Research Articles

2019  |  Vol: 5(2)  |  Issue: 2(March-April)  |  https://doi.org/10.31024/ajpp.2019.5.2.14
Evaluation of knowledge and awareness of adverse drug reaction reporting among patients visiting a tertiary care hospital in northern India

Anupriya Thadani1, Afroz Abidi1*, Fardan Qadeer1, Deepak Bhagchandani2Roohana Hasan1, Darakhshan Rizvi1

1Department of Pharmacology, Era’s Lucknow Medical College, Lucknow, U.P. India
2Department of Medicine, King George’s
 Medical College, Lucknow, U.P. India

*Address for Corresponding Author

Dr. Afroz Abidi

Professor and Head, Department of Pharmacology, Era’s Lucknow Medical College, Lucknow, U.P. India


Abstract

Objective: Spontaneous voluntary reporting of Adverse Drug Reactions (ADR) is of paramount importance to the Pharmacovigilance Programme of India, as well as for the benefit of mankind. There has however been minimal and sporadic voluntary reporting of ADRs by the patients at the various ADR Monitoring Centres (AMCs) across Northern India. Knowledge, perception, attitude, and awareness of patients are determinants of reporting practices. This questionnaire based study aims to evaluating these indicators in a tertiary care hospital and determines methods to improve existing reporting practices. Materials and Methods: This is a cross-sectional questionnaire-based observational study carried out in a tertiary care hospital over a period of 2 months. The questionnaires were filled by patients attending the OPD and returned to us. Data obtained from filled questionnaires were thereby analyzed. Results: While 74.4% respondents were aware that medicines can cause side effects, only 51.7% patients aptly feel the urgent need to report an ADR to a physician and receive prompt treatment. A majority of the respondents felt that it was the duty of the attending physician to warn the patients about the potential ADRs of medications while prescribing them, while newspaper reports and awareness campaigns could also be conducted to educate the community towards drug reactions and methods of reporting them to health care associates and receiving prompt treatment. Conclusion: The study indicates that although the respondents have an average knowledge and positive attitude towards ADR reporting and pharmacovigilance, there remains a lack of awareness and poor ADR reporting practices. Efforts are therefore required to enhance awareness and attitude towards pharmacovigilance and ADR reporting.

Keywords: Adverse drug reaction monitoring, knowledge, attitude, perception, pharmacovigilance


Introduction

The burden of Adverse Drug Reactions (ADR) in the global scenario is high and accounts for considerable morbidity, mortality and is of an unwanted economic burden to the patient. Therefore, proper monitoring of ADRs is a necessity, rather than a need of the hour. Although one of the essential objectives of the Pharmacovigilance Programme of India (PvPI) is to detect, assess, understand and prevent adverse effects to safeguard the general public, and there have been constant endeavours towards ADR monitoring, self-reporting among patients has still remained an under-exploited aspect (Waller, 2010).

The Pharmacovigilance Programme of India has commended the inclusion of patient reporting, and it has been concluded that first hand reports from “medication consumers” have several distinguishing characteristics and benefits:

  • They are uninfluenced/ unbiased by the drug presciber’s interpretation and provide essential information on causality.
  • Such direct reports explicitly mention the effects of drug reactions on the quality of life- impairment of daily activities, and effects on family and career.
  • They report different drugs and various types of reactions in contrast to the reports of professionals.
  • They actively involve patients, thus enabling general awareness and improving health literacy.

Across the globe, many countries like the US, Australia, New Zealand have allowed patients to report ADRs directly since the conception of their pharmacovigilance schemes (Van Grootheest et al., 2003). However, there still remain several countries with deficient or non-existent methods for direct patient reporting (Hugman, 2006).

In India, the option of ADR reporting by patients to PvPI was started at NCC- PvPI on August 1, 2014 (Kalaiselvan et al., 2014) (Kalaivani et al., 2015). The patient or his/her representative is encouraged to report ADRs directly to the NCC- PvPI or to the nearest AMC under PvPI by submitting a “Medicine Side Effect Reporting form for Consumers” (which is available in ten vernacular languages to remove language barrier in ADR reporting) (Lihite et al., 2015). Moreover, the Indian Pharmacopoeia Commission in 2015 has launched a revolutionary mobile app “ADR PvPI”, in order to ensure quick and hassle- free ADR reporting by the general population. ADRs can be also reported via PvPI helpline number (18001803024) on weekdays from 9:00 am to 5:30 pm. The obtained information is entered in the drug safety database, analysed and assessed by the experts to identify new signals.

Despite the continuous emphasis upon mass educational efforts and awareness, very few reports have come from the general population in the last decade. Therefore, the primary objective of this study was to evaluate the knowledge, attitude and practises (KAP) of the patients visiting a tertiary care centre in northern India about Adverse Drug Reactions and Pharmacovigilance.

In the past, most of the studies have explored and reported knowledge and perception towards ADR among health care professionals, pharmacists and medical students. However, studies on awareness among patients are limited. The secondary objective was to assess the causation of under-reporting of ADRs as perceived by the patients, and the changes that could be brought about in order to help the community recognise and report ADRs for the welfare of mankind.

Materials and Methods

The study was conducted at the Medicine OPD of a tertiary care hospital in Lucknow, Uttar Pradesh.

Study design and study participants

This was a cross-sectional, observational, prospective, questionnaire based study at a tertiary care hospital, conducted over a period of 2 months (October to December, 2017). Informed consent from the participants was obtained verbally, and confidentiality was assured.

Study questionnaire

A pre-validated questionnaire containing open and few close- ended questions regarding knowledge, attitude and perception towards ADR was developed after referring to previous studies. The questionnaire has a format that provides information regarding three distinct domains–knowledge, attitude, and practice (KAP). The questionnaire comprises 19 questions, and aspects that are explored include the knowledge of the respondents regarding ADR's, their attitudes and awareness to reporting, factors that may influence reporting, their training, and actual ADR reporting practices being followed by the respondents. The questionnaire was modified according to regional need and translated into vernacular (Hindi) language.

Data Collection

202 patients attending a tertiary care hospital were selected randomly on daily basis for one hour. Inpatients, as well as paediatric patients were excluded. The study, its purpose and research hypothesis were well explained to the patients. Basic personal information such as age, gender, educational qualifications was noted.

Data analysis

The data collected from the questionnaire was entered into Graph Pad Prism version 3.0. Chi- Square test was used to evaluate the association between variables. A p-value of less than 0.05 indicated statistical significance.

Results

Respondent characteristics

In this study, 172 patients out of the 202 patients that were selected, agreed to participate by giving verbal informed consent and 30 patients declined. Table 1 gives the demographic profile of the respondents.

Table 1. Socio-Demographic Characteristics

Groups

Number of respondents

Frequency (%)

Age (years)

19 -29

57

33.1

30-39

34

19.8

40- 49

39

22.7

50-59

26

15.1

>60

16

9.3

Gender

Male

63

36.7

Female

109

63.3

Education

12th Pass

51

29.6

Graduate

89

51.7

Post graduate

32

18.7

Occupation

Not working

40

23.2

Student

29

16.9

Government Job

34

19.8

Private Job

52

30.2

Retired

17

9.9

Of the 172 respondents, 63 were male, 109 were female. The age group ranged from 19 years and beyond, with a maximum of 57 (33.1%) respondents aged between 25 and 32 years. 51 (29.6%) respondents were educated upto 12th standard, 89 (51.7%) were graduates and remaining 32 (18.7%) were post graduates.

Knowledge

Table 2 gives details of the responses to the knowledge-based questions. Regarding knowledge about ADRs 128 (74.4%) respondents were aware that medicines can cause side effects. Most participants 72 (41.9%) selected the definition “any effect from a medication”. Almost equal proportion of responders 34 (19.8%) selected “Expected reaction after taking the normal dose” and the correct definition 38 (22.1%).

Table 2. Knowledge and questions detail

Questions

Number of respondents

Frequency (%)

Do you know whether medicines can cause ADR?

Yes

128

74.4

No

44

25.6

What does Adverse Drug Reaction- mean?

Any effect from the medication

72

41.9

Unexpected reaction after taking the normal dose

38

22.1

Expected reaction after taking the normal dose

34

19.8

Don't know

28

16.2

Which age can be harmed from Adverse Drug Reaction?

Children

51

29.7

Adult

8

4.6

Elderly           

11

6.4

All age

98

57.0

Don’t Know

4

2.3

Do you think ADR is harmful?

Very harmful

52

26.7

Somewhat serious

92

53.5

Not harmful

19

11.0

Don't know

9

5.2

Who should be notified about any serious ADR?                               

Physician

89

51.7

Pharmacist

61

35.5

Nurses

17

9.8

Pharmacovigilance centre

5

3.0

While a majority of patients enrolled in the study believed that all ages could be harmed from ADRs 98 (57.0%), 92 (53.5%) think that ADRs are “somewhat serious”. About 89 (51.7%) patients aptly feel the urgent need to report an ADR to a physician and receive prompt treatment.

The post graduates had the maximum correct response rate (15.69%) while those who were 12th pass had the least response rate (0.59%). However, the overall correct response rate was only 19.19 %. Pearson’s Chi-square test was applied using Graph Pad Prism Version 6.01 to find out any association between qualification and knowledge. A significant association was found (χ2 = 107.3; P < 0.0001) (Figure 1).

Figure 1. Association between Qualification of the patients and their knowledge about adverse drug reaction

 

 

Attitude and Practise

The response to the attitude and practice-based questions is depicted in table 3. On evaluation of attitude and the practise of patients towards ADR reporting, 92 (53.5%) feel that it is essential to gather information from the physician who has prescribed the medication. Only 2 (1.2%) patients have ever referred to the leaflet with the medication to gather information about ADRs associated with that particular drug. Only one of the patients was aware that alternative medicines, particularly herbal medicines could also cause ADR. On enquiring about medication consumption, 80 (46.5%) patients revealed that they approached a doctor for treatment, whereas 66 (38.4%) patients accepted the fact that sometime or the other, they have resorted to self-medication.

Table 3. Attitude & Practise

Questions

Number of respondents

Frequency (%)

Which resources do you use to gather information about an ADR?

Asking your physician who prescribed the medication     

92

53.5

Asking your pharmacist who dispensed the medication

46

26.7

From Books or magazine

12

6.9

From Internet

20

11.7

From the leaflet that comes with the medication

2

1.2

Do you know about herbal medicines causing ADR?

Yes

1

0.6

No

171

99.4

Where do you usually take your medicines from?

Self-medication

66

38.4

From a pharmacist

26

15.1

From a Doctor     

80

46.5

How frequently do you take medicine an Over-the-counter from the pharmacist without consulting a doctor?

Always

62

36.0

Sometimes

102

59.3

Never    

8

4.7

Do you ask about your medication's ADRs?

Yes

103

60.0

No

69

40.0

Have you ever experienced any side effect after taking a medicine?

Yes        

77

45.0

No

95

55.0

Have you ever experienced an ADR due to any herbal medication?

Yes

52

30.2

No

120

69.8

If yes, then what type of ADR have you experienced?                                

Skin problem-itching, hypersensitivity, rashes etc.

32

61.5

Gastrointestinal problem-nausea, vomiting, loose stools etc

14

26.9

Others   

6

11.6

Have you ever seen any side effect after taking medicine in other person?

Yes

103

60.0

No

69

40.0

What did you do when you or any person you know experienced an ADR?

Reported to a doctor and received treatment

80

77.8

Reported to the pharmacist and took medication from him

17

16.7

Did not do anything

6

5.5

Have you ever reported an ADR to a health care professional that you or your family have suffered?

Yes

116

67.5

No

56

32.5

Why do patients not report ADRs according to you?

Does not know if it is from the medication or not

93

54.2

The ADR is not serious

49

28.3

Common ADR

30

17.5

How can we educate the community about the importance of ADR reporting?

Doctor should explain the patient while prescribing medicines

102

59.2

Publish reports in newspaper

20

11.7

Awareness campaign

50

29.1

What advantages the community can get from ADR reporting system?

Increase medication safety                                                          

95

55.0       

Increase awareness among community                                      

40

23.3

Increase quality of life                                                                

20

11.7

Strengthen human rights                                                            

17

10.0

Nearly, all the respondents claimed to have taken an over-the-counter (OTC) medication sometime in their life. Only 8 (4.7%) respondents said that they had never taken an OTC drug in his life without consulting a doctor.

Out of the total 172 respondents, 103 (60%) felt the need and inquisitiveness to enquire about the ADRs arising from the medicines before consuming. 52 (30.2%) patients stated that they have experienced an ADR sometimes during their life, or seen an ADR in another individual 103 (60%) out of which a majority were non-specific skin problems including itching, hypersensitivity, rashes etc for which they reported to a physician and received prompt treatment.

In order to understand the psychology of the general population behind the lack of spontaneous ADR reporting, 93 (54.2) patients stated that they were not sure whether the ADR was from a medication or not. A majority of the population felt that it was the duty of the attending physician to warn the patients about the potential ADRs of medications while prescribing them, while newspaper reports and awareness campaigns could also be conducted to educate the community towards drug reactions and methods of reporting them to health care associates and receiving prompt treatment. This would lead to an increase in safe and effective use of medicines, thereby lowering the economic burden and hence, improving the overall quality of life.

Discussion

World Health Organization defines an ADR as “a response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function” (WHO, 1972). According to a report “Importance of ADR reporting in India”, the incidence of serious ADR's is reported to be 6.7% in the Indian subpopulation. A study by Ramesh et al. in 2003 showed that about 0.7% of hospital admissions were due to ADR's, and a total of 3.7% of the hospitalized patients experienced an ADR, out of which 1.3% were fatal.

Spontaneous reporting of drug reactions is essential for the success of any pharmacovigilance program. A report on the recent trends and future developments in Pharmacovigilance by Kalaiselvan et al. (2016) stated that the progress of the Pharmacovigilance Programme of India (PvPI) has, to a large extent, been impeded by the lack of coordinated spontaneous reporting which is a matter of concern, not only in India, but also around the world. Investigators across India have attempted to investigate into the reasons behind this under-reporting, the possible drawbacks specific to our system and take proper and adequate corrective measures. A study by Hardeep et al. (2013) on the KAP practices among the health care professionals also suggests that the attitude of health professionals towards ADR monitoring is a critical determinant of reporting rate.

The responses to the questions in this study indicate an average degree of knowledge in the general population regarding diverse aspects of pharmacovigilance. Bringing to limelight was the most alarming response towards reporting of ADRs caused is herbal medications. 99.4 % respondents were completely unaware that even herbal medicines could lead to ADRs. The reasonable lacunae of knowledge of the respondents observed in this study could be attributed to decreased awareness created by the medical fraternity into the subject.

Moreover, the use of Over-The-Counter (OTC) drugs was reported by 59.3% patients at some time or other. This brought forward various aspects such as poor community literacy and inadequate pharmaceutical regulatory guidelines towards safe and effective use of drugs. This was found to be in concordance with a study by Goyal et al., 2018 in which a majority of the participants had taken OTC medication, and chiefly due to its low cost.

Similar to a study conducted by Pahuja et al. (2014), a vast majority of the respondents in our study shared the view that the reporting of ADR's was necessary, but very few considered it to be an obligation. This indicates that there exists a positive attitude toward the need to report ADRs, but a relative lack of commitment to do so. Moreover, there exists incomplete information about how to report, and whom to report this information.  Therefore, educational interventions are a must to update knowledge and consequently bring a greater degree of awareness towards pharmacovigilance in the general population. Concerted efforts aiming at an active and progressive enhancement of knowledge, through educational workshops, utilization of the print and social media and awareness campaigns could possibly translate into better awareness and ADR reporting practices. This is an avenue where there is an ample scope of improvement, and needs to be certainly addressed.

Findings from published research, such as one by Alomar in 2014, suggest that if made adequately aware, patients are likely to identify and report more ADRs than health professionals. A study by Weigmann (2016) states that patients are often able to attribute quickly and correctly possible newly recognized ADRs. The experience of drug reactions is received without filtering or ‘interpretation’ by a health professional. This may add to a better understanding and evaluation into the subject.

The reporting by general population is also associated with as many shortcomings as there are benefits. Their reports, the quality of which is ‘lower’ than that of healthcare associates, may often contain incorrect clinical attributions of symptoms to specific medicines. There also exists a possible duplication of reports and potential for multiple reporting of the same ADR. This could create additional ‘noise’ that could distract from signal detection, and result in system overload. However, currently the magnitude of distraction from signals is not much, as patient reporting comprises only 10% of the total reports received (Blenkinsopp et al., 2007). Some suggestions are offered on the basis of findings of this study.

  1. Publicity of the PvPI in the visual and print media should be made, in order to make health professionals, as well as the general population at large, aware of its presence and scope.
  2. Regional awareness campaigns, workshops and training should be carried out, with assistance of funding agencies if necessary.
  3. Follow-up educational sensitization programs should be conducted yearly at all the AMCs in order to reinforce and emphasize the importance of physicians making their patients aware of drug reactions and their reporting.
  4. Paramedical staff like nurses and pharmacists should also educate patients to be involved in the reporting process.
  5. The process of reporting should be made as seamless, hassle free, convenient, and less time-consuming as possible
  6. Coordination between the National Coordinating Centre, regional and peripheral AMC and the hospitals where the actual adverse drug event is encountered is required.

Conclusion

The aim of the study was to judge the attitude and perception of the respondents towards pharmacovigilance. There is however an alarming deficiency of awareness regarding the process of ADR reporting for drugs as well as herbal medicines, and the presence and activities of the PvPI. The lack of reporting practices in the northern population can thus be attributed to these very reasons. It would therefore be of utmost importance to create awareness among the general population in order to fill the void between those who actually experience the adverse drug reaction, and the reporting authorities.

Conflicts of interest: None

References

Alomar MJ. 2014. Factors affecting the development of adverse drug reactions. Saudi Pharmaceutical Journal, 22(2):83-94.

Blenkinsopp A, Wilkie P, Wang M, Routledge PA. 2007. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. British Journal of Clinical Pharmacology, 63(2):148-156.

Goyal A, Gaur A, Chhabra M, Deepak K. 2018. Knowledge, Attitude and Practices of over the Counter (OTC) Medicines among rural Population - A Cross Sectional Study. Asian Journal of Pharmacy and Pharmacology, 4(2):227-231.

Hardeep, Bajaj JK, Rakesh K. 2013. A Survey on the Knowledge, Attitude and the Practice of Pharmacovigilance Among the Health Care Professionals in a Teaching Hospital in Northern India. Journal of Clinical and Diagnostic Research, 7(1):97-99.

Hugman B. 2006. The Erice declaration: The critical role of communication in drug safety. Drug Safety, 29:91-93. 

Importance of ADR reporting in India. Available from:http://www.pharmacovigilance.co.in .

Kalaiselvan V, Prasad T, Bisht A, Singh S, Singh GN. 2014. Adverse drug reactions reporting culture in Pharmacovigilance Programme of India. Indian J Med Res, 140:563-564. 

Kalaiselvan V, Thota P, Singh GN. 2016. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian Journal of Pharmacology, 48(6):624-628.

Kalaivani M, Kalaiselvan V, Dabhi K, Singh GN. 2015. Direct consumer reporting of ADRs to PvPI, a position paper of Indian pharmacopoeia commission. Advances in Pharmacoepidemiology and Drug Safety, 4:184.

Lihite RJ, Lahkar M. 2015. An update on the Pharmacovigilance Programme of India. Frontiers in Pharmacology, 6:194.

Pahuja R, Shrivastava B, Sharma PK , Kishore K , Mahajan S and Sood R. 2014. Awareness on Adverse Drug Reaction Reporting System in India: A Consumer Survey. American Journal of Phytomedicine and Clinical Therapeutics, 12(2):1361-1369.

Ramesh M, Pandit J, Parthasarathi G. 2003. Adverse drug reactions in a south Indian hospital -Their severity and cost involved. Pharmacoepidemiology and Drug Safety, 12:687–92.

Van Grootheest K, de Graaf L, de Jong-van den Berg LT. 2003. Consumer adverse drug reaction reporting: A new step in pharmacovigilance? Drug Safety, 26:211-7.

Waller P. 2010. An Introduction to Pharmacovigilance. Southampton, UK: Blackwell Publishing.

Weigmann K. 2016. Consumer reporting of adverse drug reactions: Systems that allow patients to report side effects of the drugs they are taking have yielded valuable information for improving drugs safety and health care. EMBO Reports, 17(7):949-952.

World Health Organization. 1972. International Drug Monitoring. The Role of National Centers. Report of a WHO Meeting. World Health Organization technical report series, 498:1–25.

Manuscript Management System
Submit Article Subscribe Most Popular Articles Join as Reviewer Email Alerts Open Access
Our Another Journal
Another Journal
Call for Paper in Special Issue on

Call for Paper in Special Issue on