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Papers by amina tebaa

Journal of Allergy and Therapy, 2019

Fixed drug eruption is the only pathognomonic clinical form of cutaneous drug reaction. It is an ... more Fixed drug eruption is the only pathognomonic clinical form of cutaneous drug reaction. It is an eruption made of one or few centimetric lesions, relapsing in the same area and leaving residual pigmentation. The bullous forms of fixed pigmented erythema are rare but can be serious in case of generalized forms. The management of this situation is based on the immediate interruption of the suspected drug, the notification to pharmacovigilance, and the hospitalization in case of extended forms with symptomatic treatment. The prevention consists in the identification and total eviction of the responsible drug. We report a rare and original case of bullous fixed drug eruption in an adult, and we discuss its diagnosis, management and prognosis.

Section 5: Patient safety and quality assurance, 2018

Background Lyell’s syndrome is one of the most severe mucocutaneous diseases, which can be life-t... more Background Lyell’s syndrome is one of the most severe mucocutaneous diseases, which can be life-threatening. However, it is rare, with a child mortality rate estimated at 7.5%. Purpose We report a case of a child who developed Lyell’s syndrome after taking carbamazepine and who was aggravated by amoxicillin, and the result of the causality assessment of the adverse drugs reaction. Material and methods A 12-year-old boy with no significant pathological history presented 20 days after taking carbamazepine, conjunctivitis and cheilitis. On the same day, the child presented with a fever and rapidly widespread generalised erythematous lesions after taking amoxicillin, which led the doctor to prescribe aspirin. The lesions evolving in a context of alteration of the general state and a fever measured at 39°C, necessitated the hospitalisation of the child. The skin histology revealed a toxic epidermal necrosis leading to Lyell’s syndrome. The diagnosis of Lyell’s syndrome of drug origin was confirmed by the anamnestic, clinical and histological elements. After a hospital stay of 21 days and symptomatic treatment, the evolution was favourable. Results In response to this acute toxidermia, we conducted a drug investigation to establish the causality assesment of the adverse drugs reaction according to French pharmacovigilance rules by the Poison Control and Pharmacovigilance Centre. After eliminating any infectious origin, the results showed that the intrinsic imputability was an I2 score for carbamazepine, an I1 score for amoxicillin and the extrinsic imputability was a B4 score for both drugs. However, the occurrence of Lyell’s syndrome is probably due to the intake of carbamazepine manifested by conjunctivitis, cheilitis and influenza-like illness at the beginning of its installation, resembling an infection leading to a prescription of amoxicillin which caused an aggravation of Lyell’s syndrome, which can be further potentiated by aspirin. Conclusion This observation illustrates the importance of the awareness of pharmacists and doctors of the risks of drug prescription that can cause Lyell’s syndrome, particularly carbamazepine. Thus, management should be systematic with any post-drug dermatological symptoms in order to prevent and further reduce the incidence of this condition and to improve the vital prognosis. Reference and/or Acknowledgements 1. Roujeau, et al. Toxic epidermal necrolysis. Journal of the American Academy of Dermatology1990;23(6):1039–1058. No conflict of interest

E3S web of conferences, 2021

On March 23, 2020, the Moroccan Ministry of Health issued a circular authorizing the off label us... more On March 23, 2020, the Moroccan Ministry of Health issued a circular authorizing the off label use of hydroxychloroquine or chloroquine in combination with azythromycin as first-line treatment for all COVID-19 patients. The aim of this study is to detect, assess and manage safety signals from individual cardiovascular adverse events (AE) reported. Methods: During the COVID19 pandemic, pharmacovigilance surveillance was based on spontaneous targeted notification in all health facilities. Newsletters with a suitable reporting form were sent and reporting of AEs was mandatory. The AEs collected were analyzed for causality assessment using the WHO method and the Preventavility method was used to detect any preventable ADR. Safety signals were detected and analyzed using a qualitative pharmacovigilance method. Results: As of December 31, 2020, a total of 527 adverse events have been reported to the NPC related to Hydroxychloroquine or Chloroquine among the Covid 19 patients. We received 09 cases of preventable AEs related to medication error including one drug interaction for 3 cases, dose errors for 5 cases and one case with both errors, these cases have been validated ad managed as safety signals. Discussion and conclusion: The detected signal concerned the QT prolongation, hypokalaemia and arrythmias, due to high dose of azithromycin and to drug interactions with hypokalaemic drugs. The signal was analyzed and validated during the technical committee, and recommendations were established to avoid the occurrence of similar cases.

To evaluate the frequency and severity of associated local reactions to BCG a retrospective study... more To evaluate the frequency and severity of associated local reactions to BCG a retrospective study was conducted on the notified in Moroccan Centre Anti Poison and Pharmacovigilance. During this period, 295 cases have been reported following vaccination with BCG local nature Males were the most concerned with 57%. Infants are much more represented (61%) than other age groups. The most local reactions are observed: becegites (37%), abscesses (20%), rash (16%), ulcers (15%), and fistula (12%). Accompanying signs of these local reactions are usually represented by a fever (6%) and lymphadenopathy (2%). BCG was injected intradermally in 87% of cases, followed by the intramuscular route (8%) and the subcutaneous route in 5% of cases. According to the classification of severity of the WHO ART, these reactions were severe in 18% of cases,

Archives Des Maladies Professionnelles Et De L Environnement, Feb 1, 2020

Objectif La presente etude vise a determiner les principaux effets indesirables survenant apres l... more Objectif La presente etude vise a determiner les principaux effets indesirables survenant apres l’injection du vaccin BCG contre la tuberculose chez l’enfant au Maroc. Methodes Il s’agit d’une etude retrospective descriptive des effets indesirables du vaccin BCG chez l’enfant de moins de 4 ans, notifies au CAPM, durant la periode 2010–2012. Resultats Durant cette periode, 194 declarations ont ete enregistrees, soit en moyenne 27 declarations/an. Les effets indesirables les plus observes sont generalement : becegites (53 %), abces (26 %), inflammation (8 %), tumefaction (6 %), suppuration (3 %), … Le sex-ratio (M/F) est de 1,3. Les nourrissons sont les plus touches avec une frequence de 91 %. Les reactions sont moderees dans 79 % des cas, severes dans 11 % des cas et graves dans 4 % des cas. L’evolution etait favorable pour 92 % des cas, pour le reste, l’evolution est non precisee. Conclusions Le vaccin BCG provoque des effets indesirables surtout de nature locale, la declaration au CAPM par les professionnels de sante est necessaire pour detecter les signaux emergents et pour surveiller l’innocuite des vaccins.

Archives Des Maladies Professionnelles Et De L Environnement, Feb 1, 2020

Objectif Le present travail consiste a dresser le profil epidemiologique du necrolyse epidermique... more Objectif Le present travail consiste a dresser le profil epidemiologique du necrolyse epidermique declare au Centre antipoison et de pharmacovigilance du Maroc (CAPM). Materiel et methodes Il s’agit d’une etude retrospective descriptive des cas spontanes du (NE), notifies au CAPM entre 2004 et 2013. Un total de 37 cas du (NE) a ete declare au CAPM, dont 84 % des cas sont des cas graves. Resultats L’âge moyen des patients etait de 47 ± 2,6 ans. Le sex-ratio (F/M) est de 4 (χ2 = 52 ; p La relation de cause a effet selon la methode de l’imputabilite de l’OMS est probable dans 51 % des couples, possible dans 38 % des couples, certaine dans 8 % des couples et inconnue dans 3 %. L’evolution est favorable dans 51 % des cas, 8 % ont gueri avec des sequelles, fatale dans 22 % des cas, alors que cette evolution est restee indeterminee dans 19 % des cas. Conclusion La necrolyse epidermique est l’urgence dermatologique la plus grave, qui impose une declaration obligatoire a la pharmacovigilance. Neanmoins une sensibilisation de la population sur les risques lies a l’automedication et des medecins aux risques de la prescription medicamenteuse irreflechie reste le meilleur moyen de prevention.

Section 6: Education and Research, 2019

Section 5: Patient safety and quality assurance, 2018

Background Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) was first descr... more Background Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) was first described for anticonvulsant drugs and the same symptoms were subsequently observed with a variety of other drugs such us anti-inflammatory drugs. An effective approach for objective causality assessment is necessary to make consistent and accurate identification of this adverse drug reaction (ADRs). Purpose To evaluate the incidence and the clinical characteristics of DRESS syndrome associated with anti-inflammatory drugs and the causality assessment for estimating the strength of relationship between drug(s) exposure and occurrence of ADR. Material and methods The database of the national pharmacovigilance centre (NPC) was used from January 2008 to January 2016 and the WHO causality assessment method was used as a tool for the clinical assessment of ADRs. Results Of the 72 reports of DRESS syndrome recorded in the NPC during 8 years, we reviewed 16 reports coded DRESS associated with anti-inflammatory drugs (22.2% of all patients) and which meet the inclusion criteria. The average age was 27 years and 56.2% were in males. The average time to DRESS onset after the start of administration of the suspected drug was 18 days. The outcome was serious in 14 cases (87.5%). The most common causative agents were prednisolone (31.2%) and ibuprofen (12.5%). Clinical presentation: fever 100%, skin rash 100%, 82% eosinophilia, lymphadenopathy 22%, cheilitis 12.5% and an altered state of consciousness 12.5%. For causality assessment: 57.7% of suspected drugs had a ‘Possible’ score and 42.1% had ‘Probable’ score. Conclusion In this retrospective study, prednisolone was the major case of DRESS syndrome and an altered state of consciousness were associated, and cheilitis with indometacin, although all patients recovered after corrective treatment. References and/or Acknowledgements 1. Bannwarth B. Critères d’imputabilité des effets indésirables des médicaments. Revue du Rhumatisme Monographies2010;77(2):173—5. 2. Akarin Hiransuthikul, Thanapoom Rattananupong, Jettanong Klaewsongkram, et al. Drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS): 11 years retrospective study in Thailand. Allergology International2016;65:432–438. No conflict of interest

Section 5: Patient safety and quality assurance, 2018

Genetic Testing and Molecular Biomarkers, Nov 1, 2016

Aim: Isoniazid (INH) is the most effective drug used as first-line tuberculosis (TB) treatment be... more Aim: Isoniazid (INH) is the most effective drug used as first-line tuberculosis (TB) treatment besides rifampicin, pyrazinamide, and ethambutol. It is also the most commonly associated with hepatotoxicity. Differences of toxicity induced by INH have been attributed to genetic variability of the N-acetyltransferase 2 (NAT2) gene which encodes a drug-metabolizing enzyme. The aim of this study was to characterize the acetylation profile of patients who developed hepatotoxicity after TB treatment by genotyping NAT2 polymorphisms. Patients and Methods: This study included 42 Moroccan patients who developed hepatotoxicity after TB treatment and 163 Moroccan controls without TB. We genotyped four selected variants of the NAT2 gene (NAT2*5, NAT2*6, NAT2*7, and NAT2*14) by Sanger sequencing for patients and real-time polymerase chain reaction for controls. Results: The majority of patients had NAT2 genotypes previously described as slow acetylators including NAT2*5/*5, NAT2*5/*6, NAT2*6/*6, and NAT2*6/*14 (78%) and none were genotyped as rapid acetylators. Controls were slow, intermediate, and rapid acetylators with frequencies of 72.39%, 21.48%, and 6.13%, respectively. Conclusion: There were no fast acetylator genotypes found among the patients having INH-hepatotoxicity. This finding suggests that slow acetylator phenotype may contribute to the development of TB treatment hepatotoxicity.

Naunyn-Schmiedeberg's Archives of Pharmacology

Therapeutic Advances in Vaccines and Immunotherapy, 2022

Background: A vaccination campaign against pandemic influenza A/H1N1 was implemented in Morocco b... more Background: A vaccination campaign against pandemic influenza A/H1N1 was implemented in Morocco between November 2009 and April 2010. Overall, 705,883 subjects were vaccinated by Pandemrix, Arepanrix, and Panenza. The adverse events following immunization (AEFIs) data comparison was made with the 2014/2015 seasonal influenza vaccination campaign that was specifically investigated. Aim: To evaluate the safety of the 2009 pandemic influenza A/H1N1 vaccine and to compare it to that of 2014 seasonal influenza vaccine. Methods: During the pandemic vaccination campaign, the Morocco Pharmacovigilance Centre reinforced passive AEFI surveillance with an active and prospective monitoring programme of 1000 immunized people over 6 months at 10 randomly selected vaccination centres. For the 2014/2015 seasonal vaccination campaign, AEFI data were collected from spontaneous notifications. Results: Active monitoring of 2009 pandemic collected 771 AEFI reports, corresponding to an AEFI incidence rat...

Archives des Maladies Professionnelles et de l'Environnement, 2020

Objectif La presente etude vise a determiner les principaux effets indesirables survenant apres l... more Objectif La presente etude vise a determiner les principaux effets indesirables survenant apres l’injection du vaccin BCG contre la tuberculose chez l’enfant au Maroc. Methodes Il s’agit d’une etude retrospective descriptive des effets indesirables du vaccin BCG chez l’enfant de moins de 4 ans, notifies au CAPM, durant la periode 2010–2012. Resultats Durant cette periode, 194 declarations ont ete enregistrees, soit en moyenne 27 declarations/an. Les effets indesirables les plus observes sont generalement : becegites (53 %), abces (26 %), inflammation (8 %), tumefaction (6 %), suppuration (3 %), … Le sex-ratio (M/F) est de 1,3. Les nourrissons sont les plus touches avec une frequence de 91 %. Les reactions sont moderees dans 79 % des cas, severes dans 11 % des cas et graves dans 4 % des cas. L’evolution etait favorable pour 92 % des cas, pour le reste, l’evolution est non precisee. Conclusions Le vaccin BCG provoque des effets indesirables surtout de nature locale, la declaration au CAPM par les professionnels de sante est necessaire pour detecter les signaux emergents et pour surveiller l’innocuite des vaccins.

This case concerns a 14-month-old girl weighing 16 kg who developed green urine 10 hours after ad... more This case concerns a 14-month-old girl weighing 16 kg who developed green urine 10 hours after administration of Propofol (2 mg/kg/h) for sedation in the intensive care unit, without medical background, Normalization of urine color 6 hours after stopping the propofol infusion has been observed.

The objective of this work is to demonstrate the interest of integration of pharmacovigilance in ... more The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP). Design and Data Collection. The integration of pharmacovigilance in MTCP was conducted in October 2012 with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010-October 2012; period 2: October 2012-December 2013). The detection of signals was based on the Information Component available in VigiMine. We used the SPSS version 10.0 and MedCalc version 7.3 for data analysis. Results. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (< 10 −3). The average age was 40.7 ± 17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7%) predominated during the first period, while skin reactions (24.1%) were in the second period (= 10 −4), and 40.9% of cases in the first period were serious against 15.8% in second period (= 0.003). Nine signals were generated (hepatic enzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting). Conclusion. The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs.

Genetic testing and molecular biomarkers, 2016

AIM Isoniazid (INH) is the most effective drug used as a first-line tuberculosis (TB) treatment b... more AIM Isoniazid (INH) is the most effective drug used as a first-line tuberculosis (TB) treatment besides rifampicin, pyrazinamide, and ethambutol. It is also the most commonly associated with hepatotoxicity. Differences of toxicity induced by INH have been attributed to genetic variability of the N-acetyltransferase 2 (NAT2) gene which encodes a drug-metabolizing enzyme. The aim of this study was to characterize the acetylation profile of patients who developed hepatotoxicity after TB treatment by genotyping NAT2 polymorphisms. PATIENTS AND METHODS This study included 42 Moroccan patients who developed hepatotoxicity after TB treatment and 163 Moroccan controls without TB. We genotyped four selected variants of the NAT2 gene (NAT2*5, NAT2*6, NAT2*7, and NAT2*14) by Sanger sequencing for patients and real-time polymerase chain reaction for controls. RESULTS The majority of patients had NAT2 genotypes previously described as slow acetylators including NAT2*5/*5, NAT2*5/*6, NAT2*6/*6, a...

To evaluate the pricipal epidemiological and evolutive characteristics of Stevens Johnson Syndrom... more To evaluate the pricipal epidemiological and evolutive characteristics of Stevens Johnson Syndrome. A retrospective descriptive study was con- ducted of all cases of Steven Johnson Syndrome was notified to Moroccan Center Anti Poison and Pharmacovigilance by professionals health be- tween the period January 2010 and December 2012. During this period, 23 cases of Steven Johnson Syndrome have been reported an average of 8 cases / year. Women are the most affected (sex ratio (F / M = 2.2). The most incriminated drugs were: Allopurinol (21%), Ethambutol, Isoniazid/Rifampi- cin, Pyrazinamide paracetamol, sulfamethoxazole / trimethoprim 5% each. The causality according to WHO method showed that 62% were probable and possible in 38% of cases. The outcome was favorable in 86% of cases, one case was fatal and 9% of cases, have not been not been specified.

Journal of Allergy and Therapy, 2019

Fixed drug eruption is the only pathognomonic clinical form of cutaneous drug reaction. It is an ... more Fixed drug eruption is the only pathognomonic clinical form of cutaneous drug reaction. It is an eruption made of one or few centimetric lesions, relapsing in the same area and leaving residual pigmentation. The bullous forms of fixed pigmented erythema are rare but can be serious in case of generalized forms. The management of this situation is based on the immediate interruption of the suspected drug, the notification to pharmacovigilance, and the hospitalization in case of extended forms with symptomatic treatment. The prevention consists in the identification and total eviction of the responsible drug. We report a rare and original case of bullous fixed drug eruption in an adult, and we discuss its diagnosis, management and prognosis.

Section 5: Patient safety and quality assurance, 2018

Background Lyell’s syndrome is one of the most severe mucocutaneous diseases, which can be life-t... more Background Lyell’s syndrome is one of the most severe mucocutaneous diseases, which can be life-threatening. However, it is rare, with a child mortality rate estimated at 7.5%. Purpose We report a case of a child who developed Lyell’s syndrome after taking carbamazepine and who was aggravated by amoxicillin, and the result of the causality assessment of the adverse drugs reaction. Material and methods A 12-year-old boy with no significant pathological history presented 20 days after taking carbamazepine, conjunctivitis and cheilitis. On the same day, the child presented with a fever and rapidly widespread generalised erythematous lesions after taking amoxicillin, which led the doctor to prescribe aspirin. The lesions evolving in a context of alteration of the general state and a fever measured at 39°C, necessitated the hospitalisation of the child. The skin histology revealed a toxic epidermal necrosis leading to Lyell’s syndrome. The diagnosis of Lyell’s syndrome of drug origin was confirmed by the anamnestic, clinical and histological elements. After a hospital stay of 21 days and symptomatic treatment, the evolution was favourable. Results In response to this acute toxidermia, we conducted a drug investigation to establish the causality assesment of the adverse drugs reaction according to French pharmacovigilance rules by the Poison Control and Pharmacovigilance Centre. After eliminating any infectious origin, the results showed that the intrinsic imputability was an I2 score for carbamazepine, an I1 score for amoxicillin and the extrinsic imputability was a B4 score for both drugs. However, the occurrence of Lyell’s syndrome is probably due to the intake of carbamazepine manifested by conjunctivitis, cheilitis and influenza-like illness at the beginning of its installation, resembling an infection leading to a prescription of amoxicillin which caused an aggravation of Lyell’s syndrome, which can be further potentiated by aspirin. Conclusion This observation illustrates the importance of the awareness of pharmacists and doctors of the risks of drug prescription that can cause Lyell’s syndrome, particularly carbamazepine. Thus, management should be systematic with any post-drug dermatological symptoms in order to prevent and further reduce the incidence of this condition and to improve the vital prognosis. Reference and/or Acknowledgements 1. Roujeau, et al. Toxic epidermal necrolysis. Journal of the American Academy of Dermatology1990;23(6):1039–1058. No conflict of interest

E3S web of conferences, 2021

On March 23, 2020, the Moroccan Ministry of Health issued a circular authorizing the off label us... more On March 23, 2020, the Moroccan Ministry of Health issued a circular authorizing the off label use of hydroxychloroquine or chloroquine in combination with azythromycin as first-line treatment for all COVID-19 patients. The aim of this study is to detect, assess and manage safety signals from individual cardiovascular adverse events (AE) reported. Methods: During the COVID19 pandemic, pharmacovigilance surveillance was based on spontaneous targeted notification in all health facilities. Newsletters with a suitable reporting form were sent and reporting of AEs was mandatory. The AEs collected were analyzed for causality assessment using the WHO method and the Preventavility method was used to detect any preventable ADR. Safety signals were detected and analyzed using a qualitative pharmacovigilance method. Results: As of December 31, 2020, a total of 527 adverse events have been reported to the NPC related to Hydroxychloroquine or Chloroquine among the Covid 19 patients. We received 09 cases of preventable AEs related to medication error including one drug interaction for 3 cases, dose errors for 5 cases and one case with both errors, these cases have been validated ad managed as safety signals. Discussion and conclusion: The detected signal concerned the QT prolongation, hypokalaemia and arrythmias, due to high dose of azithromycin and to drug interactions with hypokalaemic drugs. The signal was analyzed and validated during the technical committee, and recommendations were established to avoid the occurrence of similar cases.

To evaluate the frequency and severity of associated local reactions to BCG a retrospective study... more To evaluate the frequency and severity of associated local reactions to BCG a retrospective study was conducted on the notified in Moroccan Centre Anti Poison and Pharmacovigilance. During this period, 295 cases have been reported following vaccination with BCG local nature Males were the most concerned with 57%. Infants are much more represented (61%) than other age groups. The most local reactions are observed: becegites (37%), abscesses (20%), rash (16%), ulcers (15%), and fistula (12%). Accompanying signs of these local reactions are usually represented by a fever (6%) and lymphadenopathy (2%). BCG was injected intradermally in 87% of cases, followed by the intramuscular route (8%) and the subcutaneous route in 5% of cases. According to the classification of severity of the WHO ART, these reactions were severe in 18% of cases,

Archives Des Maladies Professionnelles Et De L Environnement, Feb 1, 2020

Objectif La presente etude vise a determiner les principaux effets indesirables survenant apres l... more Objectif La presente etude vise a determiner les principaux effets indesirables survenant apres l’injection du vaccin BCG contre la tuberculose chez l’enfant au Maroc. Methodes Il s’agit d’une etude retrospective descriptive des effets indesirables du vaccin BCG chez l’enfant de moins de 4 ans, notifies au CAPM, durant la periode 2010–2012. Resultats Durant cette periode, 194 declarations ont ete enregistrees, soit en moyenne 27 declarations/an. Les effets indesirables les plus observes sont generalement : becegites (53 %), abces (26 %), inflammation (8 %), tumefaction (6 %), suppuration (3 %), … Le sex-ratio (M/F) est de 1,3. Les nourrissons sont les plus touches avec une frequence de 91 %. Les reactions sont moderees dans 79 % des cas, severes dans 11 % des cas et graves dans 4 % des cas. L’evolution etait favorable pour 92 % des cas, pour le reste, l’evolution est non precisee. Conclusions Le vaccin BCG provoque des effets indesirables surtout de nature locale, la declaration au CAPM par les professionnels de sante est necessaire pour detecter les signaux emergents et pour surveiller l’innocuite des vaccins.

Archives Des Maladies Professionnelles Et De L Environnement, Feb 1, 2020

Objectif Le present travail consiste a dresser le profil epidemiologique du necrolyse epidermique... more Objectif Le present travail consiste a dresser le profil epidemiologique du necrolyse epidermique declare au Centre antipoison et de pharmacovigilance du Maroc (CAPM). Materiel et methodes Il s’agit d’une etude retrospective descriptive des cas spontanes du (NE), notifies au CAPM entre 2004 et 2013. Un total de 37 cas du (NE) a ete declare au CAPM, dont 84 % des cas sont des cas graves. Resultats L’âge moyen des patients etait de 47 ± 2,6 ans. Le sex-ratio (F/M) est de 4 (χ2 = 52 ; p La relation de cause a effet selon la methode de l’imputabilite de l’OMS est probable dans 51 % des couples, possible dans 38 % des couples, certaine dans 8 % des couples et inconnue dans 3 %. L’evolution est favorable dans 51 % des cas, 8 % ont gueri avec des sequelles, fatale dans 22 % des cas, alors que cette evolution est restee indeterminee dans 19 % des cas. Conclusion La necrolyse epidermique est l’urgence dermatologique la plus grave, qui impose une declaration obligatoire a la pharmacovigilance. Neanmoins une sensibilisation de la population sur les risques lies a l’automedication et des medecins aux risques de la prescription medicamenteuse irreflechie reste le meilleur moyen de prevention.

Section 6: Education and Research, 2019

Section 5: Patient safety and quality assurance, 2018

Background Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) was first descr... more Background Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) was first described for anticonvulsant drugs and the same symptoms were subsequently observed with a variety of other drugs such us anti-inflammatory drugs. An effective approach for objective causality assessment is necessary to make consistent and accurate identification of this adverse drug reaction (ADRs). Purpose To evaluate the incidence and the clinical characteristics of DRESS syndrome associated with anti-inflammatory drugs and the causality assessment for estimating the strength of relationship between drug(s) exposure and occurrence of ADR. Material and methods The database of the national pharmacovigilance centre (NPC) was used from January 2008 to January 2016 and the WHO causality assessment method was used as a tool for the clinical assessment of ADRs. Results Of the 72 reports of DRESS syndrome recorded in the NPC during 8 years, we reviewed 16 reports coded DRESS associated with anti-inflammatory drugs (22.2% of all patients) and which meet the inclusion criteria. The average age was 27 years and 56.2% were in males. The average time to DRESS onset after the start of administration of the suspected drug was 18 days. The outcome was serious in 14 cases (87.5%). The most common causative agents were prednisolone (31.2%) and ibuprofen (12.5%). Clinical presentation: fever 100%, skin rash 100%, 82% eosinophilia, lymphadenopathy 22%, cheilitis 12.5% and an altered state of consciousness 12.5%. For causality assessment: 57.7% of suspected drugs had a ‘Possible’ score and 42.1% had ‘Probable’ score. Conclusion In this retrospective study, prednisolone was the major case of DRESS syndrome and an altered state of consciousness were associated, and cheilitis with indometacin, although all patients recovered after corrective treatment. References and/or Acknowledgements 1. Bannwarth B. Critères d’imputabilité des effets indésirables des médicaments. Revue du Rhumatisme Monographies2010;77(2):173—5. 2. Akarin Hiransuthikul, Thanapoom Rattananupong, Jettanong Klaewsongkram, et al. Drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS): 11 years retrospective study in Thailand. Allergology International2016;65:432–438. No conflict of interest

Section 5: Patient safety and quality assurance, 2018

Genetic Testing and Molecular Biomarkers, Nov 1, 2016

Aim: Isoniazid (INH) is the most effective drug used as first-line tuberculosis (TB) treatment be... more Aim: Isoniazid (INH) is the most effective drug used as first-line tuberculosis (TB) treatment besides rifampicin, pyrazinamide, and ethambutol. It is also the most commonly associated with hepatotoxicity. Differences of toxicity induced by INH have been attributed to genetic variability of the N-acetyltransferase 2 (NAT2) gene which encodes a drug-metabolizing enzyme. The aim of this study was to characterize the acetylation profile of patients who developed hepatotoxicity after TB treatment by genotyping NAT2 polymorphisms. Patients and Methods: This study included 42 Moroccan patients who developed hepatotoxicity after TB treatment and 163 Moroccan controls without TB. We genotyped four selected variants of the NAT2 gene (NAT2*5, NAT2*6, NAT2*7, and NAT2*14) by Sanger sequencing for patients and real-time polymerase chain reaction for controls. Results: The majority of patients had NAT2 genotypes previously described as slow acetylators including NAT2*5/*5, NAT2*5/*6, NAT2*6/*6, and NAT2*6/*14 (78%) and none were genotyped as rapid acetylators. Controls were slow, intermediate, and rapid acetylators with frequencies of 72.39%, 21.48%, and 6.13%, respectively. Conclusion: There were no fast acetylator genotypes found among the patients having INH-hepatotoxicity. This finding suggests that slow acetylator phenotype may contribute to the development of TB treatment hepatotoxicity.

Naunyn-Schmiedeberg's Archives of Pharmacology

Therapeutic Advances in Vaccines and Immunotherapy, 2022

Background: A vaccination campaign against pandemic influenza A/H1N1 was implemented in Morocco b... more Background: A vaccination campaign against pandemic influenza A/H1N1 was implemented in Morocco between November 2009 and April 2010. Overall, 705,883 subjects were vaccinated by Pandemrix, Arepanrix, and Panenza. The adverse events following immunization (AEFIs) data comparison was made with the 2014/2015 seasonal influenza vaccination campaign that was specifically investigated. Aim: To evaluate the safety of the 2009 pandemic influenza A/H1N1 vaccine and to compare it to that of 2014 seasonal influenza vaccine. Methods: During the pandemic vaccination campaign, the Morocco Pharmacovigilance Centre reinforced passive AEFI surveillance with an active and prospective monitoring programme of 1000 immunized people over 6 months at 10 randomly selected vaccination centres. For the 2014/2015 seasonal vaccination campaign, AEFI data were collected from spontaneous notifications. Results: Active monitoring of 2009 pandemic collected 771 AEFI reports, corresponding to an AEFI incidence rat...

Archives des Maladies Professionnelles et de l'Environnement, 2020

Objectif La presente etude vise a determiner les principaux effets indesirables survenant apres l... more Objectif La presente etude vise a determiner les principaux effets indesirables survenant apres l’injection du vaccin BCG contre la tuberculose chez l’enfant au Maroc. Methodes Il s’agit d’une etude retrospective descriptive des effets indesirables du vaccin BCG chez l’enfant de moins de 4 ans, notifies au CAPM, durant la periode 2010–2012. Resultats Durant cette periode, 194 declarations ont ete enregistrees, soit en moyenne 27 declarations/an. Les effets indesirables les plus observes sont generalement : becegites (53 %), abces (26 %), inflammation (8 %), tumefaction (6 %), suppuration (3 %), … Le sex-ratio (M/F) est de 1,3. Les nourrissons sont les plus touches avec une frequence de 91 %. Les reactions sont moderees dans 79 % des cas, severes dans 11 % des cas et graves dans 4 % des cas. L’evolution etait favorable pour 92 % des cas, pour le reste, l’evolution est non precisee. Conclusions Le vaccin BCG provoque des effets indesirables surtout de nature locale, la declaration au CAPM par les professionnels de sante est necessaire pour detecter les signaux emergents et pour surveiller l’innocuite des vaccins.

This case concerns a 14-month-old girl weighing 16 kg who developed green urine 10 hours after ad... more This case concerns a 14-month-old girl weighing 16 kg who developed green urine 10 hours after administration of Propofol (2 mg/kg/h) for sedation in the intensive care unit, without medical background, Normalization of urine color 6 hours after stopping the propofol infusion has been observed.

The objective of this work is to demonstrate the interest of integration of pharmacovigilance in ... more The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP). Design and Data Collection. The integration of pharmacovigilance in MTCP was conducted in October 2012 with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010-October 2012; period 2: October 2012-December 2013). The detection of signals was based on the Information Component available in VigiMine. We used the SPSS version 10.0 and MedCalc version 7.3 for data analysis. Results. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (< 10 −3). The average age was 40.7 ± 17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7%) predominated during the first period, while skin reactions (24.1%) were in the second period (= 10 −4), and 40.9% of cases in the first period were serious against 15.8% in second period (= 0.003). Nine signals were generated (hepatic enzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting). Conclusion. The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs.

Genetic testing and molecular biomarkers, 2016

AIM Isoniazid (INH) is the most effective drug used as a first-line tuberculosis (TB) treatment b... more AIM Isoniazid (INH) is the most effective drug used as a first-line tuberculosis (TB) treatment besides rifampicin, pyrazinamide, and ethambutol. It is also the most commonly associated with hepatotoxicity. Differences of toxicity induced by INH have been attributed to genetic variability of the N-acetyltransferase 2 (NAT2) gene which encodes a drug-metabolizing enzyme. The aim of this study was to characterize the acetylation profile of patients who developed hepatotoxicity after TB treatment by genotyping NAT2 polymorphisms. PATIENTS AND METHODS This study included 42 Moroccan patients who developed hepatotoxicity after TB treatment and 163 Moroccan controls without TB. We genotyped four selected variants of the NAT2 gene (NAT2*5, NAT2*6, NAT2*7, and NAT2*14) by Sanger sequencing for patients and real-time polymerase chain reaction for controls. RESULTS The majority of patients had NAT2 genotypes previously described as slow acetylators including NAT2*5/*5, NAT2*5/*6, NAT2*6/*6, a...

To evaluate the pricipal epidemiological and evolutive characteristics of Stevens Johnson Syndrom... more To evaluate the pricipal epidemiological and evolutive characteristics of Stevens Johnson Syndrome. A retrospective descriptive study was con- ducted of all cases of Steven Johnson Syndrome was notified to Moroccan Center Anti Poison and Pharmacovigilance by professionals health be- tween the period January 2010 and December 2012. During this period, 23 cases of Steven Johnson Syndrome have been reported an average of 8 cases / year. Women are the most affected (sex ratio (F / M = 2.2). The most incriminated drugs were: Allopurinol (21%), Ethambutol, Isoniazid/Rifampi- cin, Pyrazinamide paracetamol, sulfamethoxazole / trimethoprim 5% each. The causality according to WHO method showed that 62% were probable and possible in 38% of cases. The outcome was favorable in 86% of cases, one case was fatal and 9% of cases, have not been not been specified.