Interview with Ms. Sunitha Devi Shanmugam, Regulatory Affairs Director for GSK Consumer Healthcare, South East Asia
For a long time, Asians had been practicing the tradition of self-care. In multiracial and multicultural Southeast Asia countries such as Singapore and Malaysia, people use traditional medicine from Malay, Chinese or Indian cultures to manage their health. In today’s context, self-care concept ranges from taking healthy diets and nutrition to practicing consistent physical exercise or fitness. Getting themselves over-the-counter medicine is considered a ‘quick way’ of self-care act – taking care of themselves when they are sick without consulting a doctor.
Last year, GSK announced that Zyrtec-R was made available in Singapore without the need for a prescription, allowing quick access for those who suffer from allergies. Non-prescription or over-the-counter (OTC) medicine have indisputably became an alternative option for people living on the urbanised edge. Today, people generally enjoy the convenience brought by OTC medicine which are available in the drug or pharmaceutical stores in almost everywhere in cities. This brings in the new era of self-care management in public health aspect.
OTC medicine are indeed a playing pivotal part in our self-care component. How many of you thought of getting Paracetamol or Panadol if you have slight headache? Have you thought of getting OTC medicine to ‘cure’ yourself when you feel slight discomfort to save time in making a trip to the clinic? If everyone puts effort in ‘caring for oneself’, their health is likely to be maintained and this contributes to more a sustainable healthcare system.
In our recent interview, Ms. Sunitha Devi Shanmugam, Regulatory Affairs Director for GSK Consumer Healthcare, South East Asia, said self-care itself is not just a process but a paradigm. “It is basically something such as proactive steps that people take to look after their health, essentially forming a habit and a culture.”
Accessibility and Education on OTCs are equally important
As self-care is getting more prominent, Ms. Sunitha emphasised that accessibility to the OTC drugs is not the only critical thing to be considered. She commented that the OTC drug providers or companies such as GSK also see the need of educating the pharmacies and end users on the OTC medicine that are commonly found on the shelves.
According to Ms Sunitha, who has been with GSK for 18 years, the information on the labels are strictly regulated and updated to ensure correct information is conveyed. On the bottle, there usually consists of adequate product information for safe use or possible side effects. The guidelines are in the native language of the country where the product is distributed to.
One of the hidden problem of self-care is you might not get the right medicine to solve the root of your health troubles. A lot of patients will just go to the pharmacy and ask for the only medicine they are familiar with, ‘Oh I just want the aspirin’, but not really know what would be the optimal cure for them.
It is both important to get access to OTC medicines and to get proper education related to it. “Therefore, industry plays an important role, not only to make sure the product as accessible, but also just as much the education bit that we invest in – for it be the common ailments like cold, flu, or pain. Being a responsible company, you need to make sure that aside from the quality of products and safety measures, educating people in taking the right step and dosage in the OTC drug consumption is also required. Within all our OTC medicines, we always advise people to seek doctor if they have any immediate reaction or discomfort,” said Ms Sunitha.
GSK also provides education about Dengue management across the region as part of the Allied Against Dengue (AAD) initiative. AAD is a unique coalition designed to engage physicians, pharmacists, governments and private organisations in empowering communities with the knowledge, confidence and support to make the right choices in the prevention, preparation and management of dengue fever and reduce the impact of dengue.
In the Philippines, they go to schools to teach the good habits about containment, cultivating young Dengue warriors within the community they live in. A survey was done in Indonesia and found that 30% mothers in semi-rural areas get the prescribed aspirin or ibuprofen for their children who are having fever. These kinds of medicine might pose danger to those kids who might be having Dengue fever instead of the common fever, and haemorrhage (internal bleeding) might even occur. To prevent that from happening, Ms. Sunitha said the first line of medication announced by WHO is paracetamol. Apparently, efforts are required in educating the public to ensure OTC medicine are used safely and appropriately.
Besides, most pharmaceutical companies have the 24/7 consumer relations call centre. Ms Sunitha advised that if you are not sure of anything on the label of any OTC products, call the central number to ask for more information or to clear your doubts. This can reduce the chance of misinterpreting the information. With clear instructions and multiple language-labelling, most people would be happy to have access to available OTC medicine.
“I think it is a multi-way collaboration, it is not just one person or one part. We work with governments to educate the public and pharmacies, to make sure the right information and advice are disseminated to the right people.” As education plays an important role in ensuring the public access to the right medicine, Ms Sunitha suggested to use less wordy infographics and more pictures instead to educate the public in the proper way of using OTC medicine.
Will it be a change in landscape of general practice where “OTC comes first, seeing a doctor second”?
Ms. Sunitha said, “the trend of shifting towards self-care reduced the burdens of healthcare providers. Governments are trying to make medicine as accessible as possible for people to buy them and treat themselves. Allowing people to take care of themselves with general ailments, the healthcare professionals are able to focus more on urgent unmet conditions in the medical field such as oncology, communicable diseases, and vaccinations.”
Regulatory of OTC medicine
In terms of regulatory of OTC medicine, Ms Sunitha shared that in ASEAN countries, all pharmaceutical medicines are treated the same way. The existing regulatory framework does not differentiate between the prescription and non-prescription drugs. At current stage, the regulatory measures in place for OTC medicines are different in each country.
Ms Sunitha mentioned that the challenges for regulatory pathways would be the difference in capability (skills and resources) between the ten ASEAN countries. Efforts towards harmonisation are carried out through the AFTA (ASEAN Free Trade Agreement) since 1999. Each country already has its own regulatory framework at present and know how to register products. But it is still a long way to go to the implementation of high accessibility to OTC and adequate education. “Regulators need to go into the benefit-risk model to find ways to mitigate risk and find out what is good for their society and make it accessible. GSK organised meetings like WSMI for the discussion among regulators, industries and NGOs, and to see what aspect industry can help in. The other challenge would be the varied development and economical level in ASEAN countries.”
Unlike EU, ASEAN countries have a non-binding post-implementation governance process. Thus, the pharmaceutical companies like GSK come in to implement post-market investigation for the drugs. The industry will consistently monitor the responses such as complaints, adverse reactions or side effects seen in people taking the particular drug in the market. Once the data is collected, it enters into an international database which will also share with the regulators in each country and also in the country of origin of the company.
The solution is creating a new regulatory framework or policy – a dedicated framework for the OTC medicine, and that would reduce the cost and the burden for the public healthcare system in ASEAN. Ms. Sunitha mentioned that the governments, healthcare professionals and pharma industries, collaborate to working on the same aim – regulation on the usage of non-prescription medicine in ASEAN.
To upskill the profession of pharmacists
In some developing countries, it is not necessarily seeing the chain of pharmacies in Singapore such as Guardian and Watson. In prevalence, pharmacies are practised as independent units where the public can purchase the non-prescription medicines from. “If we take the Vietnamese for instance, they are almost one of the fastest growing economies in ASEAN at the moment, and historically they have had a good relationship with their pharmacies and go to the pharmacy for any medication that they might need.” It is due to the framework in the country that has conveniently allowed the high accessibility to OTC drugs. It is good to having pharmacies everywhere, however, the concern is whether the assistant pharmacists hired by these independent pharmacies are skilled enough to provide appropriate advice. They might have no receive any proper training. “There is where industry can play a part in this,” said Ms. Sunitha. “The industry contributes by helping to upskill the pharmacists with a Global Pharmacist Programme – MyPharmAssist, a multi-channel education platform built by pharmacists for pharmacists, launched in Malaysia recently. The main purpose is to upskill the pharmacists and also assistant pharmacists in the independent pharmacies in developing countries. From industry perspective, what they can do is to provide the right information of the products so that the pharmacists can give the right instruction and advice to people.”
“The industry did a small study to see whether the Malaysians trust the pharmacies a few years ago. The study found out that the most Malaysians trust the pharmacist’s advice. Even if they go with something in mind, but if the pharmacist says “I think you should take this” they would take what the pharmacy has advised. Although they go to the GP, the urbanization of the country has led them to have more pharmacy outlets therefore they go to the pharmacies and they do trust the pharmacies,” said Ms. Sunitha.
Seeing the importance of pharmacies, Ms Sunitha deems that it is very important to train the pharmacists on asking the end users the RIGHT questions to make more informed decisions.
“Through our Allied Against Dengue programme, where pharmacies are involved in the community empowerment, some questions that they ask, if you’re having fever, ‘How long have you been it?’ and ‘Are you coming from a hotspot area?’. If the person’s residential area is classified as a hotspot area, then the pharmacists should advise him/her to see a doctor to perform a blood test. In other words, it is more of asking the right questions and channelling them to a specialist or a professional for further treatment," adds Ms Sunitha.
Collaboration between different stakeholders include governments, pharmacist associations, drug providers is very important, to educate the parties directly dealing with end users, such as the pharmacists, to deepen their understanding on common ailments, so that sound advice can be provided to patients. Profession of pharmacy should be evolved to stand side by side with the doctors. Now it is not just standing behind the counter for prescription but also over the counter, pharmacists will be able to add value to the healthcare system. First step would start from asking the right questions, to mitigate the risk of inaccurate prescription, thus leading to right treatment for the patients.
“If you provide people with the right education and information and advice, then I think people can make a right decision and more informed decision. It’s all about making the right decisions and the right information available.” Ms. Sunitha concludes, “The government and public healthcare sector in each country should work closely with the industry and other stakeholders for better self-care management.”
The content of this article is built based on the interview with Ms Sunitha Devi Shanmugam, GSK, conducted by Carmen J.W. Loh and Katya Guez.
About the Interviewee
Sunitha Devi Shanmugam is the Regulatory Affairs Director – South East Asia, GSK Consumer Healthcare.
She is a Malaysian registered pharmacist knowledgeable in Consumer Healthcare / Food regulatory management and facilitate in various Regulatory / Technical Working groups in the industry associations with top priority to focus on strategic regulatory work working with the various Regulatory Agencies across ASEAN, Hong Kong & Taiwan. This includes Environment Modification – i.e. Switch, Advertising Efforts and in the harmonization work proactively pursued by the ASEAN, Hong Kong & Taiwan Regulators for Pharmaceuticals, Health Supplements, Medical Devices and Cosmetic products.