Advertising
Guidelines for Advertising Over-the-Counter (OTC) Medicines
Direct to the Consumer
December 2005
Introduction
These Guidelines are intended to provide advertisers with a practical
interpretation of current Medicines legislation to ensure consumers are
provided with a balanced presentation of the benefits and risks associated
with all medicines.
These Guidelines now incorporate provisions for 'Generic Risk/Benefit'and
'Generic Limitation' statements as well as 'Major Risk'information. This is
considered to fulfil those requirements under Regulation 8 covering
Appropriate Precautions, Contra-indications and Adverse Effects for OTC
Medicines consistent with their various classifications under Pharmacist Only,
Pharmacy or General Sale medicines.
What all OTC Medicine Advertisements must include to comply with the Advertising Requirements of the Medicines Act 1981 (sections 56 to 62) and the Medicines Regulations 1984 (regulations 7 to 11)
Basic Requirements
Additional Requirements
Other Considerations
1. Basic Requirements
 |
|||
| Name and Physical Form | Section 57 (1)(c) | ||
| The approved trade name and description as shown on the product label | |||
| Ingredient(s) Properly Named | Reg 8 (2) | ||
| Refer to the definition of "Appropriate designation" in the Medicines Regulations | |||
| Quantities of Active Ingredients | Reg 8 (1)(a) | ||
| Refer to the definition of "Appropriate quantitative particulars" in the Medicines Regulations | |||
| Authorized Use(s) | Reg 8 (1)(b) | ||
| Approved indication(s) for the medicine | |||
| Classification | Refer Note 1 | Reg 8 (3) | |
| e.g. 'Pharmacist Only Medicine, Pharmacy Medicine' conspicuously printed or clearly spoken | |||
| Name and Address of Advertiser | Section 59 | ||
| True name and address of the person for whom the advertisement is published | |||
| The italic summaries are for guidance only. For full wording the relevant section of the legislation should be consulted. | |||
Note 1
To ensure that consumers have no doubt about the classification of a
medicine the words " Pharmacist Only Medicine" or "Pharmacy Medicine" must be
'conspicuously' stated either visually or be clearly spoken.
Emphasis should also be given to an instruction to consumers to consult their
Doctor or Pharmacist (whichever is appropriate, depending upon the
classification) for further advice (see '(iv) Further Information Sources').
2. Additional Requirements
Appropriate Precautions, Contra-indications, Adverse Effects
The Medicines Regulations 1984 require any advertisement for a medicine to include consumer information about any appropriate precautions, contra-indications and adverse effects of that medicine. This information must be readily available to consumers. Therefore, medicine advertisements directed to consumers must, where appropriate : *
- state this information in a form that is both relevant to, and easily understood by, the consumer
- prominently direct the consumer to an easily accessible source of appropriate additional information.
The latter could include instructions for consumers to refer to
advertisements with full information concurrently appearing in other (print)
media; a toll free phone number; the product packaging; the advertiser's
Internet Website; the advertiser's postal address; brochures; or instruct
consumers to contact their doctor, pharmacist or other health professional.
Other consumer information referrals include the
Consumer Medicine Information (CMI)
Sheet or the Data Sheet which
can be found on this website under 'Information for Consumers' and
'Information for Health Professionals'.
* The extent to, or manner in which, information is made available to
consumers is dependent upon the advertising medium used.
For example in print, full disclosure of information about precautions,
contra-indications and adverse effects that is both relevant to, and easily
understood by the consumer would be considered appropriate. Advertisers are
encouraged also to direct consumers to other sources of additional
information.
It is sometimes impractical to convey all the risk information in a television
advertisement in a coherent way. In these circumstances it would be considered
appropriate to direct the consumer to an easily accessible source of
additional information . This does not, however, exempt the advertiser from
including in the advertisement information about major risks of which
consumers should be made aware. Such statements should be considered part of
the advertiser's social responsibility in providing balance to any product
benefit claims and to informing any specific consumer group of the
appropriateness of the advertised medicine.
It is important and responsible to inform the consumer that:
- There are risks to be considered
- There is further information available
- The use of the medicine should be discussed with an appropriate health professional.
Where appropriate and to fulfil obligations under Regulation 8(1)(c ),(d) &(e), the following information requirements are considered to be a part of the advertiser's social responsibility in providing balance to any product benefit claims
(i) Generic Risk/Benefit Statement
| For mainstream print media: | "Medicines have benefits and some may have
risks Always read the label carefully and use only as directed" |
|
|
| For electronic media: | "Always read the label and use only as
directed" |
|
(ii) Generic Limitation Statement
| "Incorrect use could be harmful" |
|
| Applies to internal analgesic products and
any other OTC medicines where the dose range/safety profile is considered critical. |
(iii) Major Risk Information
The following groups have been identified as requiring specific warnings in advertising to the consumer
| NSAIDs (for internal use only) | "Do not use if you have stomach ulcers" |
|
|
| Sedating Antihistamines | "May cause drowsiness (avoid alcohol and driving)" |
|
|
| Pseudoephedrine | "May cause increased heart rate" |
|
This information is regarded to be the minimum requirement particularly for electronic media. It would not preclude the inclusion of any additional consumer information about any appropriate precautions, contra-indications or adverse effects associated with the medicine, or for other categories where major risk information has been identified and agreed with Medsafe following industry consultation.
In mainstream consumer print advertising full disclosure that is both relevant to and easily understood by the consumer would be considered appropriate.
(iv) Further Information Sources
In addition to directing consumers to additional sources of information as listed in these Guidelines, emphasis should also be given to an appropriate instruction to consumers to consult a health professional for further advice. Examples in use include…
| "If symptoms persist or you have side
effects, consult your doctor/pharmacist/health professional" |
|
"Consult/ask your pharmacist if XXX is right for you"
3. Other Considerations
| √ | ||
| Avoid absolute terms e.g. 'safe' or 'completely safe' | Section 57(1)(g) | |
| Must not imply the medicine cannot harm or is not habit forming | ||
| Length of time on screen (TV, cinema) | Section 57 (2) | |
| Required information must be clearly legible and displayed on screen long enough to be read by the ordinary viewer | ||
| Does not imply endorsement by any Government agency | Reg 7 | |
| Cannot claim 'approval' by Medsafe/Ministry of Health | ||
| Is not misleading | Section 57 (1) (f) | |
| Does not mislead as to nature, qualities or effects of the medicine | ||
| No testimonials | Section 58 (1)(c) (ii) & (iii) | |
| Professional recommendation and/or personal testimonials not permitted | ||
Labelling regulations
The Medicines Act, Section 57 (1) (a), (b) & (c ) refers to requirements to ensure consistency between package labeling and any advertisement for the medicine. It specifically refers to the use of statements that are contrary to, or prohibited by, or required by, (or the omission of), information required by the labeling requirements of the Medicines Regulations 1984.
Relevant Codes of Practice
It is recommended that advertisers consult the following self-regulatory Codes of Practice:
- Advertising Standards Authority Code for Therapeutic Advertising
- New Zealand Self Medication Industry (SMI) Code of Practice
Advertisements for OTC medicines need to be pre-vetted for compliance with legislative and industry code requirements regarding advertising based on agreement by the Advertising Standards Authority (ASA) and the organisations which represent the media in which the advertisements are to be published. In association with the ASA, one of the contributing members, the Association of New Zealand Advertisers (ANZA) has set up the Therapeutic Advertising Pre-vetting System (TAPS) to provide this service. Organisations must first register with ANZA, P O Box 9348, Newmarket, Auckland, phone +64 9 300 5932 in order to use the TAPS service. Contact details for TAPS are Nigel Andrews, LAPS & TAPS Adjudicator, 43 Tirohunga Drive,Henderson,Waitakere 0612, phone (09) 836 2680, fax (09) 837 5057, email: njandrews@vodafone.co.nz or Peter Pratt, 96 Hazelwood Avenue, Karori, Wellington, phone + 64 4 938 6409, fax + 64 4 934 6409, mobile 024 4921 230, email peterpratt@paradise.net.nz
Acknowledgement
Medsafe acknowledges the valuable assistance of the New Zealand Self Medication Industry (SMI) in the preparation of these guidelines.
Disclaimer
While every care has been taken in the preparation of the information contained in these guidelines, the Ministry of Health is not responsible for the results of any act or omission, done or omitted in reliance, in whole or in part, on the basis of that information, nor for any error in or omission from the guidelines. The information in the guidelines is of a general nature and should be used as a guide only to the provisions in the Medicines Act 1981 and the Medicines Regulations 1984. The Ministry recommends that before arranging for the publication of any advertisement regulated by the Medicines Act or Regulations that you seek independent legal advice.