Same Day Multiple Prescriptions
 Why is Our Government Pursuing a War on Doctors?

Free Electronic Newsletter

For Relief of Pain: Know the Federal Rules for Dispensing Controlled Substances
By David B. Brushwood, R.Ph., J.D.
University of Florida
July 2002

All prescription pharmaceuticals are highly regulated under federal law, but some are more highly regulated than are others. Products containing morphine, oxycodone, hydromorphone, methadone, and other strong opioids, are classified as Schedule II controlled substances. Pharmacists must be extremely cautious when dispensing these drugs. Controlled substances in Schedules III, IV and V, for example those products containing propoxyphene, or hydrocodone and acetaminophen in combination, are subject to fewer restrictions, but they are also closely monitored. The lowest level of federal scrutiny applies to drugs like nonsteroidal anti-inflammatory agents or tramadol. These pain medications are not even classified as controlled substances, but a prescription is required for most of them, and records of their dispensing must be maintained. The failure of patients to appreciate the rules for dispensing applicable to pharmacists may cause problems for them in the acquisition of pain medications.

Consider the following hypothetical situation:

Mary Baldwin is a chronic pain patient. She and her physician have discovered that she can manage well with high doses of a Schedule II opioid analgesic medication. Mary has not been happy with several inconveniences at her regular pharmacy, and she has decided to switch to a new pharmacy. The new pharmacy stays open until 9PM, unlike her old pharmacy that closes at 7PM. On Friday Mary visits her physician for a checkup and she receives a prescription to continue her pain medication for another month. At 8PM on that day, Mary takes this prescription to the new pharmacy. The pharmacist does not know Mary and also does not know Mary's physician. The pharmacist is uncomfortable dispensing such a large quantity of medication without prescriber verification. But Mary's physician has gone out-of-town for the weekend, and the on-call physician will not provide the requested verification. The pharmacist dispenses only a 3-day supply of medication to Mary, cautioning Mary that she must return by 8PM on Monday to receive the balance of the month's supply, following verification by her physician. On Monday the physician provides appropriate verification and the pharmacist's concerns are relieved. But Mary still has a few tablets left over and she does not return to the pharmacy until Wednesday, when her medication supply has been exhausted. The pharmacist refuses to dispense the balance of the prescription, insisting that Mary must return to her physician to obtain a new written prescription.

This patient was certainly surprised, and perhaps was angry, when she learned that she could not receive the full supply of her prescribed medication. However, the pharmacist has complied with federal law. Pharmacists have a responsibility to assure that all prescriptions are issued for a legitimate medical purpose. Insisting on verification of a prescription for an unknown patient by an unknown physician is perfectly reasonable. Dispensing a 72-hour partial supply under the described circumstances is permitted by law, but the balance must be dispensed within 72 hours following the dispensing of the partial supply. Mary should have returned to the pharmacy by Monday at 8PM to receive her additional medication.

Consider a second hypothetical situation:

Joyce Black and her new husband Tom Black enjoy playing sports together. One day Joyce fractures her wrist playing softball. It is a simple fracture that is reduced and casted in the local hospital's emergency department. The emergency physician has been acquainted with Joyce's family for many years. The physician prescribes a three day supply of a Schedule II opioid analgesic. On the prescription, the physician inadvertently writes "Joyce White" as the patient's name. This was Joyce's name before she married Tom. Joyce does not notice this use of her "old" name. Joyce and Tom take the prescription to a local pharmacy, and they present their prescription insurance card. The pharmacist refuses to dispense the medication, indicating that the patient's name on a prescription must be correct, and that the patient's name on a prescription cannot be changed even if the prescriber authorizes a change over the telephone. This is not a valid prescription. The emergency physician who treated Joyce has gone off duty and she must wait several hours in the emergency department until a new emergency physician can sort things out and write a new prescription for her.

The pharmacist is following the law in this hypothetical situation. There are certain pieces of information on a prescription that can be changed by a pharmacist after contacting the prescriber to authorize the change, but the patient's name cannot be changed. This patient must repeat the aggravation and frustration of a long and painful wait in the emergency department. She should have assured that her name was correct on the prescription.

Sometimes the rules of dispensing interfere with the ability of pharmacists to provide quality care. As much as a pharmacist might want to "let it slide" and "do the right thing," federal regulations are not trivial and they must be strictly followed. Patients who know the rules can help pharmacists overcome any barriers that the rules might otherwise create. This overview of dispensing rules is intended to help patients help themselves in the acquisition of Schedule II pain medications.

• § All controlled substance prescriptions must be issued for a "legitimate medical purpose" and in the "usual course of professional practice." Simply because a physician's order has been issued in the format of a legal prescription does not mean it is a valid prescription. Pharmacists must evaluate all controlled substance prescriptions prior to dispensing.
• § There is no limit on the quantity of controlled substance medication that may be prescribed, nor is there a limit on the frequency with which patients may receive controlled substance medications under federal law.
• § Schedule II prescriptions must be issued in writing. However, under emergency circumstances a verbal authorization to dispense a Schedule II medication is permitted, if the following conditions are met:
  • § The amount dispensed is limited to that necessary to treat the patient during the emergency.
  • § The verbal order must be reduced to writing by the pharmacist.
  • § If the prescriber is not known to the pharmacist, then the pharmacist must make a reasonable effort to assure that the order is from a valid prescriber.
  • § Within seven days of the verbal order, the prescriber must deliver a written prescription to the pharmacist.
• § A physician may fax a Schedule II prescription to a pharmacist, and the faxed prescription may serve as the original prescription if the prescription:
  • § Is to be compounded for the direct administration to a patient by infusion, or
  • § Is for a patient who is a resident of a Long Term Care Facility, or
  • § Is for a patient enrolled in hospice care.
• § Schedule II prescriptions may not be refilled.
• § After consulting with the prescriber by telephone, a pharmacist may change these pieces of information on a Schedule II prescription:
  • § Patient's address.
  • § Drug strength.
  • § Drug quantity.
  • § Directions for use.
• § A pharmacist may partially dispense a Schedule II prescription in a community setting, but the remaining portion of the prescription must be dispensed within 72 hours of the first partial dispensing. If the remaining portion is not or cannot be dispensed, the pharmacist must notify the prescriber.
• § Methadone may be prescribed to treat pain outside an opioid treatment program.

Effective pain management requires a team effort, with the patient, physician and pharmacist working together to meet patient needs. Patients who are aware of the restrictions placed on Schedule II controlled substance prescribing and dispensing by federal law can help themselves by helping physicians and pharmacists stay within the rules.