Scenario Analysis: This scenario presents a professional challenge due to the inherent risks associated with controlled substances, including diversion, misuse, and potential harm to patients. Pharmacists have a legal and ethical obligation to ensure the security of these medications and accurate reporting of their dispensing. Navigating the complexities of California’s CURES reporting requirements, maintaining physical security, and implementing robust dispensing workflows requires meticulous attention to detail and adherence to regulatory mandates. Failure in any of these areas can lead to significant legal penalties, loss of licensure, and erosion of public trust. Correct Approach Analysis: The best professional practice involves a multi-faceted approach that prioritizes immediate, accurate CURES reporting and concurrent implementation of enhanced security measures. This approach recognizes that timely reporting is a primary legal mandate and a critical tool for preventing diversion. Simultaneously, reinforcing physical security protocols and reviewing dispensing workflows addresses the broader responsibility of safeguarding controlled substances. This integrated strategy ensures compliance with California law, protects public health, and mitigates the risk of diversion. Incorrect Approaches Analysis: One incorrect approach involves delaying CURES reporting until after the physical security audit is completed. This is a significant regulatory failure because California law mandates timely reporting of controlled substance dispensing. Delaying this reporting leaves a critical window open for potential diversion and fails to leverage CURES as an active tool for monitoring and preventing misuse. It prioritizes an internal process over an immediate legal and public safety requirement. Another incorrect approach is to focus solely on enhancing physical security without addressing the immediate CURES reporting obligation. While physical security is vital, it does not fulfill the legal requirement for electronic reporting of dispensed controlled substances. This approach neglects a core component of controlled substance regulation in California, leaving the state’s monitoring system incomplete and potentially hindering investigations into suspicious prescribing or dispensing patterns. A further incorrect approach is to assume that existing dispensing workflows are sufficient and only focus on reporting and physical security. This overlooks the possibility that inefficiencies or vulnerabilities within the dispensing process itself could contribute to security risks or reporting errors. A comprehensive approach requires a periodic review and potential enhancement of dispensing workflows to ensure they align with current best practices and regulatory expectations for controlled substance handling. Professional Reasoning: Professionals should adopt a proactive and integrated approach to controlled substance management. This involves staying current with all relevant state and federal regulations, including specific requirements for CURES reporting and controlled substance security. A robust internal policy and procedure manual should be in place, regularly reviewed, and updated. Pharmacists should foster a culture of vigilance within their practice, encouraging staff to report any suspicious activities or potential security breaches. When faced with a situation like this, the immediate priority is always legal compliance, followed by comprehensive risk mitigation strategies that address all facets of controlled substance handling.

This scenario is professionally challenging because it requires a pharmacist to balance patient privacy with the legal obligation to report potential elder abuse, navigating the complexities of California’s Elder Abuse and Dependent Adult Civil Protection Act (EADACPA) and the pharmacist’s professional responsibilities. The pharmacist must act decisively while adhering to strict reporting protocols to protect a vulnerable patient. The best approach involves immediately reporting the suspected abuse to the appropriate authorities. This aligns directly with the pharmacist’s mandated reporter status under California law. Specifically, California Penal Code Section 11165.7 designates pharmacists as mandated reporters. The EADACPA requires mandated reporters to report suspected instances of abuse, neglect, or financial exploitation of elder or dependent adults to Adult Protective Services (APS) or law enforcement. Prompt reporting ensures that an investigation can be initiated to protect the patient from further harm and to hold the abuser accountable. This action prioritizes patient safety and fulfills a critical legal and ethical duty. An incorrect approach would be to counsel the patient extensively on their rights and options without making a report. While patient education is important, it does not absolve the pharmacist of their mandated reporting duty. Failing to report, even with the intention of empowering the patient, could delay crucial intervention and leave the patient vulnerable to continued abuse. This neglects the legal requirement to report suspected abuse. Another incorrect approach would be to discuss the situation with the patient’s caregiver before making a report. This action could alert the abuser, potentially leading to further harm to the patient, destruction of evidence, or intimidation of the patient. It also violates the principle of acting in the patient’s best interest by potentially compromising the investigation and the patient’s safety. Finally, an incorrect approach would be to document the suspicion in the patient’s pharmacy record but take no further action. While documentation is essential, it is insufficient on its own. The pharmacist’s legal obligation as a mandated reporter extends beyond mere record-keeping to active reporting to the relevant agencies. This passive approach fails to fulfill the protective mandate of the law. Professionals should approach such situations by first recognizing their mandated reporter status. They should then assess the situation for indicators of abuse, neglect, or exploitation. If suspicion arises, the immediate priority is to make a report to APS or law enforcement, following established protocols. Patient counseling and support can and should be provided, but only after the critical reporting obligation has been met.

This scenario presents a professional challenge due to the inherent complexity of integrating clinical pharmacology, pharmacokinetics, and medicinal chemistry principles to optimize patient care, especially when dealing with a medication exhibiting a narrow therapeutic index. The pharmacist must navigate potential drug interactions, individual patient variability, and the drug’s metabolic pathways to ensure efficacy and minimize toxicity, all while adhering to professional standards and patient safety. Careful judgment is required to select the most appropriate monitoring strategy. The best professional practice involves a proactive, evidence-based approach that considers the drug’s pharmacokinetic profile and potential for interactions. This includes reviewing the patient’s current medication list for known interactions, assessing the patient’s individual risk factors (e.g., renal or hepatic impairment), and consulting relevant clinical guidelines or drug information resources to determine the most appropriate therapeutic drug monitoring (TDM) strategy. This approach aligns with the pharmacist’s ethical obligation to ensure patient safety and optimize therapeutic outcomes, as well as the legal responsibility to practice within the scope of their professional judgment and available evidence. An incorrect approach would be to solely rely on the prescriber’s initial orders without further investigation. This fails to acknowledge the pharmacist’s role in identifying potential issues and proactively intervening. It neglects the responsibility to apply knowledge of pharmacokinetics and medicinal chemistry to anticipate problems like altered drug metabolism or excretion due to concurrent medications or patient-specific factors, potentially leading to subtherapeutic levels or toxicity. This oversight could violate professional standards of care that mandate comprehensive medication review and patient assessment. Another incorrect approach would be to arbitrarily adjust the dosage based on anecdotal information or personal preference without a systematic assessment of the drug’s pharmacokinetic parameters or the patient’s clinical status. This bypasses established protocols for dose adjustment and therapeutic monitoring, which are crucial for medications with narrow therapeutic indices. Such an action would be ethically questionable, as it prioritizes unsubstantiated judgment over evidence-based practice and could directly harm the patient by leading to inappropriate dosing. Finally, an incorrect approach would be to delay or refuse to monitor the medication despite evidence of potential issues, citing a lack of specific protocol for this exact scenario. While protocols are important, professional judgment dictates that when a medication’s known properties (e.g., narrow therapeutic index, potential for interactions) suggest a need for monitoring, and no specific protocol exists, the pharmacist should utilize their knowledge base to implement appropriate monitoring strategies in consultation with the prescriber. Inaction in the face of potential patient harm is a significant ethical and professional failure. Professionals should employ a systematic decision-making process: 1. Identify the core problem (e.g., medication with narrow therapeutic index, potential for interactions). 2. Access and critically evaluate relevant information (patient history, drug information, clinical guidelines). 3. Apply knowledge of clinical pharmacology, pharmacokinetics, and medicinal chemistry to predict potential outcomes. 4. Formulate a plan for monitoring and intervention, prioritizing patient safety and efficacy. 5. Document all assessments and actions.

Scenario Analysis: This scenario presents a professional challenge because it requires an individual to navigate the specific requirements for licensure in California, particularly concerning the purpose and eligibility for the California Practice Standards and Jurisprudence Examination (CPJE). Misunderstanding these foundational aspects can lead to significant delays, wasted effort, and potential ineligibility for licensure, impacting career progression and the ability to practice pharmacy in the state. Careful judgment is required to ensure adherence to the established regulatory framework. Correct Approach Analysis: The approach that represents best professional practice involves accurately identifying the CPJE’s role as a mandatory component for demonstrating competency in California pharmacy law and practice standards, and confirming one’s eligibility based on meeting all prerequisite licensure requirements as defined by the California Board of Pharmacy. This is correct because the CPJE is explicitly designed to assess an applicant’s knowledge of California-specific regulations and professional conduct, ensuring they can practice safely and ethically within the state’s legal framework. Eligibility is a prerequisite for taking the exam, and understanding this ensures the applicant is on the correct path to licensure. Incorrect Approaches Analysis: An approach that focuses solely on the general knowledge of pharmacy practice without verifying California-specific jurisprudence requirements is incorrect. This fails to acknowledge the unique purpose of the CPJE, which is to test knowledge of California laws and regulations, not just general pharmaceutical science. Such an approach would lead to an applicant being unprepared for the specific content of the examination, potentially resulting in failure and delaying licensure. An approach that assumes eligibility for the CPJE based on licensure in another state, without confirming specific California Board of Pharmacy requirements for examination eligibility, is also incorrect. While reciprocity or endorsement may be pathways to licensure, the CPJE is a distinct requirement for demonstrating knowledge of California’s practice standards and jurisprudence, regardless of prior licensure elsewhere. Failing to verify specific eligibility criteria can lead to premature examination attempts and wasted resources. An approach that prioritizes obtaining a passing score on the CPJE without first understanding the fundamental purpose of the examination and one’s personal eligibility is professionally unsound. The purpose of the exam is to ensure a licensee understands and can apply California’s specific legal and ethical standards. Without this foundational understanding, even a passing score might not translate to competent practice, and the individual may not have met the necessary prerequisites to even sit for the exam, rendering the score irrelevant for licensure purposes. Professional Reasoning: Professionals should approach licensure requirements with a methodical and informed mindset. The decision-making process should begin with a thorough understanding of the governing body’s regulations (in this case, the California Board of Pharmacy). This involves identifying the purpose of each required examination, such as the CPJE, and meticulously verifying all eligibility criteria before undertaking any preparatory steps or attempting the examination. This proactive approach minimizes risks, ensures compliance, and facilitates a smooth and successful path to licensure.

This scenario presents a professional challenge due to the critical intersection of medication safety, informatics, and regulatory compliance within the California healthcare landscape. The pharmacist must navigate the potential for errors introduced by a new electronic health record (EHR) system while upholding their legal and ethical obligations to patient safety. The pressure to maintain workflow efficiency must not compromise the rigorous adherence to established protocols designed to prevent medication errors. Careful judgment is required to balance technological implementation with fundamental pharmacy practice standards. The correct approach involves a proactive and systematic validation of the EHR system’s medication ordering and dispensing functionalities before full integration into patient care. This includes conducting thorough testing of order entry, dose checking, drug interaction alerts, and dispensing mechanisms against established pharmacy protocols and regulatory requirements. Specifically, this aligns with the California Board of Pharmacy’s emphasis on ensuring the accuracy and safety of prescription dispensing, which implicitly extends to the systems used to facilitate it. Furthermore, it reflects the broader principles of medication safety, such as those promoted by the Institute for Safe Medication Practices (ISMP), which advocate for robust system validation to identify and mitigate potential hazards. This approach prioritizes patient safety by ensuring the technology itself does not introduce new risks. An incorrect approach would be to proceed with the full implementation of the EHR system without comprehensive pre-launch validation, relying solely on vendor assurances or assuming existing paper-based protocols will seamlessly translate. This failure to independently verify the system’s accuracy and compliance with California regulations, particularly those pertaining to prescription accuracy and dispensing integrity, exposes patients to significant risk. It also neglects the pharmacist’s professional responsibility to ensure the integrity of the medication use process, regardless of the technological platform. Another incorrect approach is to delegate the entire validation process to IT personnel without direct pharmacist oversight and input. While IT expertise is crucial for system implementation, the ultimate responsibility for medication safety and regulatory compliance rests with the licensed pharmacist. Without pharmacist involvement in testing critical functionalities like drug-allergy checks, dose range alerts, and formulary adherence, potential safety gaps specific to pharmaceutical practice may be overlooked. This abdication of professional responsibility is a direct violation of the pharmacist’s duty of care. A further incorrect approach is to implement the EHR system and then address any identified medication safety issues reactively as they arise. This “wait and see” strategy is fundamentally contrary to the principles of proactive medication safety and regulatory compliance. California law and professional ethics mandate a preventative approach to patient care. Waiting for errors to occur before implementing corrective actions not only jeopardizes patient well-being but also represents a failure to meet the expected standards of care and a potential violation of reporting requirements for adverse events. The professional reasoning process for similar situations should involve a multi-stage approach: first, understanding the specific regulatory requirements of the California Board of Pharmacy concerning prescription dispensing and medication safety. Second, identifying the potential impact of new technologies, such as EHR systems, on these established standards. Third, developing a comprehensive validation plan that includes pharmacist-led testing of all critical functionalities. Fourth, ensuring adequate training for all staff involved in using the new system. Finally, establishing a robust post-implementation monitoring system to continuously assess performance and address any emerging issues promptly and effectively.

This scenario presents a professional challenge because it requires a pharmacist to navigate the California Board of Pharmacy’s (Board) policies regarding examination blueprint weighting, scoring, and retake limitations, which directly impact their ability to obtain or maintain licensure. Misunderstanding these policies can lead to significant delays in licensure, financial penalties, and professional setbacks. Careful judgment is required to ensure compliance and to make informed decisions about exam preparation and retake strategies. The best professional approach involves proactively understanding the California Board of Pharmacy’s official examination blueprint, including how different content areas are weighted, the scoring methodology, and the specific policies governing retakes. This includes being aware of any limitations on the number of retakes allowed within a given period or overall, and the consequences of failing to meet passing score requirements. This approach is correct because it aligns with the Board’s regulatory framework, ensuring that the candidate is fully informed and prepared according to the established standards. Adhering to these guidelines demonstrates professionalism and a commitment to meeting licensure requirements ethically and efficiently. An incorrect approach would be to assume that the examination blueprint is static and universally applied across all licensing bodies, or to rely on informal advice from peers regarding retake policies. This is professionally unacceptable because it disregards the specific regulations set forth by the California Board of Pharmacy, which are legally binding. Such assumptions can lead to incorrect preparation strategies, missed deadlines for retakes, or exceeding retake limits, potentially jeopardizing licensure. Another incorrect approach is to focus solely on passing the examination without understanding the underlying weighting and scoring mechanisms. This can result in inefficient study habits, where disproportionate time is spent on less heavily weighted topics, thereby reducing the overall effectiveness of preparation. This failure to align study efforts with the blueprint’s weighting demonstrates a lack of strategic planning and a potential misunderstanding of the examination’s design, which is a core component of the Board’s assessment process. Finally, an incorrect approach would be to ignore the retake policies and assume an unlimited number of attempts are available. This is professionally unsound as it violates explicit Board regulations. Exceeding retake limits can result in a requirement to reapply for licensure, undergo additional training, or face other disciplinary actions, all of which are significant professional detriments. The professional reasoning framework for pharmacists facing such situations should involve a commitment to continuous learning and adherence to regulatory requirements. This includes actively seeking out official documentation from the licensing board, understanding the rationale behind examination structures and policies, and developing a strategic approach to licensure that is grounded in factual information and regulatory compliance. When in doubt, consulting the official California Board of Pharmacy website or contacting them directly for clarification is the most prudent course of action.

The review process indicates that candidates preparing for the California Practice Standards and Jurisprudence Examination (CPJE) often face challenges in effectively allocating their study time and selecting appropriate resources. This scenario is professionally challenging because the breadth of material covered by the CPJE, encompassing practice standards, jurisprudence, and ethical considerations specific to California pharmacy law, requires a structured and informed approach to preparation. Misjudging the timeline or relying on suboptimal resources can lead to inadequate preparation, potentially impacting licensure and the ability to practice safely and competently. Careful judgment is required to balance comprehensive review with efficient use of time. The best approach involves a structured, multi-faceted preparation strategy that prioritizes understanding California-specific laws and regulations, integrates practice standards, and utilizes official or widely recognized resources. This includes dedicating significant time to reviewing the California Business and Professions Code, the California Code of Regulations (Title 16, Division 17), and relevant Board of Pharmacy guidelines. It also necessitates engaging with practice-oriented materials that bridge theoretical knowledge with practical application, such as case studies or mock exam questions that reflect the CPJE’s format and content. This method ensures a thorough grasp of the legal and ethical framework governing pharmacy practice in California, directly aligning with the examination’s objectives and the public protection mandate of the Board of Pharmacy. An approach that relies solely on general pharmacy knowledge without a dedicated focus on California-specific statutes and regulations is professionally unacceptable. This fails to meet the fundamental requirement of the examination, which is to assess a candidate’s understanding of the unique legal and regulatory landscape of California. Such a candidate would likely lack the specific knowledge needed to answer questions pertaining to California’s scope of practice, controlled substance laws, or compounding regulations, thereby posing a risk to public safety. Another professionally unacceptable approach is to exclusively use outdated or unofficial study materials. While general principles of pharmacy practice may be covered, these materials may not accurately reflect current California laws, regulations, or Board of Pharmacy interpretations. Relying on such resources can lead to the acquisition of incorrect information, which is detrimental to both exam performance and future practice. The Board of Pharmacy expects licensees to be knowledgeable about current legal requirements, and using outdated materials demonstrates a lack of diligence in ensuring this knowledge. A third professionally unacceptable approach is to adopt a last-minute cramming strategy without a structured timeline. The CPJE covers a substantial amount of detailed information. Attempting to absorb this material in a short period is unlikely to lead to deep understanding or retention. This approach often results in superficial knowledge, making it difficult to apply concepts to practical scenarios or recall specific legal provisions when needed. It also fails to allow for adequate practice with exam-style questions, which is crucial for developing test-taking strategies and identifying areas of weakness. Professionals should employ a decision-making framework that begins with identifying the specific knowledge domains tested by the CPJE, as outlined by the California Board of Pharmacy. This should be followed by an assessment of personal knowledge gaps. Based on this assessment, a study plan should be developed that allocates sufficient time to each domain, prioritizing California-specific legal and regulatory content. The selection of study resources should then be guided by their relevance, accuracy, and alignment with official examination content outlines. Regular self-assessment through practice questions and mock exams should be integrated throughout the preparation process to gauge progress and refine the study strategy.

Scenario Analysis: This scenario presents a professional challenge due to the inherent risks associated with sterile compounding. Ensuring the sterility, potency, and purity of compounded sterile preparations (CSPs) is paramount to patient safety and requires strict adherence to established standards. Failure to maintain these standards can lead to serious patient harm, including infections and adverse drug reactions. The pharmacist must exercise careful judgment in selecting the most appropriate quality control measures to mitigate these risks. Correct Approach Analysis: The best professional practice involves implementing a comprehensive quality control system that includes both environmental monitoring and finished product testing. Environmental monitoring, such as air and surface sampling, helps to detect potential contamination within the compounding environment. Finished product testing, including visual inspection for particulate matter and sterility testing for high-risk preparations, directly verifies the quality of the final CSP. This multi-faceted approach aligns with California Board of Pharmacy regulations and USP General Chapter , which mandate robust quality control measures to ensure the safety and efficacy of CSPs. Incorrect Approaches Analysis: Relying solely on environmental monitoring without finished product testing is insufficient. While environmental monitoring can identify potential issues in the cleanroom, it does not guarantee the sterility of every individual CSP. Contamination can occur during the compounding process itself, even in a well-maintained environment. Conversely, performing only finished product testing without environmental monitoring overlooks the critical preventative aspect of maintaining a sterile workspace. This approach is reactive rather than proactive and fails to identify and address potential sources of contamination before they impact the product. Lastly, relying solely on the manufacturer’s sterility testing for commercially available sterile ingredients, without any compounding-specific quality control, is inadequate. While manufacturers have their own quality control, the compounding process introduces new variables and potential for contamination that must be independently verified. Professional Reasoning: Professionals should approach sterile compounding by prioritizing patient safety through a risk-based quality management system. This involves understanding the potential failure points in the compounding process and implementing controls at each stage. A systematic approach that includes environmental controls, process validation, and product verification is essential. When faced with decisions about quality control, pharmacists should consult relevant regulations (e.g., California Board of Pharmacy rules) and professional standards (e.g., USP General Chapters and ) to ensure they are implementing the most effective and compliant practices.

This scenario is professionally challenging because it requires the pharmacist to bridge potential gaps in care and information transfer between distinct healthcare settings, each with its own documentation standards and communication protocols. Ensuring continuity of care for a patient with a complex medication regimen, especially when transitioning from an inpatient hospital setting to home, demands meticulous attention to detail and proactive engagement. The pharmacist must navigate potential discrepancies in medication lists, understand the patient’s adherence challenges in their home environment, and coordinate with the outpatient physician to optimize therapy. The best approach involves a comprehensive medication review that directly engages the patient and their outpatient prescriber. This includes obtaining a detailed medication history from the patient, reconciling it with the hospital discharge medication list, identifying any new medications or changes, and assessing the patient’s understanding and adherence to their regimen. Crucially, it necessitates direct communication with the outpatient physician to discuss any identified issues, propose adjustments, and ensure a unified treatment plan. This proactive, collaborative approach aligns with the California Board of Pharmacy’s emphasis on patient safety, professional judgment, and the pharmacist’s role in medication therapy management (MTM) to prevent adverse drug events and optimize therapeutic outcomes. California law and professional ethics mandate that pharmacists act in the best interest of the patient, which includes ensuring seamless transitions of care and effective communication among healthcare providers. An approach that relies solely on reviewing the hospital discharge summary without direct patient or outpatient prescriber consultation is professionally unacceptable. This fails to account for potential patient adherence issues in the home setting, misunderstandings about new medications, or the outpatient physician’s existing knowledge of the patient’s chronic conditions and treatment history. Such a passive approach risks overlooking critical information and perpetuating medication-related problems. Another professionally unacceptable approach is to simply provide the patient with the hospital discharge medication list and instruct them to follow up with their physician. This abdicates the pharmacist’s responsibility to actively manage the transition of care. While informing the patient is a component, it does not fulfill the pharmacist’s duty to reconcile medications, identify potential problems, or facilitate communication with the outpatient provider to ensure continuity and safety. This approach neglects the core principles of MTM, which emphasize proactive intervention and collaboration. Finally, an approach that focuses only on dispensing the prescribed medications without a thorough review of the patient’s overall medication regimen and adherence is also professionally deficient. While dispensing is a fundamental role, MTM extends beyond this to encompass a holistic understanding of the patient’s medication use, potential interactions, and effectiveness. Without this broader perspective, the pharmacist misses opportunities to identify and resolve drug-related problems that could impact the patient’s health and well-being post-discharge. The professional reasoning process for such situations should involve: 1) Identifying the transition of care event and its inherent risks. 2) Actively gathering information from all available sources, including the patient, hospital records, and outpatient providers. 3) Performing a thorough medication reconciliation and therapy assessment. 4) Collaborating with the patient and other healthcare professionals to develop and implement an optimized medication plan. 5) Documenting all interventions and communications.

This scenario presents a professionally challenging situation due to the inherent conflict between a patient’s expressed wishes and the pharmacist’s professional judgment regarding the appropriateness of a medication. The pharmacist must navigate the legal and ethical obligations to respect patient autonomy while also upholding their duty to ensure patient safety and provide appropriate pharmaceutical care, as mandated by California Pharmacy Law and professional ethical guidelines. Careful judgment is required to balance these competing interests. The best approach involves a direct, empathetic, and collaborative conversation with the patient. This entails actively listening to the patient’s reasons for requesting the medication, exploring their understanding of the condition and the proposed treatment, and then clearly and respectfully explaining the pharmacist’s concerns based on professional knowledge and available evidence. This approach prioritizes patient-centered care, open communication, and shared decision-making, aligning with the California Business and Professions Code sections pertaining to the practice of pharmacy and the ethical principles of beneficence and non-maleficence. It allows for the possibility of patient education, alternative solutions, or referral if appropriate, while maintaining the pharmacist’s professional responsibility. An incorrect approach would be to immediately refuse the request without further discussion. This fails to acknowledge the patient’s autonomy and can erode trust. Ethically, it neglects the principle of respect for persons and professionally, it misses an opportunity for patient education and problem-solving. Another incorrect approach is to dispense the medication despite professional reservations solely to avoid confrontation or to satisfy the patient’s immediate demand. This violates the pharmacist’s duty to ensure the medication is safe and effective for the patient, potentially leading to harm and contravening California Pharmacy Law that requires pharmacists to exercise professional judgment in dispensing. Finally, an incorrect approach would be to dismiss the patient’s request without attempting to understand their perspective or offering any alternative. This demonstrates a lack of professional engagement and fails to provide the comprehensive pharmaceutical care expected of a licensed pharmacist. Professionals should employ a decision-making framework that begins with active listening and information gathering, followed by an assessment of the situation based on professional standards and legal requirements. If concerns arise, a collaborative discussion with the patient, exploring their rationale and providing clear, evidence-based explanations, should be the next step. This process allows for informed decision-making that respects patient rights while safeguarding their well-being.