Adverse drug events are a public health concern because of its high occurrence incurring in additional costs to health services. Adverse drug events in hospitalized patients are an emerging condition associated to significantly increased hospital stay, costs, and morbidity. [5] Antibiotics are among the most commonly knowing their actual rate and classification will allow to intervening in the process of drug use in hospitals.

This, was the reason of the present study to assess the rate of adverse events due to antibiotic use in hospitalized patients was chosen. Pharmacovigilance is an integral part of drug therapy. Still, it is not widely practiced in Indian hospitals. In various studies, adverse drug reactions have been implicated as a leading cause of considerable morbidity and mortality [6]. Indian reports on ADR monitoring have been very few. This may be because ADR monitoring is still evolving here. After decades of hibernation, the need for an efficient pharmacovigilance programmed was felt, the result of which was the institution of National Pharmacovigilance Programmed in November 2004 [7]. Under this programmed, the Central Drugs Standards Control Organization, New Delhi officiates as the central co-coordinating body under which two zonal, five regional and 24 peripheral centers have been established. The objective of this programmed is to create awareness among the health professionals on ADR monitoring and to encourage a reporting culture.

Hospital-based ADR monitoring and reporting programmed aim to identify and quantify the risks associated with the use of drugs. This information may be useful in identifying and minimizing preventable ADRs while generally enhancing the knowledge of the prescribers to deal with ADRs more efficiently.

Aim and objective

(a) To evaluate antibiotic exposure in inpatients in clinical departments of CIMS hospital

(b) To determine the frequency of medication-related events;

MATERIAL METHOD:

This was a prospective reporting study conducted by department of pharmacology and medicine, Chhattisgarh institute of medical sciences (CIMS), Bilaspur, a tertiary care teaching government hospital. This is a 650 bedded hospital covering maximum patient from poor section of society.

The study was conducted over a period of 6 months from Jan 2011 to June 2011. The data of inpatients from the medicine departments of hospital, those who were on antibiotics treatment were collected by the team of our trained medical students of our college and validated by pharmacologist and clinician. Approval of the Institutional Human ethics committee was obtained prior to the study.

The study was planned with a notification form, a patient and reaction detail documentation form, adr assement form and adr classification form. The information gathered by the forms were: socioeconomic data (age, sex, body weight, height, race, pregnancy and employment), anamnesis data (drug history, physical illnesses, alcohol consumption, nicotine or drug abuse and previous ADRs), currently administered drugs (dose, timing and way of administration), manifestations thought to be ADR, including the timing of

On set and ending, implicated drug(s), severity, predisposing factors and final comments.

The following medical records were excluded :patients coming from the intensive care unit; patients staying less than 48 hours in the hospital; and those who received antibiotics for the treatment of fungal or protozoan infections.

The medical students posted to the department attended rounds with doctors and filled the form and reported adverse drug events. All severe adverse reactions were immediately reported to the physician.

INFORMATION SHEET ABOUT PATIENT:--

1. Serial number

2. Date of an admission

3. Date of discharge

4. Age

5. Sex

6. Weight

7. Relevant investigations

8. Diagnosis-provision and final

9. Total duration of hospital stay

ABOUT DRUG:

1. Day of starting drug

2. Dosage form of drugs

3. Name of drugs

4. Dose

5. Frequency of administration

6. Route of administration

7. Duration of therapy

8. Total no of drugs

9. Adverse drug reactions

11. Outcome management

The ADRs were classified according to the Wills and Brown classification [7]. The severity of the reaction was determined according to Hartwig et al.[8] as given below:

Mild reactions which were self limiting and able to resolve over time without treatment and did not contribute to prolongation of length of stay.

Moderate ADRs were defined as those that required therapeutic intervention and hospitalization prolonged by 1 day but resolved in <24 h or change in drug therapy or specific treatment to prevent a further outcome.

Severe ADRs were those that were life threatening, producing disability and those that prolonged hospital stay or led to hospitalization, required intensive medical care, or led to the death of the patient.

Patient outcomes were reported as:

Fatal

Fully recovered (Patient fully recovered during hospitalization)

Recovering (Patient recovering, but not fully recovered during hospitalization)

Unknown (not documented after initial report in chart)

RESULTS:

Table 1, 1600 forms were analysed (1300 adults: 46% male, 54%female; 300 children:50% male, 50% female).

TABLE-1

N=1600	Male	Female
Adults(1300)	598(46%)	702(54%)
Children(300)	150(50%)	150(50%)

Ceftriaxone (36%) was the most widely used antibiotics, cefotaxime (25%), inj ampicillin (16%), ofloxacin 10%, amikacin 6%, gentamicin 6%,ciprofloxacin 5%, piperacillin+ toza 2%.

FIGURE-1

Ceftriaxone/ cefotaxime were administered chiefly in respiratory tract infections, urinary tract infections and gastro enteritis.

Ofloxacin was primarily the only drug in acute gastro enteritis. Gentamicin and amikacin were used for urinary and respiratory tract infection.

58% percent of the recipients of antimicrobial drugs received only one agent, 22% were treated with two agents and the remainder received several antimicrobials .

Many adult inpatients had concomitant diseases: hypertension (35%), diabetes mellitus (18%), dyslipidemia (10%), chronic obstructive pulmonary disease (COPD; 8%) and hepatic failure (5%). Parenteral administration was the most widely used route of administration (Fig. 2).

FIGURE- 2

Adverse events were reported in sixty six patients.

Drug ceftrioxane resulted in skin rashes and diarrahea in the patients, later after 5 days therapy 18 patients developed leucopenia. Out of 18 patient 16 were adults (12 male and4 females) and 2 male children

Drug cefotaxime developed leucopenia 7 days after therapy in 8 patient..

Drug ofloxacin was the drug given alone for gastro enteritis developed life threatening complications(rashes, urticaria,perspiration) in 12 patients, later 10 patient detoriorated with shock and non recordable bp/ pulse. Shifted to emergency ward. All cases recovered and shifted to amikacin and gentamicin out of them 10 were adults (2 male and8 females) and 2female children.

After ciplox 10 adult patient(6 female and 4 males) and 2 children (1 male and 1 female) developed skin rashes and urticaria Amikacin given resulted after 3 days into renal changes and test detected uremia in 6 patient. Later afer 3 days resulted in raised urea and creatinine.

Same adverse affect was seen with 3 patience with gentamicin. In both cases Drugs were withdrawn and ciplox/oflox was started.

Piperacillin and Toza resulted with life threatening reaction in nine patients i.e angio neurotic odema and hypertension which were treated in ICU recover after 3 days.

Organ system involved No patients of ADR

Gastrointestinal disorder 05

Renal disorder 06

Hypertension 09

Urtacaria 30

Blood and lymphatic system 23

Hypersensitisy reaction 03

Total 66

DISCUSSION:

In our study the incidence rate of ADR was 4%. In a review, pir Mohamed et al reported ADR frequency between 10% to 20% in inpatient (9). Various study in the world had reported the incidence rate ranging from 6% to20%. In the study by Gor et al the prospective part of study showed incidence rate was 3% and on the other hand retrospective study analysis showed ADR only 1%. This clearly shows that when ADR are looked for occurrence more patient of ADR can be picked up(10)

As documented, most of ADR develop within first 10 days of administering the drug.(11). In our study also most of ADR develop within first 10 days of hospitalization. This emphasizes the need of observing patients closely in initial period of treatment.

Although our study used a spontaneous reporting system for ADR monitoring, the presence of trained medical students in the wards and their constant encouragement might have helped clinicians and nurses to notify ADRs that resulted in better reporting than comparable studies in India.

This study, together with previous results, indicates that the prescribing of antibiotics in our teaching hospital could be excessive. A number of strategies (educative and persuasive, facilitative and restrictive) have been proposed to improve antibiotic use. Unfortunately, educational programmes alone do not seem to have the desired effect [12].

These procedures together with specific educational programmes should improve the antibiotic use in our hospital and should therefore result in reduced bacterial resistance, hospital costs and the time spent in hospital [12].

ADR monitoring is being introduced in our hospital. However, the programme has so far been implemented only in the in-patient medical wards of the hospital. With the encouraging support of the hospital authorities and clinicians of the hospital, we believe that it will be possible to expand the programme to other departments of the hospital in future.

CONCLUSION:

This study concludes that awareness has to be promoted about adr monitoring (pharmacovigilance) at all level in the medical field. Proper antibiotic use can be done supported by pharmacovigilance, rational therapeutics and good educational programe. Proper use of antibiotics will result in decreased hospital stay, desrease cost and prevent bacterial resistance.

Lastly, this study suggested that hospital-based monitoring is a good method with which to detect known and unknown links between drug exposure and ADRs. The clinicians should make an attempt for early detection and be vigilant about safety profile monitoring of the prescribed medications.

REFRENCES:

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[2] Mazzeo F, Capuano A, Motola G, Russo F, Berrino L, Filippelli A, et al. Antibiotic use in an Italian university hospital. J Chemother

2002;14:332–5.

[3] Vlahovic-Palcevski V, Morovic M, Palcevski G. Antibiotic utilizationat the university hospital after introducing an antibiotic policy. Eur J Clin Pharmacol 2000;56:97–101.

[4] Thurmann PA. Methods and systems to detect adverse drug reactions in hospitals. Drug Saf 2001;24:961–8.

[5]Otero López MJ, Domínguez-Gil A. Acontecimientos adversos por medicamentos: una patología emergente.

[6] R. Arulmani SD Rajendra and B Suresh Adverse drug reaction monitoring in a secondary care hospital in South India. British journal clinical Pharmacology. Med. Feb 2008 V. 65(2)

[7]. Wills s brown D.A proposed new means of classifying adverse drug reaction to medicines, pharm.j.1999;262:163-5

[8].Hartwig sc, siegelj,Schneider pj. Preventability and severity assessment in reporting adr. Am.j. hosp pharm. 1992;49:2229-32

[9]. Pir mohammed et al 2000 adverse drug reaction. Br. Med.jr. 318; 1295-98

[10]. A.P. Gor, S.V. Desai. Adverse drug reaction (ADR) in the in patient of Medicine Department of a rural Tertiary care teaching hospital and influence of pharmacovigilance in reporting ADR indian I pharmacology. Med. Feb 2008; Vol 40; issue 1; 37-40.

[11] Eileen g, hollcend,phevmd. And frank.v. degrig m.d. drug induced disorder D. family physician November 1997; 2:10

[12]. Filomena Mazzeo, Annalisa Capuano, Analia Avolio, Amelia filippelli, Franciso Rossi. Hospital based intensive monitoring of antibiotic induced adverse events in a university hospital. Pharmacology research. Med : 51 (2005) 269-274

Received on 23.12.2011

Modified on 20.01.2012

Accepted on 23.01.2012

Research J. Pharmacology and Pharmacodynamics. 4(1):Jan. - Feb., 2012, 13-16