Search

Christian Kunow, Bernhard Langer Department of Health, Nursing, Management, University of Applied Sciences Neubrandenburg, Neubrandenburg, GermanyCorrespondence: Bernhard LangerDepartment of Health, Nursing, Management, University of Applied Sciences Neubrandenburg, Brodaer Straße 2, Neubrandenburg, 17033, GermanyTel +49 395 5693-3107Fax +49 395 5693-73107Email langer@hs-nb.deBackground: In Germany, over-the-counter (OTC) medicines for self-medication may only be dispensed by community pharmacies (CPs). From the customer’s point of view, “adequate” counseling includes not only the recommendation of medicines that meet guidelines, but ao the dispensing of low-priced medicines. This is all the more important in Germany against the background of free pricing and a lack of obligation to display prices. The aim was to analyze the dispensing and possible price variability of OTC medicines for headache.Methods: The cross-sectional design of the study based on the simulated patient methodology (SPM) included all 42 CPs of the German big city Potsdam and used eight trained simulated patients (SPs). Between October and December 2020, four different SPs visited each CP four times with two almost identical scenarios with the demand for a medicine for headache.Results: All 168 planned visits were successfully completed and ibuprofen (60.1%) was dispensed most frequently. Across all dispensed medicines, prices varied from € 0.93 to € 9.97 (∆ 972%; median € 3.46 [interquartile range (IQR) € 2.25]). For repeated dispensing of the same CPs, the price variability was a maximum of € 8.77. In addition, packs with ≤ 10 tablets were dispensed in 47.6%, with 11 to 20 tablets in 50.6%, and with > 20 tablets in 1.8% of visits.Conclusion: Increasing price transparency and strengthening price competition could make it easier for customers to access OTC medicines according to their personal needs.Keywords: pricing, dispensing, OTC medicines, headache, community pharmacies, simulated patient

Background: The sale of over-the-counter (OTC) medicines from pharmacies can help individuals self-manage symptoms. However, some OTC medicines may be abused, with addiction and harms being increasingly recognised. This review describes the current knowledge and understanding of OTC medicine abuse. Approach: Comprehensive search of international empirical and review literature between 1990 and 2011. Findings: OTC medicine abuse was identified in many countries and although implicated products varied, five key groups emerged: codeine-based (especially compound analgesic) medicines, cough products (particularly dextromethorphan), sedative antihistamines, decongestants and laxatives. No clear patterns relating to those affected or their experiences were identified and they may represent a hard-to-reach group, which coupled with heterogeneous data, makes estimating the scale of abuse problematic. Associated harms included direct physiological or psychological harm (e.g. opiate addiction), harm from another ingredient (e.g. ibuprofen-related gastric bleeding) and associated social and economic problems. Strategies and interventions included limiting supplies, raising public and professional awareness and using existing services and Internet support groups, although associated evaluations were lacking. Terminological variations were identified. Conclusions: OTC medicine abuse is a recognised problem internationally but is currently incompletely understood. Research is needed to quantify scale of abuse, evaluate interventions and capture individual experiences, to inform policy, regulation and interventions.

As part of the FDA's current review of its regulatory approach to nonprescription medicines, it is necessary for stakeholders to contribute to the ongoing discourse. Reclassification of prescription medicines to over-the-counter status is an important topic attracting the attention of many in the United States and elsewhere. This article presents a detailed examination of FDA's application of switch regulatory policy, the use of innovative consumer communication and education tools in the OTC environment and overall public health impact of the switch using the Nicorette case as an example. Post switch evidence shows that OTC reclassification of Nicorette achieved the anticipated goal of balancing increased access with decreased control in the OTC atmosphere resulting in a positive public health outcome in the area of smoking control.

The first part of this investigation developed and described quantitative answers to questions that FDA has posed through the administration of an electronic survey questionnaire. The goal of this part was to qualitatively probe these issues further by conducting telephone interviews with key opinion leaders in the United States, Canada, the United Kingdom and Australia. This study aimed to extend the earlier effort and gain additional insight into issues described above and explored the opinions of thirty six key opinion leaders and stakeholders in the area of OTC medicines regulation from the United States, United Kingdom, Australia, and Canada. Results suggest that potential improvements to the US regulatory framework can include creation of an intermediate, pharmacist-controlled class of OTC medicines, delineation of data requirements in a guidance document to support a switch petition, regulation of nontraditional medicines (dietary supplements and nutraceuticals) also as per current OTC stan...

Objectives: To determine the strategies used by GPs to make medicines, both prescribed and over-the-counter (OTC), cheaper for patients when deciding whether, and what, to prescribe.Method: Five focus groups were conducted in three Health Authorities in the Northwest of England. Between 10 and 11 GPs participated in each group.Results: GPs used a wide range of strategies to try to make medicines either cheaper for patients or to increase their perceived value for money. These strategies included using the prescription charge system to the patient's best advantage, by recommending the purchase of an OTC medicine or increasing the amount of medicine supplied. They could also prescribe more effectively by reducing the number of prescribed items or prescribing a medicine perceived to be more efficacious and more expensive to the healthcare system, to paying patients. Respondents also mentioned questionable practices such as re-using returned medication and prescribing more for a family member that was exempt ...

Abuse of over-the-counter (OTC) medicines is an under-researched and neglected area within the field of substance abuse. The aim of this paper is to raise awareness of the issues surrounding this subject. The paucity of research makes it difficult to comment conclusively on the problem, but studies based on pharmacist perceptions indicate that middle-aged females are particularly affected by OTC medication abuse. The most problematic of the OTC medicines is currently perceived to be Nytolr`, the brand name for the sedative antihistamine diphenhydramine, and which is marketed as a sleep aid. Diphenhydramine is used as a case study to illustrate the type of drugs available OTC and the potentially harmful problems that can arise as a consequence of their unregulated use and supply.