Medications

All medications should be treated with caution and followed strictly as directed.




Medicine can be prescribed or purchased for a variety of reasons:
  • Treatment
  • Prevention
  • Reduction of symptoms associated with a condition
  • Immediate pain relief
  • Management of chronic pain or inflammation
  • Supplements - for examples vitamins and tonics
Whatever the reason behind it, all medicines have the ability to hurt, as well as heal. As such, it is vital that you know:
  • what the medication is for
  • what side effects to be aware of 
  • when to take your medication - for example: with food, at a certain time or times of day?
  • what to avoid doing while taking this medication - for example: are you allowed to drive, or operate heavy machinery?
  • whether other non-prescription medications, including herbal preparations and simple vitamins, may counteract, interfere or reduce the effectiveness of your primary medication. A lot of herbal ingredients that may seem harmless actually contain certain plant extracts that can be very dangerous if used in the wrong combination with 'western' medications.
Always ask your health store to check for contra-indications and then double check with your pharmacist or GP (or vice versa). It is always better to be safe, than sorry.


Does your usual medication look different suddenly? 

Pharmac has produced an easy to understand PDF that outlines changes that can be made periodically to the packaging, brand or appearance of your normal medication. You can find this PDF at the bottom of this page. If you are concerned, always speak with your pharmacist, GP or you can call Pharmac toll free on 0800 66 00 50.

Medsafe

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand. Medsafe's mission is "to enhance the health of New Zealanders by regulating medicines and medical devices to maximise safety and benefit."

In carrying out its functions, Medsafe is accountable to the Ministry of Health. It is also accountable to the pharmaceutical industry for those activities which are funded by fees collected from the industry.

Medsafe is responsible for administering the Medicines Act 1981 and Regulations 1984.  

Medsafe regulates products used for a therapeutic purpose. 

This includes:
  • medicines
  • related products
  • herbal remedies
  • medical devices
  • controlled drugs used as medicines
"Therapeutic purpose" is defined in Section 4 of the Medicines Act, and includes the treatment, diagnosis and prevention of disease or the modification of a physiological function. It also includes cleaning, soaking or lubricating contact lenses, effecting contraception or inducing anaesthesia.

"Medicine" is defined in Section 3 of the Medicines Act. A product is a medicine if it has a pharmacological effect and is used in humans primarily for a therapeutic purpose.

"Related product" is defined in Section 94 of the Act. It is a product that is primarily a food, dentifrice or cosmetic, but has a secondary therapeutic use. Examples of related products include throat lozenges and fluoride toothpastes.

"Herbal remedy" is a special sub-category of medicine defined in Section 2 of the Medicines Act. 

A herbal remedy is a medicine that:
  • does not contain a prescription, restricted or pharmacy-only medicine; and
  • consists of a substance derived from plant material that has been dried or crushed (or derived through any other similar process). It may also be an aqueous or alcoholic extract of the dried or crushed plant material, or a mixture of that material with another inert substance.
"Medical device" is defined in Section 2 of the Medicines Act. Medical devices exert their therapeutic effect by physical rather than pharmacological means. The term covers products ranging from wound dressings to heart valves.

How are therapeutic products regulated?

The objective of the medicines legislation is to manage the risk of avoidable harm associated with the use of medicines. 

The legislation is designed to ensure that:
  • medicines meet acceptable standards of safety, quality and efficacy;
  • personnel, premises and practices used to manufacture, store and distribute medicines comply with requirements designed to ensure that products meet acceptable standards right up until they are delivered to the end-user; and
  • information about the selection and safe use of medicines is provided to health professionals and consumers.
Medsafe is responsible for applying a framework of controls designed to ensure that the therapeutic products available in New Zealand are those that can be expected to have greater benefits than risks if used appropriately. 

This is achieved through:
  • pre-marketing approval of products; and
  • post-marketing surveillance.
Pre-marketing approval must be obtained for new and changed medicines. New medicines cannot be marketed in New Zealand without the consent of the Minister of Health (or his delegate). Medicines to which changes have been made cannot be marketed without the consent of the Director-General of Health (or her delegate). Data that satisfactorily establish the quality, safety and efficacy of the product, for the purposes for which it is to be used, must be submitted for evaluation before consent can be granted.

The pre-market approval system for medicines is managed by Medsafe. The subsidisation of medicines is managed by PHARMAC (the Pharmaceutical Management Agency).  PHARMAC is a Crown Entity whose primary objective is to secure for eligible people in need of pharmaceuticals, the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the funding provided. Medsafe and PHARMAC work independently, and Medsafe is not involved in funding issues.

Post-marketing surveillance monitors the safety of medicines and medical devices in use. Products shown to be unsafe are removed from use, and prescribers are advised about new safety information for products. 

Post-marketing surveillance is achieved through activities such as:
  • monitoring adverse reactions to medicines used in New Zealand and monitoring the international literature and other information sources;
  • testing marketed medicines against product quality standards;
  • handling complaints and investigations; and
  • auditing and licensing medicine manufacturers.

Consumer Medicine Information (CMI) 

Consumer Medicine Information (CMI) is useful information about your medicine and contains advice such as what the medicine is used for, how it should be taken, what side effects can occur, whether you can drive or drink alcohol while taking the medicine, and what to do if you miss a dose. However,  Consumer Medicine Information does not contain all the available information about the medicine. Ask your doctor or pharmacist if you have any questions or concerns about taking the medicine.

Pharmaceutical companies are responsible for producing Consumer Medicine Information however in New Zealand there is no legal requirement for them to do so. 

The Consumer Medicine Information that is on this website has been written by pharmaceutical companies, using Guidelines set by Medsafe. The companies self-assess what information goes in each Consumer Medicine Information guide against the requirements of the Guidelines. Medsafe does not evaluate or approve Consumer Medicine Information, therefore Medsafe is not responsible for the information contained in Consumer Medicine Information.

Each month, more Consumer Medicine Information guides are added to this website. If you cannot find Consumer Medicine Information  for your medicine, it is most likely because the pharmaceutical company that makes or distributes your medicine has not yet written the Consumer Medicine Information . Your doctor or pharmacist should be able to provide you with the information you need.

Consumers' Rights 

Patients have the right to treatment that meets appropriate ethical and professional standards, including the right to be fully informed about the risks and benefits relating to efficacy and safety of medicines. A full copy of the Code of Consumers' Rights is available on the Health and Disability Commissioner's web site.

Queries about the content of  Consumer Medicine Information should be directed to the pharmaceutical company (name and contact details are included at the end of each Consumer Medicine Information guide). If you believe the  Consumer Medicine Information breaches the Guidelines, then forward your concern to the CMI Co-ordinator at Medsafe (Head Office) who will investigate the issue.


Contact details

Medsafe - New Zealand Medicines and Medical Devices Safety Authority
P O Box 5013
Wellington 6011

Telephone:  04 819 6800      
Fax: 04 819 6806
Website: http://www.medsafe.govt.nz

For General Enquiries or Feedback Email:                  becci_slyfield@moh.govt.nz
For Medical Device or WAND-Related Queries Email:     devices@moh.govt.nz
 
Investigation and Enforcement Team
Postal Address:
Medsafe
P O Box 7772
Wellesley Street
Auckland

Email: medclearance@moh.govt.nz




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Subpages (1): Supplements
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Kate Johns,
Jun 11, 2012, 4:40 PM
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