The Influx of Non-Approved Medication (Drugs) and its associated dangers

Drugs or medications treat and cure illnesses in patients suffering from various health conditions. Without these potentially life-saving medications, treating diseases and ailments would prove challenging. This is why such drugs need to be approved by the proper authority, such as the Food and Drugs Authority (FDA), and prescribed by qualified physicians before being administered.

While FDA approval and prescription through the correct channels are essential, there is a significant influx of unapproved drugs in the market today. These unregulated drugs are often used by people?who may not consider the health risks and associated implications. At the same time, certain FDA-approved medications?should only be administered to patients through a physician but make their way onto the streets.?An example is Tramadol, a medication used to treat severe pain. This drug is supposed to be available under a doctor's prescription but is now sold by unauthorized and unlicensed chemical sellers. As a result, people abuse Tramadol to get high rather than its intended use to help soothe excessive pain after a surgical procedure.

A visit through the principal streets of Accra brought about some intriguing revelations. Interacting with 47-year-old Al-Hassan, a hawker who sells drugs for a living, revealed that although the business is risky, it is necessary for survival. "I've been in this business for over 15 years, and that's what I found myself doing. There is nothing I know best than the business of selling drugs. That's how I feed my family.??Though I do not have the license to operate, I believe I'm helping many people in my community who cannot afford to buy drugs at the pharmacies. I plan on opening a chemical shop once I get a license to operate," he noted. Al-Hassan's customers are local head porters (Kayayei), street hawkers, and food vendors.

Speaking to 23-year-old Amina, head porter (Kayayoo), at the Tema Station in Accra, she admitted that buying drugs from unlicensed chemical sellers poses a danger but going to the pharmacy is a stressful experience. "I can't afford to buy drugs at the pharmacy because they demand a prescription before they can sell any drug to you. Usually, I need just one or two blisters of painkillers to keep me going after a hard day's work.

With as little as GHS4.00, I can get myself a blister or two of paracetamol tablets without any stress. I have three children, and I'm struggling to cater to them. What will happen if two of my children get sick simultaneously? How will I be able to take them to the hospital? All I need is to rush to this chemical seller, explain things to him, and he will give me some drugs to administer to my children. That has always been the trend, and I prefer to keep it that way. Allah takes care of us no matter what," said Amina.

Adding his voice, a pharmacist at the Korle-Bu Teaching Hospital, whom I spoke with under anonymity, believes people continue to buy and use unapproved FDA drugs without considering their potential health implications. In addition, drugs that couldn't meet the FDA requirements and standards are often among the drug sellers' wares.

"Interestingly, many of these drugs are sold by unlicensed, unregistered chemical sellers. People believe so much in these people who sell these drugs. They go to any extent to defend the potency of such drugs. For them, these drugs work perfectly, and they care less about any dangers associated with them.?????????????????

We all know that unapproved prescription drugs pose significant risks to patients because the FDA has not reviewed them for safety, effectiveness, and quality. Without proper FDA review, there is no way to know if these drugs are safe and effective for their intended use. In addition, we can't know whether they are manufactured in a way that ensures consistent drug quality or if their labels are complete and accurate. Such drugs result in patient harm, and the agency works to protect patients from the risks posed by these drugs," stresses the pharmacist.

According to the World Health Organization (WHO), people must seek the advice of medical professionals before making healthcare decisions. Drug use can be grouped into three key areas: Compassionate Use, Off-Label Use, and Clinical Trials. Compassionate use of unlicensed drugs serves the need of patients with severe, debilitating diseases without alternative approved therapies. On the other hand, off-label drug use refers to the use of drugs outside the indications of the licensed product or under different conditions in terms of dose, route of drug administration, and contraindications. Finally, clinical trials are studies that prospectively allocate human participants to different interventions to estimate the effects on health outcomes.

During the Ebola outbreak, WHO introduced a new term: Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI). Its purpose is for experimental interventions carried out outside of clinical trials during an emergency to be guided by specific ethical and scientific criteria.

The suggestion that these interventions must be scientifically reviewed and approved by regulatory agencies included an ethics committee with informed consent. It acknowledged uncertainty regarding safety and efficacy, avoided unfounded expectations, and appropriately monitored the outcomes. However, WHO laid down requirements such as no possibility of clinical trials, no proven intervention, preliminary evidence of efficacy, safety, and approvals from relevant authorities.

Food and drug agencies worldwide balance their goal to eliminate unapproved prescription drugs from the market with patient access to medically necessary drugs. They critically consider the possible effects on patient access, including whether any action would lead to an interruption in the drug supply before initiating action against an unapproved drug.

In some instances, these regulatory agencies permit unapproved drugs to be marketed if healthcare professionals rely on them to treat severe medical conditions when there is no FDA-approved drug to treat the condition or an inadequate supply of FDA-approved drugs.

In the United States of America, FDA approval is required by law. This means that federal law requires all new drugs to be demonstratively safe and effective for their intended use before marketing. However, some drugs are available even though they have never received the required FDA approval. Interestingly, many healthcare professionals and patients are uninformed that some of the drugs prescribed are not FDA-approved.

The Food and Drugs Agency has a two-way approach to help assure patient safety. This is called the" risk-based approach." Under this approach,?manufacturers of unapproved drugs are encouraged to obtain approval to be legally marketed in the U.S.

Since 2006, the agency has worked to eliminate unapproved drugs from the market. As a result, many drugs have been removed from the market, including several drugs with significant safety concerns. The agency uses a risk-based approach, which enables it to prioritize drugs that pose the highest risk to public health without imposing an undue burden on patients or unnecessarily disrupting the availability of drugs on the market.

Many factors come into play regarding the issue of unapproved drugs and pricing. For example, when there is a sole source of an FDA-approved drug, market dynamics may enable the company seeking approval to set a higher fee than when the drug faces competition.

However, healthcare professionals and patients have assurances that the FDA-approved version is safe and effective for its intended use and is manufactured according to federal quality standards.

Though the FDA in America does not have the authority to regulate drug prices, it's aware of price fluctuations that might occur based on its regulatory actions and takes steps to minimize the duration of such price spikes. Such an FDA approval process might increase a drug's cost over the short term. However, the risks to the individual patient are substantially reduced, and the benefits are assured for the long term.

Although the FDA approves all prescription drugs sold in the United States, the agency cannot limit how doctors prescribe drugs once they're on the market. As a result, doctors who direct patients to take medications for unapproved conditions?can create a situation where patients are unknowingly at risk for dangerous and unexpected side effects due to off-label use.

Some 170 million Americans take prescription drugs. Adverse reactions?kill more than 2,400 people each week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations. This makes prescription drugs the fourth leading cause of death in the United States. Prescription drugs are the third cause of death among hospitalizations and deaths from prescribing errors, overdosing, and self-medication.