Antidiabetics and antihypertensive medications use in Morocco: a pharmacoepidemiological descriptive study

Background: In Morocco, and many other African countries, there is a paucity of antihypertensive and antidiabetics use amongst the general population. Aim: To investigate the epidemiological profile of antihypertensive and antidiabetics use and analysis their adverse reactions. Setting: This study was conducted in the prefecture of Figuig, Morocco. Methods: A cross-sectional descriptive study. Data was collected using semi-structured questionnaire about their pharmacological treatment and presented using descriptive statistical analysis. Results: Sample of 244 subjects, predominantly women 58.15% (p < 0.03) composed of diabetic patients 56.96% (n = 139) and hypertensive patients 43.03% (n = 105). After adjustments, 60.24% of all patients were under monotherapy. The diabetics were being treated using the Biguanide class (26.92%), insulin (20.0%) and sulfonylureas (10.0%) while hypertensive patients were treated by Calcium Channel Blockers (27.36%), Angiotensin Converting Enzyme Inhibitors (21.05%), Angiotensin T-Blockers (16.84%), Diuretics (7.36%) and ß-adrenergic receptors blockers (3.15%). In total, 23.00% of all subjects have experienced negative side-effects, mostly, reported (90.38%) to health professionals and 23.52% of them have interrupted temporarily or try to change their treatment. Gastro-intestinal problems were the most adverse reactions reported (11.11%) followed by headache, dizziness and tinnitus (6.66%) and asthenia, feeling sick and feeling of faintness (5.33%). Conclusion: Managing diabetes and hypertension entails a lot of public challenges and requires more focus and interest, especially amongst the illiterate population in remote areas. Some of the suggested ways to help face the problem include the introduction of new innovative measures, systems of fellow-up and adverse reactions

Patient preferences and expectation for feedback on adverse drug reaction reports submitted in Ghana

Background: Personalized feedback received for spontaneous adverse drug reaction (ADR) reports serves as motivation for future reporting and the effectiveness of the feedback is dependent on the medium used in delivering the information. Objective: Explore expectation for feedback from patients on ADR reports submitted to the National Pharmacovigilance Centre (NPvC) in Ghana and the preferred medium for receiving the feedback information.Methods: Cross-sectional study using structured questionnaire administered through face-to-face interview from August to September 2016 to patients selected by convenience sampling. Pearson chi-square (Χ2) or Fisher's exact test was used to determine associations between background variables such as age, gender and level of education. Results: The response rate was 86.7% (n=442). Of the participants interviewed, 96.5% expected to receive feedback for ADR reports submitted. Age and level of education were the two variables significantly associated with patients' expectation for feedback. The preferred medium for receiving feedback in decreasing order of preference were, telephone call (60.4%), mobile phone short messaging services (23.0%), email (8.3%), face-to-face meeting (3.4%), personalized letter (3.4%) and publication in a newsletter (1.4%). Conclusion: Patients' expectation for receiving feedback for ADR reports submitted to the NPvC is in line with modern trends in communication. NPvC should explore these alternatives for providing feedback to patients. Thisstudy is limited to what patients' expectations and preferences were for receiving feedback on ADR reports submitted, additional study to further explore the type of information patients expect to be contained in the feedback will be useful to National Pharmacovigilance Centres

Retrospective clinical analysis of adverse drug reactions associated with antiretroviral therapy in Tlokwe district, South Africa

Background: South Africa has the highest number of patients on antiretroviral therapy (ART) globally. Various obstacles were identified that influence effective reporting of adverse drug reactions (ADRs) in resource-limited countries. This investigation aimed to identify, classify and analyse the prevalence of ART-related ADRs. Methods: This observational, quantitative and retrospective descriptive investigation utilised ADR forms completed by healthcare professionals in various healthcare facilities in the Tlokwe district, South Africa (January 2010 to December 2014). Descriptive and inferential analyses were carried out. Results: A total of 770 ART-related ADRs were included in the final analysis. The mean age was 40.1 (± 10.1%) years, with significantly higher ADRs reported in females (70.8%). In this study, 99% of the ADRs were reported by doctors. Abnormal fat distribution (58%), peripheral neuropathy (21.6%) and renal dysfunction (6.6%) were most frequently reported. Females presented with abnormal fat distribution and peripheral neuropathy at a significantly younger age (38.1 ± 4.6 vs. 43.4 ± 5.7 years, p < 0.0001 and 39.7 ± 1.1 vs. 45.1 ± 9.2 years, p < 0.001) respectively compared with males. Gender difference was practically significant (Cramer's V = 0.3) for all three of the major reported ADRs. Conclusions: Gender was highly dependent among the major reported ADR categories, and women presented with abnormal fat distribution and peripheral neuropathy at a significantly earlier age than males. This retrospective analysis can serve as aplatform for future ADR studies within this district. Sustainable and continuous efforts should be made to train and create more awareness among healthcare workers in this district

Vaccine Safety and Pharmacovigilance in the African Region

In recent years the WHO African Region has seen a growth in clinical development of new vaccines as well as their introduction into the national immunization programmes of many countries. Recognizing the critical need for vaccine safety and pharmacovigilance; WHO has been supporting individual and institutional capacity building in the Region to strengthen the monitoring and response to adverse events following immunization through implementation of the Global Vaccine Safety Blueprint. This framework is discussed along with general points about the importance of ensuring vaccine safety and the system needed to enable this. The article ends with a brief overview of the status of vaccine safety and pharmacovigilance and the key priorities for countries in the Region for the immediate future

A Pharmacovigilance Study of Adults on Highly Active Antiretroviral Therapy; South Africa: 2007-2011

Background: Of the 1.6 million South African people infected with human immunodeficiency virus (HIV); approximately 970;000 (55) have been initiated on HAART. Despite these numbers; very little has been published about the safety profile of antiretroviral (ARV) medicines in the country. This study was performed at the Medunsa National Pharmacovigilance Centre and aimed to describe the demographic characteristics of patients enrolled in the pharmacovigilance surveillance study; highly active antiretroviral therapy (HAART) initiation regimen patterns; reasons for regimen changes; and adverse effects of ARV medicines. Methods: A cohort study of HIV-infected individuals aged 15 years or older who were on ARV medicines was conducted at four sentinel sites. Results: After HAART initiation; with an average lapse of 17.8 months (range: 0 - 83.8 months); 2;815 patients were enrolled into the study. Results show that patients were observed for 1;606.2 person-years for pharmacy visits (collection of ARV medicines) and 817.1 person-years for clinical visits (consultation with the doctor). Females constituted 69.6 (1;958/2;815) of the study population. Almost all patients initiated HAART on first-line regimens (2;801/2;815). Some patients (6.7; 190/2;815) dropped out of the study after HAART initiation. Reasons for regimen changes were not recorded for 2.5(22/891) of the patients who changed regimens. The primary reason for regimen changes was drug-related toxicity (76.1; 678/891); mostly evident in patients taking first-line regimens. Adverse effects experienced by patients were polyneuropathy (24.0; 163/678); lipodystrophy (23.9; 162/678); neuropathy (10.6; 72/678); and suspected lactic acidosis (3.8; 26/678). Conclusion: The majority of prescribers complied with the HAART guidelines and initiated most patients on first-line regimens. However; adverse effects are evident in patients taking first-line regimens. We recommend that the Department of Health should introduce less toxic first-line ARV regimens. Future efforts will aim to initiate patients on HAART and enrol them into the study simultaneously to determine early risk profiles of ARV medicines

Les effets indesirables dus aux antibiotiques : etude retrospective sur trois ans au centre regional de pharmacovigilance de Sfax

Les effets indesirables aux antibiotiques constituent un reel probleme de sante publique. Dans ce travail; ont ete analyses la frequence; les types; les facteurs predisposant et la gravite des effets indesirables aux antibiotiques. Notre etude; de type retrospectif; porte sur les cas d'effets indesirables aux antibiotiques obtenus par notification spontanee au centre regional de pharmacovigilance de Sfax durant une periode de trois ans. Parmi 249 cas d'effets indesirables medicamenteux; 82 cas (32;93) ont ete lies aux antibiotiques. L'age variait de 5 a 86 ans. Il s'agissait de 55 femmes et de 27 hommes. Soixante dix effets indesirables lies aux antibiotiques (85.36) parmi 82 etaient de nature immunoallergique. Dans 60 cas (73.17); les patients avaient des antecedents medicaux: atopie; allergie medicamenteuse; maladies auto-immunes ou pathologies chroniques necessitant une polymedication. 54 patients (65.85) prenaient 3 medicaments ou plus. Les formes graves ont ete observees chez 12 patients parmi 82 (14.63). La polytherapie; les maladies chroniques et l'age avance sont des facteurs favorisant la survenue des effets indesirables aux antibiotiques. Nos resultats soulignent le risque augmente chez les sujets ayant un antecedent d'allergie a un antibiotique de developper une allergie a un autre antibiotique

Pharmacovigilance et impact du traitement preventif intermittent a la Sulfadoxine-pyrimethamine chez la femme enceinte a Selingue au Mali

Cette etude avait pour but d'evaluer l'impact du traitement intermittent preventif (TPi) et les effets adverses associes chez la femme enceinte vivant en zone hyperendemique de Selingue sur l'issue de grossesse. La pharmacovigilance a pour objet; la surveillance du risque d'effet indesirable resultant del'utilisation des medicaments et produits a traitements a la S-P aux femmes enceintes a des intervalles definis apres environ 18-20 semaines de grossesse. L'enquete sur le comportement et les attitudes pratiques (CAP) nous a permis d'interviewer 210 femmes enceintes vues en consultation prenatale au niveau des centres de sante du district sanitaire de Selingue. La quasi-totalite de nos femmes (99) affirme connaitre le paludisme et 84;8connaitre les signescliniques du paludisme (tableau 1). L'automedication etait pratiquee par 40des femmes enceintes. Une faible proportion des femmes affirment posseder des moustiquaires (8;6) tandis que 14;3affirment utiliser des moustiquaires impregnees d'insecticides. Le taux d'anemie severe etait de 30;5(Hb 7 g/dl) apres la premiere dose et de 13;3apres la seconde dose de S-P. Parallelement; le taux d'anemie moderee (Hb 7-9g /dl) a diminue de 54;8apres la premiere dose a 26;2apres la seconde dose. Ce taux d'anemie etait plus eleve chez les multigestes (32;1) comparees aux primigestes (21;7). Nous n'avons observe aucun cas d'echec therapeutique a la S-P ni d'infection placentaire dans notre etude. Le taux de prematurite etait de 3tandis que le taux du petit poids a la naissance etait de 17;6. Les effets secondaires etaient essentiellement des nausees et embarras gastrique (1;9a la 1e dose S-P et 1apres la 2e dose de S-P). Nous n'avons note aucun cas d'effets secondaires severes ni de malformations a la naissance des nouveau-nes. En conclusion; le TPi a la S-P a ete bien tolere par les femmes enceintes vivant a Selingue et presente tres peu de reactions secondaires mineures. La S-P est actuellement le seul antipaludique a dose unique qui possede un effet prolonge et qui a des proprietes ideales (cout faible; assez de donnees disponibles sur sa tolerance et sa facilite d'utilisation) pour une meilleure utilisation au cours de la grossesse.) affirme connaitre le paludisme et 84;8connaitre les signescliniques du paludisme (tableau 1). L'automedication etait pratiquee par 40des femmes enceintes. Une faible proportion des femmes affirment posseder des moustiquaires (8;6) tandis que 14;3affirment utiliser des moustiquaires impregnees d'insecticides. Le taux d'anemie severe etait de 30;5(Hb 7 g/dl) apres la premiere dose et de 13;3apres la seconde dose de S-P. Parallelement; le taux d'anemie moderee (Hb 7-9g /dl) a diminue de 54;8apres la premiere dose a 26;2apres la seconde dose. Ce taux d'anemie etait plus eleve chez les multigestes (32;1) comparees aux primigestes (21;7). Nous n'avons observe aucun cas d'echec therapeutique a la S-P ni d'infection placentaire dans notre etude. Le taux de prematurite etait de 3tandis que le taux du petit poids a la naissance etait de 17;6. Les effets secondaires etaient essentiellement des nausees et embarras gastrique (1;9a la 1e dose S-P et 1apres la 2e dose de S-P). Nous n'avons note aucun cas d'effets secondaires severes ni de malformations a la naissance des nouveau-nes. En conclusion; le TPi a la S-P a ete bien tolere par les femmes enceintes vivant a Selingue et presente tres peu de reactions secondaires mineures. La S-P est actuellement le seul antipaludique a dose unique qui possede un effet prolonge et qui a des proprietes ideales (cout faible; assez de donnees disponibles sur sa tolerance et sa facilite d'utilisation) pour une meilleure utilisation au cours de la grossesse

Les effets indesirables medicamenteux : experience de l'unite de pharmacovigilance de Monastir

Introduction : Les effets indesirables medicamenteux representent une cause importante de morbidite voire de mortalite. Notre etude a pour objectifs d'analyser les aspects epidemiologiques; cliniques et chronologiques des effets indesirables et de cerner les differents medicaments impliques dans l'apparition d'effets indesirables. Materiel et methodes : Etude retrospective portant sur toutes les observations notifieesa l'unite de pharmacovigilance de Monastir pendant 45 mois (de avril 2004 a decembre 2007). L'imputabilite medicamenteuse a ete etablie selon la methode de Begaud et al. Resultats : Nous avons ete sollicites pour etablir l'imputabilite medicamenteuse de 277 evenements. L'origine medicamenteuse a ete retenue pour 157 patients (56;6). Il s'agissait de 77 hommes et 80 femmes. L'age des patients a varie de 1 a 87 ans avec une mediane de 39 ans. La majorite des effets imputes aux medicaments etaient des manifestations cutanees (70;7) suivies des effets indesirables hepatiques (10;2). Les autres evenements etaient a type de syndrome pseudo parkinsonien; des reactions anaphylactiques et hematologiques. Les beta-lactamines etaient les plus incriminees aux manifestations cutanees (35); suivies des autres anti-infectieux (30). Conclusion : Nous avons mis en evidence une predominance des effets indesirables cutanes et une implication accrue des anti-infectieux dans la survenue de ces effets

Alertes sanitaires: quelques elements de pharmacovigilance

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Risques d'interactions medicamenteuses: 7 principes a observer pour une bonne pratique

Avant d'associer deux medicaments; il faut reflechir aux risques encourus par le patient; tout particulierement quand les effets indesirables lies a une interaction entre ces deux medicaments ont ete decrits. Le plus souvent; on est confronte au cas d'un traitement medicamenteux deja installe; auquel on envisage d'ajouter un autre medicament. Parfois; on est amene a retirer un medicament d'une association jusque-la bien supportee. Et ce retrait peut provoquer un desequilibre de posologie pour le medicament restant. D'autres fois; ce sont deux medicaments qui sont susceptible d'agir l'un sur l'autre qui sont administres en meme temps.Pour prevenir les effets indesirables par surdosage; par addition d'effets indesirables; ou encore par sous dosage et defaut d'efficacite; de l'un ou de deux medicaments de l'association; on peut guider sa pratique autour de 7 principes simples; mais fondamentaux