Source: Australian Department of Health
The Therapeutic Goods Administration (TGA) is advising health professionals and consumers that there are shortages of multiple brands of sertraline 50 mg and 100 mg tablets. Shortages are expected to continue until at least late February and potentially until April 2021.
Sertraline tablets are used to treat depression, social anxiety disorder or social phobia, and pre-menstrual dysphoric disorder. Sertraline tablets are marketed in Australia under multiple brand names such as Zoloft, Eleva, Sertra, APO-sertraline, Sertraline Sandoz and Setrona.
Dates for anticipated return to supply of sertraline tablets are published on our website. Sponsors of these medicines can update the information about the shortage at any time.
In order to reduce the impact of these shortages on patients, the TGA has authorised the supply of overseas-registered products under Section 19A of the Therapeutic Goods Act 1989. However, given the high demand volume for sertraline tablets, the s19A products may not be sufficient to ensure all Australian patients have access to medicines they need.
For this reason, the TGA has also issued a Serious Shortage Substitution Notice (SSSN) for sertraline tablets. The notice will allow pharmacists to dispense an alternative strength of sertraline tablets, with the consent of the patient, without requiring a new prescription.
The SSSN must be given effect under state or territory law before pharmacists can supply according to the specified substitution. The patient’s consent is required, but the pharmacist does not require prior approval from the prescribing doctor. Pharmacists should notify the prescriber of the substitution as soon as possible.
The SSSN will be effective from 16 February 2021 until 30 June 2021. However, the TGA may lapse it prior to this date, if it becomes evident that normal supplies become available to meet demand in Australia.
Information for consumers
Talk to your doctor or pharmacist if you have any questions regarding the above information.
If you are considering substituting 100 mg tablets for your usual 50 mg tablets, ask your pharmacist for advice on how to break the tablets. You may need to ask them to cut the tablets for you to get the prescribed dose.
Information for prescribers
Bear in mind the current shortage of sertraline tablets when prescribing. Any changes to treatment should be carefully discussed with your patients, including any possible adverse effects.
Information for pharmacists
Use your professional and clinical judgement to determine whether a patient is suitable for substitution under the SSSN. Ensure the patient is fully informed and consents to the change.
Please refer patients to their doctor if substitution is not appropriate or where alternative treatments may be more appropriate.
For patients who are suitable for and consent to substitution:
- counsel them thoroughly, including about how to cut unscored 100 mg tablets for a 50 mg dose
- advise them to monitor for any side effects and to contact a doctor or pharmacist immediately if they have any concerns
- recommend that they discuss alternative treatment options with their doctor where appropriate.
The SSSN must be given effect under state or territory law before you can supply. States and territories may also apply specific conditions to the pharmacist substitution, such as keeping a record of the substitute medicine and communication with the prescriber.