Counterfeit medicines

Medicine Matters - by Teodoro B. Padilla

Posted at Nov 07 2013 11:34 AM | Updated as of Nov 07 2013 07:34 PM

While counterfeit items such as fake movies, computer software, bags, and clothes sabotage the economy, counterfeit medicines do more than that.

Counterfeit medicines defraud patients. They also deny patients the therapies they need to help them get well. They increase chances of developing complications that could worsen the disease. In many cases, fake medicines cause great harm such as allergic reactions, heavy metal poisoning, as well as promote drug resistance to strains of diseases.

Fake medicines are found everywhere in the world. Emerging economies, as well as highly developed countries with strong regulatory systems, have fallen victims to pharmaceutical counterfeiting.

In a Group of Eight meeting in 2012, world superpowers that include the US, UK, Germany, Japan, Italy, Canada and Russia issued the Camp David Declaration, which highlighted, among others, the importance of intellectual property rights and the commitment to fight counterfeit medical products.

“To protect public health and consumer safety, we also commit to exchange information on rogue Internet pharmacy sites in accordance with national law and share best practices on combating counterfeit medical products,” the Declaration read.

It has also been reported that in developed countries with effective regulatory systems, the incidence of counterfeiting is extremely low with less than 1% of market value. On the other hand, many African countries, and in some countries in Asia, Latin America, and countries in transition, a greater percentage of medicines on sale may be spurious/ falsely-labeled/ falsified/ counterfeit (SFFC).

SFFC medicines are those that are deliberately and fraudulently mislabeled with respect to identity and/or source, said the World Health Organization (WHO). They may include products with the “correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging."

In the Philippines, one report disclosed that up to 10% of medicines sold might be counterfeit. In fact, government agents seized PhP700 million worth of fake medicines and health supplements in Binondo early this year.

CLOSER TO HOME

The threat of fake medicine is real. This threat could not be more real and closer to home than with Dr. Maria Minerva P. Calimag, a professor of Pharmacology, Anesthesiology and Clinical Epidemiology at the Faculty of Medicine and Surgery at the University of Santo Tomas.

Dr. Calimag’s father suffered from gouty arthritis and was in pain for sometime when a friend told him that a certain Chinese medicine affords excellent relief of pain.

Her father took the medicine said to contain snake bones, which did relieve him of his symptoms. Over the years, he developed diabetes and had several fractures of his left femur and his right hip that required surgery.

The family was clueless about the link that tied all these events together until Dr. Calimag’s father suffered from another fall that resulted in brain bleed, requiring another surgery. This time, he developed high grade fever, extremely low blood pressure and severe perspiring after coming out of surgery and anesthesia.

As a doctor working with drugs and adverse drug reactions, Dr. Calimag realized that her father was probably suffering from an adrenal insufficiency that can be caused by being exposed to steroids over a long period of time. Apparently, the Chinese medicine is adulterated with steroids and phenylbutazone, a strong nonsteroidal anti-inflammatory (NSAID) drug.

Over the years, other patients taking this drug either suffered from adverse events related to the steroid component such as adrenal shutdown, diabetes, pathologic fractures, and necrosis of the femoral head as in her father's case.

Following this close encounter with counterfeit medicines, Dr. Calimag used her expertise in pharmacovilance to raise awareness about the dangers of fake drugs. At the moment, she is one of the lead advocates of the Samahan Laban sa Pekeng Gamot (Coalition Against Fake Medicine), a multi-stakeholder alliance aiming to promote awareness and educate the public about the risks and dangers associated with counterfeit medicines.

The group worked closely with the government in the signing of Presidential Proclamation 2082 that declares the third week of November as "National Consciousness Week against Counterfeit Medicines." Signed in 2010, the said Proclamation recognizes the “serious threat to public health due to counterfeit medicines continue to exist and may potentially harm thousands of Filipinos."

As Chair of the Committee on Food, Drug and Cosmetics of the Philippine Medical Association (PMA), Dr. Calimag promotes the rational use of medicines, consumer awareness and the grassroots advocacy for timely reporting of adverse events related to medicines.

The public may access the Food and Drug Administration’s Adverse Drug Reaction (ADR) or Bantay Gamot Report form on www.fda.gov.ph to report fake medicines. ADR reports, at times, lead to the detection of counterfeit drugs. Patients may also report by calling 1-800-10-FAKEMED, a hotline being maintained by the multi-stakeholder group called Safe Medicines Network (SMN).

Dr. Calimag’s personal advocacy aims to empower the public to be vigilant about the medicines they take. After all, their lives and health are at stake.

Email the author at [email protected]

Disclaimer: The views in this blog are those of the blogger and do not necessarily reflect the views of ABS-CBN Corp.