It’s hard to ignore the fact that we are in the midst of a nationwide opioid epidemic. In fact, a nationwide public health emergency was declared on October 26, 2017 as a means to combat the opioid abuse crisis.
This epidemic has an impact on pharmacies in a myriad of ways, and the pressure to keep up with a changing regulatory environment is immense. Pharmacies are required to balance their duty to provide patient care and dispense valid prescriptions, along with their legal obligation to use their professional judgement to prevent the diversion of controlled substances.
In addition to identifying the validity of a prescription, pharmacies must also keep up with the rapidly changing regulatory landscape across the states being utilized to address the opioid epidemic, including:
- PDMP Requirements
- Initial Rx Limits
- Partial Fill
- Drug Disposal
- Suspicious Order Records & Reporting
- Opioid Antagonist Dispensing
So what regulations will be or are being used to address the opioid epidemic? What’s their impact at the community pharmacy level? More importantly, how can community pharmacies proactively stay abreast of current and changing regulatory requirements to help fight this epidemic?
Per the DEA, much of the major drug abuse in this country is the result of legitimately made pharmaceuticals and chemicals being diverted from their lawful use into illicit drug traffic. Consequently, the DEA has placed stringent legal controls over controlled substances used for medical purposes. These controls include required DEA registration for all individuals who export, import, manufacture and distribute controlled substances, as well as health care professionals, including pharmacists and pharmacies, who dispense, administer, and prescribe these drugs.
Many patients suffer from chronic pain, which often involves prescribing opioids. Although a patient’s need to receive an assessment and treatment of pain is essential, it must be balanced with a prescriber who properly assesses and treats that pain — and pharmacists who have a corresponding responsibility to determine whether the treatment is being used for a legitimate medical purpose.
In addition to federal requirements, most states have their own laws and regulations for the handling of controlled substances by pharmacists.
That being said, how does one stay on top of the ever-changing landscape at this crucial time? Bula Intelligence offers a platform that reports and analyzes the regulations and laws for you, so that you can make sure you stay in compliance with regulations surrounding this hot topic.
Use Bula to make sure you’re on top of regulatory challenges.
Recently, there have been many changes regarding verifying the validity of a prescription. From PDMP requirements and initial prescription limits to partial fills, electronic prescribing of controlled substances and prescribing authority, there are regulations you must be aware of to avoid fines or other serious repercussions.
Do you have the tools you need to efficiently monitor requirements?
With Bula you can learn how you need to dispose of drugs in your state, for example. What kind of receptacle do you need? What about a mail back program? Are there other DEA-approved mechanisms on the horizon? If these proposed bills pass, what changes will you need to make in your pharmacy in order to stay compliant?
Bula specializes in pharmacy regulations to deliver you the most concise and clear information possible.
Ask yourself: how am I currently learning about suspicious orders and opioid antagonists? Do you feel that you are receiving the exact information you need on time to where you are confident your pharmacy is not falling behind on the rapidly changing environment? How prepared are you?
There is a prescription drug use epidemic in the United States. With pharmacists at the forefront of this issue, this dilemma is faced daily. On one hand, providing adequate patient care, treating chronic pain, and dispensing legitimate prescriptions and the other hand, preventing drug diversion, misuse and abuse and not negatively contributing to the copious number of deaths annual from drug overdoses.
Federal law and the DEA regulate and enforce controlled substances laws with state laws adding restrictions to react to state-specific issues. So long as pharmacists are aware of the red flags and can resolve issues, drug diversion will be limited. As pharmacists have a corresponding responsibility to dispensing legitimate prescriptions, pharmacists should follow their professional judgment, federal and state law, and their common sense when dispensing controlled substances.
The risks of not complying include rescinded payments, fines and, in some cases, criminal liability. While challenges remain, the practice of pharmacy has always been a well-respected profession dedicated to providing vital patient care. Staying on top of regulatory requirements allows pharmacists and pharmacies to continue to provide the essential services and care needed by their communities, while also, being part of the solution in addressing the current opioid epidemic facing the nation.