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.
LABELING AND EFFECTIVENESS TESTING; SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE. FINAL RULE.
Summary: The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the-counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. The FDA received nearly 2,900 submissions in response to the sunscreen 2007 proposed rule. The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application, and requires OTC sunscreen products to comply with the content and format requirements for OTC drug labelling contained in the 1999 Drug Facts final rule.
OVER-THE-COUNTER LAXATIVE POLYETHYLENE GLYCOL 3350: AN EVIDENCE-BASED APPRAISAL.
By: EG Zurad, JF Johanson.
Summary: A review of of chronic constipation and the role played in its treatment by laxatives in general and by polyethylene glycol 3350 in particular. Constipation, often defined differently by patients and physicians, is typically associated with excessive straining, hard stools, infrequent bowel movements, and sensations of incomplete evacuation. This review concludes that polyethylene glycol 3350, an osmotic laxative available over the counter, has been shown to be safe and effective in treating chronic constipation in children and adults, including the elderly, across multiple clinical trials, with a safety profile comparable to that of placebo. Polyethylene glycol 3350 received a grade A recommendation for improving stool frequency and consistency from the American College of Gastroenterology Task Force on Chronic Constipation.
ACUTE SORE THROAT REVISITED: CLINICAL AND EXPERIMENTAL EVIDENCE FOR THE EFFICACY OF OVER-THE-COUNTER AMC/DCBA THROAT LOZENGES.
By: JS Oxford, M Leuwer.
Summary: The recent human influenza (H1N1 virus) pandemic has exposed the central role of sore throat in the basic clinical presentation of the disease. ‘Acute sore throat’ is a term often used to describe pharyngitis, tonsillitis and laryngitis that occur for a short period of time. On average, regardless of a pandemic influenza year, an adult may experience 2-3 sore throats over a period of 12 months, whereas children are more susceptible and are likely to experience more sore throat episodes because of their immune naivety. Following the recent flu season in the UK, it would appear to be an opportune time to revisit the role of self-prescribed sore throat remedies that, alongside NHS Direct in the United Kingdom (UK), can alleviate pressures on general practitioners. Most cases of acute sore throat resulting from upper respiratory tract infections (URTIs), caused by a range of viruses, are generally not serious and are self-limiting, usually improving within 1 week.
EMERGENCY CONTRACEPTION IN AUSTRALIAN COMMUNITY PHARMACIES: A SIMULATED PATIENT STUDY.
By: K Queddeng, B Chaar, K Williams.
Summary: Australia joined the worldwide movement to increase the availability of the emergency contraceptive pill (ECP) by rescheduling from Prescription to Pharmacist Only status in 2004. However a protocol developed to aid in the provision of the ECP placed extensive requirements on the pharmacist. This study investigated the provision of the ECP by community pharmacists in Sydney, Australia. The ECP was supplied in 95% of the 100 community pharmacies visited. Patient privacy was observed in 90% of consultations, which in general were succinct and friendly. Clinical assessment of the patient that met all the requirements was observed in 18%, partial assessment in 69%, and inadequate assessment in 13% of consultations. Provision of required information to the patient was sufficient in 42%, partial in 55%, and inadequate in 3% of consultations. This study highlighted a need to standardize procedures in regard to the ECP service to present a more consistent level of service to the public.
PROVISION OF THE EMERGENCY CONTRACEPTIVE PILL WITHOUT PRESCRIPTION: ATTITUDES AND PRACTICES OF PHARMACISTS IN AUSTRALIA.
By: SY Hussainy, K Stewart, CB Chapman, AJ Taft et al.
Summary: As 5 years have elapsed since the emergency contraceptive pill (ECP) was made available without prescription in Australia, information was sought about the current attitudes and practices of pharmacists in relation to their increased role in ECP provision through a mail survey of 750 pharmacies during 2008-9. Response rate was 29%. Most pharmacists used a protocol to guide ECP dispensing (77.3%) and the majority had declined ECP provision (75.1%) in certain circumstances. Many usually counselled where confidentiality could be assured (62.8%), and agreed that it is a pharmacist’s role to counsel on regular contraception (81.9%). Factors significantly associated (p <= .05) with dispensing practices included pharmacists’ attitudes towards acceptability of advance prescription, their age, gender and pharmacy accessibility. Overall pharmacists had stronger, more conservative attitudes than overseas pharmacists; however, the issues that emerged were similar to those reported overseas. To address these, revised training for local pharmacists is recommended.
PARENTS’ DECISION FOLLOWING THE FOOD AND DRUG ADMINISTRATION RECOMMENDATION: THE CASE OF OVER-THE-COUNTER COUGH AND COLD MEDICATION.
By: Y Hanoch, M Gummerum, ST Miron, M Himmelstein.
Summary: In 2007, the FDA recommended against parents administering over-the-counter cough and cold medications (OTC-CCM) to children under 2 years of age because serious and potentially life-threatening side effects can occur. This study examined the impact of FDA’s recommendations against giving children under 2 years old OTC-CCM. About33% of our sample of parents had never heard of the FDA recommendations. Of those who were aware, 32.9% intended to continue administering OTC-CCM, and another 36.7% were not sure what to do. Parents’ confidence in the FDA recommendations predicted whether they would continue or stop administering OTC-CCM to their children.
THE MINI-WRIGHT PEAK FLOW METER: A MONITORING DEVICE FOR THE SELF- MANAGEMENT OF ASTHMA.
By: N A Zimmermann.
Summary: Peak flow meters are portable devices used for measuring peak expiratory flow and monitoring asthma symptoms. The Mini-Wright Peak Flow Meter, first developed in the 1950s, is widely accepted because of its accuracy, affordability, and portability.
NON-PRESCRIPTION MEDICINES AND AUSTRALIAN COMMUNITY PHARMACY INTERVENTIONS: RATES AND CLINICAL SIGNIFICANCE.
By: KA Williams, LM Emmerton, R Taylor, J Werner, IS Benrimoj.
Summary: This study was conducted to quantify pharmacy intervention rates for non-prescription medications, to document the clinical significance of these interventions, and to determine the adverse health consequences and subsequent health care avoided as a result of the interventions, recorded in two field studies. The rate of professional intervention for pharmacist-only and pharmacy medicines is 5.66 per 1000 unit sales. The main impact of the interventions was avoidance of urgent general practitioner (GP) visits, followed by avoidance of regular GP visits and accident and emergency treatment. The most common adverse health consequences avoided were exacerbations of an existing condition (e.g. hypertension, asthma) and adverse drug effects. This study demonstrates the way in which community pharmacy encourages appropriate non-prescription medicine use and prevents harm through intervening at the point of supply.
DEVELOPING CONSUMER-CENTERED, NONPRESCRIPTION DRUG LABELING: A STUDY IN ACETAMINOPHEN.
By: JP King, TC Davis, SC Bailey, KL Jacobson, et al.
Summary: In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely to be poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage. This study elicited subject feedback about active ingredient and dosing information on over-the-counter (OTC) acetaminophen feedback, on proposed plain-language text and icons, using focus groups. Individual interviews revealed that <50% of participants routinely examine product label information. Only 31% know acetaminophen is in Tylenol. The groups achieved consensus on a preferred icon for acetaminophen, desired explicit statement of potential liver damage in the warning against simultaneous use of acetaminophen products, and indicated preference for an icon and wording for maximum dose.