Introduction

Every drug has its own beneficial and detrimental effects. While the efficacy of the drug can be quantified with ease, the safety of the drug cannot be quantified2. The dose of the drug determines whether it is a medicine or a poison. Unnecessary and undesirable effects of a drug cause a wide range of morbidity and mortality. Adverse drug reaction has a major impact on public health by imposing a considerable economic burden on the society and the already-stretched health-care systems 13. These effects can be traced back to the Thalidomide disaster14. These effects range from the spontaneous reaction or effects due drug overdose, intolerance, effects due to sudden drug withdrawal, teratological effects, drug abuse etc.  It is estimated that ADRs account for 0.2 – 24% of hospital admissions and 3.7% of patients have fatal ADRs15 (Extreme age patients have a higher incidence of ADRs when compared to normal population
Recent estimates suggest ADRs to be the fourth major cause of death in the United States of America (USA). While no official scale exists yet to communicate overall drug risk, the iGuard Drug Risk Rating System (Ref) classifies the drugs into five classes as: Red (high risk), Orange (elevated risk), Yellow (guarded risk) and, Blue (general risk), Green (low risk). The reporting of ADRs could reduce the incidence of ADRs 3.
Pharmacovigilance relates to detection, assessment, understanding and prevention of adverse effects or any other drug related problems.  The main source of ADR data are spontaneous reporting by doctors, nurses, and Pharmacists from their experiences on ADRs reporting centers prevailing in hospitals, clinical trials including post marketing surveillance and some special studies like case control studies and cohort studies. Spontaneous reporting accounts for successful Pharmacovigilance.
The Uppasala Monitoring Centre, established by the WHO maintains an International Database adverse drug reports (currently about 4.7 million case reports) received from several national centers (96 member countries). However, still, it is estimated that only 6-10% of all ADRs are reported4. This high rate of under-reporting can delay signal detection and consequently has negative impact on to public health. Many factors are associated for under-reporting ADRs among health professionals. These factors have been broadly classified as personal and professional characteristics of health care professionals and their knowledge and attitudes to reporting1. 
The monitoring of ADR is still evolving in India. After decades of hibernation, the National Pharmacovigilance program started in 2004 is still in its infancy.  India became a collaborating member of the WHO-ADR monitoring program 30 years after its establishment. The pattern of drug use and ADRs in India is quite different due to socio-economic, ethnic, nutritional and other factors8. The Drug Controller General of India (DCGI) and Indian Council of Medical Research (ICMR) have established ADR monitoring centers in many hospitals in the major cities of India.  The CDSCO, New Delhi (Ref) is the central coordinating body under which two zonal; five regional and 24 peripheral centers have been established3. The WHO worldwide and the CDSCO, India has banned many drugs. Some of the recently banned drugs in India are gatifloxacin and sibutramine due to their wide range of detrimental effects. Though many studies have established the lack of awareness of health care professionals on drug reporting to the Pharmacovigilance Centre, prevent study was undertaken to know the status among health care physicians of our Centre.
Review of the literature:
               Earlier studies were conducted on the awareness of adverse drug reactions and their reporting among health care professionals. Adverse reactions account for 5% of hospital admissions and causes death in 0.1% of hospital inpatients(Ref). This is mainly because the number of drug prescribed is high and a number of new drugs are introduced in the market It increases the costs of patient care, causes the patient to lose confidence in their doctors. Spontaneous drug reporting schemes form the cornerstone of clinical post marketing surveillance. Since 1964, in the UK reporting has been restricted to the doctors and dentists but recently reporting scheme for pharmacists has been introduced while in the US even patients are allowed to report of the ADRs 7About 90% of doctors are aware of the National Pharmacovigilance center in India but only 40% of them have reported any suspected adverse drug reactions to the ADR to the monitoring centre1,2.But in other studies the awareness is only 43% and only 2% of doctors have reported to the ADR monitoring centre3 .More than 90% of doctors feel that this system is beneficial and in improving the patient care1.Doctors suggest that the assistance of pharmacist would help in detection, management and reporting of ADR(95%)2.Lack of confidence of giving a negative feedback prevents the doctors from reporting of ADRs. Mild adverse reactions , the knowledge to manage and immediate management also prevent the reporting of ADRs. Educating the nursing staff will also improve the reporting of ADRs. Nearly 85% of ADRs were reported among inpatients4. There is a higher incidence of ADRs among the pediatric and the geriatric age groups7 .Doctors feel that the reporting of ADRs is a professional obligation(80%)3.About 85% of the doctors feel that the reporting of ADR should be voluntary. Some also feel that the reporting should be enumerated. When asked about the classification of ADRs only 80% of the prescribers were able to classify them6. About 60% of the doctors feel that ADRs should be reported to the HOD, 43% to the department of pharmacology and only 6% National ADR monitoring center and 56% to the WHO ADR monitoring centre6. Naranjo algorithm is used for estimating the probability of a drug causing adverse reaction.  Many of the practitioners feel that only allopathic drugs and vaccines cause ADRs3.

Aims and Objective:

1. To find out personal experience on the ADRs among health care professionals.
2. To elicit the knowledge, attitude and practice among health care professional in terms of ADR among them

Material and Methods

The present work on awareness and personal experiences on adverse drug reaction among doctors, nurses and pharmacist was carried out in our 600  bedded teaching hospitals where 150 Doctor (Faculty and senior residents), 260 Nurses and 25 Pharmacists have been employed. The Institutional Ethical Committee approved the work. The questionnaires were also given to other 35 pharmacists employed in a near by Health Centre and in pharmacy shops. They were explained about the objectives of the study and asked to answer the question and returned to us. The colors of the questionnaires used for Doctors were pink, Nurses were green and pharmacists were white. Then they were segregated and the data were entered in Microsoft Excel spread sheet and analysed using SPSS software version 17    .
• Design of study: - Questionnaire Survey method involving Doctors, Nurses and Pharmacists.
• Place of study: Tertiary care rural teaching hospital with 560 beds with bed occupancy of 82%, and 900 out patients per day.
• Materials: Doctors (200),\Nurses (260) Pharmacists(20)employed in the hospital were be the subjects of study
• Inclusion criteria: Only Doctors, Nurses and Pharmacist willing to participate in the study were included

• Method: A Common questionnaire was issued to every doctor, nurse and pharmacist after a brief introduction, and they were requested to answer each question/ statement.
• Period of study:  JUNE TO SEPTEMBER 2011
• Data analyzing:  Data were be entered in MS excel sheet and analyzed using SPSS Package V.17
• Neurological drugs cause high incidence of ADR followed by antibiotics. Among the antibiotics Amoxicillin, Cephalosporin’s and Clindamycin are the most important in causing ADRs. NSAIDs also cause some adverse drug reactions. Some established ADRs are chloramphenicol induced aplastic anemia(Ref), NSAID induced hepatitis or nephritis, antithyroid drugs causing granulocytopenia and phenylpropalamine induced cerebral hemorrhage. ADRs to new drugs are NSAID induced upper g.i hemorrhage, reduced libido by new SSRIs like sertraline, fluoxamine, hypersensitivity reactions to montelukast, Zafirlukast.Skin manifestations were the important manifestation affecting for 2-3% of hospitalized patients followed by edema, cough, vomiting, diarrhea, hypoglycemia, liver failure and renal failure4 The management an ADR includes drug withdrawal, introducing a new drug or reducing the dose4, 7.

Results and Observations

Of the 141 questionnaires were distributed, 72 for doctors, 46 for pharmacists, 23 for nurses returned the questionnaire.
The age of the respondents varied from 30 years to 60 years with experience from 1 year to 30 years in tertiary care teaching hospital in Trichy. 
The questions are classified into three categories to know about 1. Awareness and personal experiences on ADRs, 2. ADRs in medical practice and 3. Phamacovigilance

Books remained the main source knowledge of ADRs among health care professionals. This was followed by seminar among doctors and pharmacists. Nurses came to know about ADR from somebody (Table 1).

Table 1

Awareness and personal experience

The respondents agree that drugs remain the main cause of ADRs (Table 2). Only a few disagree that drugs were not a cause of ADRs

Table 2

Cause of ADRs

When asked to rate about their knowledge on ADR, majority of the respondents feel that they have a moderate knowledge on ADRs. Nearly 50% of pharmacists feel their knowledge was good on ADR.

Table 3

Knowledge on ADR

More than 60% of respondents felt that they had sufficient knowledge to manage ADR (Table 4).

Table 4

Knowledge to manage ADR

Nearly 50% of doctors and nurses have not reported ADR to the Pharmacovigilance center. About 40% of pharmacists have reported to the pharmacovigilance center (Table 5).

Table 5

Reports of ADR to the Pharmacovigilance center

More than 50% of respondents feel that uneducated patients reported of the ADRs. About 55% of doctors feel that even educated patients reported with ADRs. About 50% of doctors feel that ADRs were common among outpatients. But nearly half of the nurses responded feel that inpatients reported with ADRs. Pharmacists feel that ADRs were common among both inpatients and outpatients.

Table 6

Education of patients

When the respondents were asked about the drugs causing ADRs, antibiotics and analgesics was the major group of drugs. Of these sulpha group of drugs, metronidazole, 3rd generation cephalosporins, NSAIDS like diclofenac, tramadol cause important ADRs. Metformin, metoclopramide, cisapride, antiulcer drugs were the other group of drugs  causing ADR.

Table 7

Management of ADRs:

Table 8

Name of the drug

The main manifestations produced by these drugs were skin rashes, epigastric pain, nausea, vomiting, diarrhea, followed by hypoglycemia, dizziness, drowsiness, seizure, tachycardia, tremors etc.

Table 9

Nature of ADRs

These were mainly managed by stopping the drug, treating with drugs like steroids, H2 blockers, proton pump inhibitors, adrenaline etc.

Table 10

Management of ADRs/treatment

The majority of respondents feel that the ADRs would be managed by giving another drug and withdrawal of the drug causing ADR. Only 25% of doctors would refer the case of ADR to another doctor. But nearly 50% of nurses and pharmacist feel that the cases of ADR could be referred to another doctor (Table 11). More than 50% of the responders would explain about the ADR to the patient. They would also ask the patient to report immediately in case of ADR encountered and to carry the previous history of drugs causing ADRs.

Table 11

Referring to another doctor

Only 30% of doctors and nurses were aware of the National Pharmacovigilance Program started by the CDSCO. On the contrary, 54.3% of pharmacists were aware the program. About 60% of doctors and pharmacists feel the program was good. But nearly 50% of nurses and 40% of doctors feel that it is complicated (Table 12).

Table 12

Impression about program

About 60% of pharmacists have undergone training reporting of ADR but only 13% of nurses and 5% of doctors have been trained on the same (Table 13).

Table 13

Training

About 90% of doctors and nurses have not seen the ADR reporting form by CDSCO in contrast 65% of pharmacists have seen the same.

Table 14

ADR reporting form by CDSCO

Nearly 65% of the responders would gladly accept when asked to report about ADRs experienced by them on a regular basis (Table15).

Table 15

Acceptance to report ADRs

Nearly 70% of the respondents say that only less than 2 patients report to them of the ADRs experienced by them (Table 16).

Table 16

 Number of reports

About 50% of doctors and nurses discuss with head of the department of the ADRs experienced by them. But 55% of pharmacists get help from the Pharmacovigilance Center.

Table 17

Response towards ADRs reporting

When the respondents were asked about their awareness of the types of ADRs, nearly 70% of the respondents were aware of the types of ADRs.

Table 18

Type A (pharmacological adverse effects)

Table 19

Type B (immunoallergic reactions):

Table 20

Type C (spontaneous diseases):

Nearly 40% of the respondents disagree that alternative medicines do not cause ADRs.

Table 21

Alternative medicine and ADRs

More than 70% of the respondents feel that allopathy is the safest medicine. Nearly 15% of the doctors and 8% of doctors and nurses and pharmacist feel that homeopathy is also safe. But according to 16% of doctors and 20% of pharmacists, ayurveda also remains to the safest mode of medicine.

Table 22

Safest medicine

DISCUSSION

This study establishes about the knowledge and experiences about the ADRs among the health care professionals.
Books remained the main source knowledge of ADRs among health care professionals. This was followed by seminar among doctors and pharmacists. Nurses came to know about ADRs from somebody. This shows the lack of awareness of the nursing staff about ADRs.  When asked to rate about their knowledge on ADR, majority of the respondents feel that they have a moderate knowledge on ADRs. Nearly 50% of pharmacists feel their knowledge was good on ADR. This shows the need for conducting seminars and symposium on ADRs and their management.  
Nearly 40% of the respondents disagree that alternative medicines do not cause ADRs. But according to many studies, allopathic drugs and vaccines cause ADR.
Majority of the respondents say that only less than 2 patients report to them with ADRs but according to a recent study 2.9-5% of all hospital admissions are caused by ADRs and nearly 35% of patients experience ADR during hospital stay8.
When the respondents were asked about the drugs causing ADRs, antibiotics and analgesics was the major group of drugs. Of these sulpha group of drugs, metronidazole, 3rd generation cephalosporins, NSAIDS like diclofenac, tramadol cause important ADRs. This is mainly because these are the most common therapeutic agents used in medical practice and the over usage and the unwanted usage of these drugs by the patients. 
The main manifestations produced by these drugs were skin rashes, epigastric pain, nausea, vomiting, diarrhea, followed by hypoglycemia, dizziness, drowsiness, seizure, tachycardia, tremors etc. These ADRs can be prevented by the restricted use and reduced dosage of the prescribed drugs.
The majority of respondents feel that the ADRs would be managed by giving another drug and withdrawal of the drug causing ADR. These were mainly managed by stopping the drug, treating with drugs like steroids, H2 blockers, proton pump inhibitors, adrenaline etc. Thus adequate knowledge of the management of ADRs and immediate management of the same are the important drawbacks which prevent the reporting of ADRs among health care professionals.

Only 25% of doctors would refer the case of ADR to another doctor. But nearly 50% of nurses and pharmacist feel that the cases of ADR could be referred to another doctor. This shows that the doctors are able to manage and treat the ADRs reported by the patients.
More than 50% of the responders would explain about the ADR caused by the drug to the patient. They would also ask the patient to report immediately in case of ADR encountered and to carry the previous history of drugs causing ADRs. In this way the patient would be benefited by preventing over dosage, continued use of the drug and immediate treatment. This would also help in reducing the fear of the patients.
When the respondents were asked about their awareness of the types of ADRs, nearly 70% of the respondents were aware of the types of ADRs. This establishes adequate knowledge of health care professionals of the types of ADRs.  But in other studies conducted among prescribers, only 30% of them were able to describe the types of ADRs6.  
About 50% of doctors and nurses discuss with head of the department of the ADRs experienced by them. But 55% of pharmacists get help from the Pharmacovigilance Center. This agrees with the results that about 60% 0f prescribers feel that ADR should be reported to head of the department and only 5% to the National ADR monitoring centre6. In other study conducted by (Amrita P et al) 8, only 8.84% of physicians feel that the reporting of ADR can be done at National Monitoring Center and the Regional Monitoring Centers8.
Only 30% of doctors and nurses were aware of the National Pharmacovigilance Program started by the CDSCO. On the contrary, 64.7% of pharmacists were aware the program. About 60% of doctors and pharmacists feel the program was good. But nearly 50% of nurses and 40% of doctors feel that it is complicated.  In other studies adopting the ADR system, which is simple to operate, monitoring the new drugs, creating awareness among medical staff would enhance ADR reporting rates1. This coincides with other studies, which establishes that only 43% 0f doctors were aware of the National Pharmacovigilance Centre in India3. But according to other studies nearly 90% of doctors were aware of the program2.
About 60% of pharmacists have undergone training reporting of ADR but only 13% of nurses and 5% of doctors have been trained on the same.  This could be mainly due to inadequate training of the prescribers in their undergraduate about Pharmacovigilance and the risks of drugs. Under the guidelines of the MCI in 1997, Drug Safety was included in the curriculum of Undergraduates but only a little is done in this regard11. This shows that assistance of pharmacists would help in detection, reporting and the management of ADRs1. Training programs conducted among the doctors and nurses would help them to know about the National Pharmacovigilance program.
 Nearly 50% of doctors and nurses have not reported of about ADR to the Pharmacovigilance center. About 40% of pharmacists have reported to the Pharmacovigilance center. It is said that ADR monitoring is done in hospitals without any further documentation and reporting7. Active involvement of the paramedical staff in spontaneous reporting would improve the ADR rates as they are in closer contact with the patients for a long time than doctors3.
About 50% of doctors feel that ADRs were common among outpatients. But nearly half of the nurses responded feel that inpatients reported with ADRs. Pharmacists feel that ADRs were common among both inpatients and outpatients. When the nature of ADR was studied among the patients in a hospital nearly 80% of ADRs were reported among inpatients6
Nearly 60% of the responders would gladly accept when asked to report about ADRs experienced by them on a regular basis. It is evident from various studies that the reporting of ADRs is a professional obligation and it should be voluntary. But some also feel that the reporting of ADR should be renumerated3, 7

Conclusion

This study gaps between the knowledge of National Pharmacovigilance Centre and the reporting of Adverse Drug Reaction to the monitoring Centre. Continuous medical education, training of adverse drug reaction reporting would help in improving the knowledge of both medical and paramedical staff about the reporting of ADRs.
The study was done to know about the knowledge and personal experiences of adverse drug reactions and their reporting among doctors, nurses and pharmacists. This is a questionnaire type of study and the questionnaires were distributed to the doctors, nurses and pharmacists. Books were the main source of knowledge about Adverse Drug Reactions according to the respondents, antibiotics and NSAIDS were the most common drugs causing ADRs manifesting as skin rashes. Epigastric pain, nausea, vomiting, diarrhoea etc. Though a majority of the respondents were aware of the National Pharmacovigilance started by CDSCO, any a few have reported the ADRS experienced by them to the reporting Centre. About 80% of the respondents agree that alternative medicines do not cause ADRs and allopathic is the safety medication. This study suggests that the awareness of Adverse Drug Reaction reporting and monitoring should be increased and training programs on the same to be conducted.