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

doi:10.1007/s40267-016-0280-y

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

Biomedical Sciences Research

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

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	https://doi.org/10.1007/s40267-016-0280-y
Publication status	Published (in print/issue) - May 2016

Bibliographical note

Export Date: 15 September 2018

CODEN: 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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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

Access to Document

10.1007/s40267-016-0280-y

Cite this

@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{\textquoteright} 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. {\textcopyright} 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: [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; 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{\textquoteright}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{\textquoteright}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 {\textquoteleft}Yellow Card Scheme{\textquoteright}: 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{\textquoteright} and healthcare professionals{\textquoteright} 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{\textquoteright}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{\textquoteright}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 = may,

doi = "10.1007/s40267-016-0280-y",

language = "English",

volume = "32",

pages = "209--218",

journal = "Drugs and Therapy Perspectives",

issn = "1172-0360",

publisher = "Adis",

number = "5",

}

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: [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

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

SN - 1172-0360

VL - 32

SP - 209

EP - 218

JO - Drugs and Therapy Perspectives

JF - Drugs and Therapy Perspectives

IS - 5

ER -

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

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