The regulations provide specific requirements for the prescribing and dispensing of controlled substance prescriptions. A prescription is defined as:
an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription) (21 C.F.R. § 1300.01(b)).
Thus, a medication order in a hospital or other institution is not a prescription. Most state laws also recognize this distinction, which is very important for hospital pharmacies. If a medication order is not a prescription, the pharmacy does not have to comply with all of the strict recordkeeping, labeling, and other requirements applicable to either a controlled substance prescription or a noncontrolled substance prescription for that matter. Thus, for example, unless state law provides otherwise, medication orders do not have to be on a security prescription blank and the order and label would not have to contain all the information required of a prescription.
The requirement that a prescription must be for an ultimate user precludes individual practitioners from writing controlled substance prescriptions for office use. If this is not clear enough, the regulations also state:
A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients (21 C.F.R. § 1306.04(b)).
A pharmacist who knowingly fills such a prescription would be dispensing a controlled substance pursuant to an invalid prescription and would be in violation of the law.
Those Allowed to Prescribe Controlled Substances
Those Allowed to Dispense Controlled Substances
Purpose of a Controlled Substance Prescription
Dispensing of Schedule II Controlled Substances
Dispensing of Schedule III, IV, and V Controlled Substances
Electronic Transmission Prescriptions
Transferring of Prescription Information
Return of Controlled Substances to Pharmacy for Disposal
Central Filling of Prescriptions
Internet Pharmacy Prescriptions
A medication order in a hospital or institution is not a prescription and is not required to comply with the strict requirements of the CSA.
Prescriptions under the CSA must be written for an ultimate user (e.g., a patient); prescribers are thus prohibited from writing controlled substance prescriptions for office use.
A prescription for a controlled substance may be issued only by an individual practitioner who is both (1) authorized to prescribe controlled substances in the state in which he or she is licensed to practice and (2) registered or exempt from registration under the CSA.
Individual practitioners may not delegate their prescriptive authority; however, an employee or agent may communicate it to the pharmacist or prepare the prescription for the prescriber's signature.
One way to verify that a prescription is valid is by checking the DEA registration number of the prescriber. The DEA number is a nine-character number consisting of two alphabet letters followed by seven digits.
Pharmacists employed by a pharmacy registered with the DEA can dispense controlled substance prescriptions.
Controlled substance prescriptions must be dated as of the date of issuance and may not be pre- or postdated.
Prescribers must include the following information on controlled substance prescriptions: date of issuance; name and address of patient; name, address, and registration number of prescriber; drug name, strength, and dosage form; quantity prescribed; directions for use; and prescriber signature (for written/electronic prescriptions). The pharmacist has to ensure all the required information is included on the prescription prior to filing it. In addition, prior to filing a prescription, the pharmacist must include the name or initials of the pharmacist dispensing the drug, the date dispensed, and the amount dispensed.
Based on previous DEA guidance, for C-III, C-IV, and C-V medications, the pharmacist can correct inaccurate or missing information on written prescriptions. The pharmacist is never permitted to make changes on a written prescription to the patient's name, controlled substance prescribed, or the prescriber's signature.
In August of 2022, the DEA provided that pharmacists are permitted to adhere to state regulations or policy regarding changes that can be made to a schedule II prescription after oral consultation with the prescriber. The DEA is expected to write new regulations to address this concern in the future, but until then, one should verify the most current position of the DEA and their state.
A prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of a controlled substance is upon the prescriber, but a corresponding responsibility rests with the pharmacist. Pharmacists who knowingly fill an invalid prescription are subject to CSA penalties.
Pharmacists must be vigilant regarding invalid prescriptions (e.g., fraudulent prescriptions, prescriptions exceeding the scope of practice, or prescriptions by individual practitioners not issued for a legitimate medical purpose), recognize red flags, and take appropriate steps to verify identified concerns.
A controlled substance prescription must be based on a legitimate physician-patient relationship. Facial validity of a prescription alone does not necessarily mean that a prescription is valid.
Pharmacists should not use the legitimate medical purpose rule as a reason to deny legitimate pain patients controlled substances because alternative therapies may exist. Rather, decisions should be based on the exercise of professional judgment weighing all clinical factors in the best interests of the patient.
It is illegal for a pharmacist to dispense narcotic drugs for maintaining an addiction or detoxifying an addict. A limited exception to this includes authorized prescribers treating patients under the DATA.
Prescriptions for large quantities and doses of opioid medications may be valid, but the pharmacist should not hesitate to verify the legitimacy of prescriptions for pain patients.
Schedule II prescriptions can be written or electronically prescribed. States may have additional or stricter requirements for the prescribing of schedule II medications.
Schedule II medications may be prescribed orally in emergency situations, if specific criteria are met.
Prescriptions for schedule II medications may be faxed as the original in three limited circumstances.
Schedule II prescriptions are not permitted to be refilled; however, they may be partially filled up to 72 hours when a pharmacy is "unable to supply" the entire quantity, 30 days when requested by the prescriber or patient, or up to 60 days for LTC or terminally ill patients.
A prescriber can provide a patient with multiple prescriptions on the same day for the same schedule II medication, if specific criteria are met.
Schedule III, IV, or V prescriptions may be transmitted as written, faxed, electronic, or orally ordered.
No schedule III and IV prescription may be filled or refilled more than 6 months from the date of issuance or more than five times, whichever comes first.
The DEA requires specific information to be recorded by the pharmacy for each fill and refill.
Partial fills of schedule III, IV, and V prescriptions are permitted; however, the total quantity dispensed in all partial fillings cannot exceed the total quantity prescribed.
The pharmacy label for controlled substance prescriptions dispensed must contain the date of initial fill, refill date (if applicable), pharmacy name and address, prescription number, patient name, prescriber name, directions for use, and cautionary statement (for CII-IV medications).
Regulations require that electronic controlled substance prescriptions be transmitted only through an approved application system. Pharmacies must follow specific procedures for the receipt of an e-prescription, if the transmission fails and if changes to the prescription are made.
Upon request, a retail pharmacy can transfer (in electronic form) a schedule II-V electronic prescription to another retail pharmacy for initial dispensing on a one-time basis. Specific procedures and documentation requirements must be met by both pharmacies. Pharmacies are not permitted to transfer any controlled substance prescriptions received in paper or oral form to another pharmacy for initial dispensing.
CIII-CV controlled substance prescriptions with refills may be transferred to a different pharmacy one time, if state law allows. Specific information must be documented by both pharmacies.
Patients may use take-back events, mail-back programs, and collection receptacles to dispose of unused or expired controlled medications. For retail pharmacies to offer a collection receptacle, they have to voluntarily register with the DEA as a collector.
When a patient has been admitted to a hospital and has controlled substance medications with them, the DEA has provided hospitals with options of how to deal with and/or dispose of the controlled substance medications.
The DEA permits controlled substances to be filled at central fill pharmacies, provided they have a contractual arrangement with the originating pharmacies. The prescription must be dispensed to the patient from the originating pharmacy.
In an effort to control rogue Internet pharmacies, which operate without a valid physician-patient relationship, the law requires the registration of Internet pharmacies, and that a prescription is valid only if issued for a legitimate medical purpose by a prescriber who has conducted at least one in-person medical evaluation of the patient.
The DEA has created limited exceptions for telemedicine prescribing of controlled substances without a prior in-person exam.
All states have PDMPs that collect and provide information regarding controlled substances dispensed within the state.
LTCFs do not have to register with the DEA and have numerous challenges regarding excess supplies of controlled substances. Pharmacies servicing LTCFs may use ADSs to decrease the stock of controlled substances. In addition, pharmacies servicing LTCFs may register as a collector to provide LTCFs with an option to dispose of unwanted medications.
The DEA permits prescribers to have an agency relationship with a LTCF or hospice employee, provided that there is a formal, written agreement.
The DEA permits pharmacies to place sealed emergency kits in LTCFs; however, a specific protocol has to be followed to remove a drug from the kit.
Alex Swanson is a pharmacist in a modern chain pharmacy located in a new strip mall in a trendy suburb of a major metropolitan area. Alex got a telephone call one day from a nearby community pharmacist who is part of a "hot line" to alert area pharmacists about suspicious prescriptions. The message is that a 30-year-old black male is attempting to pass a prescription for oxycodone, and the prescription appears very worn, as if many people have handled it. The pharmacist tells Alex, "The best thing to do is just say you're out of the drug. There's no sense in asking for trouble." Just as Alex hangs up the telephone, he sees a black male standing at the counter. Sure enough, he has a prescription for oxycodone 10 mg, #60, with directions for one tab every 12 hours for pain. The name of the patient on the prescription is John Smith. The paper on which the order is written is a bit frayed on the edges. Alex feels that the prescription looks authentic. It is from the major teaching hospital downtown and is written by a doctor who Alex has heard of. Alex calls the hospital, using the telephone number listed in the phone book. He is referred to the hematology department, where he finally locates a resident who knows the prescriber and the patient. The prescriber is out. The resident assures Alex that the prescription is valid. Alex fills the prescription. Two weeks later, Alex is visited by the local police, who tell him that the prescription he filled was a photocopy. The person who presented the prescription was not the patient but a friend of the patient. The oxycodone tablets Alex dispensed were sold on the playground of the local junior high school. List three factors that suggest Alex might not have met his responsibility. List three factors that suggest Alex might have met his responsibility. Can you conclude that Alex "knowingly" dispensed the invalid prescription? Is race a factor in this incident? Why or why not?
Mary Lee is a terminally ill patient in chronic, severe pain. Her physician has elected to aggressively treat her pain with oxycodone and other schedule II drugs for breakthrough pain. Mary gets her prescriptions filled at LessPay Pharmacy. Tom Tam, a pharmacist at LessPay, knows Mary's condition but became concerned after he noticed that every month, her dosages kept increasing considerably to the point that her prescriptions were for a few hundred tablets at a time. Tom became convinced that Mary was addicted to the drug and concerned that diversion was occurring because of the large number of tablets. Tom called the physician with his concerns. The physician reacted angrily and told Tom that whether Mary is addicted or not is irrelevant and none of his business and that her treatment is appropriate. To suggest diversion, the physician added, was absurd, and he abruptly hung up on Tom. When Mary came to the pharmacy a few days later with new prescriptions for even greater quantities of opioids, Tom told her that he could not fill the prescriptions any longer. Are Tom's concerns and actions justified under the corresponding responsibility doctrine? In other words, should addiction and diversion be a concern in this case? What would you do if you were Tom and had Mary for a patient? Would it matter in your actions if Mary did not have a terminal illness but did have chronic, severe pain?
Tammy is a nurse at a skilled nursing facility. One of the residents, Ben, has been experiencing increasing pain as the result of a condition with which he was diagnosed a couple of months ago by his physician. Until now, an NSAID had controlled Ben's pain. Tammy called the physician, who told her that he would now like to have Ben put on morphine. He instructed the nurse to order from the pharmacy 15 mg tablets, #50, with the directions of one every 6 hours. The nurse phoned the order into the pharmacy. Is the oral order of the nurse legal under federal law? Is this an emergency situation? If not, how should the prescription order have been transmitted to the pharmacy?
A patient presented a prescription to the pharmacy for Oxycontin 10 mg, #60, one tablet bid. The patient had no insurance and told the pharmacist that she could only afford to pay for 20 tablets presently but would come back in 5 or 6 days with enough money to pay the balance. What should the pharmacist do in this situation? Is this a valid reason for a partial fill? Does the balance of the prescription have to be dispensed to the patient within a certain time? What is in the best interest of the patient?
Mary, a patient at Primrose Pharmacy, requested a refill of her diazepam prescription on June 12. The prescription was issued on April 15 and written for one refill, which she received on May 10. Sally, the pharmacist at Primrose, called the prescriber's office for refill authorization. The physician spoke directly to Sally and authorized five refills. How should Sally handle this authorization? Should she document the authorization on the existing prescription or make a new prescription? Explain.
A patient asked the pharmacist at Redwing Pharmacy if she could get her diazepam prescription transferred to Redwing from Bluewing Pharmacy, which was in another part of the town. The pharmacist said that she would find out. After contacting Bluewing, the pharmacist discovered that the prescription had three refills remaining. Detail the recordkeeping requirements for transferring the diazepam prescription from Bluewing to Redwing. What if Redwing and Bluewing were part of the same chain and shared common electronic files? How would this change the recordkeeping requirements?