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Potential negative impact of informing patients about medication side effects: a systematic review

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Potential negative impact of informing patients about medication side effects: a systematic review. / Jose, Jimmy; AlHajri, Lamia.
In: International Journal of Clinical Pharmacy, Vol. 40, No. 4, 31.08.2018, p. 806-822.

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Jose J, AlHajri L. Potential negative impact of informing patients about medication side effects: a systematic review. International Journal of Clinical Pharmacy. 2018 Aug 31;40(4):806-822. Epub 2018 Aug 23. doi: 10.1007/s11096-018-0716-7

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Jose, Jimmy ; AlHajri, Lamia. / Potential negative impact of informing patients about medication side effects : a systematic review. In: International Journal of Clinical Pharmacy. 2018 ; Vol. 40, No. 4. pp. 806-822.

Bibtex

@article{b0ec3f1fdf4c4368b236b6cda16b9a44,
title = "Potential negative impact of informing patients about medication side effects: a systematic review",
abstract = "Background Pharmacovigilance, as it is carried out primarily by healthcare professionals is more focused on being very objective in nature. Acknowledging the importance of the subjective experience of patients in pharmacovigilance was underpinned by its unique ability to bring about a more holistic understanding through the deep information unraveled by the patients. Medication safety-related information has to be shared with patients to allow them to be actively involved in their therapy and pharmacovigilance. Despite the advantages of sharing information, it stands to reasons whether sharing information related to possible side effects would negatively affect patients and impinge upon their treatment plan and process. Aim of the Review The purpose of this systematic review was to critically assess the potential negative impact of informing patients about medication side effects by written and/or oral information on medication compliance, occurrence/development of suspected side effects and clinical outcomes. Method A comprehensive search was conducted in PubMed, and Cochrane library to identify potential records between the year 1975 and 2017; then titles, abstracts, and full texts were screened using the inclusion criteria to filter out irrelevant studies. The data extraction, and the results were narratively synthesized and presented in tables. Results A total of 2012 articles were screened for inclusion, 32 full-text articles were assessed for eligibility and finally resulting in the inclusion of 17 randomized control studies which met the set criteria. Findings unraveled that the educational intervention did not result in increased occurrence/reporting of side effects in most of the evaluated studies; except 4 studies, and no significant impact on compliance to medications and negative clinical outcome was observed. Apprehension of negative events to medications were observed in two of the four studies which evaluated these parameters. Conclusion The present review did not find enough evidence to support the over concerns on the potential negative impact of sharing of information on the adverse effects to patients, though the influence could manifest as nocebo-effect. The various components and methods employed for this information sharing process can influence the potential impact of this activity. These concerns about the undesirable effects should not deter the active involvement of patients in pharmacovigilance activities. There is a definite need to have more studies in this area, where much of concern still does exist among the various stakeholders of drug safety information. {\textcopyright} 2018, Springer Nature Switzerland AG.",
keywords = "Adverse drug reactions, Drug safety information, Nocebo effect, Patient education, Pharmacovigilance, Side effects, antibiotic agent, benzodiazepine, beta adrenergic receptor blocking agent, cotrimoxazole, dipeptidyl carboxypeptidase inhibitor, diuretic agent, erythromycin, neuroleptic agent, nonsteroid antiinflammatory agent, penicillin derivative, theophylline, anxiety, clinical outcome, diarrhea, drug effect, drug safety, drug surveillance program, drug use, drug withdrawal, human, insomnia, medication compliance, nocebo effect, patient attitude, patient compliance, patient education, patient information, priority journal, randomized controlled trial (topic), rash, Review, self report, systematic review, unspecified side effect, vivid dream",
author = "Jimmy Jose and Lamia AlHajri",
year = "2018",
month = aug,
day = "31",
doi = "10.1007/s11096-018-0716-7",
language = "English",
volume = "40",
pages = "806--822",
journal = "International Journal of Clinical Pharmacy",
issn = "2210-7703",
publisher = "Springer Netherlands",
number = "4",

}

RIS

TY - JOUR

T1 - Potential negative impact of informing patients about medication side effects

T2 - a systematic review

AU - Jose, Jimmy

AU - AlHajri, Lamia

PY - 2018/8/31

Y1 - 2018/8/31

N2 - Background Pharmacovigilance, as it is carried out primarily by healthcare professionals is more focused on being very objective in nature. Acknowledging the importance of the subjective experience of patients in pharmacovigilance was underpinned by its unique ability to bring about a more holistic understanding through the deep information unraveled by the patients. Medication safety-related information has to be shared with patients to allow them to be actively involved in their therapy and pharmacovigilance. Despite the advantages of sharing information, it stands to reasons whether sharing information related to possible side effects would negatively affect patients and impinge upon their treatment plan and process. Aim of the Review The purpose of this systematic review was to critically assess the potential negative impact of informing patients about medication side effects by written and/or oral information on medication compliance, occurrence/development of suspected side effects and clinical outcomes. Method A comprehensive search was conducted in PubMed, and Cochrane library to identify potential records between the year 1975 and 2017; then titles, abstracts, and full texts were screened using the inclusion criteria to filter out irrelevant studies. The data extraction, and the results were narratively synthesized and presented in tables. Results A total of 2012 articles were screened for inclusion, 32 full-text articles were assessed for eligibility and finally resulting in the inclusion of 17 randomized control studies which met the set criteria. Findings unraveled that the educational intervention did not result in increased occurrence/reporting of side effects in most of the evaluated studies; except 4 studies, and no significant impact on compliance to medications and negative clinical outcome was observed. Apprehension of negative events to medications were observed in two of the four studies which evaluated these parameters. Conclusion The present review did not find enough evidence to support the over concerns on the potential negative impact of sharing of information on the adverse effects to patients, though the influence could manifest as nocebo-effect. The various components and methods employed for this information sharing process can influence the potential impact of this activity. These concerns about the undesirable effects should not deter the active involvement of patients in pharmacovigilance activities. There is a definite need to have more studies in this area, where much of concern still does exist among the various stakeholders of drug safety information. © 2018, Springer Nature Switzerland AG.

AB - Background Pharmacovigilance, as it is carried out primarily by healthcare professionals is more focused on being very objective in nature. Acknowledging the importance of the subjective experience of patients in pharmacovigilance was underpinned by its unique ability to bring about a more holistic understanding through the deep information unraveled by the patients. Medication safety-related information has to be shared with patients to allow them to be actively involved in their therapy and pharmacovigilance. Despite the advantages of sharing information, it stands to reasons whether sharing information related to possible side effects would negatively affect patients and impinge upon their treatment plan and process. Aim of the Review The purpose of this systematic review was to critically assess the potential negative impact of informing patients about medication side effects by written and/or oral information on medication compliance, occurrence/development of suspected side effects and clinical outcomes. Method A comprehensive search was conducted in PubMed, and Cochrane library to identify potential records between the year 1975 and 2017; then titles, abstracts, and full texts were screened using the inclusion criteria to filter out irrelevant studies. The data extraction, and the results were narratively synthesized and presented in tables. Results A total of 2012 articles were screened for inclusion, 32 full-text articles were assessed for eligibility and finally resulting in the inclusion of 17 randomized control studies which met the set criteria. Findings unraveled that the educational intervention did not result in increased occurrence/reporting of side effects in most of the evaluated studies; except 4 studies, and no significant impact on compliance to medications and negative clinical outcome was observed. Apprehension of negative events to medications were observed in two of the four studies which evaluated these parameters. Conclusion The present review did not find enough evidence to support the over concerns on the potential negative impact of sharing of information on the adverse effects to patients, though the influence could manifest as nocebo-effect. The various components and methods employed for this information sharing process can influence the potential impact of this activity. These concerns about the undesirable effects should not deter the active involvement of patients in pharmacovigilance activities. There is a definite need to have more studies in this area, where much of concern still does exist among the various stakeholders of drug safety information. © 2018, Springer Nature Switzerland AG.

KW - Adverse drug reactions

KW - Drug safety information

KW - Nocebo effect

KW - Patient education

KW - Pharmacovigilance

KW - Side effects

KW - antibiotic agent

KW - benzodiazepine

KW - beta adrenergic receptor blocking agent

KW - cotrimoxazole

KW - dipeptidyl carboxypeptidase inhibitor

KW - diuretic agent

KW - erythromycin

KW - neuroleptic agent

KW - nonsteroid antiinflammatory agent

KW - penicillin derivative

KW - theophylline

KW - anxiety

KW - clinical outcome

KW - diarrhea

KW - drug effect

KW - drug safety

KW - drug surveillance program

KW - drug use

KW - drug withdrawal

KW - human

KW - insomnia

KW - medication compliance

KW - nocebo effect

KW - patient attitude

KW - patient compliance

KW - patient education

KW - patient information

KW - priority journal

KW - randomized controlled trial (topic)

KW - rash

KW - Review

KW - self report

KW - systematic review

KW - unspecified side effect

KW - vivid dream

U2 - 10.1007/s11096-018-0716-7

DO - 10.1007/s11096-018-0716-7

M3 - Journal article

VL - 40

SP - 806

EP - 822

JO - International Journal of Clinical Pharmacy

JF - International Journal of Clinical Pharmacy

SN - 2210-7703

IS - 4

ER -