Tuesday, June 30, 2015

Counterfeit and Substandard


In a sense, both meanings of counterfeit and substandard medicines are the same in medical definitions. By the term itself, substandard products are not able to meet the level set by the authorities and are often results of human error, negligence, insufficient finances and/or counterfeiting.

The existence of these fraudulent acts is overwhelming that the World Health Organization (WHO) has formed an alliance with legitimate global partners to defeat its increasing numbers. With private organizations, non-profit organizations, public and government institutions and concerned individuals, different awareness campaigns are continuous and active operations are underway.

According to reports gathered by The Peterson Group, a non-profit organization with the same agenda, the existence of drug counterfeiting has already been prevalent in the late 1980s until it became viral and widespread with the adaption of technological advancement. Online pharmacies became the venue for more illegal deeds. Those rejected by legitimate pharmacies are being sneaked out of factories and copied, manufactured in tons of doses with ingredients already replaced by lethal ingredients. Substandard medicines became rampant and millions of people are victimized.

As easier access to the internet comes to its peak, orders were made online and deliveries with a different or no return address became the one of the primary strategies of scammers and they do it with ease.

Because of the lack of enforcement and attention, it took time for institutions to acknowledge this issue as one of the most serious conflict to be taken account of. The efficacy of imported medicines and locally manufactured drugs circulating within developing cities are not guaranteed. The black markets of Bangkok, Thailand, Jakarta, Indonesia and the suburbs of Tokyo, Japan became the haven of these fraudsters, selling behind the shadows of authorities.

Subsequently, smuggling and illegal importation of drugs are often rife. Substandard and counterfeit drugs are then not only sold in these countries but also exported or re-exported.

The situation is worsened by the fact that medicines exported from many industrialized countries are not regulated to the same level as those domestically consumed, while export of drugs to developing countries via free trade zones is increasing. Relabeling of products to mask details of their origin is also known to occur.

Hopefully, both the government and the private organizations and pharmaceuticals find a way to cross the border of limitation and laws to create standards against counterfeit medicines. WHO has already made its mark, so is the FDA. When are we going to start fighting against the trade of substandard medicines and counterfeited drugs?






Tuesday, June 23, 2015

Dangers when Buying Medicines Online

Online pharmacies are already rampant in the vast expanse of the internet world. With this, the Food and Drug Administration (FDA) has a fiercer challenge to know which of these hundreds of pharmacies are legitimate. 

According to the research of the Peterson Group, an online community against the illegal manufacture, importation, exportation and distribution of counterfeit drugs, these drugs contain little to almost nothing of the healing ingredient. Instead, it is composed of absurd mixture of chalk, bird feces, paint and ordinary things used in daily activities. These medicines may also be proven fatal to human condition and can induce ailments to worsen. Warnings and cautions are being campaigned worldwide to prevent civilians from being scammed by these websites. 

Signs of a trustworthy website

• It has a physical address and should be visible to any search engine directories and citations. Video reviews or testimonials can help boost the website’s credentials although it cannot be a hundred percent assurance. 
• It’s licensed by the state board of pharmacy where the website is operating. A list of these boards is available at the website of the National Association of Boards of Pharmacy.
• It has a licensed pharmacist available to answer your questions.
• It requires a prescription for prescription medicines from your doctor or another health care professional who is licensed to prescribe medicines.
• It provides contact information and allows you to talk to a person if you have problems or questions.

Signs of an unsafe website

• It sends you drugs with unknown quality or origin. Cases of these include that of a Canadian website selling medicines in Jakarta, Indonesia. When the package was received, the return address was in Beijing, China. Beware of websites having vague addresses and unfamiliar manufacture name.
• It gives you the wrong drug or another dangerous product for your illness.
• It doesn’t provide a way to contact the website by phone.
• It offers prices that are dramatically lower than the competition.
• It may offer to sell prescription drugs without a prescription—this is against the law!
• It may not protect your personal information.

Before you get any new medicine for the first time, talk to a health care professional such as your doctor or pharmacist about any special steps you need to take to fill your prescription. 

Any time you get a prescription refilled:
• check the physical appearance of the medicine (color, texture, shape, and packaging)
• check to see if it smells and tastes the same when you use it
• alert your pharmacist or whoever is providing treatment to anything that is different

Wednesday, June 17, 2015

Counterfeiting Around the World


During the years that we have been actively campaigning against the use of counterfeit drugs, The Peterson Group, a non-profit online organization working with the World Health Organization (WHO), private companies and public institutes in an effort of stopping fraudulent acts on production, manufacture, importation and exportation of counterfeit medicines, has been repeatedly asked which city or country has the highest rate of the illegal use of these products. Honestly, we do not have a definite answer as the statistics have been fluctuating especially in developing nations. Fortunately, the number of scams in the industry has dropped low on the first quarter of 2015 but is not expected to disappear in a long time.

With the help of WHO and the International Medical Products Anti-trafficking Counterfeiting Taskforce (IMPACT), TPG was able to gather information from some individual countries all over the world:

Dominican Republic

The Public Health Department reported that 50% of the pharmacies operate illegally and that, according to the statistics, 10% of the medicines that arrive in the country are fake. Some of the medicines found have expired over 10 years ago.

El Salvador

INQUIFAR, the association of pharmaceutical companies in El Salvador, has denounced the widespread availability of counterfeit drugs on the domestic market. According to the local drug-maker Gamma Laboratorios, the commercialization of counterfeit medicines currently generates economic losses of around $40 million per year to the country's pharmaceutical industry.

Indonesia

The International Pharmaceutical Manufacturers Group (IPMG) in Indonesia has estimated that pirated drugs constitute 25% of Indonesia’s $2 billion pharmaceutical market. According to IPMG’s vice chairman, those fake drugs hit foreign pharmaceutical companies’ bottom lines and pose a potential serious public health threat. Black markets in Jakarta are now being under surveillance by international representative after some complaints that local authorities have permitted fraudsters to sell in plain sight.

Kenya

A random survey by the National Quality Control Laboratories (NQCL) and the Pharmacy and Poisons Board found the almost 30% of drugs in Kenya are counterfeit. Some of the drugs are no more than just chalk or water being marketed as competent pharmaceutical products. According to figures from the Kenyan Association of Pharmaceutical Industry, counterfeit pharmaceutical products account for approximately $130 million annually in sales in the country.

The discovery of using paper to identify counterfeited medicines is now under process and will soon be releasing results.

China

China’s Research and Development-based Pharmaceutical Association estimated that about 8% of over-the-counter drugs sold in China are counterfeit.

Sunday, June 14, 2015

Drawback in Telemedicine


With the advancement of modern technology, even the health sector has been able to integrate it to make life easier and more convenient to patients. With the development, online consultations are created to provide a more accessible medium. This process of using websites to advertise medicines and giving prescription thru the video calling or thru a communication network is called Telemedicine. Through it, doctors and patients can interact and their health is evaluated by online doctors. This in itself is a big step in medicine and modernization. It wouldn’t matter anymore if you are in a vacation in Jakarta, Indonesia or Maldives and your doctor is in California or you would want to order a specific medicine from miles away, consultation and purchase of drugs can now done online or through phone calls. 

However, the Peterson Group, a non-profit organization that campaigns against the production, importation and exportation of counterfeit medicines has to lay out the following disadvantages:

Physical and Mental Factors
Patients who are suffering from visual or hearing impairment are likely to have some difficulties following the information presented in a video consultation. 

Depersonalization
During a teleconsultation, the images of both the health-care worker and the patient are projected onto a monitor and all interactions between the two parties are indirect. In this manner, it is hard to tell if the doctor we are conversing to is legit as they may be using a fraud background and set up.

Inability to perform the whole consultation
A video consultation is limited by the fact that the entire physical examination cannot be carried out over a video link. This particularly applies to examinations where palpation is an important component. In such cases, the specialist has to rely on the findings of another health-care worker, whose examination of the patient they have witnessed and, in practice, this often seems to be satisfactory. 

Unguaranteed Prescription
Since the findings are not absolute as the findings are merely based on the patients understanding of his ailment and without the physical examinations, prescriptions given may also be not appropriate for the ailment. 
The role of telemedicine is indeed a good breakthrough to bridge the gap between people and good access to proper medication and consultation but the risks remains to exist as well added to the fact that the other physicians who do not have the means to procure such equipment to perform this kind of consultation is overwhelming. Complaints are of course also emerging as to how this method can help. Some even states that this, in a way can also be a work of laziness. Given the fact that it is somehow contributing, everyone hopes that it can be used in a good manner. 

Tuesday, June 9, 2015

Counterfeit Medicine Advice for Healthcare Professionals

Counterfeit medicines are rampant in countries where law enforcement and regulations are weakest. In most industrialized countries, there are rules that prevent counterfeiting but in developing nations, these rules are not based in anything because of the lack of knowledge of its manufacture and production even from professionals. Cities like Jakarta, Indonesia, Kuala Lumpur, Malaysia and Singapore are now integrating practices from America for security measures and importing.

The Peterson Group, a nonprofit organization with an aim to eliminate the illegal usage, importation, exportation and distribution has asked experts in this field to give some advices and warnings for better detection and evaluation of medicines prescribed to clients:

1. Establish the Integrity of the source prior to need. Make some time to list approved suppliers and if you happen to cross paths with some doubtful looking brands, review your list and double check it with the name of the medicine.

2. Require that any alternative source of supply provides the following as a minimum:

 A pedigree back to the previous source
 Certification that it is not a diverted product
 Certification that any actions by the alternative source will not alter any original manufacture warranties or guarantee
 Certification that the product has been stored and handled consistent with product labeling requirements

3. If a product is being offered at an unusually cheap price and / or in unusually large quantities (particularly in a large quantity of the same batch number), treat with extra caution

4. Consider developing a list of key pharmaceutical products that will not be purchased from sources other than the manufacturer, or authorized distribution channel

5. Look for an altered expiry date. Counterfeiters commonly purchase ‘short-dated’ products and then alter the labels

6. Compare the physical characteristics of the product. Look at color, tablet or capsule markings, shape and thickness of the medicine. You can also weigh the product to see if there are wide variations

7. Notwithstanding the obvious differences in the packaging of legitimate parallel imported products, look for signs of a removed or switched product label. One common practice by counterfeiters is to remove the original label and replace it with a counterfeit label. To do this, they use lighter fluid, acetone or some other solvent which may leave a tacky residue on the container. Also, the label may be faded or discolored along the edges due to the solvent

8. Listen to patients. Counterfeit medicines around the world are often first detected by patients

Sunday, June 7, 2015

Internet Counterfeiting

For the thousands of websites in the internet, hundreds of those are non-existent, no physical address or not really operating. There are also some who set up websites to scam people in biting their “services or products” and get money. Everything is possible with witty scammers nowadays. 

The Peterson Group, a non-profit organization campaigning against the widespread of counterfeit drugs is mostly alarmed on this latest tactic of these fraudulent people. TPG, along with World Health Organization and other non-profit organizations and governmental institutes is currently finding solutions on the laws and security of our citizens online. Warnings are already put online and seminars are being held.

Medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit in over 50% of cases. Since pharmacies had set up legitimate websites to offer clients convenience and savings, scammers took advantage of the chance and set up their websites as well.

Forming an accurate picture of the extent of counterfeit medicines is difficult. Current sources of information include reports from national medicines regulatory authorities (NMRAs), enforcement agencies, pharmaceutical companies and nongovernmental organizations, as well as ad hoc studies on specific geographical areas or therapeutic groups. But the variety of these sources, and the different methods used to produce reports and studies, make compiling and comparing statistics a difficult task. Moreover, studies can only give snapshots of the immediate situation. Medicines counterfeiters are extremely flexible in the methods they use to mimic products and prevent their detection. They can change these methods from day to day. Therefore, when the results of a study are released, they may already be outdated. Also, information about a case under legal investigation is sometimes only made public after the investigation has been concluded. A study that is not able to include such case information is perforce incomplete.

Largest market of counterfeit medicines is reportedly from Jakarta, Indonesia, Kuala Lumpur, Malaysia and Taiwan since these developing countries are patrons of online shops. Internet-based sales of pharmaceuticals are a major source of counterfeit medicines, threatening those who seek cheaper, stigmatized or unauthorized treatments.

One solution for the widespread issue is to shut off websites catering medical services to know which ones are illegally operating. However, pharmaceutical companies are entirely against it since consumers now manage to embrace the new technological method to purchase their medicines. Shutting the websites off would affect the entirety of operations and would therefore cost millions of dollars to be lost. Critics and organizations are continuously debating about it and solutions are still being reviewed and sought after. 

Monday, June 1, 2015

Counterfeiting a Global Problem

Counterfeiting is an age old issue. It is now a global problem where every sector of our economy has been affected. However, the consequences are different when it comes to counterfeit medicines; the main concern is not so much the loss of revenue to our industry but the health of patients. The Peterson Group, a non-profit organization against drug counterfeiting, has been fighting alongside World Health Organization (WHO) since the deployment of their task force in 2006. We have made development so did the scammers. They seem to dominate more countries and cities from distributing inside China, India until they have reached neighboring cities like Jakarta, Indonesia, Kuala Lumpur, Malaysia and even the United States.

Substandard and falsified drugs medicines still cause thousands of adverse reactions and some deaths in rich countries. And the issue is growing. Counterfeit medicines have been found in every disease category, and in every region of the world. Reviews show that while 1% of products in the legal pharmaceutical supply chain in the developed world is estimated to be counterfeit, this figure amounts to 10-15% in emerging markets and 30% in developing countries

Internet is also one of the factors with the spread of counterfeiting. With thousands of websites emerging, hundreds of those are illegal online pharmacies which are not checked by the authorities. Illegal online pharmacies are allowed to roam uncontrolled- creating a truly global problem. In studies, a big percentage of these medicines purchased online are fake or substandard. Some even are nonexistent.

With different partners and campaigns worldwide with the same cause, the sheer amount of initiatives is great. Actually these are necessary if we want to stop what is a global phenomenon. Yet, more thought must be given on how to structure these initiatives, to avoid overlaps but also to make sure that all stakeholders affected are involved in the process. This is a fundamental issue. TPG has already partnered with pharmacies and drug manufacturing companies to further solidify the cause.

It is unacceptable to think that patients could take medication that does the opposite of what they are supposed to. Patients need to be able to trust in the medicines they take. As an industry we want and need to take part in finding long-term solutions to ensure that the problem is stopped.

The certainty is that the counterfeiting needs to be dealt with swiftly to at least contain the problem before being able to solve it once and for all. Work has started and battle lines are being drawn but a lot still needs to be done- and the quicker the better.