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13 February 2008

Changes to methylphenidate and dexamphetamine Special Authority

Outline of the changes

We’re making some changes to the Special Authority forms for the Attention Deficit and Hyperactivity Disorder (ADHD) treatments methylphenidate and dexamphetamine. From 1 April 2008, there will be separate Special Authority forms for methylphenidate and dexamphetamine. In addition, the way subsidy for these treatments can be accessed through specialist referral is clarified.

What the changes will mean

For patients The changes shouldn’t have any impact on people prescribed methylphenidate or dexamphetamine. For health professionals Special Authority applications for methylphenidate or dexamphetamine will need to be made on the relevant individual form for each medicine. There is also a minor change to the form, changing the order of the applications for each indication. For both initial and renewal applications for ADHD in patients aged 5 years or over, medical practitioners who are not psychiatrists or paediatricians must provide the name of the specialist who is recommending treatment. The specialist needs to have been consulted and recommended treatment within the last two years for the application to be valid. Existing Special Authority approvals continue to be valid until expiry.

More information

More detailed information on these changes can be found on the following pages. If you have any queries about these changes, you can call our toll free number (9am to 5pm) on 0800 66 00 50.

Pharmaceutical Management Agency

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Level 14, Cigna House, 40 Mercer Street, PO Box 10-254, Wellington 6143, New Zealand Phone: 64 4 460 4990 - Fax: 64 4 460 4995 - www.pharmac.govt.nz

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Why the changes are happening

The Special Authority forms are being split to enable smoother processing by HealthPAC. During consultation on several proposed changes to the forms (see below), we received sufficient feedback around the use of recommending specialists’ names to suggest that clarifying the wording around this is warranted. This is reflected in the changes to the wording for applications for ADHD for patients aged 5 years or over. The changes will be published in the Pharmaceutical Schedule as shown below. Changes from the existing wording is shown in bold (additions) and strikethrough (deletions):

Applications only from a paediatrician, psychiatrist or general any other medical practitioner on the recommendation of a relevant specialist. Either: Applicant is a specialist paediatrician or psychiatrist; or Both: Applicant is a medical practitionerGP and a specialist has recommended treatment confirms that a relevant specialist has been consulted within the last 2 years and has recommended treatment for the patient; and Provide name of a the recommending specialist Note that ‘on the recommendation of a relevant specialist’ has been added to the definition of renewal applicant types to be consistent with the initial application forms. Approvals for both initial and renewal applications will still be for 24 months.

What changes were originally proposed?

On 23 November 2007 we sent out a consultation letter seeking feedback on our proposal to make changes to the methylphenidate/dexamphetamine Special Authority forms. We proposed to: • add a “Retail pharmacy – Specialist” restriction to the listing of dexamphetamine and methylphenidate, to bring the subsidy requirements in line with the Misuse of Drugs Regulations 1977; replace the existing Special Authority with two separate Special Authorities, one for each pharmaceutical; and amend the criteria relating to specialist treatment recommendation (including adding a requirement for patients to have seen a specialist in person within the past 18 months).

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Our proposal was that the first two changes would take effect from 1 April 2008, and the amendment relating to the specialist treatment recommendation would take effect from 1 August 2008.

What feedback was received?

We appreciate all the feedback we received and acknowledge the time people took to respond. All consultation responses were considered in their entirety in making a decision on the proposed changes. Some key themes raised during consultation and our response to the feedback are outlined on the following page.

Pharmaceutical Management Agency

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Level 14, Cigna House, 40 Mercer Street, PO Box 10-254, Wellington 6143, New Zealand Phone: 64 4 460 4990 - Fax: 64 4 460 4995 - www.pharmac.govt.nz

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Theme There was sufficient feedback around the use of recommending specialists’ names to suggest that clarifying the wording around this is warranted. We received feedback that the changes should be accompanied by comprehensive notification and explanation. Several consultation responders didn’t agree with our interpretation that it is a legal requirement for a prescription written by a GP to be endorsed with the name of the recommending Specialist and date of recommendation. Consultation responses also highlighted the logistical problems associated with adding a Retail pharmacy-Specialist restriction. There was mixed feedback around the proposed requirement for patients to have seen a specialist within the previous 18 months. Several responders felt it was important for patients to receive ongoing specialist review. Others felt that if patients were well stabilised on therapy they could be appropriately managed in primary care. Many responders raised the issue of access to specialists, and questioned the capacity of specialist services to cope. One responder commented that it would be helpful to have the ADHD applications before the narcolepsy applications on the form.

Response

This is reflected in the new wording.

We agree and will be communicating these changes widely. We acknowledge this feedback and as a result have decided not to implement this part of the proposal at this time. We are continuing to work with the Ministry of Health on this issue.

Given the potential issues regarding access to services we have decided not to implement this part of the proposal at this time.

The new forms will have the applications re-ordered so that ADHD applications come before narcolepsy.

Pharmaceutical Management Agency

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Level 14, Cigna House, 40 Mercer Street, PO Box 10-254, Wellington 6143, New Zealand Phone: 64 4 460 4990 - Fax: 64 4 460 4995 - www.pharmac.govt.nz