Using primary care prescribing databases for pharmacovigilance

British Journal of Clinical Pharmacology

Volumn 71, Issue 2, 2011, Pages 244-249

  Naina Mohamed, Isa ^a   Helms, Peter J ^a   Simpson, Colin R ^a   Milne, Robert M ^a   McLay, James S ^a  

^a UNIVERSITY OF ABERDEEN   (United Kingdom)

Author keywords

Adverse drug event; Adverse drug reaction; Health database; Pharmacovigilance; Practice team information (PTI) database

Indexed keywords

AMLODIPINE;

AGED; ANKLE EDEMA; ARTICLE; BACKACHE; DATA BASE; DERMATITIS; DIARRHEA; DIZZINESS; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; ELECTRONIC PRESCRIBING; FATIGUE; FEMALE; FLUSHING; HEADACHE; HUMAN; INDIGESTION; LEG CRAMP; LEG PAIN; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; MYALGIA; NAUSEA; PERIPHERAL EDEMA; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; PRURITUS; RASH; SIDE EFFECT; SWEATING; VIVID DREAM; XEROSTOMIA;

ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AMLODIPINE; ANTIHYPERTENSIVE AGENTS; DATABASES, FACTUAL; DRUG PRESCRIPTIONS; FAMILY PRACTICE; FEMALE; HUMANS; MALE; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; MIDDLE AGED; PRIMARY HEALTH CARE; SCOTLAND;

EID: 78650974134     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2010.03816.x     Document Type: Article

References (32)

1. World Health Organization. Safety monitoring of medicinal products. Guidelines for setting up and running a Pharmacovigilance Centre. Uppsala Monitoring Centre, 2000. Available at (last accessed 20 February 2010).
2. Uppsala Monitoring Centre. Glossary of terms used in Pharmacovigilance. Available at (last accessed 28 June 2010).
3. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis and management. Lancet 2000; 356: 1255-9.
4. World Health Organization. Safety of medicines - a guide to detecting and reporting adverse drug reactions. WHO/EDM/QSM/2002.2.
5. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K, Park BK, Breckenridge AM. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. Br Med J 2004; 329: 15-9.
6. Medicines and Healthcare products Regulatory Agency. Available at (last accessed 28 June 2010).
7. Rawlins MD. Spontaneous reporting of adverse drug reactions. I: the data. Br J Clin Pharmacol 1988; 1: 1-5.
8. Lumley CE, Walker SR, Hall GC, Staunton N, Grob PR. The under-reporting of adverse drug reactions seen in general practice. Pharm Med 1986; 1: 205-12.
9. Martin RM, Kapoor KV, Wilton LV, Mann RD. Underreporting of suspected adverse drug reactions to newly marketed ('black triangle') drugs in general practice: observational study. Br Med J 1998; 317: 119-20.
10. Bourgault C, Senecal M, Brisson M, Marentette MA, Gregoire JP. Persistence and discontinuation patterns of antihypertensive therapy among newly treated patients: a population-based study. J Hum Hypertens 2005; 19: 607-13.
11. Burke TA, Sturkenboom MC, Lu S, Wenworth CE, Lin Y, Rhoads GG. Discontinuation of antihypertensive drugs among newly diagnosed hypertensive patients in UK general practice. J Hypertens 2006; 24: 1193-200.
12. Gregoire JP, Moisan J, Guibert R, Ciampi A, Milot A, Gaudet M, Cote I. Determinants of discontinuation of new courses of antihypertensive medications. J Clin Epidemiol 2002; 55: 728-35.
13. Bloom BS. Continuation of initial antihypertensive medication after 1 year of therapy. Clin Ther 1998; 20: 671-81.
14. Jones JK, Gorkin L, Lian JF, Staffa JA, Fletcher AP. Discontinuation of and changes in treatment after start of new courses of antihypertensive drugs: a study of a United Kingdom population. Br Med J 1995; 311: 293-5.
15. Veronesi M, Cicero AFG, Prandin MG, Dormi A, Cosentino E, Strocchi E, Borghi C. A prospective evaluation of persistence on antihypertensive treatment with different antihypertensive drugs in clinical practice. Vasc Health Risk Manag 2007; 3: 999-1005.
16. Caro JJ, Speckman JL, Salas M, Raggio G, Joseph JD. Effect of initial drug choice on persistence with antihypertensive therapy: the importance of actual practice data. Can Med Assoc J 1999; 160: 41-6.
17. Esposti LD, Esposti ED, Valpiani G, Martino MD, Saragoni S, Buda S, Baio G, Capone A, Sturani A. A retrospective, population-based analysis of persistence with antihypertensive drug therapy in primary care practice in Italy. Clin Ther 2002; 24: 1347-57.
18. Naina Mohamed I, Helms PJ, Simpson CR, McLay JS. Using routinely collected prescribing data to determine drug persistence for the purpose of pharmacovigilance. J Clin Pharmacol; (published online ahead of print 16 April 2010) doi:10.1177/0091270010366444.
19. Information Services Division Scotland. Information Services Division website. Available at (last accessed 28 June 2010).
20. Stuart-Buttle CDG, Read JD, Sanderson HF, Sutton YM. A language of health in action: read codes, classifications and groupings. AMIA Annu Symp Proc 1996; 75-9.
21. Wainwright D, Waring T. The information management and technology strategy of the UK National Health Service. IJPSM 2000; 13: 241-59.
22. Primary care clinical informatics unit (PCCIU). Available at (last accessed 28 June 2009).
23. Ruilope LM, Malacco E, Khder Y, Khandra A, Bonner G, Heintz D. Efficacy and tolerability of combination therapy with valsartan plus hydrochlorothiazide compared with amlodipine monotherapy in hypertensive patients with other cardiovascular risk factors: the VAST study. Clin Ther 2005; 27: 578-87.
24. Imbs JL, Nisse-Durgeat S. Efficacy and tolerability of candesartan cilexetil vs. amlodipine assessed by home blood pressure in hypertensive patients. Int J Clin Pract 2005; 59: 78-84.
25. Fogari R, Mugellini A, Derosa G. Efficacy and tolerability of candersatan cilexetil/hydrochlorothiazide and amlodipine in patients with poorly controlled mild-to-moderate essential hypertension. JRAAS 2007; 8: 139-44.
26. Osterloh I. The safety of amlodipine. Am Heart J 1989; 118: 114-1119.
27. Zidek W, Spiecker C, Knaup G, Breuer HWM. Comparison of the efficacy and safety of nifedipine coat-core versus amlodipine in the treatment of patients with mild-to-moderate essential hypertension. Clin Ther 1995; 17: 686-700.
28. General Practice Research Database website. Available at (last accessed 28 June 2010).
29. Milne RM, Taylor MW, Taylor RJ. Audit of populations in general practice: the creation of a national resource for the study of morbidity in Scottish general practice. J Epidemiol Community Health 1998; 52: (1 Suppl.): 20S-4S.
30. Scotland National Health Service. Scottish Programme for Improving Clinical Effectiveness in Primary Care (SPICE). Available at (last accessed 28 June 2010).
31. Pirmohamed M, Park BK. Adverse drug reactions: back to the future. Br J Clin Pharmacol 2003; 55: 486-92.
32. World Health Organization. Safety of medicines - a guide to detecting and reporting adverse drug reactions. Why health professionals need to take action. World Health Organization, 2002. Available at (last accessed 1 April 2010).