An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey.

This study aimed to evaluate the awareness of nurse/midwives regarding pharmacovigilance as well as their knowledge and experience in identifying and reporting adverse reactions of drugs. Nurse/midwives (n = 329), working in four state hospitals, were provided a questionnaire with a view of identifying their knowledge and skills pertaining to pharmacovigilance. Around 45% of the participants claimed to have knowledge of pharmacovigilance but only 23.3% of them could define it correctly. Although 24.3% of the participants acknowledged that adverse reactions should be reported to a centre, only 1.2% of them named this centre (Turkey Pharmacovigilance Centre-TUFAM). The present study indicates that nurse/midwives have insufficient knowledge of pharmacovigilance practices. Hence, it is essential to include pharmacovigilance training in their undergraduate and graduate education programs, and to promote reporting of adverse reactions.

Introduction

Pharmacovigilance is defined as “a multidisciplinary field which studies the science and activities relating to the detection, assessment, understanding, and prevention of adverse reactions of drugs”.[1] Pharmacovigilance system in Turkey was started in 2005 as Turkey Pharmacovigilance Centre (TUFAM), a part of Ministry of Health General Directorate for Pharmaceuticals and Pharmacy, Republic of Turkey. Pharmacovigilance contact points were created which were responsible for encouraging health institutions to report adverse reactions, collect pharmacovigilance data, and convey them to TUFAM, and to organize training sessions when necessary.

Under-reporting of adverse drug reactions (ADRs) is very common. Healthcare professionals need to be sensitized and motivated regarding ADR reporting.[23] Many a times, nurses/midwives, being the first contact with patients throughout the day, also need to be sensitized regarding the reporting culture. Principles of safety of medicines are essential in nursery/midwifery practices which require the right medicine to be given to the right patient in the right way and dose, and at the right time. They observe the effects and adverse reactions of medicines after implementation and take interventions accordingly.[45] Only a few studies evaluating the awareness of nurse/midwives regarding pharmacovigilance have been conducted.[678] Hence, this study was aimed at evaluating the awareness and practice of nurse/midwives regarding pharmacovigilance.

Materials and Methods

This cross sectional study was conducted in four state hospitals located in the city of Adana from April to May 2010. The midwife/nurses who were on duty during the time the study was conducted and those who consented to participate were enrolled in the study. Those who worked in internal medicine, surgery, paediatrics, and intensive care units were included in the study. Emergency services and surgical theatres were excluded. Ethical approval was obtained from the ethical review board of Cukurova University. The participants were informed about the aims of the study and their verbal consent was obtained before the study was conducted.

A questionnaire was developed comprising 27 questions, which included questions regarding demographic details, knowledge, and attitude regarding adverse reactions and pharmacovigilance. The practice of principles of safety of medicines as mentioned above by the participants was also assessed. The questionnaire was first administered to 12 nurses/midwives (three from each hospital), who were not included in the final participants. In light of the suggestions, the questionnaire was revised.

Statistical analysis of the data was performed using SPSS version 17.0. Categorical measurements (e.g., gender and education level) were presented in numbers and percentages while continuous data (e.g., age and knowledge score) were presented using mean and standard deviation (median and minimum-maximum values when necessary). The comparison of the categorical measurements was performed using Chi-square test, comparison of the continuous measurements such as knowledge score was conducted using independent samples t-test, and the comparison of more than two groups was analyzed using one way ANOVA. P value of less than 0.05 was considered statistically significant.

Results

A total of 389 nurses/midwives participated in the study. It was found that average age of the nurse/midwives participating in the study was 31.9 ± 0.72 years (range 18 to 57 years), average years of experience was 10.26 ± 0.79 years (range 0 to 40 years) and average working hours in a week was 43.25 ± 54 (range 40 to 64 hours). Of all the participants, 43.2% have a Bachelors degree and 32.5% work in surgical units. The most common drug groups causing adverse drug reactions as identified by the participants were antibiotics (38.6%) and analgesics (8.8%).

Table 1 included the knowledge, attitudes, and practice of the participants about pharmacovigilance. Around 45% of the participants claimed to have knowledge of pharmacovigilance, but only 23.3% could correctly define it. The correct definitions were associated with those participants who worked in intensive care units (52.5%), graduated from medical vocational high schools (51.6%), and who had over 20 years of experience in profession (57.9%). It was found that 24.3% of the nurse/midwives acknowledged the necessity of reporting the adverse reactions to a centre, but the percentage of those who gave the name of this centre (TUFAM) was only 1.2%. Of those who knew the centre, 25% had a masters degree; this finding was found to be statistically significant (P < 0.05).

Table 1

Knowledge, attitudes, and practice of participants regarding pharmacovigilance (n = 329)

About 65% of the participants admitted to encountering adverse reactions during their work. The clinics were adverse reactions were frequently encountered were internal medicine services (78.2%), paediatric services (70%), surgical services (61.7%), polyclinics (42.9%), and intensive care units (21.9%). A statistically significant relationship was detected between the clinics the participants work and encounter of adverse reactions (P < 0.05).

Table 2 demonstrates the practices of the participants with regard to their medication practices. Majority of the participants stated that they check the expiry date, read the instructions, and check drug interaction. The ratio of noticing the mistakes in medication ranges from 30% to 58%. Administering wrong dose of medication was found to be highest in surgical services, and lowest in intensive care units; the difference was found to be statistically significant (P < 0.05).

Table 2

Comparision between change in tail flick latency after treatment with amlodipine and its combination with tramadol

Discussion

ADRs are one of the most serious worldwide health problems globally, and Turkey is no exception. Rational drug use lays down an ethical burden on the shoulders of doctors, nurse/midwives, and all health professionals to ensure the proper treatment of their patients. One of its components is to report ADRs to the concerned system.

Our study aimed to evaluate the knowledge, attitude and practices of the nurses/midwives regarding pharmacovigilance. It was observed that only 23.3% of the participants could define pharmacovigilance correctly and antibiotics were the most common drug group identified. Similarly, a study reported that antibiotics and anti-cancer drugs were identified as the common drug groups by doctors and nurses respectively.[9]

A review by Shepherd[10] found that the adverse reactions were encountered by 1.6% and 41.4% of the healthcare professionals, while the present study found a prevalence of 65.3%. This percentage may seem to be higher than the ones in literature, but the participants are thought to have indicated any adverse reactions they have encountered in their entire professional career. Although 24.3% of the nurse/midwives stated they acknowledged that they should report adverse reactions to a centre (TUFAM), the percentage of those who knew the name of the centre correctly was very low (1.2%). Given the fact that the majority of those who knew that adverse reactions should be reported to a centre had at least a bachelor degree (43.3%), the importance of nursing/midwifery education becomes apparent. Overall, low knowledge and practice was observed in the participants.

The comparison of the percentage of encountering adverse reactions according to the clinics showed that adverse reactions were most common in internal medicine services (78.2%) and least in intensive care units (21.9%). Adverse reactions in the intensive care units were relatively less encountered in spite of greater chances of polypharmacy. This was in contrast to a study conducted by George et al.[11] where adverse effects were more commonly seen in intensive care units.

Although the nurse/midwives were responsive to checking the expiry date of medicines (84.2%) and reading instructions (91.5%) before medication, they were less careful in checking the drug interactions (60.8%). Taking into consideration that drug interaction may cause serious adverse reactions, improvement is this aspect is needed. Administering wrong doses was found to be encountered mostly in surgery clinics and least frequently in intensive care units. This can be as a result of high patient circulation and patient load in the surgery clinics.

The present study indicates that nurse/midwives working in different hospitals located in Adana have insufficient knowledge of pharmacovigilance practices. It is therefore suggested that undergraduate and graduate programs should include pharmacovigilance training and insist on the principles of medicine safety. It is essential to increase the responsiveness of the health professionals on the issue, to develop a database of adverse reaction reports and to apply this information for improving safety in therapeutics.