Memorandum – for internal use only
To
[email address]
CC
TGM, Mental Health; Manager &
Team Leader CM;
From
Trish Mahoney
Subject
Dexamfetamine tabs 5mg – Potential
stock issue
Date
16/11/2015
__________________________________________________________________________
Patient Group Risk
Issue
Supplier
PSM t/a API
Brand
PSM
Therapeutic Group
Nervous System
Chemical
Dexamfetamine maleate
Presentation
Tablet
Strength(s)
5mg
Contractual Status
Sole Supply
Date
16/11/2015
Pharmaceutical Use & Original Decision Criteria
Dexamfetamine sulphate 5 mg tablets are indicated in the treatment of well-established and
proven narcolepsy. It is also indicated for children with refractory hyperkinetic states under
the supervision of a physician specialising in child psychiatry
Background
PSM/API advised 3/11/2015 that it would be OOS of dexamfetamine tabs if an export licence
was not received urgently. At that time PSM/API had 4 weeks stock, and suggested limiting
orders.
PHARMAC staff contacted Medicines Control to expedite the licence and the licence was
received by PSM/API on 10 November 2015. This allowed PSM/API to request manufacture
and delivery of the active ingredient (dexamfetamine) which is expected to be received early
December, and then manufacture/packaging and delivery of product would take up to 7 days.
This means that there is a potential for there to be stock shortages for some patients in early
December 2015 until expected resumption of supply week ending 20/12/2015
PHARMAC staff will be following up around PSM/API’s application for licences to ensure that
the situation does not arise again.
Usage Data Units/Month
57,000 tabs
Demographic
00 to 09
147
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10 to 19
242
20 to 29
195
30 to 39
134
40 to 49
99
50 to 59
51
60 to 69
26
70 to 79
11
80 to 89
5
90 and Over
1
~530 prescriptions; 760
Prescriptions/Month
Gender
Male & Female
dispensings
4T
Stock Situation
Stock Availability
Potential Out of Stock
Outage From 7/12/2015
Expected Duration
1 - 7 days
Restock Date 11/12/2015
Recall Status
Not Applicable
Recall Level
Not Applicable
There appear to be limited alternative therapeutic options for patients. The main alternative
option is methylphenidate, however our data indicate that 50%-60% of the patient group has
already been prescribed methylphenidate and moved to dexamfetamine. We note that any
move to a new medication would require a new Special Authority and/or new prescription
and therefore a visit to prescriber.
PHARMAC’s Management Plan
Options
Restrict sales from PSM t/a API, and advise wholesalers of issue to
limit orders; issue a letter to prescribers asking for Rxs to be amended
to 15+15 till 1 Jan 2016. Note to pharmacists requesting dispensings
be restricted.
PSM/API are preparing a letter for the market for PHARMAC review to
advise of supply issue.
Alternate Product 1
4T
Current Status
Supplier
4T
Comments
4T
Alternate Product 2
4T
Current Status
Supplier
4T
Comments
4T
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2 of 3
4T
Other Parties
4T
Recommendations/Actions/Updates
4T
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3 of 3
F A C S I M I L E
To
All community pharmacies
From
PHARMAC
Subject
TWO ISSUES - dexamfetamine sulfate
tablets & nystatin oral liquid
Date
23 November 2015
Pages
2
THIS FAX CONTAINS TWO ISSUES FOR PHARMACY INFORMATION
1. Potential supply issue for dexamfetamine sulfate tabs 5 mg
There is currently limited supply of dexamfetamine sulfate 5 mg tablets (PSM).
There is no immediate risk of an out-of-stock situation with dexamfetamine sulfate 5 mg tablets,
based on expected usage. However, there is very limited supply and further supplies are not
expected until mid-December 2015. The stock issue is due to logistic arrangements, which have
been resolved, but there may be a delay in resupply of stock.
There may be instances where you need to dispense dexamfetamine sulfate 5 mg tablets
in less than the prescribed volumes. This alteration would need to be endorsed by the
prescriber.
We have written to prescribers who have a large number of patients on dexamfetamine to request
they modify the dispensing period on their scripts, to dispense in 10 day lots as for other Class B
controlled drugs (eg morphine). As a Class B1 controlled drug pharmacists must ensure
dexamfetamine sulfate 5 mg tablets are dispensed as instructed by the prescriber in accordance
with the relevant legislation.
PHARMAC is working closely with the supplier, PSM (trading as API), to ensure supply is
maintained. PSM is managing the supply of dexamfetamine sulfate 5 mg tablets through limiting
the quantities purchased through wholesalers. We recommend that you contact PSM directly if
you are unable to procure sufficient supply for your patient:
NZ Freephone 0508 776 746
2. Change in price and subsidy for Aspen nystatin oral liquid 100,000 u per ml (Nilstat)
PHARMAC recently notified of a price change for the Nilstat brand of nystatin oral liquid 100,000
u per ml from 1 December 2015. This price change will now not occur until
1 February 2016.
This facsimile message contains information that is confidential and which may be subject to legal privilege. If
you are not the intended recipient, you must not peruse, use, disseminate, distribute or copy this message. If you
have received this message in error, please notify us immediately by facsimile or telephone (call us collect) and
return the original message to us by mail. Thank you.
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The price and subsidy in Section B and Part II of Section H of the Pharmaceutical Schedule for
Aspen Pharma’s Nilstat brand of nystatin oral liq 100,000 u per ml will be as follows from 1
February 2016:
Current subsidy
New subsidy
Chemical and presentation
Brand
Pack size
(until 31 Jan 2016)
(from 1 Feb 2016)
(ex-man., ex. GST)
(ex-man., ex. GST)
Nystatin oral liq 100,000 u per ml
Nilstat
24 ml OP
$3.35
$2.55
Please note that the December 2015 Pharmaceutical Schedule Update will show the price and
subsidy decrease for 1 December 2015, but this change has now been revoked.
Thank you for your patience.
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2 of 2
XX November 2015
Name
Position
Organisation
Address line 1
Address line 2
Address line 3
Dear
Dexamfetamine sulfate 5 mg tablets (PSM) limited supply.
We are aware you have prescribed dexamfetamine sulfate 5 mg tablets to at least XX patients in
the last few months. There is currently limited supply of dexamfetamine 5 mg tablets (supplied by
PSM (trading as API)). This is due to a delay in the arrival of the active ingredient into New
Zealand for manufacture.
We are working closely with PSM to ensure stock is manufactured as quickly as possible.
To assist in managing the limited available stock we ask you to:
• please specify on any dexamfetamine prescriptions that it be dispensed in amounts of 10
days supply, like you would for other Class B controlled drugs (ie morphine).
This will help ensure that stock of dexamfetamine sulfate 5 mg tablets continues to be available
until the new stock arrives, which is expected mid-December 2015. Pharmacists may contact you
to confirm prescription changes if they need to dispense less than the prescribed quantity due to
a stock shortage.
The Misuse of Drugs legislation does not allow pharmacists to modify dispensing frequencies on
controlled drug triplicate prescriptions, hence our request to you.
If you have any questions regarding supply of dexamfetamine sulfate 5 mg tablets, please contact
PSM’s customer services on:
NZ Freephone 0508 776 746.
Thank you for assisting us in managing this stock issue.
Yours sincerely
Nina Sawicki
Deputy Medical Director
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Document Outline
