Introduction

Morphine was included in the World Health Organization (WHO) Model List of Essential Medicines in 1977 [1]. It is an indispensable drug for managing cancer pain. An unwavering availability of opioids is crucial for effective pain and palliative care and for managing opioid dependence [2, 3]. Conversely, opioids have been legally classified as controlled drugs due to abuse and dependence potential, posing a barrier to their legitimate medical use.

Barriers to access to morphine are especially high in Low Middle-Income Countries [4]. In India, more than 1 million new cases of cancer are detected annually, with pain and its inadequate management being a frequently prevalent problem [5], although India perceives several narcotic drugs as essential [6]. The Lancet Commission’s report of 2017 quantified the inequalities in medicinal opioid availability access across the globe. India distributed 43 mg morphine equivalent which was enough to meet only 4% of the total palliative care needs [7]. Moreover, stringent regulations on the medical use of opioids and a lack of formal pain management training present an enormous impediment to the safe and effective use and prescription of opioids [8].

On the other hand, in the Western world, a remarkable rise in opioid use to treat chronic pain, and the ensuing rise in opioid abuse have amassed concern from the public health sector [9]. There has been a dismal panic originating from the various reports of addiction and opioid-related deaths [10–12]. Between 2001 and 2014, in the United States of America, opioid prescription-related deaths have soared from 1.9 to 5.9 per 100,000 [13]. Nevertheless, even the most developed nations faced severe shortages in the supply of opioids due to the challenges during the COVID-19 pandemic [14].

A survey conducted in 2007 concluded that difficulty with procurement and distribution due to restraining laws, costs, bureaucracy, and concerns of addiction, have constrained the legitimate medical use of opioids [15]. An exigency due to the precipitous increase in the occurrence of opioid-related deaths is further complicated by insufficient training and physician education regarding opioid prescribing [16].

However, such fear of opioid addiction and overdose can have grievous consequences for cancer patients suffering from severe undertreated pain. Therefore the pattern of morphine consumption was studied for over a decade and so was the use of safety protocols for prescribing opioids, followed in a tertiary cancer hospital in New Delhi.

Patients and methods

We performed a retrospective study to analyse the pattern of morphine consumption from 2008 to 2020, in a tertiary cancer hospital in New Delhi, India. The hospital has a dedicated tertiary-level palliative care department with monthly audits and frequent reviews of safety protocols and prescription practices. Data on patient registrations and revisits in the hospital, and with the Department of Palliative care and inpatient admissions to the Pain and palliative care ward were collected from Medical Records Section. Data relating to morphine consumption was retrieved from the Outpatient Pharmacy retrospectively. Total oral morphine dispensed over thirteen years, and morphine consumption per visit was calculated and studied. Ethics committee approval was obtained from the Institute Ethics Committee (IEC-616/03.09.2021).

Results

Patient data

The number of new cancer patients visiting the hospital increased every year, from 8793 patients in 2008 to 13008 patients in 2019 but fell to 7093 patients in 2020. Out of these, patients with high symptom burden or poor performance status or advanced disease were primarily registered with the palliative care clinic. The number of such patients also increased from 295 patients in 2008 to 1120 patients in 2019 but were fewer in 2020. All other patients also received palliative care consultations. Justifiably, the number of visits of these patients to the hospital and the pain clinic also increased every year. Inpatient admissions to the palliative care ward, as recorded since 2010 increased consistently (Table 1).

Oral morphine consumption data

Morphine consumption showed a continual rise from 4.89 kg in 2008 to 11.53 kg in 2019 but showed a drastic fall to 5.63 kg in 2020 (–50% annual change) (Table 1, Fig. 1). The steady incline was accompanied by a corresponding rise in out-patient attendance to pain and palliative care clinic from 4457 patient-visits in 2008 to 17857 visits in 2019, with a sharp decline to 6398 patients in 2020. Notwithstanding the rise in patient footfall in the hospital, the trend for total oral morphine consumption as well as the oral morphine dispensed per patient per visit showed an increase from 1.1 grams in 2008 to 2.06 grams in 2012, followed by a gradual decline to 0.89 grams of oral morphine prescribed per patient visit in 2020 (Fig. 2). Divergence incidence reported was nil [17].

Figure 1. Annual percent change in morphine consumption from years 2008–2020

Figure 2. Morphine consumption in grams per capita visit for years 2008–2020

Discussion

With the rising incidence of cancer as well as opioid-related deaths reported worldwide, it was decided to perform a survey of the opioid-use data of the past thirteen years spanning the journey since the initiation of dedicated palliative services at the study institute till the current integrated structure. The number of new cancer patients and hospital visits to the cancer centre soared unswervingly. With the establishment of dedicated palliative care services and a dedicated pain and palliative care ward, well equipped with a fluoroscopy-enabled intervention room, the number of patients admitted to the ward also showed a constant upsurge. Over the years, the department has held monthly clinical audits and updated and monitored the safety protocols for opioid prescription.

Despite various studies quoting opioid-sparing properties of adjuvant drugs and neurolytic blocks and behavioural intervention, the morphine consumption trend has, often, been used to gauge advances in the quality of pain management services [18, 19]. In the present observational study, oral morphine consumption dispensed on an outpatient basis was used instead of total opioid consumption in the hospital, to evade bias owing to distinct clinical uses of opioids (e.g., intravenous fentanyl and morphine for perioperative care).

We found morphine consumption showed a continual rise from 4.89 kg in 2008 to 11.53 kg in 2019. This increase was accompanied by a parallel rise in out-patient attendance to pain and palliative care clinics from 4457 patient visits in 2008, to 17857 patient visits in 2019. This constant and parallel rise can be ascribed to advances in palliative care [20–22], growth of educational opportunities for healthcare professionals involved in pain and opioid prescribing [23–25], and initiation of clearer policies governing the medical use of opioids. However, owing to the COVID-19 pandemic, ensuing nationwide lockdowns, and resulting barriers [26] to access to healthcare, patient attendance as well as morphine dispensed in the hospital saw a sharp fall.

To avoid being misled by the wavering trend in total oral morphine consumption in the backdrop of an increasing number of patients and revisits, the authors calculated and plotted the trend for oral morphine dispensed per patient visit. However, this trend, over thirteen years, was unmatched: although morphine consumption had increased, the consumption pattern per patient visit did not show a similar consistent rise. In cases of addiction or dependence or increased dosing, opioid consumption is expected to increase. However, the present data show an irregular fluctuating pattern of demand and supply of morphine, with an eventual decline over more than a decade of quality improvement measures, suggestive of the judicious use of opioids.

A separate cross-sectional observational study conducted at the study centre interviewed patients who were receiving uninterrupted morphine for chronic cancer pain for ≥ 12 months; the most recent prescription showed a morphine equivalent dosage of ≥ 60 mg. Patients were screened for the presence of comorbid mental disorders or probable substance use disorders. None of the participants had psychiatric or substance use disorder [17]. Meticulous prescription practices are followed at the study centre to reinforce the responsible and judicious use of oral morphine for cancer pain, and to prevent drug abuse (Fig. 3). Safe prescription protocols are followed at the institute.

Figure 3. Comprehensive management of ‘total pain’

Palliative care referrals

Integration of palliative oncology

Education

Communication

Screening

Starting opioids

Figure 4. Management protocol for patients presenting with cancer pain

Prescription

Multimodal techniques

Changes made during the COVID-19 pandemic

Conclusions

To optimize opioid use we need to educate health­care professionals, caregivers, and policymakers. The present study was limited by the inherent nature of the study design that did not consider individual patient data or any clinical variables such as relief in pain or other symptoms in cancer patients. Lower potency opioids such as tramadol were not studied.

Morphine consumption can be a deceptive marker for quality and access to palliative care. This study highlights the importance of multidisciplinary actions and interventions to achieve pain relief and palliation of symptoms which thereby reduce morphine consumption.

Apprehension amongst doctors, due to reports of opioid overdose and abuse should not deprive patients of adequate pain relief. Appropriate opioid prescriptions should always be accompanied by immaculate assessment and continuing education of the patient, caregivers, and health care professionals.

The COVID-19 pandemic and ensuing travel restrictions have added health-related suffering of vulnerable populations highlighting the role of policy decisions and strategic interventions to ensure the availability, accessibility, and affordability of essential medicines for primary, intensive, and palliative care [38].

Declarations

Authorship: AP is the chief investigator; AP with critical input from all authors, wrote the protocol for the study. AP and SB coordinated data collection, with input from all authors. HKR analysed the data. All authors had access to all study data, discussed the interpretation of findings and take responsibility for data integrity and analysis. AP and SB drafted the manuscript. All authors contributed to the analysis plan and provided critical revision of the manuscript for important intellectual content.

Ethics

Ethics committee approval was obtained from the Institute Ethics Committee, AIIMS, New Delhi (IEC-616/03.09.2021)

Data sharing

The data that supports the findings of this study are available at Medical Records Section, All India Institute of Medical Sciences, New Delhi and available on request from the first and last authors. The data are not publicly available due to privacy and ethical restrictions.

Declaration of conflict of interest

The authors declare that there is no conflict of interest.

Funding

The authors did not receive any financial support for the research, authorship, and/or publication of this article.