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1.
Nurse Educ Pract ; 63: 103387, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35803182

ABSTRACT

BACKGROUND: Unsafe practice is an important issue for the nursing profession however few studies have sought to identify how nurses recognise and respond to unsafe practice. OBJECTIVES: To identify the behaviours and cues that registered nurses recognise as indications of unsafe practice, perceived factors that contribute to unsafe practice and action nurses take in response. DESIGN: Qualitative descriptive study. SETTINGS: New Zealand health care settings. PARTICIPANTS: New Zealand registered Nurses (n = 13). METHODS: Data were collected via semi-structured interviews and analysis was conducted using constant-comparative and thematic analysis. RESULTS: Nurses identified a range of behaviours, cues, contributing factors and responses to unsafe practice. Three themes emerged from the data: Uncertainty, 'sensing' unsafe practice and disrupted professionalism. CONCLUSION: Understanding the challenges nurses face every day in recognising and responding to unsafe practice in increasingly complex nursing contexts is key to understanding how unsafe practice may be further addressed in clinical practice. Nurses in this study recognised overtly unsafe behaviour and subtle cues as indications of unsafe practice. Participants also identified factors which they perceived contributed to the occurrence of unsafe practice including high workloads and poor skill mix as well as organisational cultures that failed to support safe practice.


Subject(s)
Nurses , Organizational Culture , Humans , New Zealand , Qualitative Research
2.
J Clin Nurs ; 30(7-8): 1168-1183, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33484009

ABSTRACT

AIMS: This study aimed to identify behaviours and cues that nurses recognise as indications of unsafe practice, perceived factors that contribute to unsafe practice and actions nurses take in response. DESIGN: Cross-sectional survey. METHODS: National cross-sectional survey of a random sample of registered nurses (n = 231) in New Zealand, in 2017-2018. The STROBE Checklist was used to report this study. RESULTS: Nurses reported a high rate of episodes of unsafe practices and recognised a range of behaviours and cues that alerted them to the potential for unsafe practice. Several organisational issues were perceived to contribute to unsafe practice occurring. The reporting of episodes of unsafe practice and perceived organisational support was low for nurses compared with managers. CONCLUSION: Failure to recognise and respond to unsafe practice may indicate a tolerance for substandard practice by individual nurses, or by the organisation. Nurses who recognise unsafe practice must be supported by the organisation.


Subject(s)
Nursing , Cross-Sectional Studies , Humans , New Zealand , Occupational Health , Surveys and Questionnaires
3.
Int J Health Policy Manag ; 5(5): 333-5, 2016 Feb 21.
Article in English | MEDLINE | ID: mdl-27239884

ABSTRACT

Hyosun Kim's report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it.


Subject(s)
Direct-to-Consumer Advertising/standards , Government Regulation , Internet , Marketing/standards , Prescription Drugs , Humans , Marketing/methods , United States , United States Food and Drug Administration
4.
J Adv Nurs ; 72(3): 488-500, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26586009

ABSTRACT

AIM: To determine how nurses recognize and respond to unsafe practice. BACKGROUND: Practice guidelines and standards outline safe practice. Nurses face challenges in recognizing and responding unsafe practice. DESIGN: Whittemore and Knafl's revised framework for integrative reviews guided the analysis. DATA SOURCES: A comprehensive search of literature exploring the identification and response to unsafe practice, was undertaken in CINAHL, Medline, Embase and PsychoINFO databases for the period 2004-2014. REVIEW METHODS: Nineteen articles from 15 studies were included in the review. A mixed method integrative approach was used to review data and draw conclusions. RESULTS: Behaviours and cues that indicate unsafe practice are influenced by organizational and individual characteristics. Individual nurses responses are variable and there are professional and personal costs associated with being reported or reporting unsafe practice. CONCLUSION: The small number of studies reviewed limits the conclusions that can be drawn from the review but suggest that nurses can identify unsafe practice in their peers. Individual nurses' recognition and response to unsafe practice in their peers contributes to patient outcomes and safety. Nurses need awareness training and strategies to respond to unsafe practice and reporting systems that protect reporters from repercussions. Further research investigating organizational factors and individual factors that contribute to a shift in practice across safety boundaries is required.


Subject(s)
Nurse's Role , Nursing Care/standards , Nursing Staff, Hospital/psychology , Patient Safety/standards , Practice Guidelines as Topic , Safety Management/standards , Attitude of Health Personnel
5.
Med J Aust ; 202(11): 587-90, 2015 Jun 15.
Article in English | MEDLINE | ID: mdl-26068692

ABSTRACT

OBJECTIVES: To describe how ethics is practised in a health care setting, and to ascertain whether there was interest in establishing clinical ethics support services. DESIGN AND SETTING: Observations and interviews undertaken between April and November 2012 in a large NSW urban hospital with newborn care, maternity and oncology departments and analysed by coding and categorising the data. MAIN OUTCOME MEASURES: Key themes in the participants' attitudes to professional ethics were identified. RESULTS: Ethics is not typically an explicit feature of clinical deliberations, and clinicians tend to apply basic ethical principles when ethical problems are identified. They also discuss difficult decisions with colleagues, and try to resolve ethical differences by discussion. Participants judged the ethics of clinical practice to be "mostly right", primarily because ethics is "part of the fabric" of everyday clinical work that aspires to "optimising care". Nevertheless, most clinicians would welcome ethics support because ethics is integral to health care practice, is not always "done well", and may be the source of conflict. CONCLUSIONS: Ethics is very much a part of the fabric of clinical practice, and the ethical challenges that arise in patient care in this particular setting are generally managed adequately. However, many clinicians have concerns about the ethical aspects of some practices and decisions, and believe that access to expert ethics support would be useful. Helping clinicians to provide ethically sound patient care should be a priority for health care providers across Australia.


Subject(s)
Attitude of Health Personnel , Delivery of Health Care/ethics , Anthropology, Cultural , Female , Humans , Male , Surveys and Questionnaires
6.
Aust Health Rev ; 39(1): 44-50, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25514126

ABSTRACT

OBJECTIVE: To investigate the range, frequency and management of ethical issues encountered by clinicians working in hospitals in New South Wales (NSW), Australia. METHODS: A cross-sectional survey was conducted of a convenience sample of 104 medical, nursing and allied health professionals in two NSW hospitals. RESULTS: Some respondents did not provide data for some questions, therefore the denominator is less than 105 for some items. Sixty-two (62/104; 60%) respondents reported occasionally to often having ethical concerns. Forty-six (46/105; 44%) reported often to occasionally having legal concerns. The three most common responses to concerns were: talking to colleagues (96/105; 91%); raising the issue in a group forum (68/105; 65%); and consulting a relevant guideline (64/105; 61%). Most respondents were highly (65/99; 66%) or moderately (33/99; 33%) satisfied with the ethical environment of the hospital. Twenty-two (22/98; 22%) were highly satisfied with the ethical environment of their department and 74 (74/98; 76%) were moderately satisfied. Most (72/105; 69%) respondents indicated that additional support in dealing with ethical issues would be helpful. CONCLUSION: Clinicians reported frequently experiencing ethical and legal uncertainty and concern. They usually managed this by talking with colleagues. Although this approach was considered adequate, and the ethics of their hospital was reported to be satisfactory, most respondents indicated that additional assistance with ethical and legal concerns would be helpful. Clinical ethics support should be a priority of public hospitals in NSW and elsewhere in Australia.


Subject(s)
Ethics, Clinical , Patient Care/ethics , Adult , Aged , Cross-Sectional Studies , Female , Hospitals, Public , Humans , Male , Middle Aged , New South Wales , Young Adult
7.
Aust Health Rev ; 38(2): 160-8, 2014 May.
Article in English | MEDLINE | ID: mdl-24589424

ABSTRACT

OBJECTIVE: National medicines policies (NMP) provide a means for governments to achieve their objectives in relation to pharmaceuticals and other medicines. This research aimed to identify challenges to implementing the objectives of the Australian NMP from the perspective of key stakeholders. METHODS: In 2012 and 2103, we conducted 30 semistructured interviews with stakeholders involved in the discovery, clinical testing, regulation and funding of medicines in Australia. We asked participants to describe their careers and to give their opinions on specific issues surrounding drug development, clinical research, regulation and subsidisation in Australia. Data were analysed using Morse's outline of the cognitive basis of qualitative research and Charmaz's outline of data analysis in grounded theory. The initial phase of 'open coding' revealed findings that could be mapped to three of the four objectives of the NMP. We then conducted 'focussed coding' for themes relevant to these objectives. RESULTS: Participants identified many issues relevant to the ongoing evolution of the NMP, relating primarily to ongoing tensions between the commercial objective of ensuring a viable medicines industry, and the non-commercial objectives of ensuring that medicines are safe, effective and affordable. There were also several other challenges identified to the achievement of both the commercial and non-commercial objectives of the NMP. These included limits to government funding, globalisation, consumer advocacy, changing scientific paradigms and new information technologies. CONCLUSIONS: There are many issues that need to be addressed if policymakers are to achieve the best outcomes from the NMP. Tensions between the commercial and non-commercial objectives of the NMP suggest the need to ensure that one stakeholder group's imperatives do not stifle those of other groups. At the same time, there are several emerging issues that are likely to concern all stakeholders equally, and these are both challenges and opportunities for new kinds of collaboration. What is known about the topic? We know that stakeholders have several concerns about medicines policy, but little is known about the specific challenges to implementing medicines policy from the perspective of those involved. What does this paper add? We demonstrate that stakeholders have many concerns that could impact the implementation of medicines policies. These relate primarily to ongoing tensions between the objective of ensuring a viable medicines industry, and the objectives of ensuring that medicines are safe, effective and affordable. There are also several issues that potentially pose a challenge to achieving both the commercial and non-commercial objectives of the NMP. These include limits to government funding, globalisation, consumer advocacy, changing scientific paradigms and new information technologies. What are the implications for practitioners? Policymakers need to systematically address the barriers to the ongoing implementation of the NMP. Policymakers should also ensure that one imperative (such as the commercial imperative) does not stifle other objectives. Other emerging issues are likely to concern all stakeholders, and these provide opportunities for new kinds of collaboration among stakeholders.


Subject(s)
Biomedical Research/standards , Clinical Trials as Topic/standards , Drug Industry/standards , Health Policy , Prescription Drugs/standards , Australia , Biomedical Research/economics , Clinical Trials as Topic/economics , Drug Discovery/economics , Drug Discovery/standards , Drug Industry/economics , Financing, Government , Fund Raising/methods , Humans , Interviews as Topic , Policy Making , Prescription Drugs/economics
8.
Health Expect ; 17(1): 15-26, 2014 Feb.
Article in English | MEDLINE | ID: mdl-21838831

ABSTRACT

OBJECTIVE: To compare the relative importance of medicine attributes and decision-making preferences of patients with higher or lower levels of insurance coverage in a publicly funded health care system. DESIGN AND SETTING: Cross-sectional telephone survey of randomly selected regular medicine users aged ≥18 years in the Hunter Valley, NSW, Australia. MAIN VARIABLES STUDIED: Questions about 27 medicine attributes and active involvement in decisions to start a new medicine. RESULTS: After adjustment, there were few differences between the 408 concession card holders (high insurance) and 410 general beneficiaries (low insurance) in their assessment of the importance of medicine attributes. For both groups, the explanation of treatment options, establishing the need for the medicine, and medicine efficacy and safety were the most important considerations. Medicine costs, the treatment burden and medicine familiarity were less important; the views of family and friends ranked lowest. There was a statistically significantly greater influence of the regular doctor for the concession card holders than general beneficiaries (93.6 vs. 84%, adjusted OR 2.80, 95% CI 1.31, 5.99). Concession card holders were more likely to favour doctors having more say in the decision-making process (crude OR 1.69, 95% CI 1.28, 2.24), and more likely to report the most recent treatment decision being made by the doctor alone, compared with general beneficiaries (61.2 vs. 40.3%). CONCLUSION: Medicine need, efficacy and safety are viewed as paramount for most patients, irrespective of insurance status. While patients report the importance of participation in treatment decisions, delegation of decision making to the doctor was common in practice.


Subject(s)
Decision Making , Fees, Pharmaceutical/statistics & numerical data , Insurance Coverage/statistics & numerical data , Insurance, Pharmaceutical Services/statistics & numerical data , Patient Preference , Aged , Australia , Cost-Benefit Analysis , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Patient Participation , Socioeconomic Factors
9.
Aust Health Rev ; 37(1): 32-40, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23237385

ABSTRACT

OBJECTIVE: To create and report survey-based indicators of the affordability of prescription medicines for patients in Australia. METHOD: A cross-sectional study of 1502 randomly selected participants in the Hunter Region of NSW, were interviewed by telephone. MAIN OUTCOME MEASURE: The self-reported financial burden of obtaining prescription medicines. RESULTS: Data collection was completed with a response rate of 59.0%. Participants who had received and filled at least one prescription medicine in the previous 3 months, and eligible for analysis (n=952), were asked to self-report the level of financial burden from obtaining these medicines. Extreme and heavy financial burdens were reported by 2.1% and 6.8% of participants, respectively. A moderate level of burden was experienced by a further 19.5%. Low burden was recorded for participants who said that their prescription medicines presented either a slight burden (29.0%) or were no burden at all (42.6%). CONCLUSION: A substantial minority of participants who had obtained prescription medicines in the 3 months prior to survey experienced a level of financial burden from the cost of these medicines that was reported as being moderate to extreme.


Subject(s)
Medication Adherence/statistics & numerical data , Prescription Drugs/economics , Adolescent , Adult , Aged , Australia , Cost Sharing/economics , Cost Sharing/standards , Cross-Sectional Studies , Female , Financing, Personal , Humans , Interviews as Topic , Male , Middle Aged , New South Wales , Prescription Fees , Self Report , Socioeconomic Factors , Young Adult
10.
PLoS One ; 7(4): e34314, 2012.
Article in English | MEDLINE | ID: mdl-22509289

ABSTRACT

UNLABELLED: OBJECTIVE, DESIGN, SETTING AND PARTICIPANTS: The objective was to investigate media influence on consumers' health related behaviours. A cross-sectional survey of randomly selected adults (18+ years) residing in the Hunter Region of New South Wales Australia was conducted. The sample was selected using a combination of the white pages and random digit dialling. MAIN OUTCOME MEASURES: The proportions of respondents who recalled seeing or hearing about conditions or treatments in the media over the 12 months prior to interview (August 2009-August 2010) and their subsequent health related behaviour. RESULTS: Although most survey participants reported seeking health information from their doctors, around two-thirds of survey participants (551, 68.8%) recalled hearing, seeing or reading about one or more medical conditions (total = 1097 instances) in the mainstream media over the past 12 months. Almost 40% of respondents (307, 38.4%) stated that they had looked for more information about a condition as a result of hearing about it in the media, and most used the internet (269, 87.4%). More than a quarter of respondents (215, 26.9%) indicated that they had asked their doctor about a condition they had heard about in the media. Around half of those who asked their doctor (109, 50.6%) reported that their inquiry resulted in them receiving treatment, of whom almost half (53, 48.3%) reported being prescribed a medicine. CONCLUSION: The survey results show that consumers become aware of medicines through traditional media and then to learn more often turn to the internet where quality of information may be poor.


Subject(s)
Health Behavior , Information Seeking Behavior , Internet , Mass Media , Adolescent , Adult , Data Collection , Disease , Female , Humans , Male , Middle Aged , Young Adult
11.
BMC Public Health ; 11: 892, 2011 Nov 24.
Article in English | MEDLINE | ID: mdl-22114865

ABSTRACT

BACKGROUND: When a medicine such as rofecoxib (Vioxx) is withdrawn, or a whole class of medicines discredited such as the selective COX-2 inhibitors (COX-2s), follow-up of impacts at consumer level can be difficult and costly. The Australian Longitudinal Study on Women's Health provides a rare opportunity to examine individual consumer medicine use following a major discrediting event, the withdrawal of rofecoxib and issuing of safety warnings on the COX-2 class of medicines. The overall objective of this paper was to examine the impact of this discrediting event on dispensing of the COX-2 class of medicines, by describing medicine switching behaviours of older Australian women using rofecoxib in September 2004; the uptake of other COX-2s; and the characteristics of women who continued using a COX-2. METHODS: Participants were concessional beneficiary status women from the Older cohort (born 1921-26) of the Australian Longitudinal Study on Women's Health who consented to linkage to Pharmaceutical Benefits Scheme data, with at least one rofecoxib prescription dispensed in the 12 months before rofecoxib withdrawal. A prescription was defined as one dispensing occasion. Women were grouped by rofecoxib pattern of use: continuous (nine or more prescriptions dispensed in the 12 months prior to rofecoxib withdrawal) or non-continuous (eight or less prescriptions dispensed in the 12 months prior to rofecoxib withdrawal) users. Incidence rate per 100,000 person days and incidence risk ratio described uptake of alternate medicines, following rofecoxib withdrawal. Kaplan-Meier curves described differences in uptake patterns by medicine and pattern of rofecoxib use. Patterns of use of COX-2s in the next 100 days after first COX-2 uptake were described. RESULTS: Medicine switches and pattern of medicines uptake differed significantly depending upon whether a woman was a continuous or non-continuous rofecoxib user prior to rofecoxib discrediting. Continuous rofecoxib users overwhelmingly switched to another COX-2 and remained continuing COX-2 users for at least 100 days post-switch. CONCLUSIONS: The typical switching behaviour of this group of women suggests that the issues leading to the discrediting of rofecoxib were not seen as a COX-2 class effect by prescribers to this high use group of consumers.


Subject(s)
Cyclooxygenase 2 Inhibitors , Lactones , Safety-Based Drug Withdrawals , Sulfones , Aged , Aged, 80 and over , Australia , Contraindications , Female , Humans , Longitudinal Studies
12.
Aust Health Rev ; 35(1): 37-44, 2011 Feb.
Article in English | MEDLINE | ID: mdl-21367329

ABSTRACT

OBJECTIVE: To assess patients' prescription medicine cost consciousness and explore the implications of further cost sharing increases for affordability. DESIGN AND PARTICIPANTS: A telephone interview survey of 818 randomly selected prescription medicine users (408 concession card holders, 410 general beneficiaries) resident in the Hunter Valley region of New South Wales, Australia. MAIN OUTCOME MEASURES: Degree of prescription cost consciousness; attitudes towards prescription use and cost sharing; self-rated capacity to manage further co-payment increases and differences between concession card holders and general beneficiaries in these measures. RESULTS: The majority of participants were cost conscious medicine users who act responsibly towards medicine use and believe that cost sharing is appropriate. Although there were no differences in cost consciousness scores, card holders appeared more sensitive to prescription costs and increases. Conversely, general beneficiaries were more likely to report difficulties with cost (avoiding seeing a doctor, not collecting prescription medicines, stopping or reducing the dose of a prescribed medicine). Although almost 75% of respondents reported that a co-payment increase would cause financial difficulty, only 28% indicated this would change their medicine use. CONCLUSIONS: These results suggest that most Australian patients are cost conscious but many are also close to facing difficulties with prescription costs. Further increases in PBS cost sharing could compromise prescription affordability, particularly for general beneficiaries.


Subject(s)
Cost Sharing , Financing, Personal , Prescription Fees , Adolescent , Adult , Aged , Cross-Sectional Studies , Female , Humans , Interviews as Topic , Male , Middle Aged , New South Wales , Young Adult
13.
Aust Health Rev ; 33(2): 231-40, 2009 May.
Article in English | MEDLINE | ID: mdl-19563311

ABSTRACT

In this paper we argue that Australia's pharmaceutical cost sharing policy has been applied as if cost sharing is unproblematic for medicine affordability and good health outcomes. Australian and international experience with pharmaceutical cost sharing strongly suggests a negative impact on affordability and quality use of medicines, disproportionately affecting low income patients. We argue that Australia's use of cost sharing reflects the currency of a cognitively powerful and morally charged idea - moral hazard. Moral hazard refers to the change in behaviour induced by insurance coverage. Applied to pharmaceuticals, this means that low out-of-pocket cost will lead to waste. Moral hazard mixes the explanatory power of price with the intuitively cogent notion that if people do not experience consequences they will behave irresponsibly. Cost sharing policy has gone unscrutinised and uncontested not because cost sharing is unproblematic, but because in the light of the idea of moral hazard it has all the question-deadening weight of common sense.


Subject(s)
Cost Sharing , Drug Costs , Health Policy , Health Services Accessibility/economics , Insurance, Pharmaceutical Services/economics , Australia , Humans
15.
J Public Health Policy ; 29(1): 106-20, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18368023

ABSTRACT

This paper outlines the increasing salience of drug "innovation" in the debate for reform of Australia's pharmaceutical policy, particularly change to Australia's price control mechanisms. The pharmaceutical industry has consistently criticised the central role of price control in Australia's pharmaceutical regulatory regime as an impediment to drug innovation and industry growth. Despite ambivalent or contrary evidence on the impact of price control on drug innovation, this criticism, and the appeals for reform it supports, appear to be increasingly influential in directing pharmaceutical policy. This is particularly evident in the implementation of the Australia/United States Free Trade Agreement, which has led to a weakening of the historical process of evidence-based reference pricing in Australia. Should drug innovation come to dominate Australian pharmaceutical policy, there is the potential to precipitate a devaluing of the current public orientation of regulation and diminish equitable access to affordable pharmaceuticals. The manner in which trade policy has effectively undermined a publicly funded pharmaceutical benefits scheme has clear implications for many countries that maintain such programmes.


Subject(s)
Drug Industry/economics , Health Policy , Therapies, Investigational/economics , Australia , Cost Control , Costs and Cost Analysis , Drug Industry/organization & administration , Humans , International Cooperation , National Health Programs/organization & administration , United States
16.
Med J Aust ; 187(4): 236-9, 2007 Aug 20.
Article in English | MEDLINE | ID: mdl-17564580

ABSTRACT

Draft legislation introduced to Parliament on 24 May 2007 proposes changes to the Pharmaceutical Benefits Scheme (PBS), including the creation of two formularies. The F1 formulary will contain single brand drugs that are not considered "interchangeable on an individual patient basis", while the F2 formulary will contain mainly older drugs (many of them generic) for which there is at least one alternative product considered to be clinically interchangeable. Drugs in F1 will not be compared with those in F2 for pricing purposes, even if clinical trial data show them to be equivalent (or even inferior) for the same clinical indication. This undermines the evidence-based approach to reference pricing currently used in the PBS. Other changes require compulsory price disclosures and price cuts for generic medicines. While positive, these amendments are unlikely to deliver generic medicine prices as low as those in other developed countries. This is important, in view of growing evidence of the unaffordability of prescription medicines in the Australian community.


Subject(s)
Drug Costs , Drugs, Generic/economics , Health Care Reform , Insurance, Pharmaceutical Services , Reimbursement Mechanisms/organization & administration , Australia , Humans
17.
Arch Intern Med ; 165(21): 2493-6, 2005 Nov 28.
Article in English | MEDLINE | ID: mdl-16314546

ABSTRACT

BACKGROUND: It is believed that pharmaceutical industry sponsorship of clinical research leads to the development of multiple ties between clinicians and the pharmaceutical industry. To quantify this relationship we conducted a survey of medical specialists listed in the Medical Directory of Australia in 2002 and 2003. METHODS: A questionnaire was mailed that elicited information about all aspects of research relationships between clinicians and pharmaceutical companies. The odds of reporting multiple additional ties (financial and professional) with pharmaceutical companies by clinicians who had an active research relationship were compared with those who did not. All clinicians who returned a completed questionnaire about their research activities were included in the study. RESULTS: A questionnaire was mailed to 2120 medical specialists; 823 (39%) responded. Of these, 338 (41%) reported involvement in industry-sponsored research in the previous year. They were more likely than others to have been offered industry-sponsored items or activities valued at more than 500 AU dollars (>382 US dollars; odds ratio [OR], 3.5; 95% confidence interval [CI], 2.6-4.7) and support for attending international conferences (OR, 5.4; 95% CI, 3.9-7.4). The strongest associations were seen for acting as a paid consultant to industry (OR, 9.0; 95% CI, 3.9-20.4) and for membership on advisory boards (OR, 6.9; 95% CI, 5.1-9.6). There was a strong relationship between research collaboration and accumulation of industry ties. For 1 additional tie the OR was 2.2 (95% CI, 1.2-3.8) and rose to 6.3 (95% CI, 3.5-11.1) with 3 ties and 41.8 (95% CI, 14.5-143.4) with 6 or more ties. CONCLUSIONS: Medical specialists who have research relationships with the pharmaceutical industry are much more likely to have multiple additional ties than those who do not have research relationships. Institutional review should discourage clinical researchers from developing multiple ties.


Subject(s)
Biomedical Research , Drug Industry , Interprofessional Relations , Australia , Female , Humans , Male , Middle Aged , Research Support as Topic , Retrospective Studies , Surveys and Questionnaires
18.
Global Health ; 1: 15, 2005 Oct 06.
Article in English | MEDLINE | ID: mdl-16209703

ABSTRACT

On 1 January 2005, a controversial trade agreement entered into force between Australia and the United States. Though heralded by the parties as facilitating the removal of barriers to free trade (in ways not achievable in multilateral fora), it also contained many trade-restricting intellectual property provisions and others uniquely related to altering pharmaceutical regulation and public health policy in Australia. The latter appear to have particularly focused on the world-respected process of federal government reimbursement after expert cost-effectiveness evaluation, popularly known as the Pharmaceutical Benefits Scheme ('PBS'). It remains uncertain what sort of impacts--if any--the Australia-United States Free Trade Agreement ('AUSFTA') will have on PBS processes such as reference pricing and their important role in facilitating equitable and affordable access to essential medicines. This is now the field of inquiry for a major three year Australian Research Council ('ARC')-funded study bringing together a team of senior researchers in regulatory theory from the Australian National University and pharmacoeconomics from the University of Newcastle. The project proposes to monitor, assess and analyse the real and potential impacts of the AUSFTA in this area, providing Australian policy-makers with continuing expertise and options. To the extent that the AUSFTA medicines provisions may represent an important precedent in a global strategy by industry on cost-effectiveness evaluation of pharmaceuticals, the study will also be of great interest to policy makers in other jurisdictions.

19.
Med J Aust ; 182(11): 557-60, 2005 Jun 06.
Article in English | MEDLINE | ID: mdl-15938681

ABSTRACT

OBJECTIVES: To characterise research relationships between medical specialists and the pharmaceutical industry in Australia. DESIGN AND SETTING: Questionnaire survey of medical specialists listed in the Medical Directory of Australia and believed to be in active practice, conducted in 2002 and 2003. MAIN OUTCOME MEASURES: Details of medical specialists' involvement in pharmaceutical industry-sponsored research, and reports of potentially undesirable research outcomes. RESULTS: Of 2120 specialists approached, 823 (39%) responded. Participation in pharmaceutical industry-sponsored research was more commonly reported by those in salaried practice (49%) than those in private practice (33%); P < 0.001. 216 reported that industry had made initial contact, compared with 117 who had initiated contact with industry. 14.0% of respondents reported premature termination of industry-sponsored trials, which they considered appropriate when in response to concerns about adverse drug effects. 12.3% of respondents reported that industry staff had written first drafts of reports, which they viewed as an acceptable practice for "internal" documents only. Of greatest concern to respondents were instances of delayed publication or non-publication of key negative findings (reported by 6.7% and 5.1% of respondents, respectively), and concealment of results (2.2%). Overall, 71 respondents (8.6%) had experienced at least one event that could represent breaches of research integrity. CONCLUSIONS: These data indicate a high level of engagement in research between the pharmaceutical industry and medical specialists, including those in private practice. Examples of possibly serious research misconduct were reported by 8.6% of respondents, equivalent to 21% of those with an active research relationship with industry.


Subject(s)
Conflict of Interest , Drug Industry , Ethics, Research , Medicine/statistics & numerical data , Research Personnel , Research Support as Topic , Scientific Misconduct , Specialization , Australia , Humans , Physicians , Private Practice , Publication Bias , Surveys and Questionnaires , Treatment Outcome
20.
Soc Sci Med ; 60(7): 1437-43, 2005 Apr.
Article in English | MEDLINE | ID: mdl-15652677

ABSTRACT

All Australian citizens are provided affordable access to prescription medicines through the nation's system of universal pharmaceutical subsidies--the pharmaceutical benefits scheme. The rapid increase in pharmaceutical related expenditure has generated the concern that Australians are taking advantage of prescription subsidies and are using more medicines than are necessary, thereby creating a 'moral hazard'. This concern is predicated on a number of assumptions about patient behaviour rather than on empirical observation. These assumptions amount to a view that patients are consumers who treat prescription medicines as common goods subject to informed and rational calculation of the cost and benefits of their use. This paper reports the findings of an in-depth interview study undertaken to explore how prescription cost influences Australians' medicine use. Qualitative data were analysed to compare medicine users' descriptions of the role of prescription cost in medicine use against the assumptions that underlie the belief in moral hazard. Moral hazard did not appear to be significantly operating in the accounts of medicine use collected for this study. Interviewees' accounts of medicine use revealed an act characterised by ambivalence, a mix of desire and antipathy, faith and suspicion. Medicines appeared in interviewees' accounts as both pharmacologically and symbolically potent substances, which despite their familiarity as objects, are often mysterious to non-expert patients. Cost appeared as a secondary factor in patients' decision to access a prescription medicine. Using a prescription was predicated on the medicine being necessary, with necessity typically established by an expert doctor prescribing the medicine. Prescription medicines did not appear as 'common goods' where subsidised access motivates a 'consumer' to demand more or make the prospect of prescription use more attractive or necessary.


Subject(s)
Drug Prescriptions , Drug Utilization/ethics , Health Knowledge, Attitudes, Practice , Health Services Misuse , Morals , Australia , Decision Making/ethics , Drug Prescriptions/economics , Fees, Pharmaceutical , Health Behavior , Humans , Insurance, Pharmaceutical Services , Interviews as Topic , National Health Programs
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