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TGA announces more medicine shortages are now impacting Australia 

The Therapeutic Goods Administration (TGA) is advising health professionals and consumers that there is an ongoing shortage of medicines containing olmesartan or prazosin as the sole active ingredient.

In order to reduce the impact of these shortages, the TGA has issued Serious Shortage Substitution Notices for each medicine allowing pharmacists to make substitutions for prescriptions for specific strengths of medicines, replacing them with alternative strengths of the same medicine.

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 notices apply from 4 September 2020 until 31 December 2020. The TGA says it may lapse the notices prior to this date, if it becomes evident that supplies become available to meet demand in Australia.

Pharmacists are being advised to use their professional and clinical judgement to determine whether a patient is suitable for substitution under the Serious Shortage Medicine Substitution Notice.

“Ensure the patient is fully informed and consents to the change,” the TGA said.

“Please refer patients to their doctor if substitution is not appropriate or where alternative treatments other than substitution may be more appropriate”.

For patients who are switched:

  • counsel them on the difference in the number of tablets they should take and ensure that this is appropriate for them
  • give them a Consumer Medicine Information (CMI) leaflet and discuss possible adverse events.

The Serious Shortage Substitution Notices must be given effect under state or territory law before you can supply according to the specified substitution.

States and territories may also apply specific conditions to the pharmacist substitution, such as recording and prescriber communication requirements, the TGA said.

Olmesartan and prazosin tablets are used to treat high blood pressure, while prazosin is also used to treat prostate problems, Raynaud’s disease and certain types of heart failure.

Meanwhile, the TGA has also updated the database of section 19A approvals to import and supply medicines to address medicine shortages.

This database provides information on medicines not on the Australian Register of Therapeutic Goods (ARTG) that are approved for import and supply in Australia because:

  • there is a shortage of a medicine registered in Australia; and
  • the medicine is needed in the interest of public health.

The most recent updates include products listed to replace Neo-Mercazole carbimazole 5mg tablet bottle and Minims Prednisolone Sodium Phosphate 0.5% 5mg/mL eye drops.


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