Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions

M.A. Aldeyab, S.C. Noble, M. Cuthbert, S. Maxwell, J. Dear, A. Boyter

    Research output: Contribution to journalArticle

    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.
    LanguageEnglish
    Pages209-218
    Number of pages10
    JournalDrugs and Therapy Perspectives
    Volume32
    Issue number5
    Early online date3 Feb 2016
    DOIs
    Publication statusPublished - May 2016

    Fingerprint

    Health Promotion
    Drug-Related Side Effects and Adverse Reactions
    Public Health
    Scotland
    General Practitioners
    Pharmacies
    Cost-Benefit Analysis
    Delivery of Health Care
    Research

    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

    Cite this

    Aldeyab, M.A. ; Noble, S.C. ; Cuthbert, M. ; Maxwell, S. ; Dear, J. ; Boyter, A. / Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions. In: Drugs and Therapy Perspectives. 2016 ; Vol. 32, No. 5. pp. 209-218.
    @article{6013da6871af49979721ae52e9e2e787,
    title = "Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions",
    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. {\circledC} 2016, Springer International Publishing Switzerland.",
    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",
    author = "M.A. Aldeyab and S.C. Noble and M. Cuthbert and S. Maxwell and J. Dear and A. Boyter",
    note = "Export Date: 15 September 2018 CODEN: DTHPE Correspondence Address: Aldeyab, M.A.; University of Strathclyde Institute of Pharmacy and Biomedical SciencesUnited Kingdom; email: Mamoon.Aldeyab@northerntrust.hscni.net 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; Rodr{\'i}guez-Mongui{\'o}, 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., S{\o}ndergaard, 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",
    year = "2016",
    month = "5",
    doi = "10.1007/s40267-016-0280-y",
    language = "English",
    volume = "32",
    pages = "209--218",
    journal = "Drugs and Therapy Perspectives",
    issn = "1172-0360",
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    }

    Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions. / Aldeyab, M.A.; Noble, S.C.; Cuthbert, M.; Maxwell, S.; Dear, J.; Boyter, A.

    In: Drugs and Therapy Perspectives, Vol. 32, No. 5, 05.2016, p. 209-218.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Assessment of the impact of the Scottish public health campaign on patient reporting of adverse drug reactions

    AU - Aldeyab, M.A.

    AU - Noble, S.C.

    AU - Cuthbert, M.

    AU - Maxwell, S.

    AU - Dear, J.

    AU - Boyter, A.

    N1 - Export Date: 15 September 2018 CODEN: DTHPE Correspondence Address: Aldeyab, M.A.; University of Strathclyde Institute of Pharmacy and Biomedical SciencesUnited Kingdom; email: Mamoon.Aldeyab@northerntrust.hscni.net 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

    PY - 2016/5

    Y1 - 2016/5

    N2 - 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.

    AB - 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.

    KW - adalimumab

    KW - amoxicillin

    KW - atomoxetine

    KW - candesartan

    KW - ciprofloxacin

    KW - clomipramine

    KW - cyclizine

    KW - desogestrel plus ethinylestradiol

    KW - dextromethorphan

    KW - diclofenac

    KW - drug

    KW - etanercept

    KW - etonogestrel

    KW - exendin 4

    KW - fluorescein

    KW - influenza vaccine

    KW - levonorgestrel

    KW - nitrofurantoin

    KW - omeprazole

    KW - paracetamol

    KW - pseudoephedrine

    KW - ramipril

    KW - rivaroxaban

    KW - sertraline

    KW - simvastatin

    KW - tramadol

    KW - unindexed drug

    KW - varenicline

    KW - venlafaxine

    KW - Wart virus vaccine

    KW - abdominal pain

    KW - adverse drug reaction

    KW - anxiety

    KW - arthralgia

    KW - Article

    KW - blister

    KW - breast tenderness

    KW - breathing disorder

    KW - depression

    KW - dizziness

    KW - dyspnea

    KW - epidemiology

    KW - erythema

    KW - fatigue

    KW - general practitioner

    KW - guilt

    KW - headache

    KW - health promotion

    KW - hearing impairment

    KW - human

    KW - indigestion

    KW - injection site swelling

    KW - insomnia

    KW - myalgia

    KW - nausea

    KW - pain

    KW - pharmacist

    KW - pruritus

    KW - public health campaign

    KW - rash

    KW - self report

    KW - side effect

    KW - swelling

    KW - tachycardia

    KW - thorax pain

    KW - time series analysis

    KW - United Kingdom

    KW - unspecified side effect

    KW - urticaria

    KW - vivid dream

    KW - voluntary reporting

    KW - vomiting

    KW - weakness

    KW - weight gain

    U2 - 10.1007/s40267-016-0280-y

    DO - 10.1007/s40267-016-0280-y

    M3 - Article

    VL - 32

    SP - 209

    EP - 218

    JO - Drugs and Therapy Perspectives

    T2 - Drugs and Therapy Perspectives

    JF - Drugs and Therapy Perspectives

    SN - 1172-0360

    IS - 5

    ER -