All medications should be treated with caution and followed strictly as directed. Medicine can be prescribed or purchased for a variety of reasons:
Whatever the reason behind it, all medicines have the ability to hurt, as well as heal. As such, it is vital that you know:
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. MedsafeMedsafe 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:
"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:
"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:
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 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:
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 MedicopakOne tablet once a day or five tablets four times a day, with Medico Pak your daily medication schedule is personalised by your pharmacist and made more convenient. Just tear off the correct dosage pottles into your handbag or pocket as you leave the house and the chances of forgetting your medication are reduced instantly. All the details are printed on the back of each pottle so you can even check on what you have and haven’t taken and when. No more multiple bottles and packets to carry around or dose times to remember, Medico Pak has made life easier for so many people who are on a regular medication schedule. The Benefits of Medico Pak The simple straightforward convenience of Medico Pak has made so many people’s lives easier by reducing the stress that can be associated with managing and remembering multiple dosage medication. Medico Pak helps:
Douglas Pharmaceuticals Phone - 09 835 0660 Website - http://medicopak.co.nz/ Email - info@medicopak.co.nz |
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