Roles of Community Pharmacists in Screening and Disseminating of Information about Non-Steroidal Anti-Inflammatory Drugs Risks: Implications for Drug Safety Assessment

Background: The increasing use of non-steroidal anti-inflammatory drugs (NSAIDs) both on prescription and over the counter raises a major global health concern because of the risks associated with their use if no proper guidance is given by the health care provider. This study assessed the roles of community pharmacists in screening and disseminating information about the risks associated with NSAID use in Zambia. Methodology: This was a national cross-sectional study in which a structured self-administered questionnaire was administered to 245 registered community pharmacists in Zambia. Stata/BE, version 15.1 (Stata Corporation, College Station, Texas, USA) and multivariate logistic regression model was used to determine factors associated with information dissemination about ADRs of NS-NSAIDs. Results: 231 of the 245 distributed questionnaires were returned giving a response rate of 94.3%. All (100%) participating community pharmacists claimed to have practiced dispensing NSAIDs. However, only 26 (11.0%) and 71 (30.8%) regularly screened for risk factor of selective COX-2 NSAIDS (SC2-NSAIDS) and non-selective NSAIDS (NS-NSAIDs) respectively. Information dissemination on adverse drug reactions (ADRs) of SC2-NSAIDS was regularly provided by only 22 (9.5%) of pharmacists while that of NS-NSAIDs was regularly provided by 49 (21.2%). In the multivariate logistic regression model, being the owner of a pharmacy (AOR: 5.4, CI: 1.84 - 16.4) was significantly associated with information dissemination about ADRs of NS-NSAIDs while an hour increase in the working hours per day (AOR: 0.9, CI: 0.64 - 0.95) was associated with less likelihood of information dissemination. Conclusion: Pharmacists working in community pharmacies in Zambia did not regularly screen and disseminate information about the risks associated with NSAID use. Therefore, pharmacists should be able to screen and monitor patients at risk and be aware of the majority of risk factors while dispensing NSAIDs to minimize the associated complications.

Risk management of drug products in FDA: the development and implication

This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages： the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed.

Analyzing the risk of drug abuse for morphine-containing Chinese patent medicines in China

Chinese patent medicines（CPMs） are widely used across China, and they are differently administrated from chemical drugs. For traditional reasons, CPMs may contain opium-derived compounds, such as morphine, which may pose the issues of drug abuse and addiction. In the present study, we aimed to evaluate the present risk of morphine-containing CPMs in causing drug abuse and addiction, based on a questionnaire-based approach and from a medicinal administrative perspective. We chose 76 CPMs containing morphine from government document and set them as the study group, and 10 chemical drugs containing morphine were set as the control group. Because there is no ready-made method, we created an evaluation sheet consisting of five questions to evaluate each drug and generate a risk-value score. Crosstabs analysis using SPSS 15.0 was conducted to obtain the influencing factors. We found that the study group obtained a mean score of 2.04 for the risk value, which was five times of that of the control group. Specifically, no maximum limit of morphine or codeine was set in product quality standards for more than four-fifth of the drugs. Moreover, 46.0% of package inserts failed to show any warning about addiction or prohibition over the long-term use of the drugs. The number of ingredients, as well as the functions of the drugs, was found to correlate with the risk value. Our findings suggested that CPMs were more risky in causing drug abuse and addiction than chemical drugs. Approaches, such as i） controlling the number of ingredients, ii） setting up maximum limit of morphine or codeine in quality standard, iii） providing more information on the package insert of drugs and iv） monitoring the drug containing both morphine and ephedrine, will be effective in reducing the risk of drug abuse and addiction.