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The fear of using tramadol for pain control (tramadolophobia) among Egyptian patients with cancer Samy A. Alsirafy 1 Radfan N. Saleh 2, 3 Radwa Fawzi 2 Ahmad A. Elnaggar 4 Ahmed M. Hammad 1 Wessam El-Sherief 1, 2 Dina E. Farag 1 Riham H. Radwan 2 1 Palliative Medicine Unit, Kasr Al-Ainy Center of Clinical Oncology & Nuclear Medicine, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt 2 Department of Clinical Oncology, Kasr Al-Ainy Center of Clinical Oncology & Nuclear Medicine, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt 3 Aden Refinery Company Hospital, Aden, Yemen 4 Department of Medical Oncology, Faculty of Medicine, Zagazig University, Sharkia, Egypt Corresponding author: Samy A. Alsirafy Palliative Medicine Unit Kasr Al-Ainy Center of Clinical Oncology & Nuclear Medicine (NEMROCK) Kasr Al-Ainy School of Medicine, Cairo University PO Box 99, Manial El-Roda; Cairo, 11553; Egypt Tel: (+20) 111 80 35647 e-mail: [email protected] 1 Abstract Background: Tramadol is the only available World Health Organization (WHO) step-II analgesic in Egypt. However, it is becoming a stigmatized drug because of its abuse/misuse. The fear of using tramadol for pain control (tramadolophobia) by Egyptian patients with cancer is a frequent problem in our practice. Aim: This study was conducted to explore the prevalence of and the reasons behind tramadolophobia among Egyptian patients with cancer. Design: A structured interview including open-ended and closed questions. Setting/participants: The study included 178 adult patients with cancer from two cancer centers in Cairo and Sharkia, Egypt. Results: The source of information about tramadol was a non-healthcare-related source in 168 (94%) patients, mainly the media (50%). The believed uses of tramadol were addiction-related in 94 (53%) patients, tonic (physical, sexual, and to boost alertness) in 59 (33%) and analgesic in 55 (31%). Twenty-six (15%) patients gave history of tramadol use, largely (69%) as a tonic. In case tramadol was prescribed for pain control, 90 (51%) patients refused to take it, 59 (33%) patients agreed to take it with concern about addiction and only 29 (16%) patients agreed without concerns. Among those who refused taking tramadol for pain, the mentioned reason of refusal was addiction-related fears in 57%. Conclusion: The stigmatization and misconceptions about tramadol may have resulted in tramadolophobia among the majority of Egyptian patients with cancer. This further complicates the barriers to cancer pain control in Egypt. Being the only available WHO step-II analgesic in Egypt, interventions to overcome tramadolophobia should be taken. Keywords: Cancer, pain, tramadol, abuse, phobia, Egypt 2 What is already known about the topic? Fear of prescribing/using opioids for pain represents a major barrier to cancer pain control. What this paper adds? Tramadol is becoming a stigmatized drug among patients with cancer in Egypt. The fear of using tramadol for pain (tramadolophobia) further adds to the barriers to cancer pain control. Implications for practice, theory or policy? Before commencing tramadol for cancer pain, discussions about it with patients should be routinely initiated to correct misconceptions. Interventions to correct misconceptions about tramadol at a public level are needed. Introduction Tramadol is a synthetic weak opioid agonist that is used as a step-II analgesic for mild to moderate cancer pain according to the World Health Organization (WHO) analgesic ladder (WHO 1996). In Egypt, tramadol is very important for cancer pain management. It is the only opioid available for use as a WHO step-II analgesic for mild to moderate cancer pain. Codeine and other weak opioids are not available in preparations suitable for cancer pain management. In addition, the currently available registered strong opioids’ formulations in Egypt do not come in small doses suitable for replacing weak opioids as a WHO step-II analgesic. Furthermore, tramadol is the only opioid registered in an oral immediate release form. Tramadol abuse/misuse is a rising problem in a number of countries. In an International Narcotics Control Board (INCB) survey, 33 countries (42% of those responding) reported “non-medical use and/or abuse of tramadol”. According to that survey, tramadol is under national control in 33 countries. However, few countries reported that tramadol abuse was a “significant risk” (INCB 2014). Egypt is among the countries with such “significant risk” where there is a rising tramadol abuse/misuse epidemic over the last years (Fawzi 2011, Bassiony 2015). The abused/misused tramadol is mainly a smuggled one. The Egyptian authorities reported 3 seizures of 650 million tramadol tablets in the year 2012 alone (INCB report 2015). The accumulating evidence of tramadol abuse/misuse in Egypt resulted in placing tramadol under national control in 2013 (INCB report 2015). In our practice, it is not uncommon to encounter patients who are afraid to use tramadol for pain because of its defamed reputation. The prevalent abuse/misuse of tramadol in Egypt has resulted in its stigmatization. This stigmatization may have led to the fear of using tramadol for pain control (tramadolophobia). This study was conducted to preliminary estimate the prevalence of tramadolophobia among Egyptian patients with cancer and to explore the reasons behind it. Methods The study included adult (>18 years) patients with confirmed cancer diagnosis who gave a verbal informed consent to participate in the study. Patients who already received/were receiving tramadol for cancer pain management were excluded because discussions about their concerns about tramadol may have been initiated by health care professionals. Patients were recruited from two cancer centers in Cairo (Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine [NEMROCK], Kasr Al-Ainy School of Medicine, Cairo University) and Sharkia (Department of Medical Oncology, Faculty of Medicine, Zagazig University, Sharkia) governorates. A structured interview that included closed and open-ended questions was developed for the purpose of this study (Figure 1). The questionnaire of the interview was translated into the Arabic Egyptian slang and revised by the investigators. The study was approved by the research ethics committee of NEMROCK, Kasr AlAiny School of Medicine, Cairo University. 4 Figure 1. The structured interview used to investigate tramadolophobia among patients with cancer Results The interviewers approached 293 patients with cancer among whom 281 (95.5%) agreed to participate in the study. From these 281 patients, 42 patients were excluded. The causes of exclusion were: already received/receiving tramadol for cancer pain in 22 (7.8%), missing data in 14 (5%), and age below 18 years in 6 (2%). Sixty-one (21.7%) patients said that they do not know tramadol in response to the first question and the interview was discontinued. The characteristics of 178 patients who said that they know tramadol are shown in Table 1. 5 Table 1. Patients’ characteristics n. % 95 83 53.4 46.6 Sex Female Male Age Median (range) Marital status Married Single Widow Divorced Unknown Education level Illiterate Less than high school High school University Unknown Primary cancer Breast Hematological Gastrointestinal Gynecological Head and neck Sarcomas Others 49 (20-80) 153 9 7 4 5 86 5.1 3.9 2.2 2.8 39 31 60 23 3 21.9 17.4 33.7 12.9 1.7 62 55 16 11 9 7 18 34.8 30.9 9 6.2 5.1 3.9 10.1 When they were asked about the source of information about tramadol, 168 patients (94.4%) mentioned a non-healthcare-related source, mainly the media (television) and unspecified people. Only 16 (9%) patients mentioned a healthcare-related source. Eight (4.5%) patients did not specify a source by saying phrases like “very famous” and “all people take it”. The details of the source of knowledge about tramadol as described by patients are shown in Table 2. 6 Table 2. Sources of knowledge about tramadol as described by interviewed patients * Source N % Non-healthcare-related Media (television) 89 50 People Unspecified 57 32 Street 20 11.2 Youth 15 8.2 Work 11 6.2 Abusers/dealers 9 5.1 Friend 7 3.9 Relative 7 3.9 Coffee shops 1 0.6 Wedding parties 1 0.6 Healthcare-related Pharmacy 6 3.4 Hospital 4 2.2 Patient 4 2.2 Physician 3 1.7 8 4.5 Unspecified * Patients may have enumerated more than one source When they were asked about the uses of tramadol, the answer of 94 (52.8%) patients was an abuse-related one, while 59 (33.1%) mentioned that it is used as a tonic and 55 (30.9%) as an analgesic/treatment. The uses of tramadol as described by patients are detailed in Table 3. Table 3. The uses of tramadol as described by interviewed patients * Use N % Abuse-related Narcotic/drug 58 32.6 To get a high 27 15.2 Addiction 17 9.6 Tonic Unspecified 35 19.7 Sexual 16 9 Physical 14 7.9 Alertness 10 5.6 Analgesic/treatment Analgesic 52 29.2 Treatment 3 1.7 6 3.4 Other 13 7.3 Do not know * Patients may have enumerated more than one use All patients who said that tramadol is used as a sexual tonic were males and all of them were interviewed by males. 7 When asked about the uses of tramadol, some patients specified groups using tramadol. Eight (4.5%) patients said it is used by youth, 4 (2.2%) by addicts, 4 (2.2%) by working people, 3 (1.7%) by drivers and 2 (1.1%) by losers. Twenty-six (14.6%) patients said that they used tramadol before. Tramadol was used as a tonic in 69% of these patients, following the advice of non-healthcare persons in 65%, and brought from a non-healthcare source in 50%. In 77%, the tramadol used was a smuggled one. The details of tramadol use are illustrated in table 4. Table 4. Details of previous tramadol use by 26 patients Reason to use Tonic Physical (for work) Sexual Alertness Unspecified During exams Analgesic/treatment Analgesic Flu Curiosity To get a high Who advised to use Non-healthcare Friend/colleague People (unspecified) Relative Healthcare Physician Pharmacist Unknown Type of tramadol Smuggled Legal Unknown Source Non-healthcare Friend Drug dealer Coffee shop Healthcare Pharmacy Hospital Unknown Duration of use (months) Median (range) N % 5 5 4 3 1 19.2 19.2 15.4 11.5 3.8 12 1 2 2 46.2 3.8 7.7 7.7 12 3 2 46.2 11.5 7.7 6 2 1 23.1 7.7 3.8 20 3 3 76.9 11.5 11.5 8 3 2 30.8 11.5 7.7 10 2 1 38.5 7.7 3.8 1 (0.03 – 120) In case tramadol was prescribed as an analgesic, 90 (50.6%) patients refused to take it, 59 (33.1%) patients agreed to take it with concern about addiction and only 29 (16.3%) patients agreed to take it without concerns about addiction. 8 Among the 90 patients who said they would refuse taking tramadol as an analgesic, the main cause of refusal was fears related to addiction in 51 (56.7%) patients. The causes of refusal are detailed in table 5. Table 5. Causes of refusal to use tramadol for pain among 90 patients Cause Addiction-related Addiction Narcotic Dependence Believed harmful effects Harmful/dangerous (unspecified) Central nervous system Unspecified Disorientation Agitation Depression Nervousness Kidney Liver Causes death Other Bad reputation Afraid (unspecified) Haraam (forbidden religiously) Fear of legal sanctions Ineffective Expensive Unspecified N % 29 16 9 32.2 17.8 10 16 17.8 4 3 1 1 1 2 2 1 4.4 3.3 1.1 1.1 1.1 2.2 2.2 1.1 10 5 5 3 1 1 4 11.1 5.6 5.6 3.3 1.1 1.1 4.4 These 88 patients who agreed to receive tramadol as an analgesic rated their concern about addiction as no concern in 29 (33%), mild concern in 15 (17%), moderate concern in 18 (20.5%) and severe concern in 26 (29.5%). Discussion In Egypt, cancer pain control remains largely inadequate. The most recent opioid consumption data reported by the INCB in 2015 show that there is some increase in the level of opioid consumption in Egypt (INCB narcotics 2015). However, the current figures still indicate that cancer pain is largely uncontrolled in Egypt. According to the level of consumption of narcotic drugs, Egypt is ranked 117 among countries with 75 defined daily doses for statistical purposes per million inhabitants per day (INCB narcotics 2015). The inadequate cancer pain control in Egypt is attributed to many barriers including the limited availability of opioids recommended by the WHO and the restrictive regulations that limit the accessibility of patients with 9 cancer to the available opioids (Alsirafy 2010 EJPC, Alsirafy 2010 JPSM, Alsirafy 2011). Tramadol is the only opioid available and suitable for use as a WHO step-II analgesic in Egypt. Currently, there are no other registered weak opioids or strong opioids in doses suitable for replacing tramadol. The only registered oral morphine is the 30 mg slow-release morphine tablets, which is already unavailable in Egypt for several months now. In addition to its value as a WHO step-II analgesic, immediate-release oral tramadol is the only registered opioid that can be used as a breakthrough analgesic for some patients with cancer pain in Egypt. Taking into consideration the importance of tramadol for cancer pain management, its stigmatization and the resulting tramadolophobia is expected to have a significant negative impact on cancer pain control in Egypt which is already faced by many obstacles. In the current study, tramadolophobia was highly prevalent in the studied population. In case they have pain and tramadol was prescribed for them as analgesic, the majority (84%) said they won’t take it or will take it with concern about addiction. Only 16% said they would take it without being concerned about addiction. In the absence of alternatives to tramadol, this prevalent tramadolophobia may result in significant suffering among patients with cancer pain. Patient-related barriers, especially fear-of-addiction, are among the recognized barriers to cancer pain management (Paice 1998, Paice 2014). Fear of addiction was the main reason behind tramadolophobia among the studied population. In 57% of patients, the mentioned reason of refusing to take tramadol as an analgesic was addiction-related. The percentage is expected to be higher than that because some patients may have expressed indirectly their fear of addiction by saying “it is harmful/dangerous” (18% of patients) or “it has a bad reputation” (11%). In addition to the fear of addiction, other reasons may be relevant. Some patients expressed their concerns about legal sanctions and others believed that tramadol is “haraam” (forbidden religiously). Few other patients mentioned unfounded adverse effects like hepatic and renal toxicities. It was surprising that only 31% of interviewed patients reported that tramadol is used as an analgesic while 53% and 33% reported abuse-related and tonic uses, respectively. With these high levels of 10 misconceptualization and stigmatization of tramadol, it is not at all surprising that the majority of patients with cancer would experience tramadolophobia. While tramadol abuse/misuse is a fact in Egypt, it is very much likely that the media has contributed significantly to its misconceptualization and stigmatization. The source of information about tramadol was the media (television) in half of the interviewed patients. This concurs with Fawzi (2011) who suggested that the media is a major reason for tramadol abuse in Egypt. To overcome tramadolophobia, interventions at many levels should be taken. At the level of cancer pain practice, discussions with cancer pain patients for whom tramadol will be prescribed are necessary to understand how they feel about tramadol and to correct misconceptions. In addition, there should be continuous monitoring to ensure adherence to the treatment. At the public level, evidence-based interventions to defeat the myths surrounding tramadol are needed, especially through the media which played a crucial role in misconceptualizing and stigmatizing tramadol. For example, although no exact estimations exist, tramadol is widely used to boost the sexual performance of men in Egypt (Elhadidy 2014). There is evidence to support the use of tramadol for premature ejaculation (Kirby 2015). However, the long-term use of tramadol may impair the sexual function of men. In a recent study from Egypt, tramadol-dependent (daily intake for at least one year) married men experienced a significant improvement in the sexual functions 6 months after stopping tramadol (Elhadidy 2014). Actions should be taken at a national level to combat the abuse/misuse of tramadol, which resulted in the emergence of tramadolophobia. However, there should be a balance between the regulations that limit the abuse of opioids and its availability for cancer pain management (WHO 2011). In response to the misuse/abuse of tramadol in Egypt, tramadol was put under national control in 2013 (INCB report 2015). Currently, tramadol is available only in cancer care facilities and few governmental pharmacies and only for patients with cancer. While it important to prevent the diversion of tramadol, all efforts should be made to make it available for medical use. The current study has a number of limitations. The structured interview included open-ended questions. This was necessary because of the lack of knowledge about the topic of the study. Furthermore we did not use standardized tools to assess patient11 related barriers to cancer pain management, like the Barriers Questionnaire II (Gunnar 2002). Future studies using standardized assessment tools with focus on tramadol are needed. Another limitation is that we did not include patients with cancer in “pain”. This was an exploratory study that guides future research including patients with cancer pain. Conclusions In conclusion, the results of the current study suggest that the abuse/misuse of tramadol in Egypt has resulted in tramadolophobia among patients with cancer. Interventions to overcome tramadolophobia as a barrier to cancer pain control are necessary. References Alsirafy SA. Dealing with barriers to cancer pain control in Egypt. Eur J Palliat Care 2010; 17(1): 10-11. Alsirafy SA. Regulations governing morphine prescription in Egypt: an urgent need for modification. 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