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.

Limited Percutaneous Surgical Drainage in Severe Neonatal Necrotizing Enterocolitis in Low Birth Weight Prematures

Robert Finaly, Zahavi Cohen, Vadim Kapuller, Agneta Golan, Edna Kurtzbart, Abraham Mares

Depts. of Pediatric Surgery and Neonatology, Soroka Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

The usual treatment of complicated neonatal necrotizing enterocolitis (NEC) is resection of the necrotic bowel, lavage of the peritoneal cavity and diversion enterostomy. Low-birth-weight premature neonates with this condition are in special danger if general anesthesia and full exploratory surgery is contemplated.

A relatively simple alternate procedure is percutaneous insertion under local anesthesia of a soft abdominal drain, most often in the right lower quadrant. The procedure is done in the neonatal intensive care unit without moving the whole set-up to the operating room.

4 such cases have been treated within the past year. 3 were discharged home as they did not require additional surgical treatment, not having developed intestinal stenosis or obstruction. 1 recovered from the acute episode, but succumbed to a severe intraventricular hemorrhage and respiratory failure 7 days after the procedure.

Our limited but most gratifying experience, in addition to similar experience of others, encourages us to recommend this simple surgical approach in the very sick low-birth-weight premature with fulminant NEC.

Prevalence of Medical Complaints in the Community-Dwelling Elderly

J. Gindin, M. Geitzn, M. Dushenat, H. Siboni, D. Goldstein, Z. Shapira, N. Konstantin, A. Wurm, A. Goldsmid, E. Hay-Am

Geriatric Institute of Education and Research, Kaplan Medical Center, Rehovot; Pharmacology Dept., Kupat Holim Klalit, Tel Aviv and Central District; and Kupat Holim Klalit, Rishon LeZion

We assessed the prevalence of self-reported medical complaints among the community-dwelling elderly receiving regular medication, and determined associations between health and sociodemographic variables, and the prevalence of complaints.

The study included 170 patients, 60-90 years of age, living at home. Participants were recruited from the 3 main primary care clinics in Rishon LeZion. All were receiving chronic medication and were followed-up utilizing a long-term medication card. Data were gathered in interviews held in patients' homes using a structured questionnaire which included sociodemographics, diseases and medication, mental state assessment by Katzman's score, and a list of 15 medical complaints common among the aged. Relations to age, gender, education, living arrangements, number of diseases and number of medications per patient were determined.

Mean age of participants was 73.2±6.0 years and they suffered an average of 4.07±2.16 diseases and took 5.10±2.83 types of drugs. The most prevalent complaints were: weakness and fatigue (65.0%), agitation and restlessness (56.4%), dry mouth (45.6%), constipation (43.6%) and dizziness (43.2%). The number of diseases, gender, education and age had the strongest associations with the prevalence of specific complaints, as well as their total number. The association between number of medications and mean number of complaints was of borderline significance.

Danaparoid-Sodium for Dialysis in Heparin-Associated Thrombocytopenia

Ronen Ben Ami, Ruth Rachmimov, Shlomo Berliner

Medicine Dept. D and Anticoagulation Therapy Unit, Tel Aviv-Souraski Medical Center, and Nephrology Institute, Sheba Medical Center, Tel Hashomer

Danaparoid sodium is an anticomposed of 3 glycosaminoglycans: heparan sulfate, dermatan sulfate and chondroitin sulfate. Similar to heparin, operates by activating antithrombin 3, but does not contain heparin or heparin fragments, and is therefore antigenically distinct.

Danaparoid has been advocated as a safe and effective anticoagulant for heparin-associated thrombocytopenia. However, there is little experience in its use as a substitute for heparin in hemodialysis.

We report 2 men, aged 82 and 73 years, respectively, who developed thrombocytopenia while undergoing hemodialysis with heparin, and who subsequently underwent successful dialysis with danaparoid. There was a rise in platelet levels in both while receiving danaparoid, and dialysis was completed without hemorrhagic or thrombotic complications. Danaparoid is a safe and effective substitute for heparin, and may be used as an anticoagulant in hemodialysis.

Epidural Spinal Abscess

E. Tamir, Y. Mirovsky, N. Halperin

Orthopedics Dept., Assaf Harofeh Medical Center, Zerifin

A 42-year-old man was admitted for fever and severe low back pain radiating to both legs. On MRI, an epidural spinal abscess from S1 to D10 was seen. Treatment included laminectomy, drainage of the abscess and antibiotics. Recovery was complete without neurological damage. Increased awareness of this disease may lead to diagnosis and treatment.

Nonpenetrating Deep Sclerectomy

Orna Geyer

Ophthalmology Dept., Tel Aviv-Sourasky Medical Center

This is the first report from Israel of nonpenetrating deep sclerectomy (DS), a new operation for the surgical management of glaucoma. It facilitates ocular fluid drainage without entering the eye. It involves performance of a conjunctival flap and creation of a 565 mm superficial scleral flap. A deeper scleral flap is dissected off the scleral bed together with the roof of the canal and corneal stroma, leaving behind the wall of the canal and membrane. Aqueous will flood the dissected area. A collagen device is then sutured to the scleral bed, the superficial scleral flap sutured into position and the conjunctiva closed. With this procedure, the surgeon can avoid the common complications of conventional glaucoma surgery.

We report a 6-month follow-up of 15 patients after DS. Mean preoperative intraocular pressure was 26.7+2.5 mm Hg, which decreased to 15.5+4.7. After 6 months there was no change in visual acuity after surgery. DS is associated with good middle-term intraocular pressure control and a low rate of postoperative complications. It is therefore a good alternative to standard glaucoma surgery.

Multiple Angiodysplastic Lesions of the Colon - a Therapeutic Challenge

Nir Hilzenrat, Edit Liberty

Division of Gastroenterology and Dept. of Medicine E, Soroka Medical Center and Ben-Gurion University, Beer Sheba

Colonic angiodysplasia is one of the most frequent causes of recurrent lower gastrointestinal tract bleeding, mainly in the elderly. In 50% of patients multiple angiodysplastic lesions were reported when they were the cause of rectal bleeding. Bleeding from angiodysplasia is more severe and less responsive to treatment in those with coagulation disorders. A 74-year-old woman with an artificial mitral valve who was treated with coumadine is reported. A few years after operation she began to develop severe recurrent rectal bleeding because of multiple angiodysplastic lesions along the right colon, proven by colonoscopy. She was frequently hospitalized for blood transfusions; endoscopic treatment was not feasible and the surgical risk of colectomy was very high. Treatwith estrogen and progesterone significantly decreased recurrent episodes of bleeding.

Terror in Japan: Mass-Intoxication with the Nerve-Agent Sarin

Yoram Solberg, Orit Nachtomi-Shick, Yehoshua Shemer, Menachem Alcalay

Medical Corps, Israel Defense Forces and Sheba Medical Center, Tel Hashomer

During 1994/5 the Japanese civilian population suffered 2 terror attacks by the organophosphorus nerve-agent sarin. In these 2 episodes it is estimated that more than 6000 people were injured, of whom 19 died. The quick and efficient response of the civilian emergency systems to these unforseen, attacks has to be analyzed by local authorities to determine the best solutions in case of another attack. We summarize the events, and note the emergency system's response, the need for rapid and accurate chemical identification of the toxin, the necessity for decontaminating the casualties and for providing protective gear for rescue units in the contaminated area. We also describe the clinical status of the casualties and outline the mode of therapy applied.

Early Results with Threaded Spinal Cage Fusion Systems

Ely Ashkenazi, Stephen T. Onesti

Neurosurgery Depts. of Hadassah-University Hospital, Jerusalem and Montefiore Medical Center, New York

Lumbar interbody fusion is a surgical technique used to treat symptomatic lumbar disc disease. Low back disorders are the most common of the musculoskeletal disorders causing a tremendous burden of disability. One of the causes of low back pain and radiculopathy is spinal instability, which can be treated by spinal fusion. In the past year, threaded cage systems have become available for segmental lumbar fusion for degenerative disc disease. These systems offer several biomechanical advantages over traditional lumbar fusion and instrumentation techniques, and are better tolerated.

From December 1996 until June 1997 we operated and fused spines of 17 patients, using 2 different fusion systems (anterior and posterior approaches). We present our early results.

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.

Verapamil-Associated Liver Injury

Majed Odeh, Arie Oliven

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

Hepatotoxicity due to verapamil is very rare and to the best of our knowledge only 10 cases have been reported. A 54-year-old woman developed cholestatic liver injury and pruritus following treatment with sustained-release verapamil (240 mg/day) for arterial hypertension. The pruritus and all hepatic biochemical abnormalities completely resolved after withdrawal of the drug. Similar to previously reported cases, the pathogenic mechanism of verapamil-associated liver injury in our patient was, most probably, idiosyncratic. These cases emphasize the need for awareness of the possibility that verapamil may occasionally induce liver injury, sometimes severe and potentially fatal.

Esophageal Carcinoma Presenting as Fever of Unknown Origin

Sody Naimer, Alexander Levine

Depts. of Family Medicine, Beer Sheba, and Gush Katif Medical Center

Fever of unknown origin presents both a clinical and diagnostic challenge and is usually caused by inflammatory and neoplastic diseases. We present a unique case of a previously healthy 77-year-old woman whose sole complaint was fever. Complete hospital investigation failed to reveal the underlying process. 4 months after the onset of fever, dysphagia appeared and she was then diagnosed as suffering fsquamous cell carcinoma of the esophagus. The question of early barium swallow X-ray in such cases is raised.