Drug Quality and Security Act: How It Impacts Your Healthcare

May 20 • Health • 171 Views • Comments Off on Drug Quality and Security Act: How It Impacts Your Healthcare

Compounded drugs are created with the patient in mind. Compounding allows pharmacists to create unique mixtures of manufactured drugs, which are often mixed in unregulated environments. In response to a meningitis outbreak, the Food Drug Administration (FDA) and Congress passed the Drug Quality and Security Act in 2013.What exactly does this act mean for your healthcare? There is more info below.

Drug Quality and Security Act: How It Impacts Your Healthcare

Tragedy Resulting In Action

In 2012, a meningitis outbreak killed 64 people and sickened more than 750. The cause was a tainted spinal steroid injection manufactured by the New England Compounding Center. A number of issues lead to the tainted injections. The injection was a suspended compound, meaning there was no way to filter the drug to remove fungi and other bacteria. Also, because the injection is administered by spinal column there was no way to add preservatives or additives to prevent fungal growth.

In response to the meningitis outbreak, as well as other compounding and drug supply chain safety concerns, we need to understand more about the DQSA/DSCSA (Drug Quality and Security Act and Drug Supply Chain Security Act). The act is comprised of two parts. The first is the Compounding Quality Act. Previous to this act compounding pharmacists had little regulatory restrictions. This is because manufactured drugs are heavily regulated, and by the time they reach the compounding stage, it is expected that the drugs have already passed regulatory standards. The Compounding Quality Act subjects compounding pharmacies that wish to volunteer to the same regulatory standards as manufacturers able to do so. This voluntary compliance system would register the compounding pharmacy as outsourcing facilities. The second part of the Drug Quality and Security Act is the Drug Supply Chain Security Act. This act requires all homogenous case or package of drugs to that enter the supply chain to have barcodes that have track and trace abilities.

Direct Patient Impact

Many opponents of the Drug Quality and Security Act claim that the act does not go far enough to regulate all compounding pharmacies. Further, pharmacies that choose to volunteer as an outsourcing facility would have a marketable advantage. This means hospitals may buy more products from qualified compounding pharmacies, even if they are more expensive. Compounding is an excellent way for pharmaceutical companies to sell more products. Under the veil of the compound, pharmaceutical companies can mark up their products or even delay patent renewals under complicated legal pathways. For the patient, this means increased prices for their compounded medications.

Healthcare is constantly changing for better or for worse. It is something that affects all of us. With that said, you have the right to know how different laws and legislation affects you personally and your healthcare.

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