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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA,BANGALORE ANNEXURE - II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1. NAME OF THE CANDIDATE DR. GURUPRASAD NARENDRA BANAVASI AND ADDRESS P.G.STUDENT IN DEPARTMENT OF PHARMACOLOGY K.V.G. MEDICAL COLLEGE, SULLIA 574327 2. NAME OF THE INSTITUTION K.V.G. MEDICAL COLLEGE, SULLIA 3. COURSE OF STUDY AND M.D. PHARMACOLOGY SUBJECT 4. DATE OF ADMISSION TO 20-04-2009 COURSE 5. TITLE OF TOPIC A STUDY OF PRESCRIPTION PATTERN IN THE DRUG THERAPY OF E.N.T (EAR, NOSE AND THROAT) INFECTIONS AT K.V.G. MEDICAL COLLEGE HOSPITAL, SULLIA (D.K.) KARNATAKA. 1 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNA TAKA, BANGALORE. PROF'ORMA FOR REGISTRATION OF DISSERTATION TOPIC: A STUDY OF PRESCRIPTION PATTERN IN THE DRUG THERAPY OF E.N.T. (EAR, NOSE AND THROAT) INFECTIONS AT K.V.G. MEDICAL COLLEGE HOSPITAL, SULLIA (D.K.) KARNATAKA Dr. GURUPRASAD NARENDRA BANAVASI POST GRADUATE STUDENT DEPARTMENT OF PHARMACOLOGY K.V.G MEDICAL COLLEGE, SULLIA. 2 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 Need for the study: Infections of the ear, nose and throat (E.N.T) are common clinical problems occurring in the general population. These are afflictions /clinical entities frequently seen in both children and adults and responsible for considerable morbidity, distress and rarely mortality. Respiratory tract infections are among the most important human health problems because of their high and frequent incidence1 .Upper respiratory tract infections (URTI) constitute the majority of respiratory tract infections and the presenting manifestations are coughs or colds. Coughs and colds are also known as the common cold, coryza, acute nasopharyngitis or acute pharyngorhinitis. Drug therapy for the symptoms of upper respiratory tract infections are sought for the relief of discomfort and for the alleviation of the anxiety that the URTIs are potentially serious. These URTIs and other ENT infections [eg.tonsillitis, otitis media etc.] are generally caused by microorganisms viz. bacteria, fungi and viruses and accordingly, the treatment involves the use of appropriate antimicrobials with concurrent supportive drug therapy. Interestingly, it is clear that the common cold which is viral in origin is difficult to cure and its treatment is largely symptomatic. It has been reported that even symptomatic therapies such as oral or intranasal sympathomimetics may provide only temporary clinical relief. According to the available medical literature drug therapy for viral common cold is empirical and produces very few therapeutic benefits. Moreover, all the available symptomatic treatment regimens for common cold have associated side effects. However, for other ENT infections several treatment regimens have been in use. Antimicrobials, anti-inflammatory agents, sympathomimetic agents, antihistamines, mucolytics, expectorants and cough suppressants are prescribed either individually or in combination. The supportive measures include soothing remedies (syrups and lozenges)2, saline nose drops3, oral hydration and mist therapy4 and oral hot fluids5. 3 In this context, the use of antimicrobials and other additional measures assumes importance and calls for caution and restraint. The ultimate aim of the drug therapy of ENT infections is to eradicate infections and minimize the morbidity and the complications thereof. Moreover, the efficacy of the drug therapy in common cold and that of the supportive measures such as steam and cold mist therapy in other ENT infections have been debatable and questioned by some authors 6 . However, with the establishment of the efficacy of certain antimicrobials in ENT infections other than common cold, selection of appropriate antiinfectives with or without certain supportive measures is made possible. The purpose of treating ENT infections is to prevent complications and ensure adequate therapeutic benefit with least adverse effects. In fact, the study of any prescription pattern involves medical auditing and it includes monitoring and evaluation of the various prescriptions to ensure rationality in medical care. Accordingly, this study envisages compilation and evaluation of the pattern, trend, rationality and frequency of the use of drugs in the treatment of ENT infections, with emphasis on the available treatment regimens. 6.2 Review of literature: The use of the available treatment regimens in ENT infections depends on the identification and diagnosis of the particular clinical entity. The ENT infections known to occur are quite a few in number and include common cold, tonsillitis, pharyngitis, sinusitis, non-allergic rhinitis, adenoid infection, epiglottitis, laryngitis, acute and chronic suppurative otitis media, acute and latent (masked) mastoiditis, labyrinthitis and infections of the ear canal,such as furunculosis, otomycosis, etc7. 4 Treatment schedules advocated are based on the particular ENT infection diagnosed. Accordingly, several classes of drugs have figured in the list of medicines for the treatment of various ENT infections. The list comprises mainly the antimicrobials for eradicating the infections. Antimicrobials employed include sulfonamides, penicillins, macrolides, fluoroquinolones, cephalosporins, aminoglycosides, tetracyclines and combinations of penicillins with beta lactamase inhibitors. In addition, several supportive measures have also been used for symptomatic relief. Despite the availability of a number of drugs, the consensus of opinion in the medical literature is that the cure of viral common cold is still elusive. In a vast majority of ENT infections, adjuncts such as analgesics [eg.paracetamol] and antiinflammatory drugs [eg.ibuprofen] are claimed to provide much sought-after relief. However, the efficacy of other supportive measures in common cold viz. demulcent [soothing] syrups, oral hydration, saline nose drops, soothing homemade remedies such as lemon tea specially in young children has also been highlighted. Antihistamines (H1 receptor blockers) eg.diphenhydramine; centrally acting cough suppressants, eg.codeine, noscapine and dextromethorphan; mucolytics eg.Nacetyl cysteine; topical sympathomimetic drugs eg. ephedrine, oxymetazoline, phenylephrine and phenylpropanolamine; orally administered sympathomimetic drugs eg. pseudoephedrine and phenylpropanolamine; anticholinergics (eg. ipratropium); topical anaesthetic agents eg. benzocaine are among the adjuncts used in ENT infections with reports on their relative merits and demerits. Thus, the availability of a list comprising a wide variety of therapeutic agents belonging to different categories for the drug therapy of ENT infections noteworthy. 5 Interestingly, there are several enlightening reports on certain topics such as: pattern of antibiotic drug prescription in primary care in adult acute respiratory tract infections in Sicily8; pattern of drug utilization in acute tonsillitis in a teaching hospital in Nepa19. A survey of the prescription pattern has also been undertaken in a tertiary care hospital of Eastern Nepall0. 6.3 Objectives of the study a) To evaluate the trend and pattern of drug prescriptions for ENT infections in a teaching hospital. b) To study the rationality of the antimicrobial and the adjunctive drug therapy. c) To monitor adverse effects, if any. 7. MATERIALS AND METHODS 7.1 Source of data: This study seeks to record the observations prospectively and will be carried out at the K.V.G. Medical College Hospital, Sullia for a period of 15-18 months. In this context, the focus is on the co-ordination of ENT specialists and other hospital staff in the out patient department and wards. Medical case records will be the source of data and the data are recorded in a specially designed proforma. 7.2 Method of collection of data: The relevant data will be collected from the department of ENT, K.V.G. Medical College Hospital, Sullia in a specially prepared proforma with the following details. 1. Demographic data: Age, gender, address, OP/IP number and date of examination/admission of patients. 2. Disease data: Type and duration of ENT infection. 6 3. Data pertaining to drugs. Drug / drugs prescribed, dose, frequency and duration. 4. Data pertaining to investigations: Culture and sensitivity tests, if any. 5. Data pertaining to adverse effects referable to ENT and other organs systems, if any. Note: The aforementioned proforma, however, is subject to modifications if required, after an initial pilot study. Inclusion criteria: Patients above five years of age of either gender suffering from any of the common and routinely noticed ENT infections, in particular, reporting at K.V.G. Medical College Hospital, Sullia. Exclusion criteria: Surgical and allergic disorders pertaining to the ENT. Follow-up: Not applicable because the emphasis is on a curative approach in general. Follow -up period: Not applicable. 7.3. Does the study require any investigation/intervention to be conducted on patients/humans/animals? If so,please describe briefly. NOT APPLICABLE 7.4 Has ethical clearance been obtained from your institution in case of7.3? YES 7 8. REFERENCES: 1. W.H.O. document; Dept. of child and adolescent health and development; Cough and cold remedies for the treatment of acute respiratory infections in young children; 2001;01-32. 2. Randall JE., Hendley JO., A decongestant- antihistamine mixture in the prevention of otitis media in children with colds; Pediatrics; 1979., 63:483 485. 3. Bollag D., Albrecht E., Wingert W., Medicated versus saline nose drops in the management of upper respiratory infection; Helv. Paediat Acta., 1984., 39:341-345. 4. Richardson PS., Phipps RJ., The anatomy, physiology, pharmacology and pathology of tracheobronchial mucus secretion and the use of expectorant drugs in human disease; Pharmac Ther B., 1978; 3:441-479. 5. Sakettho K., Januszkiewicz. A., Sackner MA., Effects of drinking hot water, cold water and chicken soup on nasal mucus velocity and nasal airflow resistance; Chest 1978;74:408-410. 6. Garrison JC., Histamine, bradikinin, 5- hydroxytryptamine, and their antagonists., In; Goodman-Gilman.A et al eds; The pharnlacological basis of therapeutics 8th ed; 1990 : 575-599. 7. Dhingra PL., Diseases of Ear Nose and throat, 4th edition; 2007:Elsevier publication: 48-55. 8. Mazzaglia G., Greco S., Lando C., Cucinotta G. and Caputi A.P., Adult acute upper respiratory tract infections in Sicily: pattern of antibiotic drug prescription in primary care ;Journal of Antimicrobial chemotherapy; 1998.,Vol. 41 : 259-266. 8 9. Rehan HS., Patten of drug utilization in acute tonsillitis in a teaching hospital in Nepal; Indian Journal of otolaryngology and Head and Neck surgery., July 2003; 55(3): 176179. 10. Das BP., Sethi A., Rauniar G.P., Sharma SK., Antimicrobial utilization pattern in outpatient services of ENT department of tertiary care hospital of Eastern Nepal. Kathmandu university medical journal 2005; 3(4): Issue 12:370-375. 9