Why Pharmacies Should Make Compliance a Priority
Pharmacies in the United States are required to have compliance systems in place. If they do not, they can find themselves subject to fines (both civil and criminal), as well as audit fines. Pharmacies across the United States can find themselves in a lot of trouble if they do not comply with compliance requirements and can find themselves under investigation by the Drug Enforcement Agency (DEA). Complying with government requirements is very important. There is an almost infinite number of compliance requirements that pharmacies have to adhere to, and unfortunately for them, they must meet every single one and cannot use ‘there were too many’ as an excuse.
In this article, we will hope to tell you who pharmacies should make compliance a top priority, as well as what some compliance requirements are, and the consequences of not adhering to compliance requirements. We understand compliance requirements can be difficult, especially considering that they come from multiple agencies, but it is important that they are adhered to, lest you find yourself in a lot of trouble. Hopefully, by the end of this article, you will understand why compliance should be a top priority.
Here is why pharmacies should make compliance a priority.
Regulations You Must Be Aware Of
It is important you are aware of all of the regulations introduced to govern pharmaceutical compliance. It is only by knowing these that you can go about maintaining pharmacy compliance, so research and study them extensively. Here are three of the most important regulations you should be aware of, and the ones that can impact you the most severely if they are overlooked.
FWA
Fraud, waste, and abuse (FWA) are very important regulations associated with pharmaceutical compliance. You must ensure that you have your Code of Ethics in place in order to comply with this regulation. You are required to monitor any instance of fraud extensively, you are required to distribute your pharmaceutical drugs in a careful manner, according to government guidelines, and you are required to monitor the potential abuse of pharmaceutical drugs, so as to not waste them.
HIPAA
It is important that you train your employees properly. If your training is not up to scratch, auditors will punish you, and you could be subject to fines. You are required legally to ensure that all of your employees are trained in HIPAA properly so that they can handle sensitive information and the data of your patients. If they are not HIPAA trained, they should not be given access to sensitive information or the information of your patients. HIPAA training should take place annually.
Verification of Exclusion
Pharmacies that receive any public funds, whether they be Medicare funds or Medicaid, must ensure that they are checking their employees through the Office of Inspector General (OIG) and System for Award Management (SAMS) exclusion databases every single month. If their employees are included on any of these lists, then they must be removed immediately from any provision of care services. If you do not, you can find yourself in a lot of trouble.
Punishment
If a pharmacy does not make compliance a top priority, they can wind up in a lot of trouble. A pharmacy who does not take compliance seriously can expect to receive fines, both civil and criminal, and from auditors. Punishment can vary from an infraction to infraction, but at the very least, you will be put under investigation by a government body, who if you are found guilty, will introduce sanctions and measures to ensure you do not make the same mistakes again. If you continue to make mistakes, you can have your pharmacy closed down. It is important, for these reasons, that you do take compliance very seriously. It is worth mentioning, even the smallest infarction can lead to the DEA investigating you.
Confusion
Due to how extensive compliance requirements can be, pharmacies quite often find themselves confused and unsure of how to proceed. It can be complicated even more by the fact that there is no single source of information for regulations and compliance, and rather, it is up to the pharmacy to extensively research and study their compliance requirements. This is where most of the confusion arises, for pharmacies can be uncertain of where they must look in order to find out about their compliance requirements.
However, as mentioned in our introductory paragraphs, confusion is not a defence that will work, and rather, auditors will likely impose stronger sanctions or larger fines on a pharmacy who constantly argues confusion. By opening a pharmacy, you opened yourself up to these compliance requirements, so you must ensure that you keep up to date with everything. Auditors will try to issue you with the maximum fine that they can if you argue ignorance.
Culture of Compliance
The best way for you to introduce and maintain your compliance regulations is to create a culture of compliance in your workplace. As pharmacists are driven by care for their patients, they must ensure that medication is dealt with appropriately and carefully, but because of the fact that they are driven by care for patients, they do not always have the time to focus on compliance.
This can be a big problem, however, and can lead to your pharmacy finding itself in a lot of trouble, and your pharmacists and technicians risking losing their jobs. It is important that while stressing the importance of patient care, they must adhere to compliance regulations.
While it can, of course, seem like a lot of work, once they have adjusted to adhering to compliance regulations, it will come as second nature to them. By cultivating a culture of compliance, you safeguard yourself and your pharmacy. If your employees do not adhere to compliance regulations, you will be the one that is punished, and in turn, you will have to punish them. It is important you stress this to them so that they can understand that if they do not comply with compliance regulations, they can find themselves at risk of being out of work.
We hope that now, by the end of this page, you understand the importance of compliance regulations, and why pharmacies should make compliance a top priority. Compliance can be a headache, yes, but it is a necessary evil to ensure your pharmacy runs the way that it is meant to, and to ensure your patients are dealt with fairly.
