Public health response to a large-scale endoscopy infection control lapse in a nonhospital clinic.

OBJECTIVE: To determine whether transmission of blood-borne pathogens (BBPs) (hepatitis B virus [HBV], hepatitis C virus [HCV] and HIV) occurred as a result of endoscopy reprocessing failures identified during an inspection of a nonhospital endoscopy clinic in 2011. METHODS: The present analysis was a retrospective cohort study. Registered notification letters were mailed to 6992 patients who underwent endoscopy from 2002 to 2011 at one Canadian nonhospital endoscopy clinic, informing them of the infection control lapse and offering BBP testing. Multimedia communications and a telephone line supplemented notification. A retrospective study of patients with BBPs was performed with viral genetic testing and risk factor assessment for eligible patients. Risk for infection among patients whose procedure was within seven days of a known positive patient was compared with those whose procedure was performed more than seven days after a known postive patient. The seven-day period was selected as the period most likely to present a risk for transmission based on the documented cleaning procedures at the clinic and the available literature on virus survival. RESULTS: Ninety-five percent (6628 of 6992) of patients/estates were contacted and 5042 of 6728 (75%) living patients completed BBP testing. Three were newly diagnosed with HBV and 14 with HCV. Twenty-three and 48 tested positive for previously known HBV or HCV, respectively, 367 were immune to HBV due to natural infection and one was immune to HBV due to immunization. None tested positive for HIV. Sequencing did not reveal any relationships among the 46 unique case patients with viral genetic test results available. Ninety-three percent of patients reported alternative risk factors for BBP. An increased risk for infection among those who underwent a procedure within seven days of a known HBV or HCV case was not demonstrated. CONCLUSIONS: Endoscopy reprocessing failures were not associated with an increased risk for BBP among individuals tested.

OBJECTIF: Lors de l'inspection d'une clinique d'endoscopie non hospitalière en 2011, déterminer si des pathogènes à diffusion hématogène (PDH; virus de l'hépatite B [VHB], virus de l'hépatite C [VHC] et VIH) sont transmis à cause de la défaillance du retraitement de l'endoscopie. MÉTHODOLOGIE: Dans la présente étude de cohorte rétrospective, les chercheurs ont posté une lettre recommandée à 6 992 patients qui avaient subi une endoscopie entre 2002 et 2011 dans une clinique canadienne d'endoscopie non hospitalière pour les informer d'une défaillance du contrôle des infections et leur offrir un test de dépistage des PDH. Les communications multimédias et les appels téléphoniques ont complété cet avis. Les chercheurs ont effectué une étude rétrospective des patients ayant des PDH au moyen de tests génétiques viraux et d'une évaluation des facteurs de risque des patients admissibles. Ils ont comparé le risque d'infection entre les patients dont l'intervention avait eu lieu dans les sept jours suivant celle d'un patient positif connu ceux dont l'intervalle dépassait sept jours. Cette période de sept jours était la plus susceptible de constituer un risque de transmission compte tenu des mesures de nettoyage attestées à la clinique et les publications sur la survie des virus. RÉSULTATS: Les chercheurs ont pris contact avec 95 % (6 628 cas sur 6 692) des patients et des successions, et 5 042 des 6 728 (75 %) patients vivants ont effectué le test de dépistage des PDH. Trois ont obtenu un nouveau diagnostic de VHB et 14, de VHC. De plus, 23 et 48 ont obtenu des résultats positifs à un VHB ou à un VHC déjà connu, respectivement, 367 étaient immuns au VHB en raison d'une infection naturelle et un, grâce à la vaccination. Aucun n'a obtenu de résultat positif au VIH. Le séquençage a révélé l'absence de lien entre les 46 cas uniques de patients pour qui les résultats du test génétique étaient disponibles. Aussi, 93 % des patients ont signalé d'autres facteurs de risques de PDH. Par ailleurs, on n'a pu démontrer d'augmentation du risque d'infection chez les personnes qui avaient subi une intervention dans les sept jours suivant un cas connu de VHB ou de VHC. CONCLUSIONS: L'échec de retraitement de l'endoscopie ne s'associait pas à une augmentation du risque de PDH chez les personnes qui subissaient un test de dépistage.

Pharmacogenomic investigation of adverse drug reactions(ADRs): the ADR prioritization tool, APT.

BACKGROUND: The impact of genetic factors on the risk of adverse drug reactions (ADRs) is being increasingly recognized as clinically important. ADR Prioritization Tool (APT) was developed to facilitate the prioritization of drugs and their associated ADRs for future pharmacogenomic studies. OBJECTIVES: To describe a novel tool developed for the prioritization of pharmacogenomic investigation of ADRs and discuss the impact of specific scoring criteria. METHODS: APT scores were based on 25 key scientific and feasibility criteria relevant for clinical research evaluating the genetic basis of ADRs, with a maximum possible score of 60 points. The tool was independently applied to five ADRs (warfarin-induced bleeding/thrombosis, cisplatin-induced ototoxicity, methotrexate-induced neutropenia, carbamazepine-induced Stevens-Johnson syndrome, and abacavir-induced hypersensitivity) by two researchers. Scores were compared using the intraclass correlation coefficient (ICC) to determine level of agreement. RESULTS: Overall scores for target ADRs ranged from 19.5 to 44 points (33-73% of maximum possible score). Cisplatin-induced ototoxicity, a frequent and severe ADR, received the highest score (44). Lower scores were obtained for abacavir-induced hypersensitivity (19.5) and methotrexate-induced neutropenia (28). High agreement was observed between the scientific, feasibility, and total scores from two reviewers (ICC values = 0.895, 0.980, and 0.983, respectively). CONCLUSION: Application of APT enables simple and direct comparison of potential study targets for research groups embarking on pharmacogenomic investigation of ADRs. Research teams will be able to identify which study targets are best suited for their research environment and discern how to optimize resource allocation for successful discovery and replication of clinically relevant biomarkers.

Legislative and regulatory modernization for therapeutic products.

This presentation is intended to show how the work coming from scientists, physicians, and other healthcare professionals is incorporated into the regulatory assessment of therapeutic products in Canada. One of the primary objectives within the regulatory environment is to provide information back to healthcare professionals and patients in order to help them make informed decisions. The current regulatory system for health products in Canada and why it needs modernization is addressed; a "lifecycle approach" to the regulation of health products is presented; the Food and Consumer Safety Action Plan and Bill C-51, a bill to amend the Food and Drugs Act is reviewed; and the challenges and opportunities for Canada and its fellow regulators are examined.