Opioid-prescribing Practices in Chronic Cancer Pain in a Tertiary Care Pain Clinic.

INTRODUCTION: Under treatment of pain is a recognized global issue. Opioid analgesic medication is the mainstay of treatment in cancer patients as per the World Health Organization (WHO) pain relief ladder, yet 50% of cancer patients worldwide do not receive adequate pain relief or are undertreated. AIM: The aim of this study was to audit the ongoing opioid-prescribing practices in our tertiary cancer pain clinic during January-June 2010. MATERIALS #ENTITYSTARTX00026;
METHODS: The prescribed type of opioid, dose, dosing interval, and laxatives details were analyzed.
RESULTS: Five hundred pain files were reviewed and 435 were found complete for audit. Three hundred forty-eight (80%) patients were prescribed opioids. Two hundred fifty-nine (74.4%) received weak opioids while 118 (33.9%) received strong opioids. A total of 195 (45%) patients had moderate and 184 (42%) had severe pain. Ninety-three (26.7%) patients received morphine; however, only 31.5% (58 of 184) in severe pain received morphine as per the WHO pain ladder. Only 73 of 93 (78.4%) patients received an adequate dose of morphine with an adequate dosing interval and only 27 (29%) were prescribed laxatives with morphine.
CONCLUSION: This study shows that the under treatment of pain and under dosing of opioids coupled with improper side effect management are major issues.

INTRODUCTION

Opioid analgesic medication is the mainstay of pain treatment in cancer patients, according to the guidelines of the World Health Organization (WHO) for cancer pain relief.[1-3] The WHO ladder approach was found effective and safe in 70–90% of advanced cancer patients.[4] However, various reports indicate that over 50% of cancer patients worldwide do not receive adequate pain relief or are untreated,[56] and the unrelieved cancer pain persists as a significant public health concern.[7]

Several factors are reported to contribute to the inappropriate use of opioid analgesics in cancer pain, e.g., insufficient education of doctors and nurses,[8-10] exaggerated concerns about the risks of abuse and diversion of opioids,[11] fear of side effects,[12] and inappropriate attitudes among physicians, patients, and the family members of cancer patients. Furthermore, existing national legislations and policies can be of potential impediment to adequate opioid use.[13] There is paucity of data from suffering cancer pain patients and opioid-prescribing practices from the Indian population.

This retrospective study analyzed the opioid prescribing practices in a tertiary care center taking into consideration the initial dose, duration, dosing schedule, and the adjunct drugs used for side effect management.

MATERIALS AND METHODS

This study was conducted in a pain center of a tertiary cancer hospital in India, after the approval from the hospital ethics committee.

Data of all patients who visited the pain clinic during the period of 6 months during January–June 2010 were analyzed. Those patients whose data sheets and case record forms were not fully and appropriately filled were excluded. In mild pain, nonopioids ± adjuvants (include TCA, anticonvulsants, steroids); in moderate pain weak opioids ± nonopioids ± adjuvants; and in severe pain strong opioids ± nonopioids ± adjuvants are recommended as per the WHO pain ladder (1986). The opioids commonly used are morphine, fentanyl, tramadol, codeine, and propoxyphene. The data of the first visit are recorded as per the case record form. The prescribed type of opioid, initial dose, dosing interval, and use of adjuncts were compared with WHO pain guidelines (1984) from the computer database using Microsoft Excel.

RESULTS

Five hundred case files were reviewed, of which only 435 case files were found to be eligible for audit due to their complete legible entries. A total of 56 (13%) patients had mild pain, 195 (45%) had moderat,e and 184 (42%) patients had severe pain on the numerical pain scale [Table 1]. On data analysis, it was found that, 85 (43.5%) patients with moderate pain were treated with either inadequate weak opioids or NSAIDs only as per the WHO pain ladder. A total of 119 patients with severe pain (64.6%) received inadequate analgesics [Table 2].

Table 1

Severity of pain using the numerical rating pain scale (0–10)

Table 2

Details of opioids used and the adjunct drugs as well as the incorrect level of the ladder

A total of 348 (80%) patients were prescribed opioids including 259 (74.4%) weak opioids and 118 (33.9%) strong opioids. Figure 1 shows that only 93 (26.7%) patients received oral morphine where as only 26 (7.4%) patients received transdermal fentanyl patches. Overall, the percentage of patients receiving morphine was 21.37% (93 of 435 patients) of which only 16.78% (73 of 435 patients) had received a proper dose with a proper dosing interval. In our study, we found that only 73 (78.4%) patients had received an adequate dose of morphine with an adequate dosing interval [Figure 2] as per the standard guidelines. Of weak opioids, tramadol was prescribed in 148 (42.5%), codeine in 63 (18.1%), and propoxyphene in 72 (20.6%) patients.

Figure 1

Different types of opioid prescriptions

Figure 2

Number of patients receiving an adequate morphine dose

After analyzing the data, it was found that only 48% prescriptions were adherent to the WHO pain relief ladder while 52% were nonadherent [Figure 3]. Severe pain was treated with morphine (31.5%) and tramadol (30.4%), and in moderate pain, tramadol (33.3%) [Table 2] was used. Figure 4 shows the dose and dosing interval of morphine and fentanyl patch prescriptions.

Figure 3

Adherence of drug prescriptions to the WHO pain ladder

Figure 4

Dose and dosing interval of strong opioids

Only 26 (5.97%) patients were given fentanyl patches, of whom only 3 patients received 12.5 μg/h patch and only 2 patients received 50 μg/h patches. Eight patients (4.3%) with severe pain received fentanyl transdermal, while 13 patients (6.6%) with moderate pain received fentanyl transdermal patches [Table 2]. The median dose of tramadol was 43.75 mg, with a median dose interval of 12 h, and minimum doses of 25 mg to a maximum dose of 100 mg. The median dose for morphine was 15 mg, with a median dose interval of 7 h, with minimum doses of 5 mg to a maximum dose of 30 mg [Table 3].

Table 3

Detailed opioids prescriptions with median dose, time interval, minimum, and maximum dose

Out of 93 patients who were prescribed morphine, only 27 (29.03%) patients received the laxatives [Table 4], while 148 patients were prescribed tramadol and only 55 (37.1%) were given antiemetics [Table 4]. Sixty-two percent of patients were seen by a consultant pain physician of whom only 52% patients received a correct oral morphine prescription. A total of 24.3% patients were seen by residents and registrars, while details about the rest were unknown.

Table 4

Opioids and the adjuvant drugs prescribed to prevent side effects

DISCUSSION

This study demonstrates undertreatment and underdosing of opioid analgesics in a cancer pain clinic. We found that the prescribed analgesic regimes were not adhering to the WHO guidelines (1984) which recommend the choice of oral analgesics as per the intensity of pain (mild, moderate, and severe).[14] This study shows that the strong opioids were not prescribed despite patients reporting severe pain. Overall, only 93 patients received morphine out of 184 patients with severe pain; however, 73 received an appropriate dose with an appropriate dosing interval.

The appropriate use of opioid analgesics in cancer pain management by physicians seems to be limited for a variety of reasons, including insufficient knowledge of analgesic pharmacology, myths and misconceptions, beliefs, and attitudes (addiction and fear of adverse effects)[8-12] contributing to inadequate pain relief.[13] It has been re-emphasized that doctors are reluctant to use morphine for many reasons. There are exaggerated ideas about its poor safety profile and some think that prescribing morphine means admitting a therapeutic defeat. Many of us find it hard to come to terms with the fact that treatment has failed, the disease is progressing, and our patient will die. As physicians do not accept this, it is the patient who faces the consequences of unrelieved physical pain due to inadequate analgesia, coupled perhaps with a false hope of an eventual treatment response. Patients’ attitudes also contribute to avoiding strong opioids. Many patients are concerned that taking strong opioids means their cancer is progressing, or not knowing what is happening to their body, or having intolerable side effects.[15]

The issue of physicians’ opioid-prescribing practices in India bears great importance to comprehend the reasons of prevalent inadequate pain management. As per the International Narcotics Control Board (INCB) report (2007; E/INCB/2007/1), the average global world consumption of morphine is 5.93 mg/capita/year, while of India its only 0.6 mg/capita/year.

The INCB mission visited India during December 2010 and discussed with Ministry of Health their strong concern for the issue of nonavailability of morphine and it poor consumption. The average consumption of India should be 900 kg/year, and instead it is 120 kg only.

The government agreed that it would take necessary steps to sensitize the doctors/health workers for prescribing morphine for all palliative care by training and education. It also suggested to remind the pharmacists/chemists of their responsibility to keep a stock of morphine so as to ensure the availability of the drug to the needy patients.[16]

The inability to achieve adequate pain relief in patients taking oral morphine with severe cancer pain is a global problem faced in the world of palliative care.[17] Another undertreatment issue was related to the side effect management by using appropriately adjuvant drugs. It has already been stated that the most common physician-related barriers to cancer pain management include undue concerns about side effects to opioids, prescription of suboptimal doses of opioids, and poor management of side effects of opioids.

This study found that the prescription of drugs to prevent side effects of opioids is less than 50% of the opioid prescriptions. The concept of a rational drug use during the past few years has been the theme of various national and international meetings.[18] Treatment should be started by writing an accurate and a complete prescription, e.g., name of drugs with dosage forms, dosage schedule, and total duration of the treatment.

Since most of the patients attend the pain clinic when the chances of any active cancer therapy are already exhausted, pain physicians may not be unaware of their response to opioids, as ample time is not available for a thorough assessment of the response after opioid prescription, thus enforcing the physician to choose the course of underdosing of opioids due to the fear of side effects. However, the responsibility of pain and palliative physicians does not end with prescribing opioids, as they have to adequately counsel patients and relatives regarding the issue of the cost and accessibility of opioid drugs at their native places as per the WHO World Opioid Policy 2011. Many of the patients who need palliative treatment at native places and also attend the tertiary care cancer center for follow-up visits may require opioid refill for few months. These patients should undergo a reassessment of the current pain status and their actual need of opioids; otherwise, there is a potential for error.[19]

Lastly, the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, which was rightfully intended to prevent the diversion of opioids to illicit nonmedical users can make the logistics of opioid prescription so complex that physicians end up fearing criminal prosecution.[20] Recent studies document fear of opioid addiction among nurses and physicians, thus leading to prescription of ineffective doses.[21-23] Though the fear of addiction was a global problem in 1995, it still remains a top barrier to prescribing analgesics as evidenced by a survey of health professionals in hospice and palliative care from Asia, Africa, and Latin America.[24]

The corrective measures may include a thorough assessment of patients by proper history and physical examination, to ensure a proper follow-up; need to communicate with the patients, by educating the pain physicians; and lastly, building a relationship with the patient based on trust. The results of this study can serve as a baseline for subsequent audit to assess the impact of various interventions employed and the overall patient satisfaction.

CONCLUSION

This study shows that undertreatment and underdosing of opioid analgesics is a big issue in the cancer pain clinic. Majority of outpatients with moderate to severe cancer are prescribed inadequate analgesics during their first visit.