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Table of Contents
ORIGINAL ARTICLE
Year : 2021  |  Volume : 9  |  Issue : 3  |  Page : 181-186

Knowledge, attitude, and practice of Ayurveda pharmacists toward pharmacovigilance and adverse drug reaction reporting: a cross-sectional study


Central Ayurveda Research Institute, (CCRAS, Ministry of AYUSH) Bengaluru, Karnataka, India

Date of Submission06-Mar-2021
Date of Decision22-Jul-2021
Date of Acceptance26-Jul-2021
Date of Web Publication28-Sep-2021

Correspondence Address:
Dr. Raghavendra Naik
Central Ayurveda Research Institute, #12, Manavarthekaval, Uttarahalli Hobli, Kanakapura Main Road, Talaghattapura Post, Bengaluru 560109, Karnataka.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JISM.JISM_19_21

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  Abstract 

Background: Reporting adverse drug reactions (ADRs) is an important part of pharmacovigilance practice. Considering the significance of this area, the Ministry of AYUSH has introduced a new Central Sector scheme for promoting pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs. Being key health‑care professionals, physicians, pharmacists, technicians, and nurses have immense responsibility in effective implementation of pharmacovigilance programs through the surveillance and reporting of ADRs. Objective: The present study was planned with an objective to evaluate the knowledge, attitude, and practice (KAP) of Ayurveda pharmacists toward pharmacovigilance and ADR reporting. Materials and Methods: A total of 22 pretested questions about KAP regarding ADRs and pharmacovigilance in a Google form were made available to 170 Ayurveda pharmacists at their workplace by e‑mail. Results: In the present study, total, 80 responses were received, yielding a response rate of 47%. Most of the participants (81.5%) had knowledge about the pharmacovigilance program for ASU&H drugs and also the location of their nearest pharmacovigilance center. At the same time, 34.6% among them were not aware that a specific format is available for reporting ADRs and only 42% had the knowledge that the Ministry of AYUSH is monitoring the pharmacovigilance program for ASU&H drugs in India. However, most of them (95.1%) thought that it was their responsibility to report ADRs and 92.6% of the participants wanted to make ADR reporting mandatory to pharmacists. More than half of the participants (55.6%) had come across ADRs at their workplace, and the majority of them (72.8%) had reported them. More than half of the pharmacists (51.9%) who were involved in the program revealed that they had faced problems while reporting ADRs at their workplace. Conclusion: Even though there was a positive attitude toward ADR reporting, limited knowledge about the importance of the program needed to be addressed through educational initiatives, regular sensitization, and awareness programs.

Keywords: Adverse drug reaction, Ayurveda, drug safety, pharmacist, pharmacovigilance


How to cite this article:
Naik R, Shubhashree M, Chandrasekharan C, Bhat S. Knowledge, attitude, and practice of Ayurveda pharmacists toward pharmacovigilance and adverse drug reaction reporting: a cross-sectional study. J Indian Sys Medicine 2021;9:181-6

How to cite this URL:
Naik R, Shubhashree M, Chandrasekharan C, Bhat S. Knowledge, attitude, and practice of Ayurveda pharmacists toward pharmacovigilance and adverse drug reaction reporting: a cross-sectional study. J Indian Sys Medicine [serial online] 2021 [cited 2021 Dec 2];9:181-6. Available from: https://www.joinsysmed.com/text.asp?2021/9/3/181/326834




  Introduction Top


Pharmacovigilance is an important element of any medical intervention. It is useful to assure the safety of medicines and protect consumers from their harmful effects. Pharmacovigilance aims at enhancing patient safety by assessing the risk–benefit profile of medicines.[1] Awareness and training programs regarding ADRs related to the Indian system of medicine through a structured pharmacovigilance program are necessary. Considering the significance of this area, the Ministry of AYUSH has introduced a new Central Sector scheme for promoting the pharmacovigilance of ASU&H drugs. The prime objective of the scheme is to develop the culture of documenting adverse effects and to undertake safety monitoring of ASU&H drugs.

The common myth regarding herbal medicines is that these medicines are completely safe. This belief has led to large-scale self-medication by people all over the world, often leading to disappointing end results and side effects. Lack of information to consumers about the proper use of drugs can lead to serious consequences such as ADRs and drug–drug interactions. Hence, practitioners and health-care workers in ASU&H hospitals now need to be vigilant about the safety monitoring of drugs in the interest of public health.

Among the health-care team, pharmacists play a significant role not only in the dispensing but also in the detection and reporting of suspected ADRs. Pharmacists as drug experts are expected to have more knowledge regarding safety aspects of medicines.[2] The role of pharmacists, traditionally, was limited to the preparation and dispensing of drugs prescribed by the physicians. Now, the role has been expanded to various aspects of patient care, which includes reporting of ADRs, improving patient health, and economic outcomes. The participation of pharmacists in ADR reporting will be important to counter the underreporting of the ADRs. The early detection of ADRs can prevent morbidity and mortality in patients.[3],[4] Nevertheless, being the most accessible health-care professionals, pharmacists have a crucial role in ensuring safety by proper drug administration, detecting and reporting ADRs, especially in areas where access to general practitioners/primary care physicians is limited.[5]

Findings from various studies have revealed that ADR reporting by health-care providers is linked to their KAP about pharmacovigilance.[6] A review of published literature revealed that not a single study has been reported to be related to the assessment of KAP of pharmacovigilance among Ayurveda pharmacists in India. Hence, this study was conducted with an objective to assess their KAP about pharmacovigilance, which will be further beneficial in taking necessary steps to improve the documentation and reporting culture by the pharmacists.


  Materials and Methods Top


Type of Study

This cross-sectional, questionnaire-based study aimed at assessing the KAP toward pharmacovigilance and ADR reporting among Ayurveda pharmacists working in different parts of India.

Study Duration

The study was conducted for a period of three months from June 2020 to August 2020. However, to reduce the error of recall, the data were collected within a two-month period.

Sampling Method and Source of Data

The convenient sampling method was used in which Ayurveda pharmacists working in different parts of India were requested to provide their responses.

Validity and Reliability of the Study Tool

The survey questionnaire was designed and prepared by referring to previously published literature on KAP studies related to Ayurveda,[7],[8] pharmacovigilance,[9],[10] pharmacists,[11],[12] and health-care workers.[13] An initial draft was made by referring these available data collection instruments with suitable customization for the present study. A questionnaire with both open- and close-ended questions covering points such as personal, sociodemographic data including name, age, sex, educational experience, participants’ KAP toward pharmacovigilance, and ADR reporting was developed. Two researchers reviewed the questionnaire and checked the questions’ consistency, clarity, and relevance. Moreover, a pilot study was initially done among 10 Ayurveda pharmacists to assess the content and face validity of the tool and whether data collection procedures were feasible or not. Data obtained from the pilot study were excluded from the reported study results.

Data Collection Procedure

Totally 22 questions, comprising eight questions each related to knowledge and attitude, six questions related to practice were included in the questionnaire. The pretested questionnaire in Google form was made available to 170 Ayurveda pharmacists via e-mail.

Data Management and Analysis

After receiving the responses, data were checked and the responses with complete data were included in the study. The survey questionnaire was analyzed question wise, and their percentage value was calculated with the help of a Microsoft Excel spreadsheet in MS Office 2010. The result was presented using simple frequencies with percentages in appropriate tables.


  Results Top


Out of the 170 Ayurveda pharmacists approached through e-mail, 80 pharmacists had responded, yielding a response rate of 47%. Of those who responded, the majority of the respondents were in the age group of 21–30 years (86.25%) and 31–40 years (12.5%). Among these 80 pharmacists, 65 (81.25%) were male and 15 (18.75%) were female. Educationally, most of the participants were diploma in pharmacy graduates (48, 60%) followed by Pharm D and B Pharm graduates. Most of the pharmacists had experience between one and six years. The demographic details are shown in [Table 1].
Table 1: Demographic details of the participants

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Knowledge

Eight questions were designed to investigate the participants’ knowledge regarding pharmacovigilance and ADRs reporting. Among the participants, 82.7% selected the statement, which is the best pharmacovigilance definition according to the WHO and 11.1% considered it as guidelines to identity and to check the quality and purity of a drug. Participants were then asked about their knowledge regarding the purpose of pharmacovigilance: 76.5% pharmacists responded that it deals with drug safety, 12.5% responded that it deals with good manufacturing practices, and the remaining 11.25% considered it as a good dispensing practice or one that deals with clinical studies. Among the respondents, 81.5% were aware of a separate pharmacovigilance program for ASU&H drugs in India whereas the remaining 17.3% were not aware of the existence of pharmacovigilance programs. Their nearest pharmacovigilance center was known to 72.8% respondents, whereas 27.2% people did not know about it. A significant portion of respondents (88.9%) were aware of ADRs. Among them, 77.8% had knowledge regarding to whom ADRs should be reported. It is observed that only 65.4% of participants knew about a separate format available for ADR reporting whereas 34.6% did not know about the separate format for reporting ADRs. This was a critical observation associated with the current ADR underreporting. When asked about the ministry/department/organization that is monitoring ADRs and pharmacovigilance programs for ASU&H drugs in India, the participants were provided a list of options. In fact, only 42% of participants responded that the program is monitored by the Ministry of AYUSH; the remaining 28.4% and 25.9% of participants selected the Ministry of Health and Family Welfare and Central Council for Research in Ayurvedic Sciences (CCRAS), respectively [Table 2].
Table 2: Knowledge of participants regarding pharmacovigilance and ADR reporting

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Attitude

There were eight questions related to the attitudes of the pharmacists toward ADR reporting and pharmacovigilance. Among the 80 pharmacists, 70.4% believed that Ayurvedic medicines were safe to be prescribed whereas 29.6% did not. At the same time, 74.1% pharmacists believed that Ayurvedic preparations could cause ADRs and 25.9% believed that it would not cause ADRs. It is found that 66.6% thought that only herbo-mineral preparations were the cause for ADRs. An encouraging finding of this study was that the majority of participants (95.1%) considered that it is essential to report ADRs. Moreover, 98.8% of pharmacists thought that ADR reporting would be helpful in providing quality care to the patients and 7.92% of participants disagreed that ADR reporting would be helpful in providing quality care to the patients. Data from the current study showed that 87.7% of respondents believed that ADRs could also happen due to negligence on the part of the pharmacists and the majority of them (92.6%) thought that ADRs reporting should be made mandatory for the pharmacists also [Table 3].
Table 3: Attitude of participants regarding pharmacovigilance and ADR reporting

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Practice

Six questions were designed to investigate participants’ practice toward pharmacovigilance and ADRs reporting. More than half the responders (55.5%) had experienced ADRs in their practice whereas 44.4% had not come across any. When assessing the actual practice of the study participants regarding ADR reporting, 72.8% had reported ADRs in their working period. The ADR reporting forms were available at their workplace for 71.6% of pharmacists. Overall, 65.4% of pharmacists were trained to report ADRs, which shows that there is a need of more training for pharmacists also. The result of the present study showed that 51.9% of participants had faced problems while reporting ADRs at their workplace. The major factor that discourages the participants from reporting ADRs was fear of facing legal problems (54.3%). About 22.2% believed that it was not their responsibility to report ADRs. Among the other reasons, 14.8% found lack of time and 8.6% showed lack of interest in reporting [Table 4].
Table 4: Practice of participants regarding pharmacovigilance and ADR reporting

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  Discussion Top


This may be the first ever study reported with regard to pharmacovigilance and ADRs reporting among Ayurveda pharmacists working in different hospitals of India. The aim of this study was to assess the pharmacists’ KAP with regard to ADRs reporting and to determine the major barriers. Out of the 170 Ayurveda pharmacists approached through e-mail, only 47% responded even after three reminders. As reported in some published studies, it is possible that participants who feel uncomfortable in responding due to their lack of knowledge on the basic concepts of subjects may decline the participation. If that is the case, it is possible that only those who had adequate knowledge of pharmacovigilance and ADRs responded to the questionnaire and this could have influenced the study results.[9] During the administration of the questionnaire to the participants, a detailed explanation has not been provided to the participants. This may also be one of the contributing factors in not understanding the gravity and procedure of the project, leading to a less participation rate.

The majority of the responders had good knowledge about pharmacovigilance and ADRs reporting. The results from this study show that the majority of pharmacists had good knowledge regarding the concept of pharmacovigilance and ADRs in terms of their definitions and purposes. However, complete knowledge regarding the structure of a national pharmacovigilance program for ASU&H drugs, reporting the ADR and its format, is still lacking. To overcome these lacunae and to improve their knowledge, the topic “pharmacovigilance” can be incorporated in the pharmacy syllabus. Also, ADR reporting guidelines can be made available in the form of booklets and posters at noticeable locations in health-care facilities. Lack of knowledge about what is an ADR, what is to be reported, who can report, when to report, how to report, where to report, whom to report etc. can hamper ADR reporting. Therefore, various interventional strategies and regular pharmacovigilance programs/training need to be planned at the workplace for improving ADR reporting.

In general, the respondents had a very positive attitude toward ADR reporting and pharmacovigilance. An encouraging finding of this study was that the majority of participants considered that it is essential to report ADRs, which would be helpful in providing quality care to the patients. So, there is a need to emphasize to the Ayurveda pharmacists that all ADRs must be reported regardless of whether they are mild or serious. The majority of the responders believed that ADRs could also happen due to negligence on the part of pharmacists. The ADRs reporting should be made mandatory for the pharmacists also. An interesting observation was that all the respondents were willing to participate in pharmacovigilance program/training. These findings suggest that there is a need for more awareness programs for improving awareness about the pharmacovigilance and the ADR reporting.

It is reported that many low- and middle-income countries are facing the challenge of low ADR reporting, as low ADR reporting generates minimum signals and thus lacks the pharmacovigilance data.[14] Similar practices were observed in the present study, where 72.8% had reported ADRs in their working period. It is observed that only 65.4% of pharmacists were trained to report ADRs, which shows that there is a need of more training for pharmacists also. Most of the respondents had faced problems while reporting ADRs at their workplace. Among the different reasons, the fear of facing legal problems is observed as a major problem that is associated with ADR reporting by pharmacists.


  Conclusion Top


The findings of the present study provide a basis to develop and implement strategies to improve ADR reporting by pharmacists. Even though the pharmacists have a positive attitude toward ADR reporting and pharmacovigilance, they have limited knowledge and practice with regard to ADR reporting. Ayurveda pharmacists who participated in the present study responded that they did not report ADRs because of different reasons and this shows the need for interventional educational programs to effectively increase knowledge and awareness. In order to minimize the underreporting, regular sensitization of all health-care workers on the importance of pharmacovigilance is also crucial. There is scope for improving the ongoing pharmacovigilance activities for ASU&H drugs in India by involving health-care workers, especially Ayurveda pharmacists.

Limitations of the Study

There are some limitations to the present study. The main limitation of the study was the small sample size and the relatively less response rate (47%). The questionnaire in the Google form was sent through e-mail, and the participants were requested to fill and submit their responses. It remains to be determined whether the results can be extrapolated to other methods of data collection, such as the direct interview method. It is possible that only those who had adequate knowledge responded to the questionnaire and this could have influenced the study results. Also, some of the statements in the questionnaire were positive and may have influenced the participants’ responses.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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