Safe Handling of Oral Anti cancer Agents: Perspectives from Breast Cancer Patients at National Cancer Centre

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1 Safe Handling of Oral Anti cancer Agents: Perspectives from Breast Cancer Patients at National Cancer Centre ABSTRACT Sim M.H. 1, Leow Y.C. 2 and Chan A. 3 Department of Pharmacy, Faculty of Science, National University of Singapore 10 Kent Ridge Road, Singapore National Cancer Centre 11 Hospital Drive, Singapore Objectives: To investigate breast cancer patients attitude, adherence and practices with their oral anti cancer agents. For the purpose of this paper, anti cancer agents would include cytotoxics and hormonal agents. Method: A single centre, cross sectional, interviewer administered survey was carried out at the Outpatient Pharmacy of National Cancer Centre (NCC), Level 1. Descriptive statistics were evaluated using Statistical Package for Social Science (SPSS) Results: Of the 126 surveys, 121 fit the inclusion criteria, of which 57 are breast patients. Only 10 (17.5%) indicated that oral and parenteral anti cancer agents are equally potent. Eight (14.0%) considered their oral anti cancer agents to be more potent than the parenteral ones. All disagreed or strongly disagreed that it was difficult to understand their regiment and 51 (89.5%) disagreed or strongly disagreed that it was difficult to adhere. 49 (86.0%) would dispose the bottles used to contain their oral anti cancer agents directly or indirectly down the chute and only six (10.6%) would inform their healthcare professionals about any leftover medications before the next refill or appointment. Conclusions: Patients seemed to be able to understand and adhere to the treatment regimen well. However, more can be done to educate patients about the nature of oral anti cancer agents and their safe handling. INTRODUCTION There is a high incidence of breast cancer in Singapore. From 2001 to 2005, breast cancer was the most frequent cancer among local females, accounting for 29.4% of all incidences (Lee, 2007). Breast cancer incident rate in Singapore has increased at an annual average rate of 3.6% from 1968 to 1992 and this rate is expected to increase more sharply in the future (Seow, 1996). Once diagnosed, modalities include surgery, as well as adjuvant drug therapy. Adjuvant therapy includes radiation therapy, chemotherapy and/or hormone therapy. Conventionally, chemotherapy is given intravenously. With the development of oral anticancer agents, patients have more choices and improved convenience with receiving treatment 1 Student 2 Student 3 Assistant Professor 1

2 than before. Yet, this implies that patients have to assume greater responsibilities for their treatment, with regards to adherence and safe handling of their medications (potential biohazards). However, many studies have shown the decrease of adherence to tamoxifen over time and rates of adherence to oral chemotherapy range from less than 20 to 100%. For example, adherence (defined as patients having their prescriptions filled and medicines available on at least 80% of the days) to tamoxifen therapy in the long term has been found to be dependent on patients perceived risks associated with the disease, benefits from therapy, nature and severity of side effects; their knowledge and understanding of their condition, financial resources as well as complexity and duration of the regimen (Viele, 2007). Another agent, anastrozole also showed that patient s adherence decreased over time and patients may be suboptimally adherent (Partridge, 2008). At the National Cancer Centre (NCC), oral cytotoxics such as Capecitabine (Xeloda ) is used for chemotherapy; Tamoxifen, Anastrozole (Arimidex ), Letrozole (Femara ) and Exemestane (Aromasin ) are commonly used for hormone therapy. With the exception of Tamoxifen, the remaining medications have been approved by FDA only in the last ten years. As such, specific guidelines to their safe handling have not yet been established. However, good practices include having patients and/or their caregivers to wash their hands before and after handling their medication even if they wear gloves and to return unused medication to the pharmacy for disposal instead of discarding them in the household trash or flushing them down the toilet to avoid contaminating landfills and water supplies. Patients and their caregivers are also advised not to crush the tablets and/or open the capsules to avoid releasing particulate matter which contaminates the environment and also potentially put others at increased risk of exposure to these anti cancer agents (Bartel, 2007). Given the relative novelty of these agents, safety studies have not been done to evaluate these chemotherapeutic drugs for mutagenic effects due to increased exposure. Therefore, it is prudent to do a study on patients practices with both cytotoxics and hormonal agents. METHOD The study was a single centre, cross sectional, interviewer administered survey. Cancer patients seen at the Outpatient Pharmacy of NCC, who are currently treated on oral anti cancer treatment, either as chemotherapy or hormone therapy are interviewed. Patients recruited must have either been on the medicine for at least a cycle (chemotherapy) or three months (hormone therapy) if the medicine is their first oral anti cancer medicine and/or have been on other forms of oral anti cancer medicines. Before the survey, all patients (or caregivers) are required to give their consent and are informed of their rights and that participation is strictly voluntary. In further compliance with ethical requirements, the survey was subjected to approval by the Institutional Review Board (IRB) and both interviewers underwent an online training on the modules Human Research and Good Clinical Practice with Collaborative Institutional Training Initiative (CITI). To ensure that patients (or caregivers) fully understood the questions, only patients who are able to speak English or Mandarin are interviewed. In addition, as the data are collected by two interviewers, a Mandarin version of the survey questions was available to ensure that the meaning conveyed to the patients was as close as possible to the intended meaning and there is maximal consistency among the interviewers. 2

3 All data were validated before use. Surveys with more than two questions incomplete and patients who do not seem to be able to understand the questions asked of them are omitted. The remaining data are then analysed using Statistical Package for Social Sciences (SPSS). Descriptive statistics are obtained to identify patients practices with their medicines, attitude and adherence to their regimen. RESULTS A total of 126 surveys were collected. Five were rejected as they do not meet the inclusion criteria. Of the remaining surveys, 57 (47.2%) involved breast cancer patients; of which 27 (47.4%) were on tamoxifen, 11 (19.3%) on anastrozole, eight (14.0%) on letrozole, eight (14.0%) on capecitabine and three (5.3%) on exemastane. Patients demographics All patients interviewed with breast cancer were females. Figure 1: Histogram and normal curve of age distribution of patients Age Frequency Age Mean =54.91 Std. Dev. = N =57 The mean age of the patients was about 55 years, with the majority of the patients falling in the range of 50 to 65 years old. 3

4 Table 1: Educational level of patients Educational level Frequency Percent (%) Uneducated Primary Secondary Pre University University Unknown More than half (54.4%) had secondary school education with the majority (79.0%) having only secondary school education or less. Two (3.5%) of the patients educational level was unknown because the survey was conducted with the caregivers who were not aware of their educational levels. Figure 2: Bar graph showing distribution of cancer stages of patients Cancer_stage Frequency I II III IV 0 Cancer_stage Majority of the patients (68.4%) had early stage breast cancer stage 0 to II. The remaining 18 (31.6%) had late stage breast cancer. Stage 0 breast cancer refers to patients with carcinoma in situ. In addition, 56 (98.2%) of the patients had ECOG staging of 1 and only one (1.8%) with ECOG staging of 2. 4

5 Table 2: Number of comorbidites of patients Number of comorbidites Frequency Percent (%) The comorbidites that were taken into consideration includes hypertension, diabetes, hypercholesterolemia, asthma, hyperthyroidism and heart enlargement. The majority of the patients (82.5%) had none or one comorbidites. A minority (17.5%) had two or more comorbidites. Patients attitude towards oral anti cancer agents Patients were asked to compare the safety and potency of oral and parenteral anti cancer agents. Only seven (12.3%) felt that oral and parenteral anti cancer agents are equally toxic. About half (43.9%) felt that oral anti cancer agents are safer than the parenteral ones and another 23 (40.4%) responded that they do not know if oral anti cancer agents are safer than parenteral treatment. One (1.8%) felt that none is safe and one (1.8%) felt that oral anti cancer agents are not safer than the parenteral treatment. More than half (52.6%) responded that they do not know if oral anti cancer drugs are as potent as parenteral anti cancer drugs. Only 10 (17.5%) felt that they have the same potency. On the other hand, eight (14.0%) actually considered the oral ones to be more potent than the parenteral treatment. Nine (15.8%) indicated that the oral ones are not as potent as the parenteral ones. Dosing and Compliance All patients administered their own oral anti cancer agent, except for one; where the maid was the caregiver administering the agent. 51 (89.5%) disagreed or strongly disagreed that it was difficult to adhere to their regimen. Only two (3.5%) were neutral and four (7.0%) agreed that it was difficult to adhere to their regimen. When asked to rate their adherence (with 10 being very adherent and 1 as not adherent), the mean score was 9.42, with the median and mode as 10. All disagreed or strongly disagreed that it is difficult to understand their dosing schedule. All but two claimed that they would not change the dosage on their own. Of the two who would change the dosage, one would decrease the dose and one would skip a dose. The reason they changed the dose was due to side effects. However, when asked what they would do if they missed a dose of their oral anti cancer medicine, a variety of responses were given. None of the patients on capecitabine replied that they would resume taking the dose if it is within six hours of the missed dose and only seven (14.3%) of the patients on hormonal agents replied that they would resume taking dose if it is within twelve hours of the missed dose. 5

6 Table 3. Responses of patients on capecitabine to a missed dose, n=8 Responses Frequency Percent (%) Skip the dose Resume taking the dose when remember Skip the dose if more than 3 hours Resume if within 12 hours Table 4. Responses of patients on hormonal agents to a missed dose, n=49 Responses Frequency Percent (%) Skip the dose Resume taking the dose if within 6 hours Resume taking the dose within 12 hours Resume taking the dose when remember Resume taking when remember; skip if too close to next dose I do not know The majority (94.7%) felt that follow up appointments and laboratory tests are important and should not be missed. Storage and handling More than half (52.6%) claimed that they would store their oral anti cancer agents separately from other medications. All patients interviewed also indicated that they would not wear gloves when handling their oral anti cancer agents; though one claimed that her caregiver wears gloves. More than half (52.6%) responded that they do not wash their hands after handling their oral chemotherapeutics. Only 15 (26.3%) would wash their hands though one claimed that she would wipe her hands with alcohol disinfectant instead of washing. Nine (15.8%) were not consistent in washing their hands and two (3.5%) could not remember if they washed their hands after handling their oral chemotherapeutics. All claimed that they would not crush their tablets or open the capsules. Table 5.1. How patients would handle their dropped medication, n=57 Frequency Percent (%) Depends on location Independent of location Never dropped before

7 Table 5.2. Course of action taken by patients after picking up the dropped medication, n=57 Frequency Percent (%) Consume Throw Never dropped before Only 15 (26.3%) would throw their dropped medication into the bin regardless of location. More than half (64.9%) would pick up their medication with their fingers or receptacles and consume; though five (8.8%) insisted that they have never dropped their medication before and would therefore not want to consider the hypothetical situation. Of the 27 (47.4%) patients who were asked how they would pick up the dropped medication before throwing or consuming it, 25 (92.6%) would pick up the medication with their fingers and only two (7.4%) would pick up using receptacles. None of the patients would bring the bottles of their oral anti cancer agents to the pharmacy for disposal. Two thirds (66.7%) would throw them into their home waste paper basket which is emptied daily and 11 (19.3%) would throw them directly into the chute. Generally, these bottles were disposed similarly to their household trash. Two (3.5%) claimed that they would keep the bottles for reference and two (3.5%) would throw them into recycling bags. When asked what they would do with leftover medication before the next appointment or refill, more than half (54.4%) would continue with their medication and one patient who is on capecitabine claimed that he would continue into the rest period of the cycle. Only six (10.6%) indicated that they would tell or show the extra medication to their doctors or pharmacists. 10 (17.5%) of the patients responded that they never had extras before and hence would not consider the hypothetical situation. DISCUSSION Patients generally seemed to have no problems with understanding and adhering to their anticancer treatment regimen. However, their varied responses to a missed dose suggest that patients are probably too complacent with their medication habits. It was also surprising that 14.0% considered their oral anti cancer agents to be more potent than the parenteral ones. Patients ignorance about the nature of oral anti cancer agents is further highlighted when 43.9% felt that the oral anti cancer agents are safer than parenteral anti cancer agents. This underestimation of their oral anti cancer agents might account for patients complacency. Patients handling practices with their oral anti cancer agents also showed their lack of knowledge in this area as well as lack of understanding about the nature of the medicine. The oral anti cancer agents were regarded by patients as any other ordinary medicine as shown when more than half (64.9%) would pick up and consume their dropped medications. When disposing dropped medication or empty bottles of their oral anti cancer agents, these were regarded as ordinary household trash, with 86% disposed directly or indirectly down the chute. Similarly, when there were leftover medications, only 10.6% would highlight this to their healthcare professionals. This is again probably due to patients lack of knowledge or complacency with their medication. 7

8 Limitations As patients were required to recall their practices and adherence to their medication, recall bias was an inherent limitation of this study. Patients were also assumed to be entirely honest with the interviewers, especially when asked about their adherence to the treatment regimen. Furthermore, as only Mandarin and/or English speaking patients were included in this study, there could be a slight bias against patients from other races who were not able to speak the above two languages. CONCLUSION Patients clearly need to be educated about the nature of their medications, particularly on how they should handle and dispose of their medication appropriately. Though all patients are educated on how to take their oral anti cancer agents and the course of action in the event of a missed dose, more can definitely be done to reinforce their knowledge. The current practice of giving patients an information leaflet about their medication does not seem to be effective. Healthcare professionals could also play a more active role in educating their patients to allow patients to assume appropriate responsibility in managing their condition and medication. In addition, as these patients do not bring to the attention of their healthcare providers in the event of leftover medications, all healthcare providers should be more proactive in checking any such balances with patients. REFERENCES Partridge, A. H., LaFountain, A., Mayer, E., Taylor, B. S., Winer, E., Asnis Alibozek, A.(2007), Adherence to Initial Adjuvant Anastrozole Therapy Among Women With Early Stage Breast Cancer, Journal of Clinical Oncology, Vol 26(4), pp Bartel S.B. (2007), Safe practices and financial considerations in using oral chemotherapeutic agents, Am J Health Syst Pharm, Vol 64, Suppl 5, S8 S11 Lee, H.P., Ling, A., Chow, K.Y. and Razal, L.A. (2007), Singapore Cancer Registry Interim Report Trends in Cancer Incidence in Singapore , National Registry of Diseases Office Seow, A., Duffy, S.W., McGee, M.A., Lee, J. and Lee, H.P. (1996), Breast Cancer in Singapore: Trends in Incidence , International Journal of Epidemiology, Vol 25(1), pp Viele, S.C. (2007), Managing oral chemotherapy: The healthcare practitioner s role, Am J Health Syst Pharm, Vol 64, Suppl 5, S26 ACKNOWLEDGEMENTS The author would like to thank Dr. Alexandre Chan for his kind guidance and the pharmacists at the National Cancer Centre for their assistance. 8