תוצאת חיפוש

Use of Unlicensed and Off-Label Drugs in Hospitalized Children

M. Lifshitz, V. Gavrilov, R. Gorodischer

Toxicology Unit, Pediatrics Dept. A, Soroka Medical Center, and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

Many drugs used in children are based on pharmacological data obtained in adults. Therefore, many drugs are either unlicensed for use in children or are prescribed outside the terms of the product license (off-label). This pilot study assessed use of unlicensed or off-label drugs in hospitalized children.

Drug orders of patients admitted to a general pediatric ward were reviewed retrospectively in a random sample. Assessment was based on the data of the Physicians' Desk Reference and the Israel Drug Compendium. 80 different drugs and 278 drug orders were written for 92 patients (0.5 months - 11 years old, mean 26.9 months) in 97 admissions. Of these 52.9% were either off-label or unlicensed. Patients received 1 or more unlicensed or off-label drugs in 64.9% of admissions. They were more often off-label than unlicensed. The main reasons for use of off-label drugs were unusual doses and inappropriate age. The main reason for unlicensed drugs was modification of a particular formulation of a licensed drug.

This pilot study indicates that use of drugs in an off-label or unlicensed manner in children is probably quite frequent in Israel. Our data emphasize the need for licensing a large number of drugs for use in children, based on the same scientific principles as in adults. Further collaborative studies in different pediatric centers in Israel, involving different types of pediatric settings (ambulatory and in-hospital), is required to evaluate comprehensively the magnitude of this preliminary finding.

Follicular Splenic Lymphoid Hyperplasia Associated with EBV Infection

Boleslaw Knobel, Enrique Melamud, Sharon Nofech-Moses, Liliana Zeidel

Dept. of Medicine B and Institute of Pathology, Edith Wolfson Medical Center, Holon and Sackler Faculty of Medicine, Tel Aviv University

Massive splenomegaly is defined as a spleen weighing about 10 times normal weight. We describe a 36-year-old man who had huge splenomegaly and secondary pancytopenia simulating malignant lymphoma for about 3 months. Splenectomy was necessary because of the suspicion of hematologic malignancy, especially isolated lymphoma of the spleen, and pain and mechanical abdominal disturbances.

On operation, the spleen was 25 cm long and weighed 250 g. There was florid, reactive follicular lymphoid hyperplasia. Immunohistochemical staining with CD-20(L26), CD-45Ro(UCHL), bcl-2 oncoprotein (Dakopatts), EBV (anti-EBV mol weight 60 KD, Dakopatts) was consistent with reaction to EBV infection and not with follicular lymphoma. Lack of PCR amplification using DNA extracted from paraffin-embedded splenic tissue indicated absence of a monoclonal B cell population carrying rearranged immunoglobulin genes. The lymphocytic population was proven polyclonal by the negative results of PCR for the bcl-2 gene rearrangement. EBV seroconversion from high titer antibodies of anti-EBV-VCA-IgM to negative, and from negative EBNA to positive was consistent with an apparent primary EBV infection.

We have not found on computerized search a previous report of reactive follicular splenic hyperplasia to EBV infection causing huge splenomegaly, with or without EBV-induced infectious mononucleosis.

Listeria Monocytogenes Infections - Ten Years' Experience

Tova Rainis, Israel Potasman

Infectious Disease Unit, Bnai Zion Medical Center, and Faculty of Medicine, Technion, Haifa

7 cases of listeriosis were diagnosed here between 1988-1997 (6 in last 3 years), or 2.94/100,000 admissions. 2 elderly patients suffered from meningitis and 2 pregnant women presented with premature contractions, 1 of whom delivered a premature, infected baby. 2 other patients had fever and gastroenteritis.

Listeria monocytogenes was isolated from blood in 4, CSF in 2 and the placenta in 1. It was isolated from those with bacterial meningitis. All patients recovered. Both increased awareness for prevention and better diagnosis are essential to reduce morbidity from this unusual pathogen.

Fulminant Meningococcemia Presenting as a Gastroenteritis - Like Syndrome

A. Hussein, Y. Naschitz, D. Yeshurun

Depts. of Emergency Medicine and of Medicine A, Bnai Zion Medical Center and Bruce Rapport Faculty of Medicine, Haifa

Neisseria meningitidis infection (meningococcemia) is very common throughout the world. It usually presents as meningitis or sometimes pharyngitis. A gastroenteritis-like syndrome, with diarrhea, vomiting and abdominal pain, may occur in children but is very rare in adults. Search of the medical literature revealed only 3 such cases, all in young adults.

We report an 80-year-old woman who presented with fever, diarrhea and abdominal pain. Meningococcus infection was later suspected, and proved by culture. Although treatment was intensive and included ceftriaxone (Rocephin) and garamycin, she did not respond and died 40 hours after admission. We draw attention to the possibility that what is usually a common symptom can be the first presentation of a serious, often fatal condition.

EBV-Related Post-Transplantation Lymphoproliferative Disorder

D. Doron, O. Papo, O. Portnoy, E. Granot

Depts. of Pediatrics, Pathology, and Radiology, Hadassah University Hospital, Jerusalem

We describe a 4.5-year-old girl in whom post transplantation lymphoproliferative disorder was diagnosed 1 year after liver transplantation. She ran a complicated course with multiple organ involvement: respiratory failure which required mechanical ventilation, renal failure, bone marrow depression and severe protein-losing enteropathy.

Multisystem Disease Caused by BCG Imitating Miliary Tuberculosis

I. Tsikonov, D. Yeshurun, J.E. Naschitz

Dept. of Medicine A, Bnai Zion Medical Center and B. Rappaport Faculty of Medicine, The Technion, Haifa

As the prevalence of tuberculosis is on the rise in western countries, we present a 79-year-old man who developed a pulmonary tuberculosis-like syndrome following immunotherapy with BCG for carcinoma of the urinary bladder. The symptoms subsided following 3-drug antitubercular treatment, and the addition of steroids following negative cultures for Mycobacterium tuberculosis. The course of this disease, named BCG-osis, is much more favorable than miliary tuberculosis, even with milder treatment. It is important to keep in mind this phenomenon now that there is increasing treatment of cancers with BCG.

The Challenge of Space-Occupying Lesions in the Iliopsoas Space

Irena Tsikonova, Jochanan E. Naschitz, Simona Croitoru, Elisha Barmeir, Daniel Yeshurun

Depts. of Medicine and Diagnostic Imaging, Bnai Zion Medical Center, and Bruce Rappaport Faculty of Medicine, The Technion, Haifa

Mass lesions in the iliopsoas compartment (MLIPC) are uncommon in patients in departments of medicine and their incidence and etiologies are unclear. In a prospective study we diagnosed various MLIPCs in 7 patients during a 10-year period, representing 0.03% of admissions. Symptoms included abdominal or flank pain (4 cases), pain along the thigh (5), diminished psoas muscle strength (2), fever (2), and hypotension (1). MLIPC was suspected on clinical grounds in 5 cases. In all cases the diagnosis was established by computed tomography (CT). Tissue was sampled by needle biopsy in 4 and on surgery in 1. MLIPCs were caused by hemorrhage (2), infection (2), neoplasia (2) and inflammatory mass (1). Often MLIPCs are life-threatening so their timely diagnosis by early CT scan is important.

Second Degree A-V Block in Graves© Disease

Yoram Singer, Pesach Shvartzman

Dept. of Family Medicine, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

Cardiac tachyarrhythmias are common in thyrotoxicosis. We report an uncommon case of a 53-year-old woman with Grave's disease who developed second degree A-V block while euthyroid on propylthiouracil. The most likely mechanism is an autoimmune response causing infiltration of the cardiac conduction pathways.

Management of Malignant Bowel Obstruction in Home Care

Menahem Sasson, Pesach Shvartzman

Dept. of Family Medicine, Kupat Holim Klalit and Ben-Gurion University of the Negev, Beer Sheba

Malignant bowel obstruction occurs in about 10% of those with advanced abdominal cancer and in about 25% of those with advanced pelvic cancer. Such patients usually develop nausea, vomiting, constipation, abdominal dilatation and colicky pain. Traditional therapy consists of intravenous fluids and decompression by duodenal tube, gastrostomy or operation but postoperative mortality is high. Treatment requires hospitalization and therefor such patients have not been considered candidates for home care.

Palliative medical techniques can cope with this syndrome and allow home care. Hypodermoclysis, non-prokinetic anti-emetics like haloperidol and scopolamine, octeotride, corticosteroids, and narcotics for severe abdominal pain can alleviate symptoms. Medications can be combined and infused subcutaneously in a syringe driver and patients can remain with their families in their natural environment. Such techniques can give these patients who have short life expectancies reasonable quality of life.

Primary Care Physicians in Israel Compared with European Countries

P. Shvartzman, R. Gross, H. Tabenkin, D. Yuval, M. Grinshtein, B. Wienka

Dept. of Family Medicine, Ben-Gurion University of the Negev, Beer Sheba;

Brookdale Institute, Jerusalem; and Nivel Institute, Maastricht, the Netherlands

This study compares Israeli primary care physicians with those of European countries. In Israel a larger proportion of those in primary care are women. The Israeli physicians see many patients a day, but almost never make home visits. They also report for work the fewest hours a day, but spend 21 hours a month in continuous medical education. (more than Europeans?) The Israeli primary care physician scores high in screening for breast cancer and blood cholesterol level, but very low in the fields of minor surgery and alcohol and smoking prevention, contraception, nutrition counseling and normal pregnancy follow-up. Residency training and education may be inadequate, and more emphasis has to be put on the health system and recognizing environmental influences.

Intra-Osseous Ganglion of Scaphoid and Lunate Bones

M. Kligman, M. Roffman

Dept. of Surgery, Carmel Medical Center, Haifa

We present a patient with intra-osseous ganglion of the left scaphoid and lunate bone. These were excised and a bone graft inserted. 1 year after operation the patient was free of pain, without limitation of wrist motion. Intra-osseous ganglion of the carpal bone is not common and lunate and scaphoid intra-osseous ganglion has rarely been reported. Awareness of this condition may lead to earlier diagnosis and treatment, with satisfactory outcome.

Recurrent Tuberculosis in a Psychiatric Hospital

A. Zeenreich, B. Gochstein, A. Grinshpoon, M. Miron, J. Rosenman, I. Ben-Dov

Pulmonary and Radiology Institutes, Chaim Sheba Medical Center, Tel Hashomer and Tel Aviv University; Israel Ministry of Health; and Gan Meged Hospital

During 1987-1996, 39 of 720 patients hospitalized (most for severe schizophrenia) were diagnosed as having active pulmonary tuberculosis (5.4%, 975 per 105 per year). In 1992-1993, after a cluster of 5 cases was found, all patients were screened by PPD skin test and chest X-ray and 16 more cases were identified. Diagnosis was confirmed bacteriologically in only 10 of them but there were typical radiological findings in the others. 39 were treated with a multi-drug regimen. In addition, 333 exposed patients and 21% who had converted their skin tests were given isoniazid preventive therapy. A small increase in levels of liver enzymes was common, but significant abnormality (over 4 times the upper limit of normal) was found in only 7 patients, in whom therapy was therefor stopped or changed. During a follow-up period of 4 years, 2 more developed tuberculosis and 33 converted their PPD reactivity status. We conclude that an outbreak of tuberculosis in a psychiatric hospital can be controlled with a relatively low rate of side-effects by using systematic diagnostic and therapeutic measures. However, single step screening is not sufficient. Routine screening of all new patients, a high index of suspicion and contact investigation are needed.

Patients' Opinions of the Role of Primary Care Physicians and the Organization of Health Care Services

Revital Gross, Hava Tabenkin, Shuli Bramli, Pesach Schvartzman

JDC-Brookdale Institute, Jerusalem; Dept. of Family Medicine, HaEmek Hospital, Afula; Kupat Holim Clalit, Northern District; Institute for Specialization, Ben-Gurion University, Northern Branch; and Dept. of Family Medicine, Ben-Gurion University of the Negev and Kupat Holim Clalit, Beer Sheba

Patients' opinions of the role of the primary care physician were studied. The study population consisted of Hebrew-speaking members of the Clalit Sick Fund, aged 18+, who visited primary care and specialty clinics. Interviews took place during January-March 1995 in the Emek and Jerusalem, and during August-October 1995 in Beer Sheba. A total of 2,734 interviews were conducted, and the response rate was 88%. 64% of the respondents preferred the primary care physician as the first address for most problems occurring during the day. Multivariate analysis revealed that the variables predicting this preference were: being over age 45, having completed less than 12 years of schooling, being satisfied with the physician, and when a child's illness was involved. Whether the physician was a specialist had only a marginal effect. The findings also show that among those who did go directly to a specialist for the current visit, 49% would still prefer the primary care physician to be the first address for most problems. However, half of the respondents initiated the current visit to the specialty clinic themselves. The findings also showed that a preference for the primary care physician to be the first address had an independent and statistically significant effect on the following aspects of service consumption: taking the initiative to go to a specialist, the intention to return to the primary care physician or to the specialist for continuing care, and the patient's belief that referral to a specialist was needed. The findings of the study may be of assistance to policy-makers on the national level and to sick funds in planning the role of the primary care physician, so that it corresponds, on the one hand, to the needs of the sick funds and the economic constraints in the health system, and on the other, to the preferences of the patient.

Sunscreen Use in an Urban Negev Population

Pesach Shvartzman

Family Medicine Dept., Ben-Gurion University of the Negev, Beer Sheba

The use of sunscreen in the Negev population was assessed. The study population included 1458 subjects, mean age 35.5‏±14.2 years, half born in Israel and 25% in East Europe. Two-thirds were exposed to the sun 1-2 hours a day and 13% 4 hours a day or more. Only about 15% used sunscreen while shopping, 69% used it at the beach, and less than half applied it to children being sent to school. Sunscreen use was greater in women (p<0.000001), especially those with sensitive skin (p<0.0001) and red hair (p<0.0001). No significant association was found with age, education or country of birth.

Telling the Bad News: do the Elderly Want to Know Their Diagnoses and Participate in Medical Decision Making?

Sara Carmel, Alon Lazar

Sociology of Health Unit, Faculty of Health Sciences, and Dept. of Behavioral Sciences, Ben-Gurion University of the Negev, Beer Sheba

In view of reported changes in western countries in the preferred model of doctor-patient relations, we evaluated the wishes of elderly persons for open doctor-patient communication with regard to terminal disease. Data was collected in 1994 from 987 elderly persons (70+) by structured interviews. Most of respondents wanted open communication and wished to be involved in medical decisions regarding life-sustaining treatment. However, only a minority tell their physicians and/or family members of their wishes. This suggests that most of the elderly expect physicians to be the first to initiate discussions of these issues. The results also indicate that among the elderly, those more educated, less religious, and those living in Israel longer, are more likely to want open communication with their physicians. This is explained by the relationship of these characteristics with the dominant cultural values of this group, and its acceptable models of relations in other areas of life.