ADJUNCTIVE DRUG UTILIZATION PATTERN IN ONCOLOGY DEPARTMENT OF A TERITIARY CARE HOSPITAL IN SOUTH INDIA

Size: px

Start display at page:

Download "ADJUNCTIVE DRUG UTILIZATION PATTERN IN ONCOLOGY DEPARTMENT OF A TERITIARY CARE HOSPITAL IN SOUTH INDIA"

Jayson Webster
5 years ago
Views:

Page1297 Indo American Journal of Pharmaceutical Research, 2015 ISSN NO: 2231-6876 ADJUNCTIVE DRUG UTILIZATION PATTERN IN ONCOLOGY DEPARTMENT OF A TERITIARY CARE HOSPITAL IN SOUTH INDIA G.

1 Page1297 Indo American Journal of Pharmaceutical Research, 2015 ISSN NO: ADJUNCTIVE DRUG UTILIZATION PATTERN IN ONCOLOGY DEPARTMENT OF A TERITIARY CARE HOSPITAL IN SOUTH INDIA G. Sneha *1, S. Aparna 2, B.N.V.B. Sri Lakshmi 3, A. Sravya Varma 4, Dr. D.S. Raju Naidu 5 1,2,3,4 Chalapathi Institute of Pharmaceutical Sciences, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India. 5 Government General Hospital, Guntur, Andhra Pradesh, India. ARTICLE INFO Article history Received 29/03/2015 Available online 09/04/2015 Keywords Adjunctive Drugs, Drug Utilization, Quality of Health Care, Adverse Events. ABSTRACT The objective of the study is to know the proportion of adjunctive drugs used, to improve the quality of health care like appropriate drug usage, reduce potential side effects, to list out drug chart for proper planning of indent and budget of adjunctive drugs. The study was conducted in the Oncology (Radiotherapy) Department of Guntur Medical College, Government General Hospital, Guntur. The study method includes prioritizing the patients based on inclusion and exclusion criteria with the approval from ethical committee. Information regarding adjunctive drug utilization is collected with the aid of a data collection form from the inpatient s case sheets. In our study, 226 patients of all age groups were observed over the period of 6 months. Prevalence of cancer was more at years of age group. Out of all the most commonly observed types of cancer in the patients were cervix n= 60 (26.54%) followed by Head and Neck n = 54 (23.9%). 32 adjunctive drugs and their oral formulations (77%) were used than parenteral formulations (23%). Ondansetron (17.5%) was the mostly prescribed drug followed by diclofenac (12.7%) and ranitidine (12.5%) and other commonly used drugs are Metronidazole, Ciprofloxacin, B-Complex, and Pantoprazole. From our study we conclude that 32 adjunctive drugs and their oral formulations were mostly prescribed, among them antibiotics, antiemetics, and NSAIDs were inappropriately used. The study assisted health care team in cognising the appropriate drug therapy and adverse drug reactions management and in precise indent and budget preparation without any drug lackage. Corresponding author Gogineni Sneha Pharm. D, Department of Pharmacy Practice, Chalapathi Institute of Pharmaceutical Sciences, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India sneha.gogineni9@gmail.com Please cite this article in press as Gogineni Sneha et al. Adjunctive Drug Utilization Pattern in Oncology Department of A Teritiary Care Hospital in South India. Indo American Journal of Pharm Research.2015:5(03). Copy right 2015 This is an Open Access article distributed under the terms of the Indo American journal of Pharmaceutical Research, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Page1298 INTRODUCTION Cancer is a term used for diseases in which cells abnormally divides without control and are able to invade to other tissues [1].

According to the WHO annually people die of cancer in India with prevalence of 500,000, this number is expected to rise to 700,000 by 2015 [3].

2 Page1298 INTRODUCTION Cancer is a term used for diseases in which cells abnormally divides without control and are able to invade to other tissues [1].Cancer is one of the common cause of deaths in India and has profound social and economic consequences, often leading to family impoverishment and societal inequity [2]. According to the WHO annually people die of cancer in India with prevalence of 500,000, this number is expected to rise to 700,000 by 2015 [3]. Oncology is a highly researched therapeutic area with huge number of drugs entering into the market with wide range of side effects due to high toxicity and narrow therapeutic window of chemotherapeutic drugs [4]. In oncology ADRs are so common, predictable and are inevitable which needs alternative therapy of their management and prevention. DUR affords pharmacist the opportunity to identify trends in prescribing within groups of patients with chronic diseasestates such as cancer, asthma, diabetes, high blood pressure, arthritis and others [6]. Prospective DUR involves comprehensive review of patient s drug therapy before a medication was dispensed, pharmacist routinely perform reviews in their daily practice by assessing prescription medications. DUR programs as quality assurance measure provide corrective action; prescriber feedback and further evaluations are made for more efficient use of scarce health care resources [5, 6,9]. Pharmacist play a key role in this process because of their expertise in the area of medication therapy management and their participation can directly improve the quality of care for patients by preventing the unnecessary drug therapy, adverse drug reactions and improve overall drug effectiveness [5, 6,7,8]. Drug utilization review supports intervention that will improve patient outcome, list out the drugs used in patients, managing drug flow in and out and budget of floor pharmacies. It affords the pharmacist or other health practitioners the opportunity to interact with patients and members of health care team to work on treatment plan for each patient. The main objective of the present study is to know the proportion of adjunctive drugs used, to improve the quality of health care like minimizing drug duplication, reducing potential side effects, to list out drug chart for proper planning of indent and budget of drugs in Oncology (Radiotherapy) Department. MATERIALS AND METHODS A Non-experimental prospective observational study was conducted over a period 6 months from April to September of 2014 in the department of radiotherapy, Government General Hospital- a tertiary care hospital, Guntur, Andhra Pradesh. Inclusion Criteria: Cancer inpatients of all age groups reported to the Oncology (Radiotherapy) Department are included in the study. Exclusion Criteria: Outpatients of radiotherapy department. The study method includes prioritizing the patients based on inclusion and exclusion criteria and analyzed the pattern of adjunctive drug utilization with the approval from the chief of Oncology (Radiotherapy) department and ethical approval was obtained before the initiation of the study. The patient demographic details, present, past medical and medication history, their treatment modalities like both radical [radiotherapy (RT), chemotherapy (CT), both (RT+ CT)], palliative [radiotherapy (RT), chemotherapy (CT), both (RT+ CT)], adjunctive drugs and recent (last 2mnths)/ past surgical history were collected. Information regarding adjunctive drug was collected with the aid of a data collection form which includes class of drugs like anti emetics, antibiotics, analgesics, acid suppressing agents, bronchodilators, steroids, vitamin supplements, anti-histamines and others from the inpatient s case sheets. The collected data was tabulated and analyzed using suitable statistical tools. RESULTS In our study, 226 patients of all age groups who admitted in the inpatient oncology department were observed over the period of 6 months. The adjunctive drug therapy of all the patients were collected and documented. Out of all the most commonly observed types of cancer in the patients was cervix n= 60 (26.54%) followed by head and neck n = 54 (23.9%). Next preceding cancers was breast n= 33 (14.60%), lung, vault n=18 (7.96%), endometrial, Hodgkin s and Non- Hodgkin s lymphoma n=11(4.86%). Fig 1: Type Wise Distribution of Cancer.

Page1299 The maximum prevalence of most of the cancer was in between the age group of 46-60 years. Further information is given in Table 1. Table 1: Age Wise Distribution of Patients.

3 Page1299 The maximum prevalence of most of the cancer was in between the age group of years. Further information is given in Table 1. Table 1: Age Wise Distribution of Patients. AGE Male Female 5-30 years 3.53%(n=8) 10.17%(n=23) years 10.17% (n=23) 17.25%(n=39) years 9.29%(n=21) 22.12%(n=50) > 60 years 14.15%(n=32) 13.27%(n=30) In this area cancer prevalence was predominant in females n= 152 (67.25%). At sixty years of age both males n=32 (14.15%) and females n=30 (13.27%) were having similar prevalence. People of younger age (5-25 years) were also suffering from cancer. In our study we observed that gynaecological cancers n=180 (80%) were seen mostly than other types (20%). Fig 2: Type Wise distribution of Cancers in Females. The total adjunctive drugs and their quantities have been listed. Further information is given in Table 2. Table 2: Drug Utilization in Radiotherapy Department. S.NO DRUG PARENTERAL FORMULATIONS ORAL FORMULATIOMS PERCENT AGE NUMBER PERCENTAGE NUMBER PERCENTA GE 1. Ondansetron % % 17.5% 2. Diclofenac % % 12.7% 3. Ranitidine % % 12.5% 4. Metronidazole % % 9.48% 5. Ciprofloxacin % % 7.36% 6. B-complex % 6.51% 7. Pantoprazole % 6.46% 8. Loperamide % 3.83% 9. Chlorpheneramine % % 3.30% maleate 10. Dexamethasone % - 3.2% 11. Paracetamol % % 2.38% 12. Deriphylline % % 2.44% 13. Hyoscine % % 2.1% 14. Metaclopromide % % 1.94% 15. Phenytoin % 1.24% 16. Ethamsulate % % 17. Amoxicillin % % 0.88% clavulonate 18. Aceclofenac % 0.85% 19. Mannitol % % 20. Ceftriaxone % % 21. Prednisolone % 0.58% 22. Tramadol % % 23. Fluconazole % %

Page1300 24. Amlodipine - 240 0.44% 0.34% 25. Bisacodyl - 180 0.33% 0.25% 26. Furosemide 120 0.74% - 0.16% 27. Furazone - 80 0.14% 0.11% 28. Potassium sulphate 60 0.37% - 0.08% 29.

4 Page Amlodipine % 0.34% 25. Bisacodyl % 0.25% 26. Furosemide % % 27. Furazone % 0.11% 28. Potassium sulphate % % 29. Magnesium sulphate % % 30. Piperacillin % % tazobactum 31. Mixtard(human % % insuline) 32. Filgrastim % % TOTAL The oral formulations (77%) of 32 adjunctive drugs were mostly used than parenteral formulations (23%). Ondansetron was the mostly prescribed drug (17.5%) followed by diclofenac (12.7%) and ranitidine (12.5%) and other commonly used drugs were metronidazole (9.48%), ciprofloxacin (7.36%), B-Complex (6.51%), and Pantoprazole (6.43%). Whereas filgrastim (0.02%), mixtard (0.04%), piperacillin + tazobactum (0.06%), Magnesium sulphate (0.08%), potassium sulphate (0.08%) were used less than 0.1%. We further classified the drug usage pattern based on needs of their usage like drugs used to prevent toxicities, drugs used in management of chemotherapy induced, and radiation induced adverse effects. Table 3: Drugs Used To Prevent Toxicities. Toxicities Type of Drug To Prevent Toxicities Proportion of Drugs Used To Prevent Toxicities Bladder toxicity Mesna 100%(n=176) Electrolyte imbalance Potassium sulfate 100% (n=60) Magnesium sulfate 100% (n=60) Nausea and vomiting Ondansetron 70% (n=8649) Dexamethasone 50.7% (n=1154) GI-irritation Ranitidine 50.6% (n=4476) The drugs and proportions of their use for prevention of chemotherapy induced adverse drug reactions include mesna (100%), Potassium sulfate (100%), Magnesium sulfate (100%) and Ondansetron (70%) and these drugs were mostly used to prevent toxicities. The common chemotherapy and radiotherapy induced ADRs were nausea, alopecia, anorexia, vomiting, taste alteration, diarrhea, constipation, neutropenia, itching, myelosupression, Gi-irritation, skin pigmentation. And the drugs used for their management are described below. Filgrastim (100%), metachlopromide (87.0%), antibiotics like piperacillin+tazobactum (77.8%), ceftriaxone (73.3%) and dulcolax (66.6%) were used drugs to manage induced adverse drug reactions. Further information is given in Figure 3. Fig 3: Chemotherapy Induced Adverse Drug Reactions (ADRs) And Their Management. Radiation induced adverse events were managed with drugs like Mucain gel (92%), Gentian violet (86%), Metronidazole(75%), Ciprofloxacin(74.5%). Further information is given in Figure 4.

Page1301 Figure 4: Radiation Induced Toxicities and Their Management DISCUSSION Trends in cancer types and their incidence are growing day by day in a developing country like India, which is showing

5 Page1301 Figure 4: Radiation Induced Toxicities and Their Management DISCUSSION Trends in cancer types and their incidence are growing day by day in a developing country like India, which is showing a major impact on socio-economic status of people. During the period of six months we observed 226 cancer patients admitted in inpatient radiotherapy department of a tertiary care teaching hospital. Most of the cancers are seen in between the age group of 5-40 years; this number is showing that cancer prevalence has increased in both younger and middle aged persons which impacts quality of life of individual and families. The most common type of cancer observed in our study was cervix (26.54%) followed by head and neck (23.94%) and the least was urinary bladder of 0.90%. Prevalence of cancer was shown to be more in females (n=152) than males (n=74). The incidence of gynaecological cancers (80%) was more in females than the other types (20%). In a study the total cancer cases are likely to go up from 979,786 cases in the year 2010 to 1,148,757 cases by 2020 [10]. In Bhopal cancer of tongue and oral cavity has highest incidence in both males and females next to cancer of the cervix and breast in females [11]. In the present study 23% of parenteral and 77% oral formulations of 32 adjunctive drugs were commonly used. Out of the total drugs ondansetron was highly prescribed (17.5%) followed by diclofenac (12.7%) and ranitidine (12.5%) and commonly used were Metronidazole (9.48%), Ciprofloxacin (7.36%), B-Complex (6.51%), and Pantoprazole (6.43%).Whereas filgrastim (0.02%), mixtard (0.04%), Piperacillin + tazobactum (0.06%), Magnesium sulphate (0.08%), Potassium sulphate (0.08%) were used less than 0.1%. In a study the categories of drugs prescribed were Anti-ulcer drugs (82%), Anti-allergics (60%), Anti-inflammatory drugs (57%), Antibiotics (20%), Analgesics(18%), Antiseptics(9%), NSAIDS(8%), Laxatives(8%), Antiasthamatics (5%), Antitussives (3%), Antidepressants(3%), Antidiarrhoeals (2%), Antihypertensives (2%), Mucolytics (1%), Anti-convulsants (1%), Diuretics (1%) in total patients [12,13]. In the present study single therapy of ondansetron (75%), dexamethasone (23.2%) followed by metachlorpromide (1.8%) were used for prevention and management of CINV. In several studies it was shown that Ondansetron alone has less potency than the combination therapy with 5HT3 receptor antagonists + NK1 antagonists/ steroids and has less incidence of ADRs [12, 14,15]. In our study we observed that neutrophil count in patients with neutropenia was monitored inappropriately as it was known that duration of neutropenia lasts for a minimum of 5-7 days, the usage of metronidazole, duration of other antibiotics were inappropriate and G- CSF was not administered prophylactically in febrile neutropenic patients to reduce the risk of serious infections in higher risk groups. In many studies it was proved that high-risk patients require hospitalization for IV empirical antibiotic therapy; monotherapy with beta-lactam agent, such as cefepime, carbapenem (meropenem or imipenem-cilastatin), or piperacillin-tazobactam, other antimicrobials (aminoglycosides, fluoroquinolones, and/or vancomycin) plus/or G- CSF [17,18]. In low risk groups ciprofloxacin plus amoxicillin-clavulanate in combination is recommended and others including levofloxacin or ciprofloxacin as monotherapy or ciprofloxacin plus clindamycin. Empirical antifungal therapy and investigation for invasive fungal infections should be considered for patients with persistent or recurrent fever after 4 7 days of antibiotics use [16,,19,20]. In our study most of the patients were inappropriately prescribed with analgesics like NSAIDs for management of different integrities of cancer pains, which leads to misuse of NSAIDs in place of other analgesics like salicilates, opioids and tricyclic antidepressants (TCAs) which has shown to be effective than NSAIDs alone and has impact of quality of life of cancer patients. In many studies WHO analgesic scale was proved be effective in cancer pain management. Paracetamol and/or NSAIDs are shown to be effective for treating mild pain and for treating all intensities of pain for short term management. For mild to moderate pain weak opioids such as codeine, tramadol and dihydrocodeine should be given in combination with non opioid analgesics. Alternative to weak opiods, low doses of strong opiods in combination with nonopiod analgesics should be considered. In moderate to severe pain strong opioids ± paracetamol, NSAIDs should be considered [ 20].

6 Page1302 This prospective DUR study shows that pharmacist play a key role in improving overall drug effectiveness and quality of patient care by avoiding unnecessary drug therapy; minimizing adverse drug reactions, educating health care team for rational drug use and drug list preparation for proper maintenance of indent, budget in pharmacy. CONCLUSION From our study we conclude that 32 adjunctive drugs and their oral formulations were mostly prescribed, among them antibiotics, antiemetics and NSAIDs were inappropriately used. Drug utilization study assisted the health care team in cognizing the usage of appropriate drug therapy, adverse drug reactions management and in precise indent, budget preparation without any drug lackage in inpatient radiotherapy department. ABBREVIATIONS DUR- drug utilization review, ADRs- adverse drug reactions, WHO- world health organisation, G- CSF- granulocyte colony stimulating factor, NSAIDs- nonsteroidal anti inflammatory drugs, CINV- chemotherapy induced nausea and vomiting. ACKNOWLEDGEMENT Authors are thankful to the ethical committee of Govt. general hospital and Guntur Medical College for their approval to conduct the study and the physicians and nurses of radiotherapy department for their cooperation to complete the study. CONFLICT OF INTEREST Conflict of interest declared none. REFERENCES 1. Kumar,Abbas et.al; Robbin s basic pathology ;8 th edition; Elsevier publications; 1964; P.no: Prof Mohandas K Mallath, MD;The growing burden of cancer in India: epidemiology and social context; the lancet oncology; Volume 15, No. 6, e205 e212, May Cancer incidence to rise five-fold in India by 2025?; IANS Feb 3, Brazilian Journal of Pharmaceutical Sciences; vol.50,n.2,apr./jun Leon shargel, et.al; Comprehensive pharmacy review;8 th edition; Wolters Kluwer(India)Pvt.Ltd;2001;Pp-( );Pp: G.Parthasarathi,et.al; A text book of clinical pharmacy practice, essential concepts &skills; orient longman publishers;2004;pp:84-102;pp: Afsaneh Vazina et.al.non interventional drug studies in oncology: Why we need them? ; Perspect Clin Res Oct-Dec; 1(4): Maria Tavakoli-Ardakani et.al. Adjuvant systemic therapies in women with breast cancer: an audit of clinical practice in Italy. Annals of Oncology 14: , Gianpiero Fasola, et.aldrug utilization studies- An overview. International Journal of Pharmaceutical and Nanotechnology. Volume 3, Issue 1, April June Ramnath Takiar*, Projections of Number of Cancer Cases in India ( ) by Cancer Groups; Asian Pacific Journal of Cancer Prevention, Vol 11, NATIONAL CANCER REGISTRY PROGRAMME, Indian Council of Medical Research, Consolidated Report of the Population Based Cancer Registries Incidence and Distribution of Cancer: Ayesha Siddiqua1*, Drug Utilization Evaluation of Anti Cancer Drugs; Am. J. PharmTech Res. 2014; 4(3) 13. Juny Sebastian et al; The impact of delayed chemotherapy-induced nausea and vomiting on patients, health resource utilization and costs in German cancer centers, Annals of Oncology Volume 15, Issue 3 Pp FREDERICK M. SCHNELL, Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist 2003;8: James W. Gilmore, Antiemetic Guideline Consistency and Incidence of Chemotherapy-Induced Nausea and Vomiting in US Community Oncology Practice: INSPIRE Study; JOURNAL OF ONCOLOGY PRACTICE VOL. 10, ISSUE H. C. Schouten, Neutropenia management, Annals of Oncology 17 (Supplement 10): x85 x89, 2006 doi: /annonc/mdl Christopher.R, Chemotherapy induced neutropenia: important new data to guide nursing assessment and management; cancer therapy and supportive care, vol 4, no.2, march Lee s schwar t zberg, management of chemotherapy-induced neutropoenia, European oncology Alison G. Freifeld, Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update by the Infectious Diseases Society of America, Clinical Practice Guideline d CID 2011:52 (15 February) 20. Johanna N. Timmer-Bonte, Prevention of Chemotherapy-Induced Febrile Neutropenia by Prophylactic Antibiotics Plus or Minus Granulocyte Colony-Stimulating Factor in Small-Cell Lung Cancer: A Dutch Randomized Phase III Study; JOURNAL OF CLINICAL ONCOLOGY; VOLUME 23 NUMBER 31 NOVEMBER C. I. Ripamonti, Management of Cancer Pain: ESMO Clinical Practice Guidelines Published in 2012 Ann Oncol 2012; 23 (Suppl 7): vii39-vii154.

Page1303 22. Hrachya Nersesyan and Konstantin V Slavin, Current aproach to cancer pain management: Availability and implications of different treatment options, Ther Clin Risk Manag.

7 Page Hrachya Nersesyan and Konstantin V Slavin, Current aproach to cancer pain management: Availability and implications of different treatment options, Ther Clin Risk Manag Jun; 3(3): D Cameron* 1, Management of chemotherapy-associated febrile neutropenia, British Journal of Cancer (2009) 101(S1), S18 S Lisha jenny john1, drug utilization study of antimicrobial agents in medical intensive care unit of a tertiary care hospital, Asian Journal of Pharmaceutical and Clinical Research, Vol. 4, Issue 2, Bruce A. Feinberg, DO, Incidence and risk factors for chemotherapy-induced nausea or vomiting following highly or moderately emetogenic chemotherapy in community oncology practice, community oncology, Volume 7/Number 8 August Marília Berlofa Visacri 1, Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting; Brazilian Journal of Pharmaceutical Sciences vol. 50, n. 2, apr./jun., *Darshan J. Dave1, An Analysis Of Utilization Pattern Of Anticancer Drugs In Diagnosed Cases Of Carcinoma In A Tertiary Care Teaching Hospital; International Journal of Basic and Applied Medical Sciences, 2014 Vol. 4 (1) January-April, pp

Drug Utilization Evaluation of Anti Cancer Drugs

RESEARCH ARTICLE Am. J. PharmTech Res. 2014; 4(3) ISSN: 2249-3387 Drug Utilization Evaluation of Anti Cancer Drugs Ayesha Siddiqua 1 *, Hiba jafar 1, Nikhat tabassum 1,Sunaina firdous 1, Khaleequa tabassum