INTRODUCTION:

Adverse drug reactions (ADR) are a global problem today, with significant morbidity and mortality rates¹. World Health Organization (WHO) defines ADR as “response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function”². ADRs place a significant economic burden on the public healthcare³, thereby necessitating an active surveillance system to be initiated for earlier detection and prevention. This gave birth to pharmacovigilance.

Pharmacovigilance (PVi) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of drugs or any other drug-related problem⁴. WHO established this programme for International Drug Monitoring in response to the notorious thalidomide disaster in 1961^4,5.

Under this programme WHO has established its global collaborating centre at Uppsala, Sweden and also promotes and recommends setting up of PVi centers in each country⁶. By the end of 2010, 134 countries were already a part of the WHO PVi programme. The aims of this PVi programme are to enhance patient care by promoting the use of safe medicines by carefully assessing and analyzing their risk-benefit ratios, no matter how vital their therapeutic actions are⁷.

Government of India set up the National Pharmacovigilance Programme in 2004 under WHO guidelines, with the National Coordinating Centre (NCC) currently being located at Ghaziabad. However, as compared to global standards, the reporting rates from India have been dismal due to under-reporting and lack of awareness among healthcare professionals regarding pharmacovigilance⁸. The success of a pharmacovigilance program depends on the involvement of all healthcare professionals and by increasing their awareness regarding pharmacovigilance and inculcating the culture of spontaneous reporting among them⁹. Doctors constitute the key personnel in pharmacovigilance and have immense responsibility in reporting the ADRs encountered in daily clinical practice. Thus, it is important that they are aware of the basic tenets of the pharmacovigilance programme and are well versed with the reporting mechanism involved in this programme, so as to ensure higher reporting rates with precision. To ensure this, it is of paramount importance that they are trained well in various aspects of pharmacovigilance during their undergraduate level, so that after graduation they can play a vital role in ADR reporting. This study was thus done to evaluate the awareness regarding pharmacovigilance in second year medical undergraduate students in a tertiary care teaching hospital in Puducherry, India. All the participants in this study attended two routine lectures on pharmacovigilance explaining the data on PVi cited above.

MATERIAL AND METHODS:

Study setting:

Study was conducted at Sri Lakshmi Narayana Institute of Medical Sciences, Puducherry, a tertiary care teaching hospital in Southern India.

Study Population:

For this study, a total of 120 second year medical undergraduates were included to assess their knowledge regarding pharmacovigilance as they are at the fag end of their pharmacology curriculum and will play a vital role in ADR reporting in future.

Study Tools:

For the purpose of the study, a suitable, validated, cross-sectional questionnaire was used. The questionnaire consisted of 22 interactive questions (including true/false, yes/no, multiple choice questions with 4 distracters), which were split into 5 sections, namely: Definitions (2/22), Reporting (13/22), Analysis (2/22), Documentation (3/22), and Examples (2/22).

The questionnaire was designed by the pharmacology department and was validated by another faculty. The maximum score possible was 22, with each correct response to a question amounting to 1 score.

Study Conduct:

The participants, prior to questionnaire was administered to them, were personally briefed about the scope, nature and relevance of the survey and were explained the fact that participation is voluntary and they can opt out of this survey if they wish to do so, without the need for citing any reason(s). Out of the total number of 120 students, 108 students agreed to participate in the study. They were given the choice of submitting the response sheet anonymously. Later, the questionnaire was administered to them. They were made comfortable and were given 30 minutes to complete the questionnaire. During these 30 minutes, consultations between the participants were not allowed. After 30 minutes, filled out questionnaire sheets were collected and the responses were later evaluated. The results were then analyzed and expressed by means of descriptive statistics.

RESULTS:

The questionnaire was administered to 108 medical students and 108 filled out response sheets were collected (100% response rate). Out of these 108 responses, 104 were analyzed (96.3%) and the remaining 4 (3.7%) were not included in the final analysis due to incomplete information.

Among the target population selected, 65.38 % of them are knowledgeable about definitions, 66.34 % about examples, 56.87 % about reporting, 64.42 % about analysis, and 23.71 % about documentation. The overall awareness about PVi is 54.67 %. (Table –1)

TABLE-1-Category Wise and Overall Performance of the participants

Question Categories	No. of Questions	Max. Score	Score Obtained	% Awareness
Definition	2	208	136	65.38%
Examples	2	208	138	66.34%
Reporting	13	1352	769	56.87%
Analysis	2	208	134	64.42%
Documentation	3	312	74	23.71%
Total Score	22	2288	1251	54.67%

When definitions and reporting aspects were combined, 58 % of them are aware of this process of PVi. In contrast, only 40 % of them are aware of analysis and documentation process when combined. (Table – 2)

TABLE–2 Data showing the performance of the students when two parameters were combined

Broad sub categories	No. of questions	Maximum score	Score obtained	% Awareness
Definitions and Reporting	15	1560	905	58%
Analysis and Documentation	5	520	208	40%

Only 38.4 % of the test population believes that ADR reporting in India is mandatory, while 61.6 % believes it is voluntary. Major part (76.9 %) of it believes that ADR reporting is the duty of all healthcare professionals (including doctors, pharmacists, nurses and other healthcare providers), while 16.2% believe that it is the duty of doctor only. Regarding documentation, 79.2 % of the test population did not know the current location of the National Coordination Centre (NCC) for the pharmacovigilance programme of India, while 81.6 % of it know that WHO global monitoring centre is located in Uppsala, Sweden. While most of the study participants had heard of the term Adverse Drug Reaction (ADR) before, only 33.65 % of the population could correctly define it. (Not shown)

DISCUSSION:

Pharmacovigilance ultimately resulted in the detection of ADRs and has led to the withdrawal of many unsafe drugs from the market e.g. Temafloxacin, a broad spectrum antibiotic, was withdrawn from market in 1992 after a number of cases of hemolytic anemia were reported^10,
11. In a developing country like India, drug safety is often compromised due to the poor implementation of the pharmacovigilance programme. Though spontaneous reporting is one of the best ways to report an ADR, only about 10 % of the reported ones come under this category^{9, 11}.

A better understanding of the national and international pharmacovigilance programmes by the healthcare professionals, including doctors, leads to effective ADR reporting. Because of this, under reporting of ADR exists in Malaysia^9,13, China¹⁴, Nigeria¹⁵ and Italy^{16, 17}. Awareness of pharmacovigilance should be assessed right from their undergraduate training, so as to single out the deficient areas and to improve them later by means of educational interventions like continuing medical education programmes, workshops etc.

This forms the aim of our study. In our study, the test population has been exposed to pharmacovigilance through routine lectures prior to this survey. The findings of the present study revealed that the test population to a major extent (65%) is sound pertaining to definitions, examples and analysis aspect. The observation that only 56.87 % of the test population is knowledgeable in reporting indicates additional training should be imparted on this line for effective pharmacovigilance, as reporting forms the main component. Additionally, information on the aspect of documentation needs to be imparted since only a minor percentage (24 %) is well versed with this aspect. Though, the present findings have higher percentage rates when compared to Gupta et al¹⁸ and Agarwal et al¹⁹, it is evident that frequent training on all aspects of pharmacovigilance only will improve their knowledge and make them fit for shouldering responsibility after graduation.

Limitations of this Study:

The survey has been carried out only in a small population and should be conducted among more number of medical students in other teaching hospitals of the country.

Strengths of this Study:

This attempt has exposed the lacunae on the knowledge of pharmacovigilance among second year undergraduate medical students. After extending this study on larger population, steps can be taken to include the deficient aspects in the curriculum so that the future graduates can handle pharmacovigilance efficiently.

CONCLUSION:

The present study reveals that second year undergraduate medical students of Sri Lakshmi Narayana Institute of Medical Sciences, Puducherry have appreciable knowledge on the definitions, examples, analysis and reporting of pharmacovigilance. Additional training focusing on analysis is warranted and is implemented in the next batch.

REFERENCES:

1. Lazarou J, Pomeranz BH, Corey PN. Incidences of Adverse Drug Reactions in hospitalized patients: a meta-analysis of prospective studies. The Journal of the American Medical Association. 279; 1998: 1200-1205.

2. World health organization. WHO Techinical Report, 1972; 498.

3. Ayani I, Aguirre C, Gutiérrez G et al. A cost-analysis of suspected adverse drug reactions in a hospital emergency ward. Pharmacoepidemiology Drug Safety. 8; 1999: 529-534.

4. http://www.who.int/medicines/areas/quality_safety/safety_ efficacy/pharmvigi/en/ (Last accessed on 28^th January, 2014)

5. James H. Kim, Anthony R. Scialli. Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease. Toxicological Sciences. 122(1); 2011: 1-6.

6. Safety monitoring of medicinal products. The importance of pharmacovigilance. World Health Organization, Geneva, 2002.

7. Nies SA, Spielberg PS. Principles of therapeutics. In Goodman and Gilman`s The pharmacological basis of therapeutics, Edited by Hardman JG and Limbird LE. McGraw-Hill, New York. 1996; 9th ed: pp. 43-62

8. The National Pharmacovigilance Protocol, Ministry of Health and Family Welfare, Government of India.

9. Palaian S, Ibrahim MI, Mishra P. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharmacy Practice (Internet). 9(4); 2011 Oct-Dec: 228-235.

10. Michael D. Blum, David J. Graham, Carolyn A. McCloskey. Temafloxacin syndrome: review of 95 cases. Clinical Infectious Diseases. 18;1994: 946-50

11. www.fda.gov/ohrms/dockets/ac/98/.../1998-3454B1_03_WL49.pdf (Last accessed on 28^th January, 2014)

12. Hitesh Mishra, Vipin Kumar. Pharmacovigilance: Current scenario in a tertiary care teaching medical college in North India. Journal of Pharmacovigilance. 1; 2013: 2

13. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiology Drug Safety. 16(2); 2007: 223-228.

14. Li Q, Zhang SM, Chen HT, Fang SP, Yu X, Liu D, Shi LY, Zeng FD. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chinese Medical Journal (English). 117; 2004: 856-861.

15. Okezie E O, Olufunmilayo F. Adverse drug reactions reporting by physicians in Ibadan, Nigeria. Pharmacoepidemiology Drug Safety. 17(5); 2008: 517-522.

16. Bharathan B, Raju N. A survey about the knowledge, attitude and practice of adverse drug reaction reporting among doctors in Bangalore city. Sixth annual conference of the Society of Pharmacovigilance (India), Kurupanidhi College of Pharmacy, Bangalore, India .November 11-12, 2006.

17. Vora MB, Paliwal NP et al. Knowledge of adverse drug reactions and pharmacovigilance activity among the undergraduate medical students of Gujarat. International Journal of Pharmaceutical Sciences and Research. ; Vol. 3(5); 2012: 1511-1515

18. Gupta P, Udupa A. Adverse drug reaction and pharmacovigilance: knowledge, attitude and perceptions amongst resident doctors. Journal of Pharmaceutical Sciences and Research. 3(2); 2011:1064-9.

19. Apurva Agarwal, Parul Chaturvedi. Awareness, attitude and practice of pharmacovigilance among healthcare professionals and students in a tertiary care teaching hospital. International Journal of Current Research and Review. 04 (17); 2012: 1-10

Received on 05.02.2014 Modified on 25.02.2014

Research J. Pharm. and Tech. 7(4): April, 2014; Page 447-449