Quetiapine Shortages: A Pharmacist’s Guide to Mastery Preparations

In response to ongoing supply difficulties with prolonged-release (LP) quetiapine medications,the French National Agency for the Safety of Medicines and Health Products (ANSM) has authorized pharmacists to dispense masterful preparations of quetiapine immediate-release (IR) capsules as an alternative. This temporary measure aims to ensure patients continue receiving necessary treatment despite the scarcity of their prescribed LP formulations.

The ANSM,in collaboration with the Directorate General for Health (DGS),initiated this programme in early February 2025.

Harmonized Manufacturing Ensuring Availability

Masterful preparations of quetiapine are available as 100 mg and 150 mg capsules in immediate-release form. These preparations are meticulously produced by voluntary preparatory pharmacies,authorized by regional health agencies (ARS) to manufacture masterful preparations on a national scale. This coordinated effort ensures a consistent supply of these crucial medication alternatives.

Pharmacists: Dispensing Professionals in a Time of Crisis

Under the ANSM’s guidance, pharmacists are empowered to dispense masterful preparations of quetiapine IR to patients prescribed LP formulations when the latter are unavailable. Importantly, this substitution does not necessitate a new prescription order.

“Masterful preparations will not make it possible to cover all of the needs, they must be used only for patients requiring treatment with Quétiapine without any other alternative,” emphasizes the ANSM.

When dispensing these preparations, pharmacists must adhere to a precise dosage equivalency table provided by the ANSM to ensure accurate replacement of the original prescription. Dosage instructions are crucial and should be clearly communicated to patients, accompanied by detailed user sheets outlining appropriate administration and potential side effects.

Guidance for Safe and Effective Implementation

To ensure patient safety, several crucial guidelines must be followed when transitioning from LP to IR formulations:

• The first dose of the IR formulation should be administered approximately 24 hours after the last dose of the LP formulation.
• For doses of 400 mg or more, the IR formulation should be divided into two doses, taken in the morning and evening.
• Patients should be advised about the risk of drowsiness after the morning dose and cautioned against driving or operating machinery until they are aware of their individual sensitivity to this effect.
• The risk of hypotension should also be communicated to patients.

Pharmacists should consult the prescribing physician for specific recommendations or adjustments in dosage or formulations for patients with pre-existing medical conditions such as orthostatic hypotension, elderly patients, or those taking medications that may interact with quetiapine.

Ongoing Monitoring and communication

Due to potential pharmacokinetic variations between LP and IR formulations,increased alertness is recommended during the transition period. Pharmacists should advise patients to report any adverse effects or unusual symptoms to their physician. This collaborative approach ensures the continued safety and well-being of patients during this time of medication supply challenges.

What role do regional health agencies (ARS) play in the production of masterful quetiapine preparations?

Quetiapine shortages: interviewed by Archyde, Dr. amélie Laplace, a renowned hospital pharmacist and clinical coordinator, shares insights on mastery preparations

In the face of ongoing supply challenges with prolonged-release (LP) quetiapine medications, the French National Agency for the Safety of Medicines and Health Products (ANSM) has authorized pharmacists to dispense masterful preparations of quetiapine immediate-release (IR) capsules. Dr. Amélie Laplace, a leading hospital pharmacist and clinical coordinator, discusses this temporary measure and its implications for patients and healthcare professionals.

Harmonized Manufacturing Ensuring Availability

Archyde (A): Dr. Laplace, can you walk us through the process of producing these masterful preparations?

Dr. laplace (DL): Of course. These preparations are meticulously crafted by voluntary preparatory pharmacies authorized by regional health agencies (ARS). They are available in 100 mg and 150 mg capsules, ensuring a consistent supply of these crucial medication alternatives nationwide.

Pharmacists: Dispensing Professionals in a Time of Crisis

A: How are pharmacists involved in this process, and what guidelines are they following?

DL: Pharmacists are empowered to dispense these preparations when LP formulations are unavailable. They do not need a new prescription order.When dispensing, they must adhere to the precise dosage equivalency table provided by the ANSM to ensure accurate replacement. It’s crucial for them to communicate this clearly to patients, accompanied by detailed user sheets.

“Masterful preparations won’t cover all needs,” emphasizes the ANSM. “They should only be used for patients requiring quétiapine treatment without any other choice.”

Guidance for Safe and Effective Implementation

A: What are the key safety guidelines pharmacists should follow when transitioning patients from LP to IR formulations?

DL: First, the first dose of the IR formulation should be administered approximately 24 hours after the last dose of the LP formulation. For doses of 400 mg or more, it should be divided into two doses, taken in the morning and evening. Patients should be advised about the risk of drowsiness after the morning dose, and the risk of hypotension should also be communicated.

Pharmacists should consult prescribing physicians for specific recommendations, especially for patients with pre-existing medical conditions or those taking medications that may interact with quetiapine.

ongoing Monitoring and Communication

A: Given potential pharmacokinetic variations, how should pharmacists ensure patient safety during this transition period?

DL: Increased alertness is crucial. Pharmacists should advise patients to report any adverse effects or unusual symptoms to their physician. This collaborative approach ensures the continued safety and well-being of patients during this time of medication supply challenges.

A: dr. Laplace, you’ve emphasized the importance of pharmacists as key players in ensuring patient safety and continuity of treatment during this challenging period. How can we foster and recognize their vital role?

DL: (Smiling) I believe recognizing their efforts publicly is a great start. Platforms like Archyde are instrumental in spreading awareness about their role. Moreover,continuous training and support from professional bodies like the Ordre des Pharmaciens and ANSM can significantly enhance their skills and confidence in handling such situations.

Thank you, Dr. Laplace, for your invaluable insights and guidance on navigating quetiapine shortages. Your expertise has certainly clarified the path forward for pharmacists and other healthcare professionals during this challenging time.