Ian Boyd Consulting

Services

We can assist in all aspects of pharmacovigilance and drug safety including:

Risk Management Plans (RMPs)/Australian Specific Annexes (ASAs)

We have many years of experience with the preparation of RMPs for Europe and Australia and are specialists in the preparation of ASAs. In addition, we can provide a Justification for not requiring an ASA/RMPs.

Compliance with TGA Guidelines

We can assist sponsors of therapeutic goods on compliance with TGA guidelines on pharmacovigilance. Services include advice on compliance, reporting to the TGA, adverse drug reaction collection and analysis, and provision of a Responsible Person for Pharmacovigilance. We are also expert in ADR terminology and can provide MedDRA.

Periodic Safety Update Reports (PSURs)

Submission of PSURs is an essential aspect of pharmocovigilance and we can provide advice and expertise in the preparation or review of PSURs.

Safety labelling/product information

Analysis and review of safety labelling in the product information or SmPC of drugs is another essential aspect of pharmacovigilance and we can assist with the identification of safety issues and modifications to safety labelling to comply with TGA requirements.

Other Pharmacovigilance Services

We can also provide advice on signal detection and evaluation, review of safety issues, pharmacovigilance training and pharmacovigilance inspections.

Biography

Ian Boyd

Dr Ian Boyd began his career as a research chemist before becoming the Executive Officer of the Adverse Drug Reactions Unit of the Australian Therapeutics Goods Administration (TGA), a position he held for 19 years until 2007. He was also Secretary of the Australian Adverse Drug Reactions Advisory Committee (ADRAC) for 14 years. He has published widely in the area of pharmacovigilance as well as being a major contributor to the Australian Adverse Drug Reactions Bulletin which was the major flagship of ADRAC. He has represented Australia at annual meetings of national centres participating in the WHO Drug Monitoring Programme on many occasions. More recently, he led the TGA’s Adverse Drug Reactions Unit in the redevelopment of their IT infrastructure especially in the area of electronic lodgement of ADRs, conversion to MedDRA and the development of reporting and analysis tools.

In 2007 he formed Ian Boyd Consulting, a consultancy to advise European and Asia- Pacific clients in all areas relating to pharmacovigilance. During this time he has specialised in the preparation of Risk Management Plans (RMPs) and Australian Specific Annexes (ASAs).

Dr Boyd is a peer reviewer for and a member of the Editorial Advisory Board of a number of international medical journals. He is also a member of the Uppsala Monitoring Centre Signal Review Panel and a former member of the Executive Committee of the International Society of Pharmacovigilance (ISoP).

Publications

  1. Boyd IW, Wedd AG. Association of trichlorotris(tetrahydro­furan)molybdenum(III) in solution. Aust J Chem 1976; 29: 1829.
  2. Boyd IW, Dance IG, Murray KS, Wedd AG. Mononuclear oxo­thiolato compounds of molybdenum(V). Aust J Chem 1978; 31: 279.
  3. Dance IG, Wedd AG, Boyd IW. The formation and structure of the di-u-oxo-di[di(benzene thiolato)oxomolybdate(V)] dianion. Aust J Chem 1978; 31: 519.
  4. Boyd IW, Dance IG, Landers AE, Wedd AG. Triply bridged binuclear thiolate complexes of oxomolybdenum(V). Inorg Chem 1979; 18: 1875.
  5. Bradbury JR, Hanson GR, Boyd IW, Gheller SF, Wedd AG, Murray KS, Bond AM. Redox and electron spin resonance properties of oxo-thiolato compounds of molybdenum(V). Proceedings of the Third Climax International Conference on the Chemistry and the Uses of Molybdenum (Barry HF and Mitchell PCH - eds), Climax Molyb­denum Company, Ann Arbor, Michigan, 1979; 300-309.
  6. Toms-Wood A, Boyd IW. Chemistry 102B, assignments and tele­vision syllabus. Stipes Publishing Company, Urbana, Illinois, 1979.
  7. Boyd IW, Haight GP, Howlander NC. Molybdenum(IV) compounds for mediation of electron transfer. 1. Synthesis, characteris­ation and reactions of compounds containing molybdenum(IV) coordinated to trihalostannate(II) ions. Inorg Chem 1981; 20: 3115.
  8. Boyd IW, Spence JT. Molybdenum(IV)-oxo complexes with oxygen, nitrogen and sulfur ligands. Synthesis and electro­chemical studies. Inorg Chem 1982; 21: 1602.
  9. Boyd IW, Wedd AG. Oxomolybdenum(V) complexes with quinolin-8-olato, quinolin-8-thiolato and quinolin-8-aminato ligands. Aust J Chem 1984; 37: 293.
  10. Bennett MA, Boyd IW. Cyclooctyne complexes of molybdenum and tungsten. 1. Mono­cyclooctyne complexes. J Organometal Chem 1985; 290: 165-180.
  11. Bennett MA, Boyd IW, Robertson GB, Wickramasinge WA. Cyclo­octyne complexes of molybdenum and tungsten. 2. Cyclodimer­isation complexes. Crystal and molecular structure of bis(hexa­methylene)cyclopentadienonecarbonylbis(dimethyldithiocarbamato)­tungsten(II). J Organometal Chem 1985; 290: 181-197.
  12. Mathew TH, Boyd IW, Rohan AP. Hyponatraemia due to the combination of hydro chlorothiazide and amiloride (Moduretic): Australian spontaneous reports 1977-1988. Med J Aust 1990; 152: 308-309.
  13. Boyd I. Erythromycin-induced hearing loss. Lancet 1991; 337: 113.
  14. Boyd IW. Allopurinol-azathioprine interaction. J Intern Med 1991; 229: 386.
  15. Boyd I. Nocturnal cramps, quinine, and thrombocytopenia. Arch Int Med 1991; 151: 1021.
  16. ADRAC. Eosinophilia-myalgia syndrome associated with L-tryptophan use. Med J Aust 1991; 154: 295.
  17. Fairley CK, Boyd I, Purcell P, McNeil J. Flucloxacillin jaundice. Lancet 1992; 339: 679.
  18. Fairley CK, McNeil JJ, Desmond P, Smallwood R, Young H, Forbes A, Purcell P, Boyd I. Risk factors for the development of flucloxacillin associated jaundice. BMJ 1993; 306: 233-35.
  19. Boyd IW, Purcell PM, Rohan AP. Adverse effects of hypolipid­aemic agents on skeletal muscle (abstract). Clin Exp Pharmacol Physiol 1992; Suppl 21: 7.
  20. Boyd I. Captopril-induced taste disturbance. Lancet 1993; 342: 304.
  21. Boyd IW, Rohan AP. Chest pain with sumatriptan (abstract). Clin Exp Pharmacol Physiol 1993; Suppl 1: 9.
  22. Boyd IW, Rohan AP. Urinary disorders associated with cisapride. Med J Aust 1994; 160: 579.
  23. Boyd IW. Gynaecomastia in association with calcium antagonists. Med J Aust 1994; 161: 328.
  24. Boyd IW, Rohan AP. Sumatriptan-induced chest pain. Lancet 1994; 344: 1704-5.
  25. Boyd IW. Urinary symptoms in association with tiaprofenic acid (abstract).Proc Aust Soc Clin Exp Pharmacol Toxicol (Widdop RE, Ching MS - eds) 1994; 1: 12.
  26. England JDF, Walsh JC, Stewart P, Boyd I, Rohan A, Halmagyi GM. Mitochondrial myopathy developing on treatment with the HMG CoA reductase inhibitors - simvastatin and pravastatin, Aust NZ J Med 1995; 25: 374.
  27. Boyd I. Benign intracranial hypertension induced by minocycline. Current Therapeutics 1995; 36: 70-71.
  28. Boyd IW. Hypertension with moclobemide. Lancet 1995; 346: 1498.
  29. Boyd IW. Angio-edema and ACE inhibitors. Aust NZ J Med 1995; 25: 746-747.
  30. Boyd IW. Comment: HMG-CoA reductase inhibitor-induced impotence. Ann Pharmacother 1996: 30: 1199.
  31. Boyd IW. Serum sickness-like reactions in association with cefaclor (abstract). Proc Aust Soc Clin Exp Pharmacol Toxicol (Ching MS, Widdop RE - eds) 1996; 3: 29.
  32. Boyd IW. Alendronate and oesophagitis - is it the result of reflux? (abstract) Proc Aust Soc Clin Exp Pharmacol Toxicol (Loiacono RE, Widdop RE - eds) 1997; 4: 62.
  33. Boyd IW. Venlafaxine withdrawal reactions. MJA 1998; 169: 91-2.
  34. Boyd IW. Comment: hyponatraemia with venlafaxine. Ann Pharmacother 1998; 32: 981.
  35. Boyd IW. Cefaclor-associated serum sickness. MJA 1998; 169: 443-4.
  36. Boyd IW. Adverse drug reactions of dicloxacillin versus flucloxacillin (abstract). Proc Aust Soc Clin Exp Pharmacol Toxicol (Hodgson WC, Loiacono RE - eds) 1998; 5: 60.
  37. Boyd IW. Angiotensin receptor antagonists. Aust Prescr 1999; 22: 53.
  38. Boyd IW. Postmarketing surveillance: strengths and limitations. The flucloxacillin-dicloxacillin story. MJA 1999; 171: 219.
  39. Boyd IW, Mathew TH, Thomas MC. COX-2 inhibitors and renal failure: the triple whammy revisited. MJA 2000; 173: 274.
  40. Buchbinder R, Forbes A, Kobben F, Boyd I, Snow RM, McNeil JJ. Clinical features of tiaprofenic acid (Surgam) associated cystitis and a study of risk factors for its development. J Clin Epidemiol 2000; 53: 1013-9.
  41. Boyd IW. The role of Australian Adverse Drug Reactions Committee (ADRAC) in monitoring Drug Safety (abstract). Toxicology 2001; 164: 8.
  42. Boyd IW. Comment: history of drug-induced hepatitis and risk of amoxicillin/clavulanate-induced hepatotoxicity. Ann Pharmacother 2001; 35: 1677.
  43. Savage R, Boyd I, Coulter D. Celecoxib: an adverse reaction profile. Proc Aust Soc Clin Exp Pharmacol Toxicol 2001; 9: 51.
  44. Boyd IW. The role of Australian Adverse Drug Reactions Committee (ADRAC) in monitoring Drug Safety. Toxicology 2002; 181-182: 99-102.
  45. Lawrence G, Menzies R, Burgess M, McIntyre P, Wood N, Boyd I et al. Surveillance of adverse events following immunisation: Australia. 2000-2002. Commun Dis Intell 2003; 27: 307-323.
  46. Lawrence G, Boyd I, McIntyre P, Isaacs D. Surveillance of adverse events following immunisation: Australia. 2002-2003. Commun Dis Intell 2004; 28: 324-338.
  47. Lawrence G, Boyd I. Surveillance of adverse events following immunisation for children aged less than 7 years, 1 January to 30 June, 2004. Commun Dis Intell 2004; 28: 490-492.
  48. Purcell PM, Boyd IW. Bisphosphonates and osteonecrosis of the jaw. MJA 2005; 182: 417-18. .
  49. Boyd IW. Tramadol and seizures. MJA 2005; 182: 595-96.
  50. Isaacs D, Lawrence G, Boyd I, Ronaldson K, McEwen J. Reporting of adverse events following immunization in Australia. J Paediatr Child Health 2005; 41: 163-66.
  51. Fontana RJ, Shakil AO, Greenson JK, Boyd I, Lee WM. Acute liver failure due to amoxicillin and amoxicillin/clavulanate. Dig Dis Sci 2005; 50: 1785-90.
  52. Lawrence G, Boyd I, McIntyre P, Isaacs D. Surveillance of adverse events following immunisation: Australia, 2004. Commun Dis Intell 2005; 29: 248-262, Erratum Commun Dis Intell 2005; 29: 416.
  53. Darby J, Lynton-Moll C, Boyd I. Electronic submission of suspected adverse reactions to drugs and vaccines [online]. In: Wise M, Grain H, Chu S (Eds). HIC 2005 and NINZ 2005: Proceedings. Brunswick East, Vic.: Health Informatics Society of Australia 2005: [303-308].
  54. Lawrence G, Boyd I. Supplementary report: surveillance of adverse events following immunisation for children aged less than 7 years in Australia, 1 January to 30 June, 2005. Commun Dis Intell 2005; 29: 413-416.
  55. Savage RL, Highton J, Boyd IW, Chapman P. Pneumonitis associated with leflunomide: a profile of New Zealand and Australian reports. Int Med J 2006; 36: 162-69.
  56. Boyd IW, McEwen J, Calcino LJ. A study of codispensing with sodium alendronate in Australia. Br J Clin Pharmacol 2006; 61: 470-71.
  57. Boyd IW, Purcell PM. Osteonecrosis of the jaw with bisphosphonates – a new association of major importance. Drug Safety 2006; 29: 968 (abstract).
  58. Ronaldson KR, O’Shea JM, Boyd IW. Risk factors for rhabdomyolysis with simvastatin and atorvastatin. Drug Safety 2006; 29: 1061-67.
  59. Lawrence G, Boyd I, McIntyre P, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2005. Commun Dis Intell 2005; 30: 319-333.
  60. Ronaldson KR, Boyd IW. Risk factors for rhabdomyolysis with simvastatin and atorvastatin. Drug Safety 2006; 29: 1191-92.
  61. Boyd IW. Questions and answers: reporting adverse reactions associated with Chinese herbal medicine. Aust J Acupuncture Chinese Med 2006; 1: 17-18.
  62. Lawrence G, Boyd I. Supplementary report: surveillance of adverse events following immunisation for children aged less than 7 years in Australia, 1 January to 30 June, 2006. Commun Dis Intell 2006; 30: 438-442.
  63. Pillans PI, Boyd IW. Toenails and agranulocytosis. Int Med J 2007; 37: 572-75.
  64. McEwen J, Boyd IW. National pharmacovigilance centres and AEFIs – practical experience from Australia (abstract). Drug Safety 2007; 30: 919-990.
  65. Lawrence G, Aratchige PE, Boyd I, McIntyre P, Isaacs D. Annual report on surveillance of adverse events following immunisation in Australia, 2006. Commun Dis Intell 2007; 31: 269-282.
  66. Boyd IW, McEwen J, Calcino LJ, Zhang JY, Walsh RL. Co-dispensing of contraindicated drugs with cisapride. J Pharm Pract Res 2008; 38: 23-27.
  67. Edwards B, Gounder M, McKoy J, Boyd I et al. Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. Lancet Oncology 2008; 9: 1166-1172.
  68. Boyd I. Mometasone and arrhythmia. WHO Pharm Newsletter 2012; 20-24.
  69. Boyd I, Friden S, Johansson J, Grabham A. Reports of arrhythmia in patients taking the non-systematic corticosteroid mometasone (abstract). Drug Safety 2012; 35: 896-897.
  70. Boyd I. Tapentadol and aggressive reaction. WHO Pharm Newsletter 2013; 4: 19-21.
  71. Boyd I. Tapentadol and delusion. WHO Pharm Newsletter 2013; 5: 23-25.
  72. Boyd I. Pazopanib and pericardial effusion. WHO Pharm Newsletter 2013; 6: 30-32.
  73. Boyd I. Parathyroid hormone and myocardial ischaemia. WHO Pharm Newsletter 2014; 1: 21-23.
  74. Boyd I. Vemurafenib and renal failure. WHO Pharm Newsletter 2014; 3: 23-27.
  75. Beckmann J, Hagemann U, Bahri P, Bate A, Boyd IW et al. Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Safe 2014; 37: 743-759.
    76.  
  76. Boyd I. Pamidronic acid and optic neuritis. WHO Pharm Newsletter 2014; 5: 18-20.
  77. Boyd I. Dronedarone and vision abnormal. WHO Pharm Newsletter 2014; 6: 28-32.
  78. Boyd I. Temsirolimus and cardiac infarction. WHO Pharm Newsletter 2015; 1: 29-33.
  79. Boyd I. Golimumab and migraine. WHO Pharm Newsletter 2015; 2: 27-30.
  80. Boyd I. Atomoxetine and dystonia in paediatric patients. WHO Pharm Newsletter 2015; 4: 20-23.
  81. Boyd I. Sartori D, Hult S. A signal based on spontaneous reports of atomoxetine and neutropenia in paediatric patients. Drug Safe 2015; 38: 990.
  82. Boyd I. Atomoxetine and neutropenia in paediatric patients. WHO Pharm Newsletter 2015; 6: 16-19.
  83. Boyd I. Deferasirox and pancreatitis in paediatric patients. WHO Pharm Newsletter 2015; 6: 20-23.
  84. Boyd I. Febuxostat and allergic vasculitis. WHO Pharm Newsletter 2016; 3: 23-27.
  85. Boyd I. Thiamazole and rhabdomyolysis. WHO Pharm Newsletter 2016; 4: 17-21.
  86. Boyd I. Denosumab and lichen planus. WHO Pharm Newsletter 2016; 6: 15-18.
  87. Boyd I. Denosumab and vasculitis. WHO Pharm Newsletter 2016; 6: 19-22.

Contact

Phone
+ 61 2 4455 4136
+ 61 438 667 822

Fax
+ 61 2 4455 4136

Email
ian@ianboydconsulting.com.au

Address
386 Croobyar Road
Croobyar NSW 2539
Australia