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An increasing number of second-generation antiepileptic drugs have become available as generics. There is an ongoing debate as to whether this opens up ways to save costs or if efficacy and tolerability of an established treatment are at stake. We here present a retrospective analysis of outpatients treated with lamotrigine regarding the frequency of treatment switches and its effects on seizure control and tolerability. In 13 of 285 patients under treatment with lamotrigine the prescribed drug was changed; in 6 of these seizure relapse occurred after a period of 3 months to 6 years of seizure freedom and 3 patients experienced new side effects. Compared to matched controls, the risk for loss of seizure control was significantly elevated by a factor of 17; adverse events were three times more frequent (n.s.). Consecutive determinations of serum levels suggest that these problems were related to changes in the pharmacokinetics of different formulations. Frequent problems related to a switch of medication are discussed under medical and socio-economic aspects.

Background and Objective: The German federal Health Insurance law to strengthen competition between the pharmaceutical companies commits pharmacies to hand out drugs from discount contract drug suppliers of a patient's health insurance company. Thus patients are confronted with constantly changing drug packets. This study aimed at exploring whether patients have been properly informed about the new discount contracts and if they have experienced changes and problems in their long- term medications., Methods: Between May and June 2008 male and female patients older than 50 years who had a statutory health insurance and had been diagnosed with coronary heart disease for at least one year answered a standardized questionnaire filled in by doctors' assistants or general practitioners in the doctors' network "Weschnitztal"., Results: Of the 188 patients participated in this study 63,8% were informed about health insurance discount contracts. 31,3% of the patients reported that a positive effect due to the discount contracts was that they were discharged from paying the drug prescription fee, 22,2% mentioned that cost saving for the health insurance could also be positive. 120 patients (63,8%) knew that the names of their long-term drugs could change.101 of the questioned patients (53,7%) identified a change in their long-term drugs, 51,5% felt insecure about the permanent changes. 21,7% experienced adverse e effects due to the new drugs. 19% of the patients had serious problems regarding medication intake., Conclusion: This study demonstrates that the information which patients have on the new health insurance law is not adequate enough. Many of them felt insecure because of the changes of long-term medications. One fifth of the patients reported errors in their drug intake or their confusion about their drugs. There is a high risk that these circumstances may trigger further diseases or complications. The cost savings as intended by the health insurance companies may therefore not be achieved by discount contracts.

Introduction: Since 2007 German health insurance funds may conclude discount contracts with pharmaceutical companies for individual drugs. According to German legislation pharmacies are liable to preferentially dispense these drugs to patients of the respective funds if the prescribed drug is identical regarding active ingredient, strength, package size, and route of administration, and is approved for the same indication. We aimed to assess the number and nature of clinically relevant differences between prescribed drug and its legal alternatives., Methods: Using databases and expert systems of the drug information system AiD KLINIK we evaluated all 258 412 exchangeable drug pairs of the German market currently regulated by discount contracts., Results: 15,7 % of the drug pairs differed in dosage, in one quarter each colour or shape was significantly different, and in roughly 3 % the size of the substituted drug differed by more than 50 %. In 9,43 % splitting characteristics of solid oral doses differed and in 1,87 % the substituted drug contained additives with allergenic potential not present in the primarily selected drug. On average 0,44 clinically relevant differences could be calculated in each substitution., Conclusion: This study has revealed that current legal provision ignore important medical criteria of the substitution process including individual risks (e. g. allergies). Patients will have to change the drug application process and will therefore need appropriate information and training. All these differences between substitutional drug pairs should already be known when prescribing so as to maintain patient safety in the face of this merely cost-saving measure.

Since the introduction of generic drugs to the pharmaceutical market a sometimes emotional debate exists whether they are well-investigated and of high quality. There is some uncertainty about whether evidence of bioequivalence is enough to guarantee efficacy and safety of generic drugs. Some physicians ask the question if competent authorities are able to ascertain that the pharmaceutical quality of generics is acceptable. Doctors and patients sometimes are ill at ease about the interchangeability of innovator and generic products. This article describes how the European Union legislation ensures that a generic drug is only approved if its risk-benefit relationship is favourable and that it is essentially similar to the innovator product. In this context pharmacokinetic parameters are accepted as surrogates for clinical results because bioequivalence means therapeutic equivalence as well. For most drugs, current bioequivalence testing generally enables clinicians to routinely substitute generic for innovator products. Published findings, however, suggest that particular drugs may not be ideally suited for generic substitution when a patient is already on that drug. These are the so called critical dose medicinal products (drugs with a narrow therapeutic range). When starting a new therapy with any generic drug, however, its similarity to the innovator drug in terms of efficacy, safety and quality is guaranteed.

Therapy with recombinant growth hormone is currently approved for the indications growth hormone deficiency,Turner syndrome, chronic renal failure, small for gestational age (SGA) and Prader-Willi syndrome. Positive experience from on-going clinical studies (e.g. on obesity, type 2 diabetes, Crohn's disease) support an extended range of applications for recombinant growth hormone. However, growth hormone therapy is very expensive. On the other hand, biosimilars are already available that are significantly lower in price. During the coming years, research must show whether the efficacy and safety of biosimilars (including possible new indications) are equal to that of the established preparations.

Medical drugs are usually grouped together because they exhibit identical or similar chemical and pharmacological properties. Thus, for example, all known statins lower morbidity and mortality in coronary patients. In the meantime, three beta blockers have been shown to have a life-prolonging effect in mild-to-moderate cardiac insufficiency. The question is: to what extent are the preparations interchangeable? The beta blockers in particular manifest numerous other properties--such as beta 1 selectivity, vasodilatory or antioxidative actions which, under certain circumstances may even be decisive for the success or failure of treatment. The mortality-lowering effect of high-dose ACE inhibitors in patients with a high cardiovascular risk has to date, been shown only for a single preparation. For others, the high dose (effect) has yet to be confirmed. Also, with every new substance, a new side effect profile is introduced, which may result from the tiniest alteration to the active agent molecule, but also by a different preparation method. In consequence, unexpected effects, such as allergic reactions, may occur. This not only makes the grouping of similar substances, but also the interchange of "me-too" or generic preparations, problematic.