Use Of Tapentadol Research Articles

A Study on Tapentadol Misuse and Abuse among Heroin Users Attending a Deaddiction Center in Kashmir

Abstract Background: Tapentadol is a powerful opioid receptor agonist and a norepinephrine reuptake inhibitor, making it a centrally acting analgesic. In India, where the government is trying to combat an ongoing opioid crisis, the lack of scheduling of tapentadol creates an easy opportunity for its misuse. We aim to analyze the demographic and clinical characteristics of heroin users who also abuse tapentadol concurrently through our cross-sectional study done at the drug-deaddiction center situated at the community center of SMHS Hospital, Srinagar, Kashmir. Material and Methods: It was a cross-sectional study done at the Community Centre of SMHS hospital Srinagar, which houses the drug deaddiction centre run by the Psychiatry Department of GMC(Government Medical College) Srinagar. From 1st June 2023 until 30th November 2023, we gathered data for our investigation. After gaining informed consent, all the first-time heroin-dependent patients at the deaddiction facility who admitted to using tapentadol were included in the study. Patients’ age, sex, marital status, family composition, and level of education were analysed in accordance with a predefined proforma. In addition, the modified Kuppuswamy scale was used to categorise patients based on their socioeconomic status. Parameters such as the pattern of tapentadol use, the route of heroin use, and the comparison of the psychoactive effects of tapentadol and heroin were recorded using a proforma to create a clinical profile of such patients. Results: Our sample comprised 100 participants. The prevalence of tapentadol abuse among heroin users in our study came out to be 16%. The average age of our study participants was 25.11 ± 2.99 years. The vast majority of our patients were male (97%). The vast majority (58%) of our participants were from lower socioeconomic status. Ninety-eight percent of our subjects used oral tapentadol while there were 2 (2%) instances of intravenous tapentadol use. The majority of participants used the “Tapal” brand (60%). Tapentadol was mainly obtained either through a chemist’s shop (35%) (with or without a prescription) or through a friend (37%). Half of the subjects (50%) obtained tapentadol for the purpose of managing heroin withdrawal. Thirty-five percent of participants used tapentadol in a dependent manner, while the remaining 65% either misused or abused the drug. Conclusion: The continued heroin usage crisis, lenient tapentadol procurement regulations, and the use of nonevidence-based drugs for the treatment of opioid use disorder all contribute to the problem of tapentadol abuse in our region.

Prevalence and Profile of Tapentadol Use in Patients Visiting a Drug De-addiction Center in Kashmir

Background: Misuse of prescription opioids has been a hazard lately with tapentadol being a recent addition to the list. Tapentadol is a schedule H1 opioid (Drugs and Cosmetics Rules, India), approved for the management of moderate-to-severe acute and chronic pain. Aims and Objectives: We examined the prevalence of tapentadol use among patients attending the Drug De-addiction Center, Government Medical College, Srinagar, Kashmir, along with their sociodemographic and clinical profiles. Materials and Methods: It was a cross-sectional study. Patients who reported current tapentadol use were included in the study. Results: In a span of 4 months, a total of 104 patients using tapentadol were seen. Our study mostly consisted of young, unmarried males. More than half of our study participants had concurrent opioid dependence. In our study, no participant had ever injected tapentadol. Conclusion: Tapentadol is becoming infamous as a cheap and ready-to-available drug, replacing other opioids during their nonavailability. This should be a potentially alarming sign for drug control authorities. As such, its sale and supply should be well regulated.

Quality use of publicly subsidised tapentadol in Australia: a population-based analysis.

Sustained-release (SR) tapentadol was listed on Australia's Pharmaceutical Benefits Scheme (PBS) in 2014 for chronic severe pain requiring long-term opioid treatment. Dispensings have increased since listing despite declining trends in other PBS-listed opioids. Preferential prescribing of SR opioids may increase the risk of dependence and accidental overdose, particularly when used to treat acute pain. To explore the quality use of publicly subsidised tapentadol in Australia. We examined annual initiation rates and patterns of use of tapentadol (SR) in the dispensing records of a 10% random sample of PBS-eligible Australians (2014-2021). We used national tapentadol sales data to assess the proportion of sales attributable to the PBS. Tapentadol initiation increased from 2014, peaking at 7.5/1000 adult population in 2019 before declining to 5.3/1000 in 2021. We identified 63 766 new users between 2014 and 2020, of whom 92.8% discontinued in the first year following initiation, 58.0% had only a single dispensing and 34.3% had no other opioids dispensed in the 3 months before or after initiation. 27.8% of new users were dispensed tapentadol on the same day as potentially interacting medicines. There was a sustained drop in the proportion of sales attributable to the PBS from June 2020 onwards, from an average of 69.1%, to 63.9% of pack sales. Patterns of use suggest tapentadol (SR) is generally used for short duration. Although most tapentadol sold in Australia is subsidised, there is evidence of a shift towards private sales.

Tapentadol Versus Oxycodone for Opioid-Related Adverse Drug Events and Clinical Outcomes After Inpatient Surgery

Oxycodone is a commonly prescribed opioid for postoperative pain. However, there has been a marked increase in the use of tapentadol over the previous decade due to a perceived superior safety profile of tapentadol compared to oxycodone. There is limited real-world evidence on the safety of tapentadol compared to oxycodone after surgery. The primary objective was to examine the impact of tapentadol compared to oxycodone use on the incidence of opioid-related adverse drug events after surgery. Data for adult surgical patients receiving tapentadol or oxycodone during hospitalization between January 1, 2018, and December 31, 2021, were collected from electronic medical records of 3 tertiary metropolitan hospitals in Australia. The primary outcome was the incidence of opioid-related adverse events. Patients receiving tapentadol or oxycodone were matched using nearest-neighbour propensity score matching. In the matched cohorts (n = 1,530 vs n = 2,775; mean [standard deviation] age 62.3 [17.0] years vs 61.9 [standard deviation 17.9] years; 43% vs 45% male for the tapentadol vs oxycodone groups, respectively), patients given tapentadol experienced a similar incidence of adverse events overall (14.4%, 220/1,530 vs 12.6%, 349/2,775; P = .100; 95% CI −.35% to 3.95%). Secondary outcomes included an increased risk of delirium (2.7%, 41/1,530 vs 1.3%, 37/2,775), arrhythmias (3.4%, 52/1,530 vs 2.2%, 62/2,775), and length of hospital stay (5 [range 1–201] vs 4 [range 1–226] days) compared with oxycodone use. Further real-world studies are warranted to determine the impact of tapentadol use on a broad range of patient outcomes. PerspectiveThis study provides an early signal that tapentadol use may be associated with an increased risk of some adverse events and a longer length of stay. Further research is needed to examine the impact of tapentadol use on a broad range of patient outcomes in clinical practice settings.

Tapentadol, an opioid as a strategy for the treatment of chronic pain? A narrative review

Chronic pain affects approximately 30 % of the world population. Tapentadol can be an analgesic option for patients who do not respond adequately to commonly used opioids. This study reviewed the general aspects of Tapentadol pain treatment and its possible association with increased oxidative stress, as well as the benefits of its association with antioxidant substances. The search was carried out in the Medline (Pubmed), Scopus, Web of Science, and Google academic databases, including studies since the registration of the drug in 2008. The selected articles were those related to the use of Tapentadol for chronic moderate to severe pain, but not cancer-related pain, in adults and the elderly. Tapentadol is a µ opioid receptors agonist and inhibits noradrenaline reuptake. Although Tapentadol causes fewer adverse effects than other conventional opioids, studies have shown the induction of oxidative stress by this drug, but without having elucidated the mechanisms.

Increased incidence of mixed drug toxicity deaths involving tapentadol - A forensic study.

Tapentadol is a relatively new synthetic opioid analgesic prescribed for the management of moderate to severe pain. While tapentadol has been shown to be more effective than traditional opioid analgesics, it still carries the risk of addiction, abuse, and misuse. In Australia, tapentadol has become one of the top five most commonly prescribed opioid drugs, with prescriptions increasing by approximately 150,000 each year since it first became available. The rapid increase in tapentadol prescriptions has occurred in parallel to an increasing number of post-mortem tapentadol detections in South Australia (SA). While the number of deaths in SA related to tapentadol use was low in the current study, findings suggest that an increasing trend of deaths involving tapentadol will continue in parallel to a rapidly increasing number of prescriptions, mirroring trends associated with traditional opioids in SA. As a comparatively new opioid analgesic, monitoring future trends will be important to determine if additional prescribing education, intervention, or restrictions are required.

Trends in dispensing and utilisation of sustained-release tapentadol in Australia.

ObjectivesTapentadol is a µ-opioid agonist, moderate noradrenaline reuptake inhibitor (NRI) and very weak serotonin reuptake inhibitor. The sustained release (SR) formulation is indicated for relief of chronic moderate to severe pain. We examined utilisation trends and concordance with prescribing guidelines of prescription SR tapentadol in Australia between 2014-2021. ApproachWe used a 10% sample of Australian Pharmaceutical Benefits Scheme dispensing data linked to death records. We assessed incidence, prevalence, and trends in monthly dispensed prescriptions between June 2014 (date of public subsidy) and September 2021. We defined incident users in adults aged ≥18 years as no tapentadol dispensings in the previous year. We assessed characteristics of initiators and patterns of utilization in the year following initiation, including prescription strengths, concurrent dispensing of tapentadol and medicines with known interactions or contraindications, and switching to other opioids. Results4,883,840 prescriptions of tapentadol were dispensed during the study period. Total monthly dispensed prescriptions increased from 2,040 (June 2014) to 91,300 (September 2021). The lowest strength formulations (50mg, 100mg) comprised nearly three quarters of all dispensed prescriptions (3,628,400; 74.3%). We identified 66,334 new episodes of tapentadol use. Incidence rose from 0.8/1000 population in 2014 to a high of 8.4/1000 in 2019, dropping to 5.5/1000 in 2020. Most people initiating tapentadol were aged 45-84 years (48,464; 73.1%) and female (37,709; 56.9%). More than half (38,157; 57.5%) did not receive a second tapentadol dispensing within 90 days of initiation. 10,868 (16.4%) were dispensed a non-opioid medicine with known interaction on the same day as initiation, and 23,205 (35.0%) were concurrently dispensed tapentadol and other opioids. ConclusionThe only approved subsidized indication is tapentadol SR for chronic pain. However, the very high prevalence of single dispensings of tapentadol SR suggests it may be being used off-label for acute pain instead of tapentadol immediate-release; this would be less safe, less effective and also against Australian therapeutic guidelines.

Characterizing the Experience of Tapentadol Nonmedical Use: Mixed Methods Study

BackgroundThe prevalence of abuse, diversion, and web-based endorsement of tapentadol (extended-release [ER], immediate-release [IR]) has been characterized as low compared with other prescription opioids. Little is known about individual experience with tapentadol nonmedical use (NMU).ObjectiveThis study aims to pilot web-based survey technologies to investigate the motivation for tapentadol NMU, sources of procurement, routes of administration, tampering methods, doses used, and impressions of tapentadol products (Nucynta and Nucynta ER).MethodsRecruitment flyers and banner advertisements were placed on the Bluelight website [DragonByte Technologies Ltd] with a link to a web-based survey (Qualtrics) designed to query about individuals’ lifetime tapentadol NMU. This web-based survey was followed by an interactive web-based chat (Cryptocat) with respondents who were willing to be contacted. Respondents were queried about sources for obtaining tapentadol, motives for use, routes of administration, tampering methods, drugs used in combination, tablet strengths and dosages, and reasons for continued or discontinued use. Desirability and attractiveness for NMU was rated.ResultsWeb-based recruitment successfully attracted difficult-to-find study participants. A total of 78 participants reported that tapentadol was obtained from friends and family (ER 11/30, 37%; IR 18/67, 27%), the internet (ER 11/30, 37%; IR 12/67, 18%) or participants’ own prescriptions from a doctor (ER 9/30, 30%; IR 17/67, 25%). It was used nonmedically for pain relief (ER 18/30, 60%; IR 33/67, 49%) and multiple psychotropic effects, including relaxation (ER 13/30, 43%; IR 29/67, 43%), reduction in depression or anxiety (ER 7/30, 23%; IR 30/67, 45%), or getting high (ER 12/30, 40%; IR 33/67, 49%). Tapentadol was primarily swallowed (ER 22/30, 73%; IR 55/67, 82%), although snorting (ER 2/30, 7%; IR 8/67, 12%) and injection (ER 2/30, 7%; IR 5/67, 8%) were also reported. The preferred dose for NMU was 100 mg (both ER and IR). The participants reported tapentadol use with benzodiazepines (ER 12/21, 57%; IR 28/47, 60%). Most participants had discontinued tapentadol NMU at the time of survey completion (ER 22/30, 73%; IR 55/67, 82%). Reasons for discontinued ER NMU included side effects (10/22, 46%) and lack of effective treatment (10/22, 46%). Reasons for discontinued IR NMU included lack of access (26/55, 47%) and better NMU options (IR 21/55, 38%). Few individuals were willing to divulge identifying information about themselves for the interactive chat (8/78, 10%), demonstrating the strength of anonymous, web-based surveys. Interactive chat supported the survey findings. A subgroup of participants (4/78, 5%) reported hallucinogenic side effects with high doses.ConclusionsWeb-based surveys can successfully recruit individuals who report drug NMU and those who are difficult to find. Tapentadol NMU appears to occur primarily for pain relief and for its psychotropic effects. Although it was liked by some, tapentadol did not receive a robust pattern of endorsement for NMU.

Clinical role and safety of tapentadol in patients with cancer: A single-center experience.

To evaluate real-world data on the use of tapentadol (TAP) in cancer patients. Single-center retrospective study. Curative/palliative. Patients who started TAP between October 2014 and December 2018 at our institution. The primary outcome was the reason for TAP initiation. Secondary outcomes included prescription duration, TAP cessation rate, reason for cessation, and adverse events (AEs). Since the palliative care team (PCT) tended to prescribe to cancer patients with intractable pain more often than patients in usual care, and also tended to prescribe opioids based on their characteristics, we decided to compare patients with and without PCT intervention. There were 175 patients who first received TAP during the study period, of whom 81 patients (46.3 percent) were male. The median age was 60 years. TAP was prescribed for opioid-naive patients in 45 (26 percent) cases and opioid switch in 130 (74 percent) cases. When comparing the PCT group (n = 121) and the non-PCT group (n = 54) using univariate analysis, the PCT group had a higher opioid switch rate (81.8 percent vs 57.4 percent, p < .001), higher proportion of patients with neuropathic pain (NP) (65.3 percent vs 16.7 percent, p < .001), and a higher proportion of patients with a history of nausea (41.3 percent vs 18.5 percent, p < .01). The cessation rate due to AEs was 8 percent overall. Palliative care physicians prescribed TAP for patients with NP or a history of nausea. Opioid-naive patients were preferred by oncologists. TAP has good tolerability in both groups, with a low dropout rate due to AEs.

Characteristics of fatal tapentadol-related toxicity in Australia.

Tapentadol is a centrally acting opioid analgesic prescribed for the treatment of moderate to severe pain. The study aimed to determine the characteristics of Australian toxicity deaths related to tapentadol. All cases in which tapentadol use was coded contributory to death (n=159) were retrieved from the National Coronial Information System (1 July 2000-31 December 2020). The mean age was 48.5 (18-81) and 56% were female. Documented histories of problems with chronic pain (66%), mental health (60.4%), substance use (44%) and injecting drug use (23.3%) were common. The majority of deaths were deemed unintentional (76.1%) and in 18.9% pre-existing disease was co-contributory. The median peripheral blood tapentadol concentration was 1.00 mg L-1 (0.02-47.00), and the median aortic concentration was 2.05 mg L-1 (0.10-30.00). In all cases, psychoactive drugs other than tapentadol were also detected, most commonly antidepressants (72.3%), opioids (66.7%), hypnosedatives (64.2%) and gabapentinoids (43.4%). Of cases where autopsies were conducted, 27.7% were diagnosed with cardiomegaly and 18.5% with severe coronary artery stenosis. Pulmonary oedema (68.1%), aspiration of vomitus (39.5%) and acute pneumonia (26.9%) were common. The typical tapentadol-related toxicity death involved unintentional death in the presence of multiple drugs, although a notable minority were intentional self-harm. Multiple morbidities were common. The identification and characteristics of these cases indicate that the adverse event profile of tapentadol needs to be considered in the setting of polypharmacy.

Tapentadol: Use and Abuse

Tapentadol is a synthetic opioid analgesic that has been on the market in India since 2011. According to international studies, there is a low danger of abuse and diversion. Prescription opioid pain reliever abuse remains a major public health concern. Tapentadol, a prescription painkiller, differs from opioids such as oxycodone and morphine in that it has two modes of action: opioid receptor agonism and norepinephrine reuptake inhibition. Tapentadol has been on the market in India for eight and a half years. Our center was the topic of a single peer-reviewed research in 2017 that detailed two instances of abuse. Tapentadol is less likely to be diverted, abused, addicted, overdosed, or sold on the street than other prescribed opioids. This article reviews uses, pharmacological properties and abuse of tapentadol as it is the most serious issues like addiction, seeking behavior, withdrawal, and physical dependency .The main challenge with tapentadol use is controlling the ratio of MOR agonist to NRI. Finally, tapentadol provides both nociceptive and neuropathic pain relief, but there are concerns about abuse and reliance.&#x0D; Keywords: Tapentadol, Abuse, Opioid, Addiction.

Tapentadol and Oxycodone/Naloxone Prescribing Patterns in Primary Health Care in Catalonia, Spain: A Cross-Sectional Study.

ObjectiveTo characterize the use of tapentadol and the combination oxycodone/naloxone in primary health care. Data on their use and possible misuse will allow the identification of risk factors and to design protocols to reduce and prevent avoidable harm to patients being treated for pain.DesignA descriptive, cross-sectional and multicenter study was performed.SettingFifty-three primary health care teams, which provides healthcare for 1,300,000 inhabitants.PatientsA total of 1840 patients had active prescriptions of tapentadol and 985 of oxycodone/naloxone.MethodsDemographic (age, sex) and clinical (glomerular filtration rate; active liver disease; dosing and duration of treatment), prescribed daily dose (according to age, sex, length of treatment), concomitant analgesic treatment and diagnosis. Patient information was obtained from medical records.ResultsMost of the patients were women (>74.0% in both cases), and the average age was 69.3 years (women: 70.1±13.2; men: 66.7±13.9 years) in the case of tapentadol and 70.6 years (women: 64.0±13.6; men: 72.6±14.3 years) in the case of oxycodone/naloxone. Only 12.2% of patients taking tapentadol and 12.1% taking oxycodone/naloxone had a normal renal function. In both cases, 4.1% of patients had active liver disease. The average length of treatment was 246.4 days in oxycodone/naloxone and 199.0 days in tapentadol. It was recorded that 85.1% of patients in the case of tapentadol and 89.0% in the oxycodone/naloxone had at least another drug prescribed for pain. About 42.2% of patients treated with tapentadol and 34.4% of patients treated with oxycodone/naloxone had associated neuralgia as a diagnosis.ConclusionThe pattern of use and profile of patients with tapentadol and oxycodone/naloxone had more similarities than differences, and suggested that prescribing practice, and monitoring should be assessed regularly to ensure patient safety and effective management of pain.

Cost-Effectiveness Analysis of Tapentadol Versus Oxycodone/Naloxone in both Branded and Generic Formulations in Patients with Musculoskeletal Pain.

Current evidence shows that tapentadol hydrochloride prolonged-release is more cost effective than other opioids. However, the introduction into the market of generic formulations of traditional comparators, leading to potential savings due to their lower price, creates space for further research. The objective of this study is to evaluate and compare the efficacy of tapentadol versus oxycodone/naloxone and the economic impact of the two alternatives in both branded and generic formulations. A cost-effectiveness analysis was performed using the third-payer perspective (TPP), with specific reference to the Italian National Health Service. A Markov model was implemented to simulate transitions between states, comparing two arms: The first arm simulated the administration of tapentadol, while the second simulated the administration of oxycodone/naloxone, both branded and generic. The results were reported in terms of net monetary benefit (NMB). The willingness to pay (WPT) was estimated at €35,000/quality-adjusted life year. Tapentadol was dominant in all scenarios, assuming a population of 1000 individuals over a 1-year time horizon. In all cases, although the prices of oxycodone/naloxone generic formulations were lower, the costs associated with treatment discontinuation were always higher than those associated with tapentadol. The comparison with the branded formulation of oxycodone/naloxone was associated with the highest savings of €431.77 per patient, and with the highest NMB of €1943.77 per patient. The results of this pharmacoeconomic evaluation promote the use of tapentadol in comparison with oxycodone/naloxone, confirming the results obtained in previous studies with reference to the generic formulations.

Nitric oxide modulates tapentadol antinociceptive tolerance and physical dependence

Tapentadol, an analgesic with a dual mechanism of action, involving both μ-opioid receptor agonism and noradrenaline reuptake inhibition (MOP-NRI), was designed for the treatment of moderate to severe pain. However, the widely acknowledged risk of analgesic tolerance and development of physical dependence following sustained opioid use may hinder their effectiveness. One of the possible mechanisms behind these phenomena are alterations in nitric oxide synthase (NOS) system activity. The aim of the study was to investigate the tolerance and dependence potential of tapentadol in rodent models and to evaluate the possible role of nitric oxide (NO) in these processes. Our study showed that chronic tapentadol treatment resulted in tolerance to its antinociceptive effects to an extent similar to tramadol, but much less than morphine. A single injection of a non-selective NOS inhibitor, NG-nitro-L-arginine (L-NOArg), reversed the tapentadol tolerance. In dependence studies, repeated administration of L-NOArg attenuated naloxone-precipitated withdrawal in tapentadol-treated mice, whereas a single injection of L-NOArg was ineffective. Biochemical analysis revealed that tapentadol decreased nNOS protein levels in the dorsal root ganglia of rats following 31 days of treatment, while no significant changes were found in iNOS and eNOS protein expression. Moreover, pre-treatment with L-NOArg augmented tapentadol antinociception in an opioid- and α2-adrenoceptor-dependent manner. In conclusion, our data suggest that the NOS system plays an important role in the attenuation of tapentadol-induced tolerance and withdrawal. Thus, inhibition of NOS activity can serve as a promising treatment option for long-term tapentadol use by extending its effectiveness and improving the side-effects profile.

Comparison of opioid prescribing upon hospital discharge in patients receiving tapentadol versus oxycodone following orthopaedic surgery.

Background The changing of opioids during the transition of care from hospital to home may be associated with harm. Objective To compare patients receiving tapentadol IR versus oxycodone IR following orthopaedic surgery during hospitalisation with regard to the changing of opioids at hospital discharge. Setting A major metropolitan tertiary referral hospital in Australia. Methods This is a retrospective cohort study. Participants included adult orthopaedic surgery patients receiving postoperative tapentadol IR or oxycodone IR during hospitalisation between 1 January 2018 and 30 June 2019. Main outcome measure The proportion of patients for whom the opioid prescribed was changed at hospital discharge. Results The study cohort included 199 patients. Of these, 100 patients received oxycodone and 99 patients received tapentadol post-operatively during hospitalisation. The mean age was 66years (SD, 12years) and 111 (56%) were female. The most common surgeries were total knee arthroplasty (91, 46%), total hip arthroplasty (63, 32%) and shoulder surgery (26, 13%). Patients in the tapentadol group were more likely to be changed to a different opioid upon hospital discharge than the oxycodone group (57% versus 9%, difference 48% [95% CI 36-59%, p < 0.01). After adjusting for confounders, post-operative tapentadol use was more likely to be associated with opioid changing upon discharge (OR 16.5, 95% CI 6.7 to 40.8, p < 0.01). Conclusions The post-operative use of tapentadol IR during hospitalisation was associated with an increased likelihood of opioid changing at hospital discharge. This practice could have patient safety implications.

Risk indicators in tapentadol use: opportunities to improve outcomes with a personal pharmaceutical care approach in community pharmacies

Opioids have historically been the pharmacological choice in the treatment of moderate to severe pain of oncological and chronic origin but they have also become a growing and controversial tool in the treatment of non-oncological pain that requires a risk/ benefit evaluation. The present study focuses on the opioid tapentadol, the newest opioid considered highly effective in treating cancer and non-cancer pain. According to the WHO Collaborating Center for Drugs Statistics Methodology, the stated Tapendatol Defined Daily Dose (DDD) for oral administration is 400 mg but the prescribed doses range from 100 mg/day in patients without previous opioid treatments up to a maximum of 600 mg/ day. However, the DDD is a unit of measurement that does not have to reflect the prescribed daily dose (PDD) because therapeutic doses usually differ from DDDs by taking into account individual patient considerations and pharmacokinetic conditions. This retrospective observational study in a community pharmacy on the island of Tenerife (Canary Islands, Spain) is based on the 471 dispensations of opioids for the year 2020, of which 213 correspond to tapentadol (45.2%). In 2020, among the 62 patients using opioids, 58% (36) were treated with tapentadol. For both genders, the predominant age range among tapentadol users is over 61 years, accounting for 70% of the sample (50% women and 20% men). Regarding the origin of the prescription of tapentadol, 68% of the prescriptions were originated in Primary Care services and only 14% were prescribed at a Hospital. Recorded tapentadol PDDs range from 25 mg/day to 500 mg/day but the most prescribed PDD in both women (22%) and men (11%) was 100 mg/day. When studying the polymedication of tapentadol users we observed that 36% of them are also treated with benzodiazepines (34% women and 2% men), 34% also use SSRI antidepressants (32% women and 2% men), 15 % take antiepileptic drugs (13% women and 2% men) and 8% receive TCA antidepressants. The tapentadol dispensing was also recorded in synergy with other major opioids. Thus, 3.2% of patients (women over 61 years of age) receive a combination of oral tapentadol (150 mg and 200 mg) and oral sublingual fentanyl (0.13 mg - 0.4 mg/day). Therefore, the authors believe that in any pharmaceutical care intervention on opioids treatment users, especially dispensing and follow up, is an ideal time to promote a safer user of Tapentadol and to detect and to avoid potential drug related problems (DRP) and negative medicine outcomes (NMO).

'Extreme personal stress' and 'a lot of pain': Exploring the physical, mental and social contexts of extramedical pharmaceutical opioid use in Australian paramedic case descriptions.

Despite growing concerns over the extramedical use of pharmaceutical opioids, few studies have focused on the contexts that shape this use or how it might lead to harm. There is also limited research examining how contexts might vary across different opioids, such as those with well-established abuse liabilities (e.g. oxycodone) and newer 'atypical' opioids (e.g. tapentadol). We aimed to address these gaps. We analysed Australian paramedic case descriptions for tapentadol cases (n = 82) and a representative sample of oxycodone cases (n = 82) from a 6-year period (2013-2018). We used framework analysis to identify 'contexts' shaping extramedical use from cases where use of tapentadol or oxycodone was assessed to have significantly contributed to the attendances. Demographically, case descriptions from both drug types were broadly similar (approximately 55% female, 44% were 35-54 years old), as were the contextual factors. The most prevalent contexts common to both oxycodone and tapentadol cases were psychological distress, physical pain and social stressors. Suicidal intent was present across multiple contexts. This study is one of the first to explore the contexts of extramedical pharmaceutical opioid use leading to acute harm. Our analysis found patients in complex, emergency situations, seeking rapid relief from physical pain, psychological distress, social issues and/or suicidal thoughts. These data highlight the complex needs of those experiencing harm from extramedical pharmaceutical opioid use, regardless of opioid type, and the importance of contextual factors shaping both use and subsequent harm.

Acute colonic pseudo‐obstruction leading to perforation: a case‐control study investigating associations to tapentadol

AbstractBackgroundAcute colonic pseudo‐obstruction (ACPO) is an uncommon syndrome where the large bowel dilates in the absence of mechanical obstruction and may progress to perforation. A recent increase in the incidence of ACPO complicated by colonic perforation had been noted at the Alfred Hospital, coinciding with the introduction of the analgesic tapentadol. This led to an investigation of potential associations between complicated ACPO and tapentadol, together with other identifiable factors.MethodsThis was a retrospective case‐control study. Eight cases were identified and confirmed radiologically. Four matched controls were identified for each case based on age, sex and comparable diagnosis at the time of presentation.ResultsThirty‐five male and five female patients of similar age and comorbid disease were reviewed. Tapentadol use (p = 0.42) and duration (p = 0.81) and mean tapentadol dose (p = 0.07) did not differ between groups. Other associations included alcohol use of greater than three standard drinks per day (p = 0.031) and ondansetron use (p = 0.039) among cases. Mean (± SD) duration of opioid use was significantly longer in the cases than controls (7.6 ± 1.6 vs 5.0 ± 3.1 days respectively; p = 0.023; odds ratio 2.57, 95% confidence interval 1.1–5.8). Mean opioid dose (p = 0.68) did not differ between groups.ConclusionPseudo‐obstruction causing colonic perforation was associated with alcohol use of greater than three standard drinks per day, longer in‐hospital opioid use and ondansetron use, but not with the use, duration or mean dose of tapentadol. Data should be combined with data from other sites to strengthen associations.

Opioid use and harms associated with a sustained-release tapentadol formulation: A post-marketing surveillance study

AimsA sustained-release formulation (SRF) of tapentadol has been marketed in Australia since February 2013. This study examined tapentadol SRF extra-medical use, attractiveness for extra-medical use, and associated harms in Australia. MethodsThis post-marketing study comprises analyses of Australian community sales data (2011–2017) for eleven pharmaceutical opioids (prescription and over-the-counter codeine disaggregated); calls to three poisons information centres (covering five of the eight jurisdictions in Australia) related to pharmaceutical opioids and coded by the centres as ‘misuse’ or ‘abuse’ (2011–2017); and interviews with people who inject drugs (n = 888) recruited as part of the Illicit Drug Reporting System (IDRS) from all Australian capital cities (2017). ResultsPopulation-level availability of tapentadol SRF increased from market launch, comprising the sixth largest market share of all opioid unit sales, and third greatest share in oral morphine equivalent milligrams sold, in December 2017. Lifetime tapentadol SRF use among the IDRS sample (n = 888) was low (1.5%; 95%CI 0.9–2.5), with few reporting past-6 month non-prescribed use or injection. Non-fatal overdose following tapentadol use was self-reported by less than 1% (95%CI 0.1-0.8). Between 2013–2017, 1.1% (n = 25) of pharmaceutical opioid ‘misuse/abuse’ calls were related to tapentadol, and predominantly the SRF. ConclusionsIncreasing utilisation of tapentadol sustained-release formulation was observed, along with indications of extra-medical use and harms associated with use, although on a smaller scale relative to other opioids. These findings need to be interpreted in the context of the low level of exposure to tapentadol sustained-release formulation among the sentinel population of people who inject drugs.

Tapentadol vs oxycodone/naloxone in the management of pain after total hip arthroplasty in the fast track setting: an observational study

BackgroundIn recent years, joint replacement surgery has gradually progressed towards the fast-track model, and early rehabilitation immediately after surgery is regarded fundamental for optimal recovery of function: the aim of the present study is to describe the efficacy in perioperative management of pain in patients undergoing total hip replacement surgery and treated with tapentadol or oxycodone/naloxone in combination with ketoprofene.MethodsSingle-center retrospective study on patients with moderate-severe pain, referred to total hip replacement. Patients received either tapentadol (100 mg/twice-daily post-surgery – treatment group) or oxycodone/naloxone (10 mg/5 mg post-surgery – control group) plus ketoprofen 100 mg/ twice daily. Supplemental analgesia (paracetamol 1 g or morphine 0,1 mg/kg sc) was provided if needed. Pain at rest and pain during movement were evaluated on a daily basis for 4 days post-op, after which patients were usually discharged. All adverse events were reported and compared between the two groups.Results106 patients were analyzed in the tapentadol group and compared to 105 patients treated with oxycodone/naloxone. Both pain intensity at rest and upon movement were significantly lower in the tapentadol group at all follow-up times (p < 0.001). Throughout T1-T4, supplemental analgesia was needed by significantly less tapentadol patients compared to the control group. Similarly, regarding side effects, a significantly higher occurrence of post-op nausea, vomit, itching and constipation was observed in the control group (p < 0.001 in all cases).ConclusionResults from the present study support the use of tapentadol in combination with ketoprofen for the management of moderate-severe pain in the setting of major orthopedic surgery, given its effectiveness in reducing pain intensity, and its satisfactory tolerance.