Research Ethics in Behavioral Interventions Among Special Populations: Lessons From the Peer Approaches to Lupus Self-Management Study.

BACKGROUND: Research involving a homogenous cohort of participants belonging to a special population must make considerations to recruit and protect the subjects. This study analyses the ethical considerations made in the peer approaches to lupus self-management project which pilot tested a peer mentoring intervention for African American women with systemic lupus erythematosus. METHODS: Considerations made at the outset of the project are described and their justifications and reasoning are given. Through analysis of feedback from a postintervention focus group and mentors' logs, implications on program outcomes and participant satisfaction are discussed. RESULTS: Feedback indicated the importance of recruiting and training capable mentors, consistent contact from study staff to avert adverse events and avert fear or mistrust and careful consideration that must go into the pairing of mentors and mentees. Participant feedback also indicated that sensitive topics must be addressed carefully to prevent distress and dissatisfaction. CONCLUSIONS: Applying the lessons learned from this work as well as the considerations that proved successful may improve the contextualization and ethical conduct of behavioral interventions in special populations resulting in improved tailoring and acceptability toward historically underserved individuals.

The implications of methylphenidate use by healthy medical students and doctors in South Africa.

BACKGROUND: The use of medical stimulants to sustain attention, augment memory and enhance intellectual capacity is increasing in society. The use of Methylphenidate for cognitive enhancement is a subject that has received much attention in the literature and academic circles in recent times globally. Medical doctors and medical students appear to be equally involved in the off-label use of Methylphenidate. This presents a potential harm to society and the individual as the long-term side effect profile of this medication is unknown. DISCUSSION: The implication of the use of Methylphenidate by medical students and doctors has not been fully explored. This article considers the impact of this use on the traditional role of medicine, society, the patient and suggests a way forward. We discuss the salient philosophy surrounding the use of cognitive enhancement. We query whether there are cognitive benefits to the use of Methylphenidate in healthy students and doctors and whether these benefits would outweigh the risks in taking the medication. Could these benefits lead to tangible outcomes for society and could the off label-use of Methylphenidate potentially undermine the medical profession and the treatment of patients? If cognitive benefits are proven then doctors may be coerced explicitly or implicitly to use the drug which may undermine their autonomy. The increased appeal of cognitive enhancement challenges the traditional role of medicine in society, and calls into question the role of a virtuous life as a contributing factor for achievement. In countries with vast economic disparity such as South Africa an enhancement of personal utility that can be bought may lead to greater inequities. SUMMARY: Under the status quo the distribution of methylphenidate is unjust. Regulatory governmental policy must seek to remedy this while minimising the potential for competitive advantage for the enhanced. Public debate on the use of cognitive enhancement is long overdue and must be stimulated. The use of Methylphenidate for cognitive enhancement is philosophically defendable if long-term research can prove that the risks are negligible and the outcomes tangible.

Three arguments against prescription requirements.

In this essay, I argue that prescription drug laws violate patients' rights to self-medication. Patients have rights to self-medication for the same reasons they have rights to refuse medical treatment according to the doctrine of informed consent (DIC). Since we should accept the DIC, we ought to reject paternalistic prohibitions of prescription drugs and respect the right of self-medication. In section 1, I frame the puzzle of self-medication; why don't the same considerations that tell in favour of informed consent also justify a right of self-medication? In section 2, I show that the prescription drug system was historically motivated by paternalism. In section 3, I outline the justifications for the DIC in more detail. I show that consequentialist, epistemic, and deontic considerations justify the DIC. In sections 4-6, I argue that these considerations also justify rights of self-medication. I then propose that rights of self-medication require non-prohibitive prescription policies in section 7. I consider two objections in sections 8 and 9: that patients ought not to make medically risky or deadly decisions, and that unrestricted access to prescription-grade pharmaceuticals would result in widespread misuse and abuse. Section 10 concludes.

Irrational use of antibiotics and role of the pharmacist: an insight from a qualitative study in New Delhi, India.

WHAT IS KNOWN AND OBJECTIVE: The overall volume of antibiotic consumption in the community is one of the foremost causes of antimicrobial resistance. In developing countries like India, pharmacists often dispense 'prescription-only' drugs, like antibiotics, to patients who do not have a prescription. Not much data is available regarding detailed information on behaviour of antibiotic use by community pharmacists which is of particular significance to develop a suitable and sustainable intervention programme to promote rational use of antibiotics. A qualitative study was conducted to understand the dispensing practices and behaviour of community pharmacists to develop policy interventions that would improve the use of antibiotics at the community level. METHODS: Focus group discussions (FGDs) were held for five municipal wards of Delhi with retail pharmacists, public sector pharmacists and the office bearers of pharmacists' associations. Data on antibiotic use and resistance were collected earlier from these five wards. FGDs (n = 3 with 40 pharmacists) were analysed through grounded theory. RESULTS AND DISCUSSION: Four broad themes identified were as follows: prescribing and dispensing behaviour; commercial interests; advisory role; and intervention strategies for rational use of antibiotics. FGDs with pharmacists working in the public sector revealed that, besides the factors listed above, overstock and near-expiry, and under-supply of antibiotics promoted antibiotic misuse. Suggestions for interventions from pharmacists were the following: (i) education to increase awareness of rational use and resistance to antibiotics; (ii) involving pharmacists as partners for creating awareness among communities for rational use and resistance to antibiotics; (iii) developing an easy return policy for near-expiry antibiotics in public sector facilities; and (iv) motivating and showing appreciation for community pharmacists who participate in intervention programmes. WHAT IS NEW AND CONCLUSIONS: Inappropriate antibiotic dispensing and use owing to commercial interests and lack of knowledge about the rational use of antibiotics and antibiotic resistance were the main findings of this in-depth qualitative study. Community pharmacists were willing to participate in educational programme aimed at improving use of antibiotics. Such programmes should be initiated within a multidisciplinary framework including doctors, pharmacists, social scientists, government agencies and non-profit organizations.