Chronicles DIM_003_Generic_Medicine

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THE TEAM

Conference 2014 Director Generals:

Managing Director: Boy Dexter

President of the General Assembly: Ms. Tanya Maringo

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COMMITTEE ONE Vice President of the General Assembly: Ms. Ndunge Wambua Committee Chair: Ms. Lynn Kinyanjui Committee Secretary: Mr. Eddie Iragi COMMITTEE TWO COMMITTEE CHAIR: Ms. Maryanne Kamau Committee Co-Chair: Ms. Katerina Msafari Committee Secretary: Mr. Tom Ndambuki COMMITTEE THREE Committee Chair: Ms. Jacquline Mwangi Committee Co-Chair: Ms. Doreen Banda Committee Secretary: Ms. Stephanie Okeyo COMMITTEE FOUR Committee Chair: Ms. Judie Ombuor Committee Co-Chair: Mr. Ken Tanui Committee Secretary: Mr. Ian Githinji ECOSOC Vice President of the Economic & Social Council: Mr. Brian Kamau Committee Chair: Ms. Michelle Njoki Committee Secretary: Ms. Stella Kariuki SECURITY COUNCIL Mr. Yussuf Kimtai

This week’s thought - Celebration! “Life is what you celebrate. All of it. Even its end.”

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By: Jacquline Wangui Mwangi Chairperson of the SOCIAL, CULTURAL AND HUMANITARIAN COMMITTEE, 13th Kenya MUN Session.

THE US E AN D ABUS E OF G ENERIC MEDICIN E

especially those purchased through the black market

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he availability and use of generic drugs as alternatives to pharmaceutical brand names have had a significant effect on equitable access to medicines and cost savings for health care consumers. The U.S Food and Drug Administration (FDA) considers a generic drug to be ‘an identical or bioequivalent, to a brand name drug in dosage, form,safety,strength, route of administration, quality, performance characteristics and intended use.

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Understanding the Generic Superhero

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eneric drugs represent a sigh of relief for many citizens of developing countries as they can’t afford medication amid the skyrocketing costs of healthcare associated with the use of brand drugs. Generic drugs enter the market after the patent expiration of the brand drug also referred to as the ‘innovator’. In order to receive approval for marketing, a generic drug must meet the same batch requirements for identity, strength, purity, and quality and be therapeutically equivalent to the branded product. Additionally, the drug must be manufactured according to the regulations


FEATURE ST ORY

required by the FDA (or in the case of Kenya, the Kenya National Quality Control Labs and the Pharmacy and Poison Board). For the generic drug to be therapeutically equivalent, two clinical characteristics must apply: it must be pharmaceutically equivalent and bioequivalent. Pharmaceutically equivalent means that the active ingredient, dose form, route of administration and strength are the same for both the branded drug and its corresponding generic version. On the other hand, bioequivalence means that both products would have comparable bioavailability when studied under similar conditions.

A Shot in the Arm W

hile direct cost savings are a significant advantage for generic drugs, the industry has had its share of challenges. They have now been awash in controversy amid counterfeit drugs in the black market posing as generics.

Counterfeits which are commonly made and distributed by criminal gangs have been defined by the W.H.O as ‘medicines which are deliberately and fraudulently mislabeled with respect to identity and source. They may include products with the correct ingredients or with wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging’. Generally, for the

criminal gangs involved in the black market, the contents of the package are not their concern; rather it is the outward package itself that is made to look the part. As Roger Bate, a renowned economist, points out, ‘most counterfeits are most interested in the packaging- the product must look the part, whether it’s a Louis Vuitton purse, Rolex watch or an antibiotic.’

The problem of counterfeit drugs first hit the headlines when fake versions of the erectile dysfunction medicine, Viagra, began to be offered through unlicensed internet sites at less than half its prescription value. As with any illegal activity, the scope of the problem is impossible to define with precision. Estimates from reputable researchers on the proportion of counterfeit drugs in the pharmaceutical market range from highs of 40, 30 and 17%.

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FE ATU R E S T ORY

The Effects C

ounterfeits pose a serious threat to global health and the fact that the black market keeps increasing is something to show that the risks they pose have been largely underestimated. In Kenya, a 2005 survey by the Kenya National Quality Control Laboratories found that almost 30% of the drugs in Kenya were counterfeit. Globally, conclusive research reveals that there are more than 800 illegal products circulating the global market with a value of close to 200billion USD.

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A fake rolex watch will probably tell time but when it does not, anyone can tell it’s fake. In comparison, the ineffectiveness of fake drugs can only be revealed when a life has been put at risk.

The effects arising from this abound; death being in the forefront. W.H.O estimates that 1 million deaths occur from malaria each year due to the very accessible counterfeit drugs. Aside from the hefty death toll caused by these, counterfeits undermine incentives to engage in research and development of the pharmaceutical industry. Moreover, they increase costs of legitimate medicine and could result in drug resistance in diseases such as malaria and tuberculosis.


FEATURE ST ORY

The Challenges of Fighting Back

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lthough counterfeits are a major global public health problem, the fight against them has been marred by issues mainly of inconsistent implementation of regulations and unclear solutions. Worth noting is that counterfeits pose as generics and hence the fight against the fakes is linked to the eradication of generics. Whereas generics have almost become a livelihood necessity to the majority in Kenya and other developing countries, the eradication of drugs sold through the black market could lead to a denial of the right to live. One street trader in Lome’, Togo said recently that ‘the day the authorities eradicate the black market for pharmaceuticals they will be signing our death warrant. ’ Sad to note, the youth, in the quest to make a quick buck, have been widely involved in criminal gangs taking part in the sale of ‘generics’ in the black market. There ought to be a lot of sensitization on this issue so that they can learn to make money through genuine ways that do not involve criminal activities. The youth can also be of help by reporting such criminal gangs to authorities so that action can be taken to reprimand the various actors in the black market. In conclusion, it ought to be recognized that promotion of generics as an alternative to pharmaceutical brands should be done with utmost regulation and enforcement of quality standards coupled with implementation of punitive legislation for criminal gangs involved in the black market.

H

ow can you tell the difference between a legitimate drug and a counterfeit drug? It is not always easy, and some counterfeit drugs mimic legitimate ones so well that, without running a laboratory test, it is very difficult to tell the difference. However, there are telltale signs of counterfeit drugs that should raise a red flag. These signs include unanticipated side effects and changes in packaging, labeling, color, taste, and pill shape.

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Packaging – Does the packaging look as though it has been compromised? Labeling – Is the label on crooked? Is it different than the label the prescription drug had before? Pill Appearance – Are the pills cracked or chipped? Has the pill color changed? Does it appear a shade different from earlier prescriptions? Pill Taste – Did the drug taste different? Side Effects – Did you experience any adverse effects? If you answered “yes” to any of the questions above, report it. Take action. By being proactive, you can make a difference in your health or the health of a loved one.

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A LP H A C H R ON I CLE S

Sustaining Attraction

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ttraction is both complex and simple at the same time. Creating it is the simple part, sustaining it over time is the complex part. That is one reason why all romance novels, chick flicks, and fairy tales end on a“happily ever after,” note, presuming attraction, once created, will be automatically sustained. Nothing could be further from the truth. It is not automatically sustained, in fact, the opposite is true: it automatically dwindles. This news is not of course well received by most people who desperately want to believe what they have been taught their whole life. They believe that while the dwindling of desire does indeed happen to others, it simply will not happen to them. After all, in their case, the attraction is simply too strong not to last. Arrogantly believing this, they march blissfully towards the cliff like so many who came before them,

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now chastened by the hard fall of reality. What you have to do is separate the feeling of attraction from the initial category and the sustenance category, being careful not to make decisions based on initial attraction alone. That fades, and it will fade for you too. In March, I had three different female friends rolling the name of the guy they just met off their tongues like it was a piece of exquisite candy. Now, none of those three wants anything to do with the former Mr. Wonderful. Luckily, none of them made any long term decisions based on short term feelings of attraction, but the contrast between now and then is distinct, to the point of amusement. The skill comes in distilling those characteristics that contribute to initial attraction (i.e. she’s hot, in shape, and lots of fun) from those characteristics that contribute

to sustaining attraction (mutual beliefs and values, a shared outlook on life, understanding of money, business skills within a relationship, etc.) This is not easy to do. After all, if she’s hot, you can forgive her for overspending on occasion, and that’s fine for initial attraction. But if you take that habit and project it out over five years when she’s run up every credit card you have, you’ll see why it’s not an attraction trait to be sustained. Women make men stupid, and men make women crazy. But you have to see beyond those characteristic that created the initial attraction (i.e. she was hot and had a great smile) to see if there are traits that lead to sustaining that attraction. They may exist, or they may not. But if you want to have a lasting relationship, you have to be able to see if they are there or not, and make decisions accordingly. Else you’ll be just another guy wondering why the women he used to be so attracted to “changed”.


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Letters to the Editor What’s your Experience with Chronicles so far? Onesmus Ritho: It has been a good experience as it has opened my eyes to what am capable of doing. Editor: Well, that’s very encouraging. Anything you’d like us to improve on? Onesmus Ritho: Yes. Market the magazine more so that it can get to reach to the target clients who are the youths by availing more copies of this magazine to schools and colleges or by organizing concerts and events that will create awareness for the magazine. We can also get sponsors to advertise with us. Editor: Dully noted. We hope you’ll continue to support us by sharing more of your views about our magazine. Njenga Micugu: I’d say it was fair. We had a good platform for debate but am not sure if the projects we said we’ll do came to pass i.e. the talk show etc. Editor: Any suggestions on how we can tackle these issues together? Njenga Micugu: I’ll try and attend most of your meetings but i don’t know if there are other times (or events) when the Chronicles Media team meets to share ideas Editor: Yes actually. We do meet from time to time to brainstorm on new ideas or projects that we can participate in as a group e.g. the Korogocho Childrens Home project in which we partook in alongside the Rotaract Club of UoN. Be sure to check your mails for future updates on meetings.

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