If you want to add dispensing controlled substances to your practice, there are many rules and regulations you must follow. Because controlled substances include narcotics, which can be lethal if abused or ingested incorrectly, the regulations can be considered strict.
As a physician dispensing 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.
Dispensing Controlled Substances
The government classifies drugs into five schedules. These are the drugs that need to be heavily moderated due to their negative effects if misused. Drugs can fall into five different schedules.
Schedule I drugs are highly addictive. Most drugs in this class have no medical use and include such drugs as LSD, heroin and peyote. Marijuana, however, has been recently approved for medicinal purposes in some states.
Schedule II drugs are also highly addictive. Many of these drugs are used for medicinal purposes. Examples are dilaudid, Demerol, Percocet, Oxycontin, and Fentanyl.
Schedule III drugs are less addictive but still have the potential of being misused. Examples are Vicodin and Tylenol with codeine.
Schedule IV and V drugs have a low potential for abuse when compared to schedule I and II drugs. Examples include Xanax, Valium or Lorazepam. Robitussin and Phenergan are also included in this class.
You can dispense schedule II through V class of drugs only and you must follow all Drug Enforcement Administration rules strictly when dispensing controlled substances.
DEA Regulations On Dispensing Controlled Substances
The Drug Enforcement Administration makes it clear that when you are dispensing controlled substances 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) for dispensing controlled substances.
Rules for Processing
You are the only one in your office who can be dispensing controlled substances to a patient. Plus, the prescriptions you write must be detailed and include the patient’s full name and address.
They must include the date issued, your name and DEA number. It also must detail name of medicine, dosage, strength, quantity and if refills are allowed. Including cautionary warnings, and clear instructions for use are necessary.
You may never post date a prescription. Everything you write on a prescription must be legible and written in ink. You must manually sign the prescription.
If you can only fill part of a prescription through in office dispensing, you must fill the remaining prescription within 72 hours.
State Board of Pharmacy Regulations
You must be licensed by your State’s Board of Pharmacy for dispensing 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.
Doctor shopping has been used for years by addicts who try and manipulate physicians to get prescriptions for narcotics.
Making Changes to a Prescription
As a physician, you are limited to the changes you can make to a prescription. Items you cannot change include the patient’s name, the controlled substance being prescribed, and your signature. The DEA prevents you from changing these items and information related to the drug when dispensing controlled substances.
Prescriptions by Schedule
Each schedule of drugs has specific and detailed prescription filling regulations.
Schedule II drugs include morphine and amphetamines. Physicians cannot fax or email prescriptions. Schedule II prescriptions are only valid for 90 days. They cannot be refilled and are limited to a 30-day supply.
Schedule III drugs are valid for 180 days or up to five refills. A maximum of 30-day supply. This class of drugs can be faxed but not emailed.
Schedule IV and V drugs can be faxed and given orally. You may dispense up to a 90-day supply for drugs that fall under this category. These are also valid for 180 days or up to five refills.
Physicians can prescribe opioid treatment medications to patients who are fighting a narcotic addiction. An example may include methadone or suboxone. However, you must obtain an Opioid Treatment Program license from the DEA before doing so.
One of the most important regulations in dispensing drugs is to keep good records. You must document everything about your prescription and your dispensing controlled substances practices to include who is receiving the drugs, why they are receiving them and why they are necessary.
It is up to you, the physician, to make sure you stay abreast of any changes in regulations at both the state and federal levels. For example, rules vary in emergency situations. Knowing these differences will help you adhere to the strict rules set for dispensing controlled substances.
Furthermore, prepackaged medicines and accompanying software are making great leaps to provide physicians and patients with the best quality service and product, backed by extreme safety practices.
The drugs you plan to dispense, especially if controlled substances, come with heavy restrictions. However, it can be well worth your effort to provide this additional service to your patients.