Scheda di revisione: Safe and Appropriate Medication Use

📋 Course Outline

1. Prescription Principles and Responsibilities
2. Authorized Healthcare Prescribers
3. Benefit–Risk Assessment
4. Narcotics and Related Medicines
5. Restricted Prescription Medicines
6. Prescription Forms and Requirements
7. Temporary Use Authorizations
8. Generic Medicines and Substitution
9. Pharmacist Roles and Self-Medication
10. Off-Label Prescribing

📖 1. Prescription Principles and Responsibilities

🔑 Key Concepts & Definitions

• Medical prescription : Controlled by a social organization such as the CPAM, dispensed by the pharmacist, and carried out by the patient or another healthcare professional.

📝 Essential Points

• A medical prescription may concern medicines, orthoses, prostheses, and other medical devices, and has social, medical, and legal implications.

💡 Memory Hook

Prescribe → control → dispense → execute

📖 2. Authorized Healthcare Prescribers

★ Must-know

📌 Physicians may prescribe when registered with the CNOM, but prevention, occupational health, PMI, and public-health physicians may prescribe only exceptionally in an emergency.

📌 Dentists, midwives, nurses, and laboratory or radiology directors prescribe only within their fields of competence, while nurses generally cannot prescribe medicines.

Further detail

📌 Hospital interns may prescribe under the responsibility of the head of department, and residents in clinical placements may prescribe under the responsibility of their supervisor.

📌 Advanced practice nurses may prescribe medicines in collaboration with the referring physician for patients with stable chronic conditions, a possibility established since 2018.

💡 Memory Hook

Broad physician authority versus profession-limited prescribing

📖 3. Benefit–Risk Assessment

🔑 Key Concepts & Definitions

• Therapeutic education : Explains the treatment’s purpose, administration method, interactions, monitoring, and potential adverse effects with the appropriate response.

📝 Essential Points

• Before prescribing, the clinician must determine whether treatment is essential, whether alternatives exist, and whether the treatment is adapted to the patient.

• Prescription assessment must consider:

  • Galenic form
  • Interactions
  • Monitoring
  • Patient understanding
  • Practical feasibility

📌 A physician must examine the patient before prescribing, except for the SAMU regulating physician, whose telephone prescriptions are highly supervised and limited to very few medicines.

💡 Memory Hook

GICSR: Galenics, Interactions, Control, Understanding, Realizability

📖 4. Narcotics and Related Medicines

★ Must-know

• The related medicines requiring specialist initiation are:
  • Clonazepam
  • Methylphenidate
  • Oxybate

📌 For narcotics and related medicines, treatment overlap is prohibited, the prescription must reach the pharmacist within three days, and dispensing begins on the day the pharmacist first reads it.

Further detail

• Fentanyl and morphine are very powerful analgesics, whereas methadone is used to support withdrawal from opioid dependence.

📌 The pharmacist keeps a copy of a narcotic prescription for three years and sends another copy to the CPAM.

💡 Memory Hook

Specialist initiation → prescription → pharmacy control

📖 5. Restricted Prescription Medicines

★ Must-know

• Restricted prescription categories include:
  • Hospital use
  • Hospital prescription
  • Initial hospital prescription
  • Special monitoring
  • Prescription reserved for specified specialists

Further detail

• Erythropoietin is initially prescribed by a nephrologist for kidney disease or by an oncologist or hematologist for blood disease.

📖 6. Prescription Forms and Requirements

★ Must-know

• A simple prescription contains:
  • The date
  • Patient information
  • Prescriber information
  • The prescription
  • The prescriber’s signature

📌 An ALD prescription is divided into two zones: the upper zone contains ALD-related medicines reimbursed at 100%, while the lower zone contains unrelated medicines reimbursed at their usual rate.

• A secure prescription for narcotics follows the simple prescription rules but writes the prescription and doses in words, states the number of specialties in the lower-right box, and carries the prescription number in the lower-left box.

📌 All prescriptions should be legible and precise about doses, timing, meals, and other treatments, and the first presentation must occur within three months, except for secure prescriptions, which must be presented within three days.

Further detail

• Prescriptions may cover:
  • Nursing care
  • Physiotherapy
  • Speech therapy
  • Diagnostic examinations
  • Medical transport
  • Medical equipment
  • Medical certificates
  • Hospitalization

💡 Memory Hook

Ordinary prescription versus ALD’s two zones

📖 7. Temporary Use Authorizations

📝 Essential Points

📌 A recommendation for temporary use concerns an available medicine with an existing marketing authorization used to meet an otherwise uncovered therapeutic need when the benefit–risk ratio is presumed favorable, and it cannot exceed three years.

📌 An authorization for temporary use concerns exceptional temporary use for a rare or serious disease without a therapeutic alternative and may be nominative for one patient or cohort-based for a group.

💡 Memory Hook

RTU covers an existing approved medicine; ATU covers exceptional temporary use

📖 8. Generic Medicines and Substitution

🔑 Key Concepts & Definitions

• Generic medicine : A copy of a medicine whose patent has expired and which has the same qualitative composition, bioequivalence, and prescribing conditions as the originator, while costing less.

★ Must-know

• Bioequivalence compares the generic with the originator using AUC, Cmax, and Tmax, with each generic-to-originator ratio required to fall between $0.8$ and $1.25$.

📌 Since 1999, a pharmacist may or must substitute an originator with a generic when the medicines belong to the same group and have the same galenic form, the patient is informed and agrees, and the prescriber has not opposed substitution.

Further detail

📌 When the prescriber writes “non-substitutable,” the patient loses third-party payment and must pay the costs before later reimbursement by Health Insurance.

💡 Memory Hook

Generic and originator share bioequivalence, but the generic costs less

📖 9. Pharmacist Roles and Self-Medication

🔑 Key Concepts & Definitions

• Self-medication : The purchase of non-prescription medicines from pharmacies, pharmacies’ websites, or the internet for benign or short-duration symptoms, without reimbursement and with pharmacist advice.

★ Must-know

• The pharmacist may:

  • Check prescriptions
  • Dispense medicines and medical equipment
  • Substitute generics
  • Participate in primary care and screening
  • Participate in vaccination and health monitoring
  • Cooperate with other professionals

• The main risks of self-medication are:

  • Delayed diagnosis
  • Incorrect use
  • Adverse effects
  • Medication errors
  • Drug interactions
  • Accumulation of expired medicines

Further detail

• According to the WHO, 40% of medicines found on the internet are counterfeit and may be ineffective or dangerous.

💡 Memory Hook

Advice and checking reduce the risks of self-medication

📖 10. Off-Label Prescribing

★ Must-know

📌 Off-label prescribing is permitted only when supported by clearly documented scientific data, does not expose the patient to unacceptable risk, and respects the patient’s right to appropriate and safe care.

📌 An off-label medicine is not reimbursed and the prescription must carry the mention “NR” for non-reimbursed.

Further detail

• Off-label prescriptions concern 15–20% of prescriptions and are especially frequent in pediatrics, geriatrics, oncology, and rare diseases.

📊 Synthesis Tables

RTU and ATU comparison

Feature	RTU	ATU
Medicine status	Already has marketing authorization	Outside authorization or still under evaluation
Purpose	Unmet therapeutic need	Rare or serious disease without an alternative
Patients	General indication framework	One patient or a patient cohort
Duration	Maximum three years	Exceptional and temporary