IntroductionThere have been substantial changes in the nature of reporting pathways and review of suspected adverse drug reactions (ADRs) in Australia since the establishment of the now defunct Advisory Committee on Safety of Medicines early in 2010.ObjectivesThe aim of this study was to (1) examine the reporting in Australia of suspected ADRs from various sources, including general practitioners (GPs), since 1990; (2) compare the reporting of Australian GPs with that in two other countries (New Zealand and the United Kingdom [UK]) with comparable safety monitoring programmes for the period 2007-2019; and (3) explore the extent to which Australian reporting of suspected adverse reactions has motivated communication to healthcare professionals in the period 1995-2019.MethodsAnnual reporting of sources of ADRs in Australia were obtained from Government reports, the Australian Statistics in Medicines and Therapeutic Goods Administration (TGA) websites. Details of the annual reporting by GPs in the UK were obtained from published sources and have been provided on request by the Medicines and Healthcare products Regulatory Agency. Details of the annual reporting by GPs in New Zealand were provided on request from the Centre for Adverse Reaction Monitoring. All issues of the Australian Adverse Drug Reactions Bulletin were accessed from the National Library of Australia, and issues of the Medicines Safety Update from February 1995 to December 2019 were accessed online from the TGA website. Each issue was searched to identify and score safety advisories.ResultsFrom 1990 to 2002 in Australia, overall reporting gradually increased, and the three major groups of reporters (GPs, hospitals and sponsors) each contributed about 30%. The relative contributions to reporting changed in the period 2002 to 2009. There was then a steep fall in reporting from GPs and the start of a very marked increase in reporting from product sponsors. GP reporting in Australia was lower than the two other comparable countries (New Zealand and the UK), and continues to fall, while in the UK at least, GP reporting is rising. The analysis of safety advisories shows a relatively stable Australian content from 1995 to 2008, followed by a sharp decline, so that by 2019 and 2020 there was barely any Australian reporting-driven content. In 1995 and 1996, Australian reports of suspected adverse reactions were the sole apparent reason for the publication of safety advisories. From 1997 to about 2008, Australian reports of suspected adverse reactions were the major reason for publication, but after this time, Australian reports became less important. During this later period, the apparent motive for publication of the safety advisory shifted to being based primarily on a publication in the medical literature, or publicity, but was sometimes based on an overseas regulator's advice or action, or action by a product sponsor.ConclusionIt is our contention that the decline in GP reporting in Australia and the current paucity in details of Australian reports in safety advisories are closely linked.
The Therapeutic Goods Administration has since 2013 neglected its long tradition of publishing regular bulletins and updates about medicine safety issues directed to Australian healthcare professionals. Recent publication policy is confused with information about clinically important safety issues published only in the alternative Safety Information Alerts and, unlike other comparable regulators, a failure to publish direct healthcare professional communications.
The importance of pharmacovigilance (PV) for safe medicines and their safe use has increasingly been recognised during the last few years [1]. PV has been subject of intense research and regulation. In particular, it has earned more and more importance and attention in low-resource countries. This is largely due to the globalisation of trade and the availability of new, highly effective but potentially harmful chemical medicinal products in those parts of the world where traditional treatments, in particular herbal or other complementary remedies, used to prevail. A plethora of publications, guidelines and information about newly observed or further investigated adverse drug reactions (ADRs) from all over the world creates a growing burden for people working with medicines or patients to keep abreast of this development. Largely due to the global availability of information through the Internet, patients are nowadays more and more critical and often concerned about, or even frightened of, potential ADRs of their medicines. This poses an additional demand on the up-todate capacities of their doctors and other healthcare professionals (HCPs). A particular challenge is the multidisciplinary character of PV which requires know-how in topics as different as molecular mechanisms of ADRs, clinical medicine, pharmacoepidemiology, information technology, pharmaceutical manufacturing, legal aspects, public health situations on various levels, and traditions in The views expressed in this article reflect a consensus reached between the personal views of all authors. They do not necessarily reflect the views of the authors’ employers or any institutions the authors are otherwise affiliated to.
ABSTRACTAimTo measure the rate of co‐dispensing of contraindicated drugs with cisapride 12 months prior to and 12 months after a period of publicity; and to assess the impact of the publicity, the ‘Dear Healthcare Professional letters‘, changes to the product information and pharmaceutical benefits subsidy restrictions.MethodMedicare Australia's Pharmaceutical Benefits Scheme database was searched to identify a cohort of patients who had been dispensed both cisapride and a contraindicated drug in a 12‐month period before and after a period of publicity.ResultsThe number of patients dispensed cisapride fell from 42 319 in 1998 to 2849 in 2001 after the publicity, and significantly after the restriction was placed on cisapride as a pharmaceutical benefit in 2000. In 1998, 11% of patients were dispensed a contraindicated drug 30 days after cisapride dispensing and this figure fell to 9.7% in the 2001 cohort. When the analysis was restricted to the dispensing of the specific drugs that had been named in the publicity letters (‘named’ drugs), a contraindicated drug was dispensed to 3.3% in 1998 and 2.7% in 2001.ConclusionThe large fall in the use of cisapride from 1998 to 2001 was more likely due to the pharmaceutical benefits subsidy restrictions rather than the publicity or regulatory actions during 2000. While the proportion of patients who were dispensed a contraindicated drug showed a small fall, it was unlikely to be clinically significant. When the analysis was restricted to patients who were dispensed only a ‘named’ drug, the reduction from 1998 to 2001 was small and statistically insignificant. Sponsor‐initiated communication failed to ensure optimal prescribing and dispensing of drugs.
Dr. Ian W. Boyd from the Adverse Drug Reactions Unit at the Therapeutic Goods Administration, speaks about recent developments of adverse drug reactions among Chinese medicine practitioners. Boyd also elaborates on the strategies for encouraging such practitioners to report suspected adverse events.
Aim To estimate the percentage of patients dispensed alendronate who were also dispensed another drug for treatment of an upper gastrointestinal disorder ('GI' drug).Methods The Australian Health Insurance Commission (HIC) Pharmaceutical Benefits Scheme (PBS) database was searched to identify a cohort of patients for whom alendronate or calcitriol had been dispensed and had also been dispensed a GI drug.Results The number of patients dispensed a GI drug were 6.7% for alendronate and 7.5% for calcitriol with H-2-receptor antagonists accounting for the majority of usage. This difference of - 0.8% (95% confidence interval -1.6, 0.1) is not significant.Conclusion There was no excess use of GI drugs in patients taking alendronate compared with those taking calcitriol and the Australian HIC PBS database is useful for identifying large numbers of patients who have been dispensed combinations of drugs.
Established in 1990, the British Council for Offices' (BCO) mission is: To research, develop and communicate best practice in all aspects of the office sector. It delivers this by providing a forum for the discussion and debate of relevant issues. BCO members are organisations and individuals involved in creating, acquiring or occupying office space, in both private and public sectors. The BCO seeks to advance the collective understanding of its members, enabling them to work together to create more effective office space. In addition to its national programme of events, research and publications, the BCO also runs regional chapters in Scotland, the North, the Midlands and South West & Wales. These chapters provide additional meeting points for the members through programmes of technical visits, seminars and luncheon meetings. These groups also allow members to focus on issues of special, local concern. BENEFITS OF MEMBERSHIP
The Australian adverse drug reaction reporting system is acknowledged as one of the best in the world. Despite its small population of less than 20 million people, Australia's current ADR reporting rate of over 12,000 reports per year places it in the top few nations in terms of reports per capita. The ADRAC program has been in operation for over 30 years. Australia was a founding member of the WHO International Drug Monitoring Programme which commenced in 1968 and currently there are about 153,000 reports in the ADRAC database. Reports from health professionals have uncovered a number of significant safety problems over the years. Of particular importance are flucloxacillin-induced hepatitis, amoxycillin/clavulanate-induced hepatitis, and the association of cystitis with tiaprofenic acid. The number and quality of the reports has allowed an understanding of the characteristics of the reactions and, using ADRAC reporters as a major source of cases, case-control studies have been completed which have identified risk factors. ADRAC's review of Australian reports has highlighted many important associations that have been disseminated through the Australian Adverse Drug Reactions Bulletin.
Cyclooctyne (C8H12) in excess reacts with the dialkyldithiocarbamato complexes M(S2CNR2)2(CO)2 (R = Me, Et; M == Mo, L = PPh3; M = W, L = CO, PPh3) to give a mixture of two complexes, M(S2CNR2)2)(CO){(C8H12)2CO} (1–4) and M(S2CNR2)2(C8H12){(C5H12)2CO} (5–8). These contain tetrahapto-bis-(hexamethylene)cyclopentadienone, (C8H12CO, formed by the condensation of two molecules of cyclooctyne with one molecule of CO. Crystals of W(S2CNMe2)2(CO){(C8H12)2CO} (3) are monoclinic, space group P21/n, with a 15.132(1), b 15.705(2), c 11.346(1) Å, β 93.68(2)°, and Z = 4. The structure was solved by heavy-atom methods and refined by least-squares methods to R = 0.027 (Rw = 0.045) for 5811 unique data [I ≧ 3σ(I)]. The molecule is approximately pentagonal bipyramidal, with terminal CO and one sulphur atom of a bidentate Me2NCS2 ligand in the axial positions. The equatorial sites are occupied by the other sulphur atom of this Me2NCS2 ligand, the second bidentate Me2NCS2 ligand, and the mid-points of the coordinated CC bonds of η4-(C8H12CO. As in other cyclopentadienone complexes, the CC distances in the η4-dienone are almost equal (av. 1.45 Å) and the CO group is bent away from the plane of the ring (dihedral angle 17.6°). Infrared and NMR (1H, 13C) data suggest that complexes 5–8 are similar to 1–4, with cyclooctyne acting as a 2π-electron donor in place of CO.
Cyclooctyne (C8H12) reacts with the dialkyldithiocarbamato complexes Mo(S2CNR2)2(CO)2(PPh3) and W(S2CNR2)2(CO)3 (R = Me, Et) in a 1:1 mol ratio to give the divalent metal alkyne complexes M(S2CNR2)2(CO)(C8H12). These are oxidized by bromine or iodine to tetravalent metal alkyne complexes MX2(S2CNR2)2(C8H12) (M = Mo, W; X = Cl, Br; R = Me, Et). Carbon-13 NMR and IR spectroscopic data indicate that in these compounds and in the triethylphosphine complexes MBr2(CO)C8H12)(PEt3)2 (M = Mo, W) cyclooctyne behaves as a 4π-electron donor, whereas in the oxomolybdenum(IV) cyclooctyne complexes MoO(S2CNR2)2C8H12) (R = Me, Et) it donates approximately π-electrons owing to competing π-donation from the oxo ligand.