INTRODUCTION:

A negative effect following an ingestion of a drug is referred to as Adverse drug Event (ADE) also as defined by WHO as' any untoward medical occurrence that may present during treatment with a medicine, but which does not necessarily have a causal relationship with treatment.¹ Adverse drug reactions (ADRS) are an important source of morbidity and mortality which accounts for approximately 5.3% of hospital admissions^2,3. The incidence of fatal ADR ranges 0.23% - 0.41%.⁴

A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose which: results in death, life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.³

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.⁵

Many countries have recognized the importance of pharmacovigilance and have joined the WHO Programme for International Drug Monitoring.⁶ In India on July 2010, the Government of India initiated the Pharmacovigilance Programme of India (PvPI) with AIIMS, New Delhi and NCC for monitoring ADRs in the country for safeguarding public health by assuring the safety of medicinal products.⁷

Traditionally only health care professionals (HCPs) report ADRs to the national pharmacovigilance system but the consumers also have the rights to report ADR of the drug consumed.⁸ According to the review article⁹. Consumer reporting has some advantages like directness, proper estimation of the burden of ADRs for individuals, early detection of ADRs, ADR reporting of over the counter medicines and promotion of consumer rights. Knowing importance of consumer reporting, direct patient reporting systems exist in many countries from decades.¹⁰ National Coordination Centre(NCC)-PvPI has also launched “Medicines Side Effect Reporting form for Consumers” in 2014.¹¹ Patient or his/her representative(relative) are encouraged to report ADRs either directly to the NCC-PvPI through toll free helpline number or an email id or to their nearest AMC under PvPI by submitting the blue form. However, annual performance report of PvPI 2014-2015 suggests that consumer reporting is as low as low as 0.08% in India.11 Annual performance report 2014-15 of PvPI showed only 27 consumer reports out of 34, 988 ADR reports submitted to Vigi Base.

Reasons for under reporting of ADRs:

1. Lack of knowledge on how, what, and where to report

2. Lack of time

3. The drug-reaction association is uncertain

4. The reaction is already well known

5. Guilt or fear of litigation

6. Belief that all registered medicines are safe

7. Non-availability of reporting forms

8. Problems with establishing reporting systems in hospitals

9. Insufficient training to recognise ADRs¹²

This study is centered on the remarkably low level of consumer ADR reporting in India. Knowledge and attitude about ADR reporting among consumers are one of the most important determinants of consumer ADR reporting. Observation of ADR reporting practice can be useful in exploring the probable causes of under reporting as well as preferred method of ADR reporting amongst consumers. Hence, the present study was designed to evaluate knowledge, attitude and practice regarding ADR reporting among consumers.

OBJECTIVES:

1. To assess Knowledge, Attitude and Practice about ADR reporting in patients coming to the tertiary care teaching hospital

2. To sensitize the patients about ADR reporting

METHODS:

This cross sectional, Observational study was conducted at a tertiary care teaching hospital of rural Chhattisgarh. A investigator administered questionnaire was given to the patients coming to outdoor patient departments of Medicine, Surgery, Obstetrics and Gynaecology and Dermatology.

The study was carried over for 3 months from January 2023 to March 2023. The questionnaire was available in both English and Hindi. A total of 100 consumers (Patients) were included in the study.

The questionnaire also gathered personal information like their age, sex, education, employment status, presence of any addiction, also origin like urban or rural.

The results were tabulated and analyzed on an excel sheet.

RESULTS:

In our study out of 100 respondents 68 were females and 32 were males. Maximum (48%) of the respondents were from the age group of 20-40 years. 64% of the respondents were from rural background. 53% of consumers had education upto 10th standard, 26% were educated till 12th and 18% were graduates and remaining 3% were illiterate. The employment status was working 55% and nonworking 45%. (Table-1)

Table-1 Demographic characteristics of the respondents

Characteristic

Range

Percentage

Age

Less than 20yrs

20-40yrs

40-60 yrs

Above 60yrs

Sex

Males

Females

Education

Illiterate

Upto 10th

Upto 12th

Graduates

Origin

Rural

Urban

Working status

Unemployed

Employed

As regards to knowledge regarding ADR 38% knew that medicines had the potential to cause unwanted effects. Figure-1.

Figure-1 Knowledge regarding ADR caused by medicines

Figure-2 Region specific response of consumers about ADR

This knowledge was better in urban population (78%) as compared to rural (22%). Figure-2

As far as experience of adverse effects (16%) indicated that they had encountered them, 58% never experienced adverse effects, whereas 28% were uncertain whether they experienced or not. Commonly encountered ADRS as skin rashes (45%), GIT disturbances-Nausea, vomiting, diarrhea (34%), fever (12%), weight loss (7%), weight gain (1%), others like dryness of mouth (2%).

Majority of them (38%) did not do anything on experiencing ADR, only 25% reported it to the doctor and took treatment. 88% approved that ADR should be reported. None of them think that consumers should report ADR, maximum feel its responsibility of doctor to report ADR(58%). On relating to the question that consumers should be taught how to report ADR, majority (73%) agreed. 28% knew about the system of ADR reporting. As a final call of awakening 58% promised to report ADR themselves.

DISCUSSION:

Medicines play a vital role in our lives. If they have beneficial effects and at the same time they have adverse effects. The pharmacovigilance programme of India (PvPI) was initiated by the government of India for monitoring ADRs in the country for safeguarding public health. Most of the studies had explored the knowledge and perception about ADR reporting amongst healthcare providers, nurses, pharmacist and medical students as study population but on patients studies are limited.^13,14,15

Consumers are the end users of pharmaceutical products, to ensure the safe use of them is the ultimate goal of pharmacovigilance activities. Its very important to improve consumer reporting in India. A total 100 patients from various OPDs like Medicine, Surgery, Obstetrics and Gynaecology and Dermatology were included in the study. ADR reporting by consumers is found to be quite low in India. Many people who consume medicines do not have a proper understanding of ADRs as shown by other studies.^16,17. Only 38% knew that medicines could cause ADR. This low level of awareness can be improved by measures like conducting awareness programmes and campaigns as suggested by the study conducted about ADR at Beaumont hospital in Ireland.¹⁷

Table-2 Attitude and Practice of consumers on occurrence of ADR

Questions

Opinion

Percentage of responses

Did you experience ADR?

Yes

Can’t say

Common ADRs encountered after taking medicines

GIT disturbances-Nausea, vomiting, diarrhea

Skin rashes

Fever

Weight loss

Weight gain

Others

What did you do after experiencing ADRs?

Nothing

Stopped taking medicines

Took another medicines on own

Reported to the doctor and took treatment

Reported to the pharmacist and took treatment

Do you think ADRs should be reported?

Yes

Who is the right person to report about ADR?

Doctor

Pharmacist

Nurse

Consumer

Drug manufacturing company

Do you think consumers should be involved in ADR reporting?

Yes

Should consumers be taught how to report ADR?

Yes

Will you report ADR?

Yes

Poorer knowledge about ADRs is found more in consumers of rural background as 53% of participants were educated till 10th standard as similarly justified by other studies.¹⁸

38% consumers who experienced ADR didn't report it by any method. The common reasons for underreporting is lack of knowledge that side effects were medicine related and also the belief that the side effect would resolve on its own. Skin rashes were the most common experienced ADR (45%).Here counseling plays a major role in improving understanding and reporting of ADR.

88% of people believe that the ADR should be reported which depicts that if proper knowledge is given underreporting would decrease.

59% of them reported the ADR to the doctor, none of them used a consumer reporting programme which correlates with a deficit in awareness about the programme in public. In Spite of the fact that the consumer ADR reporting was launched in 2014, knowledge regarding reporting is still low.

Consumers should be encouraged to fill ADR as it’s available since 2014 and those reports should be addressed via mail to pvpi@ipcindia.net or pvpi.ipcindia@gmail.com or can call helpline 1800-180-3024 to report ADR. This is also mentioned in similar study.¹⁶

While educating the patients it should be kept in mind that awareness of ADR so that they can recognise any unusual effect of medicine is important along with contacting the doctor for the same.Also existence and importance of ADR reporting system.

CONCLUSION:

ADRs are one of the important factors which can cause death or debilitating conditions, also it increases length of hospitalization, number of drugs causing financial as well as emotional burden.So proper detection, assessment, monitoring and management on time are also important steps along with reporting of ADR.The general population needs to be should be time to time educated regarding possible ADRs and its reporting in hospitals and pharmacy whenever they are prescribed medicines. Also use of audio visual aids along with use of social media can be encouraged. Also the health care providers should be updated about possible adverse effects by means of workshops, conferences and training sessions.

CONFLICT OF INTEREST:

None.

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Received on 20.10.2023 Modified on 15.11.2023

Res. J. Pharmacology and Pharmacodynamics.2024;16(1):58-61.

DOI: 10.52711/2321-5836.2024.00011