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The American population is getting older, and manual dexterity declines with age, but for some reason tablets keep getting smaller and harder to pick up. Kitchen tools are made with fatter handles that are easier to hold, and clocks have larger numbers that are easier to read with aging eyes, but pills keep shrinking. They may be easier to swallow, but only if you can get your fingers on them. If the people who have the trademark “Good Grips” came out with a line of pills, they would probably find a market with no trouble at all.

Time magazine has an interesting report on counter-detailing, focusing on South Carolina’s SCORxE program: South Carolina Offering Prescribing Excellence (yes, that’s the way Time reports it, not SCOPE which seems more logical.) The idea is that the state funded program has pharmacists visiting physicians, offering objective information about drug selection and countering the efforts of corporate representatives to promote more expensive drugs when a generic drug can do the same job at a lower price. The report estimates that every dollar spent on the program saves $2 in drug costs. While South Carolina tends to be a conservative state, and opposition to a program of using state money to counter corporate effort was expected, the program seems to be popular.

But according to Time, there is a major debate going on – should the people doing the counter-detailing work bring pizza?

It’s amazing how many parents child-proof their homes, put in latches so that kids can’t get to cleaning supplies, put plugs in electrical outlets and gates in front of stairs – but don’t have a proper medicinal teaspoon. When a prescription calls for giving a child one teaspoonful of a liquid, it does NOT mean take a teaspoon out of the kitchen drawer – it means use an accurate measure. A medicinal teaspoon has 5 milliliters, while household teaspoons may have anywhere from 3 to 6 milliliters.

The best medicinal teaspoons are the ones that look like test tubes with marks on the side. They can be a little bit harder to use, and a lot harder to clean, than some other designs, but they give a more accurate measurement than either the ones that look like spoons or the ones that are packaged with bottles of pediatric medicine.

The purpose of this column is to offer advice about saving money on prescription drugs – which usually reduces to asking questions of your physician and pharmacist. But, there are two other questions you should ask that can save more than money – they may save your life. These are the questions that may prevent prescription errors, and they should be asked before you say good-bye, before you leave the physician’s office, before you leave the pharmacy.

When your physician hands you a prescription, look at it, and read it. If it isn’t clearly written, so that you can read it with no difficulty, as “would you please rewrite this legibly?” You may not recognize the word, you may not be familiar with quadragintesimal either (it means “in forty parts” according to the Hutchinson Dictionary of Difficult Words) but you can read it, and that’s what’s important. Read the prescription aloud to your physician, to be sure you’re reading it correctly. If you can’t read the prescription, don’t assume that anybody else can, because an illegible prescription increases the risk that your pharmacist will make a mistake.

Physicians’ handwriting has been the subject of a lot of jokes – but when it leads to medication errors it’s not funny. Too often, drug names, when written, can look alike. One of the classic examples was Lasix (a diuretic) and Losec (to reduce stomach acid). Amrinone has been confused with amiodarone, hydroxyzine with hydralazine. A well written prescription should really have a lot more information than most of them do. Ideally, the prescription should have the patient’s name, gender, age and diagnosis. You want the pharmacist to have enough information to do a proper double check on the physician, to confirm that the MD didn’t order an adult dose for a child, didn’t put a decimal point in the wrong place, didn’t confuse two drugs with similar names. Some day, there may be a computer system that will give the pharmacist all that information, and print the prescription legibly, but until then, just make sure that you can read the prescription yourself. Sloppy handwriting can turn OD (once a day) into QID (four times a day), or QOD (every other day). It takes just a few extra seconds to make sure that the prescription is legible, and if it isn’t, to ask your physician to rewrite the prescription to prevent an error.

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When your pharmacist hands you a filled prescription, and this applies mostly to refills, take it out of the bag, open the vial, look at the tablet or capsule, and if it doesn’t look familiar, ask him to double check that it was filled correctly. You can even ask him to show you the stock bottle, the one that he dispensed from, to verify that it’s the right drug.

One of the most important advances in keeping drug costs down was generic dispensing. Generic drugs are as good as their brand name equivalents, and a lot less expensive. The disadvantage is that because the same drug from different manufacturers won’t look alike, you can’t identify a drug by its appearance. One month, a drug may be a round tablet, and the next month an oval tablet. One month, it may be a blue capsule, and the next month it may be red. Most of the time these changes in appearance will be the result of buying the drug from different manufacturers – but every now and then, it will be because the pharmacist grabbed the wrong bottle from the shelf. The prescription may have been perfectly legible, and given the pharmacist all the information needed to double check that its’ an appropriate drug in the right dose, but that won’t help if he grabs the 10 milligram tablets instead of the 5 milligram ones. You may not know what the drug looks like the first time, but if it looks different when you go back for a refill, ask the pharmacist to double check. Most of the time, hopefully all of the time, it will be because the drug came from a different manufacturer – but check anyway. If the drug comes in the original manufacturer’s package, compare the manufacturer’s label with the pharmacy label, make sure they agree. An increasing number of pharmacies are using bar code readers to do this step, but do it yourself anyway.

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Most of the time, both physicians and pharmacists do everything right, and that’s good – but there are still going to be exceptions. Asking some questions can save money. Asking other questions can save your life.

Question:

Can you recommend a conversion from Ritalin 10mg tid to Focalin?

Answer:

Focalin, Novartis’ brand of dexmethylphenidate (there is a generic product available from Teva Pharmaceuticals) is the dextrorotatory form of methylphenidate (Ritalin, also from Novaris, is the best known brand of methylphenidate) which is used for treatment of attention deficit disorder. If anybody wants a really good discussion of stereochemistry and how it affects drug therapy, here’s a link to a paper that appeared in the Primary Care Companion to the Journal of Clinical Psychiatry but I’ll try to offer an explanation anyway.

Lots of chemical compounds can rotate a beam of polarized light, and lots of compounds exist in two forms, mirror images of each other. These compounds will have the same number of atoms, the same molecular weight, the same formula, but (for want of a better example), like your two hands, they don’t fit in the same glove. The molecular structure that twists a beam of polarized light to the left is called the levorotatory form, and the chemical structure that twists the beam to the right is called dextrorotatory. A mixture of the two forms is called racemic, and because it has equal amounts of the dextro and levo forms of the compound, a racemic mixture won’t bend a beam of polarized light at all.

As a rule, only the dextro form of a compound has any medicinal effect — the levo is inactive. There are exceptions, but no important ones. So, it’s common enough to separate the two compounds and use only the active form. When you see a drug make that begins with dex or dextro, it’s almost certainly the dextrorotatory half of a mixture of dextro and levo molecules — and the dose is just half of the dose that would be used for the mixed form. So, from the dexmethylphenidate package insert, the dosing instructions are:

For patients currently using methylphenidate, the recommended starting dose of dexmethylphenidate IR or ER is half the dose of racemic methylphenidate. Patients currently using dexmethylphenidate IR may be switched to the same daily dose of dexmethylphenidate ER. The maximum recommended dose for children and adults is 20 mg/day (10 mg twice-daily IR).

Although the House of Representatives approved HR 6331, a bill that would, among other things, reduce Medicare payments to physicians by 10%, by a lopsided vote of 355 to 59, the bill failed to pass the Senate by a large enough majority to override a threatened Presidential veto.

While the reduction in payments to physicians has been the most obvious provision in the bill, other parts directly affect pharmacy. One provision would require insurance companies to pay valid claims within 14 days of when they’re received. Another part of the bill would change the way the costs of drugs are calculated. Medicare and other insurers pay for prescriptions by paying an estimated price for the drug, plus a fee for the dispensation. These fees, which have to cover the expenses of running the pharmacy – salaries, rent, utilities – have always been low, but there was enough excess in the estimated cost of the drugs to allow pharmacies to operate at a profit. By changing the way the cost of the drugs is calculated, many small and low volume pharmacies, particularly those in rural areas, are expected to become unprofitable. The American Pharmacists Association has estimated that these cuts could force as many as 11,000 pharmacies to close.

The Senate will reopen discussion of the bill when it returns from its Fourth of July recess.

One of the most common questions any pharmacist has to answer is: is it okay to take expired drugs. It’s also one of the hardest questions, with a long answer, because the real answer is “I don’t know” and nobody accepts that even if it is the truth.

It’s important to understand what “:expired” means. It’s not an absolute state, like red light green light – it’s more of a best guess at an estimate. When you take a tablet, the weight of active ingredient isn’t absolute. The label may say “100 milligrams” but it’s actually going to be within a range, something like 90 - 110 milligrams. The exact range will vary from drug to drug, and there are other standards for uniformity, but the thing to keep in mind is that there is a range, and a drug is considered expired when, based on best estimates, it’s at the bottom of its permissible range. Drugs don’t suddenly disappear, so that they’re good on Monday and bad on Tuesday, like a dated supermarket discount. Drugs will normally degrade slowly. That means a drug that has just reached its expiration date is likely to be perfectly good. According to a report in The Wall Street Journal, of March 29,2000, the United States Department of Defense found that it had $1 billion or more of drugs on hand. In order to minimize waste, the military had the United States Food & Drug Administration analyze the drugs. They found that 90% of them were perfectly good even 15 years after they were supposed to have expired. In a published study, the Department of Pharmaceutics of the University of Texas at Austin reported that liquid preparations of metronidazole, an antiinfective agent, which had a labeled expiration date of April 1986, were still had 99.3% or labeled potency when they were assayed in January 1993. According to an article on the web site Medscape.com, Bayer Aspirin is labeled with a 2 to 3 year expiration date, but their own testing shows that the aspirin tablets are still good after 4 years, and they’ve never tested the tablets for more than 4 years.

But – and there’s always a “but” – there are lots of questions that have to be answered before assuming it’s safe to take drugs beyond their expiration date. The drugs the Department of Defense analyzed were properly stored at controlled temperatures. Drugs are likely to degrade more rapidly if they’re subjected to heat, humidity, or direct sunlight. When the Ohio State University College of Pharmacy studied the stability of a suspension of amiodarone, a heart drug, they found it was stable for 90 days in a refrigerator, but only 42 days at room temperature – and neither of these periods come anywhere near 15 years. A Polish study of the stability of cefuroxime, an antibiotic, found that the drug was stable for 2 years when properly stored, but only 6 months when subject to heat and humidity. While aspirin tablets may be stable for as long as 4 years, aspirin breaks up quickly in water. A bottle of aspirin tablets that may be stable on the shelf of an air-conditioned pharmacy, may not last nearly as long in a bathroom medicine cabinet. If the bathroom mirror fogs up when you take a shower, you have to assume that some of that moisture is also getting into the drugs in the medicine cabinet. If you don’t have air conditioning, summer heat can speed up drug degradation.

While it’s best to discuss use of drugs part their expiration with your physician or pharmacist, there are a couple of simple rules to keep in mind. Most non-prescription drugs meet the criteria for safe use after the expiration date, but many prescription drugs don’t – particularly rule #1.

1) Never take drugs past their expiration date unless you have some way of knowing if they’re working. The Medscape article had an anecdote about acetaminophen (the best known brand name is Tylenol) which still relieved pain 4 years after its expiration date. But with acetaminophen, you can tell if it’s working because if it isn’t, you’ll still feel pain – and since it’s a fairly safe drug, you can take a second dose if you have to (read the dose instructions carefully, and never exceed the maximum daily dose.) If a cough medicine isn’t working, you’ll know, because you’ll keep coughing. But – if an antibiotic isn’t working, you won’t know it, and the infection will get worse. It’s not worth the risk.

2) Don’t take chances with drugs that need precise dosing. Thyroid drugs, heart drugs and blood thinners are in this group. These drugs are too important to take chances with. Besides, these drugs are commonly dosed based on based on laboratory tests, and the price of a test is usually greater than nany money you can save on the drug.

2a) The same rule applies for any drug that may be life-saving. If you’re taking aspirin for a headache, you’ll have a headache a little bit longer. But if you’re taking thr aspirin after a heart attack to prevent another heart attack – it’s not worth the risk. Prednisone, and anti-inflammatory steroid, can be used to treat Poison Oak, but it’s also used to treat some cancers. The drug is the same, but the risks are very different.

3) Be careful with liquids. As a rule, tablets are the most stable dosage form, then capsules (the gelatin shell on a capsule may absorb water) and then liquids.

The United States Food & Drug Administration is taking action against a number of companies that have been selling unproven “cancer cures”.  False cures have been around for decades, and some were considerably more dangerous than the cancers they claimed to treat.  Others, while not directly harmful, were a waste of money, and kept patients from getting more effective treatments.  The products contain ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat’s Claw, an herbal tea called Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake, and Reishi.

The FDA warns patients against any product that makes excessive claims, and gives these examples:

• “Treats all forms of cancer”
• “Causes cancer cells to commit suicide!”
• “80% more effective than the world’s number one cancer drug”
• “Skin cancers disappear”
• “Target cancer cells while leaving healthy cells alone”
• “Shrinks malignant tumors”
• “Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments”

“Cancer” is not a single disease, but a collection of different conditions, and not all are dangerous.  Some are so slow growing that they often don’t require treatment, while others can be effectively cured through conventional treatments.  There is no “one size fits all” treatment for cancer, and any product which claims to be effective for all cancers isn’t to be trusted.

On June 10^th, the New York Times carried a report headlined Ranks of Underinsured Are Rising, Study Finds. It’s fairly well known that as many as 50 million Americans have no health insurance at all, but according to a new report from the Commonwealth Fund, an additional 25 million people had insurance policies that didn’t really insure them – not against the financial hardships of medical costs. In 2005, before the current deflation of the housing bubble, the Washington Post reported that 40% of the people who were fighting foreclosure on their homes cited health care costs as the reason for their mortgage defaults.

These people aren’t old, if they were they would have Medicare, and they’re not poor, because that’s when Medicaid steps in. Some may have been simply willing to take chances and not buy insurance policies, but others had policies that, in one way or another, didn’t provide adequate protection. One typical example is the adoption of a new pricing system, tier 4, that is being increasingly adopted by medical insurers. Under the oldest system, insurance covered most of the cost of drugs, leaving a co-payment that depended on the terms of the policy. Later, they adopted systems that set lower co-payments for generic drugs, higher payments for single source drugs that were on the insurance company’s formulary, and still higher prices for non-formulary drugs.

There was a rational basis for this, up to a point. Insurance companies spend a great deal of money evaluating the most cost effective way to treat illness. They assumed that by raising the prices on drugs that didn’t seem essential, patients would question the prescribers, and ask for less expensive generic drugs. It never really worked out, but since the system still cut costs for the insurers, there was no reason to change it. Tier 4 is something new, and applies to the most expensive drugs, regardless of medical necessity. Instead of charging a fixed co-payment, be it $10 or $20 or $40, the insurance company will pay a percentage of the costs of these drugs. That may leave the patient with bills running into the thousands of dollars. The insurers say that this system holds down costs for most policyholders – and that’s true. But for those people who require tier 4 drugs, and these are often drugs used to treat cancer, multiple sclerosis and rheumatoid arthritis, the costs can be devastating. Tier 4 began with Medicare drug plans, and is now written into 86% of these plans, and it’s beginning to turn up in private plans as well.

Another problem can be the lifetime cap – a maximum amount that the policy is worth over a lifetime. Most policies have something of this sort, a maximum lifetime payout, and the lower cost policies have lower caps. Rates may go up as medical costs increase, but the caps remain in place. For people with major chronic illnesses, a lifetime maximum of $100,000 doesn’t last very long.

The doughnut hole in Medicare Part D may not count as underinsurance, but for a lot of people it is. Here’s how CBS News described it in 2006: For all patients, Medicare covers 75 percent of the first $2,250 worth of drugs. But after that, coverage drops to zero — and doesn’t resume until the patient hits $5,100 in expenses. Then Medicare kicks in again, paying 95 percent of costs. But it’s this gap — of almost $3,000 — that many sick and disabled seniors call unaffordable.

Between 3 and 7 million people fall into the doughnut hole every year. These are people above the age of 65, with high medical costs judging from their drug bills, and (from the fact that they’re using Medicare Part D) no retiree health benefits from jobs. Medicare’s response: use generic drugs to lower costs, and buy a more expensive insurance policy that will cover the doughnut hole. There’s an extra clinker in Medicare Part D’s drug coverage – not all insurers use the same formulary. People opting for Part D should sit down and examine the formularies to be sure the drugs they’re taking are the ones that will be covered. But, under the current rules, patients can only change insurers once a year, but insurance companies can change formulary listings whenever they care to. What you see may not be what you get.

The reports in the New York Times and Washington Post show that there’s awareness of a serious problem with drug costs. So far, nobody has proposed an answer.

If your physician offers you drug samples, it may be time to start asking questions. Unless your physician can assure you that she’ll keep you supplied with samples for as long as you’re on that medication, you may be paying for those few pills for years to come. Filling a prescription is a little bit like paying taxes – you’re paying the bill, but somebody else is deciding how the money gets spent. When you do your own shopping, you get to make decisions based on price. Do you want the steak, or would you be just as satisfied with chicken? Does the brand name detergent clean better than the house brand, and if it does, how much do you care? That’s why magazines like Consumer Reports not only list the best products in each group, but also a “best buy”. There’s an old saying, you get what you pay for, but sometimes what you’re paying for is a big advertising budget, or a lunch that somebody else ate.

There’s an organization in New York City called No Free Lunch, and its goal is to encourage physicians to practice “evidence based medicine”. Evidence based medicine is a simple enough concept: get information about drugs from impartial studies, not from the companies that make money selling the drugs. Here’s what No Free Lunch has to say to patients about samples:

Many doctors provide samples to patients who lack prescription drug coverage or out of convenience. In fact, many doctors will say that obtaining samples is the primary reason they see reps. Drug companies spend ½ their promotional dollar (more than 10 billion dollars in 2002) on these samples. And for good reason: Samples are an extremely effective marketing “tool.” Samples get patients, and doctors, “hooked” on the sampled drug. But, not surprisingly, the “Sample Closet” is filled with the newest, most expensive medications, in brightly colored promotional packaging reminiscent of the supermarket cereal aisle. Though receiving a sample from your doctor may often seem convenient (and may also save you money in the short run), it may also result in you ending up on the wrong medication, and in the end costing you even more money… Furthermore, many practices do not keep proper track of which samples are given to whom; this could create a problem if a drug (or lot) were recalled. There are alternative, and preferable, ways to obtain medications–use of patient assistance programs, for example, as well as using generics whenever possible.

Having samples can lead a physician to make poor decisions. Suppose you come into the office and are diagnosed with high blood pressure. Your physician decides that you need medication – and he has samples of a new drug. You don’t know exactly what he’s thinking. Maybe it’s “I have some free drugs, I can do something nice”, or it could also be “I have some new drugs, let’s see how well they work”, but either way it’s not “what’s the best drug at the lowest price for this patient?” If the drug works, you may be taking it for years, paying extra money, either directly or through a higher co-payment.

On April 28,2008, the New York Times reported that the Association of American Medical Colleges recommended that drug and medical device companies should be banned from offering free food, gifts, travel and ghost writing services to doctors, staff members and students in all 129 of the nation’s medical colleges. While this recommendation would apply only to physicians and students at medical schools, it would probably have an influence on all practicing physicians. On May 15, 2008, New York State’s Governor, David Paterson, announced that he had proposed a law that would limit gifts by drug companies to physicians to $50 per year. The law would also require speakers at Continuing Education programs to disclose any possible conflicts of interest, and for Pharmacy Benefit Management companies, the companies that provide prescription drug insurance, to provide more information about their expenses and arrangements with both drug companies and pharmacies.

According to the press release, Lois Aronstein, New York Director of the American Association of Retired Persons, said: “Governor Paterson’s unprecedented leadership in proposing prescription drug marketing reform will lead to better prescribing practices that will positively impact the lives of all New Yorkers. AARP strongly believes that a medicine should be prescribed based on its effectiveness in treating a medical condition – not on gifts delivered by a pharmaceutical sales representative trained to promote newer, more expensive drugs over drugs that may be as effective and cheaper.”