Monday, June 14, 2010
Health Care Reform Act - An Explanation
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?
Tuesday, March 2, 2010
Get Upset Over $2.00
Thursday, February 11, 2010
Customer Savings Initiative
Tuesday, February 9, 2010
Brand vs. Generic
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.
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.
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
Friday, February 5, 2010
That's Not How It Works
When it comes to working in a pharmacy, time is an important factor. Prescriptions need to be filled quickly and accurately in order for the company to turn a profit and keep customers happy.
These are a few situations where the only appropriate response from the pharmacy is, "That's not how it works".
Patient (coming through the drive-thru and handing me an empty prescription vial): "Yeah I need a refill."
Me: "Well, you see here where it says 'Refills require authorization'? That means you're out of refills."
Patient: "No my doctor gave me a year's worth of refills."
Me: (after looking it up on the computer): "Yes, he did. 12 months ago. You need a new prescription."
Now, this could go one of two ways. Let's see what happens.
Patient: "Oh, ok. Thank you!" (and drives away)
That is the perfect response from the customer. This customer is apparently responsible enough to call his own doctor and request his own new prescription. He is what we refer to as "smart". But what about the other possible outcome of the situation? Let's take a gander.
"...You need a new prescription."
Patient: "Well, can't you call my doctor?"
Me: "Yes, we can send him a fax."
Patient: "And you'll call me when it's ready?"
Me: "Well, if you want to check back with us maybe tomorrow afternoon and see if we've heard anything by then we may have an answer for you. We make and receive dozens of phone calls all day long."
Patient: "Ugh, fine."
In this particular situation, the patient chose to be what we refer to as a "total and utter douchebag". Look, be responsible for your own shit. Call your own doctor. Keep track of your own refills. It's all on your prescription labels no matter what pharmacy you go to. If you see that you have 1 refill remaining, call your doctor! The pharmacy is responsible for filling and refilling your current ACTIVE prescriptions. Although we do it, we should not have to remind you to fill a prescription or contact your doctor or tell you the directions because you don't want to read.
These last situations are for the people who work in a pharmacy and can relate.
Customer: Yeah uh, my doctor only wrote this Vicodin script for 20 but it's supposed to be for 80. Can you call him?
Customer: Yeah I need a refill.
Me: On which medication?
Customer: Um, I can't pronounce it, ox-oxy-oxycodin-oxycodeine
Customer: Can I get a refill?
Me: On which medication?
Customer: My Vicodin.
Me: Well you just filled a 30-day supply 2 weeks ago.
Customer: Yeah, uh, I'm going to Mexico.
Me: You have one to drop off?
Customer: Yeah I have 4.
Me: When did you want to pick them up?
Customer: ...Now.
