High prevalence of off-label and unlicensed paediatric prescribing in a hospital in Indonesia during the period Aug.-Oct. 2014.

BACKGROUND: Data on off-label and unlicensed prescribing in children in Indonesia is limited. The aims of this study were to determine the prevalence of off-label and unlicensed prescribing for paediatric patients in a public hospital, Indonesia. METHOD: A retrospective cross-sectional study of 200 randomly selected paediatric patients admitted to hospital between August and October 2014, collected patient details and all drugs prescribed. Licensed drugs were classified as off-label if there was a non-compliance with the Product Information for age, weight, indication, dose, frequency and route of administration, if there was a contraindication, special precautions or not recommended for children. Unlicensed drugs were those not approved for use in Indonesia. The main outcome was the prevalence of off-label or unlicensed prescribing to infants, children and adolescents and the impact of age group on off-label prescribing. RESULTS: A total of 200 patients received 1961 medicines of which 1807/1961 (92.1%) were licensed and 154/1961 (7.9%) were unlicensed. There were 1403/1961 (71.5%) drugs prescribed off-label. More than half of the total drugs (n = 1066; 54.4%) were administered parenterally. Every patient was prescribed at least one off-label drug. Indication (n = 810; 34.6%) was the most common reason for off-label prescribing. Ranitidine was the most frequent drug prescribed off label. Darplex® (dihydroartemisinin and piperaquine), although manufactured in Indonesia, was unlicensed. There was a significant difference between age group and off-label prescribing in that children were prescribed significantly less off-label drugs (p<0.0003). CONCLUSION: This study revealed a high prevalence of off-label and unlicensed drug use in paediatric patients in this hospital, exposing them to drug treatments or regimens that had not been approved by regulatory authorities. The high incidence of invasive parenteral prescribing is of concern for paediatric patients. Incentives are needed to encourage specific drug evaluation in paediatric populations.

'I just need an opiate refill to get me through the weekend'.

In this article, we discuss the ethical dimensions for the prescribing behaviours of opioids for a chronic pain patient, a scenario commonly witnessed by many physicians. The opioid epidemic in the USA and Canada is well known, existing since the late 1990s, and individuals are suffering and dying as a result of the easy availability of prescription opioids. More recently, this problem has been seen outside of North America affecting individuals at similar rates in Australia and Europe. We argue that physicians are also confronted with an ethical crisis where a capitalist-consumerist society is contributing to this opioid crisis in which societal, legal and business interests push physicians to overprescribe opioids. Individual physicians often find themselves unequipped and unsupported in attempts to curb the prescribing of opioid medications and balance competing goals of alleviating pain against the judicious use of pain medications. Physicians, individually and as a community, must reclaim the ethical mantle of our profession, through a more nuanced understanding of autonomy and beneficence. Furthermore, physicians and the medical community at large have a fiduciary duty to patients and society to play a more active role in curbing the widespread distribution of opioids in our communities.

Serious Ethical Violations in Medicine: A Statistical and Ethical Analysis of 280 Cases in the United States From 2008-2016.

Serious ethical violations in medicine, such as sexual abuse, criminal prescribing of opioids, and unnecessary surgeries, directly harm patients and undermine trust in the profession of medicine. We review the literature on violations in medicine and present an analysis of 280 cases. Nearly all cases involved repeated instances (97%) of intentional wrongdoing (99%), by males (95%) in nonacademic medical settings (95%), with oversight problems (89%) and a selfish motive such as financial gain or sex (90%). More than half of cases involved a wrongdoer with a suspected personality disorder or substance use disorder (51%). Despite clear patterns, no factors provide readily observable red flags, making prevention difficult. Early identification and intervention in cases requires significant policy shifts that prioritize the safety of patients over physician interests in privacy, fair processes, and proportionate disciplinary actions. We explore a series of 10 questions regarding policy, oversight, discipline, and education options. Satisfactory answers to these questions will require input from diverse stakeholders to help society negotiate effective and ethically balanced solutions.

Patterns and predictors of off-label prescription of psychiatric drugs.

Off-label prescribing of psychiatric drugs is common, despite lacking strong scientific evidence of efficacy and potentially increasing risk for adverse events. The goal of this study was to characterize prevalence of off-label prescriptions of psychiatric drugs and examine patient and clinician predictors of off-label use. This manuscript presents a retrospective, cross-sectional study using data from the 2012 and 2013 National Ambulatory Medical Care Surveys (NAMCS). The study examined all adult outpatient visits to psychiatric practices for chronic care management with a single listed visit diagnosis in which at least one psychiatric drug was prescribed. The main outcome measure was off-label prescribing of at least one psychiatric drug, defined as prescription for a condition for which it has not been approved for use by the FDA. Among our sample representative of 1.85 billion outpatient visits, 18.5 million (1.3%) visits were to psychiatrists for chronic care management in which at least one psychiatric drug was prescribed. Overall, the rate of off-label use was 12.9% (95% CI: 12.2-15.7). The most common off-label uses were for manic-depressive psychosis treated with citalopram and primary insomnia treated with trazodone. Several patient and clinician characteristics were positively associated with off-label prescribing, including seeing a psychiatrist (OR: 1.06, 95% CI, 1.01-1.12; p = 0.03) instead of another type of clinician, the office visit taking place in the Western region of the country (OR: 1.09, 95% CI, 1.01-1.17; p = 0.02), and the patient having 3 or more chronic conditions (OR: 1.12, 95% CI, 1.02-1.14; p = 0.003). In contrast, having Medicare coverage (OR: 0.93, 95% CI, 0.84-0.97; p = 0.04) and receiving payment assistance from a medical charity (OR: 0.91, 95% CI, 0.88-0.96; p = 0.03) instead of private insurance were negatively associated with off-label prescribing. These results suggest that certain classes of psychiatric medications are being commonly prescribed to treat conditions for which they have not been determined by the FDA to be clinically efficacious and/or safe.

Prevalence of Inappropriate Antibiotic Prescribing in Primary Care Clinics within a Veterans Affairs Health Care System.

Data are needed from outpatient settings to better inform antimicrobial stewardship. In this study, a random sample of outpatient antibiotic prescriptions by primary care providers (PCPs) at our health care system was reviewed and compared to consensus guidelines. Over 12 months, 3,880 acute antibiotic prescriptions were written by 76 PCPs caring for 40,734 patients (median panel, 600 patients; range, 33 to 1,547). PCPs ordered a median of 84 antibiotic prescriptions per 1,000 patients per year. Azithromycin (25.8%), amoxicillin-clavulanate (13.3%), doxycycline (12.4%), amoxicillin (11%), fluoroquinolones (11%), and trimethoprim-sulfamethoxazole (10.6%) were prescribed most commonly. Medical records corresponding to 300 prescriptions from 59 PCPs were analyzed in depth. The most common indications for these prescriptions were acute respiratory tract infection (28.3%), urinary tract infection (23%), skin and soft tissue infection (15.7%), and chronic obstructive pulmonary disease (COPD) exacerbation (6.3%). In 5.7% of cases, no reason for the prescription was listed. No antibiotic was indicated in 49.7% of cases. In 12.3% of cases, an antibiotic was indicated, but the prescribed agent was guideline discordant. In another 14% of cases, a guideline-concordant antibiotic was given for a guideline-discordant duration. Therefore, 76% of reviewed prescriptions were inappropriate. Ciprofloxacin and azithromycin were most likely to be prescribed inappropriately. A non-face-to-face encounter prompted 34% of prescriptions. The condition for which an antibiotic was prescribed was not listed in primary or secondary diagnosis codes in 54.5% of clinic visits. In conclusion, there is an enormous opportunity to reduce inappropriate outpatient antibiotic prescriptions.

Errors in Antibiotic Therapy: Study with Dentist's Prescriptions in a Large Brazilian City

Objective: To evaluate errors in dental prescriptions of antibiotics for therapeutic purpose. Material and Methods: This was a descriptive study using a random and calculated sample of 366 prescriptions (July1 2011 to June 30 2012), from a total of 31 105 dental prescriptions, was surveyed in an important drugstore chain in a large Brazilian city. Data was validated by double entry in Epi-data (EpiData Assoc, Odense M, Denmark) and then analysed in SPSS (version 19.0, Chicago, IL, USA). Statistical analyses included the calculation of proportions with a 95% confidence interval (CI). Results: We identified 272 prescriptions for therapeutic purpose. Prescription errors involved spelling of the antibiotic name, dose, dosing intervals and duration of treatment. A total of 116 prescriptions (42.6%; 95% CI 36.9%-48.6%) were considered to be totally correct with regard to the generic name, dose, dosing interval and duration of the antibiotic therapy. Most of the antibiotics prescribed by dentists showed errors related to the name, dose, intervals and duration of treatment. Conclusion: These errors may compromise the effectiveness of drug therapy, contribute to microbial resistance and increase the risk of adverse events and costs of treatment.

Deprescribing psychotropic medications in aged care facilities: the potential role of family members.

There is widespread concern in Australia and internationally at the high prevalence of psychotropic medication use in residential aged care facilities. It is difficult for nurses and general practitioners in aged care facilities to cease new residents' psychotropic medications when they often have no information about why residents were started on the treatment, when and by whom and with what result. Most existing interventions have had a limited and temporary effect and there is a need to test different strategies to overcome the structural and practical barriers to psychotropic medication cessation or deprescribing. In this chapter, we review the literature regarding psychotropic medication deprescribing in aged care facilities and present the protocol of a novel study that will examine the potential role of family members in facilitating deprescribing. This project will help determine if family members can contribute information that will prove useful to clinicians and thereby overcome one of the barriers to deprescribing medications whose harmful effects often outweigh their benefits. We wish to understand the knowledge and attitudes of family members regarding the prescribing and deprescribing of psychotropic medications to newly admitted residents of aged care facilities with a view to developing and testing a range of clinical interventions that will result in better, safer prescribing practices.

[A prudent deprescription model]. / Un modelo de deprescripción prudente.

The therapeutic structure of health systems relies heavily on medical prescription, which generates a marked tendency to add drugs to a patient's medical history. There is an absence of incentives for professionals to reassess prescriptions and withdraw those with a negative or neutral risk/benefit. This can create a deviation of medical resources to the maintenance of useless or even harmful treatments. Deprescribing, a process of thoughtful medication withdrawal that complements moderate prescribing, is aimed to stop this unfair deviation of resources towards non-beneficial, if not maleficent, prescription.

Correlates of inappropriate prescribing of antibiotics to patients with malaria in Uganda.

BACKGROUND: In many rural areas of Uganda, febrile patients presenting to health facilities are prescribed both antimalarials and antibiotics, contributing to the overuse of antibiotics. We identified the prevalence and correlates of inappropriate antibiotic management of patients with confirmed malaria. METHODS: We utilized individual outpatient data from 36 health centers from January to September 2011. We identified patients who were prescribed antibiotics without an appropriate clinical indication, as well as patients who were not prescribed antibiotics when treatment was clinically indicated. Multivariate logistic regression models were used to identify clinical and operational factors associated with inappropriate case management. FINDINGS: Of the 45,591 patients with parasitological diagnosis of malaria, 40,870 (90%) did not have a clinical indication for antibiotic treatment. Within this group, 17,152 (42%) were inappropriately prescribed antibiotics. The odds of inappropriate prescribing were higher if the patient was less than five years old (aOR 1.96, 95% CI 1.75-2.19) and if the health provider had the fewest years of training (aOR 1.86, 95% CI 1.05-3.29). The odds of inappropriate prescribing were lower if patients had emergency triage status (aOR 0.75, 95% CI 0.59-0.96) or were HIV positive (aOR 0.31, 95% CI 0.20-0.45). Of the 4,721 (10%) patients with clinical indications for antibiotic treatment, 521 (11%) were inappropriately not prescribed antibiotics. Clinical officers were less likely than medical officers to inappropriately withhold antibiotics (aOR 0.54, 95% CI 0.29-0.98). CONCLUSION: Over 40% of the antibiotic treatment in malaria positive patients is prescribed despite a lack of documented clinical indication. In addition, over 10% of patients with malaria and a clinical indication for antibiotics do not receive them. These findings should inform facility-level trainings and interventions to optimize patient care and slow trends of rising antibiotic resistance.

Frailty: a key indicator to minimize inappropriate medication in older people.

Older populations are more likely to have multiple co-morbid diseases that require multiple treatments, which make them a large consumer of medications. As a person grows older, their ability to tolerate medications becomes less due to age-related changes in pharmacokinetics and pharmacodynamics often heading along a path that leads to frailty. Frail older persons often have multiple co-morbidities with signs of impairment in activities of daily living. Prescribing drugs for these vulnerable individuals is difficult and is a potentially unsafe activity. Inappropriate prescribing in older population can be detected using explicit (criterion-based) or implicit (judgment-based) criteria. Unfortunately, most current therapeutic guidelines are applicable only to healthy older adults and cannot be generalized to frail patients. These discrepancies should be addressed either by developing new criteria or by refining the existing tools for frail older people. The first and foremost step is to identify the frail patient in clinical practice by applying clinically validated tools. Once the frail patient has been identified, there is a need for specific measures or criteria to assess appropriateness of therapy that consider such factors as quality of life, functional status and remaining life expectancy and thus modified goals of care.

Antibiotic use and resistance: perceptions and ethical challenges among doctors, pharmacists and the public in Vellore, South India.

Inappropriate antibiotic use and resistance are major public health challenges. Interventional strategies require ascertaining the perceptions of major stakeholders and documenting the challenges to changing practice. Towards this aim, a qualitative study was conducted in Vellore, South India, using focus group discussions among doctors, pharmacists and public. There were eight groups with six to eight participants each. The themes explored were: understanding of infections, antibiotics and resistance; practices and pressure driving antibiotic use; and strategies for appropriate use. Data were transcribed, analysed, verified and a summary prepared with salient features and quotations. It was found that the public had minimal awareness of resistance, antibiotics and infections. They wanted symptomatic relief. Doctors reported prescribing antibiotics for perceived patient expectations and quick recovery. Business concerns contributed to antibiotics sales among pharmacists. Pharmaceutical industry incentives and healthcare provider competition were the main ethical challenges. Suggested interventional strategies by the participants included creating public awareness, better healthcare provider communication, improved diagnostic support, strict implementation of guidelines, continuing education, and strengthening of regulations. Perceived patient benefit, unrestricted autonomy and business-cum-industry pressures are promoting inappropriate use of antibiotics. Strategies improving responsible use will help preserve their effectiveness, and provide distributive justice and benefit for future generations.

Controlling pain and reducing misuse of opioids: ethical considerations.

OBJECTIVE: To help family physicians achieve an ethical balance in their opioid prescribing practices. QUALITY OF EVIDENCE: MEDLINE was searched for English-language articles published between 1985 and 2011. Most available evidence was level III. MAIN MESSAGE: It is essential to follow practice guidelines when prescribing opioids, except when another course of action is demonstrably justified. In addition, when considering the appropriateness of an opioid prescription, with its many ethical implications, the decision can be usefully guided by the application of the ethical principles of beneficence, nonmaleficence, respect for autonomy, and justice. As well, it is essential to keep current about legal and regulatory changes and provincial electronic registries of opioid prescriptions. CONCLUSION: Physicians need to ensure that their patients' pain is properly assessed and managed. Reaching optimal pain control might necessitate prescribing opioids. But the obligation to provide pain relief needs to be balanced with an equally important responsibility not to expose patients to risk of addiction and not to create opportunities for drug diversion, trafficking, and the addiction of others. Basic ethical principles can provide a framework to help physicians make ethically appropriate decisions about opioid prescribing.