The challenge of pharmaceutical promotion regulation in Malaysia.

Information on medicines provided to doctors should be of high quality to support the quality use of medicines. Pharmaceutical promotion is used by pharmaceutical companies to disseminate information about their medicines to doctors. Although the companies claim that promotion offers evidence-based information, research shows that pharmaceutical promotion often provide bias and poor quality of information that may negatively influence doctors' prescribing behaviour. In Malaysia, the pharmaceutical market is highly competitive. It appears that pharmaceutical companies actively promoting their medicines to Malaysian doctors. Given the absence of a comprehensive independent source of prescribing information in Malaysia, Malaysian doctors may be more likely to rely on medicines information provided by pharmaceutical companies. Clearly, pharmaceutical promotional activities in Malaysia need to be effectively regulated. This article will discuss the regulation of pharmaceutical promotion and current policy challenges in Malaysia

Quality of Pharmaceutical Advertisements in Medical Journals: A Systematic Review

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.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.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

Risk factors for persistent and new chronic opioid use in patients undergoing total hip arthroplasty: a retrospective cohort study

Objectives: To determine chronic opioid use pre-THA (total hip arthroplasty) and post-THA, and risk factors for persistent or new chronic opioid use post-THA. Design: Retrospective cohort study. Setting: Australian Government Department of Veterans' Affairs health claims database. Participants: 9525 patients who had an elective unilateral THA between 1/01/2001 and 12/31/2012. Primary outcome measure: Chronic opioid use. Defined as 90 days of continuous opioid use or 120 days of non-continuous use. Results: Pre-THA, 6.2% (n=593) of patients were chronic users, while 5.2% (n=492) were post-THA. Among the 492 postoperative chronic users, 302 (61%) were chronic users pre-THA and post-THA and 190 (39%) became new chronic users after surgery. Risk factors for persistent chronic use were younger age (OR=0.96, 95% CI 0.93 to 0.99/1-year increment), back pain (OR=1.99, 95% CI 1.20 to 3.23), diabetes (OR=3.52, 95% CI 1.05 to 11.8), hypnotics use (OR=2.52, 95% CI 1.48 to 4.30) and higher pre-THA opioid exposure (compared with opioid use for 94–157 days, 157–224 days (OR=3.75, 95% CI 2.28 to 6.18), 225+ days (OR=5.18, 95% CI 2.92 to 9.19). Risk factors for new chronic opioid use post-THA were being a woman (OR=1.40, 95% CI 1.00 to 1.96), back pain (OR=3.90, 95% CI 2.85 to 5.33), depression (OR=1.70, 95% CI 1.20 to 2.41), gastric acid disease (OR=1.62, 95% CI 1.16 to 2.25), migraine (OR=5.11, 95% CI 1.08 to 24.18), liver disease (OR=4.33, 95% CI 1.08 to 17.35), weight loss (OR=2.60, 95% CI 1.06 to 6.39), dementia (OR=2.19, 95% CI 1.04 to 4.61), hyperlipidaemia (OR=1.38, 95% CI 1.00 to 1.91), hypnotics (OR=1.56, 95% CI 1.13 to 2.16) and antineuropathic pain medication use (OR=3.11, 95% CI 2.05 to 4.72). Conclusions: Patients undergoing THA are exposed to opioids for long periods of time, putting them at high risk of harm related to opioid use. We identified groups at risk of chronic opioid use, including younger patients and women, as well as modifiable risk factors of chronic opioid use, including level of opioid exposure presurgery and hypnotic use. These indicators of chronic opioid use can be used by clinicians to target patient groups for suitable pain management interventions.Maria C S Inacio, Craig Hansen, Nicole L Pratt, Stephen E Graves, Elizabeth E Roughea

Collaborative medication management services: improving patient care

The document attached has been archived with permission from the editor of the Medical Journal of Australia (10 January 2008). An external link to the publisher’s copy is included.Objective: To implement and evaluate a collaborative medication management service model. Design: Participatory action research. Setting and participants: The study was conducted from March 1999 to March 2000; 1000 patients, 63 pharmacists and 129 general practitioners from six Divisions of General Practice in South Australia participated. Interventions: A collaborative service delivery model, involving a preliminary case conference, a home visit and a second case conference, was agreed through discussions with medical and pharmacy organisations and then implemented. Outcome measures: Medication-related problems; actions recommended; actions implemented; and outcomes after actions taken. Results: Overall, 2764 problems were identified. The most common medication-related problem (17.5% of all problems) was the need for additional tests. Thirty-seven per cent of problems related to medicine selection, 20% to patient knowledge, and 17% to the medication regimen. Of 2764 actions recommended to resolve medication-related problems, 42% were implemented. Of the 978 problems for which action was taken and follow-up data were available, 81% were reported to be "resolved", "well managed" or "improving". Conclusion: This implementation model was successful in engaging GPs and pharmacists and in assisting in the resolution of medication-related problems.Andrew L Gilbert, Elizabeth E Roughead, Justin Beilby, Kathy Mott and John D Barrat

Impact on drug safety of variation in adherence: the need for routinely reporting measures of dose Intensity in medication safety studies using electronic health data

Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses used when undertaking meta-analyses. Non-adherence with therapy is common in the practice setting and varies across countries and settings. Inter-country differences in the registration of medicines may also result in different product strengths being available in different countries. These two factors combined means that observational studies undertaken for the same medicine in different settings may be assessing the same medicine but in circumstances where quite different dosages are used. Given that many adverse drug effects are dose dependent, differences in dosages used could be a factor explaining differences in risk estimates observed across studies. We argue that dose intensity, which can be defined as a product of the dose prescribed and adherence to the dose prescribed over the course of treatment, should be routinely reported in observational studies of medication safety. We illustrate the issue with the example of dabigatran. The randomized controlled trial evidence underpinning dabigatran's marketing authorization resulted in uncertainty about the appropriate dose for efficacy versus safety. As a result, different dosages of dabigatran were registered in the USA and Europe. The USA registered the 150- and 75-mg dabigatran products, while the 150- and 110-mg dabigatran products were registered in Europe. Among five observational studies subsequently undertaken to resolve the safety question concerning dabigatran and risk of bleeding, only one stratified results by dose. None of the US studies stratified results by the 75-mg dabigatran dose, despite this dose not being assessed in the original trial. None of the five studies reported adherence measures, despite three separate observational studies finding between 25 and 40 % of patients were non-adherent to dabigatran. The STROBE and RECORD statements should consider adding the requirement for reporting measures of dose intensity and its component products to improve observational study reports.Elizabeth E. Roughead, Nicole L. Prat

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

Heart failure after conventional metal-on-metal hip replacements: a retrospective cohort study

Background and purpose - It is unclear whether metal particles and ions produced by mechanical wear and corrosion of hip prostheses with metal-on-metal (MoM) bearings have systemic adverse effects on health. We compared the risk of heart failure in patients with conventional MoM total hip arthroplasty (THA) and in those with metal-on-polyethylene (MoP) THA. Patients and methods - We conducted a retrospective cohort study using data from the Australian Government Department of Veterans' Affairs health claims database on patients who received conventional THA for osteoarthritis between 2004 and 2012. The MoM THAs were classified into groups: Articular Surface Replacement (ASR) XL Acetabular System, other large-head (LH) (> 32 mm) MoM, and small-head (SH) (≤ 32 mm) MoM. The primary outcome was hospitalization for heart failure after THA. Results - 4,019 patients with no history of heart failure were included (56% women). Men with an ASR XL THA had a higher rate of hospitalization for heart failure than men with MoP THA (hazard ratio (HR) = 3.2, 95% CI: 1.6-6.5). No statistically significant difference in the rate of heart failure was found with the other LH MoM or SH MoM compared to MoP in men. There was no statistically significant difference in heart failure rate between exposure groups in women. Interpretation - An association between ASR XL and hospitalization for heart failure was found in men. While causality between ASR XL and heart failure could not be established in this study, it highlights an urgent need for further studies to investigate the possibility of systemic effects associated with MoM THA.Marianne H Gillam, Nicole L Pratt, Maria C S Inacio, Elizabeth E Roughead, Sepehr Shakib, Stephen J Nicholls & Stephen E Grave

A pharmacist-led intervention for increasing the uptake of Home Medicines Review (HMR) among residents of retirement villages (PHARMER): protocol for a cluster randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>The majority of retirement village residents are at risk of medication misadventure. In a recent survey of retirement village residents in Victoria, two-thirds had at least one medication-related risk factor, and hence were eligible to receive a government-subsidised Home Medicines Review (HMR). However, only 6% of eligible residents had received a HMR in the previous 12 months. Reasons for the poor uptake of HMR, and interventions for improving HMR uptake, have been identified and developed with input from stakeholders. The trial will test the effect of <b>P</b>harmacist-conducted <b>H</b>MR to <b>A</b>ddress the <b>R</b>isk of <b>M</b>edication-related <b>E</b>vents in <b>R</b>etirement Villages (PHARMER) in improving the uptake of HMRs among retirement village residents.</p> <p>Methods/Design</p> <p>This is a multicentre prospective cluster randomised controlled trial. Ten retirement villages in Victoria, Australia will be recruited for this trial. Retirement villages will be selected in consultation with the Residents of Retirement Villages Victoria Inc. (RRVV), based on geographical locations (e.g. northeast or southwest), size and other factors. Residents from selected villages will be recruited with the help of RRVV Resident Liaison Officers using a range of strategies. Randomisation will be by geographical location to minimise contamination. Participating villages and residents will be allocated to either Pharmacist Intervention Group (PIG) or Usual Care Group (UCG). Each group will include five retirement villages and will have at least 77 residents in total. The intervention (PHARMER) comprises educating residents regarding HMR, and using a risk assessment checklist by residents to notify their General Practitioners of their medication risk. Uptake of HMR and medication adherence will be assessed in both PIG and UCG at three and six months using telephone interviews and questionnaires.</p> <p>Discussion</p> <p>This study is the first to develop and test an intervention to improve the uptake of HMR among Australian residents in retirement villages, with a view to decreasing medication risk. A multi-faceted interventional approach will be used as suggested by stakeholders. The trial is expected to be complete by late 2011 and results will be available in 2012.</p> <p>Trial Registration</p> <p>Australian New Zealand Clinical Trials Registry (<a href="http://www.anzctr.org.au/ACTRN12611000109909.aspx">ACTRN12611000109909</a>)</p

Pharmaceutical promotion : the theoretical framework of regulation.

Pharmaceutical promotion IS persuaSIve communication (World Health Organization, 2010) which often creates the impression of superior efficacy of a medicine, \vithout a\vareness of the health professionals (Mansfield & Henry, 2004). Doctors often use pharmaceutical promotion as a source of medicines information (Fischer et a1., 2009~ McKinney et aI., 1990~ National Survey ofPhysicians (2002), Poirier et aI., 1994; Prosser et a!., 2003 ~ Strang et aI., 1996; Uchenna et aI., 2010) and it may influence their prescribing pattern (Andersen et aI., 2006~ Muijrers et aI., 2005). For this reason, it is essential that the medicines information provided in pharmaceutical promotion should be effectively regulate