Every week, we will provide a brief summary and a link to the published abstract of newly published papers selected from the worldwide literature as being of particular interest to the SelfCare community.
IMPROVING THE DECISION-MAKING PROCESS FOR NONPRESCRIPTION DRUGS: A FRAMEWORK FOR BENEFIT-RISK ASSESSMENT.
By: EP Brass, R Lofstedt, O Renn.
Clinical Pharmacology and Therapeutics; 2011 December, 90(6): 791-803
Summary: Barriers to access are lower for nonprescription drugs than with prescription drugs and may permit additional consumers to obtain effective drugs, but in the absence of supervision by a health-care professional may result in unacceptable rates of misuse and suboptimal clinical outcomes. A value-tree method is proposed that defines important benefit and risk domains relevant to nonprescription drugs. This value tree can be used to comprehensively identify product-specific attributes in each domain and can also support formal benefit-risk assessment using a variety of tools. This is illustrated here, using a modification of the International Risk Governance Council (IRGC) framework, a flexible tool previously applied in a number of fields, which systematizes an approach to issue review, early alignment of stakeholders, evaluation, and risk mitigation/management. The proposed approach has the potential to provide structured, transparent tools for regulatory decision making for nonprescription drugs.
OVER-THE-COUNTER NICOTINE REPLACEMENT THERAPY FOR EVERYONE: IS IT THE BEST SOLUTION?
By: P Dome.
Medical Hypotheses 2011 December, 77(6):1048-1050
Summary: The persistent use of different forms of nicotine replacement therapy (NRT) is an under-investigated issue in medical research. While the data concerning the proportion of long-term users in the population of total NRT users seems reassuring at first glance, we must recognize that the small relative numbers (proportions) conceal a population of persistent NRT users with a considerable absolute number of members. Furthermore, only a small amount of data is available concerning the safety of persistent NRT use. Consequently, there is a need to conduct large-scale studies with the primary aim of monitoring for misuse of OTC NRT and assessing the possible physical and mental health risks of persistent NRT use.
CHARACTERISTICS OF A NONTREATMENT-SEEKING SAMPLE OF OVER-THE-COUNTER CODEINE USERS: IMPLICATIONS FOR INTERVENTION AND PREVENTION.
By: S Nielsen, J Cameron, N Lee.
Journal of Opioid Management; 2011 September-October, 7(5):363-370
Summary: Recently, there has been considerable policy and public interest in the availability of over-the-counter (OTC) codeine. This study was to better understand who develops problematic use of OTC codeine using a web-based survey with 800 people who self-reported OTC codeine use. Compared with nondependent codeine users, codeine-dependent people were younger, had lower levels of employment and education, and were more likely to report family history of substance dependence. They were more likely to have taken well above recommended doses of OTC codeine and have taken codeine for considerably longer periods of time than recommended. Implications for pharmacists and other health professionals are discussed.
AN OVER-THE-COUNTER MOISTURIZER IS AS CLINICALLY EFFECTIVE AS, AND MORE COST-EFFECTIVE THAN, PRESCRIPTION BARRIER CREAMS IN THE TREATMENT OF CHILDREN WITH MILD-TO-MODERATE ATOPIC DERMATITIS: A RANDOMIZED, CONTROLLED TRIAL.
By: DW Miller, SB Koch, BA Yentzer et al.
Journal of Drugs in Dermatology : 2011 May, 10(5):531-7
Summary: Atopic dermatitis (AD) is a prevalent skin disorder with significant cost of treatment. Several prescription device moisturizers have been approved by the FDA to treat AD but are significantly more expensive than well-crafted over-the-counter (OTC) moisturizers. The purpose of this study is to compare the clinical efficacy and cost-efficacy of a glycyrrhetinic acid-containing barrier repair cream (BRC-Gly, Atopiclair®), a ceramide-dominant barrier repair cream (BRC-Cer, EpiCeram®) and an OTC petroleum-based skin protectant moisturizer (OTC-Pet, Aquaphor Healing Ointment®) as monotherapy for mild-to-moderate AD in children. OTC-Pet is as effective in treating mild-to-moderate AD as both BRC-Gly and BRC-Cer and is at least 47 times more cost- effective.
NON-PRESCRIPTION ANTIMICROBIAL USE WORLDWIDE: A SYSTEMATIC REVIEW.
By: DJ Morgan, IN Okeke, R Laxminarayan et al.
The Lancet infectious diseases, 2011 Sep, 11(9):692-701
Summary: In much of the world antimicrobial drugs are sold without prescription or oversight by health-care professionals. The scale and effect of this practice is unknown. This study systematically reviewed published works about non-prescription antimicrobials from 1970-2009, identifying 117 relevant articles. Non-prescription use occurred worldwide and accounted for 19-100% of antimicrobial use outside of northern Europe and North America. Safety issues associated with non-prescription use included adverse drug reactions and masking of underlying infectious processes. Non- prescription use was common for non-bacterial disease, and antituberculosis drugs were available in many areas. Antimicrobial- resistant bacteria are common in communities with frequent non- prescription use. In a few settings, control efforts that included regulation decreased antimicrobial use and resistance. Non- prescription antimicrobial and antituberculosis use is common outside of North America and northern Europe and must be accounted for in public health efforts to reduce antimicrobial resistance.