Assessment of a Pharmacovigilance Module: An Interventional Study on Knowledge, Attitude, and Practice of Pharmacy Students.

BACKGROUND: The aim of the study was to assess the impact of a pharmacovigilance module on the knowledge, attitude, and practice (KAP) of pharmacy students and elucidate their feedback on the module. METHODOLOGY: Bachelor of pharmacy students at Pokhara University, Nepal, were assessed for their baseline KAP on drug safety and related issues using a KAP questionnaire (Cronbach alpha 0.70) consisting of 25 questions. Students' baseline KAP was assessed and after that, they were grouped into either control (2nd and 4th year) or test (1st and 3rd year) groups. The later received the pharmacovigilance training in three 1-h sessions spread over 6 months at 0, 90, and 180 days; the sessions covered introduction to pharmacovigilance, theoretical aspects of pharmacovigilance, and adverse drug reaction reporting procedures. KAP scores and student feedback were analyzed at 5% significance level. RESULTS: A total of 124 students (control = 56 and test = 68) were studied. The median (interquartile ranges [IQRs]) of the baseline scores prior to grouping the students into control and test groups was 20 (18.25-21.00) for knowledge, 19.5 (18.00-21.00) for attitude/practice, and 39 (37.00-41.00) for the total score. Males (n = 81) had a slightly higher median score of 40 (37-42) than females (n = 43), who had a median score of 38 (36-41). The KAP score for the control group was 40 (38-42) at baseline, 42 (20-44) during first follow-up, 41.5 (40-44) during second follow-up, and 41 (39-44.5) during third follow-up. For the test group, upon intervention, the KAP scores improved from 39 (36.25-40.75) at baseline to 42 (39.50-44.00) at the 1st follow-up, 43 (41-45) at the 2nd follow-up, and 44 (42-45) at the 3rd follow-up (P < 0.001). The median feedback score (IQR) was 86 (81.5-90.0). CONCLUSIONS: Pharmacy students had good attitude/practice scores and relatively poor knowledge scores at baseline, which improved postintervention. Student feedback about the module was positive.

Impact assessment of pharmacist-supervised intervention on health-related quality of life of newly diagnosed diabetics: A pre-post design.

INTRODUCTION: Diabetics face a series of challenges that affect all aspects of their daily life. Diabetes related complications adversely affect patient's health-related quality of life (HRQoL). Knowledge and self-care skills of diabetics are corner stones to improve their HRQoL. OBJECTIVE: To assess the impact of pharmacist-supervised intervention on HRQoL of newly diagnosed diabetics using an Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire. MATERIALS AND METHODS: A pre-post comparison study was conducted among the control group (CG), test 1 group (T1G) and test 2 group (T2G) patients with three treatment arms to explore the impact of pharmacist-supervised intervention on HRQoL of newly diagnosed diabetics for 18 months. Patients' HRQoL scores were determined using ADDQoL questionnaire at baseline, 3, 6, 9 and 12-months. T1G patients received pharmacist's intervention whereas T2G patients received diabetic kit demonstration in addition to pharmacist's intervention. CG patients were deprived of pharmacist intervention and diabetic kit demonstration, and only received care from attending physician/nurses. Non-parametric tests were used to find the differences in an average weighted impact scores (AWIS) among the groups before and after the intervention at P ≤ 0.05. RESULTS: Friedman test identified significant (P < 0.001) improvement in AWIS among the test groups' patients. Differences in scores were significant between T1G and T2G at 6-months (P = 0.033), 9-months (P < 0.001) and 12-months (P < 0.001); between CG and T1G at 12-months (P < 0.001) and between CG and T2G at 9-months (P < 0.001) and 12-months (P < 0.0010) on Mann.Whitney U test. CONCLUSION: Pharmacist's intervention improved AWIS of test groups' diabetics. Diabetic kit demonstration strengthened the disease understanding and selfcare skills of T2G patients. Disease and self-care awareness among diabetics should be increased in Nepali healthcare system by involving pharmacists for better patient's related outcomes.

Assessment of the availability and rationality of unregistered fixed dose drug combinations in Nepal: a multicenter cross-sectional study.

BACKGROUND: The medications that are registered and available in a country are meant for the prevention and treatment of ailments and diseases. However, a lack of effective regulatory bodies and operative control mechanisms, especially in developing countries, promotes irrational and inappropriate use of medicines. This study aims to evaluate the availability and rationality of unregistered fixed-dose drug combinations (FDCs) in Nepal. METHODS: A snowball sampling method with visits to 20 retail pharmacies in each of five major cities in Nepal was used to assess the availability of unregistered FDCs. To justify the rationality of the FDCs obtained from these five cities, the toolkit developed by Health Action International Asia-Pacific (HAI-AP) was used. RESULTS: Altogether, 41 unregistered FDCs were obtained from the five cities. Among the total 41 FDCs, a majority were anti-inflammatory/analgesic/antipyretics. A maximum of eight drugs and a minimum of two drugs per combination were present among the total 41 FDCs, with a majority in the form of tablets followed by suspensions. The cost ranges from a minimum of 3.7 Nepalese Rupees (NRs) (= USD 0.05) to a maximum of 240 NRs (= USD 3.15). None of the FDCs fulfilled all the fundamental requirements as stated in the toolkit; thus, they were categorized as 'irrational'. CONCLUSIONS: Unregistered FDCs are available in the Nepalese pharmaceutical market. All the unregistered FDCs found in our study were 'irrational' as per the HAI-AP toolkit. Regulatory authorities should initiate strict monitoring and appropriate regulatory mechanisms to prohibit the use of unregistered and irrational FDCs.

Assessment of utilization pattern of fixed dose drug combinations in primary, secondary and tertiary healthcare centers in Nepal: a cross-sectional study.

BACKGROUND: Prescription practices, especially in South Asian countries, have come under investigation for quality. Although there have been no studies in Nepal that have analyzed the prescription pattern of FDCs for different levels of health care centers, several studies from Nepal and other countries in the region have revealed poor medicine use practices, including irrational use of fixed-dose drug combinations (FDCs). This research aimed at assessing the utilization pattern of FDCs among primary (PHC), secondary (SHC) and tertiary health care (THC) centers in Western region of Nepal. METHODS: A cross-sectional descriptive study was conducted at primary, secondary and tertiary health care centers in Western Nepal. One hundred prescriptions from each health care center were chosen through systematic random sampling. The International Network for Rational Use of Drug (INRUD) indicators were used to assess the rationality of prescribing. Both descriptive and inferential statistics were applied. The alpha level used was 0.05. RESULTS: At the PHC center, 206 medicines were prescribed, of which 20.0% were FDCs. Antimicrobials were the most prescribed FDCs (57.1%). The unit prices of all FDCs were below 100 Nepalese Price Rupees (NPRs). At the SHC center, 309 medicines were prescribed, and 30% were FDCs. Vitamins, minerals and dietary supplements were the most prescribed FDCs (25.8%). The costs of 63.5% of FDCs were below 100 NPRs. At the THC center, 33.5% of 270 medicines were FDCs. As at the SHC center, vitamins, minerals and dietary supplements were the most prescribed FDCs (40.6%). The costs of 50.5% of FDCs were below 100 NPRs. CONCLUSIONS: FDCs were used extensively at different health care centers. The number of prescription in private centers, following established guidelines and the essential drug list (EDL), was much lower. The cost associated with the utilization of FDCs was higher in private sectors compared to public health care centers. In certain cases, the use of FDCs was questionable, and this study found a low use of essential medicines. Education to improve prescription practices at different healthcare levels is recommended.

Does pharmacist-supervised intervention through pharmaceutical care program influence direct healthcare cost burden of newly diagnosed diabetics in a tertiary care teaching hospital in Nepal: a non-clinical randomised controlled trial approach.

BACKGROUND: Cost is a vital component for people with chronic diseases as treatment is expected to be long or even lifelong in some diseases. Pharmacist contributions in decreasing the healthcare cost burden of chronic patients are not well described due to lack of sufficient evidences worldwide. In developing countries like Nepal, the estimation of direct healthcare cost burden among newly diagnosed diabetics is still a challenge for healthcare professionals, and pharmacist role in patient care is still theoretical and practically non-existent. This study reports the impact of pharmacist-supervised intervention through pharmaceutical care program on direct healthcare costs burden of newly diagnosed diabetics in Nepal through a non-clinical randomised controlled trial approach. METHODS: An interventional, pre-post non-clinical randomised controlled study was conducted among randomly distributed 162 [control (n = 54), test 1 (n = 54) and test 2 (n = 54) groups] newly diagnosed diabetics by a consecutive sampling method for 18 months. Direct healthcare costs (direct medical and non-medical costs) from patients perspective was estimated by 'bottom up' approach to identify their out-of-pocket expenses (1USD = NPR 73.38) before and after intervention at the baseline, 3, 6, 9 and 12 months follow-ups. Test groups' patients were nourished with pharmaceutical care intervention while control group patients only received care from physician/nurses. Non-parametric tests i.e. Friedman test, Mann-Whitney U test and Wilcoxon signed rank test were used to find the differences in direct healthcare costs among the groups before and after the intervention (p ≤ 0.05). RESULTS: Friedman test identified significant differences in direct healthcare cost of test 1 (p < 0.001) and test 2 (p < 0.001) groups patients. However, Mann-Whitney U test justified significant differences in direct healthcare cost between control group and test 1 group, and test 2 group patients at 6-months (p = 0.009, p = 0.010 respectively), 9-months (p = 0.005, p = 0.001 respectively) and 12-months (p < 0.001, p < 0.001 respectively). CONCLUSION: Pharmacist supervised intervention through pharmaceutical care program significantly decreased direct healthcare costs of diabetics in test groups compared to control group and hence describes pharmacist's contribution in minimizing direct healthcare cost burden of patients.

A non-clinical randomised controlled trial to assess the impact of pharmaceutical care intervention on satisfaction level of newly diagnosed diabetes mellitus patients in a tertiary care teaching hospital in Nepal.

BACKGROUND: Patient satisfaction is the ultimate goal of healthcare system which can be achieved from good patient-healthcare professional relationship and quality of healthcare services provided. Study was conducted to determine the baseline satisfaction level of newly diagnosed diabetics and to explore the impact of pharmaceutical care intervention on patients' satisfaction during their follow-ups in a tertiary care teaching hospital in Nepal. METHODS: An interventional, pre-post non-clinical randomised controlled study was designed among randomly distributed 162 [control group (n = 54), test 1 group (n = 54) and test 2 group (n = 54)] newly diagnosed diabetes mellitus patients by consecutive sampling method for 18 months. Diabetes Patient Satisfaction Questionnaire was used to evaluate patient's satisfaction scores at baseline, three, six, nine and, twelve months' follow-ups. Test groups patients were provided pharmaceutical care whereas control group patients only received their usual care from physician/nurses. The responses were entered in SPSS version 16. Data distribution was not normal on Kolmogorov-Smirnov test. Non-parametric tests i.e. Friedman test, Mann-Whitney U test and Wilcoxon signed rank test were used to find the differences among the groups before and after the intervention (p ≤0.05). RESULTS: There were significant (p < 0.001) improvements in patients' satisfaction scores in the test groups on Friedman test. Mann-Whitney U test identified the significant differences in satisfaction scores between test 1 and test 2 groups, control and test 1 groups and, control and test 2 groups at 3-months (p = 0.008), (p < 0.001) and (p < 0.001), 6-months (p = 0.010), (p < 0.001) and (p < 0.001), 9-months (p < 0.001), (p < 0.001) and (p < 0.001) and, 12-months (p < 0.001), (p < 0.001) and (p < 0.001) follow-ups respectively. CONCLUSION: Pharmaceutical care intervention significantly improved the satisfaction level of diabetics in the test groups compare to the control group. Diabetic kit demonstration strengthened the satisfaction level among the test 2 group patients. Therefore, pharmacist can act as a counsellor through pharmaceutical care program and assist the patients in managing their disease. This will not only modify the patients' related outcomes and their level of satisfaction but also improve the healthcare system.

Evaluation of academic detailing programme on childhood diarrhoea management by primary healthcare providers in Banke district of Nepal.

Academic detailing is rarely practised in developing countries. A randomized control trial on healthcare service was conducted to evaluate the impact of academic detailing programme on the adherence of primary healthcare providers in Banke district, Nepal, to childhood diarrhoea treatment guidelines recommended by World Health Organization/United Nations Children's Fund (WHO/UNICEF). The participants (N=209) were systematically divided into control and intervention groups. Four different academic detailing sessions on childhood diarrhoea management were given to participants in the intervention group. At baseline, 6% of the participants in the control and 8.3% in the intervention group were adhering to the treatment guidelines which significantly (p < 0.05) increased among participants in the intervention (65.1%) than in the control group (16.0%) at the first follow-up. At the second follow-up, 69.7% of participants in the intervention group were adhering to the guidelines, which was significantly (p < 0.05) greater than those in the control group (19.0%). Data also showed significant improvement in prescribing pattern of the participants in the intervention group compared to the control group. Therefore, academic detailing can be used for promoting adherence to treatment guidelines in developing countries, like Nepal.

Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal / Conocimientos, actitudes y prácticas de los profesionales de la salud hacia la farmacovigilancia en Nepal

Pharmacovigilance can be helpful in protecting consumers from harmful effects of medicines. Healthcare professionals should consider Adverse Drug Reaction (ADR) reporting as their professional obligation and should be aware of the existing pharmacovigilance mechanisms in their countries. In Nepal, pharmacovigilance activities were initiated in 2004. Objectives: The present study evaluated the knowledge, attitude and practices (KAP) of the healthcare professionals towards ADRs and pharmacovigilance in Manipal Teaching Hospital (MTH), a tertiary care teaching hospital attached to the regional pharmacovigilance center in western Nepal. Methods: A cross-sectional study was carried out in 2007 using a pretested (Cronbach alpha=0.72) questionnaire having 25 questions (15 questions on knowledge, 5 on attitude and 5 on practice). The correct/positive responses were given a score of ‘2’ and the wrong/negative responses ‘1’, maximum possible score of ‘50’. Results: A total of 131 responses were obtained among which 42 were incomplete and remaining 89 [females 49 (55.1%)] were analyzed. Of the 89 professionals, 29 (32.6%) were doctors, 46 (51.8) nurses and 14 (15.7%) pharmacists. The mean age was 28.32 (SD=8.46) years and the median (interquartile range) of duration of the service 14.5 (6-36) months. The total KAP scores was 40.06 (SD=3.51) for doctors, 38.92 (SD=4.83) for pharmacists, and 35.82 (SD=3.75) for nurses. Among the 89 professionals, 59 (62.3%) had not reported even a single ADR to the pharmacovigilance center. Conclusion: The healthcare professionals at the MTH had a poor KAP towards ADRs and pharmacovigilance and there is a need for educational and awareness intervention for these professionals (AU)

La farmacovigilancia puede ser útil para proteger a los consumidores de los efectos dañinos de los medicamentos. Los profesionales de la salud deberían considerar la comunicación de reacciones adversas de medicamentos (RAM) como una obligación profesional y deberían conocer los mecanismos de farmacovigilancia que existen en sus países. En Nepal, las actividades de farmacovigilancia comenzaron en 2004. Objetivos: El presente estudio evaluó el conocimiento, actitudes y prácticas (KAP) de los profesionales de la salud hacia las RAM y la farmacovigilancia en el Hospital Universitario de Manipal (MTH), un hospital universitario terciario ligado al centro regional de farmacovigilancia del Oeste de Nepal. Métodos: Se realizó un estudio transversal en 2007 usando un cuestionario pre-evaluado (alfa de Cronbach=0,72) que tenía 25 preguntas (15 sobre conocimiento, 5 sobre actitudes y 5 sobre práctica). A las preguntas correctas se les dio una puntuación de ‘2’ y a las respuestas incorrectas/negativas se les dio un ‘1’, con una puntuación máxima de 50. Resultados: Se obtuvieron un total de 131 respuestas de las que 42 estaban incompletas y las restantes 89 se analizaron [49 mujeres (55,1%)]. De los 89 profesionales, 29 (33,6%) eran médicos, 46 (51,8%= enfermeras y 14 (15,7%) farmacéuticos. La media de edad era de 28,32 años (DE=8,46) y la media (rango intercuartílico) de la duración en el servicio fue 14,5 meses (6-36). Las puntuaciones totales de KAP fueron 40,06 (DE=3,51) para médicos, 39,92 (DE=4,83) para farmacéuticos y 35,82 (DE=3,75) para enfermeras. Entre los 89 profesionales, 59 (62,3%) no comunicaron ni una sola RAM al centro de farmacovigilancia. Conclusión: Los profesionales de la saludo del MTH tienen pobre KAP sobre las RAM y la farmacovigilancia, y se necesita una intervención educativa y sobre el conocimiento para estos profesionales (AU)

Initiation of social pharmacy research in Nepal: our experiences.

Nepal experiences several medicine-use problems like any other developing country. In the recent years, there have been initiatives to introduce the concept of social pharmacy in Nepal, and there has been only a limited research in this area. The staff members at the Manipal College of Medical Sciences, Pokhara have shown keen interest in initiating several social pharmacy-related researches in the country. The members of this institute have been collaborating with two international universities, namely Universiti Sains Malaysia located in Malaysia and Chulalongkorn University located in Thailand, to get academic and technical supports. In this manuscript, the authors share their experiences in initiating social pharmacy research in the country. Authors have also mentioned the priority areas of social pharmacy research in Nepal and the importance of initiating this concept in the country.

Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal.

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Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal / Patrón y calidad de las comunicaciones científicas sobre seguridad de medicamentos producidas por un centro regional de farmacovigilancia en Nepal

Analyzing the pattern and quality of scientific communications on pharmacovigilance can help the regional centers in Nepal and other developing countries to develop approaches for communicating effectively medicine safety issues. This kind of research is lacking in developing countries. Objectives: To analyze the pattern and quality of scientific communications on drug safety produced by the regional pharmacovigilance center at western Nepal. Methods: Various conference abstracts and journal publications produced by the center during its initial four years of establishment (14th September 2004 till 13th September 2008) were identified. These communications were categorized in to case reports, review articles, conference presentations, short communications, newsletter and bulletin articles, original research and case series. In addition, the quality of the case reports were evaluated as per International Society of Pharmacovigilance/International Society of Pharmacoepidemiology (ISoP/ISPE) guidelines on the requirements for submitting case reports on adverse event reports in biomedical journals. Results: During the study period, 53 scientific communications were produced by the staff of the regional pharmacovigilance center in relation with drug safety. Among these, 18 (34%) were related to case reports and letters. The median (interquartile range) age of the patients described in the case reports was 46.5 (21.7-51.2) years. Among the total 18 ADRs, four were fixed drug eruptions, followed by contact dermatitis (n=2). Majority of the published case reports were related to skin (n=13; 72.2%). Antimicrobials were responsible for 27.8% (n=5) of the case reports. Among the 18 case reports published by the pharmacovigilance center, a majority followed the ISoP/ISPE guidelines. Few parameters like physical examination of the patient experiencing ADR, patient disposition, dosage and administration of the suspected drugs, and drug-reaction interface were missing in few of the cases. Conclusion: A high percentage of the scientific communications were «case reports». A high proportion of the case reports produced by the center were of international standards. There were lacunae in «patient disposition» in few of the reports (AU)

Analizar el patrón y la calidad de las comunicaciones científicas en farmacovigilancia puede ayudar a los centros regionales de Nepal y de otros países en desarrollo a desarrollar abordajes de comunicación efectiva de los problemas de seguridad de los medicamentos. Este tipo de investigación no existe en los países en desarrollo. Objetivos: Analizar el patrón y la calidad de las comunicaciones científicas sobre seguridad de medicamentos producidas por el centro regional de farmacovigilancia de Nepal oriental. Métodos: Se identificaron los resúmenes de conferencias y las publicaciones en revistas producidas pro el centro durante sus cuatro años iniciales desde el establecimiento (14 de septiembre de 2004 a 13 de septiembre de 2008). Estas comunicaciones fueron clasificadas en reporte de casos, artículos de revisión, presentaciones en conferencias, comunicaciones breves, newsletter y artículos de boletín, investigaciones originales y series de casos. Además, se evaluó la calidad de los reportes de casos según las guías requisitos para enviar a revistas biomédicas los reportes de casos sobre comunicaciones de eventos adversos de la International Society of Pharmacovigilance / International Society of Pharmaepidemiology (ISoP/ISPE). Resultados: Durante el periodo de estudio, se produjeron 53 comunicaciones científicas por el personal del centro regional de farmacovigilancia sobre seguridad de medicamentos. De estas, 18 (34%) estaban relacionadas con reportes de casos y cartas. La media (rango inter-cuartilico) de edad de los pacientes descritos en los reportes de casos fue de 46,5 (21,7 - 51,2) años. Del total de 18 RAM, 4 fueron erupciones de medicamentos, seguidas de dermatitis de contacto (n=2). La mayoría de los reportes de casos publicados estaban relacionados con la piel (n=13; 72,2%). Los antimicrobianos fueron responsables por el 27,8% (n=5) de los reportes de casos. Entre los 18 reportes publicados por el centro de farmacovigilancia, la mayoría siguió las guías de la ISoP/ISPE. En unos pocos casos faltaban algunos elementos como examen físico del paciente que sufrió la RAM, disposición del paciente, dosis y administración del medicamento sospechoso, y medio de la reacción medicamentosa. Conclusión: Un elevado porcentaje de las comunicaciones científicas eran reportes de casos. Una alta proporción de los reportes producidos por el centro seguían los estándares internacionales. Existe una laguna en «la disposición del paciente» en algunos de los reportes (AU)

Pattern of adverse drug reactions reported by the community pharmacists in Nepal / Patrón de las reacciones adversas comunicadas por farmacéuticos comunitarios en Nepal

The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists. Objectives: To collect the demographic details of the patients experiencing adverse drug reactions (ADR) reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs. Methods: The baseline Knowledge-Attitude-Practices (KAP) of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61) KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4) maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms. Results: Altogether 71 ADRs, from 71 patients (37 males) were reported. Antibiotics/ antibacterials caused 42% (n=37) of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22)]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20), followed by generalized edema [8.6 % (n=10)]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49) of the cases. Over two third (69%) of the ADRs had a «possible» association with the suspected drugs and a high percentage (70.4%) were of «mild (level 2)» type. Nearly two third [64.7 % (n=46)] of the ADRs were «definitely preventable». Conclusion: The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen/ Paracetamol combination use of the drug was responsible for more number of ADRs and the most common ADRs were related to dermatological system. Strengthening this program might improve safe use of medicines in the community (AU)

El programa de farmacovigilancia de Nepal tiene menos de una década de antigüedad, y está centrado en los hospitales. Este estudio muestra los resultados de un programa de farmacovigilancia comunitario, que involucra a farmacéuticos comunitarios. Objetivos: Recoger detalles demográficos del número de pacientes que sufren reacciones adversas a medicamentos (RAM) comunicadas por farmacéuticos comunitarios; identificar los medicamentos que causan las RAM y los tipos comunes de RAM; y realizar las evaluaciones de causalidad, gravedad y preventabilidad de las RAM reportadas. Métodos: Se evaluó, mediante un cuestionario validado (Cronbach alfa=0.61) 20 preguntas [(conocimiento 11, actitud 5 and práctica 4) máxima puntuación posible score 40], el valor inicial de Conocimiento-Actitudes-Práctica (KAP) de 116 farmacéuticos comunitarios del valle de Pokhara. Se selección a los 30 farmacéuticos comunitarios con puntuaciones más altas para realizar 3 sesiones formativas, cada sesión duraba de una a dos horas, que cubrían los conocimientos básicos que requerían los farmacéuticos para comunicar RAM. Los farmacéuticos del centro regional de farmacovigilancia visitaron a los farmacéuticos comunitarios formados en días alternos y recogieron las comunicaciones rellenas. Resultados: Se comunicaron 71 RAM de 71 pacientes (37 hombres). Los antibióticos/antibacterianos causaron el 42% (n=37) del total de RAM, seguidos de los antiinflamatorios no esteroidicos [25% (n=22)]. La combinación ibuprofeno/paracetamol totalizó 10 RAM. El tipo de RAM más frecuente fue el picor [17.2 % (n=20)], seguido del edema generalizado [8.6 % (n=10)]. Para resolver las RAM, el 69% del total de los pacientes (n=49) requirió tratamiento médico. Mas de 2 tercios de las RAM (69%) tenia una «posible» asociación con el medicamento sospechoso, y un alto porcentaje (70.4%) eran de tipo «suave (nivel 2)». Cerca de 2 tercios de las RAM [64.7 % (n=46)] eran «claramente prevenibles». Conclusión: El grupo más común que causo RAM fueron los antibacterianos/antibióticos. La combinación ibuprofeno/paracetamol fue responsable del mayor numero de RAM y las RAM más frecuentes estaban relacionadas con el sistema dermatológico. Reforzar este programa podría mejorar el uso seguro de medicamentos en la comunidad (AU)

Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal.

UNLABELLED: Analyzing the pattern and quality of scientific communications on pharmacovigilance can help the regional centers in Nepal and other developing countries to develop approaches for communicating effectively medicine safety issues. This kind of research is lacking in developing countries. OBJECTIVES: To analyze the pattern and quality of scientific communications on drug safety produced by the regional pharmacovigilance center at western Nepal. METHODOLOGY: Various conference abstracts and journal publications produced by the center during its initial four years of establishment (14th September 2004 till 13th September 2008) were identified. These communications were categorized in to case reports, review articles, conference presentations, short communications, newsletter and bulletin articles, original research and case series. In addition, the quality of the case reports were evaluated as per International Society of Pharmacovigilance/International Society of Pharmacoepidemiology (ISoP/ISPE) guidelines on the requirements for submitting case reports on adverse event reports in biomedical journals. RESULTS: During the study period, 53 scientific communications were produced by the staff of the regional pharmacovigilance center in relation with drug safety. Among these, 18 (34%) were related to case reports and letters. The median (interquartile range) age of the patients described in the case reports was 46.5 (21.7-51.2) years. Among the total 18 ADRs, four were fixed drug eruptions, followed by contact dermatitis (n=2). Majority of the published case reports were related to skin (n=13; 72.2%). Antimicrobials were responsible for 27.8% (n=5) of the case reports. Among the 18 case reports published by the pharmacovigilance center, a majority followed the ISoP/ISPE guidelines. Few parameters like physical examination of the patient experiencing ADR, patient disposition, dosage and administration of the suspected drugs, and drug-reaction interface were missing in few of the cases. CONCLUSION: A high percentage of the scientific communications were 'case reports'. A high proportion of the case reports produced by the center were of international standards. There were lacunae in 'patient disposition' in few of the reports.

Pattern of adverse drug reactions reported by the community pharmacists in Nepal.

UNLABELLED: The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists. OBJECTIVES: To collect the demographic details of the patients experiencing adverse drug reactions (ADR) reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs. METHODS: The baseline Knowledge-Attitude-Practices (KAP) of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61) KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4) maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms. RESULTS: Altogether 71 ADRs, from 71 patients (37 males) were reported. Antibiotics/ antibacterials caused 42% (n=37) of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22)]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20), followed by generalized edema [8.6 % (n=10)]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49) of the cases. Over two third (69%) of the ADRs had a 'possible' association with the suspected drugs and a high percentage (70.4%) were of 'mild (level 2)' type. Nearly two third [64.7 % (n=46)] of the ADRs were 'definitely preventable'. CONCLUSION: The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen/ Paracetamol combination use of the drug was responsible for more number of ADRs and the most common ADRs were related to dermatological system. Strengthening this program might improve safe use of medicines in the community.

Impact of educational intervention on the pattern and incidence of potential drug-drug interactions in Nepal / Impacto de una intervención educativa en el esquema e incidencias de interacciones medicamentosas potenciales en Nepal

Objective: To study the impact of educational intervention on the pattern and incidence of potential drug-drug interactions (DDIs). Method: All patients admitted to Internal Medicine wards of Manipal Teaching Hospital during the study period were included. Patient details were collected using a patient profile form and the datum from the filled forms was analyzed using Micromedex electronic database. An intervention was carried out through a presentation during clinical meeting and personal discussion. The target groups for the intervention included doctors and the nurses. Results: Altogether 435 patients during preintervention and 445 during postintervention were studied. The incidence of potential DDIs was 53% (preintervention) and 41% (postintervention) [chi-square =11.27, p=0.001]. The average number of drugs per patient was 8.53 (pre-intervention) and 7.32 (post-intervention) [t=3.493, p=0.001]. Sixty-four percent of the potential DDIs were of "Moderate" type and 58% had a "Delayed" onset in both the phases. Seventy percent of the potential DDIs during the pre-intervention phase and 61% during post-intervention phase had a "Good" documentation status. Pharmacokinetic mechanism accounted for 45% of the potential DDIs during pre-intervention and 36% in the post-intervention phase. Cardiovascular drugs accounted for 36% of the potential DDIs during pre-intervention and 33.2% during post-intervention phase. Furosemide was the high risk drug responsible for DDIs in both phases. The most common potential DDIs observed were between amlodipine and atenolol (4.82%) (preintervention) and frusemide and aspirin (5.20%) (postintervention). Conclusion: There was an association between potential DDIs and age, sex, and polypharmacy (AU)

Objetivo: Estudiar el impacto de una intervención educativa en el esquema y la incidencia de las interacciones medicamentosas potenciales (DDI). Método: Se incluyó a todos los pacientes que visitaron el servicio de medicina interna del Hospital Universitario de Manipal. Los detalles de los pacientes se recogieron utilizando un formulario de perfil de paciente y los datos fueron analizados utilizando la base de datos electrónica Micromedex. Se realizó una intervención mediante una reunión clínica y discusión personal. El grupo diana eran los médicos y los enfermeros. Resultados: Se estudiaron 435 pacientes durante la pre-intervención y 445 durante la post-intervención. Las incidencia de DDI potenciales fue del 53% (pre-intervención) y 41% (post-intervención) [chi cuadrado=11,27, p=0,001]. La media de medicamentos por paciente fue de 8,53 (pre-intervención) y 7,32 (post-intervención) [t=3,493, p=0,001]. El 64% de las DDI potenciales eran de tipo "Moderadas" y el 58% tenía una iniciación "Retrasada" en ambas fases. El 70% de las DDI potenciales durante la fase de pre-intervención y el 61% en la post-intervención tenían un estado de documentación "Bueno". Mecanismos farmacocinéticos contabilizaron el 45% de las DDI potenciales durante la pre-intervención y el 36 en la post-intervención. Los medicamentos cardiovasculares sumaron el 36% de las DDI potenciales durante la pre-intervención y el 33,2% en la post-intervención. La furosemida fue el de mayor riesgo de DDI en las dos fases. La DDI potencial más comúnmente observada en la pre-intervención fue entre amlodipino y atenolol (4,82%), y en la post-intervención fue entre furosemida y aspirina (5,29%). Conclusión: Existía una asociación entre DDI potencial y edad, sexo y polimedicación (AU)

Impact of educational intervention on the pattern and incidence of potential drug-drug interactions in Nepal.

OBJECTIVE: To study the impact of educational intervention on the pattern and incidence of potential drug-drug interactions (DDIs). METHOD: All patients admitted to Internal Medicine wards of Manipal Teaching Hospital during the study period were included. Patient details were collected using a patient profile form and the datum from the filled forms was analyzed using Micromedex electronic database. An intervention was carried out through a presentation during clinical meeting and personal discussion. The target groups for the intervention included doctors and the nurses. RESULTS: Altogether 435 patients during preintervention and 445 during postintervention were studied. The incidence of potential DDIs was 53% (preintervention) and 41% (postintervention) [chi-square =11.27, p=0.001]. The average number of drugs per patient was 8.53 (pre-intervention) and 7.32 (post-intervention) [t=3.493, p=0.001]. Sixty-four percent of the potential DDIs were of 'Moderate' type and 58% had a 'Delayed' onset in both the phases. Seventy percent of the potential DDIs during the pre-intervention phase and 61% during post-intervention phase had a 'Good' documentation status. Pharmacokinetic mechanism accounted for 45% of the potential DDIs during preintervention and 36% in the post-intervention phase. Cardiovascular drugs accounted for 36% of the potential DDIs during pre-intervention and 33.2% during post-intervention phase. Furosemide was the high risk drug responsible for DDIs in both phases. The most common potential DDIs observed were between amlodipine and atenolol (4.82%) (preintervention) and frusemide and aspirin (5.20%) (postintervention). CONCLUSION: There was an association between potential DDIs and age, sex, and polypharmacy.

Study of adverse drug reactions caused by first line anti-tubercular drugs used in directly observed treatment, short course (DOTS) therapy in Western Nepal, Pokhara.

OBJECTIVE: To study the Adverse Drug Reactions occurring during DOTS therapy and to assess their causality, severity and predisposing factors. METHOD: Patients undergoing DOTS treatment during the 5 month study period (20th January to 20th June, 2005) at the Regional Tuberculosis Center (RTC) in Pokhara, Western Nepal were studied. Patients and/or patient party were interviewed to detect occurrence of any ADRs during their visit to the DOTS center. Causality and severity assessment were carried out as per the 'Naranjo scale' and 'modified Hartwig and Siegel scale' respectively. Statistical analysis (Chi square test) was done to determine the predisposing factors. RESULTS: Totally 137 patients were studied among whom 54.74% (n=75) reported occurrence of ADRs. Total 29.33% of ADRs were reported by the age group 21- 30 years. Nearly half (49.33%) of the ADRs were reported by men and 33.33% were reported by the ethnic group of 'Gurungs'. Half (49.33%) of the patients were illiterate and 70.67% of the ADRs were classified as ADRs 'possibly' due to the suspected drugs and 93.33% were classified as 'mild (level 1)'. Isoniazid accounted for 49.3% of the ADRs. The most commonly reported ADR was tingling and burning sensation in hands and feet experienced by 32 (11.03%) patients. CONCLUSION: Occurrence of ADRs from antitubercular drugs was high in the population of Western Nepal. Further studies encompassing a wider population and covering different regions of Nepal are needed.

Drug utilization pattern in dental outpatients in tertiary care teaching hospital in western Nepal.

A high incidence of dental disease has been reported in Nepal. Previous studies, both in the Manipal Teaching Hospital, Pokhara, Nepal, and other centers revealed problems in the use of medicines in dentistry. A number of initiatives to improve prescribing have been carried out. The study presented here was undertaken to assess the impact of these initiatives on drug utilization among dental outpatients. The study was conducted among patients attending the dental outpatient department of the hospital over a six-month period. Demographic details were studied. The drug classes and individual drugs prescribed were recorded. The cost of drugs was calculateS using the outpatient pharmacy price list. The prescriptions were analyzed using the WHO/INRUD prescribing indicators. Anomalies were noted in prescribing. Improvement was noted in certain parameters compared to previous studies. The educational initiatives should be strengthened. Managerial interventions can be considered. Further studies are required.

Science attitudes and knowledge among preclinical medical students in Pokhara, Nepal.

Knowledge of science and the scientific method are important in learning about and using evidence-based medicine in practice. Courses in research methodology have been introduced for both medical students and practicing doctors. In Pokhara, the basic science subjects are taught in an integrated manner during the first four semesters of the undergraduate medical course. Studies on students' attitudes towards and knowledge of science are lacking in medical colleges in Nepal. Hence the study was carried out to obtain information on students' attitude towards and knowledge of science and scientific methodology among preclinical medical students and note the association, if any, of students' attitudes and their demographic characteristics. The study was carried out in March 2005 among the students of the first four semesters at the Manipal College of Medical Sciences, Pokhara, Nepal using a questionnaire developed by Hren and coworkers. Two hundred and twenty students (overall response rate 73.3%) successfully completed the questionnaire. Seventy-five respondents were Nepalese, 115 were Indians, 27 were Sri Lankans and 3 belonged to other nationalities. The X +/- SD total attitude score was 147.4 +/- 10.8 (neutral score 135). The X +/- SD scores on the subscales, value of science to humanity, value of scientific methodology and value of science to medicine were 51.3 +/- 5.4, 39.6 +/- 3.7 and 58.5 +/- 5.9 (neutral scores were 36, 51 and 48 respectively). The knowledge score measured using a set of 8 multiple choice questions was 3.3 +/- 1.4. The attitude scores were lower and the knowledge score was comparable to that reported previously in a study in Croatia but higher than that reported from Southeast Europe.