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BACKGROUND: The introduction and operationalization of the Essential Medicines (EM) concept remains a major achievement of the WHO. This study assessed the current knowledge, utilization, and perception of the Essential Medicines programme in Nigeria. METHODS: This was a cross-sectional study conducted across six tertiary health institutions in Southern Nigeria from January to July 2018. A total of 750 semi-structured questionnaires were administered to doctors, pharmacists, and nurses. The information sought included the demographic characteristics of respondents, knowledge of definition of the essential medicines concept, date of launch at the national level, current edition, current use, the advantages and disadvantages of the EM List (EML). The data were analyzed qualitatively and presented descriptively as means (SD) and percentage frequencies. RESULTS: A total of 748 respondents (487 doctors, 208 nurses, and 53 pharmacists) participated in the study. Healthcare professionals' (HCP) knowledge of the EM concept and list was poor (15%), as determined by their ability to define or describe the concept of the EML, with less than 3% of respondents aware of the current edition of the EML in use in Nigeria. Less than 20% of all respondents used the EML during their internship, with nurses using it the least and only 8% using it during their first year of practice. Over 70% of respondents could not identify notable advantages of the EML and only 14.6% agreed that the program had been successful in Nigeria. CONCLUSION: The initial global momentum following the introduction of the EM program appears to have declined with the new generation of HCPs, likely due to lack of educational reinforcement. This negatively impacts the drug use scenario within our healthcare system.

CONTEXTE: L'introduction et l'opérationnalisation du concept de médicaments essentiels (ME) restent une réalisation majeure de l'OMS. Cette étude évalue la connaissance, l'utilisation et la perception actuelles du programme des médicaments essentiels au Nigeria. METHODES: Il s'agissait d'une étude transversale menée dans six établissements de santé tertiaires du sud du Nigéria de janvier à juillet 2018. Au total, 750 questionnaires semi-structurés ont été administrés aux médecins, pharmaciens et infirmiers. Les informations recherchées comprenaient les caractéristiques démographiques, la définition du concept de médicaments essentiels, la date de lancement au niveau national, l'édition actuelle, l'utilisation actuelle, les avantages et les inconvénients de la liste des ME (LME). Les données ont été analysées de manière qualitative et présentées de manière descriptive sous forme de moyenne (SD) et de pourcentage de fréquences. RESULTATS: Un total de 748 répondants (487 médecins, 208 infirmiers et 53 pharmaciens) ont participé à l'étude. Les connaissances des professionnels de santé (PSS) sur le concept et la liste des LME étaient faibles (15%), comme le montre leur capacité à définir, fournir ou décrire le concept de LME, avec moins de 3% des répondants connaissant l'édition actuelle de la LME utilisée au Nigeria. Moins de 20% de tous les répondants ont utilisé l'EML pendant leur stage, les infirmières étant celles qui l'ont le moins utilisé, avec seulement 8% l'utilisant pendant leur première année de pratique. Plus de 70% des répondants n'ont pas pu identifier d'avantages notables de l'EML, et seulement 14,6% étaient d'accord pour dire que le programme a été une réussite au Nigeria. CONCLUSION: L'élan initial qui a suivi l'introduction du programme d'EM semble avoir diminué avec la nouvelle génération de HCP, probablement en raison du manque de renforcement éducatif. Cela a un impact négatif sur le scénario d'utilisation des médicaments au sein de notre système de santé. Mots-clés: Médicaments essentiels; Médicaments essentiels; Professionnels de la santé; Connaissances, Attitudes, Pratiques (KAP); Organisation mondiale de la santé (OMS); Nigeria.

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BACKGROUND: Systematic attention to adverse drug reactions (ADRs) started with the thalidomide disaster in the early 60s of the 20(th) century. In 1968 ten countries supported a spontaneous reporting system for ADR and collaborated with the WHO pilot research project for international drug monitoring. This survey was conducted to determine the level of awareness of resident doctors about ADRs reporting, the extent of their involvement in pharmacovigilance activities and to build a useful data base that will improve the quality of health care in Nigeria. SETTING: This cross-sectional observational survey was conducted in University of Benin Teaching Hospital (UBTH) and Irrua Specialist Teaching Hospital (ISTH), Lagos University Teaching Hospital (LUTH) and Lagos State University Teaching Hospital (LASUTH) in Edo and Lagos states, Nigeria, respectively. STUDY DESIGN / METHODS: A cross-sectional observational survey was used in this study. Total population under survey being 971 residents with the sample size of 350 statistically determined. RESULTS: The survey conducted revealed that 78.1% (258) of the respondents had inadequate knowledge about pharmacovigilance with 71.2% (235) unaware of the yellow forms for ADR reporting distributed by the National Agency for Food and Drug Administration and Control (NAFDAC). The respondents (92.4%) have observed ADRs in the course of their training and practice, yet only 25.5% of cases were reported. The reported cases (7.3%) were to the National Agency for Food and Drug Administration and Control. The study showed a statistically significant difference between the institution of respondents, knowledge and experience about pharmacovigilance (p < 0.05). CONCLUSION: There is marked under-reporting of cases and a low level of awareness about pharmacovigilance among resident doctors in Edo and Lagos states. This may be what obtains in other states in Nigeria.

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The modern treatment guideline of bronchial asthma recognize that combination of long acting beta2-agonists and inhaled glucocorticoids, enables better control of inflammation and symptoms of asthma than inhaled glucocorticoids only. These guidelines recommended that patients are educated to adjust their medication to their asthma severity using physician-guided self-management plans. However, many patients take a fixed dose of their controller medication and adjust their reliever medication to asthma symptoms Therefore, combination of formoterol and budesonide can be delivered at different dosing level without the need to change inhalers. This study examined whether asthma control improved if patients adjusted the maintenance doses(AMD) ofbudesonide/formoterol (Symbicort, 80/ 4.5 microg and 160/4.5 microg) according to asthma severity compared with traditional fixed dosing (FD) regimens. This was a prospective open randomized trial carried out in five teaching hospitals across Nigeria between 15th July 2002 and 15th July 2003. Patients with bronchial asthma who met the enrollment criteria were randomized to receive either adjustable dosing or fixed dosing for a period of twelve weeks. The results obtained at the start and the end of the study showed that budesonide/formoterol combination effectively achieved and maintained control of asthma. The adjustable dosing achieves more effective control compared to fixed dosing in terms of the number of patients that are redistributed to less severe forms of persistent asthma. The percentage of patients with intermittent asthma increased from 9.3% at randomization to 55.6% at the end of therapy with more patients at the AMD arm of treatment. Also for mild persistent asthma there was an increase from 20.4% to 24.1%. This showed that at the end of treatment, majority (79.7%) of the patients had intermittent and mild persistent asthma. The frequency of use of budesonide/formoterol in the two arms of treatment showed that patients in the adjustable groups used less number of inhalations of budesonide/formoterol for treatment on average of 2.5 inhalations per day compared to those on fixed dosing who used 4 inhalations per day (p = 0.0001). The number of times patients stayed awake because of asthma was noticed to be more reduced at the adjustable arm of treatment but this was of no statistical significance. It is therefore concluded, that budesonide/formoterol combination in a single inhaler is a simple, well tolerated, convenient treatment which provides effective control of bronchial asthma using a practical self-management plan consistent with current guidelines.

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BACKGROUND: Current treatment guidelines have clearly defined the central place and benefits of inhaled glucocorticoids in the management of bronchial asthma. However, compliance with therapy is often poor due to complexity of treatment regimens. Therefore, a single once daily regimen with a simple device, the turbuhaler might be expected to result in improved compliance and better efficiency. STUDY DESIGN: This was a prospective open randomized trial with parallel groups conducted in five tertiary medical institutions. Asthmatic patients who met the enrolment criteria were randomized to receive either budesonide 400 microg daily or beclomethasone dipropionate 400 microg twice daily for eight weeks. RESULT: At the end of the study, both drugs were found to be effective in reducing the symptoms of asthma, reduction of beta2 agonist usage and improvement in lung function tests. However Budesonide Turbuhaler provided better effects in all parameters (p < 0.05). Both drugs were well tolerated. CONCLUSION: It is therefore concluded that Budesonide Turbuhaler administered once daily at a dose of 400 microg is more efficacious than Beclomethasone dipropionate 400 microg twice daily administered via pressurized metered dose inhaler.

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The efficacy and tolerability of Felodipine extended-release was compared with Nifedipine retard in the management of patients with mild-to-moderate hypertension. A total of one hundred and thirty three patients were screened out of which one hundred and twenty-one patients were enrolled in a 9-week multicentre open, randomised rising-dose trial to receive either Felodipine 5-10 mg once daily or Nifedipine 10-20 mg twice daily. Blood pressure was measured at the end of the dosing interval that is 24 hours and 12 hours after Felodipine and Nifedipine respectively. Both drugs, Felodipine and Nifedipine were found to lower blood pressure significantly compared with baseline. After three weeks of treatment, seated blood pressure was reduced by 20/14 mmHg (systolic/diastolic) and by 24/16 mmHg after 6 weeks in the felodipine group. Corresponding values in the Nifedipine group were 16/09 mmHg and 24/13mmHg. Pulse rate was not significantly affected by either drugs. The percentage of patients who had satisfactory control after 3 weeks treatment was 57.6% for Felodipine and 33.3% for Nifedipine (significant). After dose titration (where necessary), at the end of the study the response rates were 76.3% (n=45) and 79.6% (n=43) for Felodipine and Nifedipine respectively (non significant). Both drugs were metabolically inert and did not derange the haematologic and biochemical profile of patients. They produced no significant weight changes. The pattern of side effects were similar in both groups but tended to be more severe with Nifedipine necessitating withdrawal of two patients in this group. In conclusion, Felodipine ER 5mg - 10mg once daily, and Nifedipine Retard, 20mg twice daily were equally effective medications for mild-to-moderate hypertension but Felodipine was better tolerated.

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The efficacy and safety of the oral leukotriene receptor antagonist Zafirlukast ('Accolate') was assessed as maintenance therapy for black (Nigerian) patients with mild to moderate asthma. A total of eighty-one patients aged 16-70 years were screened and sixty patients were enrolled in a 7-week multicenter open study to receive 20 mg of 'Accolate' twice daily. Those enrolled had FEV1 > or = 60%, reversibility > or = 15% and cumulative daytime asthma symptoms score > or = 10 over seven consecutive days before visit 2 to be considered eligible to receive trial therapy, and the patients were maintained on as required beta 2-agonist therapy. Efficacy was assessed by changes in symptoms, number of times beta 2-agonist was used and results of pulmonary function tests. Safety was assessed by adverse event experiences, results of laboratory tests and physical examination. At the endpoint, patients reported a statistically significant increase in lung function and a significant reduction in episodes of asthma symptoms either in the morning, day or night. The mean beta 2-agonist use was also statistically reduced over the weeks as treatment progressed while the cumulative daytime total asthma score showed a sharp decline following drug use. Change in symptoms, beta 2-agonist use and pulmonary function occurred within one week of Zafirlukast treatment and continued throughout the trial. Zafirlukast was well tolerated. Headaches and pneumonia were the only side effects in three patients and these were not considered to be related to trial therapy. No clinically significant changes were observed in laboratory test results, or on physical examination. We conclude that Zafirlukast ('Accolate') 20 mg b.d. is an effective and well tolerated medication for maintenance therapy in black (Nigerian) patients with mild-to-moderate asthma.

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