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Ethics & Legal Compliance

Ethics

The most important consideration in healthcare is patient welfare.

Ethics is a branch of philosophy that helps decide what should be done in a principled sense besides what must be done to comply with laws. In the medical industry, universities, colleges, hospitals, and other organizations form Ethical Review Boards (ERBs) (or Institutional Review Boards (IRBs)) to provide ethical guidance and ensure legal & ethical standards are followed. ERBs in hospitals can provide consultation for difficult ethical cases when they arise. Corporate compliance officers are responsible to investigate legal or ethical concerns identified in a business.

The Centers for Medicare & Medicaid Services (CMS) provide the following guidelines for compliance with federal and state law:

  • the maintenance of written policies and procedures
  • designation of a compliance officer and committee
  • conducting effective training and education
  • developing effective lines of communication
  • auditing and monitoring
  • enforcement through publicized disciplinary guidelines and policies dealing with ineligible persons
  • responding to detected offenses, developing corrective action initiatives, and reporting to government authorities

Justice means fairness and equality should be applied when providing care to all patients.

Some basic values in ethical considerations include:

  • Autonomy of the patient to choose their treatment
    • 🦅 Federal law protects the patient's right to refuse treatment
  • Beneficence when treating patients; having their best interests at heart
  • Dignification of the patient
  • Non-Maleficence when providing care
  • Justice in healthcare
  • Honesty in patient communication

Compliance with the Law

Pharmacists and technicians must be knowledgeable regarding the many federal and state regulations that affect the practice of pharmacy.

Technicians are individuals who are given a basic level of training designed to help them with important specific tasks. Pharmacists rely on pharmacy technicians as support staff to assist with essential tasks that do not require the pharmacist's skill or expertise.

All pharmacy personnel must comply with federal and state laws, under the supervision of a licensed pharmacist. Violations by technicians can also result in disciplinary actions for the supervising pharmacist.

  • Federal laws are passed by Congress and apply nationwide.
  • State laws are passed by individual legislatures and apply within their borders.
  • If laws conflict, the stricter law must be followed.

🦅 Federal law protects the patient's right to file complaints.

Regulatory Bodies

Federal Agencies

  • Food and Drug Administration (FDA): Established by the Federal Food, Drug, and Cosmetic Act (1938). Oversees safety and regulation of drugs, devices, cosmetics, supplements, and radiation-emitting products.
  • Drug Enforcement Administration (DEA): Enforces the Controlled Substances Act (1970) and regulates controlled substances.
  • Department of Health and Human Services (HHS): The primary federal agency responsible for protecting the health of all Americans. Oversees public health programs and agencies including the CDC, FDA, CMS, and NIH. During public health emergencies, HHS can expand access to care through guidance and waivers (e.g., authorizing technicians to administer vaccines).

State Agencies

Each state’s Board of Pharmacy is responsible for:

  • Licensing pharmacists and pharmacy technicians
  • Enforcing state-specific pharmacy regulations
  • Granting limited prescribing rights to certain non-physician healthcare providers (e.g., NPs, PAs, pharmacists)
🩺 Physician Specialists (Prescribers)
🆎 🧑‍⚕️ Title 💊 Prescriptive Authority
DC Doctor of Chiropractic ⚠️ Limited prescribing (mostly OTC, topical; varies by state)
DDS Doctor of Dental Surgery 🦷 Dental meds, antibiotics, anesthetics, pain relief
DMD Doctor of Dental Medicine 🦷 Equivalent to DDS; same authority
DEM Doctor of Emergency Medicine ✅ Full authority for emergency/acute meds
DO Doctor of Osteopathic Medicine ✅ Full authority (includes holistic training)
DPH Doctor of Public Health 🚫 Usually non-prescribing (unless MD/DO/PharmD also)
DPM Doctor of Podiatric Medicine 🦶 Foot/ankle meds; antifungals, antibiotics, NSAIDs
DTM Diploma in Tropical Medicine 🧪 Not a standalone prescriber; usually MD/DO specialization
DVM/DVS Doctor of Veterinary Medicine/Surgery 🐾 Full authority for animal prescriptions
MD Doctor of Medicine ✅ Full authority
OphD Doctor of Ophthalmology (MD/DO) 👁️ Eye-related meds: antiglaucoma, corticosteroids, antibiotics
PharmD Doctor of Pharmacy 💉 Limited authority under protocol (e.g., vaccines, contraceptives)

🤯 MDs can be fellows of American Academy of Pediatrics (FAAP), fellows of the American College of Obstetricians & Gynecologists (FACOG), or fellows of the American College of Surgery (FACS)

👩‍🔬 Non-Physician Prescribers
🆎 🧑‍⚕️ Title/Role 💊 Prescriptive Authority
NP Nurse Practitioner ✅ Prescribes meds incl. controlled substances (varies by state)
PA Physician Assistant ✅ Prescribes meds under physician collaboration (state-dependent)
CNM Certified Nurse Midwife 👶 Women’s health, pregnancy, labor-related meds
CRNA Certified Registered Nurse Anesthetist 🛌 Anesthetics & perioperative drugs
RN/BSN Registered Nurse ❌ Cannot prescribe medications
LPN/LVN Licensed Practical/Vocational Nurse ❌ Cannot prescribe medications
Psych NP Psychiatric Nurse Practitioner 🧠 Prescribes psychiatric drugs and controlled substances (varies)
OD Doctor of Optometry 👓 Eye meds; some controlled substances depending on state
PharmD (RPh) Pharmacist under protocol 💊 Vaccines, birth control, naloxone, tobacco cessation (state rules)

Non-Government Organizations (NGOs)

While not government entities, these organizations shape pharmacy standards:

  • American Society of Health-System Pharmacists (ASHP): Accredits pharmacy residencies and training programs; has model curriculum for technician training
  • The Joint Commission (TJC): A non-profit that establishes standards & monitors compliance for healthcare programs in the US. TJC-accredited programs include hospitals, healthcare networks, HMOs, & nursing homes.
  • Institute for Safe Medication Practices (ISMP): A nonprofit organization devoted to preventing medication errors. ISMP develops safety alerts, best practices, and error-prevention strategies widely adopted in pharmacy and healthcare settings.
  • United States Pharmacopeia Convention (USP): Develops official drug quality standards adopted nationwide via the USP–NF
  • American Society for Consultant Pharmacists (ASCP): Sets standards for the practice of pharmacy who provide medication distribution and consultation for nursing homes.
  • Accreditation Commission for Health Care(ACHC): Sets standards for pharmacies that provide services in the realm of: infusion, community retail, long-term care, & specialty pharmacy. They also administer the Pharmacy Compounding Accreditation Board (PCAB) accreditation.

⚖️ Court of Law

Being liable means you are responsible and can be prosecuted for misconduct.

Pharmacy technicians work under the direct supervision of pharmacists, but liability is shared. While pharmacists have the final authority, technicians are not shielded from responsibility. A technician can still be held liable for negligence, misconduct, or violating regulations; even if acting under a pharmacist's direction.

Judicial law has two main divisions:

  • Criminal Law: laws pertaining to a wrong to society
  • Civil Law: laws pertaining to a wrong to an individual

In civil law, there are two major subdivisions:

  • Contracts: legal agreements that have duties associated with them
  • Torts: civil wrongs that have duties associated with them, created by law

Torts are a branch of civil law in which the courts determine remedies for alleged harm suffered by people who have no formal relationship with the offender and the majority of court cases involving pharmacists are torts. These are typically negligence lawsuits, where a person or legal party who failed to use reasonable caution when providing care or services which resulted in damages to the victim. Malpractice is a type of negligence lawsuit brough against a person with a professional license.

Negligence is a failure to exercise a reasonably prudent level of care and it can result in serious patient harm.

Important Legislation

Below are vital pieces of legislation to know as a pharmacy technician.

🔗 Federal Law Reference Directory


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