Guide to Detecting Genuine Medications in Yemen SBDMA (17)

by | Jan 7, 2023 | Pharmaceuticals, A How-to Guide, Regulatory affairs | 0 comments

Guide to Detecting Genuine Medications in Yemen SBDMA

Your Guide to Detecting Genuine Medications in Yemen Amidst Counterfeit Products

Your Guide to Detecting Genuine Medications in Yemen Amidst Counterfeit Products : Counterfeit pharmaceuticals pose a severe threat to public health, especially in low- and middle-income countries like Yemen, where counterfeit products are alarmingly common. As much as 10-40% of medicines sold in these regions could be fake, containing harmful ingredients or no active ingredients at all, rendering them ineffective and potentially dangerous

Spotting counterfeit medications is crucial to safeguard your well-being amidst the proliferation of these illicit products. This guide will delve into understanding the risks of counterfeit pharmaceuticals, equipping you with the knowledge to identify genuine medications and verify their sources, while exploring legal and regulatory measures and raising awareness about this critical issue.

Understanding Counterfeit Medications

Guide to Detecting Genuine Medications

Identifying Counterfeit Medications: A Daunting Challenge

Spotting counterfeit drugs is an arduous task, as they are often designed to appear identical to the genuine product, making it nearly impossible to distinguish them without laboratory analysis. The harsh reality is that these illicit pharmaceuticals frequently contain hazardous substances like paint, chalk, or even rat poison, posing grave risks to public health and contributing to tens of thousands of preventable deaths worldwide each year.

The Illicit Pharmaceutical Trade: A Lucrative Criminal Enterprise

  1. The global market for counterfeit pharmaceuticals is a thriving illicit industry, estimated to be worth a staggering $65-200 billion annually.
  2. These counterfeit drugs target a wide range of products, from lifestyle medications in developed countries to life-saving treatments like antibiotics, antimalarials, and antiretrovirals in developing nations.
  3. The proliferation of counterfeit medicines can be attributed to various factors, including:
    • High demand for cheaper drugs
    • Low availability of medical products
    • Globalization and increased internet access
    • Complex supply chains
    • Lack of enforcement
    • Weak regulatory policies.

Yemen’s Pharmaceutical Crisis: A Perfect Storm

Factor Description
Ongoing Conflict Since the outbreak of war in Yemen 9 years ago, millions of Yemenis have faced challenges in accessing health and medical services due to the collapse of state institutions and damage to health facilities.
Reliance on Aid Yemenis have relied on aid from donor countries and international organizations to obtain medicines, but this aid is often delayed due to war conditions and local mismanagement.
Smuggling and Counterfeits An estimated 30% of all seemingly legitimate medicines enter Yemen through illicit channels, with the Houthi militias controlling a significant portion of the pharmaceutical industry and engaging in large-scale smuggling
Lack of Oversight While the Supreme Authority for Medicines claims only a small number of medicines were withdrawn last year due to non-compliance, there are allegations that Yemen has become a ‘dumping ground’ for counterfeit and smuggled medicines
Deadly Consequences Incidents like the death of 11 children who were injected with expired medicine and the recent tragedy at the Leukemia Pediatric Center, where 10 children died and 19 others were harmed by a contaminated, smuggled drug, highlight the severe consequences of the counterfeit drug crisis in Yemen

The prevalence of counterfeit medications in Yemen is a multifaceted issue, exacerbated by ongoing conflict, lack of oversight, and the infiltration of illicit supply chains, posing a severe threat to public health and safety.

Spotting Counterfeit Medications

Identifying Counterfeit Medications: Key Signs to Watch For

There are several telltale signs that can indicate a medication is counterfeit, including spelling errors, changes in appearance, quality issues, and compromised packaging 1. However, it’s crucial to note that laboratory testing is the only definitive way to confirm a medication’s authenticity 1. Here are some key signs to watch out for:

  1. Appearance and Packaging Discrepancies:
    • Variations in color, size, shape, or texture compared to the genuine product
    • Misspellings or poor print quality on labels and packaging
    • Damaged, unsealed, or tampered packaging
    • Missing or incorrect expiration dates, lot numbers, or other identifying information
  2. Quality and Performance Issues:
    • Unexpected side effects or lack of therapeutic effect
    • Unusual taste, smell, or discoloration of the medication
    • Crumbling, chipping, or chalky texture of pills or capsules
  3. Suspicious Pricing and Sources:
    • Significantly lower prices than expected for the genuine product
    • Offers from online pharmacies that do not require a valid prescription
    • “Too good to be true” claims or unrealistic promises

Reporting Suspected Counterfeit Medications

If you suspect a medication is counterfeit, do not take it. Instead, contact your doctor, pharmacy, and And Enopharm quality department immediately to report the suspected counterfeit product. Additionally, you can report any suspected counterfeit medications to the relevant regulatory authorities.

If you believe you have already used a counterfeit product, it is crucial to seek medical attention and report the incident to the pharmacy, your healthcare provider, and local health authorities. Reporting suspected counterfeit medical products helps authorities identify and address the issue, ultimately protecting public health and safety.

Verifying Medication Sources

Purchasing from Reliable Sources

Purchasing prescriptions from reputable, brick-and-mortar pharmacies is generally safe in the U.S. The National Association of Boards of Pharmacy (NABP) also provides a ‘Buy Safely’ site to help identify reliable online pharmacies 1. However, in Yemen, the situation is more complex, and extra precautions are necessary.

  1. Licensed Pharmacies and Inspections
    • If you must buy medicines while traveling in Yemen, take steps to reduce the chances of buying counterfeit drugs, such as only buying from licensed pharmacies and inspecting the packaging closely.
    • In 2011, there were 3,315 licensed pharmacies and 4,133 drug stores in Yemen.
    • However, most pharmacies are not owned by qualified pharmacists and lack access to up-to-date drug information resources.
  2. Pharmaceutical Industry and Imports
    • Yemen has 9 local pharmaceutical industries, but they only cover 10-20% of the total pharmaceutical market. Most medicines are imported from 50 countries through 400 importers
    • The Yemen Drug Company (YEDCO), established in 1964, is the main pharmaceutical company in Yemen, producing over 60 medicinal products.

Verifying Credentials and Qualifications

Aspect Details
Licensing Authority The Yemeni Supreme Medical Council (YSMC) is the licensure body system for healthcare providers and the accreditation authority for medical education schools in Yemen.
Primary Source Verification DataFlow Group is a trusted partner of YSMC for Primary Source Verification (PSV) services, verifying the education credentials of healthcare practitioners seeking license or renewal with YSMC.
PSV Benefits DataFlow offers industry’s fastest processing time (average 25 working days), easy online application process, dedicated customer support, global network of over 115,000 Issuing Authorities, and compliance with data protection standards like GDPR.
Pharmacist Qualifications Only 10% of pharmacists working in pharmacies and drug stores have graduated from government-recognized colleges. The rest have unrecognized qualifications.
Licensing Exam There is no licensing exam required to practice pharmacy in Yemen.

Addressing Challenges and Risks

  1. Availability and Affordability
    • Availability and affordability of medicines is a major concern in Yemen. Public sector access is poor compared to the private sector
  2. Prescription Practices
    • Dispensing of prescription medicines without a valid prescription is a major issue in Yemen.
    • Unqualified dispensers often diagnose, prescribe, and dispense medicines, leading to health risks
  3. Recommendations
    • To lower the risk, buy medicines from a registered pharmacy, either in-person or online through a registered Australian pharmacist
    • Inspect the packaging closely for any signs of tampering or counterfeiting

Verifying medication sources in Yemen requires extra vigilance due to the prevalence of counterfeit drugs, lack of oversight, and challenges in the pharmaceutical industry and healthcare system. By following best practices and purchasing from licensed and reputable sources, you can reduce the risk of obtaining counterfeit medications.

Legal and Regulatory Measures

Combating Counterfeit Pharmaceuticals: A Multifaceted Approach

Measures to combat counterfeit pharmaceuticals include strengthening legislation, enhancing enforcement, improving supply chain security, advancing detection technologies, and raising public awareness. International cooperation, harmonized regulatory frameworks, and a whole-of-society approach are essential to effectively restrict the proliferation of counterfeit medicines.

Yemen’s Regulatory Landscape

  1. The Medicines Authority in Yemen is responsible for controlling the quality of officially imported medicines, but has limited ability to address the issue of smuggled medicines, which is the responsibility of border authorities.
  2. Calls have been made to raise awareness, seize companies flouting rules, and facilitate the legal and regulated import process for authorized medicines to address the issue of counterfeit and smuggled medicines in Yemen.
  3. The Supreme Authority for Medicines and Medical Supplies in Taiz recently destroyed 2 tons of smuggled medicines that were seized by the military police.
  4. The Director General of the Supreme Authority for Medicines and Medical Supplies, Dr. Muhammad Al-Sufi, stated that smuggled medicines are a ‘silent killer’ and urged pharmaceutical facilities to not deal with them.
  5. Since the outbreak of the war in 2015, medicine smuggling has been a major challenge for Yemen’s health authorities.

Recent Enforcement Actions

  1. In May 2023, the Health Ministry in Sanaa destroyed 60 tons of smuggled medicines and medical supplies that did not meet specifications and standards.
  2. Dr. Abdul Qadir Al-BakIri, Director General of the Supreme Authority for Medicines and Medical Supplies in Aden, stated that fighting medicine smuggling is the responsibility of border guards, and called for raising awareness to stop the import of unchecked medicines.

Strengthening Regulatory Framework

  1. There is a need for updated laws and regulations to require pharmacy and drug store owners to hire qualified and registered pharmacists, and to implement penalties for non-compliance.
  2. Collaboration is needed between pharmacy colleges and the Ministry of Public Health to develop a policy requiring pharmacists to attend continuous medical education courses.

International Efforts

The Therapeutic Goods Administration (TGA) in Australia works to keep fraudulent medicines out of the marketplace, seizing and destroying any counterfeit medicines found to be imported into the country.

Raising Awareness and Education

Addressing the Challenges: A Multipronged Approach

Raising awareness and education about the dangers of counterfeit medications in Yemen is a crucial step in combating this public health crisis. A multipronged approach is needed to tackle this issue effectively:

  1. Strengthening the Yemeni Pharmacovigilance Center (YPVC):
    • The YPVC plays a vital role in monitoring medication safety and adverse events, but faces challenges such as lack of awareness and resources.
    • Increasing the YPVC’s capacity through additional funding, training, and resources can enhance its ability to detect and report counterfeit medications.
  2. Improving Coordination and Information Sharing:
    • Fostering better coordination and information sharing among healthcare professionals, regulatory authorities, and law enforcement agencies can help identify and address counterfeit medication issues more effectively.
  3. Enhancing Supply Chain Controls:
    • Implementing stricter supply chain controls, such as serialization and track-and-trace systems, can help prevent the infiltration of counterfeit medications into the legitimate supply chain
    • Facilitating the legal and regulated import process for authorized medicines can reduce the reliance on unofficial and potentially counterfeit sources.
  4. Raising Public Awareness:
    • Conducting public awareness campaigns to educate Yemenis about the dangers of counterfeit medications, how to identify them, and the importance of obtaining medicines from legitimate sources.
    • Engaging community leaders, religious institutions, and local organizations can help disseminate this information more effectively.
  5. Healthcare Professional Education:
    • Providing training and education for physicians, pharmacists, and other healthcare professionals on the latest developments in pharmaceutical counterfeiting, detection methods, and best practices for prescribing and dispensing medications.
    • Updating the pharmacy curriculum in Yemeni universities to align with current standards and emphasize the importance of pharmaceutical care and clinical pharmacy services.
  6. Promoting Responsible Prescribing and Dispensing:
    • Implementing stricter regulations and penalties to discourage the dispensing of medications without a valid prescription.
    • Raising awareness among healthcare professionals and the public about the risks associated with self-medication and the importance of seeking professional medical advice.

By addressing these various aspects through a comprehensive and coordinated effort, Yemen can make significant strides in raising awareness, improving education, and ultimately reducing the prevalence of counterfeit medications and their associated risks.

Conclusion

The proliferation of counterfeit medications in Yemen is a grave public health concern, exacerbated by ongoing conflict, lack of oversight, and the infiltration of illicit supply chains. Addressing this crisis requires a multifaceted approach, involving strengthened legislation, enhanced enforcement, improved supply chain security, and advanced detection technologies. Additionally, raising awareness and education among healthcare professionals, regulatory authorities, and the general public is crucial to combat the dangers of counterfeit pharmaceuticals.

Ultimately, a collaborative effort from all stakeholders, including international organizations, government agencies, and local communities, is essential to mitigate the risks posed by counterfeit medications in Yemen. By prioritizing this issue and implementing robust measures, Yemen can safeguard the health and well-being of its citizens and prevent the devastating consequences of counterfeit drug proliferation.

FAQs

Q: How can I identify counterfeit pharmaceuticals? A: To spot counterfeit pharmaceuticals, look for typographical errors on labels or packaging, such as misspellings of the product name, manufacturer, or main ingredients. Additionally, be alert to any changes in the medication’s appearance, such as alterations in size and shape between refills, which could indicate a counterfeit product.

Q: What should I do to verify the authenticity of my medication? A: To verify if your medication is genuine, check for the consistency in labeling and packaging with previous purchases, and ensure that the product matches the description provided by legitimate sources. You may also contact the manufacturer or consult a healthcare professional if you have doubts about the medication’s authenticity.

Q: Can you tell me the methods to distinguish fake drugs from real ones? A: Fake drugs can be identified through several red flags: if they contain incorrect amounts or different ingredients than specified, claim to have unusual properties or side effects, differ in shape, size, taste, or color, are improperly labeled or unlabeled, or have an expired or missing expiry date.

Q: Which regions experience the highest rates of counterfeit drug incidents? A: In 2020, North America experienced the highest rate of counterfeit medicine seizures, accounting for 32% of incidents globally. It was followed by the Asia Pacific region at 23%, with Latin America, Eurasia, Near East, Europe, and Africa each having around 3%. Counterfeit drugs are a significant issue across both developed and developing nations.

 

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