Medications: Common risk management issues
by Olga Maystruk, Designer and Brand Strategist,
Tanya Babitch, Assistant Vice President of Risk Management, and
Robin Desrocher, Director, Risk Management
How do I prescribe medications for off-label use?
Once the FDA approves a drug, healthcare providers may prescribe the drug for an unapproved use, often called off-label use, if they determine that it is medically appropriate for the patient.
Prescribing medication for off-label use is not without risk. When prescribing medication for off-label use, counsel the patient and document accordingly. There should be strong scientific support for using off-label drugs. Otherwise, the physician runs the risk of an adverse drug reaction and allegations of negligence in the event of a lawsuit.
In addition, physicians are encouraged to have a thorough discussion with the patient regarding off-label use, the rationale for prescribing the medication, its risks, benefits, and alternatives. The patient should be informed about what drugs are approved to treat their condition. This conversation, and any education or resources supplied to the patient, should be documented in the patient’s medical record. Information is available on the FDA website.
Read more about off-label drug use in our Reporter CME article, Prescribing issues: Opioids and off-label medications.
You can also view a real-world example of risks associated with off-label medication usage in Dermatology case study: Failure to properly treat.
What if sample medications or prescription pads are stolen?
Guarding against theft of sample medications and prescription pads is prudent risk management practice. Sample medications should be stored in areas accessible only to physicians and clinical staff members. While many physicians are now prescribing electronically, some do maintain prescription pads in their practices. Prescription pads should not be readily accessible to patients or visitors, and access should be limited to approved staff members. Locking up prescription pads offers additional protection.
If prescription pads or controlled substances go missing, the theft should be reported to local law enforcement and the Drug Enforcement Agency. If Texas providers’ prescription pads are missing, local pharmacies and the Texas State Board of Pharmacy (TSBP) should be notified. Physicians should use the TSBP reporting form to report lost, stolen, or destroyed Schedule II official prescription forms.
How should I manage sample medications in my practice?
It is important to have a sample medication policy in place. This policy should outline a method for maintaining, tracking, and documenting sample medications given to patients. In addition, a protocol should be developed for monitoring samples for expiration dates, and appropriate disposal of expired samples.
In Texas, prescribers must document sample medications dispensed to a patient in their medical record. Entering specific data including drug names, lot numbers and expiration dates will facilitate the identification of dispensed medications in the event of a drug recall. If you’re not familiar with the reporting features of your EHR, please check with the vendor. When using paper medical records or an EHR platform without a sample medication tracking feature, you may consider the use of a medication sample log or another reliable tracking method for this process. If using a log, include the patient’s name, drug name, lot number and expiration date, and maintain this information in a secure location.
The Texas Administrative Code 169.7 requires that all physicians maintain a copy of each signed request form for sample dangerous drugs for two years from the date of acquisition. Dangerous drugs are defined as any medications that require a prescription.
If practicing outside of Texas, please check with your state medical board for guidelines on sample medication documentation. Read more on this topic in our Reporter CME article, Medication and prescribing safety.
May I still write paper prescriptions for controlled substances in Texas?
Electronic prescribing of controlled substances has been required for Texas physicians since January 1, 2021. Legislation passed in 2019 mandates that controlled substances be prescribed electronically, with a few exceptions.
Prescribers may request a waiver from the electronic prescribing requirements for economic hardship; technological limitations not within control of the physician; or other exceptional circumstances. Waivers can be obtained from the Texas Medical Board. Once approved, waivers will be issued for one year. Physicians may apply for a subsequent waiver no more than 30 days before an active waiver expires.
Should I check the Texas Prescription Monitoring Program (PMP) prior to prescribing any controlled substance?
As of March 2020, Texas physicians and providers are required to check the Texas PMP before prescribing certain types of controlled substances: opioids; benzodiazepines; barbiturates; or carisoprodol. There are some exceptions, including inpatient, emergent, or hospice care. The monitoring program is currently managed by the Texas State Board of Pharmacy. Controlled substances not included in these categories do not require PMP checks, but you may choose to do so at your discretion. The PMP allows practitioners to both access a patient’s prescription history and review their own prescribing history. This information may identify any fraudulent prescription activity or identify patients receiving controlled medication from multiple sources. PMP checks should be documented in the patient’s record. The PMP Aware User Support Manual offers additional guidance on downloading PDFs into the record as well as other information. More information is available on the TMLT Resource Hub.
Can I purchase approved drugs or medical devices from a vendor not licensed to sell in Texas?
The Texas attorney general and the federal government have taken actions against physicians arising from the purchase and use of medical products and drugs that are allegedly not legal for use in the United States. Under Texas law, each proven violation may result in a civil penalty of not more than $20,000 per violation, with additional penalties if the consumer was over the age of 65. Each individual use of the product may be deemed a distinct statutory violation by the attorney general, so the fines can be very large.
Below are common actions that violate the law, most prominently the Texas Deceptive Trade Practices Act (DTPA). The DTPA has been interpreted as essentially a strict liability statute, so that fines may be pursued even if the physician did not intend to violate the law.
Scenario 1
In an attempt to save money for their patients, a physician is buying a medical device from an internet distributor who offers discounts. The distributor is unlicensed and unauthorized to do business in Texas.
Scenario 2
A physician purchases a drug on a website believing the goods are approved for use in the U.S., but the products are not "FDA approved" or labeled for domestic distribution. This renders the products "misbranded."
Either of these actions may give rise to a charge of numerous “laundry list” acts that violate the DTPA. If you have questions or concerns about the possible violation of the DPTA for drugs or devices being used by you or within your practice, please contact a healthcare attorney for legal guidance.
Are staff members allowed to call in, enter, or refill medications for physicians?
Some physicians choose to delegate communication of prescriptions to pharmacies to select staff members. Under the Texas Health and Safety Code 483.022, physicians shall maintain a written list with the name(s) of staff members authorized to communicate prescriptions to a pharmacy. These individuals are considered designated agents. Upon request by a pharmacist, physicians must provide written authorization for their designated agents. It is essential that you maintain this list and update it as needed.
Revised April 27, 2022