Therapy through video games and their regulation

090702-N-1783P-003The use of video games in areas such as science, medicine and healthcare is not a new concept. In fact clinical trials have been looking at using games as a new form of rehabilitation for at least 15 years. In the past few years however, the use of video games as therapies has increased due to the desire of medical professionals to find newer, innovative and cost-effective methods of treatment.

The Black Triangle Scheme

Pharmacovigilance legislation in the European Union (E.U.)

Blog23-image 3The European Union (E.U.) has adopted numerous laws in order to strengthen its position and act as a governing body for those countries under its umbrella. One such area in which this is happening is through a Regulatory scheme which has been in place in the United Kingdom for many years – ‘The Black Triangle Scheme ‘. This scheme is used to monitor the safety of New Medications and Vaccines throughout all EU member states.

The scheme focuses on medications which are being monitored particularly closely due to the fact that relatively little information is known about them outside of clinical trials; for example it may have been placed on the market only recently.

New medications to the market may have only recently finished clinical trials involving relatively small groups of selected individuals who take the medication for a relatively short period of time and may not be fully representative of the consumers who will ultimately purchase or be prescribed this medication. However, this by no means implies they are unsafe.

Paediatric Investigation Plans

Paediatric Investigation Plans

Paediatric Investigation Plans

Historically, there have been relatively few clinical studies on how medicines affected children in Europe and what the prescribing dose should be. This was in part due to children making up a smaller percentage of the patient population as well as it being seen as unethical to conduct clinical trials on children.

With no clear guidance for the pharmaceutical industry, this resulted in fewer medicines being available for children who required treatment; therefore children were often prescribed medicinal products off-label i.e. being given medicines for unapproved indications or age groups. Recognised by the industry as unsuitable and unsafe, new regulations and guidelines were brought out to help address this issue.