תוצאת חיפוש

Regulation of Natural Medicines in Israel and Abroad

T. Lavy, B. Haran, J. Shemer, S. Shani

Israel Ministry of Health, Pharmaceutical Policy and Economics Unit; Israel Center for Technology Assessment in Health Care; Gertner Institute for Epidemiology and Health Policy Research; Sackler Faculty of Medicine, Tel Aviv University

Hand-in-hand with the public's growing interest in health care, there has been an increasing demand for natural health products considered both safe and medically effective. But many such products have not been shown to meet efficacy and safety criteria and therefore can not be registered as pharmaceuticals. On the other hand, it is quite clear that some products do have pharmacological activity and are being used for therapeutic or preventive effects.

In Israel, the marketing rules for food or dietary supplements prevent their manufacturers from claiming medicinal/healing properties that the product might have, and allow only limited health statements. But great demand for these products has created massive publication attributing medicinal indications for products whose quality, efficacy and safety have neither been examined nor proven according to accepted medical criteria.

We review the regulation and supervision of natural health products in Israel and other developed countries and find a broad range of opinions about natural health products. They range from acceptance as conventional drugs reimbursable by the health insurance, as in Switzerland and Germany, to their status as dietary supplements requiring no significant authorization or supervision, as in the USA.

Analysis of the current situation in Israel and the western world would indicate that some natural health products do possess pharmacological activity and therefore manufacturers should be allowed to make limited claims for specified therapeutic properties. A stricter set of registration regulations are needed for proof of safety, efficacy and quality of these products, but more lenient than those for registering a pharmaceutical product.

Preservation of the Larynx in Advanced Cancer

Edward Rosenblatt, Nava Siegelmann-Danieli, Jemal Zidan, Nisim Haim, Abraham Kuten

Oncology Dept., Rambam Medical Center and Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa

The effectiveness of sequential chemo-radiotherapy in preserving the larynx in advanced laryngeal carcinoma was assessed. 4 Unselected patients (19 men and 2 women, mean age 60 years) with advanced squamous cell carcinoma of the larynx (T3-4/N0-3) received induction chemotherapy consisting of 2-3 cycles of cisplatin (100 mg/m²) and 5-flourouracil (1000 mg/m²/day) as a continuous infusion on days 1-5 followed by definitive radiotherapy: 50 Gy to the whole neck, 70 Gy to the larynx and clinically involved nodes, using a combination of 6 MV photons and 9-12 MeV electrons.

19 of The 21 patients responded to combined therapy but there was no response to induction therapy in 2 (10%) and 2 did not complete therapy due to severe toxicity. At a mean follow-up of 40 months, 7 had undergone total laryngectomy (33%), for an overall 5-year laryngeal preservation rate of 66%. Reasons for total laryngectomy in 2 patients were no response and in 5 tumor recurrence.

Mean survival was 39 months (range 11-46 months); at last follow-up 17 of 21 were alive and disease-free, 11 of whom had a functional larynx (65% of survivors). 2 died due to disease progression and 1 due to a cardiovascular event. Sequential chemo-radiation allows laryngeal preservation in about 2/3 of surviving patients without compromising survival.

Israel Hospital Pharmaceutical Services: A National Survey 

S. Livny, A. Hammerman, S. Shani, J. Shemer

Hiliel Yaffe Medical Center, Hadera; Israel Center for Technology Assessment in Health Care; Gertner Institute, Tel HaShomer; Dept. of Internal Medicine, Sheba Medical Center, Tel HaShomer; and Sackler School of Medicine, Tel Aviv University

Results of a 1996 survey of hospital pharmaceutical services in Israel are presented. A questionnaire was mailed to 46 pharmacy directors in Israel hospitals of which a total of 33 were returned (72%).

The main services provided at hospital pharmacies are production of pharmaceuticals and inventory management. The pharmacy directors estimated that more then half of their pharmacists' time was spent on technical work that did not need their academic, professional knowledge. In Israel general hospitals there are on the average 1.23 full time pharmacist positions per 100 hospital beds and 1.09 positions for other pharmacy employees.

A similar survey carried out in the United States showed an average of 7.4 pharmacists per 100 hospital beds. Pharmacists there have broad clinical roles which, in general Israeli pharmacists do not have.

Computer systems are used in our pharmacies mainly for inventory management. About half of the directors did not think that the location, structure and furnishings of their pharmacy were appropriate for its role.

Under current conditions, Israel hospital pharmacies are not organized to provide pharmaceutical services beyond inventory management and pharmaceutical production. Appropriate budgets and personnel are required to develop clinical pharmacy services at Israel hospitals. This would lead to improved quality of drug treatment and cost-containment and would allow pharmacists to exploit their knowledge, skills and training that under the current system, are only partially utilized.

Clozapine in the Treatment of Schizophrenia

M. Mark, R. Magnezi, O. Luxenburg, M. Siebzehner, J. Shemer

Israel Center for Technology Assessment in Health Care, Sackler Faculty of Medicine, Tel Aviv University

Schizophrenia is associated with brain abnormalities and is typically evidenced by disorganized speech and behavior, delusions, and hallucinations; it usually requires extended hospitalization. Its incidence in the western world is estimated at 4-7 cases/10,000/year.

A method of shortening hospitalization and improving level of functioning is the use of unique medication, including clozapine, which has been in use in Israel for the past 6 years.

We report 327 patients who participated in a community rehabilitation program and were treated with clozapine. They were compared with 417 patients who corresponded to the guidelines of the Director of Mental Health Services for treatment with clozapine, but were not treated with it for reasons not defined in the guidelines.

The study included those 25-44 and 45-64 years of age and according to the division of the population of patients hospitalized in both government and private hospitals. The project demonstrates the savings from use of clozapine as opposed to the alternative of hospitalizing these patients. It also shows the complexity and difficulty in assimilating new technologies, in relation to the influence of social considerations and supplier/insurer accounting on the patterns of technological assimilation.

The Israeli Pharmaceutical Market

Segev Shani, Joshua Shemer

Pharmaceutical Policy and Economics Unit, Israeli Center for Health Technology Assessment in Health Care, Gertner Institute for Epidemiology and Health Policy Research, Tel Hashomer and Sackler Faculty of Medicine, Tel Aviv University

The pharmaceutical market in Israel has undergone many major changes over the past 2 years. We detail measures taken with regard to drug prices and utilization, from 1992 until 1995, when the National Health Insurance Law was implemented. This provides an information base for marketing and dispensing of drugs, economic planning in the public health system, and for physicians and pharmacists in clinical practice.

The national expenditure on pharmaceuticals in 1994 was 9.4% of the annual national health expenditure. From this fact, and the number of registered drugs and the number of clinical trials conducted, it appears that our pharmaceutical market is quite diversified and well developed compared to other markets in the western world. This size advantage enables our sick funds to purchase drugs at much lower prices than the private sector.

Nephron-Sparing Surgery - Initial Experience with 50 Patients

Sarel Halachmi, Alexander Kastin, Boaz Moskovitz, Ofer Nativ

Urology Dept., Bnai Zion Medical Center, Haifa

During recent years the use of the new imaging techniques, ultrasonography and computerized tomography, has increased. The accessibility to these methods has changed the pattern of detection of renal lesions. Over 90% of renal masses are now discovered incidentally, while investigating nonurological symptoms. Therefor, most lesions are discovered in their early stages.

The gold-standard procedure for removing renal masses is radical nephrectomy, which ensures complete removal of an organ-confined lesion, but involves loss of functional tissue. This might be critical in patients with a single kidney, or reduced nephron function. There are several diseases characterized by multiple renal lesions, such as Von Hippel-Lindau and tuberous sclerosis in which radical treatment may lead to chronic dialysis in young patients.

Nephron-sparing surgery was developed in order to preserve as much functional tissue as possible while removing safely any suspicious renal lesion. This new technique, not involving radical surgery, should be evaluated in cases of renal tumors for its ability to achieve the same cancer cures rates. We present our experience with our first 50 patients who underwent nephron-sparing surgery for removal of renal lesions.
 

Conservative Approach in Abdominal Trauma in Childhood

Nir Shoham, Yechiel Sweed

Dept. of Ophthalmology, HaEmek Medical Center, Afula and Dept. of Pediatric Surgery, Nahariya Medical Center

To determine the results of the conservative approach in the treatment of pediatric abdominal trauma, we retrospectively analyzed data from the files of 95 cases of abdominal trauma in children during a 5-year period.

51 patients (54%) had isolated abdominal injury, while 44 (46%) had multiple trauma. The most common causes of injury were road accidents and falls from heights (74%). CT scans were performed in 61 (64%) with positive results in 90%. Ultrasonography was done in 22 (23%) and was positive in 55%.

The spleen was the most vulnerable intra-abdominal organ (33 patients, 35%), as well as the organ most severely damaged. Other injured organs were: liver (30 cases), kidney (16), stomach (2), large blood vessels (2), and pancreas, duodenum and diaphragm (1 case each).

83 patients (87%) were treated conservatively, while 11 were operated on for penetrating abdominal trauma (3 cases), hemodynamic instability (3), positive DPL (3), and Scale 4 splenic injury and free intra-abdominal air on CT scan (1 case each). Early and late complications were mild.

It is concluded that CT is an efficient and reliable imaging method for diagnosis and staging of severity of injury in blunt abdominal trauma. Nonoperative management of solid organ injuries under careful observation in a pediatric trauma center is safe and appropriate. Most Scale 4 splenic injuries can be treated successfully without surgical intervention. Using this conservative approach there were no late complications.

Pelvic Floor Exercise and Biofeedback in Genuine Stress Incontinence

D. Gordon, D. Luxman, Y. Sarig, A. Groutz

Women and Children's Division, Liss Hospital, Sourasky-Tel Aviv Municipal Medical Center and Sackler Faculty of Medicine, Tel Aviv University

Stress urinary incontinence is a medical and social problem. In the past decade there has been increased awareness of this condition and the number of those affected who seek help is increasing. Treatment is usually surgical - elevation of the bladder neck. Pelvic floor exercise is an accepted conservative treatment modality used for mild to moderate cases that have not yet completed their families.

We present our results in 30 women, aged 28-71 years, av. 49% with genuine stress incontinence treated with pelvic floor exercise and biofeedback. 14 patients (46.7%) were completely cured and 15 (50%) were improved. In only 1 was there no improvement.

Our results show significant improvement in the duration and intensity of pelvic floor contractions after treatment. Pelvic floor exercise with biofeedback is a very important treatment modality, requiring a highly motivated patient and a physiotherapist specialized in pelvic floor exercise.

Muir-Torre Syndrome: Importance of Clinical Diagnosis and Genetic Investigation

Hana Strul, Paul Rozen, Tova Naiman, Ruth Shomrat

Gastroenterology Dept. and Genetics Institute, Tel Aviv Medical Center and Tel Aviv University

Muir-Torre syndrome is a relatively rare cutaneous manifestation of hereditary nonpolypous colorectal cancer (HNPCC). This autosomal dominant syndrome is characterized by a combination of sebaceous gland and malignant visceral tumors. The common sites of internal malignancies are the gastrointestinal tract and urinary system. It appears in early adult life and its clinical course is relatively slow.

In some families genetic diagnosis can identify asymptomatic carriers of the mutation. All first-degree relatives, especially mutation carriers, should be referred from the age of 20 years for routine follow-up and early treatment, as it has been proven to decrease morbidity and mortality.

We present a 51-year-old man with Muir-Torre syndrome diagnosed by the presence of multiple adenomas of sebaceous glands, colonic adenoma and adenocarcinoma of the duodenum. The family history was typical for HNPCC. A mutation in the hMSH2 gene on chromosome 2p was found in the patient and in several asymptomatic family members. The aim of this report is to increase awareness of this syndrome and emphasize the importance of referring patients and their families for clinical and genetic counseling and diagnosis.

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.

Professional Assessment of Senior Immigrant Physicians

N. Notzer, M.I. Zibziner, J. Shemer, M. Ravid

Sackler Faculty of Medicine, Tel Aviv University

Israel has absorbed many immigrant physicians and has utilized their skills without compromising local professional standards. In accordance with this policy a special law for the assessment of the licensing of senior immigrant physicians, mainly from the former Soviet Union, who had practiced medicine for at least 14 years was implemented in 1994.

Considering their considerable medical experience on the one hand and their lack of experience in speaking Hebrew or undergoing testing techniques, they were exempted from the written national licensing examination. Instead they were obliged to undergo a 6-month clinical observation period in a local hospital or clinic.

At the end of this period a letter of confirmation was issued which was followed by an oral assessment of their clinical ability. In the assessment session, each candidate was presented with written presentations of 4 typical clinical cases which practitioners encounter on a daily basis, in family medicine, emergency medicine, surgery, and pediatrics or gerontology. Of 114 cases prepared, 4 were selected for each candidate by the committee of 13 trained, experienced Israeli physicians.

3 members of the committee assessed each candidate using specified criteria. The assessment, which lasted about an hour, focused on the candidates' professional knowledge involved in differential diagnosis and case management.

Of 497 candidates examined between 1994 and 1996, approximately 80% passed in their first attempt. However, about 30% of the invited candidates did not appear for the exam. Characteristics of successful candidates were being young and being among the seniors with the least clinical experience. Most had specialized in internal medicine and had completed their observation period in a non-academic hospital. There they had received somewhat more attention than those who had been in academic hospitals. Significantly, the successful candidates were more proficient in Hebrew than the unsuccessful candidates, and reported no special problems during the observation period.

Changes in Structure and Process Components of Trauma Care in Emergedepartments

Rephael Joseph Heruti, Ron Ben-Abraham, Yanir Abramovitch, Michael Stein, Joshua Shemer, Baruch Marganit

Trauma Control, Israeli Center for Disease Control (ICDC), Israel Ministry of Health and Sackler School of Medicine, Tel Aviv University

In recent years there have been tremendous efforts to improve primary trauma care. The Ministry of Health and other authorities have invested in new trauma facilities in various hospitals. A nationwide survey with regard to structure and function of emergency departments was carried out. Compared to a similar survey conducted in 1992, significant progress in quality and quantity of equipment at various emergency departments was demonstrated. However, there are still differences between various hospitals. A drive to standardize trauma care will undoubtedly contribute to improvement in care of the injured.

Clinical Characteristics of those who Leave the Emergency Room Against Advice

A. Carmel, H. Amital, Y. Shemer, A. Sahar

Emergency Dept. and Dept. of Medicine B, Gertner Institute for Medical Service Research, Chaim Sheba Medical Center, Tel Hashomer and Sackler Faculty of Medicine, Tel Aviv University

The object of this study was to characterize those who leave the emergency department agmedical advice and to examine the short-term consequences. The study was conducted retrospectively 1992 and prospectively during May-August 1993 by telephone interviews. About 0.5% of all the patients who applied to the emergency department left against medical advice. Their main characteristic was that they were mostly young, single men. A wide range of complaints had brought them to the emergency department, very similar to that of the control group, but with a higher tendency to abuse drugs and alcohol. Most of those who left against medical advice had less severe disease than the controls. However 10% of them had to be hospitalized within the subsequent 2 weeks, in comparison with 4% of the controls. This study suggests that improving the efficiency of the emergency department will decrease the number leaving against advice.

Israel's ATLS Program: Summary and Outlook

Ron Ben Abraham, Michael Stein, Yoram Kluger, Gideon Paret, Avraham Rivkind, Joshua Shemer

Medical Dept., Israel Defense Forces and Israel Trauma Society

In recent years a vigorous effort has been made to improve quality of primary trauma care in Israel. Advanced trauma life support courses (ATLS) were given to physicians throughout the country, regardless of their specialties. In 7 years 4229 physicians participated in 202 courses with an average success rate of 76%. In the future, issues such as mandatory vs. voluntary training, language barriers, and continuous decline of knowledge should be addressed if momentum is to be maintained.

Conservative Approach in Children with Central Line Infection 

Zvi Steiner, Yafim Kandelis, George Mogilner, Dina Atias, Isaac Srugo

Dept. of Pediatric Surgery, and Hematology and Clinical Microbiology Units, Bnei-Zion Medical Center, and Bruce Rappaport Faculty of Medicine, The Technion, Haifa

In 1994-1995, central venous lines were placed in 47 children. All except 1 were of the Broviac type, with subcutaneous tunneling via the internal or external jugular vein. Ages were between 7 days and 16 years. Indications for central venous cannulation were chemotherapy (35 cases), TPN (5), prolonged parenteral antibiotics (4), and repeated blood transfusions (3). The catheter was the source of infection in 13 children (28%), 11 of whom were immunocompromised. The commonly identified bacteria were Staphylococcus aureus (4 cases), Pseudomonas aeruginosa (4), coagulase-negative Staphylococcus (2), and various gram-negative rods (3). All cases were treated with antibiotics through the catheter. The most commonly used were oxacillin (4), ceftazidime (4), and amikacin (4). In 10, treatment succeeded without having to remove the line. In 2 others, tunnel infection developed and the catheter had to be removed. 1 child forcefully removed his catheter before treatment could be started. There were no further complications in the group treated conservatively, except for a case of superior vena cava thrombosis in a girl with recurrent infection of the tunnel. In 7 out of 13 treatment was continued and completed at home. This saved 65 days of hospitalization out of 210. We conclude that the conservative approach to treatment is feasible in most cases of infection when the source is the central venous catheter itself. However, when the tunnel is infected, conservative treatment may be ineffective. Treatment can be carried out in the home, with economy in cost and in use of hospital beds, and is preferred by patients and their parents.