From prescription-only to over-the-counter medicines ('PoM to P'): time for an intermediate category.

BACKGROUND: Increasing numbers of medicines are being made available over the counter in the UK, by purchase in a pharmacy or from other less well-regulated outlets. When this is allowed by the Licensing Authority, it is often subject to certain restrictions. However, some drugs that could usefully be converted from prescription-only medicines (PoM status) to over-the-counter sales in a pharmacy (P status) are not suitable for full over-the-counter status, even with restrictions; and in some cases restrictions vitiate the usefulness of the medicine. AREAS OF AGREEMENT: Drugs that can acceptably be switched from PoM status to P status include those that are used in the treatment of minor ailments or injuries, for health promotion or in palliative care. AREAS OF CONTROVERSY: However, not all drugs that are being switched fall into these categories. Ready availability of antimicrobial drugs over the counter, one of which (azithromycin) has recently been switched, could encourage the emergence of resistant organisms. Drugs that are used for long-term treatment and lifestyle drugs are also controversial, particularly if their adverse effects are of potential concern. On the other hand, the availability of many drugs via the internet removes the ability of regulators to control the supply of such drugs. A POSSIBLE SOLUTION: A new category of purchase, Pharmacist Consultation and Supply, with built-in safeguards, could improve the availability of some medicines under more careful control than is currently available for over-the-counter medicines.

Should sildenafil be available over the counter?

INTRODUCTION: This article considers the process of re-classification of prescription drugs from prescription-only medications to over-the-counter (OTC) prescription drugs. SOURCES OF DATA: The recent change in classification for emergency contraception and simvastatin is explored in detail with similarities and differences being considered for a similar argument to be made for sildenafil. AREAS OF AGREEMENT: The benefits for patients, physicians and other healthcare professionals are considered in detail. AREAS OF CONTROVERSY: We raise concerns about recently developed and existing patient group directions that, although extensive in their assessment, may omit to identify significant contributory factors which would necessitate appropriate medical intervention. GROWING POINTS: While the decision for re-classification to OTC would depend on a number of factors, we argue that, with the proviso of proper assessments being made, sildenafil should be made available as an OTC medication. AREAS TIMELY FOR DEVELOPING RESEARCH: The safety and use of OTC medications for erectile dysfunction at a time when many first line prescription agents are reaching generic status.

[Drug counterfeiting--the risk to the public health]. / Podrabianie leków--zagroienie dia zdrowia publicznego.

UNLABELLED: Pharmaceutical counterfeiting and purchasing medicines from illegal distribution channels have become more and more common problem in our country. Different medicines, especially erectile dysfunction drugs are involved. The aim of this study was the qualitative analysis of fake Levitra tablets and the estimation of the risk they bear to potential users. Tablets were secured by the police and delivered to Bayer office in 2006. RESULTS: Trace amount of sildenafil (the active ingredient of Viagra) and not vardenafil (the active ingredient of Levitra) was found in tablets described as "Levitra" (vardenafil). The presence of this substance was discovered by NIR--and Raman spectroscopy. The appearance of tablets and blisters corresponded to the original product. There were no paper boxes and patient information leaflets attached. As prescription medicines erectile dysfunction drugs should be purchased from a pharmacy only. They need to be used under strict medical control.

Challenges in the assessment of erectile dysfunction and treatment with oral therapies: review with case examples.

PURPOSE: To review the clinical dimensions, etiology, assessment, and treatment of erectile dysfunction (ED) and to increase awareness of oral therapies for this condition. DATA SOURCES: Scientific literature, consensus guidelines, and manufacturers' product information and guidelines. CONCLUSIONS: A prevalent condition, particularly in middle-aged and elderly men, ED is vastly underreported and undertreated. Oral therapies, including phosphodiesterase type 5 inhibitors, are effective and well tolerated in many patients and represent potential first-line treatments for ED. IMPLICATIONS FOR PRACTICE: ED has been associated with both life-threatening illnesses and reduced quality of life. Improving recognition and treatment of this condition and counseling patients about ED represent important clinical opportunities. A broad and expanding array of ED treatments enable therapy to be individualized to the needs of patients and their partners.