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Fake medicines are a serious threat to life and healthcare

MEDICINES

Fake medicines are a serious threat to life and healthcare

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Fake medicines are a serious threat to life and healthcare

Judith arrived was in the ward with severe generalized body swelling and was out of breath. She explained that for three months, she had had no appetite, felt depressed, and had barely any energy to work. She struggled even to sustain a conversation. Lately, the only thing she was able to do was to sleep all day. She was also tired when waking up after a whole night’s sleep. The things that used to make her happy no longer did.

Prior to those three months, she had lived a normal life and had a family and thriving career. She had last experienced those symptoms ten years earlier when she was diagnosed with thyroid disease. She was started on medication and follow-up clinic. For ten years, she never failed to take medicine or attend any of her doctor’s appointments. It did not matter what was going on in her busy life. She understood that any miss-steps would put her at the risk of losing that life. That meant leaving her children without a mother, a prospect she could not countenance. She could not do anything that would negatively affect her children. She had also developed an excellent relationship with her doctor and would never want to disappoint her either.

It came as a shock when the doctor saw Judith in the condition she came in. It was not difficult to determine that it was something to do with the medicine. Either she was not taking it, which seemed unlikely, or she was the victim of something the specialist had seen quite often; counterfeit drugs. All she needed was to ask Judith if she had recently changed the pharmacy where she filled her prescription. She answered in the affirmative, and the doctor knew right away she was dealing with a double tragedy. Fake drugs fail to stop the progression of the disease for which they are prescribed while at the same time exposing the patient to side effects.

That means side effects without any therapeutic benefits. The lack of benefits is because they lack the correct dose of the active molecules. Many patients who take them will present with symptoms of the disease for which they are being treated. They feel they are not getting better despite following the doctor’s advice. It can be confusing to patients who end up getting frustrated and seeking a second opinion from other doctors. Doctors also find it frustrating, especially when they do not suspect that the medicine is. There are many times when a doctor will increase the dose of a drug to the safe maximum without getting the desired effect. This warrants a change to a different type that is more potent and reserved for more severe cases.

Problems with counterfeit medicines go beyond failed treatment and financial loss. The effects on people’s lives can often be tragic. Thyroid replacement drugs are particularly dangerous because the thyroid hormone they are meant to replace affects every cell of the body. Thyroid hormones are the chemical foundation of metabolism. Its immediate and accurate replacement is imperative for those whose thyroid gland does not function properly as more people are diagnosed with thyroid disease each year, the demand for thyroid replacement medicines increases. This demand has drawn into the market many different types of sub-standard thyroid drugs.

Levothyroxine is one of the most commonly prescribed thyroid medication in the world. It is also one of the most frequently affected by problems of all kind. Many reports have emerged in recent years about the recall of levothyroxine. The underlying issues are manifold. One cause of recall was due to the presence of impurities in batches obtained from China1. The manufacturer, Westminster Pharmaceuticals, had to recall the batches after they failed FDA inspection in the United States. In France, complaints about severe side effects became widespread2. This was after reformulation of Levothyroxine produced by Merck, one of the world’s foremost pharmaceutical companies.

There are many other reasons for the recall of levothyroxine. Some of those listed on MedPro include reasons to do with the medicine itself or the labeling of their containers. Several manufacturers have been forced to recall batches due to incorrect expiry dates, wrong potency, and even others being excessively strong3. Any of these issues can adversely affect those who depend on levothyroxine to lead normal lives. The consequences are represented in Judith’s case and can often be fatal.

These are not problems that should be associated with medicines. The production, distribution, prescription, and dispensing of medicines are processes of an exact science which ensures public safety and the normal functioning of the healthcare system. Because pharmaceuticals are high-profit products, many people exploit loopholes in the regulations. The reason why the above recalls occurred is that regulators in certain countries are well equipped and capable of enforcing rules.

Cases such as Judith show the weakness in regulation. Whether the problem lies in lack of equipment in our regulatory authorities, or corruption among officials responsible for inspection, the consequences include disease complications and loss of life. There is also a loss of trust in the system. Telling patients that they are at the mercy of unscrupulous merchants selling poor quality drugs conveys the message that they are on their own. People living with chronic diseases such as hypothyroidism, hypertension, or diabetes already endure severe psychological distress. The idea that they are being used as pawns in health system that either lacks regulation or is ill-equipped to protect them from predatory players can tip some over the edge.

The problem of poor quality medicine is a global one. Each nation must put in place mechanisms to protect its citizens from fake medicines. This must be pursued as much as matters of national security because it is a threat to people’s lives, patients’ financial stability and causes greater burden to the healthcare system because it must deal with the consequences. For victims such as Judith, the feelings of betrayal by the healthcare system they trusted and the government authorities they expect to protect them may continue to worsen their mental status already strained by living with chronic disease.

References

  1. Sandee LaMotte, CNN, August 15, 2018. Thyroid medications recalled due to risk of impurities. https://edition.cnn.com/2018/08/15/health/thyroid-medication-recall/index.html
  2. Barbara Casassus, (2018). Risks of reformulation: French patients complain after Merck modifies levothyroxine pills. BMJ 2018;360:k714.
  3. Full list of all levothyroxine recalls, FDA 2012-2017. https://www.medprodisposal.com/levothyroxine-recall

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