It would make sense that having a medical degree and years of experience would qualify you to dispense medications right there at the point of care. After all, there are not many people who know more about medications for your patients than you do.
But while this seems logical, it is not the case. In order to dispense in office, you must obtain certain certifications and meet qualifications set forth by both State and Federal governments.
Below are the certifications and other approvals you must receive before you can dispense medicines to your patients.
Current State License and DEA Number
This may seem like an obvious first step because you already have your State license and DEA number. However, it is still worth mentioning to ensure clarification of the process of being approved to dispense at your office.
Your DEA number allows you to write prescriptions that are considered controlled substances by the government. Controlled substances are ranked and put into five categories. A DEA number allows your prescriptions to be tracked and reported in case of negligent practices.
If you do not already have a DEA number, you can simply apply online using form 224. This is the application for controlled substances registration. You cannot dispense controlled substances without this approval.
You will be expected to give personal information as well as background history. If you do not supply this information, you will not be allowed to register.
Your DEA number does not allow you to dispense medications that treat narcotics addictions. That is a totally separate application and registration process.
Drug Enforcement Agency Requirements
You can dispense schedule II through V class of drugs only and you must follow all Drug Enforcement Administration rules strictly.
The Drug Enforcement Administration makes it clear that when you dispense a narcotic of any kind, it must be for a legitimate medical reason. You must make sure it meets all the regulations showing it is valid. In addition, you must verify all information on the drug to make sure it corresponds with the patient.
This means you must verify the patients name, dosage, drug being prescribed, strength and quantity before you give it to your patient.
Every few years you must register with the Drug Enforcement Administration (DEA) to dispense controlled substances.
It is important to document everything. Keeping good records can protect you and your patients, especially when it comes to controlled substances. Documentation should include your information, the patient’s information, what you are prescribing and why. Also include any progress or non-progress made by the patient.
Meet State Regulations
Most medication dispensing programs are regulated at the State level. Each State has their own set of rules and guidelines to follow.
Currently there are just a handful of States that do not allow in-office dispensing of medications. These include Texas, Montana, Wyoming and Illinois.
All other States allow doctors to prescribe medicines at the point of care, if they meet all requirements. Some States may have limitations that others do not, so it is important you check the specific regulations of your State.
Common regulations among States include the following:
- State issued controlled substance dispensing license is required for those of you who wish to dispense Drug Enforcement Administration (DEA) scheduled drugs.
- Nurse Practitioner or Physician Assistant credentials updated and legal if you plan to allow them to dispense medications.
- Your State issued dispensing license, if required, which it is in many States.
In addition to meeting these regulations, many States require you meet the Pharmacy Board regulations also.
Meet State Pharmacy Board Regulations
Pharmacy regulations vary by State but you can expect certain laws to be uniform. For instance, most states will require you follow the rules for professional conduct. This includes maintaining patient confidentiality and avoiding fraudulent activities.
Each State requires your prescription order contain specific documentation related to the medicine and the patient, especially if it is a controlled substance. Other information can include dates, quantity, refill information and more.
You may not fill an order if it is older than one year.
You must keep records of medications prescribed. These records need to be available for review by State agencies during inspections.
Furthermore, you must keep track of your inventory, use computerization of prescriptions, follow poison prevention packaging requirements, and maintain privacy and security to patients. You will need to follow safe disposal laws.
When working with a medication distributor, like when you purchase prepackaged medications, you will need to ensure that company meets all regulations as set forth by their State or Federal agencies.
All Drug Enforcement Administration rules apply when it comes to your DEA number and when prescribing controlled substances.
Once you can prove your qualifications to dispense medicines in your office, you must also provide proof that the medications you order come from safe, government approved facilities to avoid any type of errors or interactions.
Your patient’s safety must be top priority, beginning with the manufacturing and packaging facilities.
Proof of Quality at Manufacturing and Repackaging Facilities
Manufacturing facilities must do a lot of testing. And then they must test their testing methods. If the way they test the quality of the drugs they produce is not giving them the answers needed, they must improve it.
The building where any drug product will be held, processed or packaged endures strict scrutiny by the FDA. The size and location of the building are just as important as maintenance and operations. They are broken down for inspection purposes as internal and external environments.
The Federal Drug Administration (FDA) sets forth Current Good Manufacturing Practices (cGMPs) that all laboratories must follow to ensure safety when dealing with pharmaceuticals. These are the minimum requirements to pass inspection.
Standards such as this make prepackaged medication dispensing the best option. It ensures everything from production to dispensing is superior.
While this may seem like a lot of steps, it is well worth the effort. The benefits of dispensing in office are great for both you and your patient.