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Research

Cost-effectiveness of generic dabigatran

Since the enactment of Hatch-Waxman Act in 1984, use of generics has grown substantially in the US. Generics now account for nearly nine out of 10 prescriptions and are considered a cost-containment solution for escalating healthcare expenditures [1]. However, several factors may influence the use of generics including, but not limited to, the perception of the safety and effectiveness of these products [2]. The US Food and Drug Administration’s (FDA) standard of bioequivalence requires similar pharmacokinetic (PK) profiles of generic versus reference drug products with the assumption of similar pharmacodynamic (PD) effect. However, several instances related to generics substitution and treatment failures have led to concern particularly for drugs with narrow therapeutic indices and in therapeutic areas with severe effectiveness and safety outcomes.

Differences in originator and generic drug labels: impact on patient safety

The labels for established generics and their originators differ. Especially when it comes to safety messaging, these differences could have a fatal or life-threatening impact on patients, according to researchers from Switzerland [1].

Generics substitution in Finland: a pharmacy customer perspective

Generics offer less expensive alternatives to brand-name drugs. However, they must be accepted by patients to increase uptake and reduce healthcare cost. Finland adopted generics substitution in 2003. Then, in 2009, this was supplemented with a reference price system. A recent survey [1] has shown that the price of medicine is key for Finnish pharmacy customers.

US policy to combat high-priced generics

The cost of prescription drugs is a concern in the US. Drug prices typically decline once a generic drug is approved due to market competition. However, in recent years generics prices have risen and there have been shortages. The US Food and Drug Administration (FDA) has taken action to reduce prices and increase generics competition. It is hoped that this will increase access to medicines across the country.

Why does the US face high-priced generics and drug shortages?

Healthcare budgets in the US are under strain and the cost of prescription drugs is a continuous concern. Generic drugs offer cheaper alternatives to brand-name products due to competition. However, in recent years generics prices have risen in the US and there have been shortages of products.

Comparison of economic loss between generics and patented drugs in Indonesia

Poor management of the drug inventory in hospitals can be caused by stagnant and stock-out conditions, which might lead to economic loss. In order to investigate this phenomenon, researchers from Indonesia compared the economic loss between generics and patented drugs in stagnant and stock-out conditions at the Surabaya Islamic Hospital [1].

Generics outreach programmes should target high income groups

Patients with lower incomes are more likely to use generic drugs, finds a literature review from Auburn University, Alabama, USA [1].

Pharmacopeial standards may increase generics competition

Pharmacopeias, which contain descriptions of drug preparations, are critical for ensuring the safety of drug products. A study from Johns Hopkins University has now shown that pharmacopeial standards may also increase generics competition [1].

Delayed entry of buprenorphine generics cost NHS England GBP 0.5 million

A market analysis has shown that lack of competition for generic buprenorphinepatches meant the National Health Service (NHS) in England lost savings. The analysis estimates that if all generic drug products entered the market at the same time, the NHS could have saved GBP 0.5 million more over a six-month period [1].

Survey reveals attitudes to unauthorized hepatitis C generics

A survey of physicians, pharmacists, patients and other professionals in Switzerland has shown that, although most people think unauthorized generics are lower quality than their corresponding brand, they do support their import for those in need [1].