|Year : 2017 | Volume
| Issue : 2 | Page : 71-76
Factors associated with underreporting of adverse drug reactions by nurses: A narrative literature review
Nafis Haider, Faizan Mazhar
Department of Basic Medical Sciences, Prince Sultan Military College of Health Sciences, King Fahd Military Medical Complex, Dhahran, Saudi Arabia
|Date of Web Publication||15-Sep-2017|
Prince Sultan Military College of Health Sciences, Dhahran
Source of Support: None, Conflict of Interest: None
Spontaneous reporting of adverse drug reactions (ADRs) by health-care professionals is the basic method for the identification and prevention new and serious ADRs of marketed drugs. The contribution of nurses in this task can improve patient safety and reduce the extra financial burden associated with it. Although a total of 11% of ADRs in National Pharmacovigilance and Drug Safety Center were reported by nurses. The objectives of this review were to identify the possible factors that lead to underreporting of ADRs by nurses and define strategies that increase the reporting. This review has revealed various factors that influence the underreporting of ADRs and strategies to encourage reporting by nurses. Most of the identified factors are potentially modifiable. To overcome the underreporting of ADRs by nurses' main interventions should be based on education, motivation, and determination.
Keywords: Adverse drug reactions, nursing, pharmacovigilance, reporting
|How to cite this article:|
Haider N, Mazhar F. Factors associated with underreporting of adverse drug reactions by nurses: A narrative literature review. Saudi J Health Sci 2017;6:71-6
|How to cite this URL:|
Haider N, Mazhar F. Factors associated with underreporting of adverse drug reactions by nurses: A narrative literature review. Saudi J Health Sci [serial online] 2017 [cited 2017 Oct 19];6:71-6. Available from: http://www.saudijhealthsci.org/text.asp?2017/6/2/71/214848
| Introduction|| |
The administration of medications is one of the most common routine procedures in the practice of nursing professionals. In this, the nurse assumes the important responsibility that aims to ensure patient safety through the safe and accurate administration of prescribed medication.
Detection of adverse drug reactions (ADRs) is among the various responsibilities of nurses with respect to medication, which is defined as “any harmful or unintended response to a medicinal product.” ADRs are a major clinical problem with huge health and socioeconomic significance., It is estimated that in Germany in the year 2011, the costs associated with ADRs accounted for an increase in the average annual expenditure of 2250 euros per patient. The same study reports that the increase in spontaneous reporting of ADRs could save around 87 million euros per year in health-care expenditure.
ADRs communication and reporting are part of the pharmacovigilance process which is defined as a public health activity aimed at the identification, quantification, evaluation, and prevention of risks associated with the use of marketed drugs. This is done through the Saudi Food and Drug Authority (SFDA) pharmacovigilance system which ensure that all information relevant to the risk benefit of a medicinal product is reported to the SFDA fully and promptly in accordance with the legislation. The reporting made by health-care professional go through a long evaluation process.
The ultimate objective of pharmacovigilance program is to detect new risks associated with the use of drugs through the assessment of reported ADRs, evaluate the risk-benefit ratio of medicines and if it is unfavorable take regulatory measures accordingly to prevent or mitigate this risk.
In Saudi Arabia, according to the SFDA guideline on good pharmacovigilance practices  and the policy on medication safety, ministry of health, Saudi Arabia (Medication Safety Policy no. MOH/MSPP/0006/01), it is stated that all health professionals, including nurses, have an obligation to report suspected ADRs detected while practicing their profession. This should be done using the specified form “form no. ADR-1” available on the SFDA website or pharmacovigilance center of each region  and on the website of the Ministry of Health.
Spontaneous reporting of ADRs by health-care personnel is currently considered as one of the basic methods for the prevention and detection of new and serious adverse reactions to marketed drugs. According to literature, the participation of nurses in reporting of ADRs improves patient safety and consequently reduces the health-care costs associated with ADRs. Abdel-Latif and Abdel-Wahab, found that among health-care professionals, nurses had the least knowledge and awareness of pharmacovigilance and ADRs reporting. According to the National Pharmacovigilance and Drug Safety Center, SFDA-Drug Sector, only 11% of ADR were reported by nurses.
The aim of this review is to identify the factors that affect reporting of ADRs by nurses and strategies that encourage reporting.
| Materials and Methods|| |
A literature search was conducted to find the available evidence regarding reporting of ADRs by nurses. The consulted databases were MEDLINE using PubMed and CINAHL. The publication period was established from the year 2000 to 2015. Articles published in English in peer-reviewed journals from any country were included provided that they fulfilled a set of predetermined criteria.
The medical subject heading terms searched in the databases were ADRs, reporting, and nursing. These were combined by using the Boolean operator “AND” between them.
Following were the selection criteria:
- Inclusion criteria: ADRs reported by nurses in hospitalized patients of any age. The review focused on the hospital setting due to the administration of a large number of treatments of greater complexity by nurses
- Exclusion criteria: Primary care, outpatient or home health care, and clinical trials. Although there is a high prevalence of ADRs in clinical trials, the reporting is not only done by the nurses but also the principal investigator of the study, therefore, they were excluded.
| Results|| |
A total of 112 articles were identified, 57 in PubMed, CINAHL 55. After reading abstracts, 34 were met the selection criteria.
In addition, two more articles were selected by the snowballing process.
Following are the results about the factors that influence the reporting of ADRs and strategies that promote their reporting.
Factors that influence reporting of adverse drug reactions by nurses
According to the identified literature, there is a large number of factors that influence the process of ADRs reporting by nursing professionals which likely leads to a frail situation of underreporting. These factors can be gathered into two categories which include the attitude of a person who reports and personal and professional factors.
The influence of the attitudes of the individual who has the responsibility to report is classified and described in detail by the theory of Inman.,, This commonly known as “Inman's criteria of seven deadly sins of the potential reporter” first published in 1976, amended in 1986 and in 1996, it was protracted. It is a list of attitudes that lead to failure to report a recognized ADR.
The first is complacency because the health professional believes that serious ADRs are well documented and only safe drugs are allowed onto the market, followed by the fear of litigation or investigations against the person who reports and guilt at having administered treatment that may have harmed a patient. Health professionals own ambition for the publication of personal case report or case series. The attitude which is reported by many authors is ignorance,,,,, that is, ignorance of the process and the requirements for reporting. Another attitude is distrust about reporting merely suspicious. Finally, the indifference of the nurse to his/her role as a clinical investigator thinking that a single case will not have relevance in the evaluation of a drug safety.
In further developments of Inman's theory, other attitudes were included: lethargy and insecurity. Lethargy is a blend of habits acquired by habit and lack of interest or time or other excuses. Insecurity refers to a difficulty to determine whether or not a drug is responsible for a particular adverse event. This latter attitude was not proposed by Inman but is included in subsequent studies.
Personal and professional factors
Reported data suggest that there is a clear underreporting by nurses.,, The presence of personal factors such as age and acquired knowledge, as well as professional factors (overwork and external motivation by the institution), influence the reporting of ADRs., On the other hand, there is a belief by the nursing staff, that they do not possess sufficient knowledge of pharmacology to identify the signs and symptoms of an ADRs, delegating this function to doctors or pharmacists.,,, This leads to making them feel that they are not well-enough trained to report ADRs.
Some authors suggest that the ADRs reported by nurses are less comprehensive than those reported by other professionals such as doctors., It has also been demonstrated that reports from the nurses were better documented but nurses reported less severe reactions compared to physicians. As shown in different studies that nurses tend to put more emphasis on application site, skin, and neurological reactions than physicians, this is because of the unique relationship between nurses and patients. Thereby, working together would not only improve the communicative relationship between doctors, pharmacists, and nurses but would also give the patients a holistic care focused on their health and wellness, reducing their hospital stay, and avoiding health-care costs added to these situations.
This difference in the severity of ADRs reported by nurses has also been observed in studies in Britain and in the Netherlands. Nonetheless, nurses are equally qualified to report untoward drug effects.,, The latter was validated by a study conducted in Sweden  in which after a short education program about ADRs in a hospital, nurses were able to report serious ADRs, additionally, the characteristics of ADRs reports from nurses were similar to those of reported by physicians. Although reporting of ADRs is a necessary responsibility of both professionals, nurses feel that they are breaching the scope of responsibility and competencies of physicians;,,, this is one of the factors to take into account to assess the reason for the low rate of reporting by nurses.
Another factor is a heavy nursing workload throughout their working hours., This leads to lack of time for reporting that contribute to the low habit of reporting.
Lack of staff motivation by the institution would be a factor. If the motivation is persistent, it produces a positive effect on staff and increases the rate of reporting. It has been shown that when motivation stopped the reporting rate dropped to the previous level.,,
Another influential element is the obligation to report all and each of the identified ADRs to the pharmacovigilance system. It has been observed that nurses are not equally aware of the reporting of expected or unexpected ADRs  and there is an increased report of serious, unknown ADRs, and those related to recently marketed drugs.
Professional experience plays an important role in reporting of ADR. Nurses with more professional experience consider that the reporting of already known adverse reactions is not necessary, favors the reporting of serious and uncommon ADRs. On the other hand, novice nurses have higher reporting rate without distinguishing the level of severity of ADRs.
It can be stated that the lack of feedback may discourage nurses from reporting. Issuance of a response from pharmacovigilance centers would help professional to understand the reporting process and important information required for reporting which can increase the rate and the quality of reporting.,
Strategies that favor increased reporting of adverse drug reactions
The consulted literature highlights various strategies that can promote the reporting of ADR by nurses, also indicate that many of the causes of the low rate of ADRs reporting are modifiable. This enables both the hospitals and the health professional to implement measures to resolve the underreporting problem. The strategies described can be classified into education information, motivation, and facilitating tools.
Continuous education is the method by which health-care professionals can develop certain skills and knowledge during their clinical practice. A study shows that  increased knowledge of pharmacovigilance, favor the recognition of various adverse reactions with a consequent increase in the quantity, and rate of reporting to the Spanish pharmacovigilance system., It is the most effective method to increase the rate of reporting. This should have focused on topics such as pharmacology, pharmacovigilance, detection, and reporting of adverse reactions. These can be carried out by specific courses, discussions in small groups, or daily sessions with pharmacists.,,,,,,, The education received by nurses not only increase the ADRs reporting rate but also allows them to increase their professional development, credentials, and acquire new skills, taking more responsibility, and autonomy in daily clinical practice.
To address the problem of underreporting, a number of alternative actions can be put into operations that promote reporting these includes constant reminders, small brochures, and posters that remind the importance, and the requirement to report. A study shows that reminders made by letters are more effective than those sent by other means such as by e-mail, as they have more impact on the person who receives it.
The nursing supervisor also plays an essential role in the promotion of the reporting, since they can initiate and direct programs that favor it. If the nursing supervisors are aware and motivated about reporting of ADRs, this should transmit to subordinate staff to raise the awareness and motivation of nurses. The individual rewards, such as positive reinforcement, could also be an interesting initiative to increase the rate of reporting since rewarding a professional act contribute to the increase motivation to report., Likewise, feedback about the sent report could also be considered as a motivation to continue reporting.,,,
As with all regulatory bodies' requirements for reporting of ADRs, the SFDA also mandate to report ADR to Saudi Adverse Event Reporting System. The SFDA pharmacovigilance system provides various reporting channels such as online, paper-based reporting form [Figure 1], verbal reporting, and other reporting means. These documents make reporting process quicker and easier for nursing professionals. Nurses should be familiar with these forms and they should be readily available to them. The existence of these documents would also increase the inquisitiveness by this new competency that has been conferred to nursing professionals.
|Figure 1: Saudi Food and Drug Authority adverse drug reaction reporting form|
Click here to view
ADRs monitoring mechanisms should be incorporated to ensure the knowledge of professionals and the patients. This means that after reporting, the adverse reaction should be included in the patient medical record and education should be given to the patient and finally be recorded in institution-specific ADR-reporting system database. In addition, ADR-reporting system should also be easily accessible for nurses.,,
| Discussion|| |
The main objective of this review was to identify the factors that affect the reporting of ADRs and strategies that improve their reporting, focusing on nursing professionals.
All the reviewed publications agreed to a common point that there is an underreporting of ADR by nurses. Nurses are directly responsible for the administration of medications, placing them in a prominent position, which allows them to immediately detect ADR derived from the administration of medication in hospitalized patients. Therefore, making an overall assessment of the surveyed literature, it is clear that, to resolve the underreporting problem, there is a need to increase the knowledge, awareness, and skills of nurses about pharmacology, pharmacovigilance, ADRs and their reporting system. It is also necessary to dedicate time in motivational activities and actions that favor the change of attitudes of the reporter. Nurses access to the system of ADR reporting is also important. In parallel to this, strategies that direct toward continues education and motivation are also necessary. These strategies will help to overcome the existing ignorance regarding the reporting of ADR, and in particular to address its importance on the safety of patients.
The principal limitation of this review is that its emphasis on the hospital setting, excluding other areas of nursing practice such as ambulatory care, home care, or clinical trials. Therefore, it is unlikely to represent the whole nursing population and generalizability of its finding is questionable to other areas of nursing practice. Nevertheless, hospitals' setting was chosen because a greater number of treatments administered by nurses with more complexity found in this area.
| Conclusion and Practical Implications|| |
This review has revealed the factors that influence the underreporting of ADRs and strategies to encourage reporting by nurses. Most of the identified factors are potentially modifiable. Given the practical relevance of this issue, it would be interesting in the future practical implication of the various strategies through prospective observational studies. This would assess the effectiveness of different strategies in relation to the variability in the rate of ADRs reporting by nurses using more relevant indicators such as increased numbers of reports and increased knowledge of ADRs among nursing professionals. This would, in turn, ensure increased capability of nurses in reporting of ADRs and thereby enhance patient safety.
We acknowledge Dr. Khalid Ahmed, head of the pharmacy department, Mohammad Al Dossary Hospital, for the review of this manuscript.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Sharon E, Axe S. The 10 'R's of safe multidisciplinary drug administration. Nurse Prescribing 2015;13:398-406.
Carleton BC, Smith MA. Drug safety: Side effects and mistakes or adverse reactions and deadly errors? Br Columbia Med J 2006;48:329.
Bäckström M, Mjörndal T, Dahlqvist R. Under-reporting of serious adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf 2004;13:483-7.
Rottenkolber D, Schmiedl S, Rottenkolber M, Farker K, Saljé K, Mueller S, et al.
Adverse drug reactions in Germany: Direct costs of internal medicine hospitalizations. Pharmacoepidemiol Drug Saf 2011;20:626-34.
Authority Saudi Food and Drug. Guideline on Good Pharmacovigilance Practices (GVP). As Amended Through; December, 2015. p. 2.
Ministry of Health South Africa. Reporting of Adverse Drug Reaction (ADR) Policy; 2012.
Saudi Food and Drug Authority NPaDSC. Adverse Drug Reaction (ADR) Reporting Form For Health Care Professionals Form NO. ADR-1; 2016.
Abdel-Latif MM, Abdel-Wahab BA. Knowledge and awareness of adverse drug reactions and pharmacovigilance practices among healthcare professionals in Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia. Saudi Pharm J 2015;23:154-61.
Duthie E, Favreau B, Ruperto A, et al
. Quantitative and qualitative analysis of medication errors: The New York experience. In: Henriksen K, Battles JB, Marks ES, et al
., editors. Advances in Patient Safety: From Research to Implementation (Volume 1: Research Findings). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005.
Hazell L, Shakir SA. Under-reporting of adverse drug reactions: A systematic review. Drug Saf 2006;29:385-96.
Morrison-Griffiths S, Pirmohamed M. Specialist nurse reporting of adverse drug reactions. Prof Nurse 2000;15:300-4.
Jimeno Demuth FJ, Manso Rodríguez G, González Iglesias V, Ordóñez Fernández L, Salgueiro Vázquez M. Pharmacovigilance and medication errors. Rev Rol Enferm 2012;35:168-78.
Bäckström M, Mjörndal T, Dahlqvist R. Spontaneous reporting of adverse drug reactions by nurses. Pharmacoepidemiol Drug Saf 2002;11:647-50.
Ekman E, Petersson G, Tågerud S, Bäckström M. Awareness among nurses about reporting of adverse drug reactions in Sweden. Drug Healthc Patient Saf 2012;4:61-6.
Li Q, Zhang SM, Chen HT, Fang SP, Yu X, Liu D, et al.
Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chin Med J (Engl) 2004;117:856-61.
Tremlett HL, Oger J. Ten years of adverse drug reaction reports for the multiple sclerosis immunomodulatory therapies: A Canadian perspective. Mult Scler 2008;14:94-105.
Kagan I, Barnoy S. Organizational safety culture and medical error reporting by Israeli nurses. J Nurs Scholarsh 2013;45:273-80.
Kiguba R, Karamagi C, Waako P, Ndagije HB, Bird SM. Recognition and reporting of suspected adverse drug reactions by surveyed healthcare professionals in Uganda: Key determinants. BMJ Open 2014;4:e005869.
Mendes D, Alves C, Batel Marques F. Nurses' spontaneous reporting of adverse drug reactions: Expert review of routine reports. J Nurs Manag 2014;22:322-30.
Krähenbühl-Melcher A, Schlienger R, Lampert M, Haschke M, Drewe J, Krähenbühl S. Drug-related problems in hospitals: A review of the recent literature. Drug Saf 2007;30:379-407.
Ruud KW, Srinivas SC, Toverud EL. Addressing gaps in pharmacovigilance practices in the antiretroviral therapy program in the Eastern Cape Province, South Africa. Res Social Adm Pharm 2010;6:345-53.
Bäckström M, Ekman E, Mjörndal T. Adverse drug reaction reporting by nurses in Sweden. Eur J Clin Pharmacol 2007;63:613-8.
Conforti A, Opri S, D'Incau P, Sottosanti L, Moretti U, Ferrazin F, et al.
Adverse drug reaction reporting by nurses: Analysis of Italian pharmacovigilance database. Pharmacoepidemiol Drug Saf 2012;21:597-602.
de Langen J, van Hunsel F, Passier A, de Jong-van den Berg L, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: Three years of experience. Drug Saf 2008;31:515-24.
Morrison-Griffiths S, Walley TJ, Park BK, Breckenridge AM, Pirmohamed M. Reporting of adverse drug reactions by nurses. Lancet 2003;361:1347-8.
Griffith R. Nurses must report adverse drug reactions. Br J Nurs 2013;22:484-5.
Ekman E, Bäckström M. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol 2009;65:43-6.
Hunt JM, Gjoka G. Nurse reporting of adverse events caused by medicines. Nurs Times 2003;99:24-5.
Johansson ML, Hägg S, Wallerstedt SM. Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: A randomized controlled study. BMC Clin Pharmacol 2011;11:14.
Moumtzoglou A. Factors impeding nurses from reporting adverse events. J Nurs Manag 2010;18:542-7.
Khoza S, Madungwe I, Nyambayo P, Mthethwa J, Chikuni O. Adverse drug reactions reporting at a referral hospital in Zimbabwe. Cent Afr J Med 2004;50:104-7.
Le J, Nguyen T, Law AV, Hodding J. Adverse drug reactions among children over a 10-year period. Pediatrics 2006;118:555-62.
John LJ, Arifulla M, Cheriathu JJ, Sreedharan J. Reporting of adverse drug reactions: An exploratory study among nurses in a teaching hospital, Ajman, United Arab Emirates. Daru 2012;20:44.