Prescription medications for LTCF residents are generally dispensed by community pharmacies pursuant to prescription orders from a prescriber. LTCFs usually store the medications for the residents and its staff administers the medications to the residents. The dispensing and storage of controlled substances in LTCFs causes the DEA many special considerations and concerns, especially because these facilities are not DEA registrants. One concern is the amount of controlled substances stored at LTCFs. The DEA prefers pharmacies that dispense to LTCF residents to dispense as minimal a quantity of controlled substances as possible. An excess supply of controlled substances is particularly troublesome for the DEA. This is one reason why the agency allows up to 60 days for the partial filling of schedule II drugs. Another means by which the stock of controlled substances in LTCFs can be reduced is by the use of automated dispensing systems (ADSs).
Until October of 2014, another concern regarding controlled substances was that the DEA prohibited a LTCF as a nonregistrant from distributing the drugs back to the dispensing pharmacy or anywhere off-site, even for destruction. Now, under new DEA regulations surrounding the disposal of controlled substances (discussed under "Return of Controlled Substances to Pharmacy for Disposal"), authorized hospitals/clinics and retail pharmacies are permitted to voluntarily maintain collection receptacles at LTCFs. As discussed earlier, it is important to note that to collect unused medications from a LTCF, the pharmacy must voluntarily register with the DEA as a collector. If a pharmacy that services a LTCF does not register as a collector, the LTCF will still have the concerns regarding the disposal of its controlled substances.
The DEA issued a final regulation in May of 2005 allowing retail pharmacies to install ADSs in LTCFs, provided that state law also permits them (70 Fed. Reg. 25462, May 13, 2005). An ADS is defined as "a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information." Thus, the pharmacy stores drugs in the ADS and controls the machine remotely. Authorized LTCF staff is allowed access to the ADS contents, which are dispensed on a single-dose basis at the time of administration pursuant to a prescription. The drugs in the ADS are pharmacy stock until dispensed.
The intent of the ADS regulations is to reduce accumulated stocks of excess controlled substances. Excess stock results because pharmacies may supply several days' quantities of drugs to patients who ultimately do not take all the medications because of death, discharge, or a change of drugs. ADSs allow the dispensing of single-dosage units of the drug, thus reducing the problem of excess stock and disposal. Retail pharmacies that install an ADS must maintain a separate DEA registration at the LTCF location. However (as mentioned under the section "Long-Term Care Facility Pharmacy"), distributions that a registered retail pharmacy makes to ADSs do not count toward the pharmacy's 5% limit that would require a separate registration as a distributor.
It is a common scenario in LTCF pharmacy, and authorized by many states, for a prescriber to communicate a drug order for a patient to a LTCF nurse and for that nurse to then communicate the order to the pharmacy. For example, a terminally ill LTCF resident might relay to a nurse that he is in severe pain. The nurse contacts the prescriber who tells the nurse to phone the pharmacy with an order for Tylenol with codeine (a schedule III opioid). The issue here is whether the nurse can lawfully be the agent of the prescriber and communicate the order to the pharmacy. In 1995, the DEA commented that a prescriber could designate in writing a responsible person at a LTCF to act as an agent. In a Federal Register posting in 2001, the DEA changed its position, stating that no agency relationship exists between a LTCF nurse and a physician. A pharmacist may only fill the order as issued by the prescriber and communicated by the prescriber or the prescriber's agent (66 Fed. Reg. 20833).
In 2009, the DEA began enforcing its position, causing several complaints regarding the DEA's policy. These complaints led to a Senate Special Committee on Aging session in March of 2010 (https://www.govinfo.gov/content/pkg/CHRG-111shrg57545/pdf/CHRG-111shrg57545.pdf) and an article in the New York Times highlighting the adverse consequences of the DEA's position for nursing home residents (https://www.nytimes.com/2010/10/03/us/03rules.html). Perhaps these events prompted the DEA to amend its position. In October of 2010, the agency issued a policy notice that it will recognize an agency relationship between a prescriber and a LTCF or hospice employee, provided there is a formal, written, and witnessed agreement between them (75 Fed. Reg. 61613). An example of such an agreement is included in the Federal Register notice. The notice lists the limited acts that an agent may perform:
Preparing a written prescription for the signature of the practitioner
Conveying orally to a pharmacy prescription orders from a practitioner for drugs in schedules III through V (but not for schedule II drugs, even in an emergency)
Transmitting a fax prescription from the prescriber, including schedule II prescriptions
The DEA permits pharmacies to place sealed "emergency kits" in LTCFs (45 Fed. Reg. 24128, April 9, 1980), which are routinely stocked with commonly dispensed prescription drugs, including controlled substances. The kits are considered extensions of the pharmacy, and the pharmacy is responsible for the proper control and accountability of the kit. It has been a common practice for the LTCF nurse to contact the prescriber on behalf of a resident in an emergency and for the prescriber to instruct the nurse to administer a controlled substance to the patient from the kit. The nurse would then subsequently notify the pharmacy, which would replace the medication in the kit and reseal it. Although many states permit this procedure, the DEA again does not recognize a nurse as an agent for this purpose, even with a formal, written agreement (75 Fed. Reg. 37463, June 2010). Thus, the prescriber must issue a prescription to the pharmacy and the pharmacist must authorize the nurse to dispense the medication from the kit.