scholarly journals Gene therapy and hospital pharmacy: the experience of the Hospital Pharmacy unit of L. Vanvitelli university hospital

ABOUTOPEN ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. 74-80
Author(s):  
Giovanni Dubuis ◽  
Francesca Marrone ◽  
Francesco Russo ◽  
Stefania Ziccardi ◽  
Rosa Annibale
Keyword(s):  
Gene Therapy ◽  
Hospital Pharmacy ◽  
Hospital Pharmacist ◽  
University Hospital ◽  
Therapeutic Success ◽  
Retinal Dystrophies ◽  
Close Cooperation ◽  
Subretinal Surgery ◽  
Biallelic Mutations ◽  
Training Of Personnel

Background: Since hospital use of gene therapy requires close cooperation between doctors and pharmacists to ensure correct drug handling and administration, it is essential to define standard operating procedures (SOPs) for each phase of the process to ensure therapeutic success in compliance with the safety of patient and healthcare professionals. Among the available gene therapy medicines, voretigene neparvovec is used to treat hereditary dystrophy of the retina caused by biallelic mutations in the RPE65 gene. The aim of this article is to describe the experience of the Hospital Pharmacy unit of L. Vanvitelli university hospital in the management of treatment with voretigene neparvovec in the first two pediatric patients treated in Italy. Methods: SOPs were developed for all phases of gene therapy management process (procurement, receipt, storage, handling, transport of the finished product and waste disposal). Particular attention was paid to the training of personnel involved, to ensure maximum compliance with the procedures at all stages of the process. Results: SOPs were developed according to the European Association of Hospital Pharmacist (EAHP) policies and in full agreement with the operating procedures established by the manufacturer, ensuring correct storage and handling of the drug, as well as safe administration to patients. Conclusions: This example confirms the importance of close collaboration in a multidisciplinary team between hospital pharmacists, ophthalmologists experienced in the treatment of patients with hereditary retinal dystrophies and surgeons experienced in subretinal surgery to ensure the correct management of gene therapy with voretigene neparvovec, through compliance with shared operating procedures.

Ostomy Patient Care Program

1972 ◽  
Vol 6 (11) ◽  
pp. 374-379
Author(s):  
Margaret C. Gebhardt ◽  
Stephen M. Caiola ◽  
Fred M. Eckel
Keyword(s):  
Patient Care ◽  
Hospital Pharmacy ◽  
Local Community ◽  
Hospital Pharmacist ◽  
Care Program ◽  
Memorial Hospital ◽  
Continuing Care ◽  
Community Or ◽  
Patient Profile ◽  
Care Information

The ostomate is often a forgotten patient with regards to proper psychological and emotional preparation for his surgery and proper continuing care of his ostomy. The pharmacist can play an important role in aiding the ostomy patient, especially in providing him adequate appliances and ostomy-care information. The development and implementation of the ostomy program of the N. C. Memorial Hospital Pharmacy is presented in detail. A brief explanation of why ostomy surgery is necessary, of the various types of ostomies and of the various appliances utilized is also presented. The following services of the program are described: Use of a patient profile card in order to have on record the patient's specific appliance and replacement parts; Fitting the new ostomate with the proper appliance and instructing him on its proper use; Interviewing patient on return clinic visits to determine if the patient is having ostomy-related problems or needs any replacement parts for his appliance; Providing patient's appliance needs through the mail or through communication with the patient's local community or hospital pharmacist, and Conducting a presurgical consultation with the future ostomate to briefly explain appliances and how their use will affect his life, plus answer questions which may be making him apprehensive.

scholarly journals A Avaliação da Assistência Farmacêutica no Complexo Hospitalar da Universidade Federal do Rio de Janeiro (CH-UFRJ)

2017 ◽  
Vol 21 (1) ◽  
pp. 18
Author(s):  
Orenzio Soler
Keyword(s):  
Human Resources ◽  
Hospital Pharmacy ◽  
Rio De Janeiro ◽  
Legal Framework ◽  
Pharmacy Education ◽  
University Hospital ◽  
Pharmacy Services ◽  
Work Process ◽  
Administration Hospital ◽  
Recursos Humanos

O objetivo do artigo foi conhecer o perfil e as características dos Serviços de Farmácia do Complexo Hospitalar da Universidade Federal do Rio de Janeiro. Constitui-se de um Relato de Experiência fundamentado na Pesquisa-Ação e no Enfoque Lógico. Dentre os principais resultados, constatou-se que a estrutura, a organização, os recursos humanos e o processo de trabalho inerentes aos Serviços de Farmácia não atendem ao escopo do arcabouço legal vigente, tornando-os ineficientes sob os aspectos do processo ensino-assistência. Por fim, infere-se que as unidades do Complexo Hospitalar não atendem as diretrizes e as estratégias para organização, fortalecimento e aprimoramento das ações e serviços de farmácia no âmbito dos hospitais. Palavras-chave: Saúde Pública. Hospital Universitário. Gestão Hospitalar. Farmácia Hospitalar. Ensino Farmacêutico. Abstract The purpose of the article was to know the profile and characteristics of Pharmacy Services of the Hospital Complex from the Federal University of Rio de Janeiro. It is condituted a case studies based on action research. Among the main results, it was found that the structure, organization, human resources and work process inherent in Pharmacy Services do not comply withthe scope of the legal framework in force, making them inefficient under aspects of teaching-process. Finally, it is inferred that the units of the hospital complex do not fulfill the guidelines and strategies for organizing, strengthening and improvement of actions and pharmacy services at the hospital settings. Keywords: Public Health. Hospitals, University. Hospital Administration. Hospital Pharmacy. Education, Pharmacy.

655 EVALUATION OF THE MODIFIED DOR TECHNIQUE FOR SURGICAL TREATMENT OF ACALASIA

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Fernando Freire Lisboa ◽  
Nathan Xavier Gomes ◽  
Pedro Arthur Nascimento Silva
Keyword(s):  
Negative Impact ◽  
Remission Rate ◽  
Clinical Stage ◽  
Stage I ◽  
University Hospital ◽  
Laparoscopic Myotomy ◽  
Therapeutic Success ◽  
Esophageal Motility Disorder ◽  
Eckardt Score ◽  
Before And After

Abstract   Achalasia is the main esophageal motility disorder and has a significant negative impact on the patient's quality of life. Achalasia patients have dysphagia and vomiting, often associated with chest pain, leading to significant weight loss. The treatment of achalasia should be primarily to decrease the pressure of the lower esophageal sphincter. There are different therapeutic options for the treatment, and laparoscopic myotomy is the standard treatment, despite the improvement of new techniques such as POEM. Methods Prospective and retrospective study carried out in a university hospital with 33 patients with achalasia, operated with the wide myotomy technique associated with modified Dor fundoplication, from January 2017 to November 2020. The diagnosis was made by clinical, endoscopic, radiological and manometric studies. Symptomatic assessment and therapeutic success were performed using the Eckardt score before and after the operation. Rezende's classification was used to classify the degree of megaesophagus. The degree of megaesophagus was correlated with the result of the technique. The results were analyzed using the IBM SPSS Statistics Version 26 software. Results Patients with idiopathic achalasia 28 (84.8%). Preoperative Eckardt score average 5.93 points, preoperative clinical stage I = 7 (21.2%), clinical stage II = 12 (36.4%) and clinical stage III = 14 (42.4%). 48-hour postoperative hospital stay. Average postoperative Eckardt score 0.30 points, with 32 (97%) clinical stage 0, and 1 (3%) in clinical stage I in the postoperative period. Remission rate of the disease after treatment 100%. There was no correlation between the degree of the megaesophagus with the preoperative symptoms or with the therapeutic result. There were no complications or need for reintervention. There were no reports of symptoms of GERD. Conclusion According to clinical, radiological and endoscopic data, the technique was considered safe and effective for the treatment and regression of achalasia symptoms in all degrees of megaesophagus in the present study. In addition, the technique was also effective as an anti-reflux mechanism, preventing the onset of symptoms of iatrogenic GERD.

Risk sharing agreements: What lessons from Italy?

2011 ◽  
Vol 27 (2) ◽  
pp. 169-172 ◽  
Author(s):  
Livio Garattini ◽  
Gianluigi Casadei
Keyword(s):  
Hospital Pharmacy ◽  
Risk Sharing ◽  
Hospital Pharmacist ◽  
Pharmaceutical Expenditure ◽  
Health Authorities ◽  
Reliable Assessment ◽  
Drug Agency ◽  
Time Frames ◽  
E Mail ◽  
Public Time

Italy is one of the few countries that have matured substantial experience of risk-sharing agreements so far. The first performance-based arrangement was agreed in July 2006, and as of October 2010, eighteen contracts have been in force.The complex management of discount schemes is entirely based on Web registries run by AIFA, the Italian drug agency. The system validates each prescription and automatically requests the hospital pharmacy by e-mail to release the drug. If a patient meets nonresponder criteria, the hospital pharmacist should apply for pay-back to the manufacturer.There are still some important question marks to address. First of all, nonresponders have to be documented by health authorities, otherwise any undocumented nonresponder will be paid as a success. Another question concerns pre-set timing. Although the scientific rationale of the nonresponder criteria for each drug has not been made public, time frames appear too short to allow a reliable assessment. Another question is whether regions, which are financially accountable in Italy for pharmaceutical expenditure, are really able to claw back refunds from manufacturers. Unfortunately here again there are no official figures, and regions do not seem yet able to quantify the amount of pay-back matured in the 4 previous years. The delayed and incomplete availability of pay-back procedures may be one explanation.

A phase I/II study of adenovirus-mediated reduced expression in immortalized cells (REIC/DKK-3) gene therapy for prostate cancer: An interim report.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 161-161
Author(s):  
Katsumi Sasaki ◽  
Yasutomo Nasu ◽  
Masami Watanabe ◽  
Haruki Kaku ◽  
Ryuta Tanimoto ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gene Therapy ◽  
Phase I ◽  
Malignant Tumors ◽  
Adenovirus Vector ◽  
Metastatic Lesion ◽  
University Hospital ◽  
Tunel Staining ◽  
In Vivo Experiments

161 Background: A new cancer therapeutic gene; REIC/Dkk-3 was found in Okayama university in 2000. In vivo experiments have demonstrated outstanding cancer-selective apoptosis effects and anti-cancer immunoactivity against various types of malignant tumors. With these positive experimental results, a phase I/II study of adenovirus-mediated REIC/Dkk-3 gene therapy for prostate cancer was initiated from January 2011 in Okayama university hospital. Methods: Two major inclusion criteria category were set up; A: A recurrence of prostate cancer following definitive endocrine therapy with/without metastasis, B: A localized prostate cancer which was considered high risk of recurrences following radical surgery according to a nomogram reported by Kattan et al. Replication-defective adenovirus vector expressing REIC/Dkk-3 (Ad-REIC) was injected directly into the prostate (or metastatic lesion in patients who received prostatectomy) in escalating doses from 1.0×1010 to 1.0×1012 viral particle (vp). Each patient in category A received total of 2 times viral injections every 4 weeks. Patients in category B also received total of 2 times viral injections every 2 weeks, then received radical prostatectomy 6 weeks after second viral injection. Results: Three patients in category A, and 9 patients in category B were entered the present study. No significant side effects were observed. In category B, signs of immunological responses in surgically removed specimens (apoptosis induction of cancer cells in TUNEL staining and infiltration of CD8 positive cells (CTL) in immunohistochemical staining) were observed in second dose. These responses were remarkably observed in the third dose. Conclusions: This initial and preliminary report suggests the favorable safety profile and positive clinical responses in a clinical trial of Ad-REIC gene therapy for prostate cancer.

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