A Prospective Observational Study of Prescribing Pattern in Respiratory Tract Infections at Tertiary Care Teaching Hospital

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1 A Prospective Observational Study of Prescribing Pattern in Respiratory Tract Infections at Tertiary Care Teaching Hospital Md Mohiuddin Shareef 1, *Ayesha Begum 1, Hashim Syed Ali Abbas H 1, Tamseel Fatima 1, Mayira Rahat Khatoon 1 And Moosa Khan 2 1 MESCO College of Pharmacy, Mustaidpura, Karwan Road, Hyderabad. 2 Department of General Medicine, Osmania General Hospital (OGH), Afzal Gunj, Hyderabad,T.S, India ayeshaali.81211@gmail.com Corresponding author: *Ayesha Begum ABSTRACT To understand the prescribing pattern of Antibiotics as well as other drugs in the Treatment of Respiratory Tract Infections ( RTIs ) at Tertiary care Teaching Hospital and to check the Rationality of the Prescription. The present study represents the current prescribing trend for RTI at OGH. Amoxicillin + Clavulanic Acid was the most commonly prescribed Antibiotic, CPM was most commonly prescribed Antihistaminic and Grillinctus and Ascoryl was most commonly prescribed cough syrups. Majority of the drugs was prescribed by Brand names.one third of the study population shows in-appropriate prescriptions, suggesting a need for programme to improve prescribing. Further studies focused on the Rationale for choice of Antibiotic for RTI, duration of Antibiotic and Drug Interactions of drugs in RTI would give additional insights into prescribing patterns of RTI drugs. The study point out the need for improved patient education on Adherence to therapy and development of Antibiotic Prescribing guidelines for RTI in India as there are no guidelines for prescribing Antimicrobial drugs in RTI, which may lead to Antibiotic Resistance in future due to over prescribing of Antibiotics. The study provides the baseline data for similar studies in future as pattern of prescribing RTI drugs keep changing. Key Words : Respiratory Tract Infections ( RTI ), Antibiotics, Anti Histaminics, Amoxicillin + Clavulanic Acid, Azithromycin, ceftriaxone, Cetrizine, Levocetrizine, Duration of Antibiotic Therapy, Rationality of Prescription.. INTRODUCTION Respiratory tract infections: Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.they're usually caused by viruses, but can be caused by bacteria. RTIs are thought to be one of the main reasons why people visit their General Practitioners or pharmacist. The Common Cold is the most widespread RTI [1]. Healthcare professionals generally make a distinction between: upper respiratory tract infections which affect the nose, sinuses and throat lower respiratory tract infections which affect the airways and lungs Children tend to get more upper RTIs than adults because they haven't built up immunity (resistance) to the many viruses that can cause these infections. [1] How respiratory infections spread RTIs can spread in several ways. If you have an infection such as a cold, tiny droplets of fluid containing the cold virus are launched into the air whenever you sneeze or cough. If these are breathed in by someone else, they may also become infected. [1] Infections can also be spread through indirect contact. The best way to prevent spreading infections is to practise good hygiene, such as regularly washing your hands with soap and warm water.. [1] Page No:419

2 Upper respiratory tract infections ( URTI ) Common upper respiratory tract infections include: The common cold Tonsillitis infection of the tonsils and tissues at the back of the throat Sinusitis infection of the sinuses Laryngitis infection of the larynx (voice box) Flu A cough is the most common symptom of an upper RTI. Other symptoms include headaches, a stuffy or runny nose, a sore throat, sneezing and muscle aches.. [1] Lower respiratory tract infections Common lower RTIs include: Flu which can affect either the upper or lower respiratory tract Bronchitis infection of the airways Pneumonia infection of the lungs Bronchiolitis an infection of the small airways that affects babies and children aged under two Tuberculosis (TB) persistent bacterial infection of the lungs. [1] Upper respiratory tract infections Common upper respiratory tract infections include: The common cold Tonsillitis infection of the tonsils and tissues at the back of the throat Sinusitis infection of the sinuses Laryngitis infection of the larynx (voice box) Flu [1] Common Cold: A cold is a mild viral infection of the nose, throat, sinuses and upper airways. It's very common and usually clears up on its own within a week or two. [2] The main symptoms of a cold include: a sore throat a blocked or runny nose sneezing a cough [2] Tonsillitis: Tonsillitis is inflammation of the tonsils. It's usually caused by a viral infection or, less commonly, a bacterial infection.tonsillitis is a common condition in children, teenagers and young adults. [3] Symptoms of tonsillitis The symptoms of tonsillitis include: a sore throat and pain when swallowing earache high temperature (fever) over 38C (100.4F) coughing headache Symptoms usually pass within three to four days. [3] Sinusitis: Sinusitis is a common condition in which the lining of the sinuses becomes inflamed. It's usually caused by a viral infection and often improves within two or three weeks. [4] The sinuses are small, air-filled cavities behind your cheekbones and forehead. The mucus produced by your sinuses usually drains into your nose through small channels. In sinusitis, these channels become blocked because the sinus linings are inflamed (swollen) [4] Signs and symptoms Sinusitis usually occurs after an upper respiratory tract infection, such as a cold. If you have a persistent cold and develop the symptoms below, you may have sinusitis. Page No:420

3 Symptoms of sinusitis include: a green or yellow discharge from your nose a blocked nose pain and tenderness around your cheeks, eyes or forehead a sinus headache a high temperature (fever) of 38C (100.4F) or more toothache a reduced sense of smell bad breath (halitosis) Making sure underlying conditions such as allergies and asthma are well controlled may improve the symptoms of chronic sinusitis. [4] Laryngitis: Laryngitis is inflammation of the larynx (voice box). In most cases, it gets better without treatment in about a week. Symptoms of laryngitis can begin suddenly and usually get worse over a period of two to three days. Common symptoms of laryngitis include: hoarseness difficulty speaking sore throat mild fever irritating cough a constant need to clear your throat The hoarse voice and speaking difficulties usually get worse each day you're ill and may last for up to a week after the other symptoms have gone. [5] In a few cases, the larynx can swell and cause breathing difficulties. This isn't common in adults but can occur in young children who have smaller, narrower windpipes. Laryngitis is often linked to another illness, such as a cold, flu, throat infection (pharyngitis) or tonsillitis, so you might also have other symptoms such as: a headache swollen glands runny nose pain when swallowing feeling tired and achy [5] Lower respiratory tract infections Common lower RTIs include: Flu which can affect either the upper or lower respiratory tract Bronchitis infection of the airways Pneumonia infection of the lungs Bronchiolitis an infection of the small airways that affects babies and children aged under two Tuberculosis (TB) persistent bacterial infection of the lungs [1] Flu: Flu is a common infectious viral illness spread by coughs and sneezes. It can be very unpleasant, but you'll usually begin to feel better within about a week. one can catch flu short for influenza all year round, but it's especially common in winter, which is why it's also known as "seasonal flu". It's not the same as the common cold. Flu is caused by a different group of viruses and the symptoms tend to start more suddenly, be more severe and last longer. [6] Some of the main symptoms of flu include: a high temperature (fever) of 38C (100.4F) or above tiredness and weakness a headache Page No:421

4 general aches and pains a dry, chesty cough [6] Bronchitis : Bronchitis is an infection of the main airways of the lungs (bronchi), causing them to become irritated and inflamed. The bronchi branch off on either side of your windpipe (trachea). They lead to smaller and smaller airways inside your lungs, known as bronchioles. The walls of the bronchi produce mucus to trap dust and other particles that could otherwise cause irritation. Most cases of bronchitis develop when an infection irritates and inflames the bronchi, causing them to produce more mucus than usual. Your body tries to shift this extra mucus through coughing. Most cases of bronchitis develop when an infection irritates and inflames the bronchi, causing them to produce more mucus than usual. Your body tries to shift this extra mucus through coughing. [7] Symptoms of bronchitis The main symptom of acute bronchitis is a hacking cough, which may bring up clear, yellow-grey or greenish mucus (phlegm). Other symptoms are similar to those of the common cold or sinusitis, and may include: sore throat headache runny or blocked nose aches and pains tiredness [7] Pneumonia: Pneumonia is swelling (inflammation) of the tissue in one or both lungs. It's usually caused by a bacterial infection. At the end of the breathing tubes in your lungs are clusters of tiny air sacs. If you have pneumonia, these tiny sacs become inflamed and fill up with fluid. [8] Symptoms of pneumonia The symptoms of pneumonia can develop suddenly over 24 to 48 hours, or they may come on more slowly over several days. Common symptoms of pneumonia include: a cough which may be dry, or produce thick yellow, green, brown or blood-stained mucus (phlegm) difficulty breathing your breathing may be rapid and shallow, and you may feel breathless, even when resting rapid heartbeat fever feeling generally unwell sweating and shivering loss of appetite chest pain which gets worse when breathing or coughing [8] Bronchiolitis: Bronchiolitis is a common lower respiratory tract infection that affects babies and young children under two years old. Most cases are mild and clear up without the need for treatment within two to three weeks, although some children have severe symptoms and need hospital treatment. The early symptoms of bronchiolitis are similar to those of a common cold, such as a runny nose and cough. [9] Further symptoms then usually develop over the next few days, including: a slight high temperature (fever) a dry and persistent cough difficulty feeding rapid or noisy breathing (wheezing) [9] Page No:422

5 Tuberculosis: Tuberculosis (TB) is a bacterial infection spread through inhaling tiny droplets from the coughs or sneezes of an infected person. It mainly affects the lungs, but it can affect any part of the body, including the tummy (abdomen) glands, bones and nervous system. TB is a serious condition, but it can be cured if it's treated with the right antibiotics [10] Symptoms of TB Typical symptoms of TB include: a persistent cough that lasts more than three weeks and usually brings up phlegm, which may be bloody weight loss night sweats high temperature (fever) tiredness and fatigue loss of appetite swellings in the neck one should see a GP if you have a cough that lasts more than three weeks or you cough up blood. [10] AIMS AND OBJCTIVES To study the impact of Prescribing Pattern of Drugs in Respiratory Tract Infections : To understand the prescribing pattern of Antibiotics as well as other drugs in the treatment of Respiratory tract infections (RTIs) at Tertiary Care Teaching Hospital. To Check the Rationality of the Prescription. MATERIALS AND METHODS The study included all patients admitted to the hospital with age group more than 18 years, those presented with the symptoms of Respiratory Tract Infections including that of Upper Respiratory Tract Infections (URTIs) and Lower Respiratory Tract Infections (LRTIs) and physical examination and appearance of symptoms and other clinical findings like computerized tomography (CT Scan) obtained within 24hours of admission. And the Patients that are already Diagnosed with Respiratory Tract Infections (RTIs) and the Patients with Co- Morbidities.The patients under 18 years age group, pregnant women, Lactating Women and patients undergone majors Surgery were excluded from our study to have better outcome of the study. The patients who are HIV positive were also excluded from the study. Study design: A prospective and observational study. Study site: The study was carried out at Department of General medicine in Out Patient and Inpatient Department of Osmania General Hospital. Population size: 100 patients size was selected for the study Study Period: The Study was carried out for 6 Months. METHODOLOGY A prospective and observational study on Prescribing Pattern of Drugs in Respiratory Tract Infections was carried with a duration of six months in tertiary care and teaching hospital of Telangana State (India). The patients parameters were monitored timely and were recorded. While studying the effects of Drugs that were precscribed for each patient was calculated on a daily basis. MATERIALS AND METHODS Suitable Data collection forms were prepared and the data collection was done in the prepared forms. The Data is Collected using Prepared forms Follow up of Patients is done to Evaluate Page No:423

6 Assessment and Rationality of Prescription Assessment and Classification of Collected Data Evaluation and Analysis of Collected Data DATA ANALYSIS Data Analysis is done based on the Parameters assessed and analyzed. The data is represented and the results are made by Graphical Data Representation DATA COLLECTION At the study sites, patients admitted to Causality department or Medical Assessment Unit. Patients are assessed and may be hospitalized with presenting signs. In hospitalized patients, the site of care (ICU or General Ward) is the sole decision of the attending physician of the causality unit. Initial physical examination such as Temp, blood pressure, pulse rate, respiratory rate, heart sounds, bronchial sounds on chest auscultation makes suspicion for pneumonia), oxygen saturation, and blood glucose are recorded in the emergency department and standard advices of computed tomography(ct scan) and initial blood tests (full blood count, urea and electrolytes) are performed in all patients. Within one hour of the admission the initial treatment is commenced. The data was collected from the hospital case record into the special form developed for the study in which all the patient demographics, past medical and social history, comorbidities (diabetes mellitus, chronic heart failure, chronic obstructive pulmonary disease, cancer, liver disease and adrenal disease), Clinical symptoms, physical examination, radiological findings and results of initial biochemical analyses, by the investigators. Study investigators independently observes the Drug Therapy and Treatment from these patients based on severity of symptoms, after the initial drug therapy was started by attending physicians with no interference from the investigators. To determine compliance/ non-compliance with guidelines, data were collected regarding the site of care and specialty of prescribers commencing initial drug therapy. Clinical response is observed daily before and after administration of drug therapy in morning and afternoon time. PLAN OF WORK Page No:424

7 RESULTS DEMOGRAPHIC PROFILE Table 1: Distribution of Subjects based on Gender Demographic Profile Total Percentage Total Sample Size % Male 67 67% Female % Table 2: Distribution of subjects based on Age Age Groups No of Patients Percentage % % % % % % % % Table 3: Distribution of Subjects based on In-patient and Out-Patient Data Total % Out Patients 33 33% In-Patients 67 67% Page No:425

8 Table 4: Distribution of Subjects based on incidence of RTIs Total % URTI s 35 35% LRTI s 65 65% Table 5: Distribution of Subjects based on Incidence of RTI s in Patients with Addictions Addictions Total Percentage Smoker 14 14% Alcoholic 07 07% Both ( S+A ) Other % 02% No-Addiction 36 36% Table 6: Distribution of Subjects based on Co-Morbidities Co-Morbidity Total Percentage Total Sample % Nil 44 44% Single 37 37% Double 17 17% Multiple 02 02% Page No:426

9 Table 7: Distribution of Subjects based on Double Co-Morbidity Double Co-Morbidity No of Patients Percentage DM + HTN 9 9% CCF + JAUNDICE 2 2% HTN + CCF 2 2% Pancytopenia + Corpulmonale 1 1% HONK + Metabolic Encephalopathy 1 1% GTCS + CVA 1 1% AKI with Anemia 1 1% Total Sample Size % Table 8: Antibiotics prescribed for study population Names of Antibiotics No of Patients Percentage Azithromycin 42 42% Amoxicillin + Clavunate 55 55% Ceftriaxone 50 50% Page No:427

10 Levofloxacin 13 13% Pipperacillin + Tazobactum 12 12% Cefixime 9 4% Doxycycline 01 1% Table 9: Distribution of Data based on Antibiotic Therapy Pharmacotherapy No of Patients Percentage Antibiotic Mono Therapy 51 51% Antibiotic Dual Therapy 22 22% Antibiotic Triple Therapy 21 21% Antibiotic Multiple Therapy 03 03% Nil 03 03% Fig 1: Results based on Antibiotic therapy Distribution of Data based on Antibiotic Therapy, it was found that Patients treated with Mono Therapy were 51% following with Dual and Triple Therapy with 22% and 21% Respectively. Page No:428

11 Table 10: Distribution of subjects based on Duration of Antibiotic Therapy Days No of Patients Percentage < 3 Days 25 25% 4-7 Days 88 88% >7 Days 02 02% Figure Number 18: Results based on duration of Antibiotics Therapy Fig 2: Results based on duration of Antibiotics Therapy Duration of Antibiotic Therapy, it was found that during treatment 88% of patients were treated with Antibiotics for 4-7 Days, 25% with 3 or <3 days and 2% for >7 days. Table 11: Distribution of subjects based on antihistaminics prescribed Drugs No of Patients Percentage CPM 44 44% Levocetrizine 14 14% Diphenhydramine 02 02% Page No:429

12 Fig 3:Results based on Antihistaminics prescribed Results: Distribution of Subjects based on Anti-Histaminics prescribed for study Population, it was found that CPM was prescribed in 44% of patients and Levocetrizine was prescribed in 14% of patients. Table 12: Distribution of Data based on Cough Syrups prescribed to the study population Syrup No of Patients Percentage Syp Ambroxil 16 16% Syp Resvas 03 03% Syp Grillinctus 19 19% Syp Ascoril 19 19% Syp Montair LC 02 02% Page No:430

13 Figure Number 20: Results based on Cough syrups Fig 4: Results based on Cough syrups Results From the above table it was found that Syp Ambroxol and Syp Grillinctus was Prescribed in 16% and 19% of patients respectively and Syp Ascoril was Prescribed in 19% of patients. Table 13: Distribution of Subjects based on Route of Administration of Drugs Formulation No of Drugs Percentage IV % Oral % Other % Total No of Drugs % Fig 5: Results based on Route of Administration Page No:431

14 Result: Details of Route of Administration of Drug Formulations, it was found that Total No of Oral Formulations were 278which counts 36.2% following with IV Formulations which are 425 and the percentage for IV formulation is 55.4%. Table 14: Prescription Indices Prescription Indices Total Total No of Drugs Prescribed 760 Average No of Drugs Prescribed per Prescription 08 Average No of Antibiotics Per Prescription 02 Average No of Drugs Prescribed in Generic 03 Average No of Drugs Prescribed in Brand 05 Report:, It was found that the Total No of Drugs thatwere prescribed are 760, among that Avg No of Drugs prescribed per prescription are 08 Drugs, Avg No of Antibiotics per prescription are 02, The Avg No of Drugs in Generic are 03 and the drugs Prescribed in Brand Names are 05 per prescription. Table 15: Potential Drug Interactions Interactions No of Patients % of Drug Interactions No Interactions 37 37% Minor 17 17% Significant ( Monitor Closely ) 28 28% Serious ( Use Alternative ) 18 18% Drug Interactions No Interactions Minor Significant Serious 18% 37% 28% 17% Figure 6: Results based on Drug Interactions Page No:432

15 Results: On studying the Drug Interactions, it was found that 37% of the population was not having any Drug Interactions in their prescriptions,28 % of the population were having significant Interactions followed by Serious and Minor Interactions which were 18% and 17% of the Total Population. Table 16: Rationality of Prescription Rationality No of Prescriptions Percentage Rational 79 79% Partly Irrational 21 21% Fig 7: Rationality of Prescriptions Result: Rationality of Prescription, it was found that 79% of Prescriptions are Rational,21% are Partly irrational. Results and Discussion The most effective method to access and evaluate the prescribing pattern of the physician is considered to be prescription based survey. The main objective of the present prospective and observational study was to study prescribing patterns of drugs in Respiratory Tract Infections in a Teaching Hospital and to check the Rationality of the Prescription. For checking the rationality of the prescription the drugs prescribed were checked for any drug interactions on Medscape & Micromedex and the prescriptions showing serious drug interactions were considered to be partly irrational. Page No:433

16 The result of the present study indicates higher incidence of RTI in Males (67%) than in females (33%) and the most effective age groups was yrs of age ( However the literature for RTI shows no significant relation between age, sex and RTI). In a Total of 100 patients 36% had no social history of smoking and Alcohol consumption. Whereas 14% had social history of smoking and 7% had social history of Alcohol Consumption and 41% had social history of both smoking and alcohol consumption. The study reveals that LRTI is more common than URTI which counted for 65% and 35% respectively.out of 100 patients that was analysed none of the patients underwent culture sensitivity test for antibiotic. For Analyzing the prescribing pattern in RTI, the pharmacotherapy of Antibiotics was classified as Mono Therapy, Dual Therapy and Multiple Therapy. Out of 100 prescriptions that were analyzed 51% patients underwent monotherapy followed by Dualtherapy (22%) and Triple Therapy (21%) whereas less no of patients were found to be treated with Multiple therapy (3%). Higher % of patients were treated with Amoxicillin + Clavulanic Acid (55%) followed by ceftriaxone (50%) then Azithromycin (42%) other less commonly prescribed Antibiotics were Levofloxacin (13%) Pipperacillin +Tazobactum (12%), cefexime (4%) and Doxycycline (1%).[kotwani etal] The duration of antibiotic therapy was taken into consideration and most of the Antibiotics were taken for 4-7 days (88%) followed by <3 days (25%) than >7 days (2%). The study shows that the 60% of the patients were prescribed with Antihistamines and the most commonly prescribed Antihistaminic was CPM (44%) followed by Levocetrizine (14%). 54% of the study population were prescribed with cough syrups and the most commonly prescribed cough syrup was Ascoryl ( Bromhexine +Guaifenesin ) and Grillinctus ( Dextromethorphan Hydrobromide ) (19%) each followed by Ambroxol ( Ambroxol )(16%). From the study it was found that out of 100 prescriptions that were analyzed, the total no of drugs prescribed was 760 and the Avg. No of drugs prescribed per prescription was 8, Avg. No of Antibiotics per prescription was 2. The % of inappropriate or partly irrational prescriptions was (21%) and the % of appropriate or Rational Prescription was (79%), No statistically significant differences in the pattern of drugs used in RTI were observed when stratified according to age, sex and co morbid conditions. Summary and Conclusion There was an excessive use of Antimicrobial drugs in RTI and there was indiscriminate use of Broad Spectrum Antibiotics which was valid in some infections but was inappropriate in others. The present study represents the current prescribing trend for RTI at OGH. Amoxicillin + Clavulanic Acid was the most commonly prescribed Antibiotic, CPM was most commonly prescribed Antihistaminic and Grillinctus and Ascoryl was most commonly prescribed cough syrups. Majority of the drugs was prescribed by Brand names.one third of the study population shows in-appropriate prescriptios, suggesting a need for programme to improve prescribing. Further studies focused on the Rationale for choice of drugs in RTI based on severity of RTI,choice of Antibiotic for RTI, duration of Antibiotic and Drug Interactions of drugs in RTI would give additional insights into prescribing patterns of RTI drugs. The study points out the need for improved patient education on Adherence to therapy and development of Antibiotic Prescribing guidelines for RTI in India as there are no guidelines for prescribing Antimicrobial drugs in RTI, which may lead to Antibiotic Resistance in future due to over prescribing of Antibiotics. The study provides the baseline data for similar studies in future as pattern of prescribing RTI drugs keep changing. 25 REFERENCES Page No:434

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