The Drug and Drug database were discussed previously. Now We look into Natural Health Products in Canada and find out why and how does Health Canada regulate NHPs. We also take an overview of Medical Devices in Canada.
Natural Health Products
Regulating vitamins and minerals as natural health products brings several advantages to Canadian consumers. The mandatory pre-market review of all natural health products ensures that what is on the label is what is in the bottle, and that health claims are supported by appropriate levels of evidence. Unlike foods, which are limited under the Food and Drug Regulations to diet-related or nutritional content claims, natural health products can make the full range of health claims that consumers and industry have requested, including risk reduction, structure-function and treatment-prevention claims, where sufficient evidence exists. At the same time, the Regulations increase the safety and efficacy of natural health products by requiring clear labelling information, for example on treatment, dosage and health warnings, as well as pre-market review and assessment, which is not generally required for foods. With this framework in place, Health Canada is helping Canadians have access to natural health products that are safe, effective, and of the highest quality.
The Natural Health Products Regulations (the Regulations) came into force on January 1, 2004, and apply to all natural health products (NHPs) as of this date. The Regulations define what NHPs are and set out the requirements for their sale, manufacture, packaging, labelling, importation, distribution, and storage. This document explains Health Canada's compliance policy with respect to these products. Persons manufacturing, packaging, labelling or importing a NHP before this date, have a transition period two years to comply with the site licence requirements of the Regulations. NHPs with a valid Drug Identification Number (DIN) have six years to obtain a product licence under the Regulations.
This policy explains the compliance approach with respect to NHPs which have not received market authorization by way of a Drug Identification Number (DIN) or an NHP product licence designated on a product label by an NPN number or a Homeopathic Medicine Number (DIN-HM). Any NHPs that have been issued market authorization but otherwise are non-compliant with the Regulations are not within the scope of this policy and will be subject to appropriate actions. The policy does not apply to foods, drugs, and cosmetics, regulated under the Food and Drug Regulations, or veterinary drugs.
Medical Devices Active Licence Listing (MDALL)
MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. This system has been designed to help health care workers, who are contemplating the purchase of a Class II, III or IV medical device, to verify that the manufacturer has an active medical device licence. Since medical device licences can be suspended by Health Canada, cancelled during the annual renewal of licences by Health Canada, or discontinued by the manufacturer, it is important to conduct this verification each time the purchase of a medical device is considered.
To search medical devices used in Canada go to http://205.193.93.51/mdall/
Sunday, June 29, 2008
Wednesday, June 25, 2008
Fish and Omega-3
What is the theory behind the possible benefits of fish oil?
Omega-3 fats can act as anticoagulants and reduce the chance of blood clot formation, which means a reduced risk of heart attack. They also have anti-flammatory properties, and inflammation is being increaingly implicated in many diseases, including heart disease.
A British trial, for example, showed that heart patients advised to eat two servings of oily fish a week, or to take daily fish oil capsules for two years, had a significantly lower death rate then patients who were told to increase their fibre intake and reduce fat consumption. An Italian study of over 2,800 heart attack survivors also showed that fish oil capsules providing 850 milligrams each EPA and DHA dramatically reduced the incidence of death in the first nine months following a heart attack.
So what is our bottom line here?Two fish meals a week with emphasis on salmon, sardines, herring and mackerel are likely to do more good than harm. Why a question of harm? Because fish can be contaminated with methyl mercury, PCBs and dixoins, all of which can present a risk to health. That's why pregnant women and young children are advised to avoid shark, swordfish, fresh and frozen tuna, king mackerel and tilefish, the ones most likely to be contaminated, and limit others to about 350grams (12 ounces) a week. Eating this much is a great idea. A study in The Lancet showed that pregnant women who consumed about 300 grams of fish or seafood a week gave birth to children with higher tested IQ scores.
For days when fish cannot be consumed, supplements may be appropriate. The fish oil used should be tested for mercury, lead, PCB, and other heavy metals. The benefits are likely to be worthwhile, and the benefits may not be restricted to the brain or the heart. Several studies have shown that eating fish twice a week can reduce the risk of macular degeneration, the leading cause of age-related blindness.
source:
BBC News (2007). Fish oil urged for heart patients. Retrieved from http://news.bbc.co.uk/1/hi/health/6676999.stm
Schwarcz, J. (2007). An apple a day. Toronto: HarperCollins.
Omega-3 fats can act as anticoagulants and reduce the chance of blood clot formation, which means a reduced risk of heart attack. They also have anti-flammatory properties, and inflammation is being increaingly implicated in many diseases, including heart disease.
A British trial, for example, showed that heart patients advised to eat two servings of oily fish a week, or to take daily fish oil capsules for two years, had a significantly lower death rate then patients who were told to increase their fibre intake and reduce fat consumption. An Italian study of over 2,800 heart attack survivors also showed that fish oil capsules providing 850 milligrams each EPA and DHA dramatically reduced the incidence of death in the first nine months following a heart attack.
So what is our bottom line here?Two fish meals a week with emphasis on salmon, sardines, herring and mackerel are likely to do more good than harm. Why a question of harm? Because fish can be contaminated with methyl mercury, PCBs and dixoins, all of which can present a risk to health. That's why pregnant women and young children are advised to avoid shark, swordfish, fresh and frozen tuna, king mackerel and tilefish, the ones most likely to be contaminated, and limit others to about 350grams (12 ounces) a week. Eating this much is a great idea. A study in The Lancet showed that pregnant women who consumed about 300 grams of fish or seafood a week gave birth to children with higher tested IQ scores.
For days when fish cannot be consumed, supplements may be appropriate. The fish oil used should be tested for mercury, lead, PCB, and other heavy metals. The benefits are likely to be worthwhile, and the benefits may not be restricted to the brain or the heart. Several studies have shown that eating fish twice a week can reduce the risk of macular degeneration, the leading cause of age-related blindness.
source:
BBC News (2007). Fish oil urged for heart patients. Retrieved from http://news.bbc.co.uk/1/hi/health/6676999.stm
Schwarcz, J. (2007). An apple a day. Toronto: HarperCollins.
Sunday, June 15, 2008
NPN, DIN-HM and DIN
This week we will discuss what is drug according to Health Canada and what are NPN, DIN-HM and DIN.
Health Canada plays an active role in ensuring that we have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products.
What is Drug?
Under the Food and Drugs Act, a drug includes any substance or mixture of substances manufactured, sold or represented for use in:
1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals;
2. restoring, correcting or modifying organic functions in human beings or animals; or
3. disinfection in premises in which food is manufactured, prepared or kept.
NPN vs. DIN-HM vs. DIN
Natural Product Number (NPN): is an eight digit numerical code following the acronym NPN assigned to each natural health product approved to be marketed under the Natural Health Products Regulations.
Homeopathic Medicine Number (DIN-HM): is an eight (8) digit numerical code following the acronym DIN-HM assigned to each homeopathic medicine approved to be marketed under the Natural Health Products Regulations.
Drug Identification Number (DIN):
A DIN is an eight (8) digit numerical code preceded by the prefix DIN which is assigned to each drug product marketed under or in accordance with the Food and Drugs Act and Food and Drug Regulations. Toothpaste and sunblock are under this category and have DINs
Drug Product Database
The DPD contains product specific information on drugs approved for use in Canada. The database is managed by Health Canada and includes human pharmaceutical and biological drugs, veterinary drugs and disinfectant products. It contains approximately 23,000 products which companies have notified Health Canada as being marketed.
Information available in the database includes the following parameters:
1. Brand Name
2. Drug Identification Number (DIN)
3. Company
4. Active Ingredient(s)
5. Route of Administration
6. Product Monograph (PM)
7. Pharmaceutical Form
8. Package Sizes
9. Therapeutic Classification (AHFS and ATC)
10. Active Ingredient Group (AIG) Number
11. Pharmaceutical Standard
12. Veterinary Species
Drug Product Database http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php
go to "DPD online query" at the bottom
Health Canada plays an active role in ensuring that we have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products.
What is Drug?
Under the Food and Drugs Act, a drug includes any substance or mixture of substances manufactured, sold or represented for use in:
1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals;
2. restoring, correcting or modifying organic functions in human beings or animals; or
3. disinfection in premises in which food is manufactured, prepared or kept.
NPN vs. DIN-HM vs. DIN
Natural Product Number (NPN): is an eight digit numerical code following the acronym NPN assigned to each natural health product approved to be marketed under the Natural Health Products Regulations.
Homeopathic Medicine Number (DIN-HM): is an eight (8) digit numerical code following the acronym DIN-HM assigned to each homeopathic medicine approved to be marketed under the Natural Health Products Regulations.
Drug Identification Number (DIN):
A DIN is an eight (8) digit numerical code preceded by the prefix DIN which is assigned to each drug product marketed under or in accordance with the Food and Drugs Act and Food and Drug Regulations. Toothpaste and sunblock are under this category and have DINs
Drug Product Database
The DPD contains product specific information on drugs approved for use in Canada. The database is managed by Health Canada and includes human pharmaceutical and biological drugs, veterinary drugs and disinfectant products. It contains approximately 23,000 products which companies have notified Health Canada as being marketed.
Information available in the database includes the following parameters:
1. Brand Name
2. Drug Identification Number (DIN)
3. Company
4. Active Ingredient(s)
5. Route of Administration
6. Product Monograph (PM)
7. Pharmaceutical Form
8. Package Sizes
9. Therapeutic Classification (AHFS and ATC)
10. Active Ingredient Group (AIG) Number
11. Pharmaceutical Standard
12. Veterinary Species
Drug Product Database http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php
go to "DPD online query" at the bottom
Monday, June 9, 2008
2007/2008 Human Development Index rankings
United Nations Development Programme (UNDP) is the UN's global development network, an organization advocating for change and connecting countries to knowledge, experience and resources to help people build a better life.
The Human Development Report (HDR) was first launched in 1990 with the single goal of putting people back at the center of the development process in terms of economic debate, policy and advocacy.
The HDI – human development index – is a summary composite index that measures a country's average achievements in three basic aspects of human development: health, knowledge, and a decent standard of living. Health is measured by life expectancy at birth; knowledge is measured by a combination of the adult literacy rate and the combined primary, secondary, and tertiary gross enrolment ratio; and standard of living by GDP per capita (PPP US$). The HDI was created to re-emphasize that people and their capabilities should be the ultimate criteria for assessing the development of a country, not economic growth.
There are 177 locations for evaluation in 2007/2008 by UNDP, and the rankings are listed on the website http://hdr.undp.org/en/statistics/
Australia ranked 3
Canada ranked 4
United States ranked 12
Hong Kong SAR ranked 21
Singapore ranked 25
China ranked 81
Source: United Nations Development Programme(n.d.). 2007/2008 Human Development Index rankings. Retrieved from http://hdr.undp.org/en/statistics/
The Human Development Report (HDR) was first launched in 1990 with the single goal of putting people back at the center of the development process in terms of economic debate, policy and advocacy.
The HDI – human development index – is a summary composite index that measures a country's average achievements in three basic aspects of human development: health, knowledge, and a decent standard of living. Health is measured by life expectancy at birth; knowledge is measured by a combination of the adult literacy rate and the combined primary, secondary, and tertiary gross enrolment ratio; and standard of living by GDP per capita (PPP US$). The HDI was created to re-emphasize that people and their capabilities should be the ultimate criteria for assessing the development of a country, not economic growth.
There are 177 locations for evaluation in 2007/2008 by UNDP, and the rankings are listed on the website http://hdr.undp.org/en/statistics/
Australia ranked 3
Canada ranked 4
United States ranked 12
Hong Kong SAR ranked 21
Singapore ranked 25
China ranked 81
Source: United Nations Development Programme(n.d.). 2007/2008 Human Development Index rankings. Retrieved from http://hdr.undp.org/en/statistics/
Sunday, June 1, 2008
Answers
1. Flax is an excellent source of omega-3 fats and it is best to consume ground flax seeds
2. True - pomegranate and blueberries have demonstrated health benefits such as lowering cholesterol
3. True - grapefruit juice is shown to alter the effect of some medications so talk to your pharmacist
4. Yes, what they say is true, avoid trans fats, which may also impair your memory alongside your arteries
5. White sugar is alright in moderate amounts they say
6. Yes, cinnamon is showing signs in studies of reducing blood glucose levels and cholesterol
source:Schwarcz, J. (2005). Let them eat flax. Toronto: ECW.
2. True - pomegranate and blueberries have demonstrated health benefits such as lowering cholesterol
3. True - grapefruit juice is shown to alter the effect of some medications so talk to your pharmacist
4. Yes, what they say is true, avoid trans fats, which may also impair your memory alongside your arteries
5. White sugar is alright in moderate amounts they say
6. Yes, cinnamon is showing signs in studies of reducing blood glucose levels and cholesterol
source:Schwarcz, J. (2005). Let them eat flax. Toronto: ECW.
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