Australian Society for Parenteral and Enteral Nutrition

For the second time in 2 years an Australia-wide shortage of intravenous multivitamins (MVI-12 and MVI-Paediatric) has developed. The Australian supplier, Rhone-Poulenc Rorer has notified us that no further new supplies of MVI-12 and MVI-Paediatric will be available for a prolonged period. Current stocks of MVI-Paediatric will be sold up until the expiry date of 1/4/99. As MVI-12 and MVI-Paediatric are the only intravenous multivitamin preparations currently registered in Australia, this presents a serious problem, particularly for patients requiring long-term parenteral nutrition therapy. Alternative supplies of intravenous multivitamins are being actively investigated. Therapeutic Goods Administration approval for alternative intravenous vitamin preparations is currently being sought as a matter of urgency. AuSPEN will be working on your behalf to assist in the facilitation of this process. Until this multivitamin shortage is resolved we would like to propose the following strategies which may minimize the impact of this problem for your patients.

Strategies to reduce the impact of the intravenous multivitamin shortage

• Use oral vitamin preparations whenever possible. Patients who have severe gastrointestinal malabsorption may still require parenteral vitamins. The importance of compliance to oral vitamins may need to be stressed to patients who are not used to taking these medications orally.

• Remember Thiamin Thiamin deficiency can develop within weeks if long-term PN patients do not receive multivitamins. This can result in death due to heart failure. An intravenous preparation of thiamin is available.

• Folate deficiency Long-term PN patients who have not received folate for 4-5 weeks may develop megaloblastic anaemia. An injectable form of folate is available.

• Conserve MVI-12 by reducing daily dose OR administering three times a week

• Do not use MVI-Paediatric for adult patients. MVI-Paediatric is also currently in short supply. MVI-Paediatric is the only intravenous multivitamin preparation suitable for paediatric patients, therefore the stocks should be preserved.

• Monitor for early signs of vitamin deficiency.

• If a multivitamin preparation is needed and not available,
  • Use an alternative intravenous multivitamin preparation not currently registered in Australia. An explanation of the application process is given below.

  • Individual vitamin preparations can be administered. Suggested doses for adults include:

    Thiamin	50mg IV at least three times a week
    Folate	0.4-1.0mg IV daily
    Ascorbic Acid	1000mg IV daily
    Cynaocobalamin	100mcg IM or SQ monthly
    Pyridoxine	5-10mg IV daily

Alternative intravenous parenteral vitamin preparations

• Mechanisms to obtain alternative intravenous multivitamin preparations

  There are a number of mechanisms under the Therapeutic Goods Act whereby multivitamin preparations that are not currently registered in Australia can be supplied legally during this shortage of MVI-12 and MVI-Paediatric. The following preparations will be available via these mechanisms:

  • Cernevit (Baxter) : for adults and children > 11 years
  • Vitalipid N and Soluvit N (Pharmacia/Upjohn) : neonates and children < 11 years

  The vitamin contents of these preparations compared to MVI-12 and MVI-Paediatric are shown in tables following. The two mechanisms under the Therapeutic Goods Act by which these preparations are available include:

  • Category A patients If a doctor believes that a patient is seriously ill with a life threatening condition, he or she is able to prescribe an unregistered product without the approval of the TGA. A life threatening condition is defined as "one in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment". The prescriber is required to complete a Category A Use Notification Form (available from the TGA) and forward this to (i) the sponsor company and (ii) the TGA. While this is suitable for practitioners caring for relatively small numbers of patients it may be cumbersome for those practitioners who routinely care for large numbers of PN patients.

  • Authorised Prescribers Section 19(5) of the Therapeutic Goods Act indicates that the TGA can authorise individual medical practitioners to prescribe unapproved products without the need for individual patient approval. In order to become an authorised prescriber for IV multivitamins the prescriber would need to be either:
    • Working in a hospital and have the approval of the Ethics Committee of that hospital for use of this unapproved product
    • Be a Specialist and endorsed by a relevant medical college or Society.
      AuSPEN has the authority to provide this endorsement. Individual medical practitioners who are members of AuSPEN can apply to AuSPEN for endorsement for the use of alternative intravenous multivitamins under subsection 19(5) of the Therapeutic Goods Act. Medical practitioners who are not members of AuSPEN but regularly care for patients receiving PN therapy may also apply to AuSPEN for endorsement. In this situation additional supportive documentation will be required. Further information and necessary documentation is available by contacting Dr. Julie Bines (see below).

Alternative intravenous multivitamin preparations available through the above mechanisms:

• Adults and children over 11 years of age An alternative to MVI-12 is Cernevit (Baxter). Cernevit is a multivitamin preparation of both water- and fat- soluble vitamins (except vitamin K). The normal daily recommended dose is 5 mls/day. Cernevit may be included in the composition of parenteral nutrition mixtures including carbohydrates, amino acids, electrolytes, trace elements and lipids, provided that compatibility and stability have been confirmed. Comparison of the vitamin content of Cernevit with MVI-12 is tabled below.

  VITAMIN	MVI-12 (10ml)	Cernevit (5ml)	AuSPEN Guidelines 1999
  Vitamin A IU	3,300	3,500	1000
  Vitamin D IU	200	220	5
  Vitamin E IU	10	11.2	10
  Vitamin K mcg	None	None	None
  Vitamin C mg	100	125	100
  Thiamin (B1) mg	3	3.52	3
  Riboflavin (B2)mg	3.6	4.14	3.6
  Niacin (B3) mg	40	46	40
  Pantothenic Acid (B4) mg	15	17.25	15
  Pyridoxine (B6) mg	4	4.54	4
  Cynanocobalamin (B12) mcg	5	6	5
  Biotin mcg	60	69	60
  Folic Acid mcg	400	414	400

• Children < 11 years of age including infants and neonates An alternative to MVI-Paediatric is a combination of Soluvit N (water-soluble vitamin preparation) and Vitalipid N (fat-soluble vitamin preparation) (Pharmacia/Upjohn). Vitalipid N should only be added to Intralipid. Soluvit N can be added to the carbohydrate/amino acid solution or to Intralipid. However, there are early reports suggesting that addition of both Soluvit N and Vitalipid N to the Intralipid solution may help conserve fat soluble vitamins A and E. The comparison of the vitamin content of Soluvit N and Vitalipid N with MVI-Paediatric is given in the table below. The suggested dose is Soluvit N 1ml/kg/day to a maximum dose of 10ml/day PLUS Vitalipid N 4ml/kg/day to a maximum dose of 10ml/day.

  VITAMIN	MVI-Paediatric 2ml/kg/day	Soluvit N 1ml/kg/day	Vitalipid N 4ml/kg/day	AuSPEN Guidelines 1999
  Vitamin A IU	920		920	1453
  Vitamin D IU	160		160	160
  Vitamin E IU	2.8		2.8	2.8
  Vitamin K mcg	80		80	80
  Vitamin C mg	32	10		25
  Thiamin (B1) mg	0.48	0.32		0.35
  Riboflavin (B2)mg	0.56	0.36		0.15
  Niacin (B3) mg	6.8	4		6.8
  Pantothenic Acid (B4) mg	2	1.5		2
  Pyridoxine (B6) mg	0.4	0.4		0.18
  Cynanocobalamin (B12) mcg	0.4	0.5		0.3
  Biotin mcg	8	6		6
  Folic Acid mcg	56	40		56

AuSPEN is working hard to minimize the impact of these shortages of intravenous multivitamin on your patients. Updates on the progress of this shortage can be obtained through the AuSPEN website (www.south.com.com.au/~hartley/home.htm) and the AuSPEN Newsletter.

Document date : MARCH 1999

Dr. Julie Bines
President,AuSPEN
Department of Gastroenterology and Clinical Nutrition
Royal Children's Hospital
Flemington Rd
Parkville 3052 Telephone: 03-9345-5060
FAX: 03-9345-6240
Email: bines@cryptic.rch.unimelb.edu.au