Vol-7, Special Issue3-April, 2016, pp2283-2291 http://www.bipublication.com
Case Report
Investigating Pharmacovigilance Challenges by Nurses of Hospitals Dependent
on Medical Sciences University of Ahvaz City
1
Azam Cheraghi Seyfabad,2*Reza Mannani
and 3SayedaliNaji
1MSc nursing Education, Department of Nursing and Midwifery,
Isfahan(Khorasgan)Branch, Islamic Azad University, Isfahan, IRAN 2
Assistant Professor Ph.D in Pharmacology,
Department of Nursing and Midwifery, Isfahan(Khorasgan)Branch, Islamic Azad University, Isfahan, IRAN
3Instructore of nursing Ph.D in Nursing Education,
Department of Nursing and Midwifery, Isfahan(Khorasgan)Branch, Islamic Azad University, Isfahan, IRAN
* Corresponding author email: Mannani.reza@gmail.com
ABSTRACT
The present research was conducted in 2015 with purpose of determining pharmacovigilance challenges by nurses of Ahvaz hospitals. The method of research was descriptive and analytical. Research population included nurses of hospitals dependent on Medical Sciences University of Ahvaz that contained 8 hospitals. The number of research samples was estimated to be 259 persons. And data collection tool was a researcher-made questionnaire which evaluated 7 aspects of nurses’ drug safety issues; and in order to analyze questions the mean value of questions was calculated using SPSS Version 20 Software. Research findings showed that nurses were mostly women and married, had university degree of B.A and have participated in training courses in relation to drug safety issues. Most members of working shift were busy with working and employment of most of them was contractual. The main challenges were respectively as following: the field of record and report-writing with mean and standard deviation of observing drug safety standards score as equal to 17/96±17/41; the field of after drug treatment with mean and standard deviation of observing drug safety standards score as equal to18/28±2/42; the field of pharmaceutical services management with mean and standard deviation of observing drug safety standards score as equal to 24/58±2/76; field of patient preparation with mean and standard deviation of observing drug safety standards score as equal to 27/78±2/62; field drug provision with mean and standard deviation of observing drug safety standards score as equal to 35/67±2/87; field of receiving pharmaceutical orders with mean and standard deviation of observing drug safety standards score as equal to 40/12±3/19 and maintenance and preparation of drug with mean and standard deviation of observing drug safety standards score as equal to 42/21±4/22. The highest challenge was related to record and report-writing index and the lowest challenge was related to maintenance and preparation of drug.
Keywords: pharmacovigilance (drug safety), pharmaceutical challenges, pharmacology, Nursing
INTRODUCTION
At the present time patient care is a complicated process; the reason of this complicacy is due to
(ICU) and nurses of surgical section, transfer of liability and accountability in patient care program (Chaboyerand et al, 2012). Nursing education as a part of higher education system is developing with a high speed in the present world which has increased concerns in relation to the quality of education of this field (Kim and et al, 2010).To be certain of correct use of medicines, nurses shall observe correct principles of drug prescription including correct patient, correct medicine, correct dosage, correct method and correct time so that to minimize medication errors. Effective pharmaceutical management is a nursing operation that connects scientific ability, technical skills and practices based on observance of regulations. Moreover standards of prescribing medication by nurses must be done with precise examination of healthcare provider, appropriateness of prescribed medication, condition of systems and vital signs and in the event of non-existence of any suspected case it must be acted in accordance with physician’s prescription. After drug intake, its operation should be investigated precisely and the resulting changes and expected and unexpected symptoms should be recorded and reported (Haghus& Ortiz, 2005). The patients transferred from ICU to surgical section are considered as vulnerable groupand compared with other patients hospitalized at these sections require a higher level of attention and care but most nurses working in surgical sections do not have the required knowledge and skill take nursing measures appropriate with mood these patients (Endacott and et al, 2010). Nonobservance of medication standards and occurrence of medication errors had led to distrust and dissatisfaction of patients from systems providing health care services which can cause serious errors in nurses’ work and create anxiety and ethical conflicts for nurses (Rezayi, 2011). Pharmaceutical challenges refer to any kind of error in pharmaceutical process whether it leads to adverse drug reaction or not, including prescription, duplication, preparation, dispensing a
prescription order and giving the ordered medication. On the other hand pharmaceutical challengeis defined as any preventable consequence as a result of incorrect use of drugs which may hurt the patient (Jolayi, 2009). Also, pharmacovigilanceis on the basis of relation between patient and health care providers who have taken responsibility. This concept requires active participation of patient in therapeutic decision-makings and interdisciplinary cooperation of all providers of health care services and its main priority is direct benefit of patient (Morak, 2010).
Prescribing medication to the patients is a complicated process and needs consciousness, decision-making and proper action of employees working in different sections of a hospital. Medication errors can occur at any point of medication prescription (Cassiani, 2005). Lack of standards of prescribing medication and medication errors which refer to improper and preventable usage of drug may occur at any point of dispensing prescription order, prescription or controlling drugs (Smeltzer& Bare, 2004). Detected prevalent errors in medication prescription include error in prescription, nonobservance of correct time of drug, nonobservance of correct method of prescribing medication, overdose, error in density of drug and mistakenly giving drug to another patient due to lack of recognition. Medication errors may lead to prescription of wrong drug or may hurt the patient. These kinds of nurses’ errors not only hurt the patient but may also deface nursing career. Drug prescription standards are acceptable levels of care in taking care or professional practices of patients and specialized strategies in clinical actions are a collection of sentences that specify title of proper actions for skillful acts or conditions; these strategies suggest standards of taking care of patient and assessment of the care in patients with similar diagnosis (Wilson &Goskowicz, 2000).
hospital and society. Nurses as providers of one of the major health care skills spending most of their time interacting with patients, shall have a sufficient degree of pharmacology knowledge so to provide a safe and qualified care. In order to achieve this, nurses should check the patients before giving drug, plan care goals, prescribe drugs safely and effectively and then assess effectiveness of prescribed drugs; moreover they need to talk with patients about their drugs and assist physician or pharmacist in handling potential problems and regulating care goals. To create these kinds of specifications in nurses, it is essential to learn knowledge and skill of pharmacotherapy (Manias,2012). The progress and improvement of technology in the present world has made challenging the fulfillment of quality and standard of taking care; cases such as transfusion equipment, rehabilitation, monitoring and wound care can be mentioned as instances. All of these can potentially escalate quality of services provided by health specialists. Nevertheless there is still a question mark on whether the employees have knowledge, competence and skill to safely use the equipment or not. In the current situation, the required time and resources to educate and empower employees is very restricted in their tensioned working atmosphere. The stress and tension that nowadays the health care providers are subjected to, require provision of qualified services creating opposition between balance of efficiency, effectiveness and maintenance of quality and standards. Moreover research indicates that lack of pharmacotherapy knowledge, incorrect pharmacological calculations, nonobservance of scheduled protocols, bad handwriting of physicians, existence of similarities and errors in shape and packages of drugs and nominal similarities of drugs are among cases that have role in medication errors and challenges. Besides these, issues such as lack of time, exhaustion, insufficient number of personnel and nonexistence or lack of facilities are among hidden issues indirectly affecting medication errors and
challenges (Baghchi&Koohestan, 2009). Taking care of patients is the major work of nurses and medication orders are an important part of treatment and care process of patient. Nurses have a significant role in preventing medication errors because they play the main role in pharmaceutical process (Unver& et al, 2012). But unfortunately the important task of giving drugs to the patients is disregarded by some nurses (Panjvini& et al, 2006). Pharmaceutical challenges make the hospitalization time longer and escalate treatment costs and can create distrust and dissatisfaction of patients from providers of health care system and also make nurses anxious and stressful (Jolayi& et al, 2009). Medication errors is one of the 5 groups of Medical errors classified by American Medical Institute and is also a global problem which can lead to serious harm and even death of patients (Jolayi& et al, 2009).
Pharmaceutical challenge is a preventable event that can lead to improper drug use or hurt patient; whereas drugs are under control of health care providers or patient (Choo& et al, 2010). Therefore the present research investigates challenges of pharmacovigilanceby nurses of Ahvaz Hospitals.
Research Methodology, Population and Statistical Sample
The research method is descriptive-applied. Research population include all nurses of hospitals dependent on Medical Sciences University of Ahvaz including 8 hospitals of IMAM, ABUZAR, RAZI, GOLESTAN, SHAFA, TALEGANI, SALAMAT and SINA. The sampling method is convenience sampling and 259 persons are chosen as research population.
Research Tools
face validity technique is used in order to specify validity of questionnaire; this technique was investigated and approve. Also reliability of questionnaire is calculated using Cronbach’s alpha among 40 samples of participants. The resulting amount of Cronbach’s alpha is between 0.758 and 0.846; this number is above 0.7 and therefore indicates that internal correlation of items is high.
In the present research the descriptive method is used to analyze data. In order to describe research units including frequency, percentage, mean, and standard deviation, the descriptive statistical methods are used and in order to analyze questions the method of calculating mean of questions using SPSS version 20 is used.
RESEARCH FINDINGS
Table No.1 Mean and Standard Deviation of Score of Observing Drug SafetyStandards in the Field of Receiving Pharmaceutical Orders in terms of Questions of Questionnaire
Questions Mean SD
1- Pharmaceutical prescriptions given by physician are legible. 3.04 0.96
2- You receive pharmaceutical prescriptions on time and without any problem. 3.69 0.62
3- Pharmaceutical prescriptions are written by physician in a complete way. 2.62 0.68
4- In pharmaceutical prescriptions, name of the drug is clear. 3.13 0.70
5- In pharmaceutical prescriptions the way of taking drug is written clearly. 2.50 0.89
6- You check the name of drug with what is written in prescription. 4.47 0.64
7- In Pharmaceutical prescriptions dose of drug is specified. 4.66 0.84
8- You check the expiration date of prescription. 2.69 0.85
9- In Pharmaceutical prescriptions the controls before giving drug to patient are specified by physician. 3.52 0.87
10- In Pharmaceutical prescriptions, time of taking drug is precisely determined by physician. 4.88 0.44
11- You seal under the pharmaceutical prescriptions after receiving them. 4.87 0.52
Findings of table 1 indicate that respectively the question number 5 (In pharmaceutical prescriptions the way of taking drug is written clearly) has the lowest score with mean and standard deviation of 2.5±0.89 and then question number 3 (Pharmaceutical prescriptions are written by physician in a complete way) with mean and standard deviation of 2.62±0.68 and question number 8 (you check the expiration date of prescription) with mean and standard deviation of 2.69±0.85.
Table No.2Mean and Standard Deviation of Score of Observing Drug Safety Standards in the Field of maintenance and Preparation of Drug in terms of Questions of Questionnaire
Questions Mean SD
1- To observe aseptic and safety principles before start working. 4.83 0.43
2- To arrange neatly drug containers and drug Trali. 4.69 0.73
3- To check drug cards of every patient. 3.01 0.97
4- To prepare drugs for each patient individually. 3.57 0.90
5- To check drug label in regard of its name, expiration date and using method. 3.40 0.88
6- To check appearance of drug in regard of color, transparency and existence of external particles. 4.51 0.83
7- To be able to calculate doses of drugs. 3.40 1.13
8- To prepare drugs in terms of written usage method. 3.80 0.80
9- To separate drugs having similar appearances. 3.17 0.86
10- To know and recognize the drugs that must to be kept in refrigerator and term of their refrigeration. 3.95 0.76 11- To have enough knowledge of methods of keeping drugs that must be kept in special conditions
(away from light). 3.83 0.91
question number 5 (To check drug label in regard of its name, expiration date and using method)with mean and strandard deviation of 3.40±0.88.
Table No.3Mean and Standard Deviation of Score of Observing Drug Safety Standards in the Field of Preparation of Patient to Receive Drug in terms of Questions of Questionnaire
Questions Mean SD
1- To explain patient, the purpose of giving drug and its effects. 3.53 0.85
2- To do the required investigations before giving a special drug. 4.30 0.72
3- To pay attention to drug interactions with diet of patient (citrus or warfarin) 4.32 0.99
4- To calm patient while preparing him to receive drug. 2.96 0.17
5- To educate the patient signs of adverse effects of drugs. 4.33 0.93
6- To pay attention to the patient’s warning about drug difference. 4.66 0.68
7- To educate the patient about needed cautions before after drug intake. 3.64 0.15
Findings of tabe 3 indicate that respectively question number 4 (To calm patient while preparing him to receive drug)has the lowest score with mean and standard deviation of 2.96±0.17 and after that question number 1 (To explain patient, the purpose of giving drug and its effects) with mean and standard deviation of 3.53±0.85 and then question number 7 (To educate the patient about needed cautions before after drug intake) with mean and standard deviation of 3.64±0.15.
Table No.4 Mean and Standard Deviation of Score of Observing Drug Safety Standards in the Field of Giving Drug to Patient in terms of Questions of Questionnaire
Questions Mean SD
1- To give drug, the label on it (tablet, liquid, powder) is controlled 3 times: before, at the time of
giving it and after 2.22 0.42
2- To control the correct dose of drug. 4.41 0.88
3- To prepare drug based on their method of taking. 4.09 0.66
4- To precisely monitor the condition of patient while giving drug. 3.60 0.73
5- To consider the exact time of giving drug. 4.33 0.58
6- To check the type of drug used by patient before giving it. 4.49 0.73
7- To control the method of giving drug before giving it. 3.52 0.98
8- To ask for permission of patient before giving drug. 2.48 0.78
9- To separate drugs having similar appearances. 3.17 0.86
10- To ask name of the patient before giving him the drug. 2.84 0.80
11- To study the last report of nurse before giving drug to the patient. 3.64 0.74
Findings of table 4 indicate that respectively question number 1 (To give drug, the label on it (tablet, liquid, powder) is controlled 3 times: before, at the time of giving it and after) has lowest score with mean and standard deviation of 2.22±0.42 and then question number 8 (To ask for permission from patient before giving drug) with mean and standard deviation of 2.48±0.78 and question number 9 (To separate drugs having similar appearances)with mean and standard deviation of 2.84±0.80.
Table No.5 Mean and Standard Deviation of Score of Observing Drug Safety Standards in the Field of Taking Care after Giving Drug in terms of Questions of Questionnaire
Questions Mean SD
1- To monitor condition of patient after giving drug. 2.94 0.78
2- To continuously check patient physically and psychologically after giving drug. 2.58 0.90
3- To monitor patient until the end of drug intake. 3.83 0.75
4- To immediately inform physician the signs of drug toxicity in patients. 4.61 0.77
Findings of table 5 indicate that respectively question number 2 (To continuously check patient physically and psychologically after giving drug) has lowest score with mean and standard deviation of 2.58±0.90 and then question number 1 (To monitor condition of patient after giving drug) with mean and standard deviation of 2.94±0.78 and question number 3 (To monitor patient until the end of drug intake.) with mean and standard deviation of 3.83±0.75.
Table No.6 Mean and Standard Deviation of Score of Observing Drug Safety Standards in the Field of Record and Report-Writing in terms of Questions of Questionnaire
Questions Mean SD
1- To record the drug given to the patient in terms of their name, time, dose, type of drug and method
of intake. 4.77 0.45
2- To record condition of patient including blood pressure, pulse and the resulting changes. 4.55 0.52
3- To record nursing interventions and special cases such as rejection of taking drug by patient due to
any reason. 4.54 0.63
4- To precisely study reports recorded previously. 4.07 0.73
Findings of table 5 indicate that respectively question number 4 (To precisely study reports recorded previously) has lowest score with mean and standard deviation of 4.07±0.73 and then question number 3 (To record nursing interventions and special cases such as rejection of taking drug by patient due to any reason. with mean and standard deviation of 4.54±0.63 and question number 2 (To record condition of patient including blood pressure, pulse and the resulting changes) with mean and standard deviation of 4.55±0.52.
Table No.7 Mean and Standard Deviation of Score of Observing Drug Safety Standards in the Field of Pharmaceutical Services Management in terms of Questions of Questionnaire
Questions Mean SD
1- The required drugs of the patient exist in the section. 3.67 0.59
2- In the event of emergency the required facilities exist in the section. 3.72 0.68
3- The resuscitation team can be accessed easily. 4.25 0.77
4- The required facilities to give drug such as drug container, card and trali exist in the
section. 4.27 1.02
5- The pharmacist is accessible for 24 hours. 2.70 0.95
6- The drugstore of hospital is open for 24 hours. 2.43 0.94
7- Giving drug to the patients is monitored sufficiently. 3.50 0.74
Findings of table 7 indicate that respectively question number 6 (The drugstore of hospital is open for 24 hours.) has lowest score with mean and standard deviation of 2.43±0.94 and then question number 5 (The pharmacist is accessible for 24 hours) with mean and standard deviation of 2.70±0.95 and question number 7 (Giving drug to the patients is monitored sufficiently) with mean and standard deviation of 3.50±0.74. Table No.8Mean and Standard Deviation of Score of Observing Drug Safety Standards in terms of Different Fields
Variable Mean SD
Receiving Orders 40.12 3.19
Maintenance and Preparation 42.12 4.22
Preparing Patient 27.78 2.62
Drug Provision 35.67 2.87
After Drug Treatment 18.28 2.42
Record and Report Writing 17.96 17.41
Pharmaceutical Services Management 24.58 2.76
drug safety standards as equal to 24.58±2.76; and field of preparing the patient with mean and standard deviation of score of observing drug safety standards as equal to 27.78±2.62; and field of providing drug with mean and standard deviation of score of observing drug safety standards as equal to 35.67±2.87; and field of receiving pharmaceutical orders with mean and standard deviation of score of observing drug safety standards as equal to 40.12±3.19; and filed of maintenance and preparation of drug with mean and standard deviation of score of observing drug safety standards as equal to 42.21±4.22. In other words the highest level of challenges is related to record and report writing index and the lowest level of challenges is related to the maintenance and preparation of drug index.
DISCUSSION AND CONCLUSION
In regard of the first purpose of research, i.e. specification of challenge extent of nurses of hospitals dependent on Medical Sciences University of Ahvaz in the field of receiving pharmaceutical orders in 2015, findings of tables 4-7 indicate that respectively question number 5(in given pharmaceutical orders, method of taking drug is stated clearly) has the lowest score with mean and standard deviation of 2.5±0.89; and question number 3 (pharmaceutical orders are written by physician completely) with mean and standard deviation of 2.62±0.68; question number 8 (you check expiration date of the prescribed drug) with mean and standard deviation of 2.69±0.85. Findings of this research is not in accordance with findings of Shams and et al (2013) research in which they compared knowledge of Pharmacology and drug calculation skills in cardiac intensive care unit among nursing students of Urmia and Khoy. Findings of their research showed that knowledge of Pharmacology in the field of nursing care, among students of Urmia Nursing Faculty was 3.43 and students of Khoy 3.48 which was an acceptable level and did not show any significant difference.
In regard of the second purpose of research, i.e. specification of challenge extent of nurses of hospitals dependent on Medical Sciences University of Ahvaz in the field of maintenance and preparing drugs in 2015, findings indicate that respectively question number 3(To check drug cards of each patient for 3 times of before, during and after giving drug) has the lowest score with mean and standard deviation of 3.01±0.97; question number 9 (to separate drugs similar in
appearance) with mean and standard deviation of 3.17±0.86; question number 5 (to check drug label in terms of its name, expiration date and method of intake) with mean and standard deviation of 3.40±0.88. These findings are in accordance with research finding of Hazrati& et al (2012) titled as “Investigating Observance Level of Drug Prescription Standards by Medical and Nursing Personnel in Treatment Training Centers of Tabriz”. Findings of their research showed that in total 49% of standards are observed which is considered an average level.
In regard of the third purpose of research, i.e. specification of challenge extent of nurses of hospitals dependent on Medical Sciences University of Ahvaz in the field of preparing patient to receive drug in 2015, findings indicate that respectively question number 4 (To calm the patient while preparing him to receive drug) has the lowest score with mean and standard deviation of 2.96±0.17; question number 1 (To calm the patient while preparing him to receive drug) with mean and standard deviation of 3.53±0.85; question number 7 (to educate patient about cautions to be taken before and after drug intake) with mean and standard deviation of 3.64±0.15. These research findings are in accordance with research findings of Marayan& et al (2007). They reported low quality of drug label of package, confusion of nurses due to diversity and difference of infusion devices and distraction of nurses by other patients or workmates or internal happenings of section, as 3 main reasons that medication errors happen.
University of Ahvaz in the field of providing drug to the patient in 2015, findings indicate that respectively question number 1 (to control the label of drug on glass (tablet, liquid, powder) for 3 times before during and after giving drug) has the lowest score with mean and standard deviation of 2.22±0.42; question number 8 (to ask for permission of patient before giving drug) with mean and standard deviation of 2.48±0.78; question number 9 (to ask name of the patient before giving drug to him) with mean and standard deviation of 2.84±0.80. These research findings are in accordance with research findings of Harding & Patrick (2008) according to which the most prevalent medical errors respectively are not giving drug, giving drug in wrong time and incorrect dose. The major reasons of these errors are lack of enough experience to read physician prescriptions, heavy workload and lack of concentration.
In regard of the fifth purpose of research, i.e. specification of challenge extent of nurses of hospitals dependent on Medical Sciences University of Ahvaz in the field of after drug treatment in 2015, findings indicate that respectively question number 2 (to continuously control physical and psychological mood of patient after giving drug) has the lowest score with mean and standard deviation of 2.58±0.90; question number 1 (to monitor condition of patient after giving drug) with mean and standard deviation of 2.94±0.78; question number 3 (to control patient until the end of drug intake process) with mean and standard deviation of 3.83±0.75. These research findings are in accordance with findings of Hazrati& el al (2012). They are also in accordance with findings of Tangu& et al (2005).
In regard of the sixth purpose of research, i.e. specification of challenge extent of nurses of hospitals dependent on Medical Sciences University of Ahvaz in the field of record and report writing in 2015, findings indicate that respectively question number 4 (to precisely check previously written reports) has the lowest score
with mean and standard deviation of 4.07±0.73; question number 3 (to record nursing interventions and special cases such as refusal of patient to intake drug due to any reason) with mean and standard deviation of 4.54±0.63; question number 2 (to record different conditions of patient such as blood pressure, pulse and resulting changes) with mean and standard deviation of 4.55±0.52. These research findings are in accordance with findings of Straton& et al (2004) research according to which carelessness, distraction of nurses are among individual factors affective in medication errors. They are also in accordance with research findings of Hazrati& et al (2012).
In regard of the seventh purpose of research, i.e. specification of challenge extent of nurses of hospitals dependent on Medical Sciences University of Ahvaz in the field of pharmaceutical services management in 2015, findings indicate that respectively question number 6 (Drugstore of hospital is open for 24 hours) has the lowest score with mean and standard deviation of 2.43±0.94; question number 5 (the pharmacist is accessible for 24 hours) with mean and standard deviation of 2.70±0.95; question number 7 (to monitor the way drug is provided to the patients) with mean and standard deviation of 3.50±0.74. These research findings are in accordance with findings of Baghchi&Koohestani (2009).
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