Abstract
Objective: The aim was to assess patterns in reporting of adverse drug reactions (ADRs) via the Yellow Card (YC) Scheme following a Scottish community pharmacy patient YC promotional campaign (January–February 2011). Methods: YC data were obtained from the Medicines and Healthcare Products Regulatory Agency (MHRA) [January 2009–February 2012]. The impact of the campaign on YC reporting rates was assessed by comparing YC submission rates before and after the intervention, using the segmented regression of interrupted time-series analysis. Results: The mean weekly reported ADRs [excluding general practitioner (GP) reports] before, during, and after the campaign were 0.029, 0.019, and 0.023 (per 10,000 inhabitants), respectively. In relation to patients’ YC reporting, the mean weekly patient-reported ADRs before, during, and after the campaign in Scotland were 0.005, 0.002, and 0.004 (per 10,000 inhabitants), respectively. The time-series analysis for monthly reported ADRs in Scotland (excluding GP reports) demonstrated no statistically significant level change (p = 0.706) and no significant trend change (p = 0.509) post-campaign. Similarly, there was no statistically significant level change (p = 0.983) and no significant trend change (p = 0.591) in patient YC reporting. Conclusions: The campaign had no statistically significant impact on influencing the reporting of ADRs. This study adds to a growing body of required information in this area, and suggests improvements if future patient ADR-reporting promotional campaigns are to be considered; the cost-effectiveness of such efforts requires further research. It is recommended that any similar future campaigns should include qualitative attitudinal data collection and evaluation to help further explore this more robustly. © 2016, Springer International Publishing Switzerland.
Original language | English |
---|---|
Pages (from-to) | 209-218 |
Number of pages | 10 |
Journal | Drugs and Therapy Perspectives |
Volume | 32 |
Issue number | 5 |
Early online date | 3 Feb 2016 |
DOIs | |
Publication status | Published (in print/issue) - May 2016 |
Bibliographical note
Export Date: 15 September 2018CODEN: DTHPE
Correspondence Address: Aldeyab, M.A.; University of Strathclyde Institute of Pharmacy and Biomedical SciencesUnited Kingdom; email: [email protected]
Chemicals/CAS: adalimumab, 331731-18-1; amoxicillin, 26787-78-0, 34642-77-8, 61336-70-7; atomoxetine, 82248-59-7, 82857-39-4, 82857-40-7, 83015-26-3; candesartan, 139481-59-7; ciprofloxacin, 85721-33-1; clomipramine, 17321-77-6, 303-49-1; cyclizine, 303-25-3, 5897-18-7, 82-92-8; desogestrel plus ethinylestradiol, 71138-35-7, 97445-53-9; dextromethorphan, 125-69-9, 125-71-3; diclofenac, 15307-79-6, 15307-86-5; etanercept, 185243-69-0, 200013-86-1; etonogestrel, 54048-10-1; exendin 4, 141732-76-5, 141758-74-9; fluorescein, 2321-07-5, 91316-42-6; levonorgestrel, 797-63-7; nitrofurantoin, 54-87-5, 67-20-9; omeprazole, 73590-58-6, 95510-70-6; paracetamol, 103-90-2; pseudoephedrine, 345-78-8, 7460-12-0, 90-82-4; ramipril, 87333-19-5; rivaroxaban, 366789-02-8; sertraline, 79617-96-2; simvastatin, 79902-63-9; tramadol, 27203-92-5, 36282-47-0; varenicline, 249296-44-4, 375815-87-5; venlafaxine, 93413-69-5, 99300-78-4
References: Classen, D.C., Pestotnik, S.L., Evans, R.S., Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality (1997) JAMA, 277 (4), pp. 301-306. , COI: 1:STN:280:DyaK2s7lsF2rug%3D%3D, PID: 9002492; Rodríguez-Monguió, R., Otero, M.J., Rovira, J., Assessing the economic impact of adverse drug effects (2003) Pharmacoeconomics, 21 (9), pp. 623-650. , PID: 12807365; Kongkaew, C., Noyce, P.R., Ashcroft, D.M., Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies (2008) Ann Pharmacother, 42 (7), pp. 1017-1025. , PID: 18594048; Pirmohamed, M., James, S., Meakin, S., Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients (2004) BMJ, 329 (7456), pp. 15-19. , PID: 15231615; Davies, E.C., Green, C.F., Mottram, D.R., Emergency re-admissions to hospital due to adverse drug reactions within 1 year of the index admission (2010) Br J Clin Pharmacol, 70 (5), pp. 749-755. , PID: 21039769; Winterstein, A.G., Hatton, R.C., Gonzalez-Rothi, R., Identifying clinically significant preventable adverse drug events through a hospital’s database of adverse drug reaction reports (2002) Am J Health Syst Pharm, 59 (18), pp. 1742-1749; Thomsen, L.A., Winterstein, A.G., Søndergaard, B., Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care (2007) Ann Pharmacother, 41 (9), pp. 1411-1426. , PID: 17666582; Heeley, E., Riley, J., Layton, D., Prescription-event monitoring and reporting of adverse drug reactions (2001) Lancet, 358 (9296), pp. 1872-1873. , COI: 1:STN:280:DC%2BD3MjgtVClsQ%3D%3D, PID: 11741629; Martin, R.M., Kapoor, K.V., Wilton, L.V., Underreporting of suspected adverse drug reactions to newly marketed (“black triangle”) drugs in general practice: observational study (1998) BMJ, 317 (7151), pp. 119-120. , COI: 1:STN:280:DyaK1czit1WqsQ%3D%3D, PID: 9657787; Hazell, L., Shakir, S.A., Under-reporting of adverse drug reactions: a systematic review (2006) Drug Saf, 29 (5), pp. 385-396. , PID: 16689555; Hazell, L., Cornelius, V., Hannaford, P., How do patients contribute to signal detection? A retrospective analysis of spontaneous reporting of adverse drug reactions in the UK’s Yellow Card Scheme (2013) Drug Saf, 36 (3), pp. 199-206. , PID: 23444232; Avery, A.J., Anderson, C., Bond, C.M., Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys (2011) Health Technol Assess, 15 (20), pp. 1-234. , COI: 1:STN:280:DC%2BC3MvovVChtQ%3D%3D, PID: 21545758; http://www.yccscotland.scot.nhs.uk/publications/Pages/Journal-Articles-regarding-Adverse-Drug-Reactions.aspx, Kitto L. Patient reporting of adverse drug reactions: a quantitative study. 2009. Accessed 27 Dec 2014; Fortnum, H., Lee, A.J., Rupnik, B., Survey to assess public awareness of patient reporting of adverse drug reactions in Great Britain (2012) J Clin Pharm Ther, 37 (2), pp. 161-165. , COI: 1:STN:280:DC%2BC38rjs1KmsA%3D%3D, PID: 21592158; http://www.yccscotland.scot.nhs.uk/training/Pages/Posters.aspx, Yellow Card Centre Scotland. Training posters. Accessed 6 July 2014; https://yellowcard.mhra.gov.uk/_assets/files/Member-of-Public-Information-Card.pdf, MHRA-Yellow Card. Patient information cards 2010. Accessed 6 July 2014; http://naturaldatabase.therapeuticresearch.com/home.aspx?cs=&s=ND&AspxAutoDetectCookieSupport=1, Natural Medicines Comprehensive Database. Accessed 6 July 2014; http://www.mhra.gov.uk/home/groups/plp/documents/websiteresources/con408250.pdf, MHRA. Trends in UK spontaneous Adverse Drug Reaction (ADR) reporting between 2008–2012. Accessed 10 Aug 2014; Wagner, A.K., Soumerai, S.B., Zhang, F., Segmented regression analysis of interrupted time series studies in medication use research (2002) J Clin Pharm Ther, 27 (4), pp. 299-309. , COI: 1:STN:280:DC%2BD38vhvFOnuw%3D%3D, PID: 12174032; Planas, L.G., Kimberlin, C.L., Segal, R., A pharmacist model of perceived responsibility for drug therapy outcomes (2005) Soc Sci Med, 60 (10), pp. 2393-2403. , PID: 15748686; Van Hunsel, F., Passier, A., van Grootheest, K., Comparing patients’ and healthcare professionals’ ADR reports after media attention: the broadcast of a Dutch television programme about the benefits and risks of statins as an example (2009) Br J Clin Pharmacol, 67 (5), pp. 558-564. , PID: 19552751; Martin, R.M., May, M., Gunnell, D., Did intense adverse media publicity impact on prescribing of paroxetine and the notification of suspected adverse drug reactions? Analysis of routine databases, 2001–2004 (2006) Br J Clin Pharmacol, 61 (2), pp. 224-228. , PID: 16433877; Leone, R., Moretti, U., D’Incau, P., Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study (2013) Drug Saf., 36 (4), pp. 267-276. , PID: 23475583; http://www.metoffice.gov.uk/climate/uk/2011/january.html, The Met Office is the UK’s National Weather Service, 2011. Accessed 4 Aug 2014; http://www.bbc.co.uk/news/uk-scotland-12141718, . Accessed 4 Aug 2014; Gedde-Dahl, A., Harg, P., Stenberg-Nilsen, H., Characteristics and quality of adverse drug reaction reports by pharmacists in Norway (2007) Pharmacoepidemiol Drug Saf, 16 (9), pp. 999-1005. , PID: 17457794; van Grootheest, A.C., de Jong-van den Berg, L.T., The role of hospital and community pharmacists in pharmacovigilance (2005) Res Social Adm Pharm., 1 (1), pp. 126-133. , PID: 17138470; Inch, J., Watson, M.C., Anakwe-Umeh, S., Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review (2012) Drug Saf., 35 (10), pp. 807-818. , PID: 22928729; Lasser, K.E., Boyd, J.W., Varenicline and smokers with mental illnesses (2008) Lancet, 372 (9645), pp. 1218-1219. , PID: 19094948; Purvis, T.L., Nelson, L.A., Mambourg, S.E., Varenicline use in patients with mental illness: an update of the evidence (2010) Expert Opin Drug Saf, 9 (3), pp. 471-482. , COI: 1:CAS:528:DC%2BC3cXltFWjs74%3D, PID: 20166836; http://www.nes.scot.nhs.uk/education-and-training/by-discipline/pharmacy/about-nes-pharmacy/educational-resources/resources-by-topic/clinical-governance/patient-safety-adverse-drug-reactions.aspx, Education for Scotland. Educational resources—patient safety: adverse drug reactions. Modules 1–6;. Accessed 10 Aug 2014UR - https://www.scopus.com/inward/record.uri?eid=2-s2.0-84963821013&doi=10.1007%2fs40267-016-0280-y&partnerID=40&md5=320ff32f5a5c2cd210f480af4e71913c
Keywords
- adalimumab
- amoxicillin
- atomoxetine
- candesartan
- ciprofloxacin
- clomipramine
- cyclizine
- desogestrel plus ethinylestradiol
- dextromethorphan
- diclofenac
- drug
- etanercept
- etonogestrel
- exendin 4
- fluorescein
- influenza vaccine
- levonorgestrel
- nitrofurantoin
- omeprazole
- paracetamol
- pseudoephedrine
- ramipril
- rivaroxaban
- sertraline
- simvastatin
- tramadol
- unindexed drug
- varenicline
- venlafaxine
- Wart virus vaccine
- abdominal pain
- adverse drug reaction
- anxiety
- arthralgia
- Article
- blister
- breast tenderness
- breathing disorder
- depression
- dizziness
- dyspnea
- epidemiology
- erythema
- fatigue
- general practitioner
- guilt
- headache
- health promotion
- hearing impairment
- human
- indigestion
- injection site swelling
- insomnia
- myalgia
- nausea
- pain
- pharmacist
- pruritus
- public health campaign
- rash
- self report
- side effect
- swelling
- tachycardia
- thorax pain
- time series analysis
- United Kingdom
- unspecified side effect
- urticaria
- vivid dream
- voluntary reporting
- vomiting
- weakness
- weight gain