RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,KARNATAKA
BANGALORE
ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FORDISSERTATION

1 / Name of the candidate and
Address(in block letters) / DR.UMESHCHANDRA.C.HONNADDI,
POST GRADUATE RESIDENT, (MD)
DEPARTMENT OF PHARMACOLOGY,
HKE SOCIETY’S MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA-585105
Permanent address / DR.UMESHCHANDRA.C.HONNADDI
FLAT NO:S-1,2ND FLOOR, A-WING,
ASIAN RESIDENCY OPPOSITE G.D.A.
TIMMAPURI CHOWK,GULBARGA-585102
2 / Name of the institution / HKE SOCIETY’S MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA-585105
3 / Course of study and subject / M.D. PHARMACOLOGY
4 / Date of admission to the course / 30/08/2013
5 / Title of Topic / DRUG UTILIZATIONSTUDY OF ANTIBIOTICS USE IN ORTHOPAEDIC UNITS OF BASAVESHWAR TEACHINGAND GENERALHOSPITAL ATTACHED TO HKE SOCIETY’S MAHADEVAPPA RAMPURE MEDICAL COLLEGE GULBARGA
6 / Brief Resume of Intended work:
6.1Need for the study:
Antibiotics are substances produced by microorganisms, which selectively suppress the growth of or kill other microorganisms at very low concentrations.
Antibiotics are commonly prescribed medicine in orthopaedics unit1. Antimicrobial prophylaxis remains the single most effective method of reducing the prevalence of infection after total joint arthroplasty2.
In orthopaedics department surgery constitutes the main manipulation and requires guided antibiotic prophylaxis. In addition to the usual nosocomial infections that commonly occur in surgical wards such as wound, urinary tract and catheter related blood stream infections
and pneumonia, specific septic diseases such as osteomyelitis, osteitis, spondylodiscitis, septic arthritis and prosthetic joint infection represent the worst complications. Successful treatment requires, besides surgical debridement, long-term systemic and high concentration local antibiotic therapy3.
Joint replacement surgery is the major procedure to alleviate pain and to improve mobility in people with damaged joints. Less than 10% of prosthesis recipients develop implant-associated complications during their lifetime, predominantly as aseptic failure4. Infections associated with prosthetic joints occur less frequently than the aseptic failures, but represent the most devastating complication with high morbidity and substantial cost. In addition to protracted hospitalization, patients risk complications associated with additional surgery and antimicrobial treatment, as well the possibility ofrenewed disability5.Prompt administration of systemic antibiotics and drainage of the involved joint can prevent destruction of cartilage, post-infectious degenerative arthritis, joint instability or deformity6.Antimicrobial prophylaxis is a necessary adjunct to the management of fractures that require surgery. In closed fractures, administration of a first generation cephalosporin 30minutes before surgery provides adequate coverage7.The aim of the present study is to evaluate the utilization pattern of antibiotics use among the patients admitted to the orthopaedics department of HKE Society’sBasveshwar Teaching and General Hospital, attached to M.R.Medical College, Gulbarga.
6.2 Review of Literature:
Infection is a very important problem in orthopaedic surgery, because of its continuing incidence, clinical importance and serious sequelae, the treatment being very difficult and expensive. Rates of infection have been reduced by antibiotic prophylaxis, but the increasing number of implants used means that there are still many patients affected each year8.Infection complicates 1-4% of total joint replacements. The majority of infections are acquired intraoperatively or immediately post-operatively as a result of wound breakdown or infection, less commonly these joint infections develop later after joint replacement and are result of hematogenous spread or direct inoculation. Rates of infection are particularly high among patients with rheumatoid arthritis, persons who were undergone previous surgery on the joint and persons with medical conditions requiring immunosuppressive therapy. Perioperative antibiotic prophylaxis, usually with cefazolin and measures to decrease intraoperative contamination, such as laminar flow, have lowered the rates of perioperative infection to <1% in many centres6.The combination of rifampin with ciprofloxacin has been used successfully to treat prosthetic-joint infections9
Drug Utilization Research/Study has been defined by the World Health Organization [WHO] in 1977 as the marketing, distribution, prescription and use of drugs in a society with special emphasis on the resulting medical, social and economic consequences10.
Drug Utilization Studies are pre-requisite for the formulation of drug policies. These studies also offer useful methods for teaching and training in drug therapy. It is well known that indiscriminate use of drug results in unwanted adverse effects and drug interactions and poses difficulties in diagnosis. The Drug Utilization Study identifies the problems that arise from drug usage in health care delivery system and highlights the current approaches to the rational use of medicines11.
The principle aim of drug utilization research is to facilitate the rational use of drugs in the population. It contributes to rational use of drugs by analyzing the drug use pattern, generating early signs of irrational drug use and suggests intervention to improve drug usage12.
6.3 Objectives of the Study:
  1. To observe the prescribing pattern of antibiotics among orthopaedicians at our hospital.
  2. To assess rationality of the prescriptions.
  3. To monitor the adverse drug reactions.

7 / Material and methods:
7.1 Source of data:
The study will be conducted on patients admitted to orthopaedicunits of HKE Society’s Basaveshwar Teaching and General Hospital, attached to M.R.Medical College, Gulbarga.
7.2 Methods of collection of data (including sampling procedure if any):
A prospective study of antibiotics use will be conducted on the patients admitted in orthopaedic units of HKE Society’s Basaveshwar Teaching and General Hospital, attached to M.R. Medical college, Gulbarga. The duration of the study will be of 12 months from June 2014 to May 2015. The prescriptions of the patients who are treated during the course of the study will be audited prospectively using a specially designed form to record the required information. All the drugs prescribed are recorded including its dosage form, route of administration, frequency of administration, indication for which prescribed and duration of therapy.
The following (WHO core indicator) drug use indicators are determined:
  • Prescribing indicator
  • Patient care indicator
  • Facility indicator
  • Complimentary indicator
Relevant data will be collected from:
  1. Personal interview with the patients.
  2. Case sheets of patients.
  3. Consultation of concerned orthopaedician, duty doctor and staff nurse if necessary.
Inclusion criteria :
All patients who have been admitted in orthopaedic units of HKE Society’s Basaveshwar Teaching and General hospital, attached to M.R. Medical college Gulbarga, from June 2014 to May 2015.
Exclusion criteria:
1. Patients on anticancer therapy.
2. Patients who are HIV+ve and HbsAg+ve.
The data collected will be analyzed statistically using descriptive statistics.
7.3 Does the study require any investigation or intervention to be conducted on patients or other humans or animals? if so please describe briefly - No
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES. Ethical clearance has been obtained from Institutional Ethics Committee ofM.R.Medical College, Gulbarga.
8 / List of References:
  1. M I Yusof, A H Yusof. Orthopaedic Infections: Organisms and Antibiotic Sensitivity, Med J Malaysia, 2004; 59(5):574-7.
  2. Marculescu CE, Osmon DR. Antibiotic prophylaxis in orthopedic prostheticsurgery. Infect Dis Clin North Am 2005; 19:931–946.
  3. Duewelhenke N, Krut O, Eysel P. Influence on mitochondria and cytotoxicity ofdifferent antibiotics administered in high concentrations on primary humanosteoblasts and cell lines. Antimicrob Agents Chemother 2007; 51: 54-63.
  4. Steckelberg JM, Osmon DR. Prosthetic Joint Infection. In: Bisno AL and Waldvogel FA eds. 3rd. Washington, DC: Am Soc Microbiol 2000:173–209.
  5. Widmer AF. New developments in diagnosis and treatment ofinfection in orthopedic implants. Clin Infect Dis 2001;33(Suppl 2):94-106.
  6. Lawrence C. Madoff. Infectious Arthritis. Longo DL, Kasper DL, Fauci AS et al, editors. Harrison’s Principles Of Internal Medicine, 18th ed. New York: McGraw-Hill Publishers; 2012.p. 2842-2848.
  7. Smith AH, and Swiontkowski MF – Infection after Internal Fixation of Fractures. Journal of the American Academy of Orthopaedic Surgeons (JAAOS) 2000;8:288-289.
  8. Purghel F, Badea R, Ciuvica R, Anastasiu A .The use of antibiotics in traumatology and orthopaedic surgery.Mædica - a Journal of Clinical Medicine, 2006; 1(3): 58-65.
  9. Franklin D. Lowy. Staphylococcal Infections. Longo DL, Kasper DL, Fauci AS et al, editors. Harrison’s Principles Of Internal Medicine, 18th ed. New York: McGraw-Hill Publishers; 2012.p.1160-1170.
  10. World Health Organization (WHO). Introduction to drug utilizationresearch. Oslo: 2003.
  11. Adiga MNS, Alwar MC, Pai MRSM, Adiga US. Pattern ofantimicrobial agents use in hospital deliveries: A prospective comparativestudy. Online J Health Allied Scs 2009;8(4):10.
  12. Palain S, Shankar PR, Hegde C, Hegde M, Ojha P, and Mishra P . Drug utilization pattern in dental out patients in Tertiary careteaching hospital in western Nepal NYSDJ, 2008; 63-67.

9 / Signature of Candidate
10 / Remarks of guide / The clinical study is very much encouraging and promising, hence recommended.
11 / 11.1 / Name and
Designation of the guide / DR.VARDHAMANE SHRENIK.H.
M.D
PROFESSOR AND HEAD
DEPARTMENT OF PHARMACOLOGY
M.R.MEDICAL COLLEGE
GULBARGA
11.2 / Signature
11.3 / Co-guide (if any) / DR.S.B.KAMAREDDY
M.S
ASSOCIATE PROFESSOR
DEPARTMENT OF ORTHOPAEDICS
M.R. MEDICAL COLLEGE
GULBARGA
11.4 / Signature
11.5 / Head of the
Department / DR.VARDHAMANE SHRENIK.H.
M.D
PRFESSOR AND HEAD
DEPARTMENT OF PHARMACOLOGY
M.R.MEDICAL COLLEGE
GULBARGA
11.6 / Signature
12 / 12.1 / Remarks of the
Chairman and
Principal
12.2 / Signature