Trail Blazing in Kudat

The map above is the District of Kudat, one of the 5 main district in Sabah. Our campaign in this district has been progressing steadily since 2004. Most of the main town located in this locality namely Kota Marudu, Pitas, Matunggong and Kudat has been visited except for Banggi island. Initially the consumer education campaign starts off from the main towns targeting health facilities like medicine shops, supermarkets, medical halls and groceries stores. Whereas Clinics and Pharmacy in these towns had been monitored since the 90's. The campaign has progress steadily to sundries shop in the outskirts of town. Lately there have been a trend of irresponsible parties to distribute unregistered health product to the rural areas. This is due to the dwindling market for their goods in the town area due to increase awareness in registered product sale. It has been encouraging to note that most retailers in the town areas know about health product registration and sale. This can be partly attributed to the efforts by licenced wholesalers who themselves have been informed about the product registration during a campaign blitz in 2004 by the department. This is an example of smart partnership between the enforcement agency and the bussiness community namely health product licensed wholesaler. We need to work together hand in hand for the journey ahead. Here are some graphic glimpses of our campaign trail in Kudat. Sundry shop owners are usually honest people trying to earn

a living and they usually ignorant about the do and don't of medicine sales

Note the simple design of the shop.. wooden structure on stilts with wire mesh

Sundry shop being far from town becomes a multi-goods stores that sells anything from diesel (for generators), to cooking gas to medicines and other daily necessities. This makes them perfect targets for unregistered medicines supplier

One of the unregistered product laced with steroids found in one of the shops in Kudat. It's called Maajun Kuat and medicines sold in this form we called "Ubat Papan" has been banned by the authorities since 2005

The Long Road Ahead

Pic showing an officer explaining the registration of health product to a stall owner / retailer
Pic showing the use of consumer education tools (phamplet and postcard) in the education campaign

Being an enforcement agency, it's not all about flexing enforcement muscle and hard punishments. In fact the best form of enforcement is consumer education. We call this as 'proactive' enforcement. This method allows the reduction of demand from the consumer thus disrupting the "demand-supply chain" of unregistered health product. This is made possible by empowering the retailers to choose to sell registered helath product only. This effort involve an intelligent planning, precise execution and a lot of patience before reaping the desired results. On our part at CPF Sabah we have so far embarked on a few education campaign targeting multi-level members of the society. It is important to get the cooperation of everyone to ensure the success of law enforcement on medicine and pharmaceuticals. It's a long road ahead.

Make a Point to Read the Label of Your Medicine

Have you been asked the name of your current medicine?
Can you name the medicine that you are taking?
Do you check the label for each medicine that you receive from the hospital, clinic or retail pharmacy?

If you answer “no” to any of the questions above please spend time to read this article now.

Compulsory Requirement for Labelling of Medicine

According to the Poisons Regulations 1952, when any poisons is supplied as a dispensed medicine it shall be labelled with certain details. This includes the name and address of the supplier or seller (in this case the Clinic, Hospital and Pharmacy it was obtained), name of the person whom the medicine is for, name of the medicine and adequate direction for the use of such medicine. Tthe medicine pack should also have the reference number as in the record called the ‘Prescription Book’ and the words ‘Controlled Medicine’.

(Pic above shows the proper labelling of dispensed medicine)

Consumer Responsibility

The government always advocates Malaysians to be smart consumers. One small step to achieve this aspiration is to read the medicine label and to know the medicine supplied to you. It’s not a surprising fact that certain members of the public neglects to read the label of their medicine. Whether this medicine is obtained from hospital, clinic, or retail pharmacy, many of us don’t take the time to read or to ask about the medicine we received. Please find the time at the end of this article to check your medicine cabinet and look at the medicine label that many of us are currently taking, it’s not surprising to find dispensed medicine labelled with the words ‘Sakit Perut’, headache, ‘muntah-muntah’, ‘cuci darah’, and many more. Some might find this amusing and strange but the bottom line it’s a sad reality. The paradigm shift in medical care is to encourage the patient to play an active role in treatment of their illnesses. The patient can play this role by taking the initiative to ensure that their medicine is clearly and completely labeled. Request the doctor or pharmacist who supplies the medicine to label the medicines properly. All patients whether adults or children have the right to expect the medicine supplied to them are appropriate, safe and effective. By fulfilling this basic consumer responsibility it is hoped that consumer will be familiar with the medicine that they are taking and take more responsibility in their treatment.

Supplier Responsibility

An example of professional duty in the medical field is to inform matters related to any diseases or medicine involving such patients in accordance with the standard clinical guidelines that focuses on the patient (patient centered). All doctors, dentists or pharmacist must ensure that the label of dispensed medicine conforms to the law. In any government medical institutions, labeling of medicine with generic or chemical name has become a norm. Such practices should be implemented in all private hospitals, clinics and retail pharmacies for the benefit of the patients. For example the common painkiller medicine containing the chemical Mefenamic Acid has been registered undert the names like Ponstan, Beafemic, Dyfenalic, Fenagesic, Hamitan, Mefemic etc. The practice of labelling using chemical name is important because it allows the consumer to know the active ingredients in each medicine and help to avoid any toxicity that might arise due to the administration of different medicines with the same active ingredients. .

Advantage of Proper Labeling

The advantages of having a proper label of medicine are as follows;
1.The patient can obtain further information about that particular medicine from reliable information sources or by referring the medicine by name to doctors and pharmacists
2. Improve patients compliance to maximize the treatment effectiveness
3. Patients able tell the name of medicine they are taking to doctors or pharmacist to avoid duplication of therapy especially for those seeking second opinion from different healthcare provider for a particular illness.
4. If adverse effects or allergic reaction occur, it will be easy for patient to recognize the medicine that causes it and to report the matter to their medical provider.
5. The patient will be able to stop taking medicine which has an active ingredient which is banned
6. Easy to understand the direction, frequency and duration of treatment for that particular medicine
7. Know the medicine proper and safe storage
8. Avoid cases of medicine mistakenly consume by individuals living in the same house.

In conclusion, by taking the initiative to ensure your medicines are labelled properly, all of us choose to become smart consumers and take full charge in the treatment of our illness.


© Sabah State Pharmacy Enforcement Branch

Importation Of Drug Into Malaysia

Many of us today take a lot of pride in using imported cosmetic product and also consuming imported medications. But have any one of us wondered how these products enter Malaysia? It is not as straight forward as some of us may think. This article is written with the hope to increase the public’s awareness regarding importation of drug and also cosmetic product.
In general, importation of drug into Malaysia is controlled by the Poisons Act 1952 and Control of Drugs and Cosmetics Regulations 1984 to ensure ‘Controlled Medicines” are imported by licensed pharmacists and to ensure medicines imported are safe, efficacious and of quality.
Before any drug can be considered to be imported into Malaysia, it must first be registered with the Drug Control Authority. Public can check whether a product is registered or not by contacting the National Pharmaceutical Control Bureau at 03-78835400 or search the website http://www.bpfk.gov.my/ . After the product is registered, the importer has to apply for an import licence to import the registered product.
Under the Poisons Act 1952, poisons means any substance listed in the first column of the Poisons List. You need an appropriate licence to import poisons. Type A license is for a licensed pharmacist to import all poisons . A type B license can be issued to any person deemed proper or fit by a licensing officer to import industrial chemicals controlled as poisons and a Type E licence to import sodium hydroxide. Application of any of the above license can be done through the Pharmacy Enforcement Division (Cawangan Penguatkuasa Farmasi). Any person found guilty of committing offences under this Act, is liable to a fine not exceeding RM 5000 or imprisonment not exceeding 2 years or both.
Starting this year (2008) under the Control of Drugs and Cosmetics Regulation 1984 importer must notify the DCA the cosmetics they intend to put in the market. Prior to this cosmetics also need to be registered with DCA, This is in-line with the harmonization requirement amongst ASEAN countries. For any query, don’t hesitate to call the local Pharmacy Enforcement Division near you.

© Sabah State Pharmacy Enforcement Branch

Health Product Registration in Malaysia

Many of us in this lifetime have bought and taken medicines. What is the probability that some of the medicines that we have been using is not registered with the Ministry of Health of Malaysia? The Control of Drugs and Cosmetics Regulations 1984 require all products imported, manufactured or sold to be registered with the Drug Control Authority (DCA). Any individual who contravenes this Regulations commits an offence and can be fined up to a maximum of RM 25,000.00 or a jail sentence for a term not exceeding 3 years or both for the first offence. For the second or subsequent offences the fine is not exceeding RM 50,000.00 or jail sentence for a term not exceeding five years or both. A company found guilty can be fined up to RM 50,000 for the first offence and up to a maximum of RM 100,000.00 for the second or subsequent offences.

Under this Regulations DCA has been established as the executive body to regulate product registration in Malaysia. The main task of this Authority is to ensure the safety, quality and efficacy of pharmaceuticals, health and personal care products that are marketed in Malaysia. Registered producs have been evaluated and tested for its efficacy, safety and quality. A registration number will be given when a product is registered with DCA. The registration number is specific to the product registered with the name, identity, composition, characteristics, origin (manufacturer) and marketing authorization holder as specified in the registration documents. It may not be used for any other product. Every registered product must have their registration number printed on its label or package. A security label (hologram Meditag®) is affixed to a registered product so that patient and enforcement officers can identify genuine products. The security label is only one of the many means that is used by the ministry to complement its enforcement activities to ensure public safety. The requirement for affixation of this security device to product label is only applicable to pharmaceutical product including health supplement and traditional product.

Registration number can be identified as a set of numbers with the alphabets “MAL” in front, followed by eight digits of number and ended with one or more alphabets. Registration of product in Malaysia has been divided into 3 categories. Each category of product can be identified by the first alphabet after the eight digits.
1) Alphabet “A” - for product containing scheduled poison as defined in the Poisons Act 1952
2) Alphabet “X” - for product not containing scheduled poison as defined in Poisons Act 1952
3) Alphabet “T” - for traditional product
Other alphabets used include C, E, R, S & V which is usually printed after the three main alphabet A, X, and T .

Monitoring of the quality of registered product in the market is carried out continuously by the Authority. Sample of products registered by the DCA may be taken and tested for compliance with official or pharmacopoeia standard or specifications. If the sample fails the test the market authorization holder will be issued a directive to recall of the product. The marketing authorization holder also is required to identify the source or cause of quality defect and action to be taken to improve quality. The registration of any product may be rejected, cancelled or suspended by the DCA if there are major deficiencies in safety, quality or efficacy of the product or failure to comply with conditions of registration.
Public is advised to report any adverse or side effect experienced due to the product consumed or used to the authority. Such reporty will be discussed by MADRAC (Malaysian Adverse Drug Reaction Committee) for further action.

MOH urged the public to stop using unregistered products. Unregistered products have not been tested for its safety, quality and efficacy and thus pose a treat to the public health. It also might be adulterated or contaminated with heavy metals or banned substances. The authenticity of the MAL number can be verified through the website, http://www.bpfk.gov.my/.


© Sabah State Pharmacy Enforcement Branch