Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France.

INTRODUCTION: Because patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities, European competent authorities implemented regulations to allow direct reporting of adverse drug reactions related to medicinal products by patients in 2012. OBJECTIVES: To describe evolution and analyze determinants of patient reporting activity in France in order to assess patient involvement in pharmacovigilance. METHOD: Using the French national pharmacovigilance database, univariate and multivariate analyses were performed to compare the characteristics of adverse drug reaction (ADR) reports from patients and healthcare professionals (HCP) between 2011 and 2020. The relationship between regional patient ADR report activity and regional care provision and socio-professional characteristics was analyzed using the principal component analysis. RESULTS: A significant and higher increase in ADR reports over time from patients (r = 0.89, p < 0.001) compared to HCP (r = 0.27, p = 0.002) has been observed. Patient ADR report activities compared to HCP concerned more women (80% vs. 55%, p < 0.001), younger age classes (p < 0.001), reporting through web portal (83% vs. 17%, p < 0.001), and less serious events (26% vs. 63%, p < 0.001). In the principal component analysis, regional patient reporting activity was related to socio-professional categories, age classes, and densities of hospital beds and physicians. CONCLUSION: Our results confirm an increasing involvement of patients in ADR report activities. The determinants of patient reporting activities are not only related to drug and medical factors but also to social factors. Digital tools may also play a role in health democracy in pharmacovigilance.

Selective musculocutaneous nerve block and infraclavicular brachial plexus anesthesia. Case report.

BACKGROUND AND OBJECTIVES: Regional anesthesia of the upper extremity may be achieved by the infraclavicular approach to the brachial plexus. METHODS: Advantages of this approach include profound anesthesia of the upper extremity with minimal risk of complications. RESULTS: Isolated block of the musculocutaneous nerve may result by this approach if biceps muscle contractions are accepted as evidence of brachial plexus location by peripheral nerve stimulation. CONCLUSIONS: Stimulation of the musculocutaneous nerve in the infraclavicular region results in biceps muscle contraction. Inadequate anesthesia of the upper extremity may result due to exiting of the musculocutaneous nerve outside the axillary sheath in this region. Evidence of more distal stimulation (finger/wrist flexion) improves the likelihood of successful block of the brachial plexus by the infraclavicular route.

[Emergency surgery in colonic obstructions. Retrospective study of 70 cases]. / Chirurgie d'urgence face aux occlusions coliques. Etude rétrospective de 70 cas.

70 patients with complete colonic obstruction requiring emergency surgery were treated at the "Clinique Chirurgicale C" between 1977 and 1984. Carcinoma was the cause of obstruction in 65 cases. Obstruction was situated on the right colon 8 times, on the splenic flexure 13 times, and on the left colon 49 times. In emergency obstruction of the right colon was treated by right hemicolectomy in 6 cases with 0 death. Obstruction of the splenic flexure was treated in 10 cases by simple loop colostomy, twice by resection with ileo-sigmoid anastomosis, 1 by resection without anastomosis with 5 deaths. Obstruction of the left colon was treated by simple loop colostomy in 46 cases. Of the 34 patients who survived after loop colostomy, 26 were reoperated and in 23 cases a resection could be performed with 2 deaths and the colostomy could be closed in a third stage in 20 cases without death. 5 years survival of curative resection was 57%. It is concluded that primary resection is the best treatment for obstruction of the right colon and of the splenic flexure. But three stage resection seems to be a good procedure for obstruction of the left colon with low mortality, low morbidity and good 5 year survival.

Total colectomy with ileorectal anastomosis in surgical management of toxic megacolon.

Twenty-five patients with toxic megacolon are reported. The most frequent etiology of this syndrome was ulcerative colitis and the main complication colonic perforation. Toxic dilatation generally involved the transverse colon. Twenty patients were treated by a surgical procedure, namely two enterostomies and eighteen colectomies. A total colectomy with ileorectal anastomosis was performed in ten patients. Mortality for the whole series was 32%, but was reduced to 14% in the last 4 years. There were no deaths and no complications needing surgical management in the group of patients treated by total colectomy with ileorectal anastomosis. However, the method resulted in one failure. The satisfactory results obtained with this procedure must be emphasized. Despite the small number of so-treated patients reported in world literature, it is suggested that total colectomy with ileorectal anastomosis must be regarded as the procedure of choice for toxic megacolon without peritonitis.

[Paraduodenal hernia: 3 cases and revue of the literature (author's transl)]. / Les hernies paraduodénales. Revue de la littérature à propos de 3 cas.

Three cases of surgically treated para-duodenal hernia are presented. The literature is reviewed. Several modalities of this entity are described as well as the embryological hypotheses to explain their genesis. The diagnosis is usually made at the time of a laparotomy for bowel obstruction. The surgical manipulations to reduce the hernia content (one or several loops of small bowel) are discussed.

[Practical problems and results of parenteral alimentation in 60 patients undergoing surgery for neoplasms of the esophagus]. / Problèmes pratiques et résultats de l'alimentation parentérale chez 60 opérés de néoplasmes de l'oesophage.

Sixty patients suffering from a neoplasm of the oesophagus underwent surgery. All received parenteral alimentation in an intensive care unit and its value was studied, in particular in the immediate postoperative period. Describing the technique used, together with the qualitative and quantitative nature of the products employed, the authors analyse the results obtained and in particular the effectiveness of treatment from the standpoint of protein balance and of body weight stability in these patients.

[Postoperative pulmonary complications following surgery for carcinoma of the esophagus]. / Complications pulmonaires post-opératoires de la chirurgie carcinologique de l'oesophage.

Pulmonary complications frequently occur during the postoperative period following surgery for neoplasms of the oesophagus. The aetiology varies according to the time of their onset but the clinical signs and treatment are essentially the same. The problems encountered and related either to anaesthesia, to the surgical approach to the position of the patient. It is after the third day that complication develop related at one and the same to the past history, classical in such patients, (tobacco, chronic bronchitis, alcoholism) and the ectopic position of an abdominal viscus.