[Drug Information Provided to Patients and Public-Present Regulatory Status and Future Prospects].

When taking a drug one must keep in mind certain risks and benefits based on the safety and efficacy information. One of the most reliable sources of information that enables patients to use drugs properly is package inserts, which are regulated under the law and therefore should include valid and accurate contents. With the recent revision of the Pharmaceutical and Medical Device Act, the information contained in the package insert, which was provided together with the drug, will now also be provided electronically and separately from the drug itself. In addition, a digital code will be displayed on the product packaging so that the latest information of the drug can be obtained from outside the package by scanning the code. The more drug information gets shared among healthcare professionals, patients and the public, the less the asymmetry in drug information among them will exist. It is necessary now more than ever to establish a framework and a system to ensure that sufficient information is provided to patients and the public to encourage their proper use of drugs. I believe that it is important for patients and the public to strive for a better understanding of drug information. It is also crucial for all relevant parties involved in drug information to work together on how best to utilize the information. In this way they would keep trying so that therapeutic effects could be maximized and the risks of side effects are minimized.

Changes in Legal Aspects of Public Education about Drugs and Their Importance.

Requirements for education on proper use of drugs were included in the junior high school educational guideline in 2012 incorporating pharmaceutical education in the obligatory school curriculum. This move is closely related to the country's new OTC drug marketing system. The amendment of the Pharmaceutical Affairs Law (PAL) in 2013 highlighted the public's own role in "promoting proper use of drugs and other related products and making greater efforts to acquire knowledge and improve understanding of their effective and safe use". Furthermore, the Law to Amend the PAL and Pharmacists Law enforced in 2014 allowed all OTC drugs to be sold online under appropriate rules. Deregulation of online sale of OTC drugs is expected further to promote self-medication for minor illnesses and require stricter measures to ensure people's safety through their proper use. These legal amendments in recent years have made people's education about proper use of drugs one of the top priorities Japan should pursue at state level. Since 2000, the author has been offering education on drugs to early primary school children as part of their healthcare education program. In the future, dedicated education on drugs will be necessary for people of all ages including not only school children but also their guardians and elderly citizens as well.

Physicians prefer greater detail in the biosimilar label (SmPC) - Results of a survey across seven European countries.

In the European Union, labels (Summaries of Product Characteristics, SmPCs) of biosimilars and their reference products are in many instances almost identical (following a generic approach) despite different data requirements for the authorization of biosimilars and generics. To understand physicians' preferences on type and detail of information in the biosimilar label and their use of information sources when prescribing biologics including biosimilars, EuropaBio surveyed 210 physicians across seven European countries. Among surveyed physicians, 90.5% use the label frequently or occasionally as an information source and 87.2% deemed a clear statement on the origin of data helpful or very helpful. When comparing excerpts from the label of an authorized biosimilar and modified texts with additional information, 78.1-82.9% preferred the samples with additional information. This survey shows that the label is an appropriate vehicle for providing physicians with information about biologics and that physicians prefer more product-specific information in the biosimilar label.

Usage of unpublished paediatric data.

The European Paediatric Regulation (EC No 1901/2006) has three main objectives: increasing the number of appropriate medicines for children, increasing information on these medicines and stimulating high-quality ethical research with children. To contribute to the information, pharmaceutical companies were required under article 45 of the Regulation to submit existing paediatric studies to regulatory authorities for review and update of the product information. Nearly, 19 000 study reports have been identified for a thousand active substances. The data are being assessed by member states' competent authorities in collaboration with European Medicines Agency (EMA). After 7 years, 262 active substances have been assessed, all of the 62 centrally approved and nearly 200 nationally approved medicines. The review so far has led to 16 new paediatric indications, of importance in addressing previously unmet needs, in particular, in younger age groups. The information is being made publicly available in an EMA database accessible directly or through the public face of the European Clinical Trials Register. This will increase awareness of existing data that are useful to researchers and other healthcare professionals, and contribute to avoiding unnecessary duplication of paediatric trials.

Regulating drug information in Europe: a pyrrhic victory for pharmaceutical industry critics?

Informed by recent sociological debates on pharmaceuticalisation, this article examines the evolution of the current EU legal proposal on prescription drug information to patients, as well as the surrounding controversies. In 2008 the European Commission proposed the relaxation of the existing rules governing drug information provision to patients by the pharmaceutical industry. Critics of the industry's influence over health policy and markets, including consumer organisations, industry-independent patient organisations and health professionals, rejected the Commission's proposal, claiming that the industry cannot be considered a reliable source of patient information due to inherent financial conflicts of interest. Since these critics were at least partially successful in rallying opinion against the Commission proposal, they functioned as countervailing forces to promotion-driven pharmaceuticalisation. Even so, as a watered-down version of the proposal moved through the European Parliament it was further modified to ultimately resemble the Swedish system that was held up as a high-quality example of industry-based information provision. Yet this article contends that the Swedish system displays evidence of corporate bias. Significantly, basing EU policy on a drug information system not resistant to corporate bias risks creating practices that violate the legally mandated mission of EU drug regulation, which is to 'promote and protect public health'.

[Regulations concerning data transparency- a comparison between the USA and Europe]. / Gesetzliche Regelungen zur Datentransparenz - USA und Europa im Vergleich.

Since 2007 a far-reaching obligation to register and publish clinical trials of pharmaceuticals on the generally accessible website www.clinicaltrials.gov has applied under the US Food and Drug Administration Amendment Act ("FDAAA") section 801. This obligation also comprises clinical trials results. In the EU clinical trials are registered with the EudraCT data base. The published data are strictly confidential and only accessible to public authorities. The publicly accessible data base Eudrapharm does not generate information on trials; there have been vague extension plans. Since 2011, § 42b of the German Drugs Act provides that the results of clinical trials need to be reported (on the "PharmNet.Bund" website) in order to improve information for doctors and patients. The US regulations serve as a role model for an approach to keeping the general public fully informed about the start and the results of clinical drug trials and to avoiding publication bias.

Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

Access to prescribing information for paediatric medicines in the USA: post-modernization.

AIMS: The aims of the present study were to examine the Physicians' Desk Reference (PDR) for changes in the listing of medicines licensed for children in the USA over a 10-year period (1998-2007). METHODS: The USA PDR was used to identify products listed in 1998, 2002 and 2007. Information about generic name (active agent), salt, strength, brand name, suitability of formulation, paediatric licensing information and the lowest age of licensing was extracted. Prescription products were collapsed down to chemical entities/fixed-dose combinations. RESULTS: Of the prescription entities listed in the PDR, 538 (55.9%), 488 (54.3%) and 394 (51.3%) were licensed for children in 1998, 2002 and 2007, respectively. There was a 39% decrease in the number of entities licensed for the newborn and a 34% decrease for children aged 2-6 years between 1998 and 2007. Formulations suitable for children were listed for 611 (63.4%), 550 (61.2%) and 430 (60.6%), respectively. Prescription entities with both a suitable oral formulation and licensing for children numbered 161 (16.7%), 148 (16.5%) and 100 (14.1%) in 1998, 2002 and 2007, respectively. CONCLUSIONS: The listings in the PDR suggest that overall access to prescribing information about drugs in the paediatric population has not shown an increase over the decade. This particularly affected the neonatal age group.

The new Food and Drug Administration drug package insert: implications for patient safety and clinical care.

The United States Food and Drug Administration (FDA) is the scientific, regulatory, and public health agency that regulates many products, including food products, drugs, medical devices, radiation emitting devices, and cosmetics for the federal government of the United States. The FDA's mission is to assure that consumer products made and sold in the United States are safe, effective, and pure. The purpose of the package insert (also known as prescription drug product insert or professional labeling) is to provide detailed drug information compiled and distributed by the drug manufacturer, after FDA review and approval. In 2006, the standard format for the package insert was changed in an attempt to make it more user-friendly and a more efficient resource tool for practitioners. According to the Institute of Medicine, in-hospital adverse drug reactions occur at a rate of 400,000 per year and incur $3.5 billion of extra hospital expense. It is expected that the new package insert format will enhance rapid access to important pharmacologic information and improve patient safety by decreasing medication errors.