FDA Compliance and the Safe Use Initiative

Posted by sleepyguy in Prescription Sleep Medicine on April 27th, 2010

In the US, over three billion prescriptions are written every year and billions more over the counter medicines will be purchased by consumers. However, too many of these people will suffer health problems and even death as a result of preventable medical errors. To reduce the risk of medical misuse, the FDA has established a Safe Use Initiative so that companies and organisations can collaborate in order to identify specific medical risks and come up with solutions to combat these risks on a cross-sector basis.

FDA Compliance is a massive part of safer medications. It is during the medication production stage that manufacturers can limit their impact on accidental medication misuse by following FDA compliance regulations and producing only safe drugs. Then it is down to the medical practitioners, pharmacists, patients and retailers among other organisations to reduce the risk of improper medication use and preventable adverse drug events.

Although sometimes there is nothing that can be done to prevent adverse drug reactions, in the majority of instances the medication misuse could have been prevented with the knowledge that we have available to us. Below is a fact sheet of information about the Safe Use initiative and the misuse of medication.

? The healthcare system is responsible for at least 1.5 million adverse drug events costing $4 billion annually.

? In a high number of cases, children suffer medical problems when they gain access to prescription drugs and digest them. Every year there are 600,000 visits to emergency wards where children aged 12 and under have ingested medication not meant for them.

? Drug abuse is one of the most prominent causes of drug misuse in America with 165,000 emergency department visits in 2006 for the non-medical use of hydrocodone, oxycodone, and methadone-containing products.

These are just some of the cases in which medical misuse occurs. Although FDA compliance helps to make sure that the medicines themselves are safe when taken properly, drug abuse, accidents in the healthcare system and children taking medicines when they are not supposed to all result in medical problems that could have been prevented by the correct parties. These include parents and guardians, medical practitioners who prescribe drugs and of course, patients themselves.

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