What Is a Controlled Substance?
The United States controls certain substances because of their abuse potential.They are categorized based on the likelihood users will become dependent and whether or not the substance has a recognized medical use.
Substances in Schedule I (1) have no recognized medical use and are highly addictive. With the exception of cannabis, these drugs are never prescribed for patients. Drugs in Schedules II (2) – V (5) have a recognized medical use and are categorized based on the likelihood of causing drug dependence. Schedule 2 has the highest abuse potential and Schedule 5 has the least.
Listings of CSs in each schedule are available on the Drug Enforcement Administration’s Website. The Texas Controlled Substances Act (Chapter 481, Texas Health & Safety Code) requires the Commissioner of Health & Human Services to list the controlled substances that Texas identifies in each Schedule annually. Essentially these schedules are identical.
Limitations on APRNs & Physician Assistants (PAs) Prescribing CSs
Most APRNs and PAs in Texas have the following limitations on prescribing or ordering controlled substances (CSs) when properly delegated by a physician.
- Schedules 3, 4 or 5, Controlled Substances
- A 90-day supply or a prescription with refills totalling a 90-day supply
- Physician must approve continuing the same CS for the same patient beyond the initial 90-days, and note the consultation in the patient’s chart
- Physician consultation required before prescribing any CS for children under 2 years without prior consultation with the physician, with consultation noted in the patient’s chart
APRNs and PAs may order or prescribe CSs in Schedule 2 only when the APRN is facility-based and prescribing for patients admitted to:
- a hospital emergency department (This does not include any free-standing ER or urgent care, regardless of ownership.);
- a hospital in-patient unit with an intended length of stay of 24-hours or longer; or
While APRNs prescribing for these patients may technically prescribe Schedule 2 drugs, pharmacies outside the facility are not permitted to fill a prescription for a Schedule signed by an APRN or PA. In 2014, despite the plain language in the law, the Texas Medical Board (TMB) decided that the provision permitting physician delegation for Schedule II prescriptions only applied to filling prescriptions within the hospital or hospice.
For decades, Texas required any person prescribing, purchasing, or supplying controlled substances (CSs) in the state to have a Texas CS registration (CSR). This state registration was in addition to the federal CSR issued by the Drug Enforcement Administration (DEA). That changed on September 1, 2016.
In an action applauded by all health care providers, the 84th Texas Legislature (2015) triggered the demise of the Texas CSR by passing Senate Bill 195 amending the Texas Controlled Substances Act. On the law’s effective date, September 1, 2016, SB 195 eliminated the state’s CSR and transferred regulation of prescribing CSs to the Texas State Board of Pharmacy (TSBP).
Texas and U.S. law are now only require those prescribing controlled substances to register with the U.S. Drug Enforcement Agency (DEA). This registration is commonly referred to as a DEA number.
Query Prescription Drug Monitoring Programs Before Prescribing
Most states, including Texas, have Prescription Monitoring Programs (PMP) . Pharmacists are required to report any CS prescription they fill for a Texas resident, regardless of whether the pharmacist filling the prescription is in-state or out-of-state. The pharmacist reports the patient’s identifying information and the prescriber’s DEA number.
The TSBP, BON, and TMB encourage prescribers to register with Texas’s PMP, the AWARxE clearinghouse. In February 2017, the Texas Board of Nursing (BON) notified APRNs with prescriptive authority that APRNs prescribing CSs should register with the PMP. They advise that using the PMP is important to protect your prescriptive authority by ensuring that patients are not filling prescription from multiple providers and that the APRN actually prescribed all the CSs the PMP is attributing to the APRN.
Prescribing for Pain
It is particularly challenging to meet the standard of care when prescribing for pain. The BON wrote Rule 228.1 to specify the minimum standards of practice for pain management, and published an article on pain management in April 2013 (page 4). The TMB is even more specific about the standards physicians providing pain management must meet. APRNs are well advised to also follow the TMB rules in Chapter 170. The
While the percentage of APRNs disciplined by the BON remains low, the number disciplined for inappropriate prescribing (usually related to failing to follow the standards related to CSs) is rising. These are often referred to “pill mill” cases, but reviewing the disciplinary orders reveals that discipline may result from two examples of inappropriate prescribing by an individual APRN to thousands of patient prescriptions written by an APRN.
This should not deter APRNs from prescribing appropriately to manage a patient’s pain, since failing to do so does not meet the standard of care. Following pain management guidelines and position statements issued by professional organizations such as the American Pain Society and American Society of Pain Management Nursing helps ensure appropriate assessment, treatment, and prescribing.
When prescribing CSs for pain, follow these tips.
- Do a thorough history & physical examination with complete documentation.
- Recognize drug-seeking behaviors.
- Know and apply clinical guidelines for treating pain.
- Unless there is a clear indication to do so, never prescribe CSs for pain before determining if other types of pain management strategies are effective.
- Check the PMP for the patient’s history of filling CS prescriptions before prescribing and when refilling a CS prescription. Use that information in treatment decision-making.
- Use pain management contracts when treating patients with chronic pain. Consider if any findings indicate a pain management contract is advisable for short-term management.
- Consider drug testing to verify the patient is taking CSs as ordered.
Summary: APRNs prescribing CSs must know the following facts and act accordingly.
- APRNs must have a current federal DEA registration. Read more about maintaining a current DEA registration in a December 22, 2016, notice from the BON.
- A physician must delegate prescriptive authority for CSs to the APRN before the APRN orders or signs a prescription for a CS.
- Most APRNs are limited to prescribing a 90-day supply of CSs in Schedules 3 -5, to persons age 2 years and older.
- Controlled substances prescriptions are tracked through the prescription monitoring program (PMP) established by the TSBP through the AWARxE clearinghouse.
- Register and check the AWARxE clearinghouse before prescribing a CS. and check your prescribing profile regularly.
- APRNs with DEA numbers should regularly query AWATxE to confirm the APRN actually issued all the prescriptions linked to the APRN’s DEA number.
- APRNs prescribing for pain must meet standards of care identified in clinical guidelines, BON Rule 228.1, and TMB rules, Chapter 170.
- American Pain Society Clinical Guidelines
- American Society of Pain Management Nursing
- BON Pain Management Rule, Chapter 228
- BPN RN Update article on pain management, April 2013 (page 4)
- Access a patient’s Schedule II, III, IV, or V prescription history through the Prescription Monitoring Program
- Drug Enforcement Agency Registration
- TMB Pain Management Rules, Chapter 170
- TSBP statement that pharmacists may dispense refills of a controlled substance prescribed by an APRN or PA if the total supply does not exceed 90 days.