It has been established for a long time that non-steroidal anti-inflammatory drugs (NSAIDs) can produce gastrointestinal hemorrhagic ulcers when administered in high doses over a continuous period of time as in man- agement of chronic pain in the elderly, but it is not clear what effect NSAIDs have on paediatric gastric bleeding, since the use is usually for a short period of time. The use of NSAIDs among febrile pediatric patients has become a common treatment even without medical prescription, and is increasingly used alongside paracetamol (acetaminophen). A four-year-old girl was admitted to our hospital with a febrile status and hematemesis that started an hour earlier. On admission, she presented with tachycardia and fever, with normal blood pressure and a sore throat that started the previous day. The girl had received, several hours prior to admission, a single oral dose of ibu- profen that represented an increment of 50% over the indicated dosage for her weight. She had received no further treatment. The clinical history was of no relevance and the throat exploration showed some erythema and inflammation but not pus. The anamnesis revealed that a high ibuprofen dose had been administered by mistake. The digestive endoscopy found a gastrointestinal haemorrhagic ulcer that was still bleeding. After supressing the drug, conducting rehydration therapy, and administering intravenous ranitidine, progres- sion was favourable and the girl was discharged on the fourth day of admission. A single overdose, due to the similarity of the packaging of different concentration of the same active principle ingredient available in our country (Spain) can produce gastric bleeding. Combined treatment with NSAIDs and acetaminophen        

 

Fig: Different  percentage of quantities of the brands of ibuprofen on sell in Spain

 

Risk mitigation during medicinal products life cycle requires harmonization of pharmacovigilance activities handled by the involved stakeholders regarding their engagement strategy to ensure compliance. Pharmacovigilance system compliance necessitates the presence of effective quality system management. Real world data indicates that compliance rate needs to be optimized via incorporated standardized parameters and well identified compliance metrics. This presentation will provide an overview of the needed strategy for building up and monitoring of the quality system of pharmacovigilance. Such driven strategy for pharmacovigilance quality management will improves compliance rate and minimize authorities’ inspections critics. 

 

Meital Simhi is a PhD student in the faculty of humanities and social sciences at Ben Gurion University. She holds a BA and MA in Social Work from Ben Gurion University. Her PhD study dealt with the relationship between social-demographic characteristics, health beliefs and treatment preferences for PPD among Israeli postpartum mothers. She has presented her thesis results at several conferences. Her PhD research proposal won awards from the ISEF Committee for excellence in education as an outstanding PhD student and from "NA'AMAT", the movement of working women and volunteers, as research that promotes the status of women's health.

The prevalence of Post-Partum Depression (PPD) is 10-20% among new mothers, with rates higher among low income

and immigrant populations. Most women do not get treatment for PPD. Antidepressants for women is usually given by a

psychiatrist or family physician. The treatment includes selective antidepressants of the Selective Serotonin Reuptake Inhibitor (SSRI) group, which regulates the absorption of serotonin. Among the drugs offered are Lexapro, Lustral, Seroxet, Prozac, and Effectin.The aims of the current study were: 1) describe the preferences for getting mental health treatment for PPD across three dimensions: type of treatment, profession of service provider, and service delivery mode 2) characterize the preferences by elements of health beliefs, health status and cultural group.

Methodology: 1000 women who attended Maternal Child Health Clinics in the Rehovot sub-district for a first medical exam

of their infant (9 weeks postpartum) participated in a cross-sectional survey. Data analysis methods: Standard bivariate and multivariate procedures using SPSS.

Results: In this sample, 10.6% of the respondents suffered from PPD as measured by the Edinburgh Postnatal Depression

Scale (EPDS), scoring over 9 on EPDS. Depressed mothers were characterized by low income, (p≤0.001 r=0.17,) and medical problems during pregnancy (p≤0.001 r=0.11,). 14.4% of the participants had family psychiatric history, 8.9% of the participants suffered from chronic diseases and 8.2% were taking regular medication. Women who breastfed their infants did not preferred medication treatment (r = -0.14, p≤0.05). Women treated with medication compared to women who did not receive medication preferred to receive professional help in a community treatment centers, (F(3,993)=2.68, p≤..05), while women who were treated in conversations and medical treatment preferred to receive private mental health (F(3,993)=3.91, p≤.05),delivered by mental health professionals(F(3,993)=6.11, p≤.001) and to receive face-to-face treatment (F(3,993)=5.48, p≤..001). Depressed mothers were less likely to prefer treatment in the community treatment center, and they often preferred not to seek treatment at all (r= -0.09, p≤.0.01). In conclusions, women who suffer from PPD represent a high-risk population who can significantly benefit from suitable, accessible treatment. This research clearly indicates the preferences of women in terms of where to receive treatment, from what type of professionals and in which modality.