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At least 307 records · Page 17Linked to original sources
PubMedDate not supplied

Pharmacists' attitudes and concerns regarding syringe sales to injection drug users in Denver, Colorado.

OBJECTIVE: To identify factors influencing pharmacists' decisions about selling syringes to injection drug users (IDUs). DESIGN: Audiotaped interviews. SETTING: Denver, Colorado. PARTICIPANTS: Thirty-two pharmacists at 24 pharmacies. INTERVENTION: One-hour semistructured interviews. MAIN OUTCOME MEASURES: Practices regarding syringe sales to IDUs and factors influencing the practices. RESULTS: Of the 32 pharmacists interviewed, 16 indicated that they sold syringes to all customers ("pro-sell"), 11 refused to sell unless shown proof of diabetic status ("no-sell"), and 5 were "undecided." Several factors influenced the decision to sell. A perceived conflict between prevention of disease and prevention of drug abuse most clearly distinguished the three categories, with pro-sell pharmacists more likely than others to prioritize disease prevention and believe that syringe sales would not increase drug abuse. Business concerns, such as the effect of the presence of IDUs on other customers and the possibility of discarded syringes around the store, were especially prevalent among no-sell and undecided pharmacists. Seventeen pharmacists did not know about Colorado laws governing syringe sales. Four no-sell pharmacists used the laws to justify their decision not to sell, and two undecided pharmacists said they used the law when they did not want to sell syringes to IDU. All pharmacists supported syringe exchange programs. CONCLUSION: One-half of the pharmacists sold syringes to IDUs, and several more indicated that they would do so if certain concerns were addressed. These data suggest that improved syringe disposal options, continuing education programs, and clarification of existing laws and regulations would encourage more pharmacists in Denver to sell syringes to IDUs.

Attitude of Health Personnel↗
PubMedDate not supplied

Counterfeit pharmaceuticals: current status and future projections.

OBJECTIVES: To examine the problem of counterfeit drugs and its effects around the world, to consider the likely directions the problem will take, and to propose options for controlling or mitigating the problem. DATA SOURCES: Recently published clinical literature identified through review of articles abstracted at MEDLINE. Search terms were counterfeiting, counterfeit drugs, substandard drugs, fake drugs, world counterfeiting, and counterfeit pharmaceuticals. Further information was abstracted from an array of informational sources, including magazines such as Business Week, newspapers such as the International Herald Tribune, National Public Radio news reports, pharmaceutical company press releases, and information from the World Health Organization. STUDY SELECTION: Multiple reviewers were used to retrieve relevant and current data. DATA EXTRACTION: Relevant data were extracted independently by multiple reviewers. DATA SYNTHESIS: Traditionally, the problem of counterfeit pharmaceuticals has been limited to developing nations in Asia and Africa. Now, drug counterfeiting is rapidly becoming a worldwide concern, and counterfeit drugs are reaching the U.S. market. This article defines the problem of counterfeit drugs in its many forms and discusses the extent of the problem, with particular attention to the respective rates of counterfeiting across the globe and the origins of counterfeit drugs. CONCLUSION: Technologic advances have worsened the counterfeit drug problem. Because drug counterfeiting is a worldwide concern, worldwide action is needed to combat the problem.

Consumer Product Safety↗
PubMed2000

Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents).

This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

Controlled Clinical Trials as Topic↗
PubMed1981

Evaluation of the Rhode Island child restraint law.

In Rhode Island, a law went into force July 1, 1980, requiring drivers to transport children who are in the front seats of vehicles in properly used child restraints. In the fourth month of the law, restraint use and travel in rear seats had increased moderately; the net result was an increase in proper restraint use in rear seats (11 to 23 per cent) and a decrease in unrestrained, front seat travel (41 to 26 per cent). (Am J Public Health 1981;71:742-743.)

Child↗
PubMed1982

An evaluation of the effectiveness of motor cycle daytime headlight laws.

Currently, 17 states mandate the daytime use of motorcycle headlights. The purpose of these laws is to make the motorcyclists more conspicuous and reduce the number of daytime multi-vehicle collisions. The effectiveness of the laws is examined by comparing the proportion of daytime fatal, front, and side-angle collisions between states with and without such laws. The comparison is based on all motorcycle fatalities recorded by NHTSA for the years 1975-80. The analysis shows no statistically significant difference between states with and without such laws, suggesting that daytime headlight laws are ineffective. Several explanations of this negative finding are explored.

Accidents, Traffic↗
PubMed1986

Evaluation of pharmacists' compliance with the Poison Prevention Packaging Act.

Sixty pharmacies in Memphis, Tennessee were given two prescriptions at seven-day intervals to determine whether the medicine would be dispensed in child-resistant containers (CRCs) as required by federal law. One prescription included the statement "dispense in child-resistant container." Without such a statement, 77 per cent of the pharmacies dispensed the drug in a CRC; the prescription with the reminder elicited a compliance rate of 75 per cent. Factors such as cost of the prescription and time required to fill the prescription had no discernible effect on local pharmacy practice to dispense the prescription in a CRC.

Drug Packaging↗
PubMed1987

Initial effects of the New York State auto safety belt law.

New York State began enforcing a mandatory automobile safety belt use law on January 1, 1985. We present a preliminary analysis of its effect on fatalities and injuries. Applying a Poisson statistical model to pre- and post-law belt usage rates together with counts of fatalities and injuries in 12 metropolitan areas, we estimate the first six months' application of the law averted 220 fatal, 1,500 severe, 4,600 moderate, and 2,600 light injuries across the state. The Poisson approach gives estimates of injuries averted considerably greater than simple year to year comparisons, indicating that media announcements have understated the efficacy of requiring safety belt usage.

Accident Prevention↗
PubMed2000

Using economic evaluations to make formulary coverage decisions. So much for guidelines.

BACKGROUND: It is mandatory for drug manufacturers requesting formulary inclusion under the British Columbia (BC) provincial drug plan to submit a pharmacoeconomic analysis according to published guidelines. These submissions are reviewed by the Pharmacoeconomic Initiative (PI) of BC. OBJECTIVE: To assess the compliance of submitted studies with specific criteria outlined in the guidelines, to assess the methodological quality of individual submissions, and to demonstrate the importance of submitting guidelines-compliant pharmacoeconomic analyses. DATA AND METHODS: All submissions between January 1996 and April 1999 assessed by the PI of BC were included. Submissions were reviewed according to a checklist to establish compliance with respect to choice of comparator drug, study perspective, sensitivity analysis, analytical horizon and discounting. Submissions were examined for association between analytical technique and author, and between source of submission and compliance. Association between compliance and recommendation for approval was also examined. RESULTS: 95 applications were reviewed. Seven submitted no analyses. There were 25 cost-comparison/consequence, 14 cost-effectiveness, 11 cost-minimisation, 9 cost-utility/benefit and 29 budget-impact analyses. 65 of these 88 submissions failed to comply with guidelines. Of these, 45% used an inappropriate comparator drug, 61% lacked a sensitivity analysis, 73% used a third-party payer and excluded a societal perspective, 66% did not provide a long term evaluation and 25% did not specify any time horizon. 80% of noncompliant studies were cost-comparison/consequence or budget-impact analyses (p < 0.001, Fisher's Exact). Of 25 cost-comparison/consequence and 29 budget-impact analyses, 19 (76%) and 24 (83%), respectively, were industry-conducted, whereas cost-effectiveness (11 of 14) and cost-utility/benefit (6 of 9) analyses were mostly subcontracted to private consultants or academics (p < 0.001, Fisher's Exact). 74% of all submissions (compliant and noncompliant) were not recommended by the PI for listing as a provincial drug plan benefit, 16% received approval for restricted benefit and 9% were recommended as full benefit. 80% of the noncompliant submissions were not recommended (p = 0.06, Fisher's Exact test). Moreover, a strong association between type of analysis and type of recommendation was found (p = 0.03, Fisher's Exact test). Cost-comparison/consequence and budget-impact analyses were less likely to be recommended. IMPLICATIONS OF FINDINGS: Our findings show poor compliance with guidelines, especially among industry-conducted studies. Possible explanations are lack of expertise in pharmacoeconomics and/or scepticism regarding the importance of guidelines and submission quality in decision making. As corroborated by the strong associations between type of recommendation and compliance, and between type of recommendation and type of analysis, these 2 characteristics have a significant impact on decision making.

British Columbia↗
PubMed1981

Laetrile: a survey of judicial and administrative activity.

The judicial and executive branches of the federal government, motivated by emotionalism, political pressure, and a self-appointed need to placate the National Cancer Institute, have reached a decision on laetrile that weakens the legal protection of the general public. Recent approval of clinical trials of laetrile by the Food and Drug Administration was not consistent with policies adopted earlier, nor was it warranted by federal court decisions.

Amygdalin↗
PubMed1996

Finland's competent authority initiatives.

Finland, as a member state of the European Union, has taken all necessary actions to implement the medical device directives. This paper presents the current situation in the area of manufacturers' registration as well as adverse incident notification. The establishment of a trans-european network between member states is strongly supported, as it could provide an efficient tool for the information exchange.

Equipment and Supplies↗
PubMed1996

Medical devices vigilance: the European approach.

Post market procedures have been foreseen within the medical device directives. This in turn, led to the preparation of the guidelines on a medical device vigilance system, which is actually the establishment of a recommended procedure to deal with reported adverse incidents. The medical device vigilance system provided a most valuable service to enhance safety of medical devices in the EU. However, a number of potential problems can arise during its implementation. Proper use of the vigilance system improves the protection of health, by reducing the likelihood of repeating the same type of incident.

Equipment Safety↗