International Journal of Risk & Safety in Medicine - Volume 20, issue 3

Authors: Ofori-Adjei, D. | Dodoo, A.N.O. | Appiah-Danquah, A. | Couper, M.

Article Type: Other

Abstract: Detailed safety review of the intestinal anthelminthics (pyrantel and niclosamide) and antischistosomal and antitrematodes (oxamniquine and triclabendazole) was conducted using publications in journals and major reference sources combined with the assessment of adverse drug reaction (ADR) reports in the database of the WHO Collaborating Centre for International Drug Monitoring in Sweden. Data from available limited publications on the subject provide evidence in support of the overall safety of these medicines with no publication citing an unfavourable safety assessment of any of the drugs. Whilst there have been concerns about the risk of seizures with oxamniquine, these concerns have not diminished …the extent to which the medicine has been used in several countries. All four medicines appear to be safe and well tolerated even when used in mass treatment campaigns in several countries. This safety review indicates that oxamniquine, triclabendazole, niclosamide and pyrantel have favourable benefit–risk profiles for use in humans. However, in order to enhance the evidence base to determine safety issues in relation to medicines that are used heavily in settings with poor or non-existent pharmacovigilance systems, it is recommended that the WHO pushes its current supportive efforts for the setting up of such systems globally, especially in resource-limited countries. The four drugs are all retained on the current list of the WHO Model List of Essential Medicines. Show more

Keywords: Niclosamide, pyrantel, triclabendazole, oxamniquine, safety review, pharmacovigilance

DOI: 10.3233/JRS-2008-0440

Citation: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 113-122, 2008

Authors: Agbabiaka, Taofikat B. | Savović, Jelena | Harris, Ross | Ernst, Edzard

Article Type: Research Article

Abstract: About one-third of the published literature on adverse drug reactions (ADRs) and adverse events (AEs) consists of case reports. Unfortunately, the majority of case reports fall short of providing sufficient details for critical evaluation. Potentially valuable information is therefore frequently lost. The study was aimed at developing a quality assessment tool for case reports of AEs. A preliminary scale of 35 items for conventional drugs (and an additional 6 items for herbal preparations) was initially developed. Forty-eight (48) experts were invited to assess this list and modify it for face and content validity in three rounds of a Delphi process. …The resulting scale of 21 items, 18 of which relates to general AEs and three items specific to herbal preparations. These items evaluate the quality of case reports in three domains: (i) drug information and therapeutic regimen (5 items); (ii) patient history, diagnosis and medications (8 items); and (iii) details of adverse events (5 items). It was tested for reliability by 16 experts using 5 randomly selected case reports. Our quality score is comprehensive and reliable. It could be an advance over existing instruments and form a basis for further developments in this area of pharmacovigilance. Show more

Keywords: Adverse events, Delphi, reliability, drug interaction, quality scale

DOI: 10.3233/JRS-2008-0435

Citation: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 123-133, 2008

Authors: Austin, David

Article Type: Research Article

Abstract: Where direct experimental research into a causal hypothesis of a disease is impossible due to ethical and practical considerations, epidemiological inference is the accepted route to establishing cause. Therefore, to examine the autism as mercury poisoning hypothesis, this paper reviews the existing scientific literature within the context of established epidemiological criteria and finds that the evidence for a causal relationship is compelling. Exposure to mercury (via vaccines and maternal dental amalgam) in utero and during infant years is confirmed; mercury poisoning is known to cause symptoms consistent with autism; animal modeling supports the link and, critically, mercury levels are higher …in both the urine and blood of autistic children than in non-autistic peers. Analogous to epidemiological evidence of the smoking–lung cancer relationship, a mercury–autism relationship is confirmed. The precautionary principle demands that health professionals not take an action if there is suspicion that the action may cause severe or lifelong health effects: it does not require certainty. Therefore, given the severity, devastating lifelong impact and extremely high prevalence of autism, it would be negligent to continue to expose pregnant and nursing mothers and infant children to any amount of avoidable mercury. Show more

Keywords: Autism, mercury, epidemiology, precautionary principle, pink disease

DOI: 10.3233/JRS-2008-0436

Citation: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 135-142, 2008

Authors: Morrato, Elaine H. | Curbow, Barbara | Crum, Rosa M. | Nowels, Carolyn | Feinleib, Manning

Article Type: Research Article

Abstract: Improving drug risk communication is a public health priority outlined by The Institute of Medicine to ensure patient safety. Physicians are an important audience of drug risk communication and effective communication is essential for promoting their adoption of risk management behavior. In this study, the authors explored information sources physicians prefer for keeping their drug safety knowledge current (particularly regarding new warnings). In a sample of US physicians, the authors found multiple resources were used for drug safety information with no single source used by everyone. Respondents had created a customized set of preferred resources with built-in redundancy. Participants discussed …the strengths and limitations of different information sources: scientific (e.g., highest credibility), third-party (e.g., fast and electronically-delivered, but patients have access to the same information) and the drug company (e.g., legally accurate, but biased). The findings highlight the challenge in delivering a consistent, timely, and persuasive drug risk message to physicians through varying layers of intermediary messengers. The authors propose a conceptual framework of the communication flow for drug safety warnings to inform future research to optimize risk communication delivery. Show more

Keywords: Drug risk communication, physicians, United States

DOI: 10.3233/JRS-2008-0437

Citation: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 143-154, 2008

Authors: Savona-Ventura, C. | Buttigieg, G.G. | Grima, S. | Vella, M.

Article Type: Research Article

Abstract: An essential element in achieving a successful birth process is the size of the infant and its relationship to the birth canal. The maternal anthropomorphic characteristics of height and weight are determinant in establishing birth canal adequacy and infant size. The present study assesses the risk element of these two factors on obstetric performance in a Mediterranean population characterised by a relatively short stature and a high prevalence of the Metabolic Syndrome. Obese women have been shown to have pregnancies which are more likely to be complicated by hypertension and diabetes when compared to their leaner counterparts. They were more …likely to be delivered by Caesarean section and vaginal delivery was more likely to be complicated by shoulder dystocia. The infants born to these mothers were heavier and were more likely to suffer from respiratory distress in the neonatal period. The short stature woman similarly had a greater likelihood of requiring Caesarean delivery in spite of having a tendency to infants with smaller birth weights than their taller counterparts. The study confirms that the maternal body habitus remains an obstetric risk consideration that needs to be addressed when deciding on management of delivery. Show more

Keywords: Anthropomorphy, obstetrics, risk factors, fetal complications, maternal complications

DOI: 10.3233/JRS-2008-0438

Citation: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 155-160, 2008

Authors: Whitstock, Margaret T. | Eckermann, Elizabeth J. | Marjoribanks, Timothy K. | Pearce, Christopher M.

Article Type: Research Article

Abstract: Lumiracoxib (Prexige© ) 200 mg was listed in Australia's Pharmaceutical Benefits Scheme (PBS) schedules on 01 August 2006. The listing was intended as a cost-minimisation strategy, as lumiracoxib 200 mg was deemed equivalent in therapeutic effect to celecoxib (Celebrex© ) 200 mg, and was available at a lower cost. By the time of listing on the PBS, a safety re-evaluation of the recommended daily dose of lumiracoxib was being considered in other national regulatory jurisdictions. Within 3 months of listing, the manufacturer revised the recommended dosage to half that of the PBS-listed dosage. However, the PBS listing was neither revoked …nor modified. At the time of listing on the PBS, lumiracoxib was known to be 17 times as biochemically selective in inhibiting the COX-2 isoform as celecoxib, and twice as selective as rofecoxib, already withdrawn for safety reasons. Safety concerns had already been raised about adverse hepatic outcomes on daily doses of lumiracoxib 200 mg. Communication of information about the risk potential of lumiracoxib was inadequate. Economic and political considerations were prioritised over patient safety, and lumiracoxib 200 mg remained available via the PBS until 10 August 2007, when it was withdrawn for safety reasons following cases of hepatic morbidity and mortality. Show more

Keywords: Lumiracoxib, Prexige, COX-2 inhibitors, coxibs, NSAIDs, pharmaceutical regulatory policy (Australia)

DOI: 10.3233/JRS-2008-0439

Citation: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 161-167, 2008

Authors: Jose, Jimmy | Rao, Padma G.M. | Jimmy, Beena

Article Type: Research Article

Abstract: Fluoroquinolones are one among the most commonly prescribed antibiotics in hospital set up. Only few published studies are available which tried to characterize the nature of ADRs to fluoroquinolones encountered in a hospital set up. The present study was aimed at analyzing the pattern of ADRs implicated to fluoroquinolone antibiotics reported spontaneously to the ADR reporting unit of a tertiary care teaching hospital in India. ADRs reported over a period of 4 years and 6 months were analyzed. Evaluation was done for patient demographics, drug and reaction characteristics, predisposing factors, and outcome of reactions. Analysis for causality, severity and preventability …was also done. Eighty ADRs associated with fluoroquinolones were notified during the evaluation period, which accounted for 5.4% of the total ADRs reported in the ADR reporting unit and 30.2% of all reports to antibacterials. Type A reactions (58.8%) accounted for majority and more were described to be common (48.8%) in the literature. Levofloxacin (48.8%) occupied the major share of the reactions reported. Pattern of ADRs observed was comparable to that reported in literature. The organ system most commonly affected was skin and appendages (32.5%) and the most frequently reported reaction was skin rash (21.3%). Interestingly, no report of reactions affecting musculoskeletal system was observed while rare reaction like nephrotoxicity was noticed. The proportion of nervous system adverse reactions noticed were higher than that observed with antibacterial agents in general. Drug dechallenge was instituted in majority (73.8%) for management of the reactions, while additional treatment was instituted in 50% of the reactions. More of the reactions were probable (52.5%) in nature on causality assessment and were of moderate (72.5%) severity. Many (23.8%) of the reactions were deemed to be preventable on evaluation. Drug–drug and drug–disease interaction were the most important factors which contributed to preventability. Even though ADRs to fluoroquinolones are considered mainly to be mild in severity, our evaluation revealed considerable number of reactions of moderate severity. The present evaluation has revealed opportunities for interventions especially for the preventable ADRs which will help in promoting safer use of this important group of antibiotics. Cautious use of these agents especially in patients with predisposing factors and proper monitoring is warranted. Spontaneous reporting programs in spite of its limitations are useful in identifying pattern of ADRs in a hospital set up. Similar hospital based evaluation will provide valuable information which would help in promoting safe use of these medications. Show more

Keywords: Adverse drug reactions, fluoroquinolones, spontaneous reports, hospital

DOI: 10.3233/JRS-2008-0441

Citation: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 169-180, 2008

Article Type: Other

DOI: 10.3233/JRS-2008-0442

Citation: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 181-182, 2008

Authors: Jureidini, Jon N. | McHenry, Leemon B. | Mansfield, Peter R.

Article Type: Correction

DOI: 10.3233/JRS-2008-0444

Citation: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 183-183, 2008