As a physician who wants to dispense controlled substances, you must follow both state and federal laws. When your state laws are different than the federal laws, you are required to follow the most stringent rules. Meaning, if you state laws are stricter than the federal laws, you must follow state rules.
Federal laws are often the least strict of the two. For example, federal law does not limit the length of time a prescription is valid, but most states have a six-month limitation.
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.
State Board of Pharmacy Regulations
You must be licensed by your State’s Board of Pharmacy to dispense controlled substances. Once approved, you must follow their prescribing regulations.
Such regulations make it very aware that Schedule III and IV controlled substances cannot be prescribed more than five times or for more than six months after the initial date of prescription. A new prescription must be written if needed after the six-month limit.
Refills are prohibited under DEA regulations.
In addition, you must check the prescription drug monitoring program when verifying prescriptions.
Prescription Drug Monitoring Program
Governments have established programs called the prescription drug monitoring program to help physicians verify whether or not a patient has been listed as an abuser of certain drugs. This monitoring system has been a terrific way to prevent patients from doctor shopping for someone to dispense controlled substances .
Doctor shopping has been used for years by addicts who try and manipulate physicians to get prescriptions for narcotics.
Documentation Requirements
One of the most important regulations when you dispense controlled substances is to keep good records. You must document everything about your prescription and dispensing practices include who is receiving the drugs, why they are receiving them and why they are necessary.
Packaging and Labeling Requirements
Controlled substances must be contained in secure packaging to avoid contamination of the medicine. Packaging much also be child-resistant to avoid any potential accidents. Controlled substances labels must be detailed and list the patient’s name, address; phone number and reason for use.
They must also list potential hazards, warnings and the prescribing doctor’s name.
Dispense Controlled Substances In An Emergency
There may be times when your patients need immediate assistance. You can dispense controlled substances in these urgent situations. However, you must be able to prove it was an emergency and that no other form of treatment was available.
The drug you prescribe must also be limited to the treatment time. Meaning, you cannot continue to provide controlled substances to your patients after the emergency, unless you write a prescription for it.
Partial Dispensing
You may not always have the exact number of controlled substances on hand to fill a complete order. In these situations, you can fill a partial prescription. The remaining medicine is to be picked up later.
Partial prescriptions must be documented as such, along with detailed descriptions of why the medicine is only partially prescribed. Include information about the patient as well. If they are terminally ill, mark that information on the prescription.
Dispensing Without a Prescription
Believe it or not, there are conditions under which you can dispense controlled substances without a prescription. The specific details are outlined in the regulations handbook. The regulations state you cannot dispense more than 8 ounces of any opium related product, and 4 ounces of any other controlled substances.
You only have a 48-hour period in which to dispense a controlled substance. This means that if you patient needs an opiate for pain and you do not have a prescription written, you can give them a maximum of 8 ounces in a two-day period.
Provide Information on Treatment for Controlled Substances
Your duty as a doctor is to protect the well being of your patients. Prescribing opiates and other addictive medicines is part of your duty. Patients are in pain and you can help them by easing that pain with medication.
There is nothing wrong in doing this. However, some of your patients will take advantage of your duties. This happens when patients become addicted to their medicine.
If you find one of your patients is addicted to their medication, it is then your duty to provide them with information on how to break their addiction.
Being addicted to narcotic can quickly lead to damaging mental and physical health of your patient. As you know, their tolerance to the medicine you prescribe grows quickly. Soon, a patient you were able to help in the beginning with pain, becomes a patient you dread seeing.
You know they are only seeking more controlled substances to feed their addiction. They will go to great lengths to maintain their addiction, including doctor shopping. Checking the national drug registry and any in-state programs you have access to that can tell you about your patient’s drug history.
As their doctor, it is up to you and your staff to introduce treatment options. They may refuse it, but that is okay. You simply need to provide them with the right information, so they can obtain help when they are ready.
If you feel their life is in danger due to their abuse of their prescriptions, you can make the referral to a treatment facility. You have the authority to recommend hospitalization for them if you feel it is needed.
The most important thing to remember is don’t forget to document everything. If it is not documented, it did not happen.