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Patient Perspectives on Medication Safety: What are Their Concerns and Contributions

  • Speech
  • 2011.11.03

International Medication Safety Conference 2011
Medication Safety – Dawn of a New Era
2 & 3 November 2011
Ballroom, 3/F., Sheraton Hong Kong Hotel & Towers 20 Nathan Road, Kowloon, Hong Kong

Community Engagement & Collaboration Forum - 'Risks Evaluation of Over– the-Counter Drugs & Health Products'

"Patient perspectives on medication safety: what are their concerns and contributions"

 

Ms Connie Lau
Chief Executive Officer
Hong Kong Consumer Council

Introduction

A theme that often runs through the news cycle, on an almost daily basis, is a perceived lack of confidence by consumers on matters of financial security, the environment, or public safety.

It is also often the response that government should be doing more to address these issues, with the suggestion that some form of regulation needs to be introduced to bring about a resolution. The role that consumers or business play in the resolution of problems, is also brought into play, but to a large extent they are usually seen as having a subordinate role. This is typically because they are viewed as incapable of regulating their own actions, or refusing to do so.

Inevitably a blame game arises where different sides are pitted against each other, even though it is clearly evident that the best means of resolving problems is through cooperation.

As Martin Luther King once said “We must learn to live together as brothers or perish together as fools".

What I would like to discuss today is the Consumer Council's perspective on medication safety, involving the rights and responsibility of the patient as a consumer, and how they, business and government can cooperate in enhancing medication safety from a consumer perspective.

When I use the term 'consumer' it is important to understand that the Consumer Council's primary function in society is to provide an advocacy role for consumers in the marketplace. Our basic role is to

  • provide information that will help in making choices between competing goods and service providers;
  • make recommendations that reflect the consumer perspective in society; and
  • assist consumers in avoiding various hazards that might arise, when they enter into a business transaction. A transaction that is often prompted or influenced by creative advertising, or other marketing activities.

In effect, our role is to make sure that the free market is working efficiently to satisfy society's needs. We do this by focusing on what can be done, not only by business, but by consumers, and if necessary by government. In the case of pharmaceuticals and other health related goods and services, this brings about various complications.

The scope of the problem

The Council's role as an advocate and mediator in consumer complaints against business, results in a significant data base of complaints against goods and service providers. These cover a wide range of subjects. For example, in 2009/2010 the Council received 31,207 cases of complaint, and the sale of over the counter drugs, and other health related products and services were not in the top ten, in terms of numbers of complaint. As of the first quarter of 2011, the Council had received a total of 16 complaints regarding alleged misrepresentations in relation to health claims, with a total of 91 complaints received in 2009, and 78 in 2010.

The levels of complaint in this sector is therefore not as high as other areas, such as telecommunications and financial services which commonly have the highest level of complaints to the Council. This might be seen as surprising, given the frequency of transactions involving over the counter drugs, and health related goods and services in our daily lives. I should quickly point out, however, that I am grateful for the fact that the complaints are not at telecommunications or financial services levels. If they were, we would be in serious trouble.

Nevertheless, when problems in the health sector do arise, they usually concern a serious public health and safety issue. A transaction that goes wrong with regard to pharmaceuticals, or other health related goods or services, can have disastrous consequences for the consumer.

Over the years, the Council's complaints database indicates that health safety concerns by consumers have covered a wide category of products. Included within the area of health safety, are not only pharmaceuticals, but beauty treatments, medical treatments, and health food claims.

Looking at pharmaceutical safety, the biggest issue we are now facing is the prevalence of counterfeit drugs being sold in the marketplace. The problem as we all know is both local and global. In particular, the 'online pharmacy' is a major distribution outlet for many dangerous products and has been the most problematic source; although we can observe that counterfeit drugs are also now being found in standard shopfront pharmacies in Hong Kong.

Counterfeit Drugs

In a major exercise this year, the Consumer Council joined with the Customs and Excise Department to publish, in the Council's CHOICE magazine, the names of shops involved in selling counterfeit drugs https://www.consumer.org.hk/sites/consumer/files/news/CounterfeitDrugsStores/list_en.pdf. The exercise has been an unqualified success in terms of publicising the problem, and has been particularly well received by the public and Mainland tourists. With regard to Mainland tourists, Hong Kong has a reputation as a safe shopping environment, and the Council's interest in this area is not only to protect public health and safety, but to protect Hong Kong's reputation.

The naming mechanism aims to alert consumers about unscrupulous traders and the drugs involved. It also serves as a reminder to other drug stores that their public reputations are at stake if they sell fake drugs.

Last year, there were 19 convicted cases of selling counterfeit drugs involving 18 shops. Among these shops, one was located on Hong Kong Island, 8 in Kowloon and 9 in the New Territories. One shop in the New Territories was charged for committing the same offence twice.

The 19 cases involved over 30 different drugs. The main offences were applying forged trademarks on drugs, which were sold as genuine items, or supplying drugs with false trade descriptions, where the actual ingredients were inconsistent with the labelling.

The legislation that has been used in these cases is the Trade Descriptions Ordinance, which makes it an offence to sell or supply goods bearing a forged trade mark or a false trade description. The maximum penalty upon conviction is a fine of HK$500,000 and imprisonment for five years.

Pharmaceuticals or medicines come within the definition of goods in the legislation, and those involved in the convictions included Viagra and Cialis, Po Sum On Oil, Po Chai Pills, Wong To Yick Wood Lock, Human Albumin 25%, Normal Serum Albumin, Kenacort-A Intramuscular, and Vitamin H-3 Injection.

The Council intends to continue this naming and shaming exercise, which will be run in tandem with any convictions that might be achieved under the Ordinance. The Council will update a list of shops involved in convicted cases of selling counterfeit drugs, and publish the list on its website for consumers' information. In its press releases and public statements relating to the naming exercises, the Council has urged the public not to consume any doubtful drugs, and where they are aware of shops selling counterfeit drugs, or they have reasonable suspicions that counterfeit drugs are being sold, to report the matter to the Customs and Excise Department on its hotline, for investigation.

Non pharmacy issues

Apart from the sale of counterfeit drugs, the Council is also concerned with unscrupulous marketing of health supplements. A lot of advertising on health supplements in the marketplace is directed at an aging and health-conscious population with claims of better health and cures for illnesses and ailments.

The Council is often made aware of various creative marketing schemes that raise serious concerns, many of which are directed at elderly people with the attraction of free health tests or seminars. For example, in some schemes, seniors are lured by free gifts and endorsements from so called experts and users, to surrender their credit cards to be swiped for products costing huge sums of money. Some of these marketing schemes take place at shopping malls on short-term tenancy. The companies involved typically move out or cease business after a short period of time, and consumers subsequently find it difficult to make a claim, or seek redress, should problems arise.

The Council's concern with many of these products is not only that that they might be a waste of money, but that they might actually be hazardous to health, or even lifethreatening. They also seriously undermine the work of legitimate suppliers of pharmaceuticals who are contributing to advances in public health.

Two such cases were highlighted in the most recent April issue of CHOICE magazine.

The first case involved an elderly woman who was taken to a health supplement business that recommended she take a 'chlorella supplement'. The recommendation was given by a person who gave the impression of being qualified to give advice on such matters. She was told to take a total of 90 tablets of the supplement three times per day for its detoxifying and slimming effects. After taking the supplement for 3 weeks, the woman suddenly felt acute pain in her chest, and was rushed to hospital, where she regained consciousness after resuscitation, and was sent to the intensive care unit for further treatment.

The consumer was told by the hospital that the condition was probably caused by an excessive intake of the supplement, which contained Vitamin K, a blood thickener for patients on Warfarin.

In another case, the Council received a complaint alleging misleading claims about a product's suitability for diabetes. An elderly diabetic man was recommended by his neighbour to attend a health seminar where he was persuaded to buy an 'enzyme product' of Chinese herbal formula, and receive free gifts. He was told that the tablets, costing $4,400 a packet of 3 bottles, were good for diabetics. He subsequently bought six packets but found that the bottles only carried labels in Japanese. Soon after taking a bottle of tablets, the consumer felt sick. When he went to consult a doctor, he was told that the calories contained in the product were too high for a person with diabetes. A blood glucose test revealed the consumer's blood sugar had gone up by 2 units.

The Council's role in regard to these complaints is to either mediate a resolution on behalf of the consumer, or if it is apparent that a breach of a law has occurred, to refer the matter to a relevant government agency for investigation.

Legislative Issues

Trade Descriptions Ordinance
While the Trade Descriptions Ordinance has been useful to prosecute sellers of counterfeit drugs, as described earlier, there are still ongoing problems with that legislation in protecting consumer interests.

The Ordinance, which is the main legislation governing misleading and deceptive practices in trade or commerce, only applies to goods. It does not apply to services. Therefore, misleading and deceptive practices relating to quasi health related services, and in particular slimming services (which are a common area of consumer complaint) are currently not covered by the legislation.

The Government has recently considered the Council's recommendations and the Secretary for Commerce and Economic Development has agreed that an amendment is needed to protect people when they buy services. The Government has indicated that it will be able to make a legislative amendment to the Ordinance, including a legal definition of improper sales practices in the 2010-2011 legislative year.

It seems therefore, that if the amendments go through, a company that for example suggests a certain percentage of its customers had succeeded in slimming, would need to make sure the percentage was accurate. Otherwise it would be at risk of breaking the law. A public consultation is to be carried out on the proposals.

Undesirable Medical Advertisements Ordinance
The other piece of legislation relevant to health safety is the Undesirable Medical Advertisements Ordinance administered by the Health Department. This legislation restricts certain advertisements relating to medical matters. It aims to protect the general public from misleading and deceptive claims regarding medicines, and improper self-diagnosis and self-medication in respect of diseases specified in the Ordinance. As such it can be seen as serving a demand that consumers have for truth in advertising.

However, notwithstanding the safeguards, the Department of Health has formed the opinion that information supplied inside any container or package containing any medicine, surgical appliance or treatment is not considered to be an advertisement, because it is not on display and is only visible to the purchaser of the product after the sale takes place.

The Department also regards information containing particulars such as composition, indications, directions, side-effects, name and address of manufacturers, etc. to be useful for the reference of doctors and pharmacists. As such, it does not constitute publication of an advertisement.

The Council has found that traders often take advantage of this anomaly, giving rise to a proliferation of infringing medical claims which appear in informational pamphlets and leaflets inserted into the package of products and are, therefore, beyond the reach of the law.

In the interest of the public, the Council strongly believes that traders making infringing medical advertising claims inside or outside the package of the product should be brought under the jurisdiction of the Ordinance.

Consumer Responsibilities

The Consumer Council plays an important role through product testing initiatives, and educational efforts through its CHOICE magazine, and elsewhere, to empower them with relevant information so they can make efficient and safe transactions. However, the Council's resources are extremely limited. The resources we do have, in order to engage in campaigns to warn consumers of dangerous products, or to investigate suspicious behaviour, are dwarfed by the resources available to our protagonists. We have to compromise (in the absence of increased funding) by being more creative in the way we do our job. Hence, the naming and shaming exercises noted above in relation to shops selling counterfeit drugs.

Empowering consumers to make good decisions in the marketplace is an important part of ensuring that consumers take responsibility for their actions. In fact, the Council has produced a document entitled 'Guide to Consumer Rights and Responsibilities' that sets the basic standard upon which the Council expects consumers to behave as responsible consumers. The Council's Guideline states:

"With rights there are also responsibilities. In conjunction with consumer rights, there is also an expectation that consumers act rationally, and accept a reasonable level of responsibility when exercising choice and entering into transactions in the marketplace. You, as consumer, have a responsibility to:

  • keep yourselves informed as best as possible;
  • exercise due care when making decisions in the marketplace;
  • consider the detrimental consequences that may arise from illconsidered decisions; and
  • honour reasonable obligations arising from your decisions."

The Guideline goes on to provide explanations as to how consumers can empower themselves and assume responsibility. This also forms an important part of our day to day work when dealing with consumer complaints.

Corporate Social Responsibility 

It is all very well to have legislative safeguards, and to have consumers who take responsibility and try to be well informed.

But, the unfortunate truth is that legislative safeguards often do not keep up with what is happening in the marketplace, resulting in loopholes. Moreover, legislative safeguards take time to adopt and implement, even if they survive the strong pressure from business not to introduce regulation.

In addition, even if a consumer assumes responsibility to the standard expected by the Council, it is often impossible, or extremely difficult to overcome the information asymmetry that consumers face when making transactions in the marketplace. This is particularly the case with complicated products such as pharmaceuticals and other health related goods and services, where consumers have little or no understanding of how the products work. More often than not, they are simply relying on trust and hope.

The business community therefore has an important role to play in ensuring we have a safe environment in which to make transactions in these products. The role that business associations play, through self regulation, is critical in this regard.

The Council is very active in promoting self regulation schemes as an adjunct to basic legislative safeguards, and has produced a document, entitled the 'Good Corporate Citizen Guide'. This document sets out the Council's views on good corporate citizenship, and an associated document sets out suggested Rules that associations can incorporate into the codes of conduct their members are required to follow.

The Guide plays an important part in the Council's discussions with various business associations, where recommendations are made as to appropriate rules for members to follow in order to address problems that arise from time to time.

In view of problems that have arisen in the past with pharmaceutical products, the Government set up a Review Committee of the Regulation of Pharmaceutical Products in Hong Kong, in 2009, to examine the regulatory environment for their manufacturing and distribution. The review acknowledged that the existing Code of Practice for pharmacies has no legal status for enforcement, and there is no Code of Practice for medicine companies to follow with regard to the handling of drugs. It has been recommended that a Code of Practice be devised for medicine companies and the law be amended to require that both medicine companies and pharmacies have to follow their respective Codes of Practice.

The Council is as always willing to assist in the drafting of relevant codes of practice related to pharmaceuticals and other health related goods and services.

Conclusion

I mentioned earlier that the Council's database on complaints did not have high numbers in regard to pharmaceuticals and other health related products. There would be a number of reasons for that. One of those reasons, I would like to think, is that cooperation between industry, the government, and consumers (through the Council and other advocacy groups) has resulted in the current level of protection for consumers which is making a real contribution to consumer safety. However, we cannot rest on our laurels.

The fact that there are only small numbers of complaints does not necessarily indicate the absence of problems or that we can be comfortable in any way. The examples of complaints and unethical conduct I have discussed above are extremely serious for consumers.

Given the nature of the products being consumed, indications that there is a problem will usually only arise when serious health complications occur. The nature of the products we are dealing with means that the danger of widespread health problems arising due to unethical behaviour, or lapses in standards is actually quite high. The consequences for society as a whole could be catastrophic. This means that vigilance needs to be a lot higher than might be the case in other areas where consumers are making transactions in the marketplace.

The Roman poet Virgil, is often quoted as saying, "The greatest wealth is health".

It is to be hoped that those of us in government, business, and civil society who have a stake in Hong Kong's wealth continue to recognise:

  • the importance of cooperating with each other to ensure that high standards are maintained; and
  • that our wealth is also measured by the degree of confidence consumers have when they enter into transactions to purchase pharmaceuticals and other health related products.

Thank You.