You Must Comply: A Look at Why Compliance Directives Matter

There are many voices in the world of compliance, and there’s a very good reason why. Compliance rules are dependent on your industry.

Compliance itself is easy to define but hard to explain. According to Merriam-Webster, it is the act of conforming, submitting, or adapting to a desire, demand, proposal, or regimen or to coercion. It’s a pretty demanding term, and it’s use in business and operations isn’t any less so.

In our industry, compliance is related to the requirement to comply with a number of rules as defined by an industry regulatory body. In Food and Pharmaceuticals, this regulatory body is known by three letters:  F, D, and A.

The Food and Drug Administration introduces a variety of guidance documents each year. So many, in fact, that they have nearly 4,000 different documents listed on their website, 18 in the month of November alone. It’s all a lot to listen to. It also means there can be a lot of impact.

Compliance in medicine isn’t just a business term for the pharmaceutical and food industries. It can also be a consumer based one. A patient that takes a prescription as directed is also defined as being compliant. As you may be able to imagine, bothersome side effects reduce a patient’s willingness to remain compliant and thus limiting the medication’s effectiveness.

It’s for those reasons that compliance has always been a problem for patients who deal with schizophrenia. According to an article in Forbes, medication for the disease often causes sedation, blurred vision, drowsiness, dry mouth and weight gain. However, new research conducted by the St. Jude Children’s Research Hospital could change all of that.

Based on the study they conducted that was published in Nature Medicine, researchers believe they have identified a small segment of ribonucleic acid, RNA, that may help patients find the silence that schizophrenics so often fail to find. Manipulation of the identified microRNA, it’s believed, could restore normal function to the brain that’s associated with much of the issues related to the disease. The article in Forbes discussed the science behind the discovery in more detail.

“Using a novel mouse model of the so-called 22q11 deletion syndrome, researchers were able to isolate miR-338-3p as the microRNA that controls production of the protein that characterizes the D2 dopamine receptor (Drd2), which happens to be the main target of antipsychotics drugs.”

This is the reason why a children’s hospital was studying the RNA to begin with. People who suffer from this deletion syndrome are more likely to suffer an impact in their behavior during childhood. As much as 43% of those impacted eventually develop schizophrenia. It’s the hope of St. Jude’s that a better understanding of schizophrenia and other neurological issues can provide a better understanding of what normal brain development looks like. Eventually, this may even unlock clues into the biology of cancer cells. That’s still, however, a long way off.

These are the reasons why our industry has compliance. A lack thereof could lead to contaminants, added side effects, or, potentially, even the death of a patient. Thus meaning, a lack of compliance on our end could lead to a lack of compliance on the end of the patient. That’s why sorting through the voices matter, why compliance doesn’t end at the counter of a pharmacy, and it’s why our company’s fundamental truth always shines through. When it comes to compliance, every point matters.