African Experts Discuss Need for Better Regulation of Medicine

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In most African countries, pharmaceutical drugs are poorly regulated or not regulated at all, posing huge risks for those who depend on them to stay healthy. But for the first time, the topic has gotten the attention of African officials, who holding a scientific conference on the topic in South Africa.

Access to safe and effective medicine can be touch and go in Africa, where the market abounds with drugs that are fake or expired.

That can have disastrous consequences, says Margareth Ndomondo-Sigonda, a Tanzanian who oversees pharmaceutical issues for an African Union agency, the New Partnership for Africa’s Development, or NEPAD.

“The situation that you see in Africa is that most of the medicines circulating in our market, more than 30 percent, either does not meet the standards, meaning that it cannot treat the disease that it is intended to, or it is falsified, meaning that it is not a real medicine,” Ndomondo-Sigonda said. “Could be that it does not have the necessary active ingredients, and therefore it may not treat or it may even cause harm to the patient instead of actually treating the disease that is intended.”

She is one of hundreds of experts who gathered in Johannesburg this week for the first-ever scientific conference bringing together pharmacists, health workers, governments and civic organizations to discuss how to better regulate the drugs that make it to health facilities across Africa.

Ndomondo-Sigonda says that most African nations lack the capacity to effectively police medicines. Nations are considering tightening and refining their testing protocols and collaborating on testing, among other interventions.

Experts also noted the role that law enforcement authorities can play in cracking down on fake drugs. While this is sure to be a long and costly process, NEPAD’s head science advisor Aggrey Ambali says these measures may end up making drugs cheaper for consumers.

If countries cooperate to test drugs, he says, they can save money. And if local drug producers are made aware of the new guidelines, they can compete more effectively.

“Without actually having the actual numbers, but the pointers are there that if this were to succeed, I think there are opportunities of trying to find ways of cutting costs which can actually be reflected in the final price of the medicine,” said Ambali.

Ndomondo-Sigonda says consumers can protect themselves now by being selective about where they buy their drugs and sticking to trustworthy health facilities.

“The minute they go and buy medicines in the open markets, that is where the problem starts, because the products in the open markets, they are not assured because you do not know where they source them from and you have a huge potential for buying counterfeit medicines in such markets,” she said.

That fact was illustrated in 2011, when the World Health Organization reported that in Nigeria, the continent’s largest pharmaceutical market, nearly two-thirds of drugs used to fight malaria were fake.

via African Experts Discuss Need for Better Regulation of Medicine.

–Anita Powell
Source: VOA News

Liberia Fights Fake Drugs

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DAKAR — Liberia is cracking down on the sellers of fake or expired pharmaceutical drugs, but has met some resistance from people, especially in rural communities, who say these black market medicines are all they can get or afford. The traffic and sale of old and counterfeit medicine—a multimillion dollar industry—is widespread in West Africa.

It is not hard to find one of Liberia’s roving drug salesmen known locally as “black bag doctors.” John Harris walking down a county highway just a few kilometers outside the capital, Monrovia, where a VOA reporter met him.

He wore a backpack and carried a bucket. Both were full of unmarked plastic bags of pills that he said were painkillers and malaria drugs. Harris said this is not what he had in mind for his life when he graduated from medical school.

“How does the government expect us to survive when there is no job? So I do this, moving from villages and towns and sell these drugs to the people,” Harris explained. “At least we are helping government. Some of the places we go, there are no health facilities. So I think we are a help.”

But it is a crime to sell medicines in the street without a license. Inspectors from Liberia’s Pharmaceutical Board have been combing the countryside looking for drug peddlers like Harris this year.

Chief Pharmacist Reverend Tijli Tarty Tyee said the pills and treatments these peddlers sell are expired, damaged by sun or humidity, or just fake.

“Medicines sold in this manner will not have the basic ingredients that will bring about cures and as a result of that,” Tyee explained, “people taking the medicines, there is a potential of having microbial resistance to the medicines. When we have resistance to our imported medication, then we are in a very serious, serious situation.”

He said he understands that people need medicines and they need them cheap.

“They want to have a shortcut in getting medicines but that shortcut is dangerous to them,” Tyee said.

The crackdown has met some resistance from local communities and from the peddlers themselves. Tyee says inspectors have been injured during “raids.”

It is harder to go after the source.

The U.N. Office on Drugs and Crime says fraudulent medicines in West Africa are both imported and manufactured locally.

It’s a diffuse supply chain with limited government oversight. Flour has been discovered packaged as the antibiotic amoxicillin. Manufacturers try to raise profit margins by reducing the amount of an active ingredient. Or real medicines can make their way into a street peddler’s backpack once they are past their expiration date.

Experts say the true scope of the problem is near impossible to measure.

The UNODC says even legitimate providers in West Africa, like pharmacists and doctors, can not be 100 percent sure that what they are administering is real.

–Ann Look

Source: VOA News

Take Action to Stop Counterfeit Malaria Drugs

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This campaign was launched by the Dutch Malaria Foundation on World Malaria Day 2013:

” If one out of three doses of anti-malaria drugs on the African market are fake or substandard, how can we expect to reduce the number of children dying from this terrible disease? Good drugs save lives. Fake drugs kill.

On behalf of millions of people that run this unacceptable risk every day, we say thank you.

–Dutch Malaria Foundation”

More information: FakeDrugsKill.org

Shelf Life of Malarone

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QUESTION

I’ve just finished reading several years’ worth of your responses to questions and I’m very impressed. Thank you for being surely one of the best sources on the web. My question pertains to the shelf life of Malarone tablets. My husband and I have been in Madagascar for three weeks now and will stay for another two and a half months. I am very preventive-oriented (long sleeves, pants and socks, mosquito tent at night) as mosquitos love me. I am not however taking a chemical prophylactic. I have brought with me 11 Malarone tablets (GlaxoKlineSmith) bought on prescription in France some years ago and whose expiration date is… 2010. If I do come down with the symptoms (likely falciparum) and test positive, would I not be better off taking these perimated pills than eventually buying counterfeit ones here, if you can get them, as I read on the internet that drug companies are very conservative re shelf life (the pills are in their original plastic/aluminum airtight wrappings)? I say I am preventive-oriented, though I admit that travelling with old Malarone (and not the 12 recommended but only 11) is not too wise.

ANSWER

Thanks so much for your question, and you certainly have done your research! I agree, often the expiry date of medications seems to be overly conservative, but unfortunately without testing the chemical properties of the tablets, you cannot know for sure whether the compounds in the drugs have begun to break down.

I understand your predicament that slightly weaker drugs might be better than counterfeit ones, but ultimately, both might not be completely effective and I would be very concerned about the possible contribution to drug resistance, if you try to treat malaria with a drug which is not fully operational. This is the same effect as taking only 11 out of the required 12 tablets for treatment; it’s like not completing a full course of antibiotics, and can assist the malaria parasite in developing drug resistance.

In your case, I have a couple of recommendations: First of all, you are unlikely to be able to find reliable Malarone, but doxycycline should be available and given how cheap it is as a generic, unlikely to be counterfeit. Given you will be in Madagascar for a reasonably long period of time, you probably should start chemical prophylaxis, and doxycycline could be a good option. The usual dose for prophylaxis is 100mg, taken orally, once a day. You will need to continue taking it every day for four weeks after you leave the malarial area. Most people tolerate doxycycline very well, but it can cause minor side effects such as stomach ache and sensitivity to the sun. You should also make sure to take it 2-3 hours before consuming any dairy products or other items containing calcium or magnesium (antacid tablets, etc), as doxycycline binds to calcium and magnesium, preventing it from being fully absorbed by the body.

Secondly, I would also investigate local pharmacies and clinics and find out which ones stock artemisinin-based combination therapies, such as Coartem, ASAQ, Pyramax or Duo-Cotecxin. Look for artemisinin-derivatives in the list of ingredients such as artesunate, dihydroartemisinin and artemether, together with a combination compound (having a second active ingredient is very important in terms of preventing development of drug resistance) such as lumefantrine, mefloquine, piperaquine and amodiaquine.

It is difficult to identify counterfeit drugs, but look for original packaging (including aluminum casings for the pills), manufacturer’s stamps and an expiry date (obviously you want to make sure the drugs have not expired!). Once you have sourced a suitable pharmacy, if you or your husband comes down with malaria (as you rightly say, once you have been positively tested for falciparum! I’m so happy you are aware of the importance of diagnosis), then you will have a sense of a pharmacy to turn to when you need treatment, though hopefully, if you start taking doxycycline, you will be completely protected!

Mobile Technology Used to Fight Malaria Drug Counterfeiting

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African Social Enterprise mPedigree Networks has been running a program in Nigeria and Ghana that allows consumers to verify the authenticity of anti-malaria drugs by using mobile phone SMS technology. With the new service, patients taking a range of medication and send a free text message to get an instant response as to whether the medications are genuine.

Counterfeit medicines often contain the wrong quantity of active pharmaceutical ingredients, which can result in illness or death. The system assigns a code that is revealed by scratching off a coating on the drugs’ packaging. This code can be text messaged by the consumer or medical professional to a free SMS (short message service) number to verify the authenticity of the drug.

If the drug packaging contains a counterfeit code, the consumer will receive a message alerting them that the pack may be a fake, as well as a phone number to report the incident. Pharmaceutical safety regulators in Ghana and Nigeria are working to ensure that the concerns of users are promptly addressed.

“Counterfeit pharmaceuticals are a big problem for developing nations, particularly in Africa. It is important that we developed an African solution to an African problem, using the resources and technologies that are widely available and easy to implement,” said Bright Simons, founder, mPedigree Network. “It’s absolutely imperative that people can trust the authenticity of the drugs they are consuming, and this system will give them an easy and effective way of doing so.”

“Over the years, we have invested a huge amount of time and money in developing drugs which will protect the health of people around the world,” said Dr. Joseph Ikemefuna Odumodu, chief executive, May & Baker Nigeria, and president, West African Pharmaceutical Manufacturers Association. “It’s in both our and our customers’ interest that they receive the full benefit of that investment. This system will safeguard both of us now and in the future.”

HP is providing the hosting infrastructure for the service, as well as the security and integrity systems, through its data centers in Frankfurt, Germany. mPedigree Network is providing the business process interfaces that allow pharmaceutical companies to code their products for the system and to monitor use of genuine and counterfeit drugs.

The service, which was endorsed by the West African Health Organization, is expected to be available for other medications and in more countries in the near future. All GSM mobile network operators in Ghana and Nigeria are signatories to the scheme.

“Technology plays a critical role in solving many serious health problems around the world,” said Gabriele Zedlmayer, vice president, Office of Global Social Innovation, HP. “While Nigeria and Ghana are the starting points for this program, we are working to create a scalable infrastructure to be used by other regions where counterfeit medicine is a growing issue.”

In November 2010, mPedigree won the start-up category of the Global Security Challenge in London, becoming the first organisation in the Southern Hemisphere to win the award according to the organizers, and in February 2011, mPedigree won the 2011 Netexplorateur Grand Prix at UNESCO in Paris, for combating fake medicine in Africa through texting.

Sources: HP Press Release (12-10-10); Wikipedia (http://en.wikipedia.org/wiki/Mpedigree)
More information: mPedigree; BBC

Malaria Prevention

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QUESTION

What are the ways in which you can prevent yourself from being infected with malaria?

ANSWER

Malaria prevention consists of a combination of mosquito avoidance measures (since malaria is transmitted by infected mosquitoes) and chemoprophylaxis (medication to prevent the establishment of malaria in your body, if you do get bitten). Although very efficacious, none of the recommended interventions are 100% effective.

Mosquito Avoidance Measures

  • Because of the nocturnal feeding habits of Anopheles mosquitoes, malaria transmission occurs primarily between dusk and dawn.
  • Contact with mosquitoes can be reduced by remaining in well-screened areas, using mosquito bed nets (preferably insecticide-treated nets), using a pyrethroid-containing flying-insect spray in living and sleeping areas during evening and nighttime hours, and wearing clothes that cover most of the body.
  • All travelers should use an effective mosquito repellent.
  • The most effective repellent against a wide range of vectors is DEET (N,N-diethylmetatoluamide), an ingredient in many commercially available insect repellents. The actual concentration of DEET varies widely among repellents. DEET formulations as high as 50% are recommended for both adults and children older than 2 months of age (see the Protection Against Mosquitoes, Ticks, and Other Insects and Arthropods section later in this chapter). DEET should be applied to the exposed parts of the skin when mosquitoes are likely to be present.
  • In addition to using a topical insect repellent, a permethrin-containing product may be applied to bed nets and clothing for additional protection against mosquitoes.

Chemoprophylaxis

      • All currently recommended primary chemoprophylaxis regimens involve taking a medicine before travel, during travel, and for a period of time after leaving the malaria endemic area. Beginning the drug before travel allows the antimalarial agent to be in the blood before the traveler is exposed to malaria parasites.
      • Presumptive antirelapse therapy (also known as terminal prophylaxis) uses a medication towards the end of the exposure period (or immediately thereafter) to prevent relapses or delayed-onset clinical presentations of malaria caused by hypnozoites (dormant liver stages) of P. vivax or P. ovale. Because most malarious areas of the world (except the Caribbean) have at least one species of relapsing malaria, travelers to these areas have some risk for acquiring either P. vivax or P. ovale, although the actual risk for an individual traveler is difficult to define. Presumptive anti-relapse therapy is generally indicated only for persons who have had prolonged exposure in malaria-endemic areas (e.g., missionaries, volunteers).
      • In choosing an appropriate chemoprophylactic regimen before travel, the traveler and the health-care provider should consider several factors. The travel itinerary should be reviewed in detail and compared with the information on where malaria transmission occurs within a given country to determine whether the traveler will actually be traveling in a part of the country where malaria occurs and if significant antimalarial drug resistance has been reported in that location.
      • The resistance of P. falciparum to chloroquine has been confirmed in all areas with P. falciparum malaria except the Caribbean, Central America west of the Panama Canal, and some countries in the Middle East. In addition, resistance to sulfadoxine–pyrimethamine (e.g., Fansidar) is widespread in the Amazon River Basin area of South America, much of Southeast Asia, other parts of Asia, and in large parts of Africa. Resistance to mefloquine has been confirmed on the borders of Thailand with Burma (Myanmar) and Cambodia, in the western provinces of Cambodia, in the eastern states of Burma (Myanmar), on the border between Burma and China, along the borders of Laos and Burma, and the adjacent parts of the Thailand–Cambodia border, as well as in southern Vietnam.
      • Additional factors to consider are the patient’s other medical conditions, medications being taken (to assess potential drug–drug interactions), the cost of the medicines, and the potential side effects.

The medications recommended for chemoprophylaxis of malaria may also be available at overseas destinations. However, combinations of these medications and additional drugs that are not recommended may be commonly prescribed and used in other countries. Travelers should be strongly discouraged from obtaining chemoprophylactic medications while abroad. The quality of these products is not known, and they may not be protective and may be dangerous. These medications may have been produced by substandard manufacturing practices, may be counterfeit, or may contain contaminants. Additional information on this topic can be found in an FDA document

Purchasing Medications Outside the United States.

Counterfeit Anitmalarial Drugs Threaten Crisis in Africa

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Hopes of at last controlling malaria in Africa could be dashed by the emergence of poor-quality and fraudulent antimalarial medicines, warn experts writing in Malaria Journal. Unless urgent action is taken both within Africa and internationally, they argue, millions of lives could be put at risk. [Read more…]