la función intestinal por debajo del mínimo necesario para la absorción de nutrientes y que precisa suplementación intravenosa para mantener la salud y/o el crecimiento. La causa más frecuente es el síndrome de intestino corto. Aproximadamente el 50% de pacientes con SIC presenta FI y requiere soporte parenteral. Teduglutida es un análogo del péptido-2 similar al glucagón (GLP-2) humano aprobado para el tratamiento de pacientes con SIC. Los resultados de ensayos clínicos han probado su eficacia: se reducen el volumen y los días de administración de nutrición parenteral y fluidoterapia. Pocas publicaciones evalúan los efectos sobre la función intestinal a largo plazo en pacientes respondedores tras la suspensión de teduglutida. Se describe un paciente con SIC tipo I (yeyunostomía terminal) debido a múltiples intervenciones quirúrgicas por enfermedad de Crohn, que recibió tratamiento con liraglutida un año y teduglutida secuencial durante 21 meses. Con el primero, se objetivó una reducción en la necesidad de aporte y débito por yeyunostomía. El análogo del GLP-2 consiguió una mayor reducción del desequilibrio hídrico que permitió suspender sueroterapia nocturna, con ganancia ponderal y mantenimiento de parámetros nutricionales, situación mantenida dos años después de su suspensión.

A cross-sectional study of prevalence, distribution, cause, and impact of blood product recalls in the United States.

Defective blood products that are recalled because of safety or potency deviations can trigger adverse health events and constrict the nation's blood supply chain. However, the underlying characteristics and impact of blood product recalls are not fully understood. In this study, we identified 4700 recall events, 7 reasons for recall, and 144 346 units affected by recalls. Using geospatial mapping of the newly defined county-level recall event density, we discovered hot spots with high prevalence and likelihood of blood product recall events. Distribution patterns and distribution distances of recalled blood products vary significantly between product types. Blood plasma is the most recalled product (87 980 units), and leukocyte-reduced products (34 230 units) are recalled in larger numbers than non-leukocyte-reduced products (8076 units). Donor-related reasons (92 382 units) and sterility deviations (22 408 units) are the major cause of blood product recalls. Monetary loss resulting from blood product recalls is estimated to be $17.9 million, and economic sensitivity tests show that donor-related reasons and sterility deviations contribute most to the overall monetary burden. A total of 2.8 million days was required to resolve recall events, and probabilistic survival time analysis shows that sterility deviations and contamination took longer to resolve because of their systemic effect on blood collection and processing. Our studies demonstrate that better donor screening procedures, rigorous sterility requirements, improved containment methods, and mitigation of recall events in high-prevalence regions will enable a more robust blood supply chain.

Formulating an Ethics of Pharmaceutical Disinvestment.

There is growing interest among pharmaceutical policymakers in how to "disinvest" from subsidized medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidized on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics literature in order to identify ethical principles and concepts that might be relevant to pharmaceutical disinvestment decisions. This revealed a number of key ethical considerations-both procedural and substantive-that need to be considered when making pharmaceutical disinvestment decisions. These principles do not, however, provide practical guidance so we present a framework outlining how they might be applied to different types of disinvestment decisions. We also argue that, in this context, even the most rigorous ethical reasoning is likely to be overridden by moral intuitions and psychological biases and that disinvestment decisions will need to strike the right balance between respecting justifiable moral intuitions and overriding unjustifiable psychological impulses.

Outbreak of Listeriosis in South Africa Associated with Processed Meat.

BACKGROUND: An outbreak of listeriosis was identified in South Africa in 2017. The source was unknown. METHODS: We conducted epidemiologic, trace-back, and environmental investigations and used whole-genome sequencing to type Listeria monocytogenes isolates. A case was defined as laboratory-confirmed L. monocytogenes infection during the period from June 11, 2017, to April 7, 2018. RESULTS: A total of 937 cases were identified, of which 465 (50%) were associated with pregnancy; 406 of the pregnancy-associated cases (87%) occurred in neonates. Of the 937 cases, 229 (24%) occurred in patients 15 to 49 years of age (excluding those who were pregnant). Among the patients in whom human immunodeficiency virus (HIV) status was known, 38% of those with pregnancy-associated cases (77 of 204) and 46% of the remaining patients (97 of 211) were infected with HIV. Among 728 patients with a known outcome, 193 (27%) died. Clinical isolates from 609 patients were sequenced, and 567 (93%) were identified as sequence type 6 (ST6). In a case-control analysis, patients with ST6 infections were more likely to have eaten polony (a ready-to-eat processed meat) than those with non-ST6 infections (odds ratio, 8.55; 95% confidence interval, 1.66 to 43.35). Polony and environmental samples also yielded ST6 isolates, which, together with the isolates from the patients, belonged to the same core-genome multilocus sequence typing cluster with no more than 4 allelic differences; these findings showed that polony produced at a single facility was the outbreak source. A recall of ready-to-eat processed meat products from this facility was associated with a rapid decline in the incidence of L. monocytogenes ST6 infections. CONCLUSIONS: This investigation showed that in a middle-income country with a high prevalence of HIV infection, L. monocytogenes caused disproportionate illness among pregnant girls and women and HIV-infected persons. Whole-genome sequencing facilitated the detection of the outbreak and guided the trace-back investigations that led to the identification of the source.