Use of Chinese Proprietary Medicines
Smart and Safe Use of Chinese Proprietary Medicines
Chinese Proprietary Medicines (CPM) refer to medicinal products, used according to the traditional Chinese medicine (TCM) system of therapeutics, that have been manufactured into finished dosage forms (for example, tablets, capsules, pills). The finished products contain Chinese herbs, animal parts and/or minerals as active ingredients.
CPM are generally safe for consumption if they are taken according to the appropriate dosage guidelines or instructions on the product label or as advised by the TCM practitioner. However, as with any other health product, they also have risks and may cause side effects.
One of the most common misconceptions is that CPM are safer than western medicines because they contain natural ingredients. While it is true that most natural ingredients are relatively safe, some herbs, animal parts or minerals are documented to contain components which are potent and can be harmful to humans when taken inappropriately. Taking CPM and other health products concurrently without medical supervision may be dangerous. An example is the interaction between CPM and western medicines which can result in unwanted effects, such as reducing the body’s absorption of either one of the medicines.
In today's globalised world, health products including CPM are easily obtained via the Internet or illegal sources such as makeshift stalls. Products from such sources are likely to be manufactured illegally in underground factories without quality control. Tests by the Health Sciences Authority (HSA) on such products have shown that individual tablets/capsules/pills sold in the same bottle or packet could well contain ingredients inconsistent with what are stated on the label. They may also be contaminated with banned toxic substances. Because of poor quality controls, the contents of each product may vary greatly from batch to batch.
How are CPM Regulated in Singapore?
In order to assure the safety and quality of CPM manufactured, imported and/or distributed in Singapore, all local CPM dealers (i.e. importers, manufacturers, wholesalers and re-packers) must be licensed by HSA. Dealers must also apply for product listing approval for each of the CPM that they want to deal with before they can import, manufacture and/or sell the products in Singapore.
To get their products successfully listed with HSA, dealers must meet relevant safety and quality requirements for their CPM. For example, dealers must ensure that the products they deal in do not contain any potent/toxic substances controlled under the Poisons Act, any synthetic chemical compounds found in western medicines, excessive levels of toxic heavy metals (e.g. arsenic, mercury, lead) and microbial contents. These regulatory standards and requirements supplement the dealers' responsibilities for their products, and thus serve to enhance consumers' safety.
In line with the approach adopted in the regulatory systems of developed countries, there is also a post-market surveillance programme in place to monitor the safety of CPM. It has two components:
- A risk-based market surveillance programme to sample and test products found in the market.
- An adverse reaction monitoring programme, which draws on HSA’s network of local healthcare professionals and international regulatory partners to pick up signals of any health products that may be causing adverse reactions. This system of checks and controls has enabled HSA to initiate timely recalls of harmful and inferior quality products.
What Can I Do as Smart Consumer?
Tip 1: Know the CPM and read the labels
Read the product insert and package so that you know its purpose and what it contains. Do not buy the product if you do not understand the product label or how to take the product safely. It is always best to talk to a medical professional if you need to clarify anything about the product. Under HSA's regulatory requirements, all CPM must be labelled in English and include important information such as the product's trade/brand name, product name, batch number, expiry date, active ingredients, and dosage. The labels must also include a bilingual advisory note to consumers.
There should be no claims on certain serious medical conditions stipulated under the law, such as cancer and diabetes. If you are suffering from any serious medical conditions, please seek medical attention promptly and do not self-medicate with CPM. For more information on the labelling requirements for CPM, including the specified list of serious medical conditions that CPM cannot make claims on, please refer to Labelling Requirements and Prohibited Claims 标签及宣称的要求 on HSA's website.
The Lion Head symbol may be seen on some health products. This distinctive and easily recognisable symbol may be used by local companies to identify themselves with Singapore. It should not be regarded as an official endorsement by HSA and/or the Government of the companies and/or their products. Please refer to the website of the National Heritage Board for more information on the use of the Lion Head.
Tip 2: Beware of ‘safety claims' that the product is 100% safe and does not interfere with western medicines
Be wary of marketing claims like the following:
- “This product is 100% safe because it is natural”
Even common herbs can cause allergic reactions in some people. Also, people may react differently to the same product.
- “CPM do not interfere with western medicines”
Most CPM ingredients have not been tested to find out if they interact with western Medicines, other traditional medicines or health supplements. If you are currently on any medication, do talk to your doctor or physician if you are planning to take a CPM product as well.
Tip 3: Remember that a long history is not always a proof of safety
Due to the emergence of innovative CPM, as well as product contamination which may occur randomly, having a long history of use in TCM practice may not mean that the CPM is absolutely safe. In addition, people may react differently to the same product.
Tip 4: Do not buy CPM from dubious sources
Do not buy a CPM product locally if it has not been listed with HSA. When in doubt, you can check with the product supplier, or do a search on the listed CPM in Singapore at the following HSA webpage: http://eservice.hsa.gov.sg/Search_CPM.
Do not put yourself at risk by purchasing products from the Internet, mail orders, street peddlers, or even well-meaning friends or relatives. Be wary when buying CPM while you are overseas too. Not only will it be difficult for you to contact the sellers, you will not be able to determine the reputation of the dealer nor be sure of the quality of the products sold.
Tip 5: Expectant and breastfeeding mothers, infants, children, the elderly, and individuals with chronic illnesses or going for surgeries should exercise more caution
Expectant and breastfeeding mothers, infants, children and the elderly, as well as individuals with chronic illnesses, should exercise extra caution when using CPM. CPM carry information on the documented side effects (e.g. nausea, vomiting) and contraindications (e.g. pregnancy, lactation) on their product labels for consumers to make an informed choice when purchasing these products. When in doubt, talk to a medical professional. In general, CPM should not be administered to infants less than 12 months of age, unless advised by TCM practitioners.
If you are scheduled for a surgical operation, do inform your doctor about any CPM you are taking. Some products may interfere or interact with anaesthetics and other medicines used during the surgery. You may also be required to stop taking these products before the operation.
What can go wrong?
HSA has received adverse reaction reports of patients who had consumed complementary medicines which includes CPM purchased overseas, through online platforms or though well-meaning friends and has issued press releases to warn the public.
Case Study 1: Overseas purchase landed him in hospital
In January 2016, it was reported that a patient in his 40s was hospitalised for Cushing’s syndrome (which is characterised by round face or ‘moon face’ and upper body obesity with thin limbs), joint pain, weight gain and insomnia after consuming a health product, ‘Huo Xue Qing Gan Jie Du Wan’ [活血清肝解毒丸]. Another patient experienced rapid relief of his joint pain after consuming ‘Huang Niu Mu Shi Ni De Jiu Xing’ [黄牛木是你的救星].
Both products did not have a list of ingredients on their labels, which CPMs are required to carry. The products were purchased overseas and had claimed to be able to treat various forms of chronic ailments, such as arthritis, liver disorders, high blood pressure, diabetes and stroke. A potent steroid, dexamethasone, which is usually prescribed for inflammatory conditions and should only be used under strict medical supervision, was detected in both products. The steroid was not declared on the product labels, making this an adulterated CPM. Its presence could have contributed to the reactions in the patients and may worsen any existing medical conditions that patients may have.
Case Study 2: Friend sold her pills that caused swollen face and throat
In December 2009, HSA reported that a 50-year-old woman was hospitalised for swollen throat and ‘moon face’ (round face) after using the product ‘Huo Luo Jing Dan’ [活絡金丹].
This product was promoted as a Chinese medicine to relieve painful conditions like rheumatism and arthritis. Through laboratory testing, three potent undeclared western medicinal ingredients, namely indomethacin, dexamethasone and prednisolone, were found. Unsupervised use of these medicines can lead to weak bones and fractures, severe infection, increased blood pressure, stomach ulcers and bleeding, and kidney failure.
The woman had bought the product from a friend, who subsequently became uncontactable.
Investigations revealed that the manufacturer as labelled on the product did not even exist.
What Should I Do When Problems Arise?
If you suspect that the CPM product you are taking is making you unwell or causing side effects, stop taking it immediately. Consult a medical professional and bring along your CPM.
You can also get in touch with the HSA at Tel: 1800 2130 800 or Email: firstname.lastname@example.org.