You are here

Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March 2016

Scheduling medicines and poisons

12 May 2016

Book pagination

3.7 Loratadine

Part A - Interim decisions on scheduling proposals referred to an advisory committee (March 2016)

3. Advisory Committee on Medicines Scheduling (ACMS#17)

3.7 Loratadine

Referred scheduling proposal
  • To increase the pack size of unscheduled loratadine (10 mg or less) divided oral preparations from 5 dosage units to 10 dosage units when used in adults and children over the age of 12 years for the treatment of seasonal allergic rhinitis.
Scheduling application

General application. The reasons for the request were:

  • This application proposes amendments to the current Schedule 2 and Schedule 4 entries for loratadine to have the pack size increased both entries from 5 dosage units to 10.
  • Since its introduction for general sale in 2012, loratadine sales have increased by 6-fold without issue, suggesting a strong demand for the medicine outside of pharmacies for self-treatment of symptoms of rhinitis.
  • Market research suggests consumers plan their allergy medication purchases in advance and furthermore suggest they require greater than 5 days' supply of loratadine.
  • A larger 10 pack size aligns with consumer behaviour for accessing more than 5 days' supply, which would make it more convenient and cost effective for a consumer.
  • Consumers use loratadine on an 'as needed' basis over the seasonal period of hay fever. Other 'as needed' medications, such as ibuprofen and paracetamol are available in larger pack sizes as general sales medicines.
  • Symptoms of seasonal hay fever may last between 4 days to 4 weeks.
  • Loratadine has minimal toxicity as compared to some analgesics.
  • Loratadine has a good safety profile, a wide therapeutic index with no unusual neurological symptoms or toxicity seen in accidental overdoses. There is a low incidence of adverse reports for Loratadine. Prolonged administration of loratadine has shown no clinically significant heart complications. Loratadine has no known potential for abuse or dependency.
  • Loratadine has a unique efficacy and safety profile which supports a larger pack size from non-pharmacy outlets with minimal risk.
  • Internationally, countries which have an equivalent regulatory system to Australia loratadine has been approved as general sales medicine without a pack size limit or is available in a much larger pack size.
Specific questions raised by the delegate

The delegate asked the committee the following question:

  1. Is a pack size of 10 dosage units appropriate for general sale?
Substance summary

Loratadine is a potent, long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity1-2. Its efficacy as a first line treatment for the symptomatic treatment of allergic rhinitis and allergic skin conditions such as urticaria (hives) has long been established. Once-daily treatment as an effective control for allergic rhinitis has been available in Australia and globally for more than 20 years.

Scheduling status

LORATADINE is currently listed in Schedules 2 and 4.

SCHEDULE 2

LORATADINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

  1. in a primary pack containing 5 dosage units or less; and
  2. labelled with a recommended daily dose not exceeding 10 mg of loratadine.

SCHEDULE 4

LORATADINE except:

  1. when included in Schedule 2; or
  2. in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
    1. in a primary pack containing 5 dosage units or less; and
    2. labelled with a recommended daily dose not exceeding 10 mg of loratadine.
Relevant scheduling history

At the May 1992 National Drugs and Poisons Scheduling Committee (NDPSC) meeting, the Committee recommended Loratadine be included in Schedule 4.

In November 1992, the NDPSC declined a proposal to reschedule loratadine from Schedule 4 to Schedule 3, due to concerns about cardiac side effects.

In April 1994, the NDPSC rescheduled loratadine tablets to Schedule 3, and loratadine syrup to Schedule 3 in November 1995.

In May 1997, the NDPSC deferred a down-scheduling application for loratadine from Schedule 3 to Schedule 2, due to an article that was published in the Lancet, raising concerns of cardiovascular safety. In August 1997 meeting, the NDPSC confirmed the current Schedule 3 entry.

In February 1999, the NDPSC considered the rescheduling of loratadine from Schedule 3 to Schedule 2. The NDPSC agreed that loratadine in preparations for oral use should be rescheduled, and that the restriction to ‘only therapeutically active ingredient’ should no longer apply. In November 1999, the NDPSC confirmed the down-scheduling of loratadine to Schedule 2.

After discussions in February 2012, the Schedule 2 and Schedule 4 entries were amended to exempt solid dose oral preparations containing 10 mg or less of loratadine in packs containing no more than 5 dosage units for the treatment of seasonal allergic rhinitis. The exemption for treatment is for adults and children over the age of 12 years.

In July 2013, the ACMS considered a proposal to reschedule loratadine from Schedule 2 to unscheduled in oral preparations containing 10 mg or less in packs containing not more than 5 daily doses for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over, with a warning label recommending a daily dose not exceeding 10 mg loratadine for adults and children with body weight over 30 kg, or recommended daily dose not exceeding 5 mg loratadine for children with body weight 30 kg and under. The Committee recommended that the current scheduling of loratadine remained appropriate, due to the risk of inappropriate use and delay in correct diagnosis, the lack of data on adverse effects/experiences/poisoning in Australia, no substantial public health benefit in exempting from schedules and a complicated dosage regimen with risk of inappropriate dosing.

Public pre-meeting submissions

Five submissions were received. Three submissions supported the proposal. The main points were:

  • The safety of loratadine is well-established, there is no evidence of misuse and abuse when in Schedule 2 or unscheduled;
  • Proposal that similar changes should be considered for other 2nd generation antihistamines where their exclusion from scheduling is currently limited to 5 dosage units, such as cetirizine and fexofenadine, which are of the same therapeutic class.

Two submissions opposed the proposal. The main points were:

  • Increase public health risk due to lack of access to advice from a health professional, particularly for consumers that are pregnant and/or breastfeeding, using loratadine for purposes other than those described and that loratadine has potential to induce cognitive impairment and sedation;
  • Small packs sufficiently accommodates the needs of consumers who may require rapid and short term relief and an increase is not warranted from a perspective of good clinical practice and optimal therapeutic outcomes.
Summary of ACMS advice to the delegate

The committee advised that the Schedule 2 and Schedule 4 entries for loratadine be amended to increase the unscheduled loratidine dosage from 5 dosage units to 10 dosage units in divided oral preparations when used in adults and children 12 years of age and over for the treatment of seasonal allergic rhinitis. The members noted that the voluntary labelled statement to seek medical advice after 5 days of treatment is inconsistent with a 10 day pack size.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the recommendations comprised the following:

  • The risk of the use of the substance: not use of alternative treatments, misdiagnosis. The benefit of ease of accessibility, customer preference. Loratadine has a positive safety profile with low toxicity even at doses greater than recommended.
  • Loratadine is currently available as an unscheduled pack for seasonal allergic rhinitis. It is available in a majority of similar countries overseas over the counter for seasonal allergic rhinitis. It is also available over the counter in some countries for additional indications, as well as an unrestricted pack size.
  • Loratadine has a well-established toxicity profile. Post market use in Australia and overseas has shown a positive risk-benefit profile. Adverse reactions are similar to placebo and no clinically significant drug interactions are noted.
  • The proposed unscheduled pack includes a dose suitable for adults and children over 12 years of age only. The packaging and labelling for the current unscheduled pack is suitable.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors22;
  • Other relevant information.
Delegate's interim decision

The delegate has considered and agrees with the advice and reasons of the ACMS, to amend the current schedule 2 and 4 entries for loratadine.

The proposed implementation date is 1 October 2016.

The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance.

Schedule 2 - Amend entry

LORATADINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

  1. in a primary pack containing 10 dosage units or less; and
  2. labelled with a recommended daily dose not exceeding 10 mg of loratadine.

Schedule 4 - Amend entry

LORATADINE except:

  1. when included in Schedule 2; or
  2. in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
    1. in a primary pack containing 10 dosage units or less; and
    2. labelled with a recommended daily dose not exceeding 10 mg of loratadine.

Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

Book pagination