I think the true answer lies with the pharmaceutical companies. Why are drugs so expensive? I hope by now, those who work in this industry know that the majority of pharmaceuticals' spending goes to advertising and marketing, NOT to research and development. There is absolutely no reason for an eye drop Rx to be $90. There is no reason to take (essentially) 2 OTC meds and combine them to "patent" a new drug. I won't name names...Vimovo...but I think the FDA needs a serious overhaul in operations and procedure. Our US Patent Office needs a review as well. Did you know that in 2002, Bristol-Myers Squibb received a new patent on their drug, Platinol, just because they put it in a brown bottle? They claimed the brown bottle protected it from light and thus preserved the drug longer. Please tell me I'm not alone in feeling that this was a stupid move on the FDA and the USPTO offices. You can have a patent on a drug and you can have a patent on a brown bottle. But just because that drug is IN that brown bottle, should not grant that drug longer exclusivity. If this is allowed, I'll go throw some Zyvoxx in a black bottle and call it "new".
We can't answer the question, "Why is it so expensive?" by saying things like, "It's your insurance" or "Because the pharmaceutical companies have to recoup their loss on R&D". Our country is the ONLY COUNTRY that has no restriction on prescription drug pricing. Prescription drugs cost Americans 4 TIMES that of any other country. Now, I know this is a capitalist economy and you're allowed to make what you can and charge whatever you want (as long as you don't have a monopoly). But the drug companies DO have a monopoly. Drug prices rise 3 times the national inflation rate every year. The top 12 US pharmaceutical companies had a combined revenue of $253.7 billion dollars reported for 2010. $65 billion was profit alone. According to CNN, aside from network and communication, and internet services, pharmaceuticals is the largest grossing industry in the world. It makes more money than oil, healthcare facilities and national defense COMBINED.
There is only one way to stop this insanity and it is through Congress. Unfortunately, drug companies in America have over 700 lobbyists who do nothing but wine and dine the Representatives and Senators. It's a tough struggle but it's already begun. Contacting your Congressmen and probing them about the situation can, and will, work.
Tuesday, November 16, 2010
Friday, October 29, 2010
Rogue Pharmacists
Rogue PharmacistsJesse C. Vivian, RPh, JD 10/20/2010 US Pharm. 2010;35(10):120-123. The profession of pharmacy is a noble one. Everyone entering the field for the past few years comes in with a doctorate-level degree, and before that a 5-year Bachelor of Science (BS) in pharmacy was required. Pharmacists subscribe to a code of ethics and take an oath to ensure the best outcomes for the patients we serve. But, as the saying goes, “it only takes one bad apple to spoil the barrel.” Every time a pharmacist does something illegal or unethical, that action reflects negatively on the rest of us. Keeping our fellow pharmacists acting within the law and following ethical standards is the best approach to protecting our status as one of the top professionals for honesty and ethical behavior and the best way to ensure our public image. But rogue pharmacists do exist, and we as a profession need to condemn their unacceptable actions and do everything we can to make sure our patients, other health care professionals, and lawmakers do not perceive the bad actors as a reflection of the whole. This month, a few recent stories about pharmacists who acted outside professional norms should serve as a reminder of why the rest of us adhere to high standards of care. Case 1On April 10, 2010, a 59-year-old pharmacist pled guilty in a federal court in New Hampshire to unlawfully dispensing and misbranding controlled substances. The former Wal-Mart managing pharmacist knowingly dispensed Schedule III drugs, including Vicodin (hydrocodone and acetaminophen), to an individual on four separate occasions in 2005 and 2006 without a valid prescription. After the conviction, the pharmacist voluntarily Case 2On July 7, 2010, two pharmacists who were owners of the Patterson Family Pharmacy in Sacramento, California, admitted to dispensing Schedule III and IV controlled substances on over 2,000 occasions. These were Internet prescriptions that were not valid because no patient-physician relationship existed. The pharmacists have agreed to pay $500,000 in civil fines.2 Case 3The Primary Care Center Pharmacy, also in Sacramento, agreed to pay $250,000 in penalties and enter into a 5-year compliance plan to settle federal charges that the pharmacy illegally dispensed controlled substances over 175 times.3 Case 4On September 3, 2010, an optometrist and a pharmacist were arrested in Kokomo, Indiana, on prescription fraud charges. The optometrist, who was not licensed to prescribe drugs, went into a K-Mart pharmacy several times and wrote controlled substances prescriptions in the names of different patients, always using the Drug Enforcement Agency (DEA) numbers assigned to other physicians and the pharmacist who filled them. Apparently, on at least one occasion, the optometrist had a legitimate prescription for OxyContin (oxycodone), but after it was filled, he traded the medication with a woman for other drugs. An undercover officer bought the oxycodone from that woman.4 Case 5A prominent 63-year-old pharmacist in Madison, Wisconsin, was arrested with an alleged coconspirator, the 55-year-old founder of the Women’s Health Center and a member of the University of Wisconsin Foundation’s Board of Directors. On September 3, 2010, the two were charged with two counts each of conspiring to deliver counterfeit prescription drugs, including controlled substances in New York. According to the complaint, an FBI informant, who was running an illegal online pharmacy, ordered millions of the antianxiety drug alprazolam and the appetite suppressant phentermine during 2008 and 2009 from the pharmacy, even though the informant did not have a license to purchase drugs. The drugs were delivered to the pharmacy from India. Some of the medications contained broken tablets and several bottles were not properly labeled. During the spring of 2010, another FBI informant ordered oxycodone, hydrocodone, and Viagra (sildenafil) from the same pharmacy. The complaint states that the pharmacist offered to sell generic Viagra to the informant. Generic Viagra is not available in the United States because Pfizer holds an exclusive patent. Investigators intercepted five packages sent to the informant by the pharmacist. Two of the packages, both from India, contained counterfeit oxycodone tablets. Another package contained about 1,000 tablets of what appeared to be Viagra, complete with the Pfizer monogram in an unlabeled container. Assays showed that the tablets did not contain any Viagra.5 Case 6A 61-year-old pharmacist working for the Pennsylvania Department of Public Welfare’s Office of Mental Health, Substance and Abuse Services—who was also secretary of a committee that approved Medicaid-paid drugs in state hospitals, prisons, and juvenile centers—was convicted on two felony charges of conflict of interest for taking payments from drug manufacturers and pocketing money for supervising pharmacy interns from Duquesne University. He could face up to 5 years in prison and $10,000 in fines. Interestingly enough, he paid more than $27,000 in civil fines after the Pennsylvania Ethics Commission cited him for state ethics violations in connection with the same allegations in 2005. The criminal complaint said the pharmacist accepted perks from Pfizer and Johnson & Johnson’s Janssen, which were promoting the use of psychiatric drugs in state hospitals. Prosecutors said he used his position to pocket $2,400 from Duquesne University for supervising pharmacy interns at state hospitals between 2000 and 2003. The pharmacist was convicted on a third misdemeanor count for failing to file a full accounting of his outside income on his state ethics disclosure forms.6 Case 7On June 4, 2010, a 53-year-old pharmacist from Elizabeth, New Jersey, pled guilty to insurance fraud and agreed to make restitution payments of more that $235,000. This leader in the Sierra Leonean community and patriarch in a fast-growing church may face up to 10 years in prison when sentenced. He was charged with pocketing money from at least 290 insurance claims billed to Medco for nonexistent prescriptions between 2008 and 2009. The father of four children immigrated to the U.S. from Sierra Leone in 1981 and graduated with a pharmacy degree from Rutgers University. He had been featured in local media for his extensive work in helping fellow immigrants adapt to life in this country.7 Case 8On August 13, 2010, a federal judge sentenced a 44-year-old pharmacist to 4 years in prison for participating in a nationwide conspiracy to sell anabolic steroids compounded at Applied Pharmacy Services located in Mobile, Alabama. He is the first of a group of five men to be sentenced and could have faced imprisonment for up to 7 years. Two of the other men convicted, who were also owners of the pharmacy, are expected to be sentenced in the near future. According to court records, Applied Pharmacy Services shipped 762,388 dosages to 17 doctors and clinics from April 4, 2004, until August 30, 2006.8 Case 9On July 1, 2010, police arrested a 61-year-old pharmacist in a Modesto, California, Rite Aid. He was described as a “traveling pharmacist,” someone who works in one location for only a few days before moving on to another one. He was observed by company loss-prevention officers as leaving the pharmacy several times during the day, going to his car, smoking cigarettes, and drinking from a mug. After the pharmacist left his car, the loss-prevention officers looked through the windows and noticed an accumulation of pills and bottles. After being seen stealing a bottle of alcohol and heading toward his car, the pharmacist was detained by the officers. Upon inspecting the car, the officers found 350 tablets of diazepam, acetaminophen with codeine, alprazolam, and several bottles of promethazine codeine syrup. The mug he had been drinking from was filled with alcohol.9 Case 10On August 12, 2010, a 37-year-old pharmacist was arrested in Vincennes, Indiana, following an investigation alleging he stole over 900 Schedule III controlled substances from a Walgreens pharmacy where he was employed in 2009. At the time of the arrest, however, he was no longer employed there.10 Case 11During a routine traffic stop on February 15, 2010, police arrested a 51-year-old pharmacist who worked at the Jasper, Texas, Wal-Mart after noticing he was driving his truck erratically. Police found a large quantity of prescription drugs in his pockets and in the truck. The drugs included hydrocodone, Vicodin, Tylenol 3 and Tylenol 4 (acetaminophen/codeine), tramadol, butalbital, codeine, ibuprofen, Xanax (alprazolam), Provigil (modafinil), bupropion, ranitidine, Viagra, Cialis (tadalafil), and Levitra (vardenafil)—all of which were allegedly stolen from Wal-Mart. When questioned, the man had no explanation for why he was in possession of the prescription medications. His bond was set at $13,500, and he was not immediately able to post bail. The police had been investigating the pharmacist after Wal-Mart officials informed them of suspicions that he was involved in the theft of drugs.11 Case 12On January 14, 2010, a 44-year-old pharmacist was arrested in Citronelle, Alabama, on charges of selling and distributing controlled substances. He was stopped as he was leaving the pharmacy where he was employed. At the time of his arrest, he was in possession of 1,000 hydrocodone tablets and 1,400 mL of codeine syrup. He is suspected of stealing at least 4,000 controlled substances and 2,000 mL of codeine syrup.12 Case 13In Plainview, New York, police arrested a 53-year-old pharmacist after they overheard what sounded like a drug deal while he was talking on his cell phone as he sat in his parked car in a gas station at 3:45 pm. Moments later a minivan arrived, and the driver got into the pharmacist’s car. The police observed what looked like an exchange of a bag of pills for cash. The minivan driver was found to have 15 Cialis pills in his possession. The pharmacist was in possession of more than 400 oxycodone tablets. While the investigation was ongoing, another vehicle pulled up. As its driver walked up to the phamacist’s car, police apprehended him. He was carrying several doses of oxycodone and methadone and was in possession of $17,000 cash. All three individuals were charged with illegal possession and distribution of drugs.13 Case 14This case is somewhat different from the others because the articles allegedly stolen by the pharmacist do not involve controlled substances. On June 9, 2010, a female pharmacist working at the University of North Carolina (UNC) Student Health Center was arrested on two counts of felony embezzlement for stealing $4,000 worth of drugs and other items including blood pressure medicines, bone loss medication, a pulmonary drug, antiaging cream, flaxseed oil, grape seed extract, and deodorant. She had been employed by UNC since 1999. Her employment was terminated on May 18 for “personal reasons,” according to university records. An anonymous tip was called into the UNC police department on April 23, 2010.14 Case 15A 50-year-old pharmacy owner in Edison, New Jersey, was arrested in July 2010 when federal marshals searched his home and several businesses he owns and found thousands of oxycodone tablets, anabolic steroids, fraudulent and blank prescription pads, three guns, and $500,000 in cash. Dubbed “Operation Oxymoron,” federal and local police agencies began investigating the pharmacist in October 2007. He allegedly filled more than 45,000 prescriptions for oxycodone that were not issued by legitimate prescribers. In all, 19 people were arrested in the sting operation, which was said to be generating about $1 million per month. Eleven other individuals are also being sought in connection with the investigation. The pharmacist faces 20 years to life in prison if convicted of all charges.15 REFERENCES1. Former Wal-Mart pharmacist pleads guilty to unlawfully dispensing and misbranding controlled substances. U.S. Department of Justice. Media release. April 12, 2010. www.justice.gov/usao/nh/press/april10/MI_Reilly.html. Accessed September 14, 2010. |
Thursday, October 7, 2010
Why, BigPharma? Why?
This list is comprised of what I feel to be the most useless, non-essential drugs on the market today. I got the idea from The Red Headed Pharmacist's Blog. In no particular order, they are:
1) Tribenzor - This "new" drug has 3 ingredients: olmesartan, amlodipine, and hydrochlorothiazide. Drug companies constantly whine that medications cost so much so that they can afford research and developement for new, innovative (key word there) medications. However, the geniuses at Daiichi Sankyo have combined 3 old drugs into 1! No need to pay generic prices for amlodipine and HCTZ, and your Tier 2 price for Benicar! Just try to get a PA on Tribenzor and (if the PA goes through) pay your Tier 3 co-pay. And those of you without insurance, just, please, don't bother.
2) Solodyn - Have you ever heard of Minocin? No, because it went generic YEARS ago and is now known as minocycline. Usually people take it twice a day and it's on $4 lists in some places. But this "brand name" drug is extended release--you just have to take it once a day! But it's near $500. Good luck.
3) Doryx - This falls into the same category as Solodyn. This is just an extended release form of doxycycline hyclate. Want it for $4 and take it twice a day? Go to Giant Eagle. Want to have your PA denied and pay $500 just to take it once a day? Go ahead and try.
4) Oracea - Oracea is right in line with Solodyn and is almost exactly the same as Doryx! It's an extended release version of doxycycline! What a joke.
5) Jalyn - OK, you want to make purple paint. If a can of blue paint costs $10 and a can of red paint costs $10, you can spend $20 and mix them. Or, you can buy the can of purple paint for +$500. That's what this is. Avodart (dutasteride) and Flomax (tamsulosin) in one can.
6) Oleptro - Oh this is a good one. Trazodone HCl was first introduced as Desyrel so long ago, that the FDA doesn't even have it in the Orange Book anymore. It was first used to treat depression. Now, it's mainly used to help people sleep. Well, now Angelini Labopharm wants to bring it back and make it extended release for depression again. Why? Why would anyone (in their right mind) take this medication. It's going to cost a fortune and there are already enough generic antidepressants on the market, I've got them falling out of my ass.
7) Silenor - This is doxepin. Why does doxepin sound familiar? Because it was already introduced as Sinequan years ago. Now it's generic and cheap for the people who need it. It comes in a capsule form. Silenor, on the other hand, is in tablet form and comes in two lower strengths. Apparently this is consider a good innovation by the FDA.
8) Suboxone - Before you start yelling at me about how this medication may have helped you, let me point something out. Suboxone is a sublingual tablet. That means you stick it under your tongue and it dissolves. Now Reckitt Benckiser decided to reformulate the damn thing into a sublingual film! So now in stead of putting a little pill under your tongue, you put a little film strip under your tongue! It's so innovative! It's just a Listerine Pocketpaks breath strip. By the way, if you go to the Suboxone site, the home page is overrun with ads for the soluable films now. It doesn't even mention the sublingual tablets. There is also a link for a coupon for $75 off your prescription. If the drug company will give you $75 off a single prescription, that should tell you how expensive this redundant medication really is.
9) Vimovo - Another great innovation from BigPharma. Take 1 generic drug, now available over the counter, and another generic drug ALSO available over the counter, and what do you get? Basically an Aleve/Prilosec combo. Now you need a prescription for this +$300 medication instead of just taking 2 things at once. Naproxen/esomeprazole. Just...why?
10) Zuplenz - Zofran is indicated for nausea associated with cancer patients/chemotherapy. it is available in generic form as ondansetron. Then Zofran ODT was released. ODT stand for orally disintegrating tablet. The ODT drugs melt in your mouth, not in your hand. Well, the makers of Zuplenz pulled a Suboxone move. They reformulated it (innovative, huh?) and now have approval for a "brand only" ondansetron film.
11) Caduet - Amlodipine and atorvastatin...Norvasc and Lipitor. Way to go combining two of your own previous drugs into one, Pfizer. Real innovative.
Another thing that pisses me off is metabolites. Medline Plus defines a metabolite as: "any substance produced during metabolism...in terms of medications, a metabolite usually refers to the product that remains after the drug is broken down by the body." Understanding this, let's look at some current BRAND NAME medications with their relative chemical name.
Xyzal - levocetirizine
Clarinex - desloratidine
Nexium - esomeprazole
Kapidex - dexlansoprazole
Lexapro - escitalopram
Focalin - dexmethylphenidate
Levaquin - levofloxacin
Do any of these sound or look familiar? You've probably seen or heard ads for them somewhere. Now, let's look at another list and try to find the similar items.
Zyrtec - certirizine
Claritin - loratidine
Prilosec - omeprazole
Prevacid - lansoprazole
Celexa - citalopram
Ritalin - methylphenidate
Floxin - ofloxacin
Do you see the difference? The first list is made up of metabolites from the second list. After being metabolized, a medication changes chemical make-up. After being metabolized, Zyrtec (certirizine) turns to LEVOcertirizine. After being metabolized, Claritin (loratidine) turns to DESloratidine. The drug companies took one step out of our bodies' process and patented the metabolized version of the chemical JUST TO MAKE MORE MONEY.
Let me make it simple. Metabolized means swallowed. Here's another example: after being swallowed, Ritalin (methylphenidate) changes to DEXmethylphenidate. In essence, these ARE NOT new, innovative drugs and insurance companies hate paying for them because they know there is a cheaper, possibly OTC item, that will work just as well.
This kind of nonsense pisses me off, it pisses my co-workers off, it pisses the entire medical field off...except for BigPharma. They just keep making money hand over fist at the general public's expense.
Friday, September 24, 2010
Dr. Marcia Angell on the Truth About Drug Companies
http://videos.med.wisc.edu/videoInfo.php?videoid=940
Monday, September 13, 2010
Top 10
Top 10 Most Expensive Cars (with top speeds):
Porsche Carrera-$440,00 (205mph)
Mercedes Benz SLR McLaren Roadster-$495,000 (206mph)
Koenigsegg CCX-$545,600 (245mph)
Saleen S7 Twin Turbo-$555,000 (248mph)
SSC Ultimate Aero-$654,400 (257mph)
Pagani Zonda C12 F-$667,300 (215mph)
Ferarri Enzo-$670,000 (217mph)
McLaren F1-$970,000 (240mph)
Lamborghini Reventon-$1.6 million (211mph)
Bugatti Veyron-$1.75 million (253mph)
Monday, August 30, 2010
You People Suck
I counted your Vicodin not once, but twice.
You think it’s 5 short so of course you’re not nice.
You bitch and complain about two dollar co-pays,
When really it’s my money that ends up paying your way.
You wanted the brand, got generic instead,
You think that they’re different—it’s all in your head.
“Why is my co-pay so awfully high?”
Fifteen isn’t bad, try one fifty-five.
Be thankful you’ve got it ‘cause some people don’t,
I offer cash prices, but take them? You won’t.
You run out of Ambien 2 weeks before you should,
Then you blamed it on me right where you stood.
You’re out of refills? Well tough shit for you.
Now you stand and ask for a free pill or two,
You don’t call your doctor ‘cause that’s our job,
When they fax it wrong, you stand there and sob.
Just be responsible and suck it up, Prick.
Keep track of your things or get beat with a stick.
If I could speak my mind I’d lose my job,
While you whine for your Adipex, you overweight slob.
You people suck.
Monday, June 14, 2010
Health Care Reform Act - An Explanation
This article is not my work. This was written by Ned Milenkovich, PharmD, JD. I am simply re-posting it here so that (hopefully) more people may read it. I read it on www.powerpak.com as a CE article. It is highly informative. Please share it with others.
Health Care Reform:
Legal Impact on the Drug & Pharmacy Disciplines
March 21, 2010 marked a historic day as Congress passed a proposed legislation entitled The Patient Protection and Affordable Care Act (the Act).1 Only a few days later, on March 23, 2010, President Barack Obama signed the bill into law, providing millions of Americans with greater access to health care. The Act, consisting of thousands of pages, contains important changes that affect the drug and pharmacy industry, among other things. This continuing education (CE) article will begin with a review of some of the global changes that have been predicted for the overall health care industry and continue with the presentation of information specific to the drug and pharmaceutical industry.
Many of the provisions in the new Act will go through a rule making process at an administrative agency level and this will provide a better sense of how the Act will be administered. State and national associations will be tracking the implementation of these regulations. This also represents an excellent opportunity for the pharmacist to get involved and impact the outcome of the regulations in an effort to keep the results favorable in regard to the drug and pharmaceutical industry.
This historic Act will result in the implementation of many sweeping and far-reaching changes for the health care system over the next few years. Changes may include new consumer protections, coverage for millions of uninsured people, penalties for individuals and businesses who do not buy insurance, attempts to control rising costs (including medication costs), and Medicare savings, as well as new taxes to pay for it all.
A YEAR-BY-YEAR LOOK
Although this is not an exhaustive list, the following is a year-by-year look at what will be coming:
2010
Adults who are currently unable to obtain coverage because of a preexisting medical condition will be able to join a high-risk insurance pool as an interim step, pending the launch of competitive health insurance marketplaces and premium subsidies, in 2014. Additionally, insurance companies will issue policies for children with preexisting conditions and will not be permitted to revoke existing policies when people get sick. Lifetime limits on coverage will be banned and new coverage and annual limits will be restricted. Preventive services will be fully covered, without co-pays or deductibles.
Coverage will be available for dependent children until they are aged 26 years. Certain small businesses will start getting tax credits to offset up to 35% of the cost of insuring their employees; that amount will rise to 50% in 2014. Health plans will be required to have, what has been termed, an effective appeals process for decisions and claims. States will be eligible to obtain grants for the initiation of programs that help consumers with complaints or questions about health insurance. The federal government will also set up a Web site to help people in different states comprehend the full extent of their insurance options. Notably, a 10% tax on indoor tanning services will be levied.
New physician-owned hospitals are barred from participating in Medicare. Medicare coverage is also expanded to individuals who have developed certain health conditions as a result of exposure to environmental health hazards. The United States (U.S.) Food and Drug Administration (FDA) is authorized to approve generic versions of biologic drugs. The Secretary of Health and Human Services (HHS) is authorized to issue grants to create or expand primary-care residency programs. Nonprofit hospitals will also be subject to a tax of $50,000 per year if they fail to meet certain requirements.
2011
Medicare will now support free annual wellness visits. There will be little or no cost sharing for preventive care, which include, immunizations and cancer screenings. Bonuses will be paid to primary-care doctors and general surgeons under certain circumstances and a new Center for Medicare and Medicaid Innovation (CMI) will be unveiled as a forum to test additional methods of providing better, more efficient care. Overpayments to private Medicare Advantage insurance plans will be slowly phased-out and Medicare Part B physician premiums and Part D drug premiums will increase for some people, based on incomes.
Pharmaceutical manufacturers will provide a 50% discount for brand-name drugs purchased through Medicare Part D. In addition, federal subsidies will add financial support for generic drugs, while the patient is caught in the Part D donut hole. Over-the-counter (OTC) medications that are not prescribed by a physician cannot be purchased any longer using tax advantaged set-asides such as Health Savings Accounts, Flexible Spending Accounts, and Archer Medical Savings Accounts.
2012
There will be new incentives to encourage health care providers to join together and facilitate Accountable Care Organizations (ACOs). The government will also track readmission rates at hospitals, which may prompt them to impose penalty fees on hospitals with the highest rates of readmission.
2013
This is when higher income taxes will begin for households with income above $250,000 and individuals above $200,000. The Medicare payroll tax on earnings above those amounts will rise from 1.45% to 2.35%. Unearned income above those amounts (e.g., dividends) will now be subject to a 3.8% tax. In addition, maximum contributions to pretax Flexible Savings Account contributions will be limited to $2500 a year. There will also be a new 2.9% excise tax on medical devices. Medicare will also sponsor a national pilot program on payment bundling—i.e., paying hospitals, doctors, and other providers based on patient outcomes, not services provided.
2014
Insurance companies will no longer be able to deny policies to anyone based on their health status; nor will they be permitted to refuse coverage for a treatment based on preexisting health conditions. The ability to charge higher rates to people based on age, geography, family size, or tobacco use will also be limited; annual limits on coverage will be abolished. Each state will open a health insurance exchange, or marketplace, for individuals and small businesses without coverage. There will be a multistate private plan available nationwide, supervised by the U.S. Office of Personnel Management. Tax credits will be available to make insurance and care affordable for people who earn too much money to qualify for Medicaid, but have incomes below 400% of the poverty level. Most people will be required to buy insurance coverage or they will pay penalties that will start at $95 in 2014 and rise to $695, or 2.5% of their income, in 2016. Employers with 50 or more workers who do not offer coverage will have to pay annual fees. Medicaid eligibility will increase to include individuals living at or below 133% of the poverty level ($14,404 for individuals) for everyone under 65 (when they qualify for Medicare).
2015
In 2015, a new Independent Payment Advisory Board will be formed to come up with ways to lower Medicare costs and promote better care. The recommendations will go to both Congress and private insurers.
2018
In 2018, the most controversial new tax will begin, a 40% excise tax on insurance companies and plan administrators for any family plan that costs more than $27,500. The tax applies to the cost above that threshold; higher thresholds will be applied for retirees over 55 and plans that cover workers in high-risk jobs.
The new health care system will have reduced the number of uninsured people by 32 million, according to the federal government’s Congressional Budget Office (CBO). That will still leave an estimated 23 million people uninsured, one-third of them illegal immigrants according to the CBO. However, coverage of legal residents too young for Medicare (those aged 65 years or less) will be 94%, an increase from the current 83%.2
LAWS DIRECTLY IMPACTING DRUG AND PHARMACY
The following sections will describe how health care reform legislation will affect the drug and pharmacy industry. These sections are entitled, Medicaid Generic Drug Reimbursement, Pharmacy Benefit Manager Transparency, DME Accreditation Exemption, Pharmacist MTM Services, The Medicare Part D Donut Hole, Long-Term Care Pharmacy Requirements, 340B Provisions, Small Business Reforms, and a miscellaneous section with information that may indirectly impact the drug and pharmacy industry or that is of general interest.
Medicaid Generic Drug Pharmacy Reimbursement (AMP Fix)
Background: The Deficit Reduction Act of 2005 (DRA) would have reimbursed pharmacies below their acquisition cost for Medicaid generic drugs. Since 2007, these cuts have been delayed because of a December 2007 court injunction. The Act improves the definition of Average Manufacturer Price (AMP) so that it includes only manufacturers’ sales to retail pharmacies. The Center for Medicare and Medicaid Services (CMS) had been directed to set a Medicaid Federal Upper Limit (FUL) for reimbursement of generics at a rate of “no less than 175% of average weighted AMP.” This increase in the FUL is particularly important because the health care reform Act also expands Medicaid coverage – which will take effect in 2014 – for individuals living at or below 133% of the federal poverty level. This is expected to add 16 million more individuals to the Medicaid program.3
Impact on the Pharmacy
The new health care reform Act requires the Secretary of HHS to implement the new Medicaid generic rates as early as October 2010. This new law serves to mitigate the impact of the dramatic generic drug reimbursement cuts that would have gone into effect had these changes not been made, in turn saving pharmacies money.
PBM Transparency in the Medicare Part D Plans and New State-Based Health Exchanges
Background: Pharmacy benefit managers (PBMs) are responsible for managing prescription drug benefits for health care plan payers. They are able to manage prescription drugs in a variety of ways; for example, they can control prescription costs and clinical interventions. With the passage of the Act, PBMs are required to confidentially disclose important financial information to the Secretary of HHS for health care plans operating in new health insurance exchanges and in Medicare Part D plans. These new state-based exchanges are set to begin in 2014. Notably, this is the first federal requirement for oversight and accountability in the PBM marketplace. These provisions also establish an important initial federal framework for the regulation of PBMs, which have otherwise been largely unregulated.
Pharmacists and Pharmacies Are Exempted From Medicare DME Accreditation Requirements
Background: The Act provides a new exemption, for most pharmacies, from the accreditation requirements to provide Medicare Durable Medical Equipment (DME). It also changes current law so that pharmacy accreditation requirements, for those pharmacies that must still obtain accreditation, are not effective until January 2011. Those pharmacies that want to engage in competitive bidding for DME would still be required to be accredited regardless.
A pharmacy can be exempt from the Medicare DME accreditation requirements if the following apply:
Has total Medicare DME billings that are 5% or less of the total prescription sales
Has not had adverse fraud or abuse determination against their business within the last 5 years
Additionally, the pharmacy must provide an attestation that DME billings are less than 5% of its pharmacy sales, according to a rolling 3-year average, and they must submit documentation that verifies such information.
Impact on the Pharmacy:
If the pharmacy is already accredited under current CMS guidelines and meets the criteria stated above, it is exempt from any re-accreditation requirements.
If a pharmacy is not currently accredited, it would be required to be accredited after January 2011, but only if the pharmacy does not meet the above criteria.
Pharmacist-Delivered Medication Therapy Management Services
Background: The health care reform Act calls for an expanded patient care role for pharmacists in new health care system models. Although pharmacists have been expanding their roles beyond the dispensing function for years, the Act intends that these new responsibilities will help ensure more appropriate use of prescription medications, especially for those patients suffering from chronic illnesses. The provisions are designed to offer incentives for medication therapy intervention that results in an increase in the appropriate medication use by patients. The bill also includes a medication therapy management (MTM) grant program that will help test new and innovative methods to provide MTM. The criteria that will define eligibility for such grants are currently unclear, but it is anticipated that these will be more defined over time by the federal government.
Impact on the Pharmacy:
Community pharmacies may be eligible for grant funding to help provide MTM services.
The Act Closes the Medicare Part D Donut Hole
Background: Medicare Part D enrollees pay a co-payment amount for their prescription drugs, which is determined by their specific plan. For standard plans, enrollees pay their co-payment until their total drug cost reaches a specified amount. In the initial coverage phase, the enrollee pays a co-pay amount and the drug plan pays the rest of the discounted drug price. The total drug cost is the co-pay amount paid by the enrollee plus the amount paid by the Medicare Part D drug plan. After the predefined total drug cost has been reached, there is a gap in coverage (this is commonly referred to as the donut hole) and the enrollee must pay the full cost for their prescription drugs until they have paid the required out-of-pocket expense. After this stage of coverage, enrollees will reach the catastrophic coverage stage and their cost for each medication decreases to a small co-pay (usually $2 to $5 each) or a 5% co-insurance, whichever is greater. During the period enrollees are in the coverage gap, or donut hole, they must still pay their monthly premium.
The Act will facilitate the close of the Medicare Part D donut hole over the next 10 years (2010-2020) through an increase in federal funds and discounts from pharmaceutical manufacturers’ on brand-name medications. Beneficiaries that have reached the donut hole in 2010 will receive a one-time $250 rebate. Beginning January 1, 2011, beneficiaries will also automatically receive a 50% discount off the negotiated price for brand-name prescription drugs that are covered under Part D and by their plan‘s formulary, including those that are being treated as if they were on plan formularies through the exceptions and appeals process. These discounts would be provided by the pharmacy at the point of sale. This discount increases to 75% on brand-name and generic medications by 2020.
The Act also allows for 100% of the negotiated price of discounted drugs (excluding dispensing fees) to count toward the annual out-of-pocket threshold that is used to define the coverage gap annually. Beginning in 2020, the 25% co-pay applies until Medicare’s catastrophic coverage kicks in.
Impact on the Pharmacy:
Medicare patients who previously struggled financially when in the donut hole should be able to purchase their full medication regimen as prescribed – which will lead to increased compliance/adherence. The new law requires that these brand name manufacturer discounts be paid to the pharmacy by a third-party entity under contract with the Secretary of Health and Human Services. The new prompt pay provisions apply to the payments that these third-party entities would have to make to pharmacies; this means that pharmacies should be paid within 14 days of dispensing the brand-name medication.
New Requirements for Long-term Care Pharmacies
Background: The Act requires Medicare Part D plans to engage in dispensing techniques that will reduce pharmaceutical waste. Starting in 2012, the waste reducing form of dispensing medication on a daily, weekly, or automated basis will be required for Part D enrollees in long-term care facilities.
Impact on the Pharmacy:
The pharmacy may have to provide dispensing services to long-term care facilities more frequently and without statutory requirements providing for the corresponding increases in dispensing fees. This provision is troubling because each Medicare Part D plan appears to be able to set its own dispensing interval, making this challenging for the long-term care pharmacy that is trying to track all the different Medicare Part D plan requirements.
340B Provisions
Background: The 340B Program4 was established by the Veterans Health Care Act of 1992, which put Section 340B of the Public Health Service Act into place. The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to certain covered entities specified in the statute.
Covered entities are extensive and include, but are not limited to, Health Resources and Service Administration (HRSA) grantees, Federally Qualified Health Centers (FQHCs) and FQHC look-alikes, family planning clinics, HIV/Ryan White clinics, state-operated AIDS drug assistance programs, black lung clinics, hemophilia treatment centers, urban Indian organizations, Native Hawaiian health centers, sexually transmitted disease and tuberculosis clinics, and disproportionate share hospitals.
The 340B price defined in the statute is a ceiling price, meaning it is the highest price a covered entity would have to pay for a given outpatient drug. Covered entities can negotiate below ceiling prices with manufacturers. As a result, 340B prices have been found to be roughly 50% of the average wholesale price.
The Act substantially expands the number of entities covered and eligible to obtain pharmaceutical discounts according to the 340B program. These 340B entities were designed to provide discounted prescription medications to uninsured individuals. Separately, HRSA has rolled out new guidelines for the 340B program; these provide permission for covered entities to contract with multiple community pharmacies with respect to dispensing of 340B program pharmacy services.
Impact on the Pharmacy:
Expansion language means that an increasingly larger number of covered entities will be able to provide discounted 340B drugs. Therefore, more community pharmacies will also have an increased opportunity to participate in the 340B program because of a recently issued HRSA guidance that allows for entities covered by 340B to contract with multiple pharmacies and provide pharmacy services.
Small Business Reforms
Background: Under the Act, pharmacy employers are required to provide health insurance to employees unless the business has 50 employees or less. If there are more than 50 employees and there is no health insurance, the federal government may assess fines and penalties. Businesses with fewer than 25 employees may receive tax credits for employee health-insurance coverage. Those businesses that have more than 200 employees are required to enroll their employees automatically in a health plan, giving them the opportunity to opt-out.
MISCELLANEOUS LAWS
The following are miscellaneous provisions in the Act that may be of interest:
The Secretary of HHS is authorized to negotiate and enter into contracts with vaccine manufacturers for the purchase and delivery of vaccines for adults. The Act then allows a state to purchase additional quantities of adult vaccines from manufacturers at the applicable price negotiated by the Secretary of HHS. The Act also requires the Secretary of HHS, acting through the Director of the Centers for Disease Control and Prevention (CDC), to establish a demonstration program that awards grants to states for improvements in the recommended provisions and immunizations allotted for children and adults through the use of evidence-based, population-based interventions for high-risk populations.
The Act amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to impact retail food establishments that are a part of a chain with 20 or more locations. If these restaurants share the same name, they are required to enhance the labeling of a food item offered for sale to incorporate a menu and menu board which should include the following: (1) the number of calories contained in the standard menu item; (2) the suggested daily caloric intake; and (3) the availability on the premises, and upon request, of specified additional nutrient information. In addition, the Act requires self-service facilities to place a sign that lists calories within each food item, or according to serving, adjacent to each food item offered. The Act also requires vending machine operators who are assigned to operate 20 or more vending machines to design and display a sign disclosing the number of calories contained in each food item offered for sale.
The Act amends Social Security Act (SSA) Title XI to require drug, device, biological, and medical supply manufacturers to report to the Secretary of HHS transfers of value made to a physician, a physician’s medical practice, a physician’s group practice, and/or a teaching hospital. Information on any known physician ownership or investment interests relating to the manufacturer must also be disclosed. This part of the Act provides penalties for noncompliance and preempts duplicative state or local laws. The Act also amends SSA Title XI to require prescription drug manufacturers and authorized distributors of record to report to the Secretary of HHS specified information pertaining to drug samples.
The Act imposes an annual fee on branded prescription drug sales exceeding $5 million for manufacturers and importers of such drugs beginning in 2010. The Act requires HHS, Veterans Affairs (VA), and Department of Defense (DOD) Secretaries to report to the Secretary of the Treasury with the total branded prescription drug sales generated by the government programs within their departments.
Finally, the Act imposes an annual fee on the gross sales receipts exceeding $5 million from manufacturers and importers of certain medical devices, beginning in 2011.
LAWSUIT AGAINST FEDERAL GOVERNMENT BY STATE ATTORNEY GENERALS
Thirteen state attorney generals are suing to overturn the Act. The lawsuit, filed in federal court 7 minutes after President Barack Obama signed the Act, underscores the divisiveness of groups affected by the reforms. Florida Attorney General Bill McCollum led the effort to file the suit that claims Congress doesn't have the constitutional right to force people to get health coverage. It also says the federal government is violating the Constitution by forcing a mandate on the states without providing resources to pay for it. The lawsuit, filed in Pensacola, Florida, asks a judge to declare the bill unconstitutional because "the Constitution nowhere authorizes the United States to mandate, either directly or under threat of penalty, that all citizens and legal residents have qualifying health care coverage." The lawsuit claims the health care bill violates the 10th Amendment, which says the federal government has no authority beyond the powers granted to it under the Constitution, by forcing the states to carry out its provisions but not reimbursing them for the costs.5
The lawsuit also says the states cannot afford the new law. Using Florida as an example, it says the overhaul will add almost 1.3 million people to the state's Medicaid rolls and cost the state an additional $150 million in 2014, growing to $1 billion a year by 2019.5
In summary, the monumental Act will affect the drug and pharmacy industry, and although the overall scope of its impact is unclear at this time, one certainly can expect to see, during the next steps of implementation, regulations that will provide additional guidance on a multitude of issues.
Health Care Reform:
Legal Impact on the Drug & Pharmacy Disciplines
March 21, 2010 marked a historic day as Congress passed a proposed legislation entitled The Patient Protection and Affordable Care Act (the Act).1 Only a few days later, on March 23, 2010, President Barack Obama signed the bill into law, providing millions of Americans with greater access to health care. The Act, consisting of thousands of pages, contains important changes that affect the drug and pharmacy industry, among other things. This continuing education (CE) article will begin with a review of some of the global changes that have been predicted for the overall health care industry and continue with the presentation of information specific to the drug and pharmaceutical industry.
Many of the provisions in the new Act will go through a rule making process at an administrative agency level and this will provide a better sense of how the Act will be administered. State and national associations will be tracking the implementation of these regulations. This also represents an excellent opportunity for the pharmacist to get involved and impact the outcome of the regulations in an effort to keep the results favorable in regard to the drug and pharmaceutical industry.
This historic Act will result in the implementation of many sweeping and far-reaching changes for the health care system over the next few years. Changes may include new consumer protections, coverage for millions of uninsured people, penalties for individuals and businesses who do not buy insurance, attempts to control rising costs (including medication costs), and Medicare savings, as well as new taxes to pay for it all.
A YEAR-BY-YEAR LOOK
Although this is not an exhaustive list, the following is a year-by-year look at what will be coming:
2010
Adults who are currently unable to obtain coverage because of a preexisting medical condition will be able to join a high-risk insurance pool as an interim step, pending the launch of competitive health insurance marketplaces and premium subsidies, in 2014. Additionally, insurance companies will issue policies for children with preexisting conditions and will not be permitted to revoke existing policies when people get sick. Lifetime limits on coverage will be banned and new coverage and annual limits will be restricted. Preventive services will be fully covered, without co-pays or deductibles.
Coverage will be available for dependent children until they are aged 26 years. Certain small businesses will start getting tax credits to offset up to 35% of the cost of insuring their employees; that amount will rise to 50% in 2014. Health plans will be required to have, what has been termed, an effective appeals process for decisions and claims. States will be eligible to obtain grants for the initiation of programs that help consumers with complaints or questions about health insurance. The federal government will also set up a Web site to help people in different states comprehend the full extent of their insurance options. Notably, a 10% tax on indoor tanning services will be levied.
New physician-owned hospitals are barred from participating in Medicare. Medicare coverage is also expanded to individuals who have developed certain health conditions as a result of exposure to environmental health hazards. The United States (U.S.) Food and Drug Administration (FDA) is authorized to approve generic versions of biologic drugs. The Secretary of Health and Human Services (HHS) is authorized to issue grants to create or expand primary-care residency programs. Nonprofit hospitals will also be subject to a tax of $50,000 per year if they fail to meet certain requirements.
2011
Medicare will now support free annual wellness visits. There will be little or no cost sharing for preventive care, which include, immunizations and cancer screenings. Bonuses will be paid to primary-care doctors and general surgeons under certain circumstances and a new Center for Medicare and Medicaid Innovation (CMI) will be unveiled as a forum to test additional methods of providing better, more efficient care. Overpayments to private Medicare Advantage insurance plans will be slowly phased-out and Medicare Part B physician premiums and Part D drug premiums will increase for some people, based on incomes.
Pharmaceutical manufacturers will provide a 50% discount for brand-name drugs purchased through Medicare Part D. In addition, federal subsidies will add financial support for generic drugs, while the patient is caught in the Part D donut hole. Over-the-counter (OTC) medications that are not prescribed by a physician cannot be purchased any longer using tax advantaged set-asides such as Health Savings Accounts, Flexible Spending Accounts, and Archer Medical Savings Accounts.
2012
There will be new incentives to encourage health care providers to join together and facilitate Accountable Care Organizations (ACOs). The government will also track readmission rates at hospitals, which may prompt them to impose penalty fees on hospitals with the highest rates of readmission.
2013
This is when higher income taxes will begin for households with income above $250,000 and individuals above $200,000. The Medicare payroll tax on earnings above those amounts will rise from 1.45% to 2.35%. Unearned income above those amounts (e.g., dividends) will now be subject to a 3.8% tax. In addition, maximum contributions to pretax Flexible Savings Account contributions will be limited to $2500 a year. There will also be a new 2.9% excise tax on medical devices. Medicare will also sponsor a national pilot program on payment bundling—i.e., paying hospitals, doctors, and other providers based on patient outcomes, not services provided.
2014
Insurance companies will no longer be able to deny policies to anyone based on their health status; nor will they be permitted to refuse coverage for a treatment based on preexisting health conditions. The ability to charge higher rates to people based on age, geography, family size, or tobacco use will also be limited; annual limits on coverage will be abolished. Each state will open a health insurance exchange, or marketplace, for individuals and small businesses without coverage. There will be a multistate private plan available nationwide, supervised by the U.S. Office of Personnel Management. Tax credits will be available to make insurance and care affordable for people who earn too much money to qualify for Medicaid, but have incomes below 400% of the poverty level. Most people will be required to buy insurance coverage or they will pay penalties that will start at $95 in 2014 and rise to $695, or 2.5% of their income, in 2016. Employers with 50 or more workers who do not offer coverage will have to pay annual fees. Medicaid eligibility will increase to include individuals living at or below 133% of the poverty level ($14,404 for individuals) for everyone under 65 (when they qualify for Medicare).
2015
In 2015, a new Independent Payment Advisory Board will be formed to come up with ways to lower Medicare costs and promote better care. The recommendations will go to both Congress and private insurers.
2018
In 2018, the most controversial new tax will begin, a 40% excise tax on insurance companies and plan administrators for any family plan that costs more than $27,500. The tax applies to the cost above that threshold; higher thresholds will be applied for retirees over 55 and plans that cover workers in high-risk jobs.
The new health care system will have reduced the number of uninsured people by 32 million, according to the federal government’s Congressional Budget Office (CBO). That will still leave an estimated 23 million people uninsured, one-third of them illegal immigrants according to the CBO. However, coverage of legal residents too young for Medicare (those aged 65 years or less) will be 94%, an increase from the current 83%.2
LAWS DIRECTLY IMPACTING DRUG AND PHARMACY
The following sections will describe how health care reform legislation will affect the drug and pharmacy industry. These sections are entitled, Medicaid Generic Drug Reimbursement, Pharmacy Benefit Manager Transparency, DME Accreditation Exemption, Pharmacist MTM Services, The Medicare Part D Donut Hole, Long-Term Care Pharmacy Requirements, 340B Provisions, Small Business Reforms, and a miscellaneous section with information that may indirectly impact the drug and pharmacy industry or that is of general interest.
Medicaid Generic Drug Pharmacy Reimbursement (AMP Fix)
Background: The Deficit Reduction Act of 2005 (DRA) would have reimbursed pharmacies below their acquisition cost for Medicaid generic drugs. Since 2007, these cuts have been delayed because of a December 2007 court injunction. The Act improves the definition of Average Manufacturer Price (AMP) so that it includes only manufacturers’ sales to retail pharmacies. The Center for Medicare and Medicaid Services (CMS) had been directed to set a Medicaid Federal Upper Limit (FUL) for reimbursement of generics at a rate of “no less than 175% of average weighted AMP.” This increase in the FUL is particularly important because the health care reform Act also expands Medicaid coverage – which will take effect in 2014 – for individuals living at or below 133% of the federal poverty level. This is expected to add 16 million more individuals to the Medicaid program.3
Impact on the Pharmacy
The new health care reform Act requires the Secretary of HHS to implement the new Medicaid generic rates as early as October 2010. This new law serves to mitigate the impact of the dramatic generic drug reimbursement cuts that would have gone into effect had these changes not been made, in turn saving pharmacies money.
PBM Transparency in the Medicare Part D Plans and New State-Based Health Exchanges
Background: Pharmacy benefit managers (PBMs) are responsible for managing prescription drug benefits for health care plan payers. They are able to manage prescription drugs in a variety of ways; for example, they can control prescription costs and clinical interventions. With the passage of the Act, PBMs are required to confidentially disclose important financial information to the Secretary of HHS for health care plans operating in new health insurance exchanges and in Medicare Part D plans. These new state-based exchanges are set to begin in 2014. Notably, this is the first federal requirement for oversight and accountability in the PBM marketplace. These provisions also establish an important initial federal framework for the regulation of PBMs, which have otherwise been largely unregulated.
Pharmacists and Pharmacies Are Exempted From Medicare DME Accreditation Requirements
Background: The Act provides a new exemption, for most pharmacies, from the accreditation requirements to provide Medicare Durable Medical Equipment (DME). It also changes current law so that pharmacy accreditation requirements, for those pharmacies that must still obtain accreditation, are not effective until January 2011. Those pharmacies that want to engage in competitive bidding for DME would still be required to be accredited regardless.
A pharmacy can be exempt from the Medicare DME accreditation requirements if the following apply:
Has total Medicare DME billings that are 5% or less of the total prescription sales
Has not had adverse fraud or abuse determination against their business within the last 5 years
Additionally, the pharmacy must provide an attestation that DME billings are less than 5% of its pharmacy sales, according to a rolling 3-year average, and they must submit documentation that verifies such information.
Impact on the Pharmacy:
If the pharmacy is already accredited under current CMS guidelines and meets the criteria stated above, it is exempt from any re-accreditation requirements.
If a pharmacy is not currently accredited, it would be required to be accredited after January 2011, but only if the pharmacy does not meet the above criteria.
Pharmacist-Delivered Medication Therapy Management Services
Background: The health care reform Act calls for an expanded patient care role for pharmacists in new health care system models. Although pharmacists have been expanding their roles beyond the dispensing function for years, the Act intends that these new responsibilities will help ensure more appropriate use of prescription medications, especially for those patients suffering from chronic illnesses. The provisions are designed to offer incentives for medication therapy intervention that results in an increase in the appropriate medication use by patients. The bill also includes a medication therapy management (MTM) grant program that will help test new and innovative methods to provide MTM. The criteria that will define eligibility for such grants are currently unclear, but it is anticipated that these will be more defined over time by the federal government.
Impact on the Pharmacy:
Community pharmacies may be eligible for grant funding to help provide MTM services.
The Act Closes the Medicare Part D Donut Hole
Background: Medicare Part D enrollees pay a co-payment amount for their prescription drugs, which is determined by their specific plan. For standard plans, enrollees pay their co-payment until their total drug cost reaches a specified amount. In the initial coverage phase, the enrollee pays a co-pay amount and the drug plan pays the rest of the discounted drug price. The total drug cost is the co-pay amount paid by the enrollee plus the amount paid by the Medicare Part D drug plan. After the predefined total drug cost has been reached, there is a gap in coverage (this is commonly referred to as the donut hole) and the enrollee must pay the full cost for their prescription drugs until they have paid the required out-of-pocket expense. After this stage of coverage, enrollees will reach the catastrophic coverage stage and their cost for each medication decreases to a small co-pay (usually $2 to $5 each) or a 5% co-insurance, whichever is greater. During the period enrollees are in the coverage gap, or donut hole, they must still pay their monthly premium.
The Act will facilitate the close of the Medicare Part D donut hole over the next 10 years (2010-2020) through an increase in federal funds and discounts from pharmaceutical manufacturers’ on brand-name medications. Beneficiaries that have reached the donut hole in 2010 will receive a one-time $250 rebate. Beginning January 1, 2011, beneficiaries will also automatically receive a 50% discount off the negotiated price for brand-name prescription drugs that are covered under Part D and by their plan‘s formulary, including those that are being treated as if they were on plan formularies through the exceptions and appeals process. These discounts would be provided by the pharmacy at the point of sale. This discount increases to 75% on brand-name and generic medications by 2020.
The Act also allows for 100% of the negotiated price of discounted drugs (excluding dispensing fees) to count toward the annual out-of-pocket threshold that is used to define the coverage gap annually. Beginning in 2020, the 25% co-pay applies until Medicare’s catastrophic coverage kicks in.
Impact on the Pharmacy:
Medicare patients who previously struggled financially when in the donut hole should be able to purchase their full medication regimen as prescribed – which will lead to increased compliance/adherence. The new law requires that these brand name manufacturer discounts be paid to the pharmacy by a third-party entity under contract with the Secretary of Health and Human Services. The new prompt pay provisions apply to the payments that these third-party entities would have to make to pharmacies; this means that pharmacies should be paid within 14 days of dispensing the brand-name medication.
New Requirements for Long-term Care Pharmacies
Background: The Act requires Medicare Part D plans to engage in dispensing techniques that will reduce pharmaceutical waste. Starting in 2012, the waste reducing form of dispensing medication on a daily, weekly, or automated basis will be required for Part D enrollees in long-term care facilities.
Impact on the Pharmacy:
The pharmacy may have to provide dispensing services to long-term care facilities more frequently and without statutory requirements providing for the corresponding increases in dispensing fees. This provision is troubling because each Medicare Part D plan appears to be able to set its own dispensing interval, making this challenging for the long-term care pharmacy that is trying to track all the different Medicare Part D plan requirements.
340B Provisions
Background: The 340B Program4 was established by the Veterans Health Care Act of 1992, which put Section 340B of the Public Health Service Act into place. The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to certain covered entities specified in the statute.
Covered entities are extensive and include, but are not limited to, Health Resources and Service Administration (HRSA) grantees, Federally Qualified Health Centers (FQHCs) and FQHC look-alikes, family planning clinics, HIV/Ryan White clinics, state-operated AIDS drug assistance programs, black lung clinics, hemophilia treatment centers, urban Indian organizations, Native Hawaiian health centers, sexually transmitted disease and tuberculosis clinics, and disproportionate share hospitals.
The 340B price defined in the statute is a ceiling price, meaning it is the highest price a covered entity would have to pay for a given outpatient drug. Covered entities can negotiate below ceiling prices with manufacturers. As a result, 340B prices have been found to be roughly 50% of the average wholesale price.
The Act substantially expands the number of entities covered and eligible to obtain pharmaceutical discounts according to the 340B program. These 340B entities were designed to provide discounted prescription medications to uninsured individuals. Separately, HRSA has rolled out new guidelines for the 340B program; these provide permission for covered entities to contract with multiple community pharmacies with respect to dispensing of 340B program pharmacy services.
Impact on the Pharmacy:
Expansion language means that an increasingly larger number of covered entities will be able to provide discounted 340B drugs. Therefore, more community pharmacies will also have an increased opportunity to participate in the 340B program because of a recently issued HRSA guidance that allows for entities covered by 340B to contract with multiple pharmacies and provide pharmacy services.
Small Business Reforms
Background: Under the Act, pharmacy employers are required to provide health insurance to employees unless the business has 50 employees or less. If there are more than 50 employees and there is no health insurance, the federal government may assess fines and penalties. Businesses with fewer than 25 employees may receive tax credits for employee health-insurance coverage. Those businesses that have more than 200 employees are required to enroll their employees automatically in a health plan, giving them the opportunity to opt-out.
MISCELLANEOUS LAWS
The following are miscellaneous provisions in the Act that may be of interest:
The Secretary of HHS is authorized to negotiate and enter into contracts with vaccine manufacturers for the purchase and delivery of vaccines for adults. The Act then allows a state to purchase additional quantities of adult vaccines from manufacturers at the applicable price negotiated by the Secretary of HHS. The Act also requires the Secretary of HHS, acting through the Director of the Centers for Disease Control and Prevention (CDC), to establish a demonstration program that awards grants to states for improvements in the recommended provisions and immunizations allotted for children and adults through the use of evidence-based, population-based interventions for high-risk populations.
The Act amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to impact retail food establishments that are a part of a chain with 20 or more locations. If these restaurants share the same name, they are required to enhance the labeling of a food item offered for sale to incorporate a menu and menu board which should include the following: (1) the number of calories contained in the standard menu item; (2) the suggested daily caloric intake; and (3) the availability on the premises, and upon request, of specified additional nutrient information. In addition, the Act requires self-service facilities to place a sign that lists calories within each food item, or according to serving, adjacent to each food item offered. The Act also requires vending machine operators who are assigned to operate 20 or more vending machines to design and display a sign disclosing the number of calories contained in each food item offered for sale.
The Act amends Social Security Act (SSA) Title XI to require drug, device, biological, and medical supply manufacturers to report to the Secretary of HHS transfers of value made to a physician, a physician’s medical practice, a physician’s group practice, and/or a teaching hospital. Information on any known physician ownership or investment interests relating to the manufacturer must also be disclosed. This part of the Act provides penalties for noncompliance and preempts duplicative state or local laws. The Act also amends SSA Title XI to require prescription drug manufacturers and authorized distributors of record to report to the Secretary of HHS specified information pertaining to drug samples.
The Act imposes an annual fee on branded prescription drug sales exceeding $5 million for manufacturers and importers of such drugs beginning in 2010. The Act requires HHS, Veterans Affairs (VA), and Department of Defense (DOD) Secretaries to report to the Secretary of the Treasury with the total branded prescription drug sales generated by the government programs within their departments.
Finally, the Act imposes an annual fee on the gross sales receipts exceeding $5 million from manufacturers and importers of certain medical devices, beginning in 2011.
LAWSUIT AGAINST FEDERAL GOVERNMENT BY STATE ATTORNEY GENERALS
Thirteen state attorney generals are suing to overturn the Act. The lawsuit, filed in federal court 7 minutes after President Barack Obama signed the Act, underscores the divisiveness of groups affected by the reforms. Florida Attorney General Bill McCollum led the effort to file the suit that claims Congress doesn't have the constitutional right to force people to get health coverage. It also says the federal government is violating the Constitution by forcing a mandate on the states without providing resources to pay for it. The lawsuit, filed in Pensacola, Florida, asks a judge to declare the bill unconstitutional because "the Constitution nowhere authorizes the United States to mandate, either directly or under threat of penalty, that all citizens and legal residents have qualifying health care coverage." The lawsuit claims the health care bill violates the 10th Amendment, which says the federal government has no authority beyond the powers granted to it under the Constitution, by forcing the states to carry out its provisions but not reimbursing them for the costs.5
The lawsuit also says the states cannot afford the new law. Using Florida as an example, it says the overhaul will add almost 1.3 million people to the state's Medicaid rolls and cost the state an additional $150 million in 2014, growing to $1 billion a year by 2019.5
In summary, the monumental Act will affect the drug and pharmacy industry, and although the overall scope of its impact is unclear at this time, one certainly can expect to see, during the next steps of implementation, regulations that will provide additional guidance on a multitude of issues.
Thursday, May 27, 2010
Sit Down and Shut Up
I can’t stress how important it is to be patient in today’s society. Rushing things will only make situations worse. Now, I’m not saying I’m innocent. I have terrible road rage and I like to tailgate, but this entry has nothing to do with tailgating. I am referring to services rendered.
Nowadays, you have to wait just about anywhere you go: restaurants, sporting events, amusement parks, movie theaters…you get the point. So why would a pharmacy be any different? Just because we have a drive-thru window doesn’t mean we have drive-thru speeds. I can’t stress that enough. Also, when we say your wait time is about 15 minutes, that time is an average allotment dependent on other factors. Moreover, we, the pharmacy staff, are people too. Do not rush us. There’s a double meaning in the word “patient”.
The Drive-Thru
Most pharmacies today have drive-thrus. These make it very convenient for busy people to drop off and pick up their prescriptions. Whether you’re a mom with three kids on the go, or an elderly disabled man who would like us to grab him a bottle of water as well, the drive-thru is an excellent addition to a pharmacy. However, if I could, I’d brick up the window in a heartbeat. We are not a McDonald’s. We are not a Wendy’s. We are not a Taco Bell. Our drive-thru is for dropping off OR picking up a prescription. The goal is for you to do so and then pull away. It is not the lazy man’s access point. Furthermore, do not sit in our drive-thru. Why would you do that? You most think you’re the only person on the planet with a prescription and that we sit around all day, scratching our asses waiting for you to show up. Our pharmacy is not a high-volume store. We process about 300 scripts a day. Some pharmacies can do over 1,000. Even at 300, we are still very, very busy. There are multiple issues that we deal with around the clock that interrupt your prescription being filled. I’ll get to those later.
The Wait Time
“It’ll be about 15 minutes”. This does not mean 10 minutes, or 5 or 2. This means that your prescription will be ready in 15 minutes, barring any interruption from:
a) other people
b) phone calls
c) insurance rejections
d) printer jams
e) system connection problems
f) out of stock issues
g) waiters ahead of you
h) any other issues
Even if we have no problems with any of the above issues, you’ve probably wandered off for 20 minutes. Then you show up wondering why your prescription took so long. I should slap you. Why it took us so long? Where the hell did you go? If you’re going to wait, wait. Don’t go anywhere. We try very, very hard to finish “waiters” as quickly and safely as we can when you say you want to wait. This adds to the chaos and stress of the pharmacy staff. If you can pick it up later, please, by all means, pick it up later. Do not commit the cardinal sin of saying you’re going to wait and then picking it up the next day. You’ve just made it onto our shit list.
Rushing Us
This happened to me just the other day: I came into work at 11am and there was a woman standing at the counter. I asked her if she had one to pick up and was told by my pharmacist that we were still working on it. There were 2 other waiters ahead of her but she continued to stand there. Her scripts came from the urgent care center next door. The urgent care had called prior to the patient coming to us and our pharmacist told them that the wait was at least 25 minutes that morning (due to another tech oversleeping). Apparently this woman came straight to the counter and expected us to push her scripts to the front of the line. I began counting the waiters ahead of her when I actually heard her say “Is there any way you could finish mine sooner? I have to…” I immediately cut her off and said “No”. I’m honestly surprised I didn’t bite her head off. Who does this woman think she is actually telling us to hurry? I looked up and said, “There are 2 people in front of you. By you standing there, (and not sitting down like the rest of the people) it’s a passive way of telling us to hurry up.” She began to mumble something about not meaning to hurry us up and blah, blah, blah. I then said, “It’s a little rude”. She mumbled something else and I just looked down and kept counting. Our pharmacist rang up the other waiters and minutes later rang up the woman who claimed not to be rushing us. The woman tried to complain about me but my boss had my back. Our pharmacist said that everyone always has an excuse as to why his or her scripts need to be done first. The woman left and I’m sure she’ll call corporate and complain. I don’t care. It had to be said. The best part? My boss had my back.
The lesson here is that you need to be patient. Patient has two meanings. The first is “able to wait without becoming annoyed or anxious”. The second is “a person receiving or registered to receive medical treatment”. Do not rush the people who offer a service—especially those who handle your medications.
Wednesday, May 19, 2010
Do You Need Patanol That Badly?
A patient had a Patanol script filled on 5/10 for 1 gtt ou bid. She has Medicaid. She called today, the 19th, and asks for a refill. I said, "are you out of eye drops because you should have plenty left"? She said she's completely out as if MY question was the dumb one. So I ran the claim through and sure enough, it rejected. Medicaid won't pay for it again until the 29th. I'd like to point out here that the 29th is still too damn soon.
And people wonder why health care costs go up.
She asks me the cost of Patanol without any insurance. I just told her it would be over $100 because usually Medicaid patients' responses to such an answer are "oh! nevermind!" and they hang up the phone (Actual retail price? About $120). But this woman wanted to piss me off. She had the nerve to contemplate paying the FULL PRICE of these damn drops while on MEDICAID. If you can afford the retail price of Patanol because your damn eyes itch, then get the fuck off of welfare! Stop taking my god damned tax dollars you fuck!
Tuesday, March 2, 2010
Get Upset Over $2.00
The past few days have been very interesting.
I often feel bad for the pharmacists out there who have to deal with the unbelievable bullshit that flows in and out of the pharmacy. Doctors and nurses do not seem to retain the knowledge regarding the process of calling in scripts. Our pharmacist had 3 scripts in a row on the voicemail today. The first didn't leave a strength for the albuterol solution, the second left out a strength for some cholesterol or blood pressure med, and the third completely forgot to leave a name for a Vicodin script. How useless can a doctor's office be? Do they have time to make stupid phone calls and wait for the pharmacists/interns to call them back for corrections or clarifications? We barely have time to receive them in the first place. When you call in a script, make sure you go through a checklist when leaving a message. Our pharmacists use one when we take them off the voicemail. Give it a try.
Yesterday, a foreign gentleman came through our drive-thru. He stated his name and began the awkward stare that ensues while I wait for them to state their purpose for visiting. Just a side note, do not just wait for me to open the window and then say "Smith" because I'll stare right back and say "Johnson". I don't read minds. I finally cracked and asked the man if he was picking up a prescription. He said yes and I proceeded to ask for the spelling of his 21-letter last name. I went to the scripts and found his script for Nexium. I rang it up and told him it would be $2.00 (thanks to Medicaid). Now, judging by this man's reaction, you would have thought I told him it will cost him both legs and an eye. He was just shocked. He proceeded to tell me it used to be free and asked me why it was $2.00 now. I did my very best to remain calm. I explained to him that as of February 1st, all Caresource, Molina, RxAmerica and other state-funded insurances were being run through Medicaid now for prescription coverage. He, of course, didn't understand and still wanted a reason for a $2.00 co-pay. I told him that his prescription coverage is different now and that two bucks would be his co-pay that day.
This is where I lost it.
The man had the nerve to pull out a STACK of $20 bills from his coat pocket. We're talking at least $500 worth of twenties. I told him he was lucky to have any coverage at all and that the cash price for Nexium was over$120. He was still confused as to why his co-pay was $2.00 and not ZERO like he normally got before Feb. 1st. In the end he paid and drove off. If I knew I wouldn't get fired, I would have slapped that man. He doesn't deserve any insurance coverage. Granted, most people out there have no clue what drugs cost. This man just assumed he was going to enjoy a free ride in our country. It pisses me off and it pisses other pharmacy employees (across the nation, I'm assuming) off too.
Thursday, February 11, 2010
Customer Savings Initiative
My place of employment has decided to implement a new "initiative". It technically involves us trying to convince people to switch their medications as they come in to the pharmacy. You heard right. We are supposed to tell people that they can save money by switching to a different but therapeutically similar generic drug. Would you like an example?
I'll use the example that Corporate gave us.
Mrs. Shelly Smith comes in with a script for Aciphex that she's been getting for 9 months.
Her brand co-pay is $30 and her generic co-pay is $10.
We are to suppose to stop her at drop-off and tell her that she can save money by switching to pantoprazole, lansoprazole, or omeprazole.
Now let's suppose she says no.
We're supposed to thank her for her consideration...fine.
But what if she says yes? Well then the shit hits the fan. First we have to set some shit up in the new computer system (which we don't have yet). Then we have to inform the patient that in order to fill their prescription, we have to contact the doctor for approval. Assuming the doctor approves this ridiculous decision, we get a verbal script over the phone and fill that new script. In a perfect world, this would take 20-30 minutes at the least. And that's if we get a hold of the MD himself/herself on the first ring when we call!
How about a dose of reality:
(I'll use drug names so as not to confuse)
Mrs. Smith says yes to us substituting omeprazole for her Aciphex (in order to save $20/month). Now our pharmacist has to stop what she is doing and call the doctor's office. Nine times out of ten, the MD is not available. They have to call us back, which means we have to tell the patient that they need to wait. Now what if you came in to a pharmacy expecting to wait 15 minutes for your prescription and now you learn that you are at the mercy of your doctor who, let's face it, doesn't care that you're at the pharmacy waiting for him to call. You've already left his office and he's made his money. He'll call the pharmacy when he gets a chance. Meanwhile, 10 minutes pass...20 minutes...30 minutes. Our pharmacist calls again to let the office know that you're still here waiting. The doctor calls back 10 minutes later and says that filling the prescription with omeprazole is OK. now you have to wait another 10-15 minutes while we type it up and fill it. All in all, you waited at least 45 minutes to get a generic drug that saves you $20. We're just getting to the good stuff.
Because we got authorization from your MD to fill a generic, your Aciphex Rx is now void in our system. I hope you like your new generic. But here you come 1 week later complaining about how omeprazole doesn't work at all and you want to return it and you want your Aciphex filled. Now we get the privilege of explaining to you that when you decided to go with omeprazole, your decision voided your Aciphex Rx. In order to fill the Aciphex, we have to call the doctor again and let him know that you don't like the omeprazole and you want Aciphex. The doctor then says to just fill the Aciphex then. Now we get to look stupid again and explain to your doctor that when he authorized a generic drug, it voided the Aciphex script. The doctor gives us a verbal Rx for Aciphex and now hates us (again this is after you wait another 30-45 minutes while we wait to hear back from the doctor). Now we have to tell you that once a prescription leaves the pharmacy we cannot take it back. You throw a fit because you're retarded and you don't have the patience of a normal human. You pay your normal $30 for your Aciphex and leave. Next month you transfer your script to some other pharmacy so you don't have to deal with this stupid shit again.
This is the dumbest idea anyone has ever come up with. I'm not even a pharmacist and I feel bad for my pharmacists. They're going to have to make 10 times as many phone calls. They're already stressed for time. They don't need this on top of what they're doing. We don't need this on top of what we're doing either. We are busy ringing people up and running to the damn drive-thru. We have to count prescriptions and meet budget everyday as well. We're already a busy pharmacy. It feels like Corporate is out of touch with the people who are actually having to do this retarded shit.
Tuesday, February 9, 2010
Brand vs. Generic
Pharmaceutical companies, such as Pfizer, AstraZeneca, Wyeth, etc. are businesses that invest in creating medications for our every day well-being. These can be blood pressure, cholesterol, antibiotics, analgesics (painkillers), or anti-psychotics. In order to create a new drug, the company must first develop a chemical. I'm going to use the drug Viagra as an example since everybody seems to know what that one's for. If you don't know, well, then you're retarded. Pfizer released Viagra in 1998. Pharmaceutical companies spend reported "millions and millions of dollars" on research and development in order to create a new drug. This money is also spent on tests and clinical trials.
Once a drug is developed by a drug company, they submit it to the Food and Drug Administration (FDA) for approval. After being approved, the drug receives a patent from the US Patent Office because technically, it is an invention. Drug patents can last between 2 and 17 years and is usually closer to the latter. During this time, the company spends more money on marketing and advertising in order to get the name of the drug out there to the public. This is when you see all the commercials on television.
Now, when you see the name of a brand name medication, you will see a big word underneath it usually in parentheses.
Once a drug is developed by a drug company, they submit it to the Food and Drug Administration (FDA) for approval. After being approved, the drug receives a patent from the US Patent Office because technically, it is an invention. Drug patents can last between 2 and 17 years and is usually closer to the latter. During this time, the company spends more money on marketing and advertising in order to get the name of the drug out there to the public. This is when you see all the commercials on television.
Now, when you see the name of a brand name medication, you will see a big word underneath it usually in parentheses.
VIAGRA
(sildenafil citrate)
(sildenafil citrate)
This word in parentheses is the chemical name of the drug--the active ingredient. Viagra's chemical name is sildenafil citrate. Just like all medication patents, Viagra's patent will expire. Its estimated expiration date is March 2012. When this date rolls around, a generic form of Viagra will become available. It will go by its chemical name of sildenafil citrate. Does this mean it's a totally different medicine? Quite the opposite. The name "Viagra" is a name that Pfizer came up with to call the drug. Even after the patent expires, the brand name drug will still be available.
Now let's look at cost. Why are brand name drugs more expensive and generics cheaper? As I mentioned before, pharmaceutical companies can spend a shit-ton of money on R&D for a single drug. After it is approved by the FDA, that company needs to start making its money back. How do they do that? Well, to begin with, drug representatives scoot around to doctors' offices dropping off information, samples, and stationary that is littered with the drug name. The doctor may or may not read about the new drug and decide it's worth prescribing. Now you have a prescription for a new drug. You take it to the pharmacy and with no insurance, you find out that your Viagra prescription is going to cost you about $150 for 10 pills. That's a real figure, too. Like I said, the drug company has to make their money back some way and in this case it's through the cost of the actual medication.
Let's fast forward to 2012. Viagra's patent has expired and "Company X" has decided to produce the generic form of Viagra. They will sell it to pharmacy wholesalers like Cardinal Health. Pharmacies that get their supplies from Cardinal Health will then order that drug. Now the pharmacy has the brand name and the generic form in stock. Our dilemma: which one do you choose and why?
As the FDA regulates all prescription and non-prescription drugs in the US market, it is their responsibility to ensure that the generic form of a drug be the same as a brand name drug in 7 categories. They are:
1) The generic form must be available in the same doses as the brand name. This means that since Viagra is available as a 25mg, 50mg, or 100mg tablet, the generic must come in those doses too.
2) The generic form must also be available in the same strengths. If Viagra contains 25mg of that active ingredient, sildenafil citrate, so, too must the generic.
3) The generic drug must be as safe as the brand name that was approved in the first place. If Viagra's main side effects are A, B, and C, sildenafil citrate's side effects cannot have a side effect of D.
4) The generic drug must be the same quality as the brand name drug. Just like the coke fiends who won't buy anything less than 60% pure, these drugs must match the brand name in quality.
5) The generic drug must work the same way as the brand name drug. If Viagra increases blood flow, so, too must sildenafil citrate. If Viagra is broken down and absorbed in the small intestine, the generic form must be absorbed into the body the same way. This is critical.
6) The way the drug is taken is also something the FDA looks for when approving a generic drug. If Viagra is only available as an oral tablet (which it is), then the generic must be taken that way as well.
7) Lastly, the generic drug must match the brand name drug in the way it is used. If viagra should be taken with food, so should the generic. If it needs to be taken 30 minutes to 4 hours prior to sexual activity, so should the generic.
Number 5 is known as bioequivalency. The definition of bioequivalency according toDictionary.com is "the condition in which different formulations of the same drug or chemical are equally absorbed when taken into the body." So, when someone tells you that the generic drug doesn't work the same, 99.99% of the time, it's all in their head. By FEDERAL LAW, it has to work the same.
I mentioned before that the chemical name is known as the active ingredient. If this is so, then what is/are the inactive ingredient(s)? Inactive ingredients are what make up the color, the shape, the size, etc. of the tablet or capsule. 99.99% of the time, these have absolutely no affect in the difference between generic and brand name drugs. These don't need to and don't have to be the same. The generic drug actuallyhas to look different or it infringes on copyright and patent laws. I can't make the same red fire truck you did and call it something else if it has your company name on it--mine has to look different somehow.
I have already mentioned cost. Since these generic pharmaceutical companies don't need to spend money on R&D, they can sell their product for less. The research and development has already been done by the brand name company. When the patent expires, this information becomes public knowledge.
What about those $4 and $10 programs?
The $4/$10 program is available at Wal-Mart, Target, Kroger, Giant Eagle, and Meijer. These big stores can afford to do this because they make money on other sales in their stores. When they give you a prescription for $4, they do not, I repeat, DO NOT bill your insurance company. They just set it to the $4 or $10 price and give it to you. CVS and Walgreen's cannot afford to do this because the majority of their business comes from prescription sales and the do not make up sales in the front store. This is a good idea for people with no insurance. If you don't have insurance, go to one of the $4 program stores and see how cheap it is. If you have insurance, it won't make a difference unless you tell the bigger store not to bill your insurance.
Let's recap:
1) Generic drugs are, BY LAW, the same as brand name drugs. They work the same!
2) Generic drugs cost less because the generic drug manufacturer doesn't need to make their millions and millions of dollars back due to R&D.
3) If you don't have insurance, go to a big store and leave us at CVS, alone.
So why get brand name drugs? See? You don't even have a reason. Most of the time, pharmacies dispense generics by default anyway.
Now let's look at cost. Why are brand name drugs more expensive and generics cheaper? As I mentioned before, pharmaceutical companies can spend a shit-ton of money on R&D for a single drug. After it is approved by the FDA, that company needs to start making its money back. How do they do that? Well, to begin with, drug representatives scoot around to doctors' offices dropping off information, samples, and stationary that is littered with the drug name. The doctor may or may not read about the new drug and decide it's worth prescribing. Now you have a prescription for a new drug. You take it to the pharmacy and with no insurance, you find out that your Viagra prescription is going to cost you about $150 for 10 pills. That's a real figure, too. Like I said, the drug company has to make their money back some way and in this case it's through the cost of the actual medication.
Let's fast forward to 2012. Viagra's patent has expired and "Company X" has decided to produce the generic form of Viagra. They will sell it to pharmacy wholesalers like Cardinal Health. Pharmacies that get their supplies from Cardinal Health will then order that drug. Now the pharmacy has the brand name and the generic form in stock. Our dilemma: which one do you choose and why?
As the FDA regulates all prescription and non-prescription drugs in the US market, it is their responsibility to ensure that the generic form of a drug be the same as a brand name drug in 7 categories. They are:
1) The generic form must be available in the same doses as the brand name. This means that since Viagra is available as a 25mg, 50mg, or 100mg tablet, the generic must come in those doses too.
2) The generic form must also be available in the same strengths. If Viagra contains 25mg of that active ingredient, sildenafil citrate, so, too must the generic.
3) The generic drug must be as safe as the brand name that was approved in the first place. If Viagra's main side effects are A, B, and C, sildenafil citrate's side effects cannot have a side effect of D.
4) The generic drug must be the same quality as the brand name drug. Just like the coke fiends who won't buy anything less than 60% pure, these drugs must match the brand name in quality.
5) The generic drug must work the same way as the brand name drug. If Viagra increases blood flow, so, too must sildenafil citrate. If Viagra is broken down and absorbed in the small intestine, the generic form must be absorbed into the body the same way. This is critical.
6) The way the drug is taken is also something the FDA looks for when approving a generic drug. If Viagra is only available as an oral tablet (which it is), then the generic must be taken that way as well.
7) Lastly, the generic drug must match the brand name drug in the way it is used. If viagra should be taken with food, so should the generic. If it needs to be taken 30 minutes to 4 hours prior to sexual activity, so should the generic.
Number 5 is known as bioequivalency. The definition of bioequivalency according toDictionary.com is "the condition in which different formulations of the same drug or chemical are equally absorbed when taken into the body." So, when someone tells you that the generic drug doesn't work the same, 99.99% of the time, it's all in their head. By FEDERAL LAW, it has to work the same.
I mentioned before that the chemical name is known as the active ingredient. If this is so, then what is/are the inactive ingredient(s)? Inactive ingredients are what make up the color, the shape, the size, etc. of the tablet or capsule. 99.99% of the time, these have absolutely no affect in the difference between generic and brand name drugs. These don't need to and don't have to be the same. The generic drug actuallyhas to look different or it infringes on copyright and patent laws. I can't make the same red fire truck you did and call it something else if it has your company name on it--mine has to look different somehow.
I have already mentioned cost. Since these generic pharmaceutical companies don't need to spend money on R&D, they can sell their product for less. The research and development has already been done by the brand name company. When the patent expires, this information becomes public knowledge.
What about those $4 and $10 programs?
The $4/$10 program is available at Wal-Mart, Target, Kroger, Giant Eagle, and Meijer. These big stores can afford to do this because they make money on other sales in their stores. When they give you a prescription for $4, they do not, I repeat, DO NOT bill your insurance company. They just set it to the $4 or $10 price and give it to you. CVS and Walgreen's cannot afford to do this because the majority of their business comes from prescription sales and the do not make up sales in the front store. This is a good idea for people with no insurance. If you don't have insurance, go to one of the $4 program stores and see how cheap it is. If you have insurance, it won't make a difference unless you tell the bigger store not to bill your insurance.
Let's recap:
1) Generic drugs are, BY LAW, the same as brand name drugs. They work the same!
2) Generic drugs cost less because the generic drug manufacturer doesn't need to make their millions and millions of dollars back due to R&D.
3) If you don't have insurance, go to a big store and leave us at CVS, alone.
So why get brand name drugs? See? You don't even have a reason. Most of the time, pharmacies dispense generics by default anyway.
Just get the generic...
I'd like to thank Adam M. for sharing this with me. It was a message he sent me:
It IS a giant myth that drug companies need to maintain their hold on the market. Do you wonder why al this r and d never leads to any great new cures. It is because the drug co. know the best way to profit is to grab a share of something already making a ton of money. That is why you have nexium, prevacid, protonix-they were developed to grab a share of old prilosecs earnings. Crestor the same with lipitor. Cholesterol, diabetes, ppis. Just a few different categories but all these variations. Nothing pioneering or revolutionary. At 1:05 lok at the chart. That chart is based on the companies listed on the bottom own figures. THEIR OWN figures they submit for analysis. Look at it: R and D is half of what they spend on marketing... This information is out there, the companies themselves don't hide it, but peope believe the same old myth.
http://www.youtube.com/wat
Monday, February 8, 2010
Underappreciated
Why is it that so many people take their pharmacy and pharmacy staff for granted? Just because we have a damn drive through doesn't make us a fast food restaurant! Don't come through our drive through and hand us 5 prescriptions and tell us you want them "now". And don't think that you're getting away with 6 different scripts from 6 different doctors all for 20 or 30 Percocet. We know what you're doing. It makes it worse when you limp in, moaning about how you're back hurts. If it was really hurt, you'd go to a specialist--not 6 ER docs in one month's time. You're not fooling anyone. Unfortunately, you're scripts are legit so we have to fill them. You're taking advantage of the doctors (although they are stupid for prescribing that shit to you) and us. It's un-fucking-believable that you can get away with this.
To all you motherfuckers cheating on Caresource/Molina (now Medicaid): Go Fuck Yourselves.
Why should my tax dollars pay for your birth control when you pull up in a Lexus and with a brand new Blackberry? What the fuck is that?! You're lucky I don't jump through that goddamned drive through window and ring your neck. I also refuse to pay for your medication just because you don't want to get a job. Being lazy shouldn't make you qualified for Medicaid. However, in Ohio, for some reason it does. I'd like to "audit" every person who comes through our pharmacy on Medicaid and see if they really need it. What percentage of Medicaid patients really need it?
Ugh...I just needed to vent.
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