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S Shani

Publications and source records attributed to S Shani.

17 recordsLinked to original sources
PubMed2001

[Adverse drug reactions definitions and terminology].

Any therapeutic substance is potentially harmful. There are many examples in the literature justifying the need to follow-up the drug throughout it's life cycle (post-marketing surveillance). It is estimated that only 50% of the undesirable reactions can be detected during the pre-marketing clinical trials. The drugs' manufacturers have the obligation to report any unwanted reaction or effect of a drug to the regulatory authorities. Furthermore, the regulatory authorities encourage physicians to report adverse effects immediately. The terminology used in these reports contains many different terms which describe an undesired reaction: adverse drug reaction, adverse event, adverse effect and side effect. The common definition of "Adverse Drug Reaction" (ADR) is: "A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or the modification of physiological function." The use of many terms for the description of the same kind of event causes disharmony and difficulties in analysis. It is of utmost importance to use compatible terms in order to achieve accord throughout the development process and marketing of a drug. Today, adverse-drug-reaction reporting is of major importance in the regulatory authorities' agenda and the regard for drug safety is rising. The aim of this review is to introduce the various terms used to describe ADR's, to discuss their advantages and shortcomings and the differences between them.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

[Israel hospital pharmaceutical services: a national survey].

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.

Hospitals, General↗
PubMed2000

[Herceptin].

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Antibodies, Monoclonal↗
PubMed2000

Setting priorities for the adoption of health technologies on a national level -- the Israeli experience.

The rapid development of new and expensive health technologies together with the limited resources available for the health care system, makes priority setting or rationing inevitable. The Israeli Health Insurance Law, enacted in 1995, determined a basic list of health services to be provided to all residents by public funding. Although the Israeli health care system has reached a high standard of medical care as expressed by parameters such as long life expectancy and low infant mortality, the social and professional demand for new and expensive health technologies is increasing. Towards the fiscal year of 1999, the Medical Technologies Administration of the Ministry of Health recommended a list of new technologies to be added to the list of health services. The Ministry of Finance allocated that year US dollars 35 million for this purpose, while a rough assessment found that there are new important technologies to be added at a cost of more than US dollars 350 million. The Medical Technologies Administration took a systematic approach of health technology assessment - ad-hoc teams were established for evaluating clinical safety, efficacy and effectiveness, conducting needs assessment and cost-effectiveness descriptions. Assessment of the data was based on evidence-based medicine. A set of criteria was determined in order to enable the prioritizing of the assessed new technologies. This procedure led to a list of technologies suggested for inclusion. The Minister of Health appointed a public committee whose purpose was to decide the technologies to be added to the list of health services. The committee, made up of representatives from the government, the sick-funds and the public, had to evaluate each technology, based on the analysis submitted to the committee, taking into consideration clinical, economic, social, ethical and legal aspects according to predefined criteria. The thorough work of the Medical Technologies Administration enabled the committee to adopt its recommended list with minor changes within a limited timeframe. In conclusion, we propose a practical and pragmatic model for the inclusion of new health technologies at a national level, based on health technology assessment and explicit priority setting.

Decision Making, Organizational↗
PubMed2000

Patients' perceptions of drug therapy counseling in Israel.

BACKGROUND: The more patients know about their medications the higher their compliance with drug therapy, reflecting an effective communication between health professionals and their patients. Numerous studies on this subject have been published, but none has been conducted in Israel. OBJECTIVES: To evaluate patients' perceptions of drug counseling by health professionals--the prescribing physician and dispensing pharmacist--and to determine whether there is a difference in the patient's perception according to his or her place of birth and mother tongue. METHODS: A total of 810 patients were interviewed following receipt of their medications from in-house pharmacies at two community clinics of Israel's largest sick fund. Each patient was interviewed in his or her mother tongue according to a constructed questionnaire, which included the patient's demographic background, type of medications received, the patient's perceptions of drug counseling given by both the physician and the pharmacist, and the patient's perception of non-prescription drug counseling given by the dispensing pharmacist. RESULTS: Of the 810 patients enrolled in this study, 32% received three or more medications at each physician visit. The main therapeutic classes of medications prescribed and dispensed were for neurological disorders, cardiovascular diseases, gastrointestinal problems and respiratory diseases. While 99% of the patients claimed that they knew how to use their medications, only 96% reported receiving an explanation from either physician or pharmacist. The quality of counseling, as evaluated by the patients, was ranked above average for 75% of the consultations with the prescribing physician and 63% with the dispensing pharmacist. CONCLUSIONS: Although few conclusions can be drawn from this study based on the initial statistical analysis of the data, the major findings were that patients value highly the counseling they receive and that 99% believe they have the requisite knowledge for using their medications. Compared to the international literature, our results--based on the patients' perceptions--indicate that counseling by pharmacists is a common and well-accepted activity in Israel and occurs at a high rate.

Counseling↗
PubMed2000

[Regulation of natural medicines in Israel and abroad].

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 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.

Biological Factors↗
PubMed1999

[The Israeli pharmaceutical market].

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.

Drug Costs↗
PubMed1998

In vitro assessment of the antimicrobial activity of a local sustained release device containing amine fluoride for the treatment of oral infectious diseases.

Dental caries and periodontal diseases are chronic infectious diseases caused by oral bacteria. Local sustained release delivery systems extend the time in which the drug is present in the oral cavity, thus enhancing its therapeutic potential while reducing its side effects. Amine-fluorides (AmF) are known anticaries agents and have recently been found to have an antibacterial effect against periodontal pathogens and caries-associated bacteria. The purpose of this in vitro study was to assess the antimicrobial activity of a local sustained release device (LSRD) containing AmF on Streptococcus sobrinus 6715. LSRD was prepared from an ethylcellulose matrix containing AmF. Release kinetics of AmF from the LSRD was measured simultaneously with its antimicrobial activity. The organic amine and the fluoride were released in different kinetics profiles: The fluoride was released faster than the organic amine. The antimicrobial activity of AmF was measured on planktonic bacteria in solution and on bacteria as part of experimental dental plaque. During a 10-day period, the concentration of the released AmF was above its MIC and no bacterial growth was observed. Bacterial counts in the dental plaque were reduced by 1 to 2 log units. Hence, the LSRD containing AmF has the potential to serve as a medicament in prevention and treatment of dental caries and periodontal diseases.

Anti-Infective Agents, Local↗
PubMed1998

Cost-benefit analysis of risperidone and clozapine in the treatment of schizophrenia in Israel.

In this study, the benefits and costs of treating schizophrenia with either risperidone or clozapine were examined. The lifetime drug-treatment cost incurred by a patient with schizophrenia in Israel was $US7561 (1996 values) with an initial 6-month trial with risperidone, compared with $US6326 with clozapine and $US3360 with typical antipsychotics. Total lifetime costs of psychiatric health services (excluding medications) by individuals who were continuously receiving typical antipsychotics were $US181,555 per patient. Assuming a 6.3% decrease in hospital use with typical antipsychotics and an absolute 30% decrease with risperidone or clozapine, the use of clozapine or risperidone reduced hospitalisation costs by $US7159 per patient, but increased community-care costs by $US1627 per patient, giving health-service benefit:cost ratios of 1.87:1 and 1.32:1, respectively. After adding indirect benefits resulting from increased work productivity (minus indirect costs related to increases in transport costs because of visits for blood monitoring during clozapine therapy), the benefit:cost ratios increased to 2.04:1 and 1.48:1, respectively. Assuming that clozapine caused a 30% decrease in hospital use by patients with new-onset schizophrenia, risperidone would have to decrease hospital use by 43.2% (i.e. a 13.2% relative advantage) for its societal benefits to justify its increased costs.

Antipsychotic Agents↗
PubMed1998

[Viagra].

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Erectile Dysfunction↗
PubMed1982

Vitamin D resistant rickets with alopecia: cultured skin fibroblasts exhibit defective cytoplasmic receptors and unresponsiveness to 1,25(OH)2D3.

A new case of vitamin D dependent rickets (Type II) with alopecia in a 5 yr old child is reported. Skin fibroblasts were propagated in culture and analyzed for cytoplasmic 1,25(OH)2D3 receptors. The rachitic cells failed to exhibit specific, high-affinity binding sites by either Scatchard analysis or sucrose density gradient. Furthermore, a rise in 24-hydroxylase activity could not be elicited following incubation of the rachitig cells with 1,25(OH)2D3. Fibroblasts from a non-rachitic child examined in parallel experiments demonstrated high affinity binding sites (Kd = 0.1 nM, Nmax = 33 fmol/100 micrograms DNA) and the induction of 24-hydroxylase activity. The molecular basis of the unresponsiveness of the cells from the rachitic child appears to be due to defective or absent 1,25(OH)2D3 receptors.

Alopecia↗
PubMed1977

Serum calcitonin and blood mineral interrelationships in normal children aged six to twelve years.

Simultaneous measurements of serum immunoreactive thyrocalcitonin (iTCT), immunoreactive parathyroid hormone (iPTH), calcium, inorganic phosphate, magnesium, and alkaline phosphatase were made in 37 normal children whose ages ranged from 6-12 years. Between the ages of 6 and 12 there is a statistically significant rise in serum iTCT levels (r = 0.4638; P less than 0.01), and a fall in serum iPTH levels (r = 0.4976; P less than 0.01). There is a highly significant inverse correlation between serum iTCT and iPTH levels (r = 0.5248; P less than 0.005). Serum iTCT levels were inversely correlated with phosphate levels (r = 0.4989; P less than 0.01), the latter being age dependent and falling significantly between the ages of 6 and 12 (r = 0.4802; P less than 0.001). There was no significant relationship between serum calcium levels and iTCT, iPTH, or age. Serum magnesium levels were not correlated with calcium, iTCT, or iPTH levels.

Adult↗
PubMedDate not supplied

The anticariogenic effect of amine fluorides on Streptococcus sobrinus and glucosyltransferase in biofilms.

Dental caries is a chronic infectious disease caused by the accumulation of bacterial plaque (biofilm) on tooth surfaces. Antibacterial agents, in addition to other preventive measures, can control dental plaque accumulation. Amine fluorides (AmF) are known anticaries agents for over 30 years. The purpose of our study was to assess the adsorption and desorption of AmF to experimental dental biofilm and to evaluate the effect of AmF on Streptococcus sobrinus 6715 and glucosyltransferase (GTF) activity in experimental dental biofilms. The experimental plaque model used in this study consists of hydroxyapatite beads coated with human saliva (sHA), followed by adsorption of S. sobrinus and synthesis of in situ polysaccharides. Our results show that the viability of S. sobrinus in biofilm decreased as the concentration of AmF and chlorhexidine (CHX) increased. The concentration of AmF and CHX required to kill S. sobrinus adherent to sHA is about 100 times greater than the concentration required to kill the same amount of planktonic bacteria. Adsorption of AmF to surfaces was more than 90% and the desorption of AmF from our experimental model was limited. Pre-adsorption of AmF on the surface increased adhesion of S. sobrinus but also resulted in surface killing of the adsorbed bacteria. At low concentrations AmF increased GTF activity in solution by about 10%, but at concentrations above 0.1 mM it inhibited GTF activity. Inhibition of GTF on the surface required about 100 times more AmF than in solution. Our results show that AmF retains its anticariogenic effects in solution and in biofilm systems.

Adult↗