Read by QxMD icon Read

Post marketing surveillance

Kingston Rajiah, Mari Kannan Maharajan, Shashina Nair
Pharmacy students' knowledge about adverse drug reaction reporting can impact their attitude towards patient care and issues on patient safety. The aim of this study was to investigate the knowledge and perception of pharmacy students about adverse drug reaction reporting and pharmacovigilance and to study their willingness to report. A cross-sectional study using a validated questionnaire was conducted among the university students. The demographic details of the respondents were studied. The number of female respondents was comparatively higher than the male respondents...
September 2016: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Anders Elgaard Kristensen, Jacob Moesgaard Larsen, Jens Cosedis Nielsen, Jens Brock Johansen, Jens Haarbo, Helen Høgh Petersen, Sam Riahi
AIMS: The validity of registry data on defibrillator lead performance is described only sparsely, despite its clinical importance. This study investigated the validity of defibrillator lead performance registry data in a nationwide and population-based registry. METHODS AND RESULTS: We identified all reported surgical interventions due to defibrillator lead events in the Danish Pacemaker and ICD Register (DPIR) from 2000 to 2013. Medical records of all patients (n = 753) were examined blinded for 5 predefined intervention types and 18 reasons for lead intervention...
October 13, 2016: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
Peter Cnudde, Ola Rolfson, Szilard Nemes, Johan Kärrholm, Clas Rehnberg, Cecilia Rogmark, John Timperley, Göran Garellick
BACKGROUND: Sweden offers a unique opportunity to researchers to construct comprehensive databases that encompass a wide variety of healthcare related data. Statistics Sweden and the National Board of Health and Welfare collect individual level data for all Swedish residents that ranges from medical diagnoses to socioeconomic information. In addition to the information collected by governmental agencies the medical profession has initiated nationwide Quality Registers that collect data on specific diagnoses and interventions...
October 4, 2016: BMC Musculoskeletal Disorders
Hitoshi Saito, Hiroyuki Kakihata, Yosuke Nishida, Sawako Yatomi, Shigeru Nihojima, Yumiko Kobayashi, Hidehiro Tabata, Makoto Nomura
This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3...
October 3, 2016: Journal of Bone and Mineral Metabolism
Ganna Kostygina, Hy Tran, Yaru Shi, Yoonsang Kim, Sherry Emery
OBJECTIVE: Despite recent increases in little cigar and cigarillo (LCC) use-particularly among urban youth, African-Americans and Latinos-research on targeted strategies for marketing these products is sparse. Little is known about the amount or content of LCC messages users see or share on social media, a popular communication medium among youth and communities of colour. METHODS: Keyword rules were used to collect tweets related to LCCs from the Twitter Firehose posted in October 2014 and March-April 2015...
October 2016: Tobacco Control
Francesco Trotta, Roberto Da Cas, Antonino Bella, Carmela Santuccio, Stefania Salmaso
BACKGROUND: Study to investigate the intussusception incidence background in the pediatric population and its temporal trend in Italy. METHODS: A cross-sectional study was conducted on the pediatric population aged 0 to 15 years, in the period 1 January 2002 to 31 December 2012. Intussusception cases were identified using the national hospital discharge database. The annual intussusception incidence, the incidence rate ratios (IRRs) and the related 95 % confidence Intervals (CI) were calculated...
September 27, 2016: Italian Journal of Pediatrics
Massimo Morfini
Replacement therapy for FVIII/IX in hemophilia A/B is more than 50 years old following the discovery of cryoprecipitate by Judith Pool in 1964. On-demand therapy and prophylaxis to treat or prevent bleedings is very demanding owing to the short half-life (HL) of factor concentrates (no more than 12-14 h for FVIII or 16-18 h for FIX). Patients are very eager to prolong the intervals between bolus. The enhanced HL of long-acting recombinant FIX (rFIX) concentrates seems to fulfill this expectance. Areas covered: Great improvements have been achieved in the bio-engineering of new rFIX concentrates...
October 2, 2016: Expert Opinion on Drug Metabolism & Toxicology
Gillian C Hall, Robert Mr Tulloh, Louise E Tulloh
PURPOSE: To provide expected incidence rates of Kawasaki disease after vaccination in routine clinical practice and as recommended within a pre-school National Immunisation Programme (NIP). METHODS: A post-immunisation risk period when Kawasaki disease onset might be associated with vaccination was defined as 28 days. Immunisation records for children under 6 years were identified from The Health Improvement Network (THIN) database of electronic UK primary health care records (2008-2012) and linked to previously validated cases of Kawasaki disease with an assigned date of onset...
September 21, 2016: Pharmacoepidemiology and Drug Safety
Kathleen M Job, Tony K L Kiang, Jonathan E Constance, Catherine M T Sherwin, Elena Yu Enioutina
Similar to other nations North American people used herbs for thousands of years to treat diseases and purify their spirits. By the middle of the 1900s, evidence-based conventional medicine received wide acceptance in Canada and the United States (US). Nowadays, people are going back to their roots and actively using herbal medicines (HMs) and natural health products (NHPs). Areas covered: This article is focusing on use and regulation of the HMs and NHPs in Canada and the US, raises concerns regarding HM and NHP safety and efficacy, offers suggestions on how to overcome these problems...
October 3, 2016: Expert Review of Clinical Pharmacology
Stephanie Ferreira Botelho, Maria Auxiliadora Parreiras Martins, Liliana Batista Vieira, Ariano Max Moreira Reis
This study investigated post-marketing safety events (PMSE) for new drugs approved in Brazil and evaluated whether a range of drug characteristics influenced the time between approval and the first PMSE. This retrospective study included new drugs registered between 2003 and 2013 by the National Health Surveillance Agency (ANVISA), which is responsible for medicines approval in Brazil. PMSE were defined as any drug safety alert or drug withdrawal from the market. The existence of risk evaluation and mitigation strategies (REMS) in the United States Food and Drug Administration (FDA) and Brazil were recorded...
August 29, 2016: Journal of Clinical Pharmacology
Jason J Howard
Due to problems with wear particle generation and subsequent loosening using conventional metal-on-polyethylene total hip replacements, there has been a shift toward alternative bearing systems, including metal-on-metal (MoM), for younger, more active patients with degenerative joint disease. Based on positive results from early short-term clinical studies, MoM hip replacements were readily adopted by orthopedic surgeons with thousands being implanted worldwide over the past decade. Unacceptably high revision rates reported by two national joint registries called into question the rigorousness of the regulatory approval process for these implants, particularly with respect to premarket data requirements to prove safety, effectiveness, and the appropriateness of the regulatory pathway chosen...
2016: Medical Devices: Evidence and Research
Massimo Morfini, Ezio Zanon
INTRODUCTION: Replacement therapy with clotting factor concentrates is the most appropriate and effective way to treat bleedings of Hemophilia A&B to prevent chronic arthropathy. Unfortunately, the short half-life (HL) of FVIII/IX concentrates obliges the patients to receive frequent infusions, a big concern for children. The development of inhibitors in about 30-45% of hemophilia A and in 3-5% of hemophilia B patient is the major adverse event of replacement therapy. AREAS COVERED: In the last few years, new rFIX have been developed with HL...
September 2016: Expert Opinion on Emerging Drugs
Lilly Q Yue, Gregory Campbell, Nelson Lu, Yunling Xu, Bram Zuckerman
Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices...
August 19, 2016: Journal of Biopharmaceutical Statistics
Dustin T Wilson, V Paul Dimondi, Steven W Johnson, Travis M Jones, Richard H Drew
Despite recent advances in both diagnosis and prevention, the incidence of invasive fungal infections continues to rise. Available antifungal agents to treat invasive fungal infections include polyenes, triazoles, and echinocandins. Unfortunately, individual agents within each class may be limited by spectrum of activity, resistance, lack of oral formulations, significant adverse event profiles, substantial drug-drug interactions, and/or variable pharmacokinetic profiles. Isavuconazole, a second-generation triazole, was approved by the US Food and Drug Administration in March 2015 and the European Medicines Agency in July 2015 for the treatment of adults with invasive aspergillosis (IA) or mucormycosis...
2016: Therapeutics and Clinical Risk Management
Sophie Fletcher, Mark G Jones, Katherine Spinks, Giacomo Sgalla, Ben G Marshall, Rachel Limbrey, Luca Richeldi
INTRODUCTION: The management of idiopathic pulmonary fibrosis (IPF) has been transformed by the recent approval of two anti-fibrotic drugs, nintedanib and pirfenidone. An increasing number of patients with IPF are receiving treatment with these novel therapies, and the risk of adverse events that may be associated with their use must be carefully evaluated. AREAS COVERED: Safety data about nintedanib and pirfenidone is critically evaluated, including data from randomized clinical trials and post-marketing reports...
August 17, 2016: Expert Opinion on Drug Safety
Kathie A Wong, Luke Hodgson, George Garas, George Malietzis, Sheraz Markar, Christopher Rao, Ludwig K von Segesser, Thanos Athanasiou
Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need...
August 11, 2016: Interactive Cardiovascular and Thoracic Surgery
Joel Lexchin, Deborah Gleeson
The Trans Pacific Partnership Agreement (TPP) is a large regional trade agreement involving 12 countries. It was signed in principle in February 2016 but has not yet been ratified in any of the participating countries. The TPP provisions place a range of constraints on how governments regulate the pharmaceutical sector and set prices for medicines. This article presents a prospective policy analysis of the possible effects of the TPP on these two points in Canada and Australia. Five chapters of relevance to pharmaceutical policy are analyzed: chapters on Technical Barriers to Trade (Chapter 8), Intellectual Property (Chapter 18), Investment (Chapter 9), Dispute Resolution (Chapter 28), and an annex of the chapter on Transparency and Anti-Corruption (Chapter 26, Annex 26-A)...
October 2016: International Journal of Health Services: Planning, Administration, Evaluation
Myriam Lingg, Kaspar Wyss, Luis Durán-Arenas
BACKGROUND: We know little about how procurement of a high-risk medical device (HRMD) affects clinical practice and outcomes. In health systems in high-income countries, and specifically those that maintain a national arthroplasty registry, procurement decisions are frequently guided by long-term clinical results, with the goal of ensuring at least standard quality of HRMDs. But in countries like Mexico, decision-making is often dominated by lowest acquisition price. We set out to study the impact of procurement for orthopaedic HRMDs on clinical procedures and outcomes...
2016: BMC Health Services Research
Takuji Komeda, Shingo Ishii, Yumiko Itoh, Masaki Sanekata, Takayoshi Yoshikawa, Jingoro Shimada
Peramivir, the only injectable anti-influenza neuraminidase inhibitor medically available in Japan at present, is considered first-line treatment in patients with high risk factors for influenza exacerbation. We conducted a drug-use investigation of peramivir in inpatients with high risk factors (old age, pregnancy, and underlying disease such as chronic respiratory disease) from January 2010 to March 2013. Data of 772 patients from 124 facilities across Japan were collected; peramivir's safety in 770 patients and effectiveness in 688 patients were examined...
October 2016: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
Son Moon Shin, Chun Soo Kim, Naveen Karkada, Aixue Liu, Girish Jayadeva, Htay Htay Han
PURPOSE: According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). METHODS: During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation...
August 5, 2016: Human Vaccines & Immunotherapeutics
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"