Exploring scenarios can significantly improve knowledge about disclosure and nondisclosure in drugs prescription for advanced practice nurses, define ethical implications for stakeholders and analyze the prescription writing process to address all possible medication errors. The case focuses on the ethical and legal implications of prescribing new medication currently in the development stage for a child under the age of 12. Furthermore, the case draws attention to the process of drug development and research on drug safety and effectiveness for children and off-label prescription medications. Thus, the purpose of this paper is to examine the case scenario and define decision-making guide.
Firstly, the new drug discussed in the scenario is currently in development, which means that the FDA has not yet approved it. The drug development process consists of five time-consuming steps, including drug research and development, preclinical research, clinical tests, FDA review, and safety monitoring after the drug becomes available in the market. Thus, the fact that the drug proceeded to the stage of clinical trials confirms its safety to some extent, even though all clinical trials imply risks for participants. People who struggle to find the right medicine for their condition from the available options often participate in clinical trials. Furthermore, the participation of people with different characteristics, such as age and ethnicity, is encouraged in the trial because it allows for more accurate information about the drug’s effectiveness.
Moreover, drug research in children is uncommon because it involves the creation of special conditions for trials. More than 30% of drugs are prescribed to children off-label, which presents a process in which FDA-approved medication is used in a different way that was not FDA approved (Allen et al., 2018). Off-label prescription is legal and is commonly used when medication is believed to perform better than any other alternatives approved for the specific condition. According to Miyagi et al. (2020), more than 62% of American children annually receive off-label prescriptions. Furthermore, the pharmaceutical industry avoids pediatric pharmacology because there is no financial motivation to develop medications for this population. Lastly, FDA requires that risks in research in pediatric trials match direct benefits to the individual child (Bhantagar et al., 2021). Thus, while research in the pediatric population is encouraged by FDA, more widespread clinical trials in pediatric pharmacology are troubled by FDA’s limitations.
Thus, considering the ethical and legal implications for stakeholders in the scenario, prescribing the investigational drug for the patient is ethical and legal. Firstly, the patient who tried all available treatment options but is unable to participate in clinical trials can request access to unapproved treatments under the Right to Try Act (FDA,2020). The act allows patients who have exhausted available treatment options to access investigational drugs that passed the first phase in clinical trials and have not yet been approved by the FDA.
Furthermore, the prescriber’s decision to fulfill the patient’s right to try an investigational drug is legal and ethical. In this case, the prescriber’s decision is sourced in the protection of the patient’s interests. Thus, even though the medication is not approved for children, off-label use is allowed if the prescriber believes that the medication will be more effective for the patient than all available approved alternatives. Furthermore, the pharmacist must provide pediatric indications and ensure a safe medication dosage following current legislation, the Best Pharmaceuticals for Children Act, and Pediatric Research Equity Act. The patient’s parents are legally allowed to assent to the prescription, while ethically, they are required to ensure that the child is included in the decision-making process.
Next, considering the aspect of disclosure in the scenario, the prescriber should fully disclose the details of the prescription, including possible negative outcomes, to ensure transparency in communication with the patient and their family. Even though only ten states, not including Texas, require disclosure of unanticipated outcomes, full disclosure is essential for the patient’s informed consent under Texas law. In addition, full disclosure is also encouraged by ethics and professional guidelines.
In case of medical error, there are two strategies an advanced practice nurse can use to guide the process of medical error disclosure to the patient and their family. The first strategy is to use a nondefensive approach and provide a full explanation to the patient and their family using nontechnical language and plan the next step together. This strategy can help maintain transparency in patient relationships and address errors in a timely manner. The alternative strategy is to seek support from an experienced colleague before disclosing an error to the patient and their family. Texas apology law prevents expressions of sympathy from being used in a lawsuit as an admission of guilt (Texas Civil Practice and Remedies Code, 2021). Thus, in both strategies, the disclosure can also feature personal expressions of sympathy.
Lastly, the process of writing prescriptions includes several important steps. The steps include writing the prescriber’s information, filing the patient’s information, writing the recipe with a clear dosage statement, and providing instructions on how to use the medication for the patient. Next, the prescription features dispensing information for the pharmacist and information about refills. The last step in writing the prescription is providing the prescriber’s signature. Errors in prescription writing present one of the most common medical errors in the healthcare system, with more than 100,000 reports on medication errors received by FDA every year (FDA, 2019). While a significant part of mistakes is sourced in confusing drug names and insufficient labeling, the strategies for minimizing medication errors require prescribers to provide more detailed instructions for patients and pharmacists. Thus, in order to reduce medication errors, prescribers should provide easy-to-read instructions written in clear handwriting.
References
Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., Johnson, P., & DeLeon, S. (2018). Off-label medication use in children, more common than we think: A systematic review of the literature. The Journal of the Oklahoma State Medical Association, 111(8), 776–783.
Bhatnagar, M., Sheehan, S., Sharma, I., Baer, G., Green, D., McCune, S., Joffe, S., & Snyder, D. (2021). Prospect of direct benefit in pediatric trials: Practical challenges and potential solutions. Pediatrics, 147(5), 1-8. Web.
FDA. (2019). Working to reduce medication errors. Web.
Miyagi, S. J., Lam, E., & Girdwood, S. T. (2020). Partnering with clinical pharmacologists to improve medication use in children. The Journal of Pediatrics, 227, 5-7. Web.
Texas Civil Practice and Remedies Code, CIV PRAC & REM § 18.061. (2021). Web.
U. S. Food & Drug Administration (FDA). (2020). Right to Try. Web.