Archive for the ‘Pmarmaceuticals’ Category

Epipen: An public health policy issue for the ages

March 13, 2017

Anaphylaxis is the severe and sudden onset of an allergic reaction triggered by allergies to a specific food, medication, insect bite/sting and/or latex. According to a press release by The Asthmas and Allergy foundation of America (AAFA), anaphylaxis is estimated to occur 1 in 50 Americans although it may be higher at 1 in 20. AAFA found many of these at risk individuals were not prepared to react to a reaction episode, due to the lack of ownership of an epinephrine auto-injector pen. Reasons for lack of ownership were not cited however in the past year attention has been drawn to its cost. Mylan, the #1 producer of the over the past 10 years, with their patented epinephrine auto-injector delivery system, the Epipen.epipen-price-under-mylan

The Business Insider performed a cost analysis of the Epipen, citing a market price increase from $100 in 2007 to $600 in 2016. Mylan’s has had few competitors. Their main competitor was Auvi-Q by Kaleo until its recall in 2015. One competitor still exists on the market today, Adrenaclick by amedra pharmaceuticals with a price tag of approximately $200 with a good prescription coupon.

The FDA has made it easier for Mylan to hike up their prices by limiting manufacturer competition through the recall or blockage of other epinephrine auto-injector devices as well as the back log for generic drugs that has been occurring producing a delay of competitors entering the market. Such politics granted Mylan the ability to increase their prices astronomically however in this past summer they received extreme backlash from two major stakeholders. Congress asked Mylan CEO to justify Epipen price hikes and the dropping of the Epipen coverage by Cigna, a major insurance company. This pushback motivated Mylan to create a generic version of this drug delivery system as well as patient coupons (up to $300) in coverage of Epipen costs to address concerns about its price. These are steps in the right direction however there needs to be more action to keep advocate for whose healthcare coverage still does not grant them the ability to pay $300 or less in out-of-pocket expenses.

I challenge the FDA to uphold their mission to protect the public’s health by ensuring safety, efficacy and security of human drugs and medical devices while accelerating innovation to make medical products more effective, safer and more affordable. The FDA must amend their current policies and procedures to promote the presence of competitors for safe and effective epinephrine auto-injector pens to eradicate the monopoly. This can be done through the overhaul of the generic drug backlog to funnel competitors into the market as well as looking for additional ways for those without adequate health insurance coverage to more affordable epinephrine auto-injector pens and discounts. I challenge competitors to propose refillable epinephrine auto-injector pens, like Dr. Cathleen London in Maine, to provide patients with an feasible alternative. A refillable pen will drastically cut down on the burden of cost for those American citizens whose lives depend on the ownership and access to epinephrine auto-injector pens in case of an anaphylactic shock episode.

Antimicrobial Resistance: The Role of Food Animal Production

March 12, 2017

Picture1Antimicrobial resistance (AMR) can arise from inappropriate use of antimicrobial medications (AMMs).  In the United States, more than 80% of all AMMs are used in food animal production, including classes of medications that are on the WHO list of critically important AMMs. Prior to 2017, many AMMs for food animal production could be purchased and used without a prescription and for purposes such as “growth promotion,” rather than for treating a documented infection.

In 2012 and 2013, the FDA released Guidance for Industry, which sought to define judicious use of AMMs in food production, as well as to recommend that the animal pharmaceutical industry voluntarily change their labeling of critically important AMMs used in food production. In short, the FDA recommended that certain AMMs should no longer be used without veterinary oversight or solely for “growth promotion.” Using these medications against their labelled purposes would then constitute a violation of the Federal Food, Drug, and Cosmetic Act.

Picture2Despite pushback from industry groups such as the National Pork Producers Council and the National Turkey Federation, which argue that there is no firm science supporting the concept that AMMs in animal production result in AMR in humans, the FDA has shown some early successes of their new guidelines. According to reports published this year, the pharmaceutical industry voluntarily either changed all new drug applications to require veterinary oversight or withdrew    the applications from consideration by January 2017.                     Credit: wellnesswarrior.org

However, there is more work to be done. Further guidance from the FDA should tighten controls on the use of AMMs in food production for disease prevention purposes. Currently, use of AMMs for disease prevention can include prophylactic administration of subtherapeutic doses for prolonged periods, dosed imprecisely in feed or water, to entire herds or flocks. Additionally, organizations focused on veterinary medicine and animal care, such as the USDA, should be made part of the Transatlantic Task Force on Antimicrobial Resistance (TATFAR). Finally, improved animal husbandry in food production facilities (decreased crowding, improved sanitation) would lead to less infectious disease.

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Credit: Ruralmadison.org

The Agony of Ecstasy: Amend the Illicit Drug Anti-proliferation Act

March 4, 2016

By refusing to amend the Illicit Drug Anti-Proliferation Act, Congress continues to stand in the way of harm-reduction services as the number of drug-related deaths continues to mount in the night life and music communities.

What is the Illicit Drug Anti-Proliferation Act?

In 2003, the Illicit Drug Anti-Proliferation Act (Read the full text here.) was passed by Congress in an effort to combat deaths due to ‘club’ drugs, such as MDMA. This act states that organizers of an event where controlled substances are suspected to be present can be charged with a felony for contributing to drug use, punishable by up to 20 years imprisonment, a fine of up to $500,000, and can have their venue seized by law enforcement.

What are the effects of this act?

This act has proven to be ineffective as stories of deaths at music events due to drug use continue to emerge. The Drug Abuse Warning network recently reported that national ED visits due to MDMA toxicity increased 120% between 2004 and 2011 while levels of MDMA use have remained relatively constant.

ecstasy graph

Past Month Ecstasy Use among People Aged 12 or Older, by Age Group: Percentages, 2002-2014. Figure produced by 2014 Drug Use report sponsored by HHS
Source: http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.htm

 

One victim of this act was 19 year-old Shelly Goldsmith, a student at the University of Virginia, who died of dehydration and heatstroke after consuming MDMA at a rave in Washington D.C. Shelley collapsed while attempting to make her way through the hot, crowded venue to the bar to buy a bottle of water.  The current act discourages venues from distributing free water to prevent heat stroke or any other harm-reduction services, else they face federal prosecution for suspicion of contributing to drug use.

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Shelley Goldsmith died at 19 years old from heatstroke after ingesting MDMA at an Electronic Dance Music concert where no free water was available, is seen here posing with Vice President Joe Biden, who authored the Anti Illicit Drug Proliferation Act
Source: https://www.amendtheraveact.org/

Advocates such as Shelley’s mother, Dede Goldsmith, have spoken to Congress on the importance of harm reduction and educating the public on safe drug use.  Senator Tim Kaine has recently announced that he intends to propose an amendment to current law which will allow venues to provide harm-reduction services without bearing the risk of legal consequences.

Unfortunately, the bill is unlikely to easily pass. Most members of Congress are nervous about appearing ‘soft’ on drug policies and will need to be shown that harm-reduction is the will of the people and that passing this amendment will save lives.

What can we do to show Congress how important this amendment is?

  • Sign the Petition! Send Congress a message that the American people want to stop the unnecessary deaths: Petition: https://www.amendtheraveact.org/sign-the-petition/
  • Donate! The organization, ATRA (AmendTheRaveAct.org) creates and distributes campaign materials to educate the public on the harms caused by this amendment
  • Speak out! By explaining the benefit of harm reduction, and the differences between harm-reduction and the promotion of drug use, you can help turn the tide of public opinion against using an abstinence only strategy to reduce drug related-deaths.

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Prescription drugs – An opportunity in Canadian healthcare

March 3, 2016

canadian-flag-with-medicineFrom the founding of Canada in 1867 it was clearly defined that the Provinces would retain control over their healthcare provision. However, on April 1st, 1984, under the Liberal government of Prime Minister Pierre Elliot Trudeau and Health Minister, Monique Begin, The Canada Health Act was passed into law.  This Federal Act codified over 70 years of Provincial and Federal legislative action, and laid a framework mandating that the Provinces provide universal healthcare to all of their citizens.

While critically important to the Canadian people, the government forgot a few important things – one in particular being coverage of prescription pharmaceuticals.

Over the 30+ years that have followed the Canada Health Act the pharmaceutical industry has rapidly expanded. Modern agents can now prevent death and debilitating illness from chronic conditions, keep a horrifying epidemic like HIV at bay, and cure previously insurmountable diseases such at hepatitis C. In fact, the the Canadian Medical Association describes that the current pharmaceutical industry costs 16% of all healthcare expenditures across the nation, with a total of 23 billion dollars being spent in 2012-2013.

In the year 2016 it is hard to believe that many Canadians across the nation are able to access the highest quality of healthcare services, know with absolutely certainty what treatment they need to lead a healthy and productive life, and yet have their medicines mockingly out of reach. In a 2014 report The Canadian Federation of Nurses Union joined calls by Provincial leaders, insurance providers and patient care advocates in clearly defining the need for coverage.

As a Family and Emergency Room physician who has spent time working with patients in rural East Africa for over five years, I believe that it is egregious that in one of the wealthiest nations on earth I still have patients in Canada with prescriptions for medicines that they cannot afford.

I whole heartedly support the mandate letter for our newest Health Minister, the Honourable Dr. Jane Philpott from our newest Prime Minister Justin Trudeau, calling for a hard look at a Federal Pharmacare Plan.

It is aptly fitting that the son of the father of modern Canadian healthcare be in the position to make the changes our Country now so desperately needs.

HPV Vaccine Introduction in Nigeria: The Way Forward for Women

March 6, 2015

Background

Human papilloma virus is a ubiquitous sexually transmitted DNA virus with several different strains. Infection with HPV has been identified as a necessary condition for developing cervical cancer, and HPV 16/18 strains cause approximately 70% of cervical cancer. While the prevalence of HPV and subsequent cervical cancer rates vary worldwide, cervical cancer rates are on the rise in Sub-Saharan Africa. Current estimates put the prevalence of HPV in Nigeria as high as 37%, compared to the estimated global prevelence of 11.7%.

Estimated Cervical Cancer Mortality Worldwide 2012

 

Preventing Cervical Cancer in Nigeria: HPV Vaccine

Currently, two vaccines exist to protect against HPV infection, but lack of access in LMICs means that the risk of dying of cervical cancer is disproportionately borne by women in developing countries. The bivalent HPV vaccine Cervarix is 98% effective at preventing HPV infection in a healthy person, thereby substantially reducing the likelihood of developing cervical cancer in those vaccinated. Currently, HPV vaccine is not widely available or affordable in Nigeria; however, introduction of Cervarix is on the political horizon.

 Politics of Introduction

The policy consideration for introduction of Cervarix is predominantly a financial one, as research indicates high willingness and intention of mothers to vaccinate, given accessibility and affordability. In 2014 Nigeria was ranked as the largest African economy after a rebasing calculation increased the previous GDP by 89%. A serious consequence of this re-basing exercise is that Nigeria is now expected to graduate from GAVI vaccine funding assistance beginning in 2015, 5 years earlier than anticipated. As the graduation process occurs, HPV vaccine introduction will be competing for an extremely limited governmental budget. Despite the negotiation of record low global prices by GAVI, serious consideration for including HPV vaccination into the national schedule will require strong and convincing advocacy aimed at the Ministry of Finance in order to provide information on the value of vaccination in the context of recent economic growth.

This information and advocacy is crucial to the success of HPV vaccine introduction, which would represent a major step forward in the prevention of cervical cancer in Nigeria.

Impact of the Affordable Care Act on Access to HIV Medications

August 19, 2014

ACA and HIV

Image Source

HIV is a disease with several unique characteristics; stigma may be unfairly attached, vulnerable populations are often affected (such as the economically disadvantaged), and effective treatment requires strict adherence to a combination of medications. These characteristics can act synergistically to challenge one’s ability to access effective treatment. This is not only a problem on the individual level, but also a problem of great public health concern, as effective HIV treatment through medication-induced suppression of the virus is not only life-saving to the individual, but has also been proven an effective method of infection prevention (preventing transmission of the virus to uninfected individuals).

Despite great advances in the treatment of HIV, of the 1.1 million HIV-positive individuals within the US:

  • Less than 40% are retained in regular medical care, with only 25% having undetectable levels of the HIV virus in their blood (signifying effective medication-induced suppression of the virus)
  • Almost half depend on Medicaid for medical coverage, which has been limited to those who either qualify financially or qualify due to a disabling AIDS diagnosis
  • Less than 15% have private health insurance coverage, but even these individuals often face challenges of preferred HIV medications being placed on high cost-sharing tiers, making them unaffordable

The Affordable Care Act

The Affordable Care Act (ACA) was passed in an effort to support health for all, with the expectation that all Americans would have health insurance. Changes within the health insurance industry that came as a result of the ACA include:

  • Private Market Reforms, which:
    • Prohibit insurers from denying coverage and/or charging higher premiums based on pre-existing conditions
    • Limit annual out-of-pocket expenses to $6,350 per individual and $12,700 per family
    • Mandate coverage of certain preventative health services without cost-sharing
  • Expansion of Medicaid Eligibility – State-specific inclusion of adults ages 19-64 at or below 133% of the Federal Poverty Level (FPL) (individual states to choose whether to expand their Medicaid programs)
  • Establishment of Health Insurance Marketplaces (or Exchanges) – To provide a “one-stop shop” for individuals to:
    • Compare qualified health plans to find that which best fits their health needs
    • Determine eligibility for affordability programs (such as Medicaid)
    • Determine eligibility for cost-sharing reductions and/or premium tax credits to help pay for private health insurance (available to certain individuals with incomes of 100-400% of the FPL)

As a result of the ACA, qualified health plans are also mandated to provide essential health benefits (EHB), including certain prescription drugs. When it comes to the coverage of prescription drugs, health plans are determined to provide EHB if they provide the greater of the following two options:

  • Coverage for at least one drug within each category/class of drugs in the United States Pharmacopeia (USP) OR
  • Coverage for the same number of drugs within each USP category/class as compared to the EHB benchmark plan (a benchmark plan is selected by each state to determine EHB that must be offered within that respective state)

Unintended Consequences

While the ACA prevented the exclusion of those with HIV as a pre-existing condition, ultimately expanding medical coverage for thousands of people within the US, prescription drug costs to HIV-positive patients continue to be unaffordable. This often comes as a result of these medications being placed on high cost-sharing tiers, with patients required to pay a percentage of the drug cost (up to 50%), as opposed to a flat copay (approximately $30-$45 per prescription for most other medications). To put these “unaffordable” costs into perspective, two of countless examples are provided below:

  • Within Ohio, Blue Cross Blue Shield, Coventry, Humana, and Medical Mutual placed all HIV medications on the highest cost-sharing tiers and/or categorized them as specialty medications, leading to patient copayments of 20-50% of the drug costs after satisfying deductibles. For example, one patient prescribed Isentress plus Truvada (a recommended first-line regimen in the National HIV Treatment Guidelines) could be expected to pay $1,200 per month after meeting a $6,000 deductible, under Humana’s qualified health plan.
  • Within Illinois, Aetna, Coventry, Health Alliance, and Humana placed most HIV medications on the highest cost-sharing tiers, requiring copayments of up to 50%, leading to out-of-pocket expenses for Atripla (again, a recommended first-line regimen in federal treatment guidelines) of over $1,100 per month.

Concern has been voiced regarding the potential of these high cost-sharing designs being used by health insurance companies as a means to discourage HIV-positive people from enrolling in their specific health plans, a practice that is not only discriminatory but also illegal. Much attention has also been given to pharmaceutical companies for high drug pricing. While pharmaceutical companies state the need to support new research and development, it has been noted that the costs of some medications to treat HIV have increased substantially. For example, the newest combination medication, Stribild, was recently given a price 33% higher than that of the older, yet comparable combination medication, Atripla.

Recommendations

  • Comprehensive HIV Medication Coverage – Another unique characteristic of HIV is that the medications to treat HIV are not interchangeable, meaning one medication cannot be automatically substituted for another medication, even within the same class. Therefore, the ACA mandate of coverage for at least one drug within each class of drugs in the USP is not sufficient in the setting of HIV, as it may be for other disease states, such as high blood pressure or cholesterol. The HIV Medicine Association (HIVMA) and the American Academy of HIV Medicine (AAHIVM) recommend coverage of all HIV medications according to the nationally recognized treatment guidelines.
  • Access to HIV Medications – The HIVMA and AAHIVM urge all stakeholders to work together to do their part in promoting access to HIV medications, often required by the United States’ most vulnerable populations. This includes insurance companies implementing reasonable cost-sharing designs, with recommendations for flat-fee copayments over those consisting of a certain percentage of the HIV medication cost. This also includes pharmaceutical companies setting prices that support access for populations most in need, as well as sustaining and expanding their copay assistance programs to be available for all HIV medications, especially supporting those patients facing high cost-sharing copayments. The HIVMA and AAHIVM also bring attention to the significant adverse consequences that come as a result of HIV treatment delay and/or interruption, including drug resistance and the development of opportunistic infections, which lead to hospitalizations and other interventions more costly than that of monthly prescription drug costs.

While the ACA has had the positive effect of providing insurance coverage to those who were often previously excluded due to having pre-existing conditions, the unintended consequence of unaffordable prescription drug coverage needs to be addressed. Optimism lies in the fact that there have been steps forward in promoting access to HIV medications; within Maryland a bill passed that limits cost-sharing for specialty drugs to $150 per month, and within Illinois a bulletin was published to notify insurers that plans with unreasonable prescription restrictions could be considered discriminatory. With the continued acknowledgement of the unintended shortcomings of the ACA and a teamwork approach to solving them, health insurance for all Americans, including prescription drug coverage, can become an affordable reality. HIV patients often unfairly face many challenges simply as a result of their HIV diagnosis; access to medications need not be one of them.

Increase Access to Buprenorphine Treatment in the United States

August 12, 2014

The U.S. faces an epidemic of heroin and prescription narcotic addiction. When prescribed in conjunction with physician supervision and adjunctive treatment like counseling and support groups, the medication buprenorphine has repeatedly been shown to be effective in treating opioid addiction. (Graph below taken from http://www.drugabuse.gov/publications/topics-in-brief/buprenorphine-treatment-opiate-addiction-right-in-doctors-office)

Buprenorphine and Buprenorphine/Naloxone Help Patients Quit Opiate Abuse graph

Under federal law, buprenorphine can only be prescribed in outpatient settings by physicians who have undergone eight hours of specialized training. Additionally, a physician can only prescribe buprenorphine to up to 100 patients at a time. This limits care for patients with opioid addiction who are interested in buprenorphine therapy, but can’t find a physician who prescribes buprenorphine and isn’t already capped.

To expand access to treatment, the 100 patients/physician cap should be eliminated or increased. Current policy makes it far easier for patients to obtain other opioids such as Dilaudid, Oxycontin, and oxycodone – which have greater potential for diversion than buprenorphine and which cannot be used to treat addiction – than to access medical therapy for substance abuse treatment. Stigmatization of substance abuse should not prevent access to this relatively safe, effective, and inexpensive therapy. Please contact your senators and representative to encourage them to lift the cap.

An End to Drug Shortages?

March 9, 2014

Drug shortages have grown exponentially. In 2011, 267 additional drugs became unavailable. Recognizing the threat to public health, the American Society of Health-System Pharmacists (ASHP), the American Society of Clinical Oncology (ASCO), the Institute of Safe Medication Practices (ISMP) are leading advocates for tighter regulations.

National Drug Shortages-Graph

Generically available intravenous agents are mostly affected. Shortages are caused by many reasons (mostly financial),  and manufacturers are not legally bound to report any production interruption or discontinuation.

 

Drugs on Shortage

Reasons for Shortages

The crisis- fueled by the Great Recession– was highly publicized with the unavailbility of chemo-therapeutics. Suddenly, cancer was a death sentence! In 2011, President Obama issued an executive order that supported the  “Preserving Access to Life-Saving Medications Act of 2011”. The bill requires a six month notification by manufacturers of any (un)planned production halts. Excluding uncontrollable cases, monetary penalty of $10,000/day of violation, up to $1.8 million/incident may be imposed. It also broadens the regulation to drugs, “for which demand exceeds supply”. All prescription drugs and biologicals are targeted.

The bill’s future remains unclear. It has two major disadvantages: Both Houses have their “own” versions, which is antagonistic. Secondly, the PhRMA-backed  majority opposes tighter governmental control. PhRMA represents the pharmaceutical industry and  lobbies for “free market” rules.

Regardless of the politics, this “nuisance” is a public health crisis. Modern medicine heavily relies on medications and bans alternative medical practices. ISMP, ASCO and ASHP argue that drug shortages cause medication errors, delay in therapy and contribute to ineffectiveness. Considering rising medical malpractice and healthcare costs, tighter governmental regulations are only beneficial.

 

 

Should poultry farmers be compensated to stop bird flu epidemics?

August 19, 2013

nepal-map1

Bird Flue (avian influenza) is a disease of birds that affects domestic birds such as chickens and turkeys. The flue is caused by viruses, resulting illnesses and deaths of flocks of birds. The bird flu causing viruses pose threats to human health also. Sporadic human cases of bird flu are possible but the disease transmission from human to human does not happen easily and therefore the risk of spreading disease in community-level is very low. The first case of the avian flu in Nepal was reported in January 2009.

Most recently 62 cases of bird flu have been recorded from 250 poultry farms in the region. A bird flu emergency is declared in parts of Nepal’s capital after fresh cases emerged in different areas of the Kathmandu valley including Bhaktapur. The Animal Health Directorate has banned trading of birds and everyday authority is slaughtering thousands of chicken (infected or not infected) to contain the disease epidemic.

Chicken farmers in the area have blamed to faulty vaccines meant to fight bird flu. The farmers have accused the vaccination made in USA that may have triggered bird flu outbreak in Bhaktapur. People believe that powerful countries have been using poor countries like Nepal as a laboratory.
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Chicken infected by Bird Flu, Bhaktapur, Nepal.
Image source: http://www.nepaldispatch.com (Date: August 17, 2013).

According to WHO, worldwide as many as 377 persons died of bird flu and they are from China, Pakistan, Bangladesh, Myanmar, Thailand, Azerbaijan, Cambodia, Zimbabwe, Egypt, Indonesia, Iraq, Laos, Nigeria, Turkey, and Vietnam. So far, human deaths due to the bird flu have been not reported from Nepal.

Nepalese farmers are bearing the unprecedented loss due to this crisis. Farmers are now starting to refuse to cooperate with government authorities to cull the non-infected chicken since the government is not increasing the compensation amount as pledged before. The poultry farmers have declared that they will not allow government to destroy their poultry unless they get compensated in line with market prices. However, they are ready to destroy the diseased birds keeping in view of protecting human health.

Virus that causes bird flu has potential for tremendous impacts in public health if the virus makes it transmission to human and maintains sustainable human to human transmission. Containing the virus before it is too late is important public health responsibilities of the government and other stakeholders. Poultry farmers only should not bear the burden of this campaign. Farmers should be compensated adequately so that the poultry business in this resource poor country remains intact and confidence of farmers stays high.

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Is Medication the Answer to America’s ADHD Epidemic?

August 18, 2013

ImageAccording to the CDC the number of children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) in the United States has increased steadily since 1997. In 2007, parents reported that almost 10% of all children ages 4-17 had an ADHD diagnosis, which is a 22% increase from just 4 years earlier in 2003. It is unknown whether this is due to an actual increase in ADHD incidence, or more diagnoses due to changing definitions of the disorder and better diagnostic tests. Regardless, ADHD is a significant problem facing America’s children today and parents are desperate to find a treatment that will enable their child to lead a normal life.

Medication is by far the most commonly used treatment for ADHD in children in the United States, with it being prescribed more often in older children (ages 11-17) and boys compared to girls.

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Percent of children aged 4-17 years with a reported diagnosis of ADHD currently taking medication for ADHD by state: United States, 2007-2008

However, the National Institute of Mental Health recommends the use of psychosocial methods such as behavioral therapy, social skills training, support groups, and parent/educator training before trying pharmaceutical approaches. Unfortunately, these alternative treatments are more time consuming and demanding of resources both in the home and the academic setting and are often dismissed when medication alone is able to treat the problem.

The rise in medication of children and adolescents has also lead to an increase in medication diversion, or ADHD medication misuse by people without an ADHD diagnosis. Its ability to enhance concentration and academic performance makes ADHD medication desirable to non-ADHD students. Additionally, the high prevalence of ADHD among their classmates and friend makes these pills very accessible.

There is no question that ADHD medication has positively changed the lives of many American children struggling with ADHD. However, medication alone is not sufficient and time and attention must be paid to ensure accurate diagnosis and dosage in each and every case, and to help prevent medication abuse.