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Scheduling delegate's final decisions, June 2016

Scheduling of medicines and poisons

23 June 2016

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2.5 Loratadine

Part A - Final decisions on matters referred to an expert advisory committee

2. Scheduling proposals referred to the March 2016 meeting of the Advisory Committee on Medicines Scheduling (ACMS#17)

2.5 Loratadine

Referred Delegate's scheduling proposal

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 12 years of age and over for the treatment of seasonal allergic rhinitis.

Applicant's application and 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 12 years of age and over for the treatment of seasonal allergic rhinitis.

The applicant's reasons for the request were:

  • To amend 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.
Substance summary

Loratadine is a potent, long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity. 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.

Current 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.
Scheduling history

At the May 1992 NDPSC meeting, the Committee recommended Loratadine be included in Schedule 4, and declined to down schedule to schedule 3 in November 1992 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.

Pre-meeting public 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.

The public submissions are available at Public submissions on scheduling matters.

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 loratadine 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 ACMS advised an implementation date of 1 October 2016.

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 advice 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;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors22;
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is 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 proposed implementation date is 1 October 2016.

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 advice 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.
Public submissions on the interim decision

No submissions were received.

Delegate's final decision

The delegate has confirmed the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the final decision and reasons are in keeping with those for the interim decision.


Footnotes

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

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