US government
United States of America

The DEA in accordance with the controlled substance act (CSA), amendments to the CSA, and the DEA’s own internal interpretations of the act, regulate the prescription and dispensing of scheduled (controlled) drugs with the purpose of limiting abuse of these drugs. The intention of the CSA was geared toward limiting abuse in outpatient settings; the CSA itself does not mention nursing homes or hospitals.

When these DEA rules, which are originally designed for outpatient/office setting, are applied to inpatient settings, like nursing homes and hospitals, they create a logistical barrier to care and make the timely dispensing of medications prescribed by medical providers very difficult.

The DEA in 2009 initiated a strict enforcement of controlled substances rules in nursing home and have taken action against some nursing home pharmacies for what they deemed to be non-compliant practices. This “non-compliance” is not associated with any abuse issues but rather the nursing homes are being caught not following outpatient procedures set by the DEA.

This is a complicated issue but below are a few of the ways this DEA action is impacting nursing home providers’ practices and the care of nursing home patients:

1. If a new order for a narcotic drug is written in the nursing home chart, the provider has to write a hard script to go with that order.

2. If the medical provider writes an order to change a pre-existing order for narcotics, the provider has to repeat the same process and write a new script for the new change in dose or interval. This creates a disincentive to making appropriate order changes in patients with uncontrolled pain.

3. If the provider is not in the nursing home facility and gives a verbal order for a narcotic, he or she would have to fax a script to the nursing home before the pharmacy can dispense what he or she ordered. If a faxed script is not possible then a separate call is required to the pharmacist to authorize an emergency dispense. Hard scripts would then have to be written for the emergency authorization as well as the original order and be faxed to the pharmacy within 7 days. Of note, some pharmacies, like Waltz pharmacy in Maine, would not even take an emergency authorization unless the patient in the nursing home is having an “actual emergency” aside from the fact that they have a doctor’s order that shouldn’t wait till the next business day to be carried out. Ironically, CMS (Centers for Medicare and Medicaid) would consider such delay in care a violation in any federal or state survey of a nursing home. CMS expect nursing homes to carry out doctors orders without delay.

4. If the nursing home pharmacy can not deliver the ordered medicine in a timely fashion the staff at the nursing home are accustomed to using the “Emergency box” (E-box) in their facility to dispense the ordered medicine, while waiting for the pharmacy to deliver. The DEA’s position now is that the nursing staff can not use the E-box without a separate prescription (in addition to the original order and script), otherwise they are considered in violation of DEA regulations. Emergency script for each “Emergency box” use in this impatient setting is what the DEA is now mandating. With this DEA interpretation, some nursing home patients may be deprived of an important stop gap measure traditionally used by nursing staff to ensure the timely dispensing of medications legitimately ordered by licensed providers.

5. In addition to writing the orders for narcotics and providing hard scripts, nursing home providers are now expected to ask for a specific number of pills even though their patients are in an inpatient setting. This means that most providers would write for larger number of pills to avoid having to repeat this process over an over again. Larger scripts means more drug wasting in the nursing homes.

6. If the strict interpretation of the DEA regulations are applied then the above issues with schedule II narcotics would also be applicable to other scheduled drugs (III-V). In fact some nursing home pharmacies are already taking this strict stance as standard of practice.

7. Last but not least, assisted living facilities are in a worse shape than nursing homes as a result of the new DEA enforcement practices. Despite having a contracted pharmacy, like nursing homes, and having more or less the same checks and balances as nursing homes, these assisted livings facilities are now required to mail hard scripts (not fax) to the pharmacy for all narcotic orders. Some assisted living facilities are reverting back to using regular outpatient office practices for their patients rather than utilizing onsite geriatric medical services because it makes it logistically easier to meet the DEA requirements.

8. At no point does the DEA allow nursing home nurses to act as the agents of the providers in prescription matters. This is contrary to the realities of geriatric work in nursing homes where the medical team is made up of providers and nurses. Nursing home nurses have traditionally been the eyes and ears and the right hand of the providers in every nursing home in the nation.

The argument against the DEA actions:

1. Doctor’s authorization in nursing homes equals doctors orders in the chart. Mandating a hard script is simply a duplication of the providers’ orders in another format and serves no purpose whatsoever.

2. Nursing homes are inpatient facilities and patients residing there are inpatients. Nursing home residents should not be treated as community dwelling outpatients who get their prescripts during outpatient office visits and have minimal changes in medications between visits. Modern Geriatric standards mean more frequent intervention and orders to meet the needs of the nursing home population. This includes frequent, sometimes daily, nursing calls to providers to address changes in patients’ status that often require new orders. The DEA requirement that these frequent orders be coupled with prescriptions is bringing this dynamic system of care to a halt.

3. Nursing homes maintain contracts with house pharmacies that follow the same checks and balances as hospital pharmacies. These checks and balances already account for the appropriate use of the nursing home “Emergency box”. As it is, two nurses are required to sign off on each access of the “Emergency box”, in addition to having a doctor’s order in the chart. These pharmacy services, and protocols are already mandatory for all nursing homes in the United States and have been proven very effective.

4. Nursing homes and hospitals follow the same protocols and have similar checks and balances, yet the DEA doesn’t apply the scheduled drugs rules to hospitals but does so in nursing homes. The explanation is that the hospitals are inpatient; We say so are the nursing homes.

5. The DEA, by applying rules designed for outpatient setting to nursing homes, are creating problems without solving any. It is widely accepted that the only major DEA related problem in nursing home is “drug diversion” by staff, not “drug abuse” by nursing home patients. The documentation and checks and balances in nursing homes, just like in hospitals, are geared to dealing with the issue of drug diversion and preventing it. The DEA’s current actions divert attention from this very real DEA related problem and focuses attention on a self created issue of paperwork compliance that does nothing to prevent drug diversion.

6. The DEA is creating unnecessary hardship for nursing home patients and providers alike in a field of Medicine where there is a real shortage of qualified medical providers. Geriatric recruitment and retention is already suffering as the unnecessary paperwork mounts. The DEA actions are exacerbating a chronic geriatric recruitment issue in nursing homes.

7. Drug wasting in nursing homes can be expected to increase as the DEA is providing an incentive for providers to write larger scripts to minimize their paperwork. When there is a change in orders, the pharmacy is not allowed to take back the unused drugs, so they are routinely wasted at a huge cost to the system.

8. The increased bureaucracy increases the chances of medication errors as the potential for providers giving slightly different instructions multiplies when orders and scripts are done in separate steps and in duplication.

9. The DEA is creating a new potential abuse issue in nursing homes that never existed before, as the new mandates are resulting in increasing number of hard prescription that the providers give to facilities only to sit in charts after being faxed to pharmacies. These signed hard scripts can be sold or used illicitly to get narcotics from outpatient community pharmacies. Most providers are genuinely concerned that the hard scripts they provide to nursing homes serve no purpose and are a liability for them and their practices.

10. CMS (Centers for Medicare and Medicaid) has long been pressing nursing homes to improve pain management for their residents. This new DEA action is a barrier to meeting that goal, and it can potentially disrupt the quality of care related to pain management.

We petition our government to instruct the DEA and CMS to take the following actions:

1. The DEA should use the same standards for all inpatient facilities, including nursing homes. Nursing homes (NF and skilled facilities) and assisted living facilities should be treated the same as hospitals and inpatient rehabilitation facilities, provided they maintain the same pharmacy checks and balances as hospitals. This should include the ability of nursing home nurses to use the “Emergency box” to fill doctors orders until the pharmacy can deliver the ordered medications.

2. Allow nursing home nurses to act as the agents of medical providers to implement and carry out doctors’ orders in their facilities. This should apply to the DEA as well as Medicare Part-D issues i.e. assist with prior authorization issues and conveying doctors’ orders to pharmacies.

3. Allow nursing home pharmacies to act as the agents of medical providers in processing prior authorizations with Medicare part-D plans for nursing home patients when providers order drugs not covered by Part-D formularies.

4. Allow nursing homes to have a less restrictive system for partial fills for PRN (as needed) as well as scheduled narcotics to decrease drug wasting and associated cost.

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