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 » Introduction
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  Table of Contents  
Year : 2015  |  Volume : 52  |  Issue : 3  |  Page : 467-470

Spontaneous adverse drug reaction monitoring in oncology: Our experience

1 Department of Pharmacology, Dayanand Medical College and Hospital, Ludhiana, India
2 Department of Pharmacology, Punjab Institute of Medical Sciences, Jalandhar, Punjab, India
3 Department of Pharmacology, Maulana Azad Medical College, New Delhi, India
4 Department of Pharmacovigilance, Novartis, Hyderabad, Maharashtra, India
5 Medical Services, Zuventus Healthcare Ltd., Mumbai, Maharashtra, India
6 Post Graduate Resident, Dayanand Medical College and Hospital, Ludhiana, India
7 Department of Oncology, Dayanand Medical College and Hospital, Ludhiana, India

Date of Web Publication18-Feb-2016

Correspondence Address:
K Kaur
Department of Pharmacology, Dayanand Medical College and Hospital, Ludhiana
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0019-509X.176713

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 » Abstract 

Background: Adverse drug reaction (ADR) monitoring is slowly developing as an important aspect of healthcare. The aim of the study was to study the pattern of adverse drug reactions in the Oncology department of a tertiary care hospital. Materials And Methods: This was a prospective study conducted in the Oncology department of a tertiary care hospital in which ADRs were reported spontaneously. The ADRs were noted from 1st January, 2007 to 30th June, 2011. Following were noted: demographics, premedication (if any), diagnosis, chemotherapy (regimen, cycles), medication history, and alteration in the treatment or co morbidities, ADRs (severity and management). Adverse drug reactions were noted by patient interview, collaborating with information on file, recording changes in the prescribing chart and investigations, consulting the doctor on duty. Results: During this study period, there were total of 14,475 visits of patients from which 2500 ADRs were recorded. Maximum number of ADRs were noted with platinum compounds (25.52%) followed by pyrimidine antagonists (19.88%). The most common malignancy reported in our hospital was Carcinoma breast (20%) followed by leukemia (12%) and Ca ovary (12%). Alopecia (27.76%) was the most common ADR followed by anemia (7.48%), thrombocytopenia (6.96%) and constipation (6.16%). Conclusion: Alopecia is the most common ADR and platinum compounds were responsible for the maximum number of ADRs. The most common carcinoma reported during this period was carcinoma breast.

Keywords: Alopecia, oncology, spontaneous adverse drug reactions

How to cite this article:
Kaur K, Sood M, Bhagat S, Singh T, Jain M, Arora D, Sekhon J S, Kaushal S. Spontaneous adverse drug reaction monitoring in oncology: Our experience. Indian J Cancer 2015;52:467-70

How to cite this URL:
Kaur K, Sood M, Bhagat S, Singh T, Jain M, Arora D, Sekhon J S, Kaushal S. Spontaneous adverse drug reaction monitoring in oncology: Our experience. Indian J Cancer [serial online] 2015 [cited 2021 May 11];52:467-70. Available from: https://www.indianjcancer.com/text.asp?2015/52/3/467/176713

 » Introduction Top

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.[1] The Pharmacovigilance Program of India (PvPI) is working in collaboration with WHO-Uppsala Monitoring Center, Sweden and contributes the Indian data to the international data base. The PvPI started in year 2010, aims to monitor the adverse drug reactions (ADRs) in Indian population; to create awareness among health-care professionals about the importance of ADR reporting in India; to generate independent, evidence based recommendations on the safety of medicines; and to monitor benefit-risk profile of medicines among others.[2] This program has become very vital as even after so many years of efforts, ADR monitoring is still in infancy in India.

As mentioned in the definition of pharmacovigilance, this branch of science not only aims to collect the data, but to use the information to increase the safe and rational use of medicines and to communicate it to the public and health professionals. Dayanand Medical College and Hospital, Ludhiana, an ADR monitoring center under PvPI, is trying to achieve the goals of PvPI. In January 2007, spontaneous ADR monitoring was started in the oncology department of the hospital on our own initiation.

Spontaneous ADR monitoring is one of the ways of reporting of suspected effects of drugs and it forms the backbone of pharmacovigilance.[3] A spontaneous report is an unsolicited communication by health care professionals (in India) to a company, regulatory authority or other organization (e.g. WHO, regional centers etc.) that describes one or more ADRs in a patient who was given one or more medicinal products and which are not derived from a study or any organized data collection scheme.[4] It can be done immediately after a new drug is marketed, can continue indefinitely and can also potentially cover all patients receiving the drug. It helps to generate safety signals by accumulating data on similar ADRs.[5] Spontaneous reporting is the most common method used in pharmacovigilance and the best one to generate signals on new or rare ADRs.[6] This system of reporting can help in giving new information on an already identified safety signal, e.g. the risk of adverse effects may be especially high in pediatric patients or any other specific group. Spontaneous reporting is a refinement of the knowledge of the already known or new adverse events, with more information about the time of onset and duration of the event.

The spontaneous reporting of ADRs in the oncology department was started with the aim to collect and report the ADRs in year 2007. The field of oncology was chosen as cancer chemotherapeutic agents are known to cause ADRs and they are well-accepted as a part of the bargain.

 » Materials and Methods Top

This prospective study was carried out by the Departments of Pharmacology and Oncology, Dayanand Medical College and Hospital (DMCH) from 1st January, 2007 to 30th June, 2011. The Institutional Ethics Committee approval was obtained prior to initiation of the study. For every adverse reaction, a separate ADR form (ADR forms provided by Central Drugs Standards Control Organization, New Delhi) was completed by the resident doctor of pharmacology department in consultation with the consultant of the oncology department. Other columns of the form were filled accordingly like any modification (addition or deletion) of drugs from the prescribing chart after consulting the doctor on duty.

All patients admitted in the oncology department for administration of cancer chemotherapeutic agents were included in this study. Patients of all ages and of both genders were included in the study. No change in the treatment decision, schedule or duration was made as part of the study. All patients were monitored for adverse reactions until their discharge from the hospital. The resident doctor noted the patient profile (name, age, sex and registration number). The diagnosis, treatment given (i.e., brand name or active ingredient (s) of the drug, dose, frequency, duration, indication, batch number), concomitant health-care product (s) (including any complementary medicines if consumed at the same time), cycle of drug administration, any premedication given, any change in the drug regimen, results of laboratory investigations, treatment of the adverse reaction and any other relevant history such as known history of allergies, pregnancy, smoking and alcohol use; state of renal and hepatic function were noted. The appropriate treatment was given for the management of ADRs.

Monitoring for adverse reactions was performed along with, until the hospital stay of the patient and he was asked to report in case of any other reaction after discharge from the hospital. The collected reports were analyzed for demographic details, drug details, causality, preventability and severity of adverse effects. During this period, the incidence of the ADRs per patients could not be calculated as the program was being set-up. As the project is still continuing in this ward, we are calculating the incidence of ADRs at regular intervals. The incidence of the ADRs per patient (who have had an ADR) was calculated by dividing the number of patients suffering from the adverse reactions with the total number of ADRs reported in the Oncology ward. We have calculated the visits of the patients as the patients came very frequently to the oncology for administration of chemotherapy cycles.

 » Results Top

Baseline characteristics

A total of 14,475 visits of patients were recorded in the oncology department of DMCH during the period from 1st January 2007 to 30th June, 2011. A total of 671 patients reported ADRs associated with cancer chemotherapeutic agents in our study out of which 351 (52.3%) were females and 320 (47.7%) were males. Mean age for males was 51.1 ± 15.1 and for females was 44.3 ± 14.2 years.

Incidence of ADRs

A total of 2500 ADRs were recorded and ADR incidence was 3.72 per patient.

Disease prevalence

The maximum number of patients had carcinoma (Ca) breast (20%) followed by Ca ovary (12%), leukemia (10%), Ca colon (9%), lymphomas (8%), Ca gall bladder (4%) and miscellaneous (37%) [Figure 1].
Figure 1: Occurrence of the different malignancies during this period

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Association with the cancer chemotherapeutic agents

In our study, it was found that platinum compounds (cisplatin, carboplatin, oxaliplatin) are responsible for maximum (638/2500 i.e. 25.52% of total) ADRs followed by pyrimidine antagonists (5-fluorouracil, cytarabine) (19.88%), anticancer antibiotics (actinomycin D, doxurubicin, daunorubicin, bleomycin) (18.68%), alkylating agents (ifosfamide) (13.88%), taxanes (paclitaxel, docetaxel) (8.76%), vinca alkaloids (vincristine, vinblastine) (4.76%), folic acid antagonists (methotrexate) (4.32%) and miscellaneous drugs (L-asparaginase, procarbazine, etoposide, irinotecan, mitoxantrone) (4.2%).


The most common ADRs seen in our study were alopecia (27.76%), anemia (7.48%), thrombocytopenia (6.96%) and constipation (6.16%) followed by anorexia, diarrhea, altered taste, neutropenia, itching, nausea, headache, vertigo, vomiting, fever, insomnia, leg pain, numbness, stomatitis, dermatological manifestations, liver dysfunction, body aches, depression, weakness, edema, bleeding, joint pain, renal dysfunction and shock in the decreasing order [Table 1].
Table 1: Spectrum of adverse drug reactions observed with cancer chemotherapeutic agents

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Among all ADRs, alopecia constituted the maximum number and was most commonly seen with platinum compounds followed by anticancer antibiotic agents, alkylating agents and taxanes in decreasing order [Figure 2]. Anemia constituted the second most common ADR and occurred most commonly with antibiotic agents followed by pyrimidine antagonists, alkylating agents, platinum compounds and taxanes [Figure 3]. The third most common ADR was thrombocytopenia and the highest incidence was seen with pyrimidine antagonists followed by antibiotic agents, alkylating agents, platinum compounds, taxanes, vinca alkaloids and folic acid antagonists [Figure 4]. Constipation was the fourth most common ADR and was reported most commonly in patients receiving pyrimidine antagonists followed by antibiotic agents, alkylating agents, platinum compounds, taxanes, vinca alkaloids and folic acid antagonists [Figure 5].
Figure 2: Cancer chemotherapeutic agents resulting in alopecia

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Figure 3: Cancer chemotherapeutic agents causing anemia

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Figure 4: Cancer chemotherapeutic agents causing thrombocytopenia

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Figure 5: Cancer chemotherapeutic agents causing constipation

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 » Discussion Top

We started collecting the ADRs in our institute before the establishment of PvPI. As an initial step, only one clinical ward was chosen so as to set an example for the hospital. Furthermore during our literature survey, we observed a dearth of reports on ADR profiles of cancer chemotherapeutic drugs. The findings of our ongoing study show that alopecia was the most common ADR with the cancer chemotherapeutic agents and it was reported most commonly with platinum compounds. The results show that the most common malignancy reported during this period in this hospital setting was Ca breast (20%) followed by Ca ovary (12%), leukemia (10%) etc., These observations are consistent with another study conducted by De A who had also reported Ca breast (19.63%), followed by Ca ovary (11.66%), Ca colon (3.07%), lymphomas (1.84%), miscellaneous (40.49%).[7] The prescribing pattern of drugs is also similar to that reported by De A in which platinum compounds accounted for 25.15% of total ADRs, antibiotics (5.89%), alkylating agents (17.29%), taxanes (11.39%), vinca alkaloids (2.36%), folic acid antagonists (1.97%), miscellaneous drugs (35.95%).[7]

Nausea and vomiting are very common adverse effects of cancer chemotherapeutic drugs,[8] but in our study; the incidence of nausea and vomiting has not been reported as all patients were receiving premedication with antiemetics and corticosteroids. The other most common ADRs seen by De A were nausea, vomiting, acidity with or without heartburn, alopecia, pruritus, with or without skin rash, constipation, chest pain, fever, gum bleeding, headache and insomnia. In our study, alopecia is the most common ADR with incidence of 27.76% among all and is found to be highest with platinum compounds followed by anticancer antibiotic agents, alkylating agents, taxanes whereas De A has reported the incidence of alopecia to be 3.05% only. In another study conducted by Lau et al.[9] the ten most common ADRs among the hospitalized oncology patients were constipation, nausea ± vomiting, fatigue, alopecia, drowsiness, myelosuppression, skin reactions, anorexia, mucositis and diarrhea.

ADRs are a global problem and substantially add to the cost of health- care.[7] Furthermore, monitoring of ADRs is an ongoing, ceaseless and continuous process.[3] ADR monitoring and reporting is still not well-established in India as is evident from few Indian reports on ADR monitoring and a few original studies performed in this regard.[3],[10],[11]

Spontaneous ADR reporting is the cornerstone of pharmacovigilance and is the mainstay of national and international drug safety evaluation in the post-approval phase.[12] Data from spontaneous reporting helps in generating signals of those rare and unsuspected adverse effects. It also provides additional information about the benefit/risk profile of a drug in clinical practice. Some of the drawbacks of spontaneous reporting include (a) under-reporting, which may be because of health professionals' inability to recognize unknown and unexpected adverse events; or due to lack of knowledge and training about ADR reporting, or due to unavailability of ADR forms, due his perception that the ADR is well-known or trivial or he is uncertain about the association; or due to lack of time or there is lack of interest;[13],[14],[15],[16],[17] (b) it only provides a numerator; information on population exposed to the drug is deficient and thus it is difficult to quantify the risk associated with the use of drug; (c) spontaneous reporting done by patients or their relatives fails to take into account important information about the patient, such as underlying medical conditions and the concomitant administration of other drugs; (d) it is generally subject to biases as sometimes the less severe and better-known effects may be reported or bias due to manufacturer's promotional claims or adverse publicity in media;[18] and some unrelated events may be reported. During this study, we tried to overcome these drawbacks e.g. to minimize the under-reporting, one resident was a full time deputed in the oncology ward for analyzing the adverse effects; the resident was fully trained for ADR reporting; all the patient details were taken from the patient and the consultant; we tried to take care of all the confounding factors during our observational study; and we excluded all unrelated events before data analysis.

One of the limitations of this study was the inability to monitor patients serially, as most of the patients were discharged from the hospital after a stay of 1 or 2 days. Even in instances like gum bleeding, which suggests underlying laboratory abnormalities like reduced platelet count, there was no scope of recalling the patients for review of their test records. Only the patients admitted for repeat cycle therapy could be linked to previous cycles.

Despite all these limitations, we made an attempt to provide help in conducting similar studies on spontaneous reporting of ADRs.

 » Conclusion Top

Our study shows that alopecia is the most common ADR reported with the cancer chemotherapeutic agents and the maximum cases of alopecia were reported with the use of platinum compounds.

 » References Top

World Health Organisation. Pharmacovigilance: Ensuring the Safe Use of Medicines-WHO Policy Perspectives on Medicines, No. 009, 2004. Available from: http://www.apps.who.int/medicinedocs/en/d/Js6164e/2.html. [Accessed on 2012 Dec 8].  Back to cited text no. 1
Central Drugs Standard Control Organisation. Pharmacovigilance Program of India. Available from: http://www.cdsco.nic.in/pharmacovigilance.htm. [Accessed on 2012 Dec 8].  Back to cited text no. 2
Dhikav V, Sindhu S, Anand KS. Adverse drug reaction monitoring in India. J Indian Acad Clin Med 2004;5:27-33.  Back to cited text no. 3
World Health Organization (WHO). Pharmacovigilance Toolkit. Available from: http://www.apps.who.int/medicinedocs/documents/s19107en/s19107en.pdf. [Accessed on 2012 Dec 24].  Back to cited text no. 4
Thakrar BT, Grundschober SB, Doessegger L. Detecting signals of drug-drug interactions in a spontaneous reports database. Br J Clin Pharmacol 2007;64:489-95.  Back to cited text no. 5
Alvarez-Requejo A, Carvajal A, Bégaud B, Moride Y, Vega T, Arias LH. Under-reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol 1998;54:483-8.  Back to cited text no. 6
De A. Monitoring of suspected adverse drug reactions in oncology unit of an urban multispeciality teaching hospital. Int J Res Pharm Biomed Sci 2010;1 (2):1-32.ISSN: 2229-3701  Back to cited text no. 7
Jordan K, Sippel C, Schmoll HJ. Guidelines for antiemetic treatment of chemotherapy-induced nausea and vomiting: Past, present, and future recommendations. Oncologist 2007;12:1143-50.  Back to cited text no. 8
Lau PM, Stewart K, Dooley M. The ten most common adverse drug reactions (ADRs) in oncology patients: Do they matter to you? Support Care Cancer 2004;12:626-33.  Back to cited text no. 9
Amrita P, Singh SP. Status of spontaneous reporting of adverse drug reaction by physicians in Delhi. Indian J Pharm Pract 2011;4:29-36.  Back to cited text no. 10
Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol 2008;65:210-6.  Back to cited text no. 11
Fletcher AP. Spontaneous adverse drug reaction reporting vs. event monitoring: A comparison. J R Soc Med 1991;84:341-4.  Back to cited text no. 12
Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:14.  Back to cited text no. 13
Hazell L, Shakir SA. Under-reporting of adverse drug reactions: A systematic review. Drug Saf 2006;29:385-96.  Back to cited text no. 14
Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999;48:623-7.  Back to cited text no. 15
Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European pharmacovigilance research group. Eur J Clin Pharmacol 1997;52:423-7.  Back to cited text no. 16
Rehan HS, Vasudev K, Tripathi CD. Adverse drug reaction monitoring: Knowledge, attitude and practices of medical students and prescribers. Natl Med J India 2002;15:24-6.  Back to cited text no. 17
Rawlins MD. Spontaneous reporting of adverse drug reactions. Q J Med 1986;59:531-4.  Back to cited text no. 18


  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]

  [Table 1]


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