Questionnaire150703(d).doc

OFF-LABEL & UNLICENSED

PRESCRIBING

Section 1: Clinical Scenarios

Section 2: Definition of “Off-label” and “Unlicensed”

Section 3: Opinions and Practices

Section 4: Some Information About You

Please place the completed questionnaire in the enclosed reply-paid envelope, or post to:

Off-label and unlicensed prescribing project

Department of Pharmacy Practice

Monash University (Parkville Campus)

Reply Paid 71413, Parkville VICTORIA 3052.

OFF-LABEL AND UNLICENSED PRESCRIBING

Commonwealth Government Statistical Clearing House Approval number

Please read prior to completing this questionnaire.

 This questionnaire should take no more than 15 minutes to complete.

 Please read the scenarios carefully and circle your response on the rating scale.

 Please accept the diagnostic decisions at face value and respond to each situation as it is described. Respond according to your opinion of what the doctor described in the scenario has done and not according to what you would have done.

 The four statements are the same in all 10 scenarios.

 Relevant product information (PI) from the MIMS is provided with each scenario.

 Note that the scenarios are concerned with information contained in the

PI and not PBS restrictions.

 Please complete all questions.

2



Section 1: Clinical Scenarios

Please read the scenario carefully and circle your response on the rating scale.

Please accept the diagnostic decisions at face value and respond to the situation as it is described.

Respond according to your opinion of what the doctor described in the scenario has done.

Case scenario 1

A doctor in a general practice sees an 8 year old boy who is experiencing difficultly hearing due to wax impaction. He tells the boy’s parents to use Coloxyl  paediatric drops – warm it and instill a few drops into the ear at night. He mentions that it’s not normally used for this purpose but that he has seen this used before during his training.

Statement Strongly agree Strongly disagree

The doctor has behaved ethically.

This prescribing represents benefits for the patient.

1

1

2

2

This prescribing represents risks to the patient. 1 2 3

The doctor has prescribed this drug appropriately. 1 2 3

Coloxyl



Drops:

Composition Poloxalkol.

Indications Faecal softener for use in infants and young children.

Dosage and Administration Children. Over 3 years. use Coloxyl tablets 50 mg.

Presentation Drops, 10% (chocolate flavour): 30 mL.

(Source: MIMS Online version 1.1, [1 May 2003 – 31 July 2003])

3

3

4

4

4

4

5

5

5

5

3






Statement

Case scenario 2

A doctor in a general practice sees a 1 year old with a skin allergy. The doctor decides to prescribe promethazine elixir. The doctor is aware of the age recommendations contained in the product information. This is the first time that the doctor has prescribed promethazine elixir to a child of this age. The doctor explains the reason for use of the elixir to the parents and tells them that it is normally only given to children 2 years and above.

Strongly agree Strongly disagree



This prescribing represents risks to the patient.

1

1

1

2

2

2

3

3

3

4

4

4

The doctor has prescribed this drug appropriately. 1 2 3 4

Promethazine elixir (from Phenergan



):

Contraindications/Precautions Use in children. This product should not be used in children under 2 years of age, because safety of such use has not been established.

(Source: MIMS Online version 1.1, [1 May 2003

– 31 July 2003])

5

5

5

5

4






Statement

Case scenario 3

An obstetrician in a hospital practice decides to prescribe a 25 year old woman nystatin vaginal cream as a prophylaxis for vaginal candidiasis during a course of antiobiotic treatment. The doctor is aware that this use differs to that listed in the product information. The doctor talks about the use of the cream with the woman.

He mentions that the cream is normally used to treat candidiasis however he has heard about its prophylactic use from recent conferences.





1

1

1

2

2

2

The doctor has prescribed this drug appropriately. 1 2

Nystatin (from Nilstat



Vaginal Cream):

Indication The cream is indicated in the local treatment of vulvovaginal candidiasis.


3

3

3

3

4

4

4

4

5

5

5

5

5






Statement

Case scenario 4

A doctor in a general practice sees a 21 year old man who presents with common warts on the hands. The man has used over-the-counter wart preparations in the past, all of which have not helped. The doctor decides to prescribe Aldara

 for the warts. The doctor has read papers on the use of Aldara



cream

in this way. The doctor talks about the use of Aldara



cream with the man and mentions that it’s not normally used for this purpose.





1

1

1

2

2

2

3

3

3

The doctor has prescribed this drug appropriately. 1 2 3

Imiquimod (from Aldara



Cream):

Indications Treatment of external genital and perianal warts/ condyloma acuminata in adults.


– 31 July 2003])

4

4

4

4

5

5

5

5

6






Statement

Case scenario 5

A geriatrician in a hospital attends to a 76 year old man with dementia. The man suffers from symptoms of restlessness and agitation. The geriatrician decides to prescribe olanzapine tablets for the restlessness and agitation. She has noticed other doctors in the hospital prescribing olanzapine for this indication. She is aware that this use differs to that listed in the product information.





1

1

1

2

2

2

3

3

3

4

4

4


Olanzapine (from Zyprexa



):

Indications Treatment of schizophrenia and related psychoses. Short-term treatment of acute manic episodes associated with bipolar I disorder.

Presentation Zyprexa Tablets (white, coated), 2.5 mg, 5 mg, 7.5 mg, 10 mg: 30's. Zyprexa Zydis wafers

(yellow), 5 mg, 10 mg: 28's.


– 31 July 2003])

5

5

5

5

7






Statement

Case scenario 6

A doctor in a general practice attends to an 8 year old boy suffering an epileptic seizure. The doctor decides to administer parenteral Valium



rectally. The doctor is familiar with the use of Valium



in this manner and knows that there is no rectal preparation available.




1

1

2

2

3

3

4

4

This prescribing represents risks to the patient. 1 2 3 4


Valium



:

Composition Active. Diazepam.

Presentation Tablets, 2 mg (white, scored, marked ROCHE 2 on reverse): 50's; 5 mg (yellow, scored, marked ROCHE 5 on reverse): 50's.

Ampoules, 10 mg/2 mL: 5's.


– 31 July 2003])

5

5

5

5

8






Statement

Case scenario 7

A doctor in a general practice diagnoses a 33 year old woman with insomnia. The doctor prescribes amitriptyline tablets for her insomnia. He recalls seeing amitriptyline tablets prescribed for this indication in the past but has not prescribed this way before. The doctor is aware that this use differs to that listed in the product information.





The doctor has prescribed this drug appropriately.

Amitriptyline (from Tryptanol



):

Indications Treatment of major depression.

Nocturnal enuresis where organic pathology has been excluded.


– 31 July 2003])

1

1

1

1 2

2

2

2

3

3

3

3

4

4

4

4

5

5

5

5

9






Case scenario 8

A doctor sees a 6 year old girl with a broken arm in the emergency department of a hospital. He decides to prescribe a drug that he’s familiar with and chooses paracetamol liquid 20mg/kg/dose 4-6 hourly when necessary for the pain. The doctor is unaware that this dose differs to that listed in the product information.

Statement Strongly agree Strongly disagree



1

1

2

2

This prescribing represents risks to the patient. 1 2

The doctor has prescribed this drug appropriately. 1 2

Parcetamol liquid (from Panadol



):

Dosage and Administration

Repeat four hourly up to four times a day if required.

Recommended dosages are based on paracetamol 15 mg/kg bodyweight.


– 31 July 2003])

3

3

3

3

4

4

4

4

5

5

5

5

10






Statement

Case scenario 9

A psychiatrist in a hospital practice increases the dose of moclobemide to 375mg twice daily for a severely depressed 30 year old. The psychiatrist has prescribed at this dose before. She is unaware that this dose differs to that listed in the product information.





1

1

1

2

2

2

3

3

3

4

4

4


Moclobemide (from Aurorix



):

Dosage and Administration The recommended dose range is 300 to 600 mg/day.

Presentation Tablets, 150 mg (oval, cylindrical, pale yellow, film coated, scored): 10's; 60's; 300 mg

(oval, cylindrical, white to yellowish white, film coated, scored, marked ROCHE 300): 10's, 60's.


5

5

5

5

11






Statement

Case scenario 10

A doctor in a general practice sees a 30 year old woman who presents with muscle pain, a result of a sporting injury. The doctor decides to prescribe rofecoxib tablets. The doctor has not prescribed rofecoxib for this indication before. The doctor is unaware that the indication differs to that listed in the product information.





1

1

1

The doctor has prescribed this drug appropriately. 1

Rofecoxib tablets (from Vioxx



):

Indications Symptomatic treatment of osteoarthritis and rheumatoid arthritis.


2

2

2

2 3

3

3

3

4

4

4

4

5

5

5

5

12



Section 2: Definition of “Off-label” and “Unlicensed”

D e f f i i n i i t t i i o n o f f o f f f f l l a b e l l : :

Off-label describes the use of medicines outside the terms of their manufacturer’s product information (e.g. the PI contained in MIMS). Use of a medicine may be offlabel for a number of reasons, including:

 dose – for example, salbutamol inhaler prescribed more frequently than 2 puffs four hourly

 indication

 age

 route

 contraindication

 duration of therapy.

D e f f i i n i i t t i i o n o f f u n l l i i c e n s e d : :

Unlicensed drug use describes the situation where the medicine is used without a manufacturer’s product information (i.e. there is no PI available in the MIMS). This can occur in a variety of ways and include:

 modifications to a licensed medicine – for example, the crushing of commercially available tablets to formulate a suspension

 manufacture of a licensed medicine under a ‘specials’ manufacturing license

 manufacture of an unlicensed medicine under a ‘specials’ manufacturing license

 use of chemicals as medicine

 use of a medicine before the granting of a license, such as in clinical trials

 imported medicines.

Note: Off-label and unlicensed prescribing is concerned with information contained in the PI and not PBS restrictions.

13



Section 3: Opinions and Practices

For the following statements, in relation to OFF-LABEL prescribing, please indicate  the response that most reflects your opinion.

Please refer to page 13 for definition of “off-label”.

Off-label prescribing is inappropriate………........… ree q

Str on gl y ag ree

So me wh at ag re e

N ei th er

ag q q q ree

So no r me di wh sag at di sa gr ee ree

Str on gl y di sag

D on

't kn ow q q

     

I feel confident prescribing medicines in an off-label manner…………….….…………………...…..

Informing the patient/parent/carer is important if a medicine is prescibed in an off-label manner…..

The benefits of off-label prescribing outweigh the risks………………………….……………....…….…...…

Off-label prescribing is illegal……………………...…

     

     

     

     

For the following statements, in relation to UNLICENSED prescribing, please indicate  the response that most reflects your opinion.

Please refer to page 13 for d efinition of “unlicensed”.

The risks of unlicensed prescribing outweigh the benefits…………………...…………………………........…..

Unlicensed prescribing is legal practice…….............…

I am uncomfortable prescribing medicines in an unlicensed manner………………………………….....…..

Unlicensed prescribing is appropriate………………....

When prescribing in an unlicensed manner, informing the patient/parent/carer is unnecessary…..

ree q

Str o n g ly ag ree me wh q

So at ag re e

N ei th er

ag ree

So n o r d isag at d isa g re e me wh

Str ree o n g ly d isag

D o n

't kn o w q q q q

     

     

     

     

     

For the following statements, in relation to

OFF-LABEL and UNLICENSED prescribing, please indicate  the response that most reflects your practice.

I prescribe in an off-label manner………….……...…….

I prescribe in an unlicensed manner……..…............… q

Ver y o ft en q

Often q

So me ti mes q

Sel d o m q

N ever

    

    

14



Section 4: Some Information About You

Please fill in details or indicate  the most appropriate response.

Q1

Q2

Sex



Male



Female

Age _______ years

Q3

Q4

Post-code of main practice location ___________

Year of medical graduation



Q4.1 Country of graduation



Australia



SKIP to Q5



Overseas

Q4.2 If overseas , then please indicate (tick ONE only)



New Zealand



United Kingdom



Europe



America



Asia



Africa



Other

Q5 How long have you been practising in the Australian Health system?

_______ years

Q6 Post-graduate qualifications (please specify) ________________________________

_______________________________________________________________________

Q7

Q8

Type of practitioner (tick ONE only)



General Practitioner



Specialist

Type of practice (tick ONE only)



Private practice only



Private practice with hospital appointment



Staff hospital appointment

Q8.1 If private practice , then please indicate (tick ONE only)



Solo



2-4 doctors





5 doctors

Q8.2 If hospital appointment , then please indicate (tick ONE only)



Public



Private



Both

Q9 Please estimate the % of your working week that is spent in clinical practice?

________

Q10

Looking back on the last ONE week, please estimate the number of prescriptions you would have written _______ prescriptions/week

15



Please estimate the time taken to complete this questionnaire



minutes

Thank you for taking the time to complete this questionnaire.

Your assistance in providing this information is very much appreciated. If there is anything else you would like to tell us on the topic of off-label and unlicensed prescribing or about this survey, please do so in the space provided below.

Please place the completed questionnaire in the enclosed reply-paid envelope, or post to:

Off-label and unlicensed prescribing project

Department of Pharmacy Practice

Monash University (Parkville Campus)

Reply Paid 71413, Parkville VICTORIA 3052.

16

Questionnaire150703(d).doc

OFF-LABEL & UNLICENSED

PRESCRIBING

Please read prior to completing this questionnaire.

Please estimate the time taken to complete this questionnaire

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Thank you for taking the time to complete this questionnaire.

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OFF-LABEL & UNLICENSED

PRESCRIBING

Please read prior to completing this questionnaire.

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