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Therapeutic Innovation & Regulatory... Jul 2024This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of...
PURPOSE
This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects.
METHODS
A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between 2017 and December 2022. The study included recalls of registered and unregistered drugs posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on relevant variables: recall year, therapeutic class, recall type, pharmaceutical company type, recall reasons and voluntary or involuntary product defect reports.
RESULTS
During the study period, a total of 371 products were recalled, with the majority being involuntary recalls (82.4%). About two-thirds of the recalls (66.0%) were related to registered products. The most common reasons for recalls were non-compliance with the manufacturer's specifications (33.2%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recalls of defective products. Innovator pharmaceutical companies requested voluntary recalls more often than generic pharmaceutical companies.
CONCLUSION
The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Significantly, more innovative pharmaceutical companies request voluntary recalls for product defects compared to generic pharmaceutical companies.
Topics: Saudi Arabia; Drug Recalls; Retrospective Studies; Humans; Drug Industry; Product Recalls and Withdrawals
PubMed: 38546962
DOI: 10.1007/s43441-024-00635-4 -
Patient Education and Counseling Jun 2024The U.S. Food and Drug Administration (FDA) currently regulates more than 190,000 different medical devices. Like all products, these devices may be subject to... (Review)
Review
OBJECTIVES
The U.S. Food and Drug Administration (FDA) currently regulates more than 190,000 different medical devices. Like all products, these devices may be subject to manufacturing problems, flawed designs, or new and unexpected risks, which in some cases require devices to be recalled. In 2021, the FDA's Patient Engagement Advisory Committee (PEAC) recommended that the FDA consider changes to the communication approach used for medical device recalls to make them more patient-focused, timely, and action-oriented.
METHODS
To support this recommendation, we conducted a rapid review of literature published from 2008-2022 to capture and examine information on risk communication approaches, methods, and best practices for recall-related communications about medical products.
RESULTS
We identified 23 articles to include in our review.
CONCLUSION
Our review found a lack of research-based studies as well as gaps in understanding about consumer perspectives, comprehension, and communication preferences related to recalls. Despite these limitations, we identified current communication approaches, numerous challenges, and recommendations for communicating medical products recall information to consumers.
PRACTICE IMPLICATIONS
Further research is needed to assess consumer attitudes, understanding, and preferences and to reach consensus on best practices for effectively communicating recall information to consumers of medical products.
Topics: United States; Humans; Medical Device Recalls; United States Food and Drug Administration; Consensus; Patient Participation
PubMed: 38484598
DOI: 10.1016/j.pec.2024.108244 -
Canada Communicable Disease Report =... Aug 2023is a non-fermenting, gram-negative bacteria that has previously been implicated in multiple nosocomial outbreaks through the use of contaminated medical devices and...
BACKGROUND
is a non-fermenting, gram-negative bacteria that has previously been implicated in multiple nosocomial outbreaks through the use of contaminated medical devices and substances. This article reports on an outbreak of infections and colonizations, involving 11 patients from five acute care hospitals in Montréal, Canada.
METHODS
One sample was not available for testing, but the remaining 10 isolates (91%) were sent for phylogenetic testing. Medical materials and the patients' environments were also sampled and cultured. Samples were tested using pulsed field gel electrophoresis and multilocus sequence typing.
RESULTS
The outbreak was found to be associated with the use of intrinsically contaminated non-sterile ultrasound gel. Relatedness of the gel's and the patients' strains was demonstrated using gel electrophoresis and multilocus sequence typing analyses. The investigation was concluded with a prompt recall of the product, and the outbreak was declared over by the end of October 2021.
CONCLUSION
Contaminated non-sterile gel caused infections and pseudo-infections in several patients.
PubMed: 38455880
DOI: 10.14745/ccdr.v49i78a03 -
Clinical Toxicology (Philadelphia, Pa.) Feb 2024We describe a rare food contamination of organically grown frozen green beans with , also called black night shade, which were widely available in supermarkets in the...
INTRODUCTION
We describe a rare food contamination of organically grown frozen green beans with , also called black night shade, which were widely available in supermarkets in the Netherlands.
CASE SERIES
To our knowledge, only three adults and one child were referred to the emergency department for observation after eating the contaminated green beans. Only minor symptoms were seen during observation. The remainder of the frozen green beans were obtained from the patients and sent for analysis within one day. Within two and a half days after the first case, a public safety warning and recall were launched.
DISCUSSION
Due to an increase in popularity of organic food, more incidents involving toxic weed contaminants like the one we describe in this report could happen when quality control in organic agriculture is insufficient. In this event, the critical control point obtained from the hazard analysis was insufficiently managed by the producer.
CONCLUSION
This report demonstrates the efficient collaboration between the Dutch Poisons Information Centre, treating physicians at the hospital and the Netherlands Food and Consumer Product Safety Authority in case of a possible public safety issue. Because of quick acting and collaboration between the involved parties, the product was quickly withdrawn from the market.
Topics: Adult; Child; Humans; Poisons; Solanum nigrum; Public Health; Drug Contamination; Hospitals
PubMed: 38451472
DOI: 10.1080/15563650.2024.2320838 -
PeerJ. Computer Science 2024Opinion mining is gaining significant research interest, as it directly and indirectly provides a better avenue for understanding customers, their sentiments toward a...
Opinion mining is gaining significant research interest, as it directly and indirectly provides a better avenue for understanding customers, their sentiments toward a service or product, and their purchasing decisions. However, extracting every opinion feature from unstructured customer review documents is challenging, especially since these reviews are often written in native languages and contain grammatical and spelling errors. Moreover, existing pattern rules frequently exclude features and opinion words that are not strictly nouns or adjectives. Thus, selecting suitable features when analyzing customer reviews is the key to uncovering their actual expectations. This study aims to enhance the performance of explicit feature extraction from product review documents. To achieve this, an approach that employs sequential pattern rules is proposed to identify and extract features with associated opinions. The improved pattern rules total 41, including 16 new rules introduced in this study and 25 existing pattern rules from previous research. An average calculated from the testing results of five datasets showed that the incorporation of this study's 16 new rules significantly improved feature extraction precision by 6%, recall by 6% and F-measure value by 5% compared to the contemporary approach. The new set of rules has proven to be effective in extracting features that were previously overlooked, thus achieving its objective of addressing gaps in existing rules. Therefore, this study has successfully enhanced feature extraction results, yielding an average precision of 0.91, an average recall value of 0.88, and an average F-measure of 0.89.
PubMed: 38435547
DOI: 10.7717/peerj-cs.1821 -
Research in Social & Administrative... Jun 2024The pharma supply chain comprises various parties including distributors, manufacturers, raw material suppliers, regulators, pharmacies, hospitals, and patients. Due to... (Review)
Review
BACKGROUND
The pharma supply chain comprises various parties including distributors, manufacturers, raw material suppliers, regulators, pharmacies, hospitals, and patients. Due to the product's complexity and transaction flows, an efficient traceability system is needed in the pharma supply chain to identify the current and all previous product owners. Digitizing the track and trace process significantly improves regulatory oversight and guarantees product quality. A distributed platform for shared data that is immutable, trustworthy, accountable, and transparent in the pharmaceutical supply chain could be built using blockchain-based drug traceability.
OBJECTIVE
This review aims to shed light on blockchain technology's significance and necessity for pharmaceutical supply chain management systems.
METHOD
A comprehensive literature review was performed between January 2017 and September 2023. The search was conducted to elaborate on blockchain technology. Blockchain is a software-based technology that logs and records transactions using a block structure arranged chronologically. Cryptography technology links and secures these blocks on a peer-to-peer network. Blockchain is anticipated to transform the pharmaceutical supply chain by giving all participants access to a single, straightforward system that provides transparency, security, and oversight of the end-to-end delivery of goods.
RESULT
In all, various literature data were included in this review. Using a supply chain powered by blockchain has many benefits. To begin with, it gives a thorough account of the entire procedure from start to finish. A single piece of software can manage the entire supply chain. Additionally, it increases communication between parties with permission. The enhanced security and traceability that blockchain offers is another important benefit. A blockchain system can track, trace, and recall products.
CONCLUSION
Blockchain-based pharmaceutical supply chain management enables the tracking of medicinal drug transactions from raw materials suppliers to end consumers. The pharma blockchain has the potential to enhance the security, integrity, data provenance, and functionality of the supply chain due to its transparency, immutability, and auditability.
Topics: Blockchain; Humans; Pharmaceutical Preparations; Drug Industry; Software
PubMed: 38423927
DOI: 10.1016/j.sapharm.2024.02.014 -
Lessons learned from postmarketing withdrawals of expedited approvals for oncology drug indications.The Lancet. Oncology Mar 2024In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).... (Review)
Review
In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Besides the EMA's conditional marketing authorisation programme and the FDA's Accelerated Approval Program, we observe a tendency towards fast approval for exploratory studies with non-randomised, uncontrolled designs and surrogate endpoints. This issue raises concerns about the robustness and effectiveness of accepted treatments, leaving patients and health-care professionals in a state of uncertainty. A substantial number of accelerated approvals have recently been withdrawn in the USA, with some still authorised in Europe, emphasising discrepancies in regulatory standards that affect both patients and society as a whole. We highlight examples of drugs, authorised on the basis of surrogate endpoints, that were later withdrawn due to an absence of overall survival benefit. Our findings address the challenges and consequences of accelerated approval pathways in oncology. In conclusion, this Policy Review calls for regulatory bodies to better align their procedures and insist on robust evidence, preferably through unbiased randomised controlled trials. Drug approval processes should prioritise patient benefit, overall survival, and quality of life to minimise risks and uncertainties for patients.
Topics: Humans; Drug Approval; Europe; Medical Oncology; Product Surveillance, Postmarketing; Safety-Based Drug Withdrawals
PubMed: 38423058
DOI: 10.1016/S1470-2045(23)00592-2 -
Heart Rhythm Jun 2024
Review
Topics: Humans; Defibrillators, Implantable; Medical Device Recalls; Pacemaker, Artificial; Equipment Failure; Cardiac Electrophysiology
PubMed: 38403233
DOI: 10.1016/j.hrthm.2024.02.039 -
PloS One 2024The results of a survey of 1,071 adults in the United States reveal that most consumers do not pay attention to, let alone understand, arbitration clauses in their...
The results of a survey of 1,071 adults in the United States reveal that most consumers do not pay attention to, let alone understand, arbitration clauses in their everyday lives. The vast majority of survey respondents (over 97%) report having opened an account with a company that requires disputes to be submitted to binding arbitration (e.g., Netflix, Hulu, Cash App, a phone or cable company), yet most are unaware that they have, in fact, agreed to mandatory arbitration (also known as "forced arbitration"). Indeed, over 99% of respondents who think they have never entered into an arbitration agreement likely have done so. Over 92% of respondents report that they have never based a decision to use a product or service on whether the terms and conditions contain an arbitration agreement. When prompted, they largely endorse the following reasons: they were unaware of the arbitration clause, they did not read the terms and conditions, and they thought they had no choice but to agree to mandatory arbitration. Moreover, many respondents presume that if a dispute arises, they will still be able to access the public courts, notwithstanding that they agreed to the terms and conditions. Consumers are largely unaware of opportunities to opt out of mandatory arbitration. They generally do not pay attention to or retain information about the steps required to opt out successfully (e.g., contacting the company within a specified time period). Generally, consumers are unaware that companies like Cash App and Venmo (mobile payment systems utilized by nearly 60% of respondents) allow customers to opt out of mandatory arbitration if they act within a limited time period. Among the minority of respondents (21%) who stated that they had been given an opportunity to opt out, vanishingly few could name any of the steps required to opt out successfully. When presented with a run-of-the-mill contract, of the type consumers routinely encounter, most respondents did not take notice of the arbitration clause. Less than 5% of respondents could recall that the contract they were shown had said anything at all about arbitration. Furthermore, most consumers misperceive the consequences of signing a predispute arbitration agreement. Most mistakenly believe that, after agreeing to terms and conditions mandating binding arbitration, they can still choose to settle their dispute in court, have a jury decide their case, join a class action, and appeal a decision made based on a legal error. For instance, less than 5% of respondents correctly reported that they could neither appeal an erroneous decision to another arbitrator (or set of arbitrators) nor start all over again in court. Less than 1% of respondents correctly understood the full significance of the arbitration agreement, as indicated by their responses to questions about whether they retained the rights to sue, have a jury decide their case, access the public courts, and appeal a decision based on a legal error. In summary, consumers are generally unaware of arbitration clauses, and they tend to hold mistaken beliefs about how arbitration agreements affect consumers' procedural rights.
Topics: United States; Negotiating; Contracts; Dissent and Disputes
PubMed: 38394135
DOI: 10.1371/journal.pone.0296179 -
Clinical Pharmacology and Therapeutics Jun 2024Drug recalls occur frequently and have the potential to impact considerable numbers of patients and healthcare providers. However, in the absence of a comprehensive...
Drug recalls occur frequently and have the potential to impact considerable numbers of patients and healthcare providers. However, in the absence of a comprehensive overview the extent of conducted recalls and their impact on patients remains unknown. To address this, we developed a comprehensive overview of drug recalls affecting patients. We compiled this overview based on the drug recall registrations from the Jeroen Bosch Hospital (JBZ), the University Medical Center Utrecht (UMCU), and the Royal Dutch Pharmacists Association (KNMP). A retrospective data analysis was conducted to identify drug recalls that affected patients. Specifically, we defined these as drug recalls that required patients to actively switch their drug to a different batch or brand of the same drug or to switch to a drug within the same or a different class of drugs. To quantify the impact, we used real-world drug dispensing data. Between January 1, 2017, and December 31, 2021, we identified 48 drug recalls that necessitated patients to make active changes to their medications an estimated 855,000 times. Most of the affected patients (292,000) were required to switch to a different brand of the same drug, whereas in 95,000 cases patients had to switch to a drug from another drug class. Our study suggests that a significant number of patients are affected by drug recalls. Future efforts are needed to elucidate patients' experiences and preferences regarding drug recalls, which could provide valuable insights to aid decision-making by relevant (national) authorities concerning drug recalls.
Topics: Humans; Netherlands; Retrospective Studies; Drug Recalls; Drug Substitution
PubMed: 38390768
DOI: 10.1002/cpt.3220