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.
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.
In order to reduce the impact of these shortages on patients, the TGA has issued Serious Shortage Substitution Notices for each medicine. The notices allow pharmacists to make substitutions for prescriptions for specific strengths of medicines, replacing them with alternative strengths of the same medicine.
The notices 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 notices apply from 4 September 2020 until 31 December 2020. The TGA may lapse the notices prior to this date, if it becomes evident that 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.
Information for prescribers
Prescribers should be alert to the current shortage of olmesartan and prazosin tablets when prescribing to your patients.
Information for pharmacists
Use your 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.
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.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.
The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
