Statement attributed to Greg Hunt, Minister for Health
“All aspects of patient care, including recommendations about appropriate treatments and interpretation of PBS eligibility, are the responsibility of the prescribing doctor. Clinical discretion, in accordance with the current clinical guidelines, is expected to be used when prescribers select the most appropriate medicine for their patient.
Patients who are experiencing issues with their medicines, including side effects, should contact their doctor or community pharmacist as a priority.
Prescribing criteria for medicines are administered by Australia’s medicines regulator, the Therapeutic Goods Administration (TGA). By law, medicines can only be listed on the PBS following a recommendation from the medical experts on the Pharmaceutical Benefits Advisory Committee (PBAC). The Government has a policy to list all medicines recommended by the independent PBAC.
Subsidy through the PBS is only provided when the medicine is prescribed and dispensed in accordance with the requirements of the TGA and also the PBS listing criteria recommend by the independent medical experts on the PBAC.
The Government is funding a program through NPS MedicineWise which aims to support the safe use of pregabalin and other pain medications, this program has so far reached over 30,000 doctors.”
Statement attributed to a spokesperson for Pfizer
"Patient safety and the appropriate use of our medicines is of the utmost importance to Pfizer.
Pregabalin is sold in Australia by a number of different companies. When prescribed and administered appropriately, as per the approved product information for patients, pregabalin is an important, effective and well-tolerated treatment option for many people living with chronic neuropathic pain and epilepsy.
The efficacy and safety of this medicine has been demonstrated in a large number of robust clinical trials among thousands of patients in the approved indications.
In cases reporting abuse-related or dependence-related events where a medical history was provided, a prior history of substance abuse (drug or alcohol) or dependence, or nicotine dependence, was frequently reported. The Product Information explains to doctors that caution should be exercised in patients with a history of substance abuse, and the patient should be monitored for signs of abuse (e.g. the development of tolerance, dose escalation and drug-seeking behaviour). Please note that in November 2018, pregabalin underwent a critical review at the 41st World Health Organisation (WHO) Expert Committee on Drug Dependence (ECDD) in Geneva. The WHO ECDD recommended keeping pregabalin under surveillance. Pfizer is pleased that the United Nations’ Commission on Narcotic Drugs endorsed the WHO Expert Committee on Drug Dependence’s (ECDD) decision (published in February 2019) to keep pregabalin under surveillance.
As per the pregabalin prescribing information, all antiepileptic drugs may increase the risk of suicidal thoughts or behaviour in patients taking these medications for any indication. It is important to note that recent reviews of suicidal behaviour and overdose as part of the European Medicines Agency (EMA) 2019 pregabalin and (gabapentin) Periodic Safety Update Report (PSUR) did not reveal any new significant safety information."