The conditions for prescription and dispensing (CPD) define how patients may access a medicine. The prescription and/or dispensing of a medicine may be restricted—meaning reserved for hospital use or to certain physicians (such as specialists), or subject to specific requirements (regarding treatment duration or additional examinations)—in the interest of patient safety.
The prescribing of healthcare products falls within the scope of physicians and certain healthcare professionals, within the limits of their professional practice: dentists, midwives, physiotherapists, podiatrists, nurses, and occupational therapists.
Medicines that present difficulties in use or risks in case of inappropriate use may only be obtained, depending on the case, with a prescription from a physician, dentist, or midwife. These are known as prescription-only medicines (PMO, Rx). They are classified into different categories based on their prescribing and dispensing rules:
- List I medicines (single dispensing with the same prescription unless otherwise specified by the prescriber) and List II medicines (renewals allowed for up to one month of treatment for a maximum of 12 months).
- Narcotics: around twenty medicines, including morphine and its derivatives, whose dispensing is subject to very strict rules (secured prescription, batch number and a micro-lettering box to prevent falsification, with quantities limited to 7, 14, or 28 days of treatment).
If a medicine is not included in these lists, it is considered “non-mandatory prescription” (PMF), or even OTC (available over the counter in pharmacies).
As an exception, community pharmacists are authorised to prescribe and administer, to certain populations, the vaccines included in the national immunisation schedule, as well as seasonal influenza and COVID-19 vaccines. They may also dispense, without a prescription, certain prescription-only medicines for the management of sore throats and cystitis in pharmacies, after performing a rapid diagnostic test (TROD).
Some prescription-restricted medicines may be dispensed to the public by a hospital pharmacy (PUI). These medicines are included on the “retrocession” list.
Medicines with Restricted Prescription
This term covers five categories of medicines belonging to List I:
- Medicines reserved for hospital use (RH): they may only be prescribed, dispensed, and used in hospitals.
- Hospital-prescription-only medicines: they may only be prescribed in hospitals. They are dispensed in any pharmacy or, in some cases, only in hospital pharmacies.
- Hospital-only initial prescription medicines: the initial prescription must be issued in a hospital, but renewal prescriptions may be issued by a community physician. Depending on the case, dispensing may occur in hospital or community pharmacies. In some situations, the number of renewals is limited, and a new hospital prescription is required after a set period (usually one year).
- Medicines restricted to certain specialists: these medicines are complex to use or treat complex diseases. They may be dispensed in hospital or community pharmacies.
- Medicines requiring special monitoring: patients treated with these medicines must undergo regular monitoring (blood tests, additional examinations, more frequent consultations). The prescription may only be renewed if these monitoring requirements are met.
Regulatory Framework – Directive 2001/83/EC
Directive 2001/83/EC includes articles dedicated to prescription and dispensing requirements.
According to Article 70:
“1. When granting a marketing authorisation for a medicinal product, competent authorities shall specify its classification as either:
— medicinal product subject to medical prescription,
— medicinal product not subject to medical prescription.
They shall apply the criteria set out in Article 71(1).
- Competent authorities may establish subcategories for medicinal products that may only be supplied on medical prescription, referring to the following classification:
a) medicinal products on prescription that may or may not be renewed;
b) medicinal products subject to special medical prescription;
c) medicinal products under ‘restricted’ medical prescription, reserved for certain specialised settings.”
These provisions are also reflected in French regulation (Article R5121-36 for prescription conditions and Articles R5121-77 et seq. for restricted-prescription medicines). According to Articles R5121-77 et seq. of the French Public Health Code, the marketing authorisation (MA) defines the prescription and dispensing conditions of a medicine.
The MA of a restricted-prescription medicine may require the prescriber to indicate on the prescription that the patient has been informed of the associated risks.
When the reference medicinal product of a generic is classified in a restricted-prescription category, the generic’s MA follows the same classification.
Evolving Toward Greater Access in Community Pharmacies
Law n° 2020-1525 of 7 December 2020 on accelerating and simplifying public action, integrated into Article L5123-2 of the Public Health Code, illustrates a desire to shift medicines towards community pharmacy distribution.
According to Article L5123-2, any request for inclusion on the hospital formulary of a medicinal product that is not classified as reserved for hospital use must be accompanied by a request for inclusion on the “community list”
Atessia’s Support
Atessia assists pharmaceutical companies in defining or modifying the prescription and dispensing conditions of their medicinal products.
This article was written by Estelle ICARD, Regulatory & Pharmaceutical Affairs Consultant.