Vigilance Program Research Articles

Pharmacy Student Facilitation of Reporting of Adverse Drug Reactions in a Hospital.

Health Canada relies on health professionals to voluntarily report adverse reactions to the Canada Vigilance Program. Current rates of reporting adverse drug reactions (ADRs) are inadequate to detect important safety issues. To assess the impact of pharmacy student facilitation of ADR reporting by pharmacists at a tertiary care teaching hospital in Canada. The intervention of interest, implemented at one campus of the hospital, was facilitation of ADR reporting by pharmacy students. The students received training on how to submit ADR reports and presented information sessions on the topic to hospital pharmacists; the pharmacists were then encouraged to report ADRs to a designated student for formal reporting. Frequency of reporting by pharmacists at the intervention campus was compared with reporting at a control campus of the same hospital. Data were collected prospectively over a 6-month pilot period, starting in April 2015. During the pilot period, 27 ADR reports were submitted at the intervention campus, and 3 reports at the control campus. All student participants strongly agreed that they would recommend that responsibility for submitting ADR reports to the Canada Vigilance Program remain with pharmacy students during future rotations. Availability of a pharmacy student to facilitate reporting of ADRs may increase the frequency of ADR reporting and could alleviate pharmacist workload; this activity is also a potentially valuable learning experience for students.

Spontaneous adverse drug reaction reporting by patients in Canada: a multi-method study-study protocol.

Background Monitoring adverse drug reactions (ADRs) through pharmacovigilance are vital to patient safety. Spontaneous ADR reporting is one method of pharmacovigilance, and in Canada all reporter types admitted to report an ADR to the Canadian Vigilance Program at Health Canada. Reports are submitted to Health Canada by post, telephone, or via the internet. The Canada Vigilance Program electronically records submitted information to detect medication safety alerts. Although previous studies have shown differences between patients and healthcare professionals (HCPs) on the types of drugs and reactions reported, relatively little is known about the importance of patient reports to pharmacovigilance activities. This article proposed a multi-method approach to evaluate the importance of patient ADR reporting on pharmacovigilance activities, by systematically review the available literature, comparing patient—versus HCPs-generated ADR reports that were submitted to the Canada Vigilance Program, and exploring patient views and experiences regarding the Canadian ADR reporting system. MethodsGuided by a risk-perception theoretical lens, the proposed multi-methods research study will involve three phases. Phase I is a systematic review of all studies that analyse the factors influence ADR reporting by patients to the pharmacovigilance schemes. Phase II is a descriptive statistical analysis of all ADR reports received by the Canada Vigilance Program database between 1 January 2000 and 31 December 2014 from patients and HCPs to compare ADRs reported by patients with those reported by HCP reports in terms of ADR seriousness, ADR classification by system organ class, and the medication involved based on the anatomical therapeutic class system. In phase III, an interpretative descriptive approach will be used to explore patient’s views and experiences on ADR reporting and usability of the Canadian Vigilance ADR report. Participants will be purposefully selected to ensure diverse backgrounds and experiences. Interviews will be digitally-recorded, transcribed verbatim, and inductively analysed to identify themes. Patients will be interviewed until theoretical saturation is achieved. DiscussionFindings from this research will highlight the role of the patients in directly reporting ADRs, and provide information that may guide streamline and optimizing patient ADR reporting. Policy makers, public health officials, and regulatory agencies will require this critical information in order to improve medication safety in Canada and worldwide.

Migration of Franklin's Gull (Leucophaeus pipixcan) and its variable annual risk from wind power facilities across the Tehuantepec Isthmus

Almost the entire global population of the Franklin's Gull performs a great spring migration from wintering areas in South America to breeding areas in North America. During this journey, the birds must pass through Tehuantepec Isthmus (in Mexico), where consistent wind regimes have led to the establishment of economically important wind farm facilities. These artificial structures present a major collision risk to birds flying at low altitudes (i.e. of <80m, which is the maximum height of a wind turbine). Franklin Gull flight paths are erratic, something thought to be related to certain environmental variables. Identifying the factors that influence the height at which this species flies, in addition to determining the peak timing of migration, might provide wind farm operators with simple ways to reduce the risk of collision. Here, we extensively monitored the migratory behavior of this species near a wind farm in the Tehuantepec Isthmus during the spring of 2008, 2009, and 2011. Specifically we recorded bird numbers, the height at which birds flew, and environmental variables. We then performed Flexible Discriminant Analysis to identify the variables that most accurately explained the variation of flight heights. Wind direction was the most important variable that explained whether birds flew at higher or lower altitudes, with birds flying at lower altitudes against headwinds from the north, because of the effect of wind shear. The total number of migratory birds differed among years (8000–66,000), suggesting the necessity of long-term monitoring to assess potential impacts. A total of 34,619 individuals were recorded flying <80m – where collision is likely – however, the proportion of birds flying in this risk height was variable among years, ranging from 35 to 71%. The peak number of individuals consistently passed between late April and early May. Therefore, wind farm managers should implement vigilance programs that are primarily focused during the peak migration period and on days with north winds to reduce the risk of this gull species colliding with wind turbine machinery.

Adverse effects of immunoglobulin G therapy: thromboembolism and haemolysis.

Adverse effects of immunoglobulin G therapy: thromboembolism and haemolysis.

The Epidemiological Relevance of Family Study in Chagas Disease

The Epidemiological Relevance of Family Study in Chagas Disease

Body mass index kinetics and risk factors of malnutrition one year after radical oesophagectomy for cancer

Malnutrition is common after oesophageal cancer surgery. This study aims to investigate body mass index (BMI) kinetics and the risk factors of malnutrition among 1-year disease-free survivors after radical transthoracic oesophagectomy for cancer. From a prospective single-institution database, 118 1-year disease-free survivors having undergone a R0 transthoracic oesophagectomy with gastric tubulization between 2000 and 2008 were identified retrospectively. BMI values were collected at the onset of the disease (pre-treatment BMI), at the time of surgery (preoperative BMI), at postoperative 6 months and 1 year after oesophagectomy (1-year BMI). Logistic regression was performed with adjustment for confounders to estimate odds ratios of the factors associated with a 1-year weight loss (WL) of at least 15% of the pre-treatment body weight (BW). At the onset of the disease, 5 patients (4%) were underweighted (BMI < 8.5 kg/m&sup2;), 65 (55%) were normal (BMI = 18.5-24.9 kg/m&sup2;), 36 (31%) were overweighted (BMI > 25 kg/m&sup2;) and 12 (10%) were obese (BMI > 30 kg/m&sup2;). Mean pre-treatment, preoperative, postoperative 6-month and 1-year BMI values were 24.64 ± 4 kg/m&sup2;, 23.55 ± 3.8 kg/m&sup2;, 21.7 ± 3 kg/m&sup2; and 21.97 ± 4 kg/m&sup2;, respectively. One-year WL ≥ 15% of the pre-treatment BW was present in 29 patients (25%): 18 among the 48 patients (37%) with a pre-treatment BMI ≥ 25 and 11 among the 70 patients (15%) with pre-treatment BMI < 25 (P = 0.006). On logistic regression, initial overweighting was the sole independent prognosticator of 1-year postoperative WL of at least 15% of the pre-treatment BW (P = 0.039; OR: 2.96, [1.06-8.32]). Postoperative malnutrition remains a severe problem after oesophageal cancer resection, even in long-term disease-free survivors. Overweight and obese patients are the segment population most exposed to this postoperative malnutrition, suggesting that such surgery could have substantial bariatric effect. A special vigilance programme on the nutritional status of this sub-group of patients should be the rule.

Vigilance der Tierarzneimittel: Gemeldete unerwünschte Wirkungen im Jahr 2010

In 2010, we observed again an increase in the number of declarations reported to the vigilance system for veterinary medicinal products up to a total of 160. The species and drug classes reported remained the same as in previous years: the majority of adverse drug reactions (ADRs) concerned either dogs or cats and the most frequently involved drugs were either antiparasitic products or antiinfectives. Adverse reactions following reconversions and 8 cases of suspected allergic reactions following the use of amoxicillin-clavulanic acid combinations in dogs were reported. Additional enquiries were processed by the Swiss Toxicological Information Centre and transmitted to Swiss medic. 11 of these reported accidental ingestions of flavoured tablets in overdose by dogs and some cats. The vaccino vigilance program received 179 declarations following immunization against blue tongue disease as well as 82 declarations following the application of other vaccines. The vigilance system increases the chance to identify rare reactions or interactions and thereby contributes to the security of veterinary medicinal products.

Prognostic impact of weight loss in 1-year survivors after transthoracic esophagectomy for cancer

Malnutrition is common 1 year after esophageal cancer surgery. However, the prognostic impact of this malnutrition on long-term outcome has been poorly reported. This study aims at determining the potential effect on disease-free survival (DFS) of weight loss observed at 1 year in disease-free survivors after curative esophageal resection. From a prospective single-institution database, 304 patients having undergone a transthoracic esophagectomy with two-field lymphadenectomy and gastric reconstruction between 1996 to 2008 were identified. Patients who died during the postoperative course (n= 24), patients who died within the first postoperative year (n= 12), patients who presented with an early recurrence within the first postoperative year (n= 20), and those who were lost to follow-up (n= 22) were excluded from the study, as well as those for whom the follow-up was shorter than 1 year (n= 21). The remaining 205 patients constituted a homogeneous group of 1-year disease-free survivors after full postoperative work-up and formed the material of the present study. Body weight (BW) values were collected before any treatment at the onset of symptoms (initial BW) and 1 year after esophagectomy. A 1-year weight loss (1-YWL) exceeding 10% of the initial BW defined an important malnutrition. Impact of the 1-YWL ≥ or <10% of the initial BW on DFS was investigated. Logistic regression was performed to identify factors affecting DFS. The mean initial BW was 69.1 ± 12 kg, corresponding to a mean body mass index (BMI) of 23.8 ± 3 kg/m(2) . Preoperatively, 32 (15%) patients were in the underweight category (BMI < 20 kg/m2), 110 (54%) were in normal (BMI = 20-24 kg/m2), and 63 (31%) were in the overweight category (BMI ≥ 25 kg/m2). Mean 1-year BW was 63.5 ± 12 kg. 1-YWL was <10% of the initial BW in 92 patients (45%) and ≥ 10% in 113 patients (55%). Accordingly, 5-year DFS rates were 66% (median: 80 months) and 48% (median: 51 months), respectively (P= 0.005). On multivariate analysis, only three independent variables affected the DFS significantly: clinical N stage (cN) status (P= 0.007; odds ratio: 1.99, 1.2-3.3), incomplete resection (P= 0.008, OR: 3.6, 1.3-9.3), and 1-YWL ≥ 10% (P= 0.004, OR: 2.1: 1.2-3.4). 1-YWL of or exceeding 10% of the initial BW in 1-year disease-free survivors has a negative prognostic impact on DFS after esophagectomy for cancer. This information offers another view on the objectives of the perioperative nutritional care of these patients. Special vigilance program on the nutritional status in post-esophagectomy patients should be the rule.

Canada's own "Dr. Safety"

A Lifetime in Safety. Ed Napke. Uppsala Monitoring Centre; 2011. This compilation of previously published articles by Dr. Ed Napke, founder of the Canadian Adverse Drug Reaction (ADR) Reporting Program, is largely a chronicle of how the program, now called the Canada Vigilance Program, was

Statin-Associated Rhabdomyolysis: Is There a Dose-Response Relationship?

Background Statins have a well-established role in prevention of vascular events but are associated with muscle-related adverse events. The dose relationship with these adverse events is unclear. We present an original analysis of Canadian and US case reports of statin-associated rhabdomyolysis with a focus on dose response. A typical clinical case is also summarized. Methods All cases of statin-associated rhabdomyolysis reported to Health Canada's Canadian Vigilance Program and to the US Food and Drug Administration's Adverse Event Reporting System from 2004-2008 were analyzed by severity and dose equivalence. Canadian national statin utilization data from 2002-2007 were used to estimate the dose-related incidence of rhabdomyolysis corrected for levels of utilization. Results The clinical case illustrates well the potential severity of statin-induced rhabdomyolysis. Combined Canadian/US data revealed an average of 812 cases of statin-induced rhabdomyolysis reported annually with a mean patient age of 64.4 years (35.5% female). The worst outcomes reported were renal dysfunction in 17.0%, acute renal failure in 19.8%, dialysis in 5.2%, and death in 7.6%. Using 10 mg atorvastatin per day as the reference dose, the odds ratios of rhabdomyolysis were 3.8 (95% CI 2.3-6.6) for 40 mg/day atorvastatin dose equivalent and 11.3 (95% CI 6.4-20.4) for 80 mg/day atorvastatin dose equivalent. Conclusions The results of our adverse drug analysis suggest a dose-response relationship. Given the widespread use of statins, the ability to predict which patients will experience serious muscle-related harm is a research priority.

Patterns of Self-Medication with Medicinal Plants and Related Adverse Events - A South American Survey

Medicinal plants are useful as a natural therapy to treat minor illnesses, as gastrointestinal disorders or as topic antiinflammatories. Also, they have been increasingly used as a coadjuvant in cronic diseases as hypertension, diabetes or hyperlipidemias. Nevertheless, many of the plants have active principles which are contraindicated or need precaution in certain illnesses as coagulation disorders or in certain states as pregnancy or breastfeeding. In this review we had compiled the side-effects, precautions and interactions with other medicines of many plants which are used in self-medication in our region. A previous population study gave us information on the consumption of medicinal plants in 73 pharmacies of the Buenos Aires province, in Argentina. During a period of one year, there were 37102 self-medicated plants, while only 1532 were prescribed by the physician. Among the most frequently self-medicated plants are Malva sylvestris L., Matricaria chamomile L, and Quassia amara. Among the most frequently prescribed are also "malva" and "chamomile", Tilia cordata Mill. and Valeriana officinalis. Based in the most consumed medicinal plants in our region, we reviewed the risks of such plants and the precautions that should be taken for a rational use. Also, we detected 15 adverse-reactions reported by the pharmacists through a pharmaceutical vigilance program, which are described and analyzed here. The results of the study and other reports suggest that adverse reactions of herbal medicines could be avoided if preventing self-medication, and taking into consideration possible contraindications and interactions.

Comparison of integron-linked antibiotic resistance genes in strains ofSalmonellaspp. isolated from swine in Chile in 2005 and 2008

Salmonella spp. isolates obtained from healthy swine in 2008 were analyzed for antibiotic resistance phenotypes and genotypes. The resistance profiles of the 2008 isolates were compared with those of a Salmonella collection isolated from the same geographical area in 2005. The 2008 isolates consisted of strains that were 97% oxytetracycline resistant, 33.3% amoxicillin resistant, 31.8% amoxicillin- plus clavulanic acid resistant, 27.5% trimethoprim-sulfamethoxazole resistant, 17.3% streptomycin resistant, and 7.2% enrofloxacin-ciprofloxacin resistant. The presence of integrons and resistance genes and their topological association in resistant strains was assessed by PCR. The prevalence of class 1 integrons was the highest, at 46.2%, while class 2 integrons were present in 17.9% of the isolates. In strains that harboured class 1 integrons, we identified 3 different gene cassette arrangements; a single class 2 integron arrangement of dfrA1-sat1-aadA1 was found. Comparison of these results with data obtained from the 2005 isolates showed that Salmonella strains resistant to amoxicillin and amoxicillin plus clavulanic acid had clearly emerged over the span of 3 years, along with an increase in the prevalence of class 1 integrons and the acquisition of new gene cassette arrangements. These findings highlight the need for continual monitoring of regional isolates to establish more efficient vigilance programs that can address variations in resistance over short periods of time within the same geographical area.

Growing support for the Canada Vigilance Program

Growing support for the Canada Vigilance Program

Distribuição espaço-temporal da mortalidade por malformações congênitas e causas mal definidas, em estados da região centro-sul do Brasil

A investigação da distribuição espacial da mortalidade por malformações congênitas pode ser útil em programas de vigilância ambiental em saúde. Foram analisados os padrões espaço-temporais da mortalidade por malformações congênitas e causas mal definidas em Estados brasileiros (MS, MT, GO, MG, SP, PR, SC e RS) e no Distrito Federal, no período de 2000 a 2004. Os valores observados foram obtidos do Sistema de Informações de Mortalidade (SIM) do Ministério da Saúde. Foi utilizado um modelo bayesiano que rende interação espaço-temporal. Muitas microrregiões com baixas taxas para malformações congênitas tiveram valores elevados para causas mal definidas, sendo que os óbitos por causas mal definidas prejudicam a identificação de microrregiões com taxas de mortalidade por malformações congênitas acima do esperado, indicativas da existência de fatores ambientais de risco para estas doenças.

Natalizumab: benefit outweighs risk in selected patients with multiple sclerosis

Natalizumab: benefit outweighs risk in selected patients with multiple sclerosis

Implicaciones ambientales de la ejecución del Programa de Vigilancia Ambiental del proyecto de construcción de la Autovía Cantabria-La Meseta

Environmental Impact Assessment plays an important role on checking possible effects of several projects. This procedure ensures that the environmental implications of decisions are taken into account before the decisions are made. Prevention is used to further define mitigation measures that must be improved. So far and being part of the global procedure, vigilance and monitoring programs should be analyzed like one of the most important parts of the Environmental Impact Assessment. Since one of the specially relevant objectives of vigilance and monitoring is to check and audit mitigation measures effectiveness, it is high recommended to analyze the results of the application of those mitigation measures. In that way it is introduced this article where we analyze the vigilance and monitoring programs results from the Construction of a Highway on Middle North Spain.

Water quality management in the lower stretch of the river Ganges, east coast of India: an approach through environmental education

The lower tidal stretch of the river Ganges, known as Hugli (ca. 280 km), flows southward before entering the Bay of Bengal forming a vast mangrove-enriched estuarine delta called Sunderbans. Hugli estuary is a typical example of tide-dominated sink for contaminants from multifarious sources. This major important river is subjected to anthropogenic stress due to the socio-economic importance of these areas based on growth of industry, agriculture, aquaculture, port activities, fishing and tourism. The living resources have been degraded recently due to increases in population pressure, pollution and natural resource consumption to the extent of overexploitation. The present paper critically examines the physicochemical characteristics and level of dissolved heavy metals at three ecologically distinct zones along the course of the river – Babughat located in the eastern part of the metropolitan megacity Calcutta (140 km upstream from seaface), Diamond Harbor (70 km upstream from sea face) and Gangasagar positioned at the mouth of the Ganges estuary. Physicochemical characteristics of this partially mixed estuary are largely influenced by the interaction of seawater and discharge of riverine freshwater, annual precipitation and surface runoff. The levels of salinity, total dissolved solids, hardness and conductivity showed an increasing downward trend. Marked increase in biochemical oxygen demand (BOD) values (2.20–5.95 mg/l) was recorded in Babughat whereas correspondingly low values (0.75–2.82 mg/l) were noticed at Gangasagar. This can be attributed mainly due to huge organic load of untreated sewage from the twin city Howrah and Calcutta situated in the east and west of the river. Spatiotemporal distribution of heavy metals reveals a wide range of variations reflecting input of huge anthropogenic inputs associated with a number of physical and chemical processes. Levels of metals registered a seasonal pattern, with an increase during late monsoon months (September–October), a period characterized by low salinity and relatively low pH of the water. Elevated levels of dissolved Hg and Pb were also recorded in Babughat, with values ranging from 0.16 to 0.95 μg/ml and 0.017 to 0.076 μg/ml, respectively, this high values for Hg can be attributed to the discharge from pulp and paper manufacturing units and to atmospheric input and runoff of automobile emission for Pb. It was revealed that the socio-economic development of Calcutta, the most potential economic zone in India situated on the east bank of Hugli river, has had a significant impact on the water quality of this major river. The deterioration of water quality is directly related to nonfunctioning and malfunctioning of wastewater treatment plants and lack of environmental planning and coordination. To restore the ecological stability and economic vitality of this river, the following measures have been suggested: (i) strong vigilance programme is to be undertaken towards installation and maintenance of the wastewater treatment plants to check the flow of persistent contaminants in the river water and (ii) execution of legislation and mass awareness programmes are to be enacted to restore the sound health of the river. The authors urge that environmental education should be used as an effective tool for water resource management dealing with intricate and complex problems in the interaction between nature, technology and human beings.

Study of Tuberculosis Outbreaks Reported in Catalonia, 1998–2002

To analyze the characteristics of tuberculosis outbreaks declared under vigilance programs in Catalonia. Descriptive study of outbreaks from 1998 through 2002 for which reports were available. An outbreak was defined as 3 or more associated cases appearing within a year. For 2 health care regions, outbreaks for which there were full surveillance reports with contact tracing were compared to outbreaks identified but which had not been fully reported. Twenty-seven outbreaks were analyzed. Nineteen (70%) occurred within families. A total of 22 outbreaks were declared upon identification of the true index case and 5 upon detection of secondary cases. The mean annual incidence of outbreaks was 0.40/100,100 inhabitants. Most cases were in males 16 to 40 years of age and involved cavitary lesions and a clinically significant diagnostic delay. Twenty-seven outbreaks caused 69 secondary cases. A longer diagnostic delay was seen to correspond to a larger number of secondary cases (P=.08). In the 2 health care regions analyzed, full surveillance reports with contact tracing were issued for 2 of the 14 outbreaks detected (14.4%). Tuberculosis outbreaks are common but investigative follow-up is scarce. The size of the outbreak is related to the length of diagnostic delay. Rapid diagnosis, contact tracing, and the issuance of a public health report should be priorities in all outbreaks detected.

Water supply reservoirs vigilance program in Seville (southwest Spain): a useful tool for active water resource management

With nearly 30 years' experience of managing stored surface water for water supply, the Municipal Water and Sewage Company of Seville (EMASESA), has introduced a Water Supply Natural Resources Vigilance Program. It consists of four levels that are mutually complementary: early warning system; vigilance of raw water resources; research; and integration of limnological knowledge. Selecting the reservoir that should be used, intake depth, transfer strategies, etc, are some examples of active management that this Vigilance Program allows us to achieve. Guaranteeing high quality raw water resources, at all times, which therefore favours their treatment, is one of the priority objectives for EMASESA. This is because it not only has repercussions from an economic point of view but it also contributes to the efficient and sustainable use of water resources.

A GEOGRAFIA MÉDICA E AS DOENÇAS INFECTO-PARASITÁRIAS

Geography is a science that has as its objective the study of the earth surface, the landscape, the individuality of places, the spaces, man and environment relations and society, and nature relations. A different conception of Geography will be approached in this study. It deals with medical Geography which has as its objective the study of the Geography of diseases, in the light of the geographic knowledge, and the distribution and prevalence of those diseases in the earth surface. Medical Geography started with Hippocrates - with medicine history - when in 480 b.C the relation between environment agents and diseases had been already shown. This theory prevailed for more than two thousand years concerning to endemic and epidemic diseases. In the last decades of the nineteen century Medical Geography underwent to a decline with the introduction of the unicausality theory, which argued that once diseases specific etiologic agents were identified as well as their means of transmission, the prevention problems and also the disease heeling would be solved. For that reason works on Medical Geography were only published after 1900 although without much importance. Unicausality theory had its crisis started between the 1930s and 1950s when the concept of multicausality came back to the academy. According to the concept the disease is a process that occurs because of severalcauses such as physical, chemical, biological, environmental, social, economical psychological and cultural agents. For that reason Medical Geography intends to understand the organization process of the geographic space done by human society in the different times and places. The comprehension of this process is very important as it allows us to understand the role of geographic space organization in the genesis and in the disease distribution, so we can establish Health Environmental Vigilance programs.