Journal of Nursing Management, 2014, 22, 322–330
Nurses’ spontaneous reporting of adverse drug reactions: expert review of routine reports DIOGO MENDES
PharmD
1
, CARLOS ALVES
PharmD
2,3
and FRANCISCO BATEL MARQUES
PharmD, PhD
4
1
Research Assistant, Central Portugal Regional Pharmacovigilance Unit, Health Technology Assessment Centre, AIBILI, Coimbra, 2PhD Student, School of Pharmacy, University of Coimbra and at CICS-UBI – Health Science Research Centre, University of Beira Interior, 3Collaborator, Health Technology Assessment Centre, AIBILI, Coimbra and 4Associate Professor, School of Pharmacy, University of Coimbra, Central Portugal Regional Pharmacovigilance Unit, Health Technology Assessment Centre, AIBILI, Coimbra, Portugal
Correspondence Diogo Mendes Unidade de Farmacovigilaˆncia do Centro AIBILI Azinhaga de Santa Comba - Celas 3000-548 Coimbra Portugal E-mail: diogomendes26@gmail. com
MENDES D., ALVES C. & BATEL MARQUES F.
(2014) Journal of Nursing Management 22,
322–330. Nurses’ spontaneous reporting of adverse drug reactions: expert review of routine reports Aim The aims of this study were to analyse spontaneously reported adverse drug reactions according to their previous description, seriousness, causality and the reporting professional. Background Previous findings showed that fewer nurses than physicians and pharmacists report adverse drug reactions. This is not attributed to any lack of ability in identifying adverse drug reactions. Method Adverse drug reactions received by the Central Portugal Regional Pharmacovigilance Unit, between 2001 and 2011, were studied. Certain and probable adverse drug reactions were included to test differences between professional groups for serious and non-serious adverse drug reactions. Results The Central Portugal Regional Pharmacovigilance Unit received 1014 adverse drug reactions. Fifty-four nurses reported 66 adverse drug reactions, whereas 232 physicians and 145 pharmacists reported 589 and 357 adverse drug reactions, respectively. Considering the number of practising professionals, it was estimated that 0.55% of nurses, 3.96% of physicians and 7.08% of pharmacists have reported an adverse drug reaction. Of the 633 adverse drug reactions assessed as certain or probable, 46 (21 serious), 387 (192 serious) and 198 (77 serious) were reported from nurses, physicians and pharmacists, respectively. There were no differences in the reporting of serious adverse drug reactions among nurses, physicians and pharmacists. Conclusions Nurses are able to identify serious adverse drug reactions although they report less than other professionals. Implications for Nursing Management Nurses need to increase their involvement in spontaneous reporting schemes by taking responsibility for routinely reporting suspected adverse drug reactions. Keywords: adverse drug reaction, nurses, pharmacovigilance, seriousness, spontaneous reporting Accepted for publication: 27 July 2012
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DOI: 10.1111/jonm.12003 ª 2012 John Wiley & Sons Ltd
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Introduction Adverse drug reactions (ADRs) are a problem of drug therapy, as they are a leading cause of morbidity and mortality in the health care process (Lazarou et al. 1998, Pirmohamed et al. 2004). Pharmacovigilance aims at the detection, assessment and prevention of ADRs, with spontaneous reporting being the most widely used method of pharmacovigilance (Lawson & Beard 2007). A spontaneous report is an unsolicited communication from healthcare professionals or consumers received by the regulatory authorities via either the voluntary or the mandatory route. It is a clinical observation that originates outside of a formal study (Ahmad et al. 2006). Spontaneous reporting systems are valuable for identifying relatively rare events and providing signals about potentially serious safety problems (Madre et al. 2006). The detection of serious and unknown ADRs provides new information about the safety profile of drugs. The identification of such reactions has resulted in many marketed drugs being withdrawn or additional information being provided to guide safer use of the product (Mann & Andrews 2007). However, under-reporting is a limitation of spontaneous reporting schemes, leading to under-estimation of the incidence of ADRs (Davis et al. 2007). The Central Portugal Regional Pharmacovigilance Unit receives spontaneous reports of suspected ADRs from healthcare professionals: physicians, nurses and pharmacists. In Portugal, the nursing profession has more practising professionals than physicians and pharmacists together. Despite this, previous findings pointed out that the spontaneous reports of suspected ADRs from nurses were relatively few when compared with those from physicians and pharmacists (Macedo et al. 2011). Other previous studies have described the contribution of the nursing profession to several pharmacovigilance systems (Hall et al. 1995, Ba¨ckstro¨m et al. 2002, 2007, Ulfvarson et al. 2007). During their professional practice, nurses have close contact with patients. They are commonly responsible for the administration of drug therapy in inpatients and usually monitor medication in nursing homes. Furthermore, as a result of their role in patient care, and their ability to identify and report ADRs, nurses have the potential to play a valuable part in enhancing pharmacovigilance systems (Hall et al. 1995, Ba¨ckstro¨m et al. 2002, 2007, Morrison-Griffiths et al. 2003, Ulfvarson et al. 2007). Therefore there is the rational to study reported ADRs evaluated by the Central Portugal Regional ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
Pharmacovigilance Unit during its 10 years’ working period. Focus was made on serious ADRs reported by nurses, physicians and pharmacists.
Methods Setting In the Central Region of Portugal there are 109 official clinics, 43 hospitals, 724 community pharmacies and a resident population of 2 375 902 (Statistics Portugal 2011). The estimated numbers of professionals employed in the Region is as follows: 9875 nurses, 5861 physicians and 2049 pharmacists (Statistics Portugal 2011). The spontaneous reporting system covers these health centres, population and professionals. Healthcare professionals may report suspected ADRs in written report forms, by telephone or electronically (e-mail or online submission). A spontaneous report is validated when it meets the primary inclusion criteria: patient, suspected medicine, adverse event and healthcare professional identified. Subsequent to this validation, an expert panel comprised of clinical pharmacologists, clinical pharmacists and physicians review the spontaneous reports and assesses ADRs according to their previous description, seriousness and causality. This is called secondary validation. At the beginning of the activity of the Central Portugal Regional Pharmacovigilance Unit, only the primary validation was produced. Forty-five per cent of all the reports were excluded because they did not meet secondary validation criteria. Spontaneous reports of suspected ADRs received by the Central Portugal Regional Pharmacovigilance Unit between January 2001 and October 2011 that met both the primary and the secondary inclusion criteria were included in the study.
Assessment of ADRs Adverse drug reactions previous description was assessed by consulting the medicines’ Summary of Product Characteristics. ADRs were classified as ‘unknown’ if they were not included in the Summary of Product Characteristics of the suspected drugs. The seriousness of ADRs was assessed according to the World Health Organization’s criteria, defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, results in persistent or significant disability or congenital anomaly or requires intervention to prevent permanent impairment or damage (WHO-UMC 2010a). 323
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The causality of reported adverse events was assessed using the global introspection method, based on the World Health Organization scale of imputability (WHO-UMC 2010b). Global introspection is a noncomputerized method used by a group of experts to express judgments about the likelihood of a causal relationship between drug exposure and observed adverse events. It is a combined assessment taking into account clinical and pharmacological aspects of the case history and the quality of the provided information (WHOUMC 2010a). The different levels of causality and their assessment criteria are listed in Table S1. The Medical Dictionary for Regulatory Activities (MedDRA) was used to classify ADRs. Drugs were classified according to the Anatomical Therapeutic Chemical classification system. Healthcare professionals were grouped according to their profession (nurses, physicians, pharmacists and pharmacy technicians) and work place (ambulatory care, hospital and community pharmacy). ADRs reported by healthcare professionals working in pharmaceutical industries or in universities were grouped as ‘other’. Only adverse drug reactions with levels of causality certain or probable were included to test differences between professional groups for reporting serious adverse drug reactions.
Data analysis Data was first analysed using descriptive statistics. Furthermore, the chi-square test was used and odds ratios (OR) with 95% confidence intervals (CI) calculated test differences between healthcare professional groups for reporting serious ADRs. The comparisons were the following: nurses vs. physicians, nurses vs. pharmacists and physicians vs. pharmacists. The Statistical Package for the Social Sciences (version 17.0; SPSS Inc., Chicago, IL, USA) was used.
Results During the study period the Central Portugal Regional Pharmacovigilance Unit received 1860 spontaneous reports of suspected ADRs. Of these, 1014 (54.5%) met the inclusion criteria. The flowchart of the study is presented in Fig. 1.
Characteristics of ADRs Table 1 displays the distribution of ADRs according to the previous description, seriousness and level of 324
causality assigned. Out of the 1014 ADRs, 154 (15.2%) were unknown and 441 (43.5%) were assessed as serious. Six hundred and thirty-three ADRs (62.4%) were assessed as certain or probable. A few examples of these reactions are listed in Table 2. Forty-six (4.5%) ADRs were simultaneously assessed as unknown, serious, certain or probable. A clinical case reported by a nurse is described in the Textbox.
Case study Mrs MS was a 23-year-old pregnant woman at 37 weeks gestation. This woman received a vaginal delivery system containing a prostaglandin indicated for induction of labour. Seventeen hours after the administration, Mrs MS had a headache and vomited. Further, fetal tachycardia was detected: the heart rate was about 190 beats per minute (bpm). Drug-induced headache, vomiting and fetal tachycardia was considered. The prostaglandin was the suspected drug and it was discontinued. The clinical status of the patient improved within 1 hour after the discontinuation of the suspected drug. The fetal tachycardia persisted for 2 hours, until the healthcare professionals decided to perform a caesarean section. The baby was born healthy and the tachycardia had reversed. Three days after the labour, both the mother and the baby were discharged.
Constant vigilance is essential when administering drugs of patients. In this particular case, continuous monitoring resulted in the identification of a serious adverse drug reaction that posed a risk to the mother and baby. Nurses need to understand the problem of ADRs and be aware of how they can be prevented and managed.
Origin of spontaneous reporting of ADRs Table 3 displays the number of ADRs according to the healthcare professionals’ working place. Ambulatory care (n = 433; 42.7%), the hospitals (n = 328; 32.3%) and the community pharmacies (n = 240; 23.7%) were the sources of the majority of the reports. Out of the 433 healthcare professionals, 54 (12.5%) were nurses, 232 (53.6%) physicians and 145 (33.5%) pharmacists. Considering the estimated numbers of professionals employed and the numbers of professionals that reported ADRs, it was estimated that 0.55% (54/9875) of nurses, 3.96% (232/5861) of physicians and 7.08% (145/2049) of pharmacists reported an ADR. Differences in the reporting rates between the healthcare professionals were statistically significant (calculations available from the authors). Nurses reported 66 (6.5%), physicians 589 (58.1%) and pharmacists 357 (35.2%) ADRs, respectively. The mean number of ADRs spontaneously reported by each nurse, physician ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
The role of nursing professionals in pharmacovigilance
1860 Spontaneous Reports (SR) of adverse drug reactions (ADRs) received in UFC
847 SR did not meet at least one of the secondary inclusion criteria
1014 SR of ADRs met the inclusion criteria
Previous description
Seriousness
Causality assessment
154 (15.2%)* unknown ADRs
441 (43.5%)* serious ADRs
633 (62.4%)* certain or probable ADRs
46 ADRs simultaneously unknown serious certain or probable
Nurses (46 ADRs)
Physicians (387 ADRs)
Pharmacists (198 ADRs)
Seriousness according to healthcare professionals
192 serious ADRs
21 serious ADRs
77 serious ADRs
*An ADR is assessed according to its previous description, seriousness and causality. For instance, a single ADR can be simultaneously assessed as unknown, serious and certain. It is not correct to sum the number of ADRs which were classified in one group (for instance, serious) with the ADRs classified in another group (for instance, certain).
Figure 1 Flowchart of the study.
Table 1 Adverse drug reactions according to their seriousness, previous description and causality assessment Causality assessed Seriousness Serious Non-Serious Total
Previous description Known Unknown Known Unknown
Certain
Probable
Possible
158 21 130 8 317
87 25 180 24 316
91 22 125 23 261
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Unlikely 8 1 9 4 22
Conditional/ Unclassified 5 2 17 8 32
Unassessable/ Unclassifiable
Total
17 4 33 12 66
366 75 494 79 1014
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Table 2 Examples of adverse drug reactions (ADRs) classified as certain or probable Healthcare professionals Nurses Physicians Pharmacists
ATC classification of the suspected medicine
Suspected ADR
Genitourinary system and sex hormones Anti-infectives products for systemic use Anti-infectives products for systemic use Anti-infectives products for systemic use Anti-infectives products for systemic use Antineoplasic and immunomodulating agents
Fetal tachycardia Pustular acne Toxicodermia Tonic seizure Taste metallic Anaphylactic shock
Previous description
Seriousnesss
Causality
Known Unknown Known Unknown Unknown Known
Serious Non-serious Serious Serious Non-serious Serious
Probable Probable Probable Certain Probable Certain
ATC, Anatomical Therapeutic Chemical Classification; ADR, adverse drug reaction. Suspected ADRs classified according to MedDRA in the Lowest Level Term (LLT).
Table 3 Healthcare professionals (HP) and adverse drug reactions (ADRs) according to the origin of the spontaneous reports Origin of report
Healthcare professionals (HP) Nurses Physicians Pharmacists Pharmacy Technicians Total ADRs Total HP
Ambulatory care
Hospital
Pharmacy
Other
Total
ADRs per HP
HP
ADRs
HP
ADRs
HP
ADRs
HP
ADRs
HP
ADRs
38 120 – –
43 390 – –
16 107 21 –
23 191 114 –
– – 119 2
– – 238 2
–
–
54 232 145 2
66 589 357 2
433 158
328 144
5 5 –
240 121
8 5 – 13
10
Average 1.2 2.5 2.3 1
1014 433
HP, number of healthcare professionals that reported suspected ADRs.
and pharmacist was 1.2, 2.5 and 2.3, respectively. Two pharmacy technicians reported two suspected ADRs.
Table 4 Differences between the proportions of serious adverse drug reactions (ADRs) reported by each professional group
Seriousness of ADRs and the reporting healthcare professional
Comparisons
Nurses, physicians and pharmacists reported 21 (45.7%), 192 (49.6%) and 77 (38.9%) serious ADRs, respectively (Fig. 1). There was no differences between nurses and physicians in the reporting of serious ADRs [(v2 = 0.258, d.f. = 1, P = 0.61); (OR = 0.85; 95% CI = 0.46, 1.58)] (Table 4). When nurses were compared with pharmacists no differences were observed [(v2 = 0.710, d.f. = 1, P = 0.40); (OR = 1.32; 95% CI = 0.71, 2.44)]. Physicians reported a higher proportion of serious ADRs than pharmacists [(v2 = 6.064, d.f. = 1, P = 0.01); (OR = 1.55; 95% CI = 1.09, 2.19)].
Characteristics of drugs The Anatomical Therapeutic Chemical classification groups of drugs suspected of causing ADRs are listed 326
Nurses vs. physicians Nurses vs. pharmacists Physicians vs. pharmacists
P
OR (95% CI)
0.61 0.40 0.01*
0.85 (0.46, 1.58) 1.32 (0.71, 2.44) 1.55 (1.09, 2.19)*
OR, odds ratio. *Significant at the 0.05 level (two-sided).
in Table 5. The drugs most commonly reported as responsible for the ADRs were anti-infectives for systemic use (including vaccines; n = 270; 26.6%), drugs active on the muscle–skeletal system (n = 153; 15.1%), on the cardiovascular system (n = 147; 14.5%), on the nervous system (n = 140; 13.8%) and antineoplasic and immunomodulating agents (n = 128; 12.6%). These five groups of drugs were responsible for 82.6% of all ADRs. Anti-infectives for systemic use were the drugs most frequently suspected of causing adverse reactions in ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
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Table 5 Anatomical therapeutic chemical classification of drugs suspected of causing adverse drug reactions (ADRs) ADRs by healthcare professional
Anatomical therapeutic chemical groups - first level (J) Anti-infectives products for systemic use (M) Musculo-skeletal system (C) Cardiovascular system (N) Nervous System (L) Antineoplasic and immunomodulating agents (A) Gastrointestinal tract (B) Blood and blood forming organs (G) Genitourinary system and sex hormones (R) Respiratory system (D) Dermatological (H) Endocrine systemic (S) Sensory organs (V) Various (P) Antiparasitic products, insecticides and repellents Total
Nurse
Physician
Pharmacist
n
(%)
n
(%)
n
(%)
47
(71.2)
156
(26.5)
67
(18.8)
0 1 8 2
(0.0) (1.5) (12.1) (3.0)
110 98 83 42
(18.7) (16.6) (14.1) (7.1)
42 48 49 84
1 3 4
(1.5) (4.5) (6.1)
26 18 14
(4.4) (3.1) (2.4)
0 0 0 0 0 0
(0.0) (0.0) (0.0) (0.0) (0.0) (0.0)
13 11 11 2 4 1
(2.2) (1.9) (1.9) (0.3) (0.7) (0.2)
66
100
589
100
Serious, unknown certain or probable ADRs
Total (%)
n
(%)
270
(26.6)
21
(45.7)
(11.8) (13.4) (13.7) (23.5)
153* 147 140 128
(15.1) (14.5) (13.8) (12.6)
6 4 3 5
(13.0) (8.7) (6.5) (10.9)
21 7 10
(5.9) (2.0) (2.8)
48 28 28
(4.7) (2.8) (2.8)
1 0 1
(2.2) (0.0) (2.2)
14 7 4 3 0 1
(3.9) (2.0) (1.1) (0.8) (0.0) (0.3)
27 18 15 6* 4 2
(2.7) (1.8) (1.5) (0.6) (0.4) (0.2)
2 1 1 1 0 0
(4.3) (2.2) (2.2) (2.2) (0.0) (0.0)
357
100
n
1014*
100
46
100
*Two ADRs were reported by pharmacy technicians.
reports from nurses (n = 47; 71.2%) and physicians (n = 156; 26.5%) whereas antineoplasic and immunomodulating agents were the drugs most commonly reported by pharmacists (n = 84; 23.5%). Of the ADRs reported by nurses, 40 (60.6%) were related to vaccines. Physicians and pharmacists reported 64 (10.9%) and 15 (4.2%) ADRs related to vaccines, respectively. Table 5 also displays the 46 simultaneously unknown, serious, certain or probable ADRs according to the Anatomical Therapeutic Chemical classification groups. Of these reactions, the anti-infectives for systemic use, accounting for 45.7%, were the drugs most commonly reported.
Discussion Spontaneous reporting is of great value in identifying ADRs and in monitoring the safety of marketed drugs (Lawson & Beard 2007). The usefulness of the spontaneous reporting schemes is reflected by the 15.2% of ADRs received by the Central Portugal Regional Pharmacovigilance Unit which were assessed as unknown. About 40% of the ADRs reported to the Central Portugal Regional Pharmacovigilance Unit were assessed ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
as serious. This result is in line with the findings of two Swedish studies, although higher rates have been found in a study conducted in the United Kingdom (Ba¨ckstro¨m et al. 2007, Ulfvarson et al. 2007 and McLernon et al. 2010). Over half of the suspected ADRs were assessed as certain or probable. These levels of causality represent a strong association between the suspected drug and the adverse event reported. The identification of ADRs assessed simultaneously as unknown, serious and certain or probable is a valuable contribute to increase knowledge on the safety profiles of drugs. Such reactions accounted for 4.5% of all cases analysed in our study, revealing the importance of the activity of the Pharmacovigilance Unit in producing knowledge on the field of drug safety. Previous studies pointed out that the nursing profession is able to detect and identify suspected ADRs (Hall et al. 1995, Ba¨ckstro¨m et al. 2002, 2007, Morrison-Griffiths et al. 2003, Ulfvarson et al. 2007, Macedo et al. 2011,). In Central Portugal, the number of nurse practitioners is superior to the number of physicians and pharmacists (Statistics Portugal 2011). However, according to our results, the number of nurses reporting suspected ADRs was inferior to the number of physicians and pharmacists involved in this 327
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process. The majority of the spontaneous reports were sent by physicians. In 2010, the number of reports from nurses was 21% of total reports in the United Kingdom, increasing compared with 2009 (Medicines & Healthcare products Regulatory Agency 2011). Between 2004 and 2010, 2.6% of the total reports registered in the Italian pharmacovigilance database were from nurses (Conforti et al. 2012). The relative contribution of the nursing profession to the global amount of spontaneous reports in Central Portugal was lower than in the United Kingdom but higher than in Italy. Unlike other countries, the nursing profession has been present in the Portuguese pharmacovigilance system since its creation in 1992 (Public Law 1992). For example, in the United Kingdom, the added value of the inclusion of nurses as reporters was evaluated prior to the acceptance of the nursing profession in the spontaneous reporting system. This was the case during the meningitis C vaccination campaign. Nurse reports received during the vaccination campaign have been used by the regulatory authorities to evaluate the contribution of this group to pharmacovigilance. As a result of that evaluation, the regulatory authorities have decided to extend the spontaneous reporting system to nurses in October 2002 (Davis et al. 2007). The findings of our study suggest that the Portuguese nurses are not fully committed to the spontaneous reporting of suspected ADRs. Further studies should be conducted in order to investigate the reasons why these professionals did not yet achieve a greater involvement in this system. The proportion of ADRs reactions reported by each healthcare profession was investigated. We found no statistically significant differences between nurses and physicians and nurses and pharmacists. Nevertheless, differences were found between physicians and pharmacists, which are in line with the conclusions of a Dutch study (van Grootheest et al. 2002). Although a previous study described that nurses reported less serious ADRs than physicians (van den Bemt et al. 1999), our results are close to those of other studies where these reactions were reported in the same proportion by nurses and physicians (Hall et al. 1995, Ba¨ckstro¨m et al. 2002, 2007). The majority of ADRs reported by the nursing professionals were related to anti-infectives for systemic use, namely vaccines. Vaccines are frequently administered by nurses and, therefore, they are in a good position to recognize adverse events that occur within the administration of vaccines (Ranganathan et al. 2003). The differences in the distribution of suspected drugs among nurses, physicians and pharmacists are 328
in relation to their different roles in the management of pharmacotherapy and their relationship with patients (Conforti et al. 2012). A limitation of this study is the under-reporting, which is common to all spontaneous reporting schemes. It is estimated that only 5–10% of all ADRs are reported (Rawlings 1988, Alvarez-Requejo et al. 1998). Another limitation is the lack of data on drug exposure. Therefore it is not possible to calculate incidence rates of ADRs. Finally, this study focused on a single region of Portugal and the results cannot be generalized to the country as a whole or to other countries. Multinational studies should be carried out in order to characterize the spontaneous reporting systems and to identify the contribution of the different healthcare professionals to pharmacovigilance.
Implications for Nursing Management The contribution of the nursing profession to pharmacovigilance in central Portugal was found to be less than that of physicians and pharmacists. Therefore, nurses need to increase their involvement in pharmacovigilance activities. Nurses have a close contact with patients because of their clinical activities. In their daily work, nurses’ involvement in the routine care of patients, namely in the management of chronic conditions, places them in a clinical position in which they are increasingly likely to observe suspected adverse reactions. Furthermore, they are aware of the clinical status and the medication used by patients. The causality assessment depends upon the available data included in the cases (Agbabiaka et al. 2008). There are barriers to the spontaneous reporting common to all healthcare professionals: (1) recognition and correct diagnosis of the clinical event; (2) a lack of attribution of an event to a drug exposure; and (3) registration of the event (Graham et al. 2000). These barriers generally reduce the level of reporting of adverse drug reactions (Inman & Weber 1986). Furthermore, the lack of knowledge about drug safety and a theory–practice gap in pharmacology education of nurses are limiting factors for their performance in pharmacotherapeutic activities (Leape et al. 1995, King 2004, Kyriacos et al. 2005). In order to overcome these limitations, educational programmes and training given to these healthcare professionals may increase their skills. For instance, the participation of nurses in active surveillance programmes promoted by Italian regional centres of pharmacovigilance led to a significant increase in spontaneous reporting by nurses ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
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(Conforti et al. 2012). In the United States of America, a nurse-led multidisciplinary project provided education for nurses resulting in an improvement of knowledge about drug safety and in a significant increase in the reporting of ADRs (Valente & Murray 2011). Furthermore, a Belgian study about the nurses’ involvement in pharmacotherapeutic activities pointed out that higher educational levels of nurses were associated with a greater involvement in identifying adverse reactions (Dilles et al. 2010). Therefore, educational sessions on pharmacovigilance activities aimed at the nursing profession need to be carried out. Our findings support the view that nurses are able to identify ADRs although they have not reported as much as the other healthcare professionals. As an implication for nursing management, it is suggested that nurses increase their involvement in spontaneous reporting schemes by undertaking responsibility in routinely reporting suspected ADRs. Pharmacovigilance centres should organise educational programmes for the nursing profession.
Conflict of interest The authors do not have any conflict of interests.
Source of funding The authors did not receive any financial support to conduct this study.
Ethical approval This research project did not require ethics approval because it only involved truly anonymised and aggregated data.
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Textbook of Pharmacoepidemiology (B.L. Strom & S.E. Kimmel eds), pp. 63–88. John Wiley & Sons, Ltd, Chichester. Mann R.D. & Andrews E.B. (2007) Introduction. In Pharmacovigilance, 2nd edn (R.D. Mann & E.B. Andrews eds), pp. 3–11. John Wiley & Sons, Ltd, Chichester. McLernon D.J., Bond C.M., Hannaford P.C. et al. (2010) Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals. Drug Safety 33 (9), 775–788. Medicines and Healthcare products Regulatory Agency (2011) MHRA annual statistics 2010/11 [WWW document]. Available at: http://www.mhra.gov.uk/home/groups/comms-ic/ documents/websiteresources/con123239.pdf, accessed 10 June 2012. Morrison-Griffiths S., Walley T.J., Park B.K., Breckenridge A.M. & Pirmohamed M. (2003) Reporting of adverse drug reactions by nurses. Lancet 361 (9366), 1347–1348. Pirmohamed M., James S., Meakin S. et al. (2005) Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. British Medical Journal 329, 15 –19. Public Law (1992) Despacho Normativo n.º 107/92, de 27 de Junho de 1992. In: Dia´rio da Repu´blica n.º 146, 27 de Junho de 1992. Serie I. Ranganathan S.S., Houhton J.E., Davies D.P. & Routledge P.A. (2003) The involvement of nurses in reporting suspected adverse drug reactions: experience with the meningococcal vaccination scheme. British Journal of Clinical Pharmacology 56, 658–663.
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Rawlings M.D. (1988) Spontaneous reporting of adverse drug reactions. British Journal of Clinical Pharmacology 26, 1–5. Statistics Portugal (2011) Statistical Yearbook of Centro Region 2010. Instituto Nacional de Estatı´stica, I.P., Lisbon, pp. 163–178. Available at: http://www.ine.pt/xportal/xmain? xpid=INE&xpgid=ine_publicacoes&PUBLICACOESpub_boui =130324937&PUBLICACOESmodo=2, accessed on 10 June 2012. Ulfvarson J., Mejyr S. & Bergman U. (2007) Nurses are increasingly involved in pharmacovigilance in Sweden. Pharmacoepidemiology and Drug Safety 16 (5), 532–537. Valente S. & Murray L.P. (2011) Creative strategies to improve patient safety: allergies and adverse drug reactions. Journal for Nurses in Staff Development 27 (1), E1–E5. WHO-UMC (2010a) World Health Organization criteria for serious adverse event or reaction [WWW document]. Available at: http://who-umc.org/Graphics/24729.pdf, accessed on 2 December 2011. WHO-UMC (2010b) The use of the WHO-UMC system for standardised case causality assessment [WWW document]. Available at: http://who-umc.org/Graphics/24734.pdf, accessed on 2 December 2011.
Supporting information Additional Supporting Information may be found in the online version of this article: Table S1. WHO-UMC causality categories.
ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
Nurses’ spontaneous reporting of adverse drug reactions: expert review of routine reports DIOGO MENDES
PharmD
1
, CARLOS ALVES
PharmD
2,3
and FRANCISCO BATEL MARQUES
PharmD, PhD
4
1
Research Assistant, Central Portugal Regional Pharmacovigilance Unit, Health Technology Assessment Centre, AIBILI, Coimbra, 2PhD Student, School of Pharmacy, University of Coimbra and at CICS-UBI – Health Science Research Centre, University of Beira Interior, 3Collaborator, Health Technology Assessment Centre, AIBILI, Coimbra and 4Associate Professor, School of Pharmacy, University of Coimbra, Central Portugal Regional Pharmacovigilance Unit, Health Technology Assessment Centre, AIBILI, Coimbra, Portugal
Correspondence Diogo Mendes Unidade de Farmacovigilaˆncia do Centro AIBILI Azinhaga de Santa Comba - Celas 3000-548 Coimbra Portugal E-mail: diogomendes26@gmail. com
MENDES D., ALVES C. & BATEL MARQUES F.
(2014) Journal of Nursing Management 22,
322–330. Nurses’ spontaneous reporting of adverse drug reactions: expert review of routine reports Aim The aims of this study were to analyse spontaneously reported adverse drug reactions according to their previous description, seriousness, causality and the reporting professional. Background Previous findings showed that fewer nurses than physicians and pharmacists report adverse drug reactions. This is not attributed to any lack of ability in identifying adverse drug reactions. Method Adverse drug reactions received by the Central Portugal Regional Pharmacovigilance Unit, between 2001 and 2011, were studied. Certain and probable adverse drug reactions were included to test differences between professional groups for serious and non-serious adverse drug reactions. Results The Central Portugal Regional Pharmacovigilance Unit received 1014 adverse drug reactions. Fifty-four nurses reported 66 adverse drug reactions, whereas 232 physicians and 145 pharmacists reported 589 and 357 adverse drug reactions, respectively. Considering the number of practising professionals, it was estimated that 0.55% of nurses, 3.96% of physicians and 7.08% of pharmacists have reported an adverse drug reaction. Of the 633 adverse drug reactions assessed as certain or probable, 46 (21 serious), 387 (192 serious) and 198 (77 serious) were reported from nurses, physicians and pharmacists, respectively. There were no differences in the reporting of serious adverse drug reactions among nurses, physicians and pharmacists. Conclusions Nurses are able to identify serious adverse drug reactions although they report less than other professionals. Implications for Nursing Management Nurses need to increase their involvement in spontaneous reporting schemes by taking responsibility for routinely reporting suspected adverse drug reactions. Keywords: adverse drug reaction, nurses, pharmacovigilance, seriousness, spontaneous reporting Accepted for publication: 27 July 2012
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DOI: 10.1111/jonm.12003 ª 2012 John Wiley & Sons Ltd
The role of nursing professionals in pharmacovigilance
Introduction Adverse drug reactions (ADRs) are a problem of drug therapy, as they are a leading cause of morbidity and mortality in the health care process (Lazarou et al. 1998, Pirmohamed et al. 2004). Pharmacovigilance aims at the detection, assessment and prevention of ADRs, with spontaneous reporting being the most widely used method of pharmacovigilance (Lawson & Beard 2007). A spontaneous report is an unsolicited communication from healthcare professionals or consumers received by the regulatory authorities via either the voluntary or the mandatory route. It is a clinical observation that originates outside of a formal study (Ahmad et al. 2006). Spontaneous reporting systems are valuable for identifying relatively rare events and providing signals about potentially serious safety problems (Madre et al. 2006). The detection of serious and unknown ADRs provides new information about the safety profile of drugs. The identification of such reactions has resulted in many marketed drugs being withdrawn or additional information being provided to guide safer use of the product (Mann & Andrews 2007). However, under-reporting is a limitation of spontaneous reporting schemes, leading to under-estimation of the incidence of ADRs (Davis et al. 2007). The Central Portugal Regional Pharmacovigilance Unit receives spontaneous reports of suspected ADRs from healthcare professionals: physicians, nurses and pharmacists. In Portugal, the nursing profession has more practising professionals than physicians and pharmacists together. Despite this, previous findings pointed out that the spontaneous reports of suspected ADRs from nurses were relatively few when compared with those from physicians and pharmacists (Macedo et al. 2011). Other previous studies have described the contribution of the nursing profession to several pharmacovigilance systems (Hall et al. 1995, Ba¨ckstro¨m et al. 2002, 2007, Ulfvarson et al. 2007). During their professional practice, nurses have close contact with patients. They are commonly responsible for the administration of drug therapy in inpatients and usually monitor medication in nursing homes. Furthermore, as a result of their role in patient care, and their ability to identify and report ADRs, nurses have the potential to play a valuable part in enhancing pharmacovigilance systems (Hall et al. 1995, Ba¨ckstro¨m et al. 2002, 2007, Morrison-Griffiths et al. 2003, Ulfvarson et al. 2007). Therefore there is the rational to study reported ADRs evaluated by the Central Portugal Regional ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
Pharmacovigilance Unit during its 10 years’ working period. Focus was made on serious ADRs reported by nurses, physicians and pharmacists.
Methods Setting In the Central Region of Portugal there are 109 official clinics, 43 hospitals, 724 community pharmacies and a resident population of 2 375 902 (Statistics Portugal 2011). The estimated numbers of professionals employed in the Region is as follows: 9875 nurses, 5861 physicians and 2049 pharmacists (Statistics Portugal 2011). The spontaneous reporting system covers these health centres, population and professionals. Healthcare professionals may report suspected ADRs in written report forms, by telephone or electronically (e-mail or online submission). A spontaneous report is validated when it meets the primary inclusion criteria: patient, suspected medicine, adverse event and healthcare professional identified. Subsequent to this validation, an expert panel comprised of clinical pharmacologists, clinical pharmacists and physicians review the spontaneous reports and assesses ADRs according to their previous description, seriousness and causality. This is called secondary validation. At the beginning of the activity of the Central Portugal Regional Pharmacovigilance Unit, only the primary validation was produced. Forty-five per cent of all the reports were excluded because they did not meet secondary validation criteria. Spontaneous reports of suspected ADRs received by the Central Portugal Regional Pharmacovigilance Unit between January 2001 and October 2011 that met both the primary and the secondary inclusion criteria were included in the study.
Assessment of ADRs Adverse drug reactions previous description was assessed by consulting the medicines’ Summary of Product Characteristics. ADRs were classified as ‘unknown’ if they were not included in the Summary of Product Characteristics of the suspected drugs. The seriousness of ADRs was assessed according to the World Health Organization’s criteria, defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, results in persistent or significant disability or congenital anomaly or requires intervention to prevent permanent impairment or damage (WHO-UMC 2010a). 323
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The causality of reported adverse events was assessed using the global introspection method, based on the World Health Organization scale of imputability (WHO-UMC 2010b). Global introspection is a noncomputerized method used by a group of experts to express judgments about the likelihood of a causal relationship between drug exposure and observed adverse events. It is a combined assessment taking into account clinical and pharmacological aspects of the case history and the quality of the provided information (WHOUMC 2010a). The different levels of causality and their assessment criteria are listed in Table S1. The Medical Dictionary for Regulatory Activities (MedDRA) was used to classify ADRs. Drugs were classified according to the Anatomical Therapeutic Chemical classification system. Healthcare professionals were grouped according to their profession (nurses, physicians, pharmacists and pharmacy technicians) and work place (ambulatory care, hospital and community pharmacy). ADRs reported by healthcare professionals working in pharmaceutical industries or in universities were grouped as ‘other’. Only adverse drug reactions with levels of causality certain or probable were included to test differences between professional groups for reporting serious adverse drug reactions.
Data analysis Data was first analysed using descriptive statistics. Furthermore, the chi-square test was used and odds ratios (OR) with 95% confidence intervals (CI) calculated test differences between healthcare professional groups for reporting serious ADRs. The comparisons were the following: nurses vs. physicians, nurses vs. pharmacists and physicians vs. pharmacists. The Statistical Package for the Social Sciences (version 17.0; SPSS Inc., Chicago, IL, USA) was used.
Results During the study period the Central Portugal Regional Pharmacovigilance Unit received 1860 spontaneous reports of suspected ADRs. Of these, 1014 (54.5%) met the inclusion criteria. The flowchart of the study is presented in Fig. 1.
Characteristics of ADRs Table 1 displays the distribution of ADRs according to the previous description, seriousness and level of 324
causality assigned. Out of the 1014 ADRs, 154 (15.2%) were unknown and 441 (43.5%) were assessed as serious. Six hundred and thirty-three ADRs (62.4%) were assessed as certain or probable. A few examples of these reactions are listed in Table 2. Forty-six (4.5%) ADRs were simultaneously assessed as unknown, serious, certain or probable. A clinical case reported by a nurse is described in the Textbox.
Case study Mrs MS was a 23-year-old pregnant woman at 37 weeks gestation. This woman received a vaginal delivery system containing a prostaglandin indicated for induction of labour. Seventeen hours after the administration, Mrs MS had a headache and vomited. Further, fetal tachycardia was detected: the heart rate was about 190 beats per minute (bpm). Drug-induced headache, vomiting and fetal tachycardia was considered. The prostaglandin was the suspected drug and it was discontinued. The clinical status of the patient improved within 1 hour after the discontinuation of the suspected drug. The fetal tachycardia persisted for 2 hours, until the healthcare professionals decided to perform a caesarean section. The baby was born healthy and the tachycardia had reversed. Three days after the labour, both the mother and the baby were discharged.
Constant vigilance is essential when administering drugs of patients. In this particular case, continuous monitoring resulted in the identification of a serious adverse drug reaction that posed a risk to the mother and baby. Nurses need to understand the problem of ADRs and be aware of how they can be prevented and managed.
Origin of spontaneous reporting of ADRs Table 3 displays the number of ADRs according to the healthcare professionals’ working place. Ambulatory care (n = 433; 42.7%), the hospitals (n = 328; 32.3%) and the community pharmacies (n = 240; 23.7%) were the sources of the majority of the reports. Out of the 433 healthcare professionals, 54 (12.5%) were nurses, 232 (53.6%) physicians and 145 (33.5%) pharmacists. Considering the estimated numbers of professionals employed and the numbers of professionals that reported ADRs, it was estimated that 0.55% (54/9875) of nurses, 3.96% (232/5861) of physicians and 7.08% (145/2049) of pharmacists reported an ADR. Differences in the reporting rates between the healthcare professionals were statistically significant (calculations available from the authors). Nurses reported 66 (6.5%), physicians 589 (58.1%) and pharmacists 357 (35.2%) ADRs, respectively. The mean number of ADRs spontaneously reported by each nurse, physician ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
The role of nursing professionals in pharmacovigilance
1860 Spontaneous Reports (SR) of adverse drug reactions (ADRs) received in UFC
847 SR did not meet at least one of the secondary inclusion criteria
1014 SR of ADRs met the inclusion criteria
Previous description
Seriousness
Causality assessment
154 (15.2%)* unknown ADRs
441 (43.5%)* serious ADRs
633 (62.4%)* certain or probable ADRs
46 ADRs simultaneously unknown serious certain or probable
Nurses (46 ADRs)
Physicians (387 ADRs)
Pharmacists (198 ADRs)
Seriousness according to healthcare professionals
192 serious ADRs
21 serious ADRs
77 serious ADRs
*An ADR is assessed according to its previous description, seriousness and causality. For instance, a single ADR can be simultaneously assessed as unknown, serious and certain. It is not correct to sum the number of ADRs which were classified in one group (for instance, serious) with the ADRs classified in another group (for instance, certain).
Figure 1 Flowchart of the study.
Table 1 Adverse drug reactions according to their seriousness, previous description and causality assessment Causality assessed Seriousness Serious Non-Serious Total
Previous description Known Unknown Known Unknown
Certain
Probable
Possible
158 21 130 8 317
87 25 180 24 316
91 22 125 23 261
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Unlikely 8 1 9 4 22
Conditional/ Unclassified 5 2 17 8 32
Unassessable/ Unclassifiable
Total
17 4 33 12 66
366 75 494 79 1014
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Table 2 Examples of adverse drug reactions (ADRs) classified as certain or probable Healthcare professionals Nurses Physicians Pharmacists
ATC classification of the suspected medicine
Suspected ADR
Genitourinary system and sex hormones Anti-infectives products for systemic use Anti-infectives products for systemic use Anti-infectives products for systemic use Anti-infectives products for systemic use Antineoplasic and immunomodulating agents
Fetal tachycardia Pustular acne Toxicodermia Tonic seizure Taste metallic Anaphylactic shock
Previous description
Seriousnesss
Causality
Known Unknown Known Unknown Unknown Known
Serious Non-serious Serious Serious Non-serious Serious
Probable Probable Probable Certain Probable Certain
ATC, Anatomical Therapeutic Chemical Classification; ADR, adverse drug reaction. Suspected ADRs classified according to MedDRA in the Lowest Level Term (LLT).
Table 3 Healthcare professionals (HP) and adverse drug reactions (ADRs) according to the origin of the spontaneous reports Origin of report
Healthcare professionals (HP) Nurses Physicians Pharmacists Pharmacy Technicians Total ADRs Total HP
Ambulatory care
Hospital
Pharmacy
Other
Total
ADRs per HP
HP
ADRs
HP
ADRs
HP
ADRs
HP
ADRs
HP
ADRs
38 120 – –
43 390 – –
16 107 21 –
23 191 114 –
– – 119 2
– – 238 2
–
–
54 232 145 2
66 589 357 2
433 158
328 144
5 5 –
240 121
8 5 – 13
10
Average 1.2 2.5 2.3 1
1014 433
HP, number of healthcare professionals that reported suspected ADRs.
and pharmacist was 1.2, 2.5 and 2.3, respectively. Two pharmacy technicians reported two suspected ADRs.
Table 4 Differences between the proportions of serious adverse drug reactions (ADRs) reported by each professional group
Seriousness of ADRs and the reporting healthcare professional
Comparisons
Nurses, physicians and pharmacists reported 21 (45.7%), 192 (49.6%) and 77 (38.9%) serious ADRs, respectively (Fig. 1). There was no differences between nurses and physicians in the reporting of serious ADRs [(v2 = 0.258, d.f. = 1, P = 0.61); (OR = 0.85; 95% CI = 0.46, 1.58)] (Table 4). When nurses were compared with pharmacists no differences were observed [(v2 = 0.710, d.f. = 1, P = 0.40); (OR = 1.32; 95% CI = 0.71, 2.44)]. Physicians reported a higher proportion of serious ADRs than pharmacists [(v2 = 6.064, d.f. = 1, P = 0.01); (OR = 1.55; 95% CI = 1.09, 2.19)].
Characteristics of drugs The Anatomical Therapeutic Chemical classification groups of drugs suspected of causing ADRs are listed 326
Nurses vs. physicians Nurses vs. pharmacists Physicians vs. pharmacists
P
OR (95% CI)
0.61 0.40 0.01*
0.85 (0.46, 1.58) 1.32 (0.71, 2.44) 1.55 (1.09, 2.19)*
OR, odds ratio. *Significant at the 0.05 level (two-sided).
in Table 5. The drugs most commonly reported as responsible for the ADRs were anti-infectives for systemic use (including vaccines; n = 270; 26.6%), drugs active on the muscle–skeletal system (n = 153; 15.1%), on the cardiovascular system (n = 147; 14.5%), on the nervous system (n = 140; 13.8%) and antineoplasic and immunomodulating agents (n = 128; 12.6%). These five groups of drugs were responsible for 82.6% of all ADRs. Anti-infectives for systemic use were the drugs most frequently suspected of causing adverse reactions in ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
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Table 5 Anatomical therapeutic chemical classification of drugs suspected of causing adverse drug reactions (ADRs) ADRs by healthcare professional
Anatomical therapeutic chemical groups - first level (J) Anti-infectives products for systemic use (M) Musculo-skeletal system (C) Cardiovascular system (N) Nervous System (L) Antineoplasic and immunomodulating agents (A) Gastrointestinal tract (B) Blood and blood forming organs (G) Genitourinary system and sex hormones (R) Respiratory system (D) Dermatological (H) Endocrine systemic (S) Sensory organs (V) Various (P) Antiparasitic products, insecticides and repellents Total
Nurse
Physician
Pharmacist
n
(%)
n
(%)
n
(%)
47
(71.2)
156
(26.5)
67
(18.8)
0 1 8 2
(0.0) (1.5) (12.1) (3.0)
110 98 83 42
(18.7) (16.6) (14.1) (7.1)
42 48 49 84
1 3 4
(1.5) (4.5) (6.1)
26 18 14
(4.4) (3.1) (2.4)
0 0 0 0 0 0
(0.0) (0.0) (0.0) (0.0) (0.0) (0.0)
13 11 11 2 4 1
(2.2) (1.9) (1.9) (0.3) (0.7) (0.2)
66
100
589
100
Serious, unknown certain or probable ADRs
Total (%)
n
(%)
270
(26.6)
21
(45.7)
(11.8) (13.4) (13.7) (23.5)
153* 147 140 128
(15.1) (14.5) (13.8) (12.6)
6 4 3 5
(13.0) (8.7) (6.5) (10.9)
21 7 10
(5.9) (2.0) (2.8)
48 28 28
(4.7) (2.8) (2.8)
1 0 1
(2.2) (0.0) (2.2)
14 7 4 3 0 1
(3.9) (2.0) (1.1) (0.8) (0.0) (0.3)
27 18 15 6* 4 2
(2.7) (1.8) (1.5) (0.6) (0.4) (0.2)
2 1 1 1 0 0
(4.3) (2.2) (2.2) (2.2) (0.0) (0.0)
357
100
n
1014*
100
46
100
*Two ADRs were reported by pharmacy technicians.
reports from nurses (n = 47; 71.2%) and physicians (n = 156; 26.5%) whereas antineoplasic and immunomodulating agents were the drugs most commonly reported by pharmacists (n = 84; 23.5%). Of the ADRs reported by nurses, 40 (60.6%) were related to vaccines. Physicians and pharmacists reported 64 (10.9%) and 15 (4.2%) ADRs related to vaccines, respectively. Table 5 also displays the 46 simultaneously unknown, serious, certain or probable ADRs according to the Anatomical Therapeutic Chemical classification groups. Of these reactions, the anti-infectives for systemic use, accounting for 45.7%, were the drugs most commonly reported.
Discussion Spontaneous reporting is of great value in identifying ADRs and in monitoring the safety of marketed drugs (Lawson & Beard 2007). The usefulness of the spontaneous reporting schemes is reflected by the 15.2% of ADRs received by the Central Portugal Regional Pharmacovigilance Unit which were assessed as unknown. About 40% of the ADRs reported to the Central Portugal Regional Pharmacovigilance Unit were assessed ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
as serious. This result is in line with the findings of two Swedish studies, although higher rates have been found in a study conducted in the United Kingdom (Ba¨ckstro¨m et al. 2007, Ulfvarson et al. 2007 and McLernon et al. 2010). Over half of the suspected ADRs were assessed as certain or probable. These levels of causality represent a strong association between the suspected drug and the adverse event reported. The identification of ADRs assessed simultaneously as unknown, serious and certain or probable is a valuable contribute to increase knowledge on the safety profiles of drugs. Such reactions accounted for 4.5% of all cases analysed in our study, revealing the importance of the activity of the Pharmacovigilance Unit in producing knowledge on the field of drug safety. Previous studies pointed out that the nursing profession is able to detect and identify suspected ADRs (Hall et al. 1995, Ba¨ckstro¨m et al. 2002, 2007, Morrison-Griffiths et al. 2003, Ulfvarson et al. 2007, Macedo et al. 2011,). In Central Portugal, the number of nurse practitioners is superior to the number of physicians and pharmacists (Statistics Portugal 2011). However, according to our results, the number of nurses reporting suspected ADRs was inferior to the number of physicians and pharmacists involved in this 327
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process. The majority of the spontaneous reports were sent by physicians. In 2010, the number of reports from nurses was 21% of total reports in the United Kingdom, increasing compared with 2009 (Medicines & Healthcare products Regulatory Agency 2011). Between 2004 and 2010, 2.6% of the total reports registered in the Italian pharmacovigilance database were from nurses (Conforti et al. 2012). The relative contribution of the nursing profession to the global amount of spontaneous reports in Central Portugal was lower than in the United Kingdom but higher than in Italy. Unlike other countries, the nursing profession has been present in the Portuguese pharmacovigilance system since its creation in 1992 (Public Law 1992). For example, in the United Kingdom, the added value of the inclusion of nurses as reporters was evaluated prior to the acceptance of the nursing profession in the spontaneous reporting system. This was the case during the meningitis C vaccination campaign. Nurse reports received during the vaccination campaign have been used by the regulatory authorities to evaluate the contribution of this group to pharmacovigilance. As a result of that evaluation, the regulatory authorities have decided to extend the spontaneous reporting system to nurses in October 2002 (Davis et al. 2007). The findings of our study suggest that the Portuguese nurses are not fully committed to the spontaneous reporting of suspected ADRs. Further studies should be conducted in order to investigate the reasons why these professionals did not yet achieve a greater involvement in this system. The proportion of ADRs reactions reported by each healthcare profession was investigated. We found no statistically significant differences between nurses and physicians and nurses and pharmacists. Nevertheless, differences were found between physicians and pharmacists, which are in line with the conclusions of a Dutch study (van Grootheest et al. 2002). Although a previous study described that nurses reported less serious ADRs than physicians (van den Bemt et al. 1999), our results are close to those of other studies where these reactions were reported in the same proportion by nurses and physicians (Hall et al. 1995, Ba¨ckstro¨m et al. 2002, 2007). The majority of ADRs reported by the nursing professionals were related to anti-infectives for systemic use, namely vaccines. Vaccines are frequently administered by nurses and, therefore, they are in a good position to recognize adverse events that occur within the administration of vaccines (Ranganathan et al. 2003). The differences in the distribution of suspected drugs among nurses, physicians and pharmacists are 328
in relation to their different roles in the management of pharmacotherapy and their relationship with patients (Conforti et al. 2012). A limitation of this study is the under-reporting, which is common to all spontaneous reporting schemes. It is estimated that only 5–10% of all ADRs are reported (Rawlings 1988, Alvarez-Requejo et al. 1998). Another limitation is the lack of data on drug exposure. Therefore it is not possible to calculate incidence rates of ADRs. Finally, this study focused on a single region of Portugal and the results cannot be generalized to the country as a whole or to other countries. Multinational studies should be carried out in order to characterize the spontaneous reporting systems and to identify the contribution of the different healthcare professionals to pharmacovigilance.
Implications for Nursing Management The contribution of the nursing profession to pharmacovigilance in central Portugal was found to be less than that of physicians and pharmacists. Therefore, nurses need to increase their involvement in pharmacovigilance activities. Nurses have a close contact with patients because of their clinical activities. In their daily work, nurses’ involvement in the routine care of patients, namely in the management of chronic conditions, places them in a clinical position in which they are increasingly likely to observe suspected adverse reactions. Furthermore, they are aware of the clinical status and the medication used by patients. The causality assessment depends upon the available data included in the cases (Agbabiaka et al. 2008). There are barriers to the spontaneous reporting common to all healthcare professionals: (1) recognition and correct diagnosis of the clinical event; (2) a lack of attribution of an event to a drug exposure; and (3) registration of the event (Graham et al. 2000). These barriers generally reduce the level of reporting of adverse drug reactions (Inman & Weber 1986). Furthermore, the lack of knowledge about drug safety and a theory–practice gap in pharmacology education of nurses are limiting factors for their performance in pharmacotherapeutic activities (Leape et al. 1995, King 2004, Kyriacos et al. 2005). In order to overcome these limitations, educational programmes and training given to these healthcare professionals may increase their skills. For instance, the participation of nurses in active surveillance programmes promoted by Italian regional centres of pharmacovigilance led to a significant increase in spontaneous reporting by nurses ª 2012 John Wiley & Sons Ltd Journal of Nursing Management, 2014, 22, 322–330
The role of nursing professionals in pharmacovigilance
(Conforti et al. 2012). In the United States of America, a nurse-led multidisciplinary project provided education for nurses resulting in an improvement of knowledge about drug safety and in a significant increase in the reporting of ADRs (Valente & Murray 2011). Furthermore, a Belgian study about the nurses’ involvement in pharmacotherapeutic activities pointed out that higher educational levels of nurses were associated with a greater involvement in identifying adverse reactions (Dilles et al. 2010). Therefore, educational sessions on pharmacovigilance activities aimed at the nursing profession need to be carried out. Our findings support the view that nurses are able to identify ADRs although they have not reported as much as the other healthcare professionals. As an implication for nursing management, it is suggested that nurses increase their involvement in spontaneous reporting schemes by undertaking responsibility in routinely reporting suspected ADRs. Pharmacovigilance centres should organise educational programmes for the nursing profession.
Conflict of interest The authors do not have any conflict of interests.
Source of funding The authors did not receive any financial support to conduct this study.
Ethical approval This research project did not require ethics approval because it only involved truly anonymised and aggregated data.
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Supporting information Additional Supporting Information may be found in the online version of this article: Table S1. WHO-UMC causality categories.
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