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.

Specialty Clinics - Gain or Loss?

Natalya Bilenko, Luna Avnon, Fanya Shimonovich, Dov Heimer

Epidemiology Dept.; and Pulmonary Unit of Soroka Medical Center; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

We evaluated the significance of first visits to our pulmonary clinic with regard to diagnosis and treatment by reviewing records of 287 new referrals by medical care providers (Sept. 1998 - Feb. 1999). At the first visit the diagnosis was changed in 30%, and treatment in 40%. These are minimal figures because evaluation had not been completed nor the diagnosis determined in all cases, while further investigation and follow-up continued.

In light of these findings, we believe that recent pressure on primary care physicians to avoid referrals to specialty clinics would result in short-term savings, but in the long term, would increase expenses and diminish quality of care. It is important to consider ways to maximize the interaction between the primary care physician and the specialist to maintain quality of care and decreases costs.

Cilazapril for Essential Hypertension Treated in the Community 

Reuven Zimlichman

Dept. of Medicine and Hypertension Institute, Wolfson Medical Center and Sackler Faculty of Medicine, Tel Aviv University

In a multicenter study in community clinics, 413 patients with mild to moderate essential hypertension were treated with cilazapril (Vasocase), 2.5 mg daily. Patients had either been untreated or had developed side-effects from previous antihypertensive treatment. When response was inadequate the dose was either increased to 5 mg or another antihypertensive medication was added, or both.

Treatment significantly reduced systolic and diastolic blood pressures. Pulse rate decreased significantly from the second month of treatment onwards. At the end of the 3rd month of treatment blood pressure was normalized or had decreased by more than 10 mmHg in 91.9% of patients. Physicians' evaluations revealed improvement in 62%; patients' self-evaluations suggested improvement in 61%. Efficacy was equal in all age groups and in both obese and nonobese patients. Antihypertensive response was superior in those with normal renal function. Side-effects were rare and similar to those reported in the literature.

Treatment of Hypertension with Losartan

R. Zimlichman

Dept. of Medicine and Hypertension, Wolfson Medical Center, Holon

The efficacy, safety and side-effects of treatment with losartan (Ocsaar) was studied for the first time in Israel in a large group of patients with mild to moderate hypertension in several community clinics. The 421 patients (51% men) aged 30-86 years (mean 58.6) received 50 mg of losartan daily, increased when necessary to 100 mg, and/or a second antihypertensive drug was given. After 4 weeks blood pressure was normalized in 344 and after 12 weeks in 363. Side-effects were minimal and treatment was effective in all age groups.

The New Family Physician

Eliezer Kitai, Avraham Sandiuk, Michael Weingarten, Shlomo Vinker

Dept. of Family Medicine, Rabin Medical Center (Beilinson Campus), Petah Tikva and Sackler School of Medicine, Tel Aviv University

The content of all consultations of a family physician during the first 2 months in a new practice and again in the same 2 months, 2 years later were analyzed. The workload did not change between the 2 periods, but in the first period there were relatively more men over the age of 60 years, and a more marked predominance of women in the 45-59 year age-group.

There were more follow-ups of pre-existing conditions during the first period, but in both periods the main reason for visits was an acute condition; a quarter of visits required only simple counseling without further investigation or prescribing of medication. During the first period 9% of visits were for the explicit purpose of getting to know the new physician, usually by women.

Thus the initial period in a new practice is not excessively burdensome, but involves seeing a number of patients who come either simply to get to know the new doctor, or to present non-chronic problems without expectation of further investigation.

Influenza Surveillance through Sentinel Reporting Clinics

T. Shohat, N. Versano, A. Kiro, G. Golan, E. Mendelson, M. Weingarten

For the Influenza Surveillance Network: Israel Center for Disease Control, Israel National Laboratory for Influenza and Central Virology Laboratory; Netka Child Health Center and Dept. of Family Medicine, Rabin Medical Center, Beilinson Campus, Petah Tikva

In a joint effort of the Israel Center for Disease Control, the National Center for Influenza in the Central Virology Laboratory, together with a group of collaborating pediatricians and family physicians, a network for influenza surveillance was established in the winter of 1996-97. Nose and throat swabs were obtained from 571 patients with flu-like illness. 133 (23%) were positive for influenza virus. Both influenza A(H3N2) and B were isolated, predominantly influenza B during the beginning of the season. Both circulating strains were antigenically similar to those included in the vaccine for 1996-1997. Patients from whom influenza virus was isolated were significantly more likely to suffer from cough and myalgia in comparison with patients whose cultures were negative (p=0.02 and 0.003. respectively). Results of the first year of surveillance indicate that sentinel reporting clinics are useful for timely detection and identification of the viral strains circulating in the community, thus allowing prompt intervention in preventing the spread of influenza. Conclusions from the first year of the study were drawn and applied in the winter of 1997-1998.

Abnormal Liver Function Tests in the Primary Care Setting

Shlomo Vinker, Sasson Nakar, Emanuel Nir, Eitan Hyam, Michael A. Weingarten

Dept. of Family Medicine, Rabin Medical Center, Sackler Faculty of Medicine; Tel Aviv University; and General Sick Fund, Central District

Results of laboratory tests ordered during a primary care encounter may reveal findings of abnormal liver function tests, including elevated liver enzymes, hyperbilirubinemia, hypoalbuminemia or abnormal coagulation tests. The object of this study was to describe the spectrum of these liver function test (LFT) abnormalities in primary care.

Results of all laboratory tests ordered during 10 months in an urban primary care clinic were retrospectively reviewed and the medical charts of patients with abnormal LFTs were studied. In 217/1088 (20%) of the tests at least 1 LFT abnormality was found in 156 patients. New diagnoses were made in 104 patients. The main diagnostic groups were: non-alcoholic fatty liver changes, Gilbert's disease, acute infectious hepatitis, alcoholic liver disease and cirrhosis and hepatotoxic drug injury. In 60 patients the physician classified the abnormality as negligible and not associated with significant disease. However, an abnormal test that had been ordered for evaluation of a specific complaint, was indeed likely to represent significant disease (X²=29.5, p<0.001). We conclude that finding abnormalities in liver function tests is common in the primary care clinic but does not often indicate significant liver disease.

Urgent, Unscheduled Self-Referrals by Ambulatory Patients

S. Vinker, S. Nakar, Z. Alon, H. Abu-Amar, G. Sadovsky, E. Hyam

General Sick Fund, Central District and Dept. of Family Medicine, Sackler Faculty of Medicine, Tel Aviv University

Direct self-referral to a consultant is common in the Israeli health system. Yet patients' reasons for their urgent, unscheduled self-referrals for ambulatory consultations (UUSR) have not been explored. We studied such consultations in an urban multi-disciplinary consultation center serving a population of approximately 100,000. Over a 3-month period such consultations in ophthalmology, ear-nose-and-throat and dermatology clinics were treated by a duty family physician (FP). The FP was instructed to focus on the urgent complaint and either to give definitive treatment and schedule a consultation when needed, or refer the patient for immediate specialist consultation. Patients treated by the FP were asked to fill an anonymous questionnaire, which 347/645 (55.4%) did.

Among the reasons for UUSR were that the patient thought that his/her complaints should be treated by a consultant (29%), the patient was sent by the FP without a consultation note (13.9%), the FP was not available (10.4%), or the patient wished to see the consultant for a second opinion (8.2%). In only 7.8% had the patient noted that his complaint needed urgent consultation. Duration of complaints, but not prior efforts to schedule a consultation, were associated with different reasons for asking for an UUSR. For various reasons patients preferred an UUSR rather than seeing their own FP. Patients' opinions regarding self-referrals are important in planning primary care facilities and FP training.

Compulsory, Ambulatory Psychiatric Treatment

R. Durst, A. Teitelbaum, Y. Bar-El, M. Shlafman, Y. Ginath

Arie Jaros Jerusalem Mental Health Center and Talbieh Mental Health Center (Affiliated with the Hebrew University-Hadassah Medical School, Jerusalem) and Israel Ministry of Health, Jerusalem District

The Treatment of Mentally Sick Persons Law of 1955, was repealed and replaced by the Law of 1991. Under the latter, the Order for Compulsory Ambulatory Treatment (OCAT) was addressed for the first time (Section 11, a-d). According to this law, the district psychiatrist instead of issuing a hospitalization order, may issue an OCAT, under which the required treatment is given within the scope of a clinic which he designates, for up to 6 months and under conditions which he specifies. This is done on the basis of psychiatric examination, or an application in writing from the director of a hospital or clinic, when continued ambulatory treatment is needed after discharge from hospital or instead of compulsory hospitalization. The district psychiatrist may extend the period of treatment for further periods, none of which is to exceed 6 months. Compulsory ambulatory treatment is to enable patients to benefit from the positive aspects of living freely in the community, while receiving prompt treatment under compulsory conditions. The concept offers a partial solution, achieving a balance between civil liberties and clinical needs, between over-confinement and under-treatment which might be dangerous or neglectful. The clinical impression has been that the OCAT has not fulfilled expectations. The purpose of this study was to examine the topic in a systematic way in Jerusalem and the soutern districts for the 4 years since inception of the law. In 44.4% of cases OCAT was proven to be effective, while in 33.1% it was found to be ineffective and did not prevent compulsory hospitalization, one of its main goals. It was partially effective in the rest of the cases. It is recommended that suitable means for the enforcement of the law be allocated and that the subject of forceful hospitalization and OCAT be made a mandatory subject in the residency program of psychiatrists.

Oral Anticoagulation Therapy in the Primary Care Setting

Shlomo Vinker, Sasson Nakar, Sergei Finkel, Emanuel Nir, Eitan Hyam

Family Medicine Dept., Sackler Faculty of Medicine, Tel Aviv University; and Shaaraim Clinic, General Sick Fund, Rehovot; Central Cinical Laboratories, and District Medical Director, Central District of the General Sick Fund

The use of oral anticoagulant therapy (OAT) to prevent thromboembolism has been widespread in recent years. The concept of high- and low-intensity regimens has facilitated treatment for many, and has lowered the hazards of overly intense anticoagulation. However, a significant proportion of patients suited to the low intensity regimen are not being treated. It is not clear whether its wider use is limited by continued debate, lack of resources, lack of expertise, or other causes. We retrospectively reviewed the medical records of 32 patients treated with OAT administered in the primary care setting. The average age was 66±11 years (range 34-84). 9 were treated with high-intensity OAT: 8 due to artificial heart valves, and 1 due to a hypercoagulable syndrome with recurrent thromboembolism. 23 were treated with low-intensity OAT, 17 of whom had atrial fibrillation. 11 were also being treated continuously with other medication which interacted with OAT or interfered with other coagulation pathways. Such medication included: aspirin, dipyridamole, amiodarone, bezafibrate and allopurinol. Of 414 coagulation tests, 57% and 65% were in the therapeutic range in the high- and low-intensity OAT groups, respectively. There was no major bleeding event, but in 2 of 8 who bled, gastrointestinal bleeding led to hospitalization. Treatment was discontinued in 1 patient because of difficulties in achieving target INR, and in the 2 hospitalized for bleeding. The percentages of test results in, above and below the therapeutic range were similar to those in other large series, for both intensity regimens. We found that a significant proportion of patients were under chronic treatment with other medication which interacted with OAT. To estimate the rate of complications in primary care OAT, larger series are needed. We conclude that OAT can be given and monitored by the family physician, and that awareness of long and short term drug interactions with OAT is mandatory.