Defining and supporting a professional role for pharmacists associated with traditional and complementary medicines: a cross-country survey of pharmacists.

Introduction: An estimated 80% of the world's population use traditional and complementary medicine (T&CM) products as part of their healthcare, with many accessed through pharmacy. This cross-cultural study posed a set of professional practice responsibilities and actions to pharmacists related to T&CM products, with a view toward developing consensus, safeguarding, and promoting the health of the public. Methods: Data were collected from 2,810 pharmacists across nine countries during 2022 via a cross-sectional online survey reported in accordance with the guidelines of STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) and the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). Results: Of the 2,810 participants from nine countries, 2,341 completed all sections of the survey. Of these, most agreed (69%) that T&CM product use was common in the community they served, but most did not have adequate training to support consumer needs. Over 75% acknowledged that there were known and unknown safety risks associated with T&CM use. Of 18 professional responsibilities posed, 92% agreed that pharmacists should be able to inform consumers about potential risks, including T&CM side effects and drug-herb interactions. The provision of accurate scientific information on the effectiveness of T&CM products, skills to guide consumers in making informed decisions, and communication with other healthcare professionals to support appropriate and safe T&CM product use were all ranked with high levels of agreement. In order to effectively fulfill these responsibilities, pharmacists agreed that regulatory reforms, development of T&CM education and training, and access to quality products supported by high-quality evidence were needed. Conclusion: General agreement from across nine countries on eighteen professional responsibilities and several stakeholder actions serve as a foundation for the discussion and development of international T&CM guidelines for pharmacists.

Practices, barriers and facilitators to the delivery of pretravel health services by community pharmacists: A scoping review using the theoretical domains framework.

BACKGROUND: The involvement of community pharmacists (CPs) in the provision of pretravel health services is increasing due to the increase in international travelers, the increased risk of travel-related diseases, and the expansion of pharmacists' scope of practice in some countries. In order to improve the quality and effectiveness of pretravel health care provided by CPs, a greater understanding of the practices, barriers, and facilitators is required. OBJECTIVE: This scoping review aimed to identify and describe existing studies on pretravel health services provided by CPs, and the barriers, and facilitators. METHODS: The PubMed, Science Direct, Scopus, and Web of Science databases were searched for pertinent studies from their inception to February 2023. A manual search was also conducted of prominent travel medicine journals, Google Scholar, and the reference lists of the included studies. Potential barriers and facilitators were mapped to the 14 domains of the Theoretical Domains Framework (TDF). RESULTS: There were twelve studies included in the review. Pretravel health advice was the most prevalent form of pretravel health services. Within ten domains of the TDF, various factors that either facilitate or impede the provision of pretravel health services by CPs were identified. CONCLUSION: The provision of pretravel health services by CPs may be affected by a number of practitioner and organizational factors. The provision of pretravel health services can be facilitated by informational resources, training and education in travel medicine, and collaboration amongst healthcare providers.

Determinants of Inadequate Empiric Antimicrobial Therapy in ICU Sepsis Patients in Al-Madinah Al-Munawwarah, Saudi Arabia: A Comparison of Artificial Neural Network and Regression Analysis.

In the management of sepsis, providing adequate empiric antimicrobial therapy is one of the most important pillars of sepsis management. Therefore, it is important to evaluate the adequacy of empiric antimicrobial therapy (EAMT) in sepsis patients admitted to intensive care units (ICU) and to identify the determinants of inadequate EAMT. The aim of this study was to evaluate the adequacy of empiric antimicrobial therapy in patients admitted to the ICU with sepsis or septic shock, and the determinants of inadequate EAMT. The data of patients admitted to the ICU units due to sepsis or septic shock in two tertiary healthcare facilities in Al-Madinah Al-Munawwarah were retrospectively reviewed. The current study used logistic regression analysis and artificial neural network (ANN) analysis to identify determinants of inadequate empiric antimicrobial therapy, and evaluated the performance of these two approaches in predicting the inadequacy of EAMT. The findings of this study showed that fifty-three per cent of patients received inadequate EAMT. Determinants for inadequate EAMT were APACHE II score, multidrug-resistance organism (MDRO) infections, surgical history (lower limb amputation), and comorbidity (coronary artery disease). ANN performed as well as or better than logistic regression in predicating inadequate EAMT, as the receiver operating characteristic area under the curve (ROC-AUC) of the ANN model was higher when compared with the logistic regression model (LRM): 0.895 vs. 0.854. In addition, the ANN model performed better than LRM in predicting inadequate EAMT in terms of classification accuracy. In addition, ANN analysis revealed that the most important determinants of EAMT adequacy were the APACHE II score and MDRO. In conclusion, more than half of the patients received inadequate EAMT. Determinants of inadequate EAMT were APACHE II score, MDRO infections, comorbidity, and surgical history. This provides valuable inputs to improve the prescription of empiric antimicrobials in Saudi Arabia going forward. In addition, our study demonstrated the potential utility of applying artificial neural network analysis in the prediction of outcomes in healthcare research.

Adequacy of Empiric Antibiotics Therapy and Its Impact on Outcomes in Adult Critically Ill Sepsis Patients: A Review.

Sepsis is a medical emergency that involves a systemic immunological response due to an infection, resulting in the end-stage-organs malfunction and death. It is associated with high mortality rate despite a better understanding of the disease pathology and the mechanism involved. This review was designed to summarise the available evidences regarding the adequacy of the empiric antimicrobial therapy (EAMT), its predictors and its impact on the outcomes in intensive care unit (ICU) sepsis patients. Providing an adequate EAMT is considered one of the cornerstones of sepsis management as it has been found to be associated with better survival and is a good predictor for shorter ICU-length-of-stay. In contrast, inadequate EAMT in sepsis patients is associated with poor clinical outcomes including increased mortality and prolonged hospital stay. Evidence from this review suggest that it is important to identify determinants of inadequate EAMT to optimise the antimicrobial therapy provided to sepsis patients. Predictors of inadequate EAMT included co-morbidities (cancer), source and type of infection, higher Acute Physiology and Chronic Health Evaluation (APACHI-II) score and long hospital stay prior to the infection. As EAMT is considered as one of the effective treatment strategies to prevent sepsis associated death, healthcare providers should ensure the adequate antimicrobial therapy is provided for sepsis patients to improve and optimise their management.

Self-Learning about Herbal and Dietary Supplements: Perspectives Using the Theoretical Domains Framework.

Background: Self-learning (SL) is a process in which individuals take the initiative to acquire knowledge with or without the help of others. Knowledge about herbal and dietary supplements (HDS) is important for pharmacists. Unfortunately, there is limited coverage of topics relating to HDS in the pharmacy curricula. The present focus group study applies the Theoretical Domains Framework (TDF) to explore pharmacy students' practices and beliefs regarding SL about HDS (SL-HDS). Methods: Focus group interviews (FGIs) were conducted between April and May 2019 among a sample of undergraduate pharmacy students at a public university (n = 20). Four FGI sessions were conducted, each lasting about 60 to 75 min, and all the sessions were audio-recorded. The interviews were transcribed verbatim and analysed using thematic content analysis. Results: Beliefs about SL-HDS were categorised into 12 domains based on the TDF. Students showed positive attitudes towards SL-HDS and agreed that their involvement in SL-HDS was instrumental in improving their knowledge about various aspects of HDS including indications, adverse effects, and HDS-drug interactions. Various facilitators and barriers influencing students' participation in SL-HDS were uncovered (e.g., access to the internet, time, availability of reference resources). The students demanded to be equipped with critical appraisal skills, as they had limited confidence in assessing literature or information about HDS. Conclusion: This study revealed that the students saw the benefits of SL-HDS. They also perceived that engaging in SL-HDS is compatible with the role of pharmacy students. The findings showed students' readiness and willingness to conduct SL-HDS.

Stakeholders' Perspectives Regarding Supply Chain System of Pharmaceuticals and Vaccines in Pakistan: A Qualitative Study.

The present study was undertaken to assess the current supply chain system of pharmaceuticals and vaccines in Pakistan in terms of structure, process, and outcomes, as well as related barriers and solutions for an effective supply chain system. A qualitative study was designed to explore stakeholders' perceptions selected using the snowball sampling technique. A semi-structured interview guide was used to interview these respondents at a convenient time and place. After data collection, recorded interviews were transcribed verbatim and subjected to thematic analysis. The results highlighted that the standard operating procedures (SOPs), checklists, and government guidelines were available at different levels, except for community pharmacies. Timely delivery of quality products and services along with market reputation, experience, and authorization were the key criteria used for supplier selection and evaluation. Good inventory management, financial models, effective coordination, training, and skill development programs were identified as key factors responsible for an efficient supply chain process. Availability of vaccines, their appropriate temperature monitoring, and transportation are also highly compromised in Pakistan. The results of the present study concluded that the current supply chain system in Pakistan is not up to the mark; major factors include poor forecasting and inventory control, delayed order placement, lack of training, inadequate involvement of professionally qualified staff, inadequate financing and procurement processes, and poor coordination and integration among all stakeholders.

Regen-Cov and Covid-19, Update on the Drug Profile and Fda Status: A Mini-Review and Bibliometric Study.

COVID-19 is caused by coronavirus (SARS-CoV-2) is a worldwide health crisis. This severe acute respiratory syndrome was declared an outbreak after the first case was reported in Wuhan, the capital city of Hubei Province in China. On March 11th, 2020, the World Health Organization (WHO) declared it as a pandemic. The pharmaceutical treatment of COVID-19 has garnered significant critical attention due to the unavailability of medications to treat COVID-19. Recently, researchers have shown an increased interest in the monoclonal antibody drugs to treat COVID-19 especially REGEN-COV (casirivimab and imde-vimab). This review aims to highlight the relation between the drug and COVID-19 and the recently updated information on the monoclonal antibody REGEN-COV from the U.S. Food and Drug Administration and other authorities. It is also designed to focus on the bibliometric data of REGEN-COV for the last three years (2020, 2021, and 2021) in PubMed and Google Scholar.

Prevalence, Predictors and Point of View Toward Self-Medication Among Residents of Riyadh, Saudi Arabia: A Cross-Sectional Study.

Irrational Self-Medication (SM) practice leads to incorrect diagnosis and is a risk factor for disease exacerbation and serious health consequences. Hence Responsible SM is vital for better health outcomes. In the present community-based study we explored the SM practice during the last 3 months, frequency, outcome, medications used, reasons influencing SM, source of the drug, and information. Data were analyzed using SPSS; chi-square test was performed to indicate significance, Odds ratio, Pearson correlation, univariant and multivariant regression analysis were performed to find out factors and predictors of SM. A total of 611 residents completed the survey. SM was practiced by 52.9% of participants during the last 3 months, with a frequency of one to two times. Headache (64.8%), pain (35.4%), fever/flu (31.4%), cold & cough (21.9%) and dysmenorrhea (20.9%) were illnesses managed using pain killers (75.9%), multivitamins (25.5%), anti-pyretic (24.7%) and herbal medicines (18.5%). Minor illness (67.9%), earlier experience (33.9%) and shortness of time to attend healthcare facilities (18.8%) were the reasons for practicing SM. Distance to healthcare and routine physical activity have significantly influenced the SM practice. Residents stated that inappropriate SM would lead to negative outcomes, including drug side effects (70%), Interaction (34.2%), poor treatment outcome (32.6%) and return of symptoms (26.5%). Interestingly, two-thirds of participants (68.9%) have recommended SM in case of minor illnesses only, 85.3% of respondents have expressed their desire to learn more about appropriate SM, and 76.6% are willing to return their leftover or unused medications to drug take-back centers.

Prevalence of Vitamin D Deficiency Between Type 2 Diabetes Mellitus Patients and Non-Diabetics in the Arab Gulf.

BACKGROUND: The link between the risk of type 2 diabetes mellitus (T2DM) and vitamin D deficiency has perplexed the medical society due to the controversy in the data available. Saudi Arabia (SA) is a sunny region; however, ample amount of data reported the increased prevalence of vitamin D deficiency along with T2DM. Thus, this study aimed to compare vitamin D deficiency between healthy and T2DM patients in SA, alongside with the risk factors associated with that. METHODS: A cross-sectional study was conducted in the Medical Unit, Taibah University in Al-Madinah Al-Munawarah, SA, from November 2017 to May 2018. The involved participants were non-diabetics and T2DM men. Measuring vitamin D for T2DM and non-diabetics group was done by trained technicians. Data analysis was done via SPSS. RESULTS: Sixty-four participants (T2DM group = 32; non-diabetics group = 32) were recruited, and the mean age of T2DM patients was 48.6 ± 10.4, while that of the non-diabetics was 42.4 ± 6.5. The mean of vitamin D level was found higher in the non-diabetic participants than in diabetic patients. There was statistically significant association between vitamin D deficiency and T2DM (P = 0.001). Besides, duration of diabetes was the only factor, found to be positively correlated with vitamin D deficiency in T2DM patients. CONCLUSION: Early screening for vitamin D serum-level is recommended for T2DM patients in Saudi Arabia. Therefore, early correction of vitamin D levels should be considered, and medical and scientific societies, along with other sectors such as the media, should highlight and increase the awareness of the importance of vitamin D and the seriousness of its deficiency.

Plant-Based Synthesis of Gold Nanoparticles and Theranostic Applications: A Review.

Bionanotechnology is a branch of science that has revolutionized modern science and technology. Nanomaterials, especially noble metals, have attracted researchers due to their size and application in different branches of sciences that benefit humanity. Metal nanoparticles can be synthesized using green methods, which are good for the environment, economically viable, and facilitate synthesis. Due to their size and form, gold nanoparticles have become significant. Plant materials are of particular interest in the synthesis and manufacture of theranostic gold nanoparticles (NPs), which have been generated using various materials. On the other hand, chemically produced nanoparticles have several drawbacks in terms of cost, toxicity, and effectiveness. A plant-mediated integration of metallic nanoparticles has been developed in the field of nanotechnology to overcome the drawbacks of traditional synthesis, such as physical and synthetic strategies. Nanomaterials' tunable features make them sophisticated tools in the biomedical platform, especially for developing new diagnostics and therapeutics for malignancy, neurodegenerative, and other chronic disorders. Therefore, this review outlines the theranostic approach, the different plant materials utilized in theranostic applications, and future directions based on current breakthroughs in these fields.

The use of herbal and dietary supplement among community-dwelling elderly in a suburban town of Malaysia.

BACKGROUND: The use of herbal and dietary supplement (HDS) in health and disease management has gained global attention. HDS are generally accepted by the public and are associated with positive health behaviours. However, several reports have been documented with regards to their potential adverse effects and interaction with conventional medicines. Limited data is currently available on the use of HDS among elderly population in Malaysia. This present study aims to investigate the prevalence of and pattern of HDS use among a sample of community-dwelling elderly in a suburban town in Malaysia. METHODS: A cross-sectional survey was conducted between March and May 2019 among the elderly aged ≥60 years old. The participants with the following criteria were included in the study: aged ≥60 years, residing in Puncak Alam and able to understand Malay or English language. Data were collected using a pre-validated questionnaire. All statistical analysis was conducted using IBM SPSS ver. 23. RESULTS: Overall, 336 out of 400 elderly responded to the survey, achieving a response rate of 84%. This study observed that almost 50% of the respondents were using at least one type of HDS in the past one month of the survey. Among HDS non-users, most of them preferred to use modern medicines (62.6%, 114/182). Among the HDS users, 75.3% (116/154) were using at least one type of modern medicine (prescription or over-the-counter medicine). Multivariate analysis showed that having good to excellent perceived health (adjusted OR = 2.666, 95% CI = 1.592-4.464), having felt sick at least once in the past one month (adjusted OR = 2.500, 95% CI = 1.426-4.383), and lower body mass index (adjusted OR = 0.937, 95% CI = 0.887-0.990) were associated with HDS use. It was noted that only a small percentage of HDS users (16.2%, 25/154) had informed healthcare providers on their HDS use. CONCLUSION: The use of HDS is common among the elderly sampled. Hence, healthcare providers should be more vigilant in seeking information of HDS use for disease management in their elderly patients. Campaigns that provide accurate information regarding the appropriate use of HDS among the elderly are pertinent to prevent misinformation of the products.

Knowledge, perceived barriers and facilitators of medication error reporting: a quantitative survey in Malaysian primary care clinics.

Background Medication errors are the most common types of medical errors that occur in health care organisations; however, these errors are largely underreported. Objective This study assessed knowledge on medication error reporting, perceived barriers to reporting medication errors, motivations for reporting medication errors and medication error reporting practices among various health care practitioners working at primary care clinics. Setting This study was conducted in 27 primary care clinics in Malaysia. Methods A self-administered survey was distributed to family medicine specialists, doctors, pharmacists, pharmacist assistants, nurses and assistant medical officers. Main outcome measures Health care practitioners' knowledge, perceived barriers and motivations for reporting medication errors. Results Of all respondents (N = 376), nurses represented 31.9% (n = 120), followed by doctors (n = 87, 23.1%), pharmacists (n = 63, 16.8%), assistant medical officers (n = 53, 14.1%), pharmacist assistants (n = 46, 12.2%) and family medicine specialists (n = 7, 1.9%). Of the survey respondents who had experience reporting medication errors, 56% (n = 62) had submitted medication error reports in the preceding 12 months. Results showed that 41.2% (n = 155) of respondents were classified as having good knowledge on medication error and medication error reporting. The mean score of knowledge was significantly higher among prescribers and pharmacists than nurses, pharmacist assistants and assistant medical officers (p < 0.05). A heavy workload was the key barrier for both nurses and assistant medical officers, while time constraints prevented pharmacists from reporting medication errors. Family medicine specialists were mainly unsure about the reporting process. On the other hand, doctors and pharmacist assistants did not report primarily because they were unaware medication errors had occurred. Both family medicine specialists and pharmacist assistants identified patient harm as a motivation to report an error. Doctors and nurses indicated that they would report if they thought reporting could improve the current practices. Assistant medical officers reported that anonymous reporting would encourage them to submit a report. Pharmacists would report if they have enough time to do so. Conclusion Policy makers should consider using the information on identified barriers and facilitators to reporting medication errors in this study to improve the reporting system to reduce under-reported medication errors in primary care.

Perceptions and Attitudes towards Medication Error Reporting in Primary Care Clinics: A Qualitative Study in Malaysia.

OBJECTIVE: To explore and understand participants' perceptions and attitudes towards the reporting of medication errors (MEs). METHODS: A qualitative study using in-depth interviews of 31 healthcare practitioners from nine publicly funded, primary care clinics in three states in peninsular Malaysia was conducted for this study. The participants included family medicine specialists, doctors, pharmacists, pharmacist assistants, nurses and assistant medical officers. The interviews were audiotaped and transcribed verbatim. Analysis of the data was guided by the framework approach. RESULTS: Six themes and 28 codes were identified. Despite the availability of a reporting system, most of the participants agreed that MEs were underreported. The nature of the error plays an important role in determining the reporting. The reporting system, organisational factors, provider factors, reporter's burden and benefit of reporting also were identified. CONCLUSIONS: Healthcare practitioners in primary care clinics understood the importance of reporting MEs to improve patient safety. Their perceptions and attitudes towards reporting of MEs were influenced by many factors which affect the decision-making process of whether or not to report. Although the process is complex, it primarily is determined by the severity of the outcome of the errors. The participants voluntarily report the errors if they are familiar with the reporting system, what error to report, when to report and what form to use.

Medication errors reported to the National Medication Error Reporting System in Malaysia: a 4-year retrospective review (2009 to 2012).

PURPOSE: Reporting and analysing the data on medication errors (MEs) is important and contributes to a better understanding of the error-prone environment. This study aims to examine the characteristics of errors submitted to the National Medication Error Reporting System (MERS) in Malaysia. METHODS: A retrospective review of reports received from 1 January 2009 to 31 December 2012 was undertaken. Descriptive statistics method was applied. RESULTS: A total of 17,357 MEs reported were reviewed. The majority of errors were from public-funded hospitals. Near misses were classified in 86.3 % of the errors. The majority of errors (98.1 %) had no harmful effects on the patients. Prescribing contributed to more than three-quarters of the overall errors (76.1 %). Pharmacists detected and reported the majority of errors (92.1 %). Cases of erroneous dosage or strength of medicine (30.75 %) were the leading type of error, whilst cardiovascular (25.4 %) was the most common category of drug found. CONCLUSIONS: MERS provides rich information on the characteristics of reported MEs. Low contribution to reporting from healthcare facilities other than government hospitals and non-pharmacists requires further investigation. Thus, a feasible approach to promote MERS among healthcare providers in both public and private sectors needs to be formulated and strengthened. Preventive measures to minimise MEs should be directed to improve prescribing competency among the fallible prescribers identified.

The use of psychotropic substances among students: The prevalence, factor association, and abuse.

This detailed review analyzed the previously published studies related to the prevalence of psychotropic substances use, associated factors, and the misuse of the psychotropics among students. A comprehensive literature search covering six databases was performed. References from published articles and reports were extracted. This helped in identifying the available information on the use of psychotropic drugs. A total of 16 articles were included in this review. There is an upsurge of using psychotropics with the preceding years. More students are exposed to the risk of using psychotropic substances due to the multiple factors like stress, increased academic workload, etc. The misuse is found to be common with prescribed psychotropic substances. Students need to be aware of the bad outcomes of using psychotropic substances. Participation of every stakeholder to curb this menace needs to be emphasized. More extensive studies are required to know about the increasing prevalence, factors, and misuse of psychotropics.

Medicines information provided by pharmaceutical representatives: a comparative study in Australia and Malaysia.

BACKGROUND: Pharmaceutical representatives provide medicines information on their promoted products to doctors. However, studies have shown that the quality of this information is often low. No study has assessed the medicines information provided by pharmaceutical representatives to doctors in Malaysia and no recent evidence in Australia is present. We aimed to compare the provision of medicines information by pharmaceutical representatives to doctors in Australia and Malaysia. METHODS: Following a pharmaceutical representative's visit, general practitioners in Australia and Malaysia who had agreed to participate, were asked to fill out a questionnaire on the main product and claims discussed during the encounter. The questionnaire focused on provision of product information including indications, adverse effects, precautions, contraindications and the provision of information on the Pharmaceutical Benefit Scheme (PBS) listings and restrictions (in Australia only). Descriptive statistics were produced. Chi-square analysis and clustered linear regression were used to assess differences in Australia and Malaysia. RESULTS: Significantly more approved product information sheets were provided in Malaysia (78%) than in Australia (53%) (P < 0.001). In both countries, general practitioners reported that indications (Australia, 90%, Malaysia, 93%) and dosages (Australia, 76%, Malaysia, 82%) were frequently provided by pharmaceutical representatives. Contraindications, precautions, drug interactions and adverse effects were often omitted in the presentations (range 25% - 41%). General practitioners in Australia and Malaysia indicated that in more than 90% of presentations, pharmaceutical representatives partly or fully answered their questions on contraindications, precautions, drug interactions and adverse effects. More general practitioners in Malaysia (85%) than in Australia (60%) reported that pharmaceutical representatives should have mentioned contraindications, precautions for use, drug interaction or adverse effects spontaneously (P < 0.001). In 48% of the Australian presentations, general practitioners reported the pharmaceutical representatives failed to mention information on PBS listings to general practitioners. CONCLUSIONS: Information on indications and dosages were usually provided by pharmaceutical representatives in Australia and Malaysia. However, risk and harmful effects of medicines were often missing in their presentations. Effective control of medicines information provided by pharmaceutical representatives is needed.

Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.

BACKGROUND: Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. METHODS AND FINDINGS: We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review. CONCLUSIONS: With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies. Please see later in the article for the Editors' Summary.

Quality of claims, references and the presentation of risk results in medical journal advertising: a comparative study in Australia, Malaysia and the United States.

BACKGROUND: Journal advertising is used by pharmaceutical companies to disseminate medicine information to doctors. The quality of claims, references and the presentation of risk results in Australia and the US has been questioned in several studies. No recent evidence is available on the quality of claims, references and the presentation of risk results in journal advertising in Australia and the US and no Malaysian data have been published. The aim of this study was to compare the quality of claims, references and the presentation of risk results in journal advertising in these three countries. METHODS: A consecutive sample of 85 unique advertisements from each country was selected from journal advertising published between January 2004 to December 2006. Claims, references and the presentation of risk results in medical journal advertising were compared between the three countries. RESULTS: Less than one-third of the claims were unambiguous claims (Australia, 30%, Malaysia 17%, US, 23%). In Malaysia significantly less unambiguous claims were provided than in Australia and the US (P < 0.001). However, the unambiguous claims were supported by more references than other claims (80%). Most evidence was obtained from at least one randomized controlled trial, a systematic review or meta-analysis (Australia, 84%, Malaysia, 81%, US, 76%) with journal articles being the most commonly cited references in all countries. Data on file were significantly more likely to be cited in the US (17%) than in Australia (2%) and Malaysia (4%) (P < 0.001). Advertisements that provided quantitative information reported risk results exclusively as a relative risk reduction. CONCLUSIONS: The majority of claims were vague suggesting poor quality of claims in journal advertising in these three countries. Evidence from a randomized controlled trial, systematic review or meta- analysis was commonly cited to support claims. However, the more frequent use of data that have not been published and independently reviewed in the US compared to Australia and Malaysia raises questions on the quality of references in the US. The use of relative rather than absolute benefits may overemphasize the benefit of medicines which may leave doctors susceptible to misinterpreting information.

Medicines information in medical journal advertising in Australia, Malaysia and the United States: A comparative cross-sectional study.

OBJECTIVE: The aim of this study was to compare the provision of medicines information in medical journal advertising in Australia, Malaysia and the United States. METHODS: A consecutive sample of 85 unique advertisements from each country was selected from the advertisements published between January 2004 to December 2006 in three widely circulated medical journals and one prescribing reference manual. The availability of brand name and generic name, indication, contraindications, dosage, side-effects, warnings, interactions and precautions was compared between the three countries. RESULTS: We examined 255 distinct advertisements for 136 pharmaceutical products. Journal advertising in Australia, Malaysia and the US usually provided brand names and generic names (range 96 -100%). Information on dosage was significantly less likely to be mentioned (32%) in the US than in Australia (92%) and Malaysia (48%) (P < 0.001). Warning information was significantly less likely to be provided in Australia (5%) than in the US (81%) and Malaysia (9%) (P < 0.001). Apart from information on brand name, generic name, warnings and dosage, other product information significantly less likely to be provided in journal advertising in Malaysia than in Australia and the US (P < 0.001). Similar trends in the provision of product information for the same medicines published in these countries were noted. Brand name and generic name were always provided in the three countries (100%). However, information on the negative effects of medicines was less frequently provided in Malaysia than in Australia and the US. CONCLUSIONS: Journal advertising in Australia, Malaysia and the US failed to provide complete product information. Low quality of information provided in Malaysia indicates the need for effective regulation of provision of medicines information in journal advertising. Different standards of medicines information provided in these three countries suggest that pharmaceutical promotion needs to be better controlled at the international level.

Quality of pharmaceutical advertisements in medical journals: a systematic review.

BACKGROUND: Journal advertising is one of the main sources of medicines information to doctors. Despite the availability of regulations and controls of drug promotion worldwide, information on medicines provided in journal advertising has been criticized in several studies for being of poor quality. However, no attempt has been made to systematically summarise this body of research. We designed this systematic review to assess all studies that have examined the quality of pharmaceutical advertisements for prescription products in medical and pharmacy journals. METHODS AND FINDINGS: Studies were identified via searching electronic databases, web library, search engine and reviewing citations (1950 - February 2006). Only articles published in English and examined the quality of information included in pharmaceutical advertisements for prescription products in medical or pharmacy journals were included. For each eligible article, a researcher independently extracted the data on the study methodology and outcomes. The data were then reviewed by a second researcher. Any disagreements were resolved by consensus. The data were analysed descriptively. The final analysis included 24 articles. The studies reviewed advertisements from 26 countries. The number of journals surveyed in each study ranged from four to 24 journals. Several outcome measures were examined including references and claims provided in advertisements, availability of product information, adherence to codes or guidelines and presentation of risk results. The majority of studies employed a convenience-sampling method. Brand name, generic name and indications were usually provided. Journal articles were commonly cited to support pharmaceutical claims. Less than 67% of the claims were supported by a systematic review, a meta-analysis or a randomised control trial. Studies that assessed misleading claims had at least one advertisement with a misleading claim. Two studies found that less than 28% of claims were unambiguous clinical claims. Most advertisements with quantitative information provided risk results as relative risk reduction. Studies were conducted in 26 countries only and then the generalizability of the results is limited. CONCLUSIONS: Evidence from this review indicates that low quality of journal advertising is a global issue. As information provided in journal advertising has the potential to change doctors' prescribing behaviour, ongoing efforts to increase education about drug promotion are crucial. The results from our review suggest the need for a global pro-active and effective regulatory system to ensure that information provided in medical journal advertising is supporting the quality use of medicines.