TGA decides to knock back schedule amendment proposals for oral contraceptives and ibuprofen
The TGA scheduling delegate has decided against proposals to adjust the current scheduling arrangements for oral contraceptives, for ibuporfen and for some Chinese medicine preparations.
The only successful application at the June meeting of the TGA’s Advisory Committee on Medicines Scheduling (ACMS) – results of which were released late last week – was a proposal to amend the Schedule 4 entry for the anti-inflammtory medicine bufexamac, to remove exceptions for suppositories and dermal use.
Two applicants had proposed to move substances used in oral contraceptive pills from Schedule 4 to
Schedule 3. These applications were to create a new S3 entry for ethinylestradiol, norethisterone, cyproterone, desogestrel, dienogest, drospirenone, estradiol, gestodene, mestranol and nomegestrol, and expand the current S3 entry for levonorgestrel.
Under the proposal, the eleven substances would also have be subject to requirements set out in Appendix M.
However this was rejected by the TGA delegate, who said “the use of oral contraceptive pills can cause significant adverse effects that are not consistent with over the counter medicines. These effects include weight gain, emotional anxiety, heavy bleeding and thromboembolism, particularly with increasing age”.
“I also note the Committee’s advice that these preparations can exacerbate the risks of cardiovascular disease (including stroke) – especially in women who are over 35, obese, smoke, have diabetes, have uncontrolled hypertension or get migraines with aura,” the delegate said.
“I am of the view that the adverse effects of oral contraceptive substances, and the potential for evolving risks over time, are significant and require management by a medical practitioner”.
“Consumers can identify when they require (oral) contraception, but consultation with a pharmacist is not sufficient to ensure safety, particularly over extended periods of time”.
The ACMS also rejected a proposal to amend the Schedule 2 entry for ibuprofen to include a modified
release (MR) dosage form, each containing 600 mg (specifically) of ibuprofen in a primary pack
containing not more than 16 dosage units.
The proposal was for ibuprofen when labelled:
- with a recommended daily dose of 1200 mg or less of ibuprofen; and
- not for the treatment of children under 12 years of age.
“While use is generally safe, it [ibuprofen] has the potential to cause significant adverse effects – including an increased risk of gastrointestinal bleeding, heart attack, stroke and kidney damage. These risks are relatively low when the substance is taken as indicated, as acknowledged through the inclusion of several ibuprofen preparations in Schedule 2 (and general sale),” the delegate said.
“However, the current proposal relates to a modified release form, with different indications and patterns of use. As such, while the chemical safety profile is generally favourable, the dosing, uses and consumer awareness of these products require careful consideration”.
The delegate also noted that down-scheduling modified release preparations would result in a complex range of ibuprofen products in Schedule 2.
“These include 200 mg and 400 mg immediate release preparations, along with a 600 mg modified release preparation. Each has a unique set of administration instructions, which without pharmacist advice may heighten the risk of dosing errors.
I also note that Australian consumers are predominantly familiar with immediate release tablets. In the case of modified release preparations, a consumer could inadvertently administer the maximum daily dose of ibuprofen in a single dose if not appropriately advised by a pharmacist”.
In the current environment, I consider that consultation with a pharmacist is required to prevent overdose”.