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pill

Do you know what is in your medicine or what it does?

Last week, I talked about how to read drug product information (PI). This week I’ll discuss the parts of the PI that I didn’t cover last week in Medication: Reading the Fine Print. This includes the more complicated concepts, which I will try to put in to simpler terms.

Let’s begin with the description, generally found about half way through the PI. This tells us the drug’s scientific name, classification and gives information about the chemicals in the drug. The additives, weight and forms of the drug are listed. The different strengths (dosages) are listed.  A diagram of the drug’s chemical make-up is included here.

Listed next is the mechanism of action, or how the drug works. The clinical pharmacology is next, which includes pharmacodynamics and pharmacokinetics. Pharmacodynamics is about what a drug does to the body. Pharmacokinetics is what the body does to the drug.

Pharmacokinetics (PK), how drugs behave once they are in the body, has four parts:

  1. Absorption – The process of how the drug is absorbed in the body.
  2. Distribution – Where the drug is distributed after it enters the body.
  3. Metabolism – How the drug is broken down by the body.
  4. Elimination – How the drug leaves the body.

PK information is hard to read. To the untrained, the terms are complicated and abbreviations are used. If you do not have a good working knowledge of science, the information has no frame of reference. However, there are some basic concepts that are useful to know and you can ask your medical provider. These are:

  • How long will it take before the drug starts to work?
  • When will it be at its peak?
  • How long does it take the drug to leave the body?
  • Should I take this drug with or without food?

A few more terms may be helpful:

  • Half-life or terminal half-life (t ½) Length of time for one-half of a substance to be eliminated from the system. A short half-life is 4 to 8 hours and a long half-life is over 24 hours.
  • Peak When the drug is at its highest in the blood.
  • Trough – When the drug is at its lowest in the blood.
  • Bioavailability – What percentage of the drug is available to be used after it enters the body.
  • Clearance – The elimination of a substance from the body.
  • Steady state – When the drug stays at a constant level in the body.
  • Therapeutic Index (TI) This is a ratio between the average effective dose and the average toxic dose. The closer the ratio is to one, the greater the risk a drug can be toxic (potentially poisonous).

The PK section is where you’ll find information about how the drug works in specific populations, such as those with kidney disease, the elderly, or children.  You will also find drug interaction information here.

For the intensely curious, the PI also includes microbiology and drug resistance information. This is followed with nonclinical toxicology. If you are wondering if the drug causes cancer in lab animals, or what it may due to a fetus, look in this section.

If you keep reading, you will come to the clinical study information. This is very interesting, especially if you want to know what your chances are of responding to the drug.

Congratulations if you made it to the end of this article. Hopefully you learned something new. In time, technical information such as this will start to make more sense.

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Medication

Do you know what the fine print says?

Your pharmacist hands you information about medication your doctor prescribed for you. The complexity of the information depends on the level of printed material and your ability to understand medical language. You may also get a neatly folded copy of the drug’s prescribing information. This is printed on white paper in very small print. It requires a magnifying glass to read it, a medical dictionary to define the terms, and training to understand it.

This piece of paper is the prescribing information (PI). It is also called the package insert. The Food and Drug Administration (FDA) requires all manufacturers to supply this with their drugs. You don’t always get one with your prescription, but you can always locate it on the internet or request a copy from the drug’s manufacturer. You find the PI under “prescribing information” or “information for healthcare professionals.” Try to use the drug’s brand name rather than its generic name for your search. For instance, Lipitor® is the brand name for generic atorvastatin. It’s like Coca Cola® and Pepsi® are the brand names for cola.

Today’s blog offers tips on how to crack the code in the PI. It will tell you what to look for, what to avoid, what to fear, and what not to fear.

Most medications have information written specifically for patients. This is a good starting point as it will give you a broad overview of the most important information. After you read the basic information, you may want to read the entire PI.

Using Lipitor as an example, let’s take a PI tour. The first things you will read are the drug’s trade name, generic name and manufacturer. Sometimes, this is followed with a box with text bold type. This is called black box information. This has to be predominately displayed and carries a serious message. Lipitor doesn’t carry a black box warning.

Norco carries a black box warning. If you do nothing else, read and understand every word in the black box. If any of it applies to you, do not take that drug unless your health care provider has adequately explained why you may take it.

If there were recent changes to the drug, this is usually listed after the black box. It’s a good place to find anything new about a drug.

Next is a summary of the drug’s highlights. This information is explored in detail later in the PI, but it is a good place to begin reading. It includes:

  • Indications and usage
  • Dosage and administration
  • Dosage forms and strengths
  • Contraindications
  • Warnings and Precautions
  • Adverse reactions
  • Drug interactions
  • Use in specific populations (this isn’t always listed in the highlights)

The full prescribing information follows. Here are some key things to know:

The indications and usage section lists the medical conditions the drug treats. Sometimes physicians will use a medication to treat a medical condition that the drug wasn’t approved for. This is called off-label use and it is legal although insurance will not always cover the drug’s expense.

Read the information about the dosage to be sure you are taking the medication properly. Your doctor may prescribe a different dose for you than is listed, and if so, confirm that you are on the dose she intended for you.

The contraindications section is really important to know. In contraindications, all the patients who should not take the drug are discussed.

In the warnings section, you’ll find the situations in which patients can take the drug but need to be closely monitored. If the PI has a black box in the beginning, this information will be repeated in the warnings section along with additional cautions. Again, if you think information in this section applies to you, talk to your health care provider before you start taking the drug.

Precautions come next. This is important because it gives more information about the safety of the drug. Advice to patients is in this section, such as if you need to drink lots of water or take medication with food. If your doctor needs to monitor your safety with periodic lab tests, this will be listed here.

Try to read the adverse reactions section. When you want to know the drug’s side effects, go to this section. The adverse reactions section may scare you but its bark is usually worse than its bite. This is where everything that is known to have happened is listed and informs patients about the drug’s risks. Look for the most common adverse reactions.

Keep an open mind and don’t be thrown by adverse reactions. If a research patient was irritable for one day that counts as an adverse event. Even if nearly everyone reported an adverse reaction does not mean that those reactions were constant or intolerable.

The drug interactions section is next, and is important to read. Listed here are the drugs that are known to interact with the drug you are considering. If you are taking a drug that is on the list, tell your provider.

The specific populations section is next. This addresses pregnancy, nursing mothers, pediatric use (infants and children), geriatric use (older adults) and if the drug works differently between genders. People with kidney or liver disease may find information here.

The rest of the PI supplies information about overdose and clinical information. You will also find clinical study information here. This is the data that proves why the drug works. You can also ask your medical provider to summarize the parts that apply to you.

Taking a new medication can be both frightening and exciting. Fear can be reduced when sound judgment is applied to solid information.  It takes practice, but if you read the PI every time you are prescribed a medication, you will be a pro in no time.

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The Gift of Life

The Gift of Life

It’s National Donate Life Month, and a time to increase awareness about organ and tissue donation. I am using this opportunity to implore readers to be organ donors.

It’s personal for me. In 2010, my stepson gave the ultimate gift of one of his kidneys to his brother’s wife. Although related by marriage to the person he was donating to, they weren’t especially close. However, he watched as my daughter-in-law (and new mom) struggled with dialysis. My stepson and father of two, was moved to help.

Donating upon death is an easy process. You register your wishes, and tell those close to you that you want to donate. It’s painless, because you are dead.

However, it’s a big deal to donate an organ when you are alive. The surgery is usually harder on the donor than on the recipient. The recovery is lengthy. There can be a significant loss of income. The family is affected, especially if they’ve never seen their healthy loved on in a hospital.  My stepson sucked up arthritic pain for a year prior to the transplant, daring not to risk kidney damage with over-the-counter pain relievers.

Afterwards, you are given a hero’s welcome, but most live donors that I’ve known, including my stepson, are humble people. They don’t want to be heroes; they just want to do the right thing. And so, my stepson quietly healed.

My daughter-in-law lost the kidney last year. It was the second donated kidney that failed, having received a kidney from her mother in 2004. That one lasted until the birth of our grandson in 2008. I am not doing her story justice, so if you are curious, you can read more about Lizz here: More Than Thursdays. She is a fantastic blogger, and just about anyone will find something interesting on her blog. Plus you can see photos of my adorable grandson.

Back to organ donation. According to the Organ Procurement and Transplant Network (OPTN), there are more than 115,000 patients on the transplant waiting list. As of this week, slightly more than 5400 transplants have occurred, using organs from 2666 donors.  To put it another way, for every 50 people who need organs, there is roughly one donor or two organs.

Live organ donation is most commonly done using a kidney, a part of a liver, and bone marrow. Lung, pancreas and intestine transplant using live organs are possible, but rarely done. The first live organ donation occurred in 1954.

There are risks for living donors, such as:

  • Anesthesia risks.
  • Surgical complications such as blood loss, blood clots, infection, pain.
  • Death.

Even the medical evaluation involves some risks. There are the usual risks associated with the procedure; the same is true for blood draws for laboratory testing and other diagnostic procedures. Potential donors may have an allergic reaction to some of the dyes used during abdominal imaging studies. There is the risk that another disease will be uncovered, although if something is detected early because of the evaluation, this could be beneficial to the potential donor. If the disease is something infectious that must be reported to the local health agency, this may bring unexpected consequences.

Another risk is that tests may uncover family secrets. An adult child may discover that the father he wanted to donate an organ to is not his biological parent. This can lead to a cascade of events beyond what anyone could predict.

There may be financial risks or hardship to the donor. In some cases, life insurance or long-term care policies may be denied or canceled, so this needs to be checked out prior to donation. If donation presents a financial hardship for the donor, there are funds for those who qualify. For more information, see the link at the end of this article for National Living Donor Assistance.

If you or someone you know is considering living organ donation, spend time research the various transplant programs. Even transplant centers that have experienced a death of one of the donors may still be a good choice if they have performed many of these procedures. Transplant centers keep records of their success rates and you have the right to this information.

Being a living donor is not for everyone. However, I hope everyone considers being a donor upon death. There are more than 115,000 people waiting to live a healthier life.

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 Healing With Humor

Humor is powerful medicine. In observance of April Fool’s Day this Sunday, I am focusing on the lighthearted side of medicine. The following quotes were taken from actual medical records dictated by physicians. These are from a column written by Richard Lederer, Ph.D. for the Journal of Court Reporting and have been reprinted on several web sites and magazines.

  • Patient has left his white blood cells at another hospital.
  • The patient’s past medical history has been remarkably insignificant with only a 40-pound weight gain in the past three days.
  • She slipped on the ice and apparently her legs went in separate directions in early December.
  • The patient had waffles for breakfast and anorexia for lunch.
  • The patient has no past history of suicides.
  • Between you and me, we ought to be able to get this lady pregnant.
  • The patient was in his usual state of good health until his airplane ran out of gas and crashed.
  • Since she can’t get pregnant with her husband, I thought you would like to work her up.
  • She is numb from her toes down.
  • While in the ER, she was examined, X-rated and sent home.
  • The skin was moist and dry.
  • Occasional, constant, infrequent headaches.
  • Coming from Detroit, this man has no children.
  • Patient was alert and unresponsive.

Note: Stay healthy so you don’t end up in the hands of a physician who writes these types of medical notes.

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The Healing Power of Nature

In every walk with nature, one receives far more than one seeks. ~ John Muir

Although it is still cold here, spring is clearly present.

Although it is still cold here in the Sierra foothills, spring is here. There is a lot going on in my life, and if I look for beauty, my load seems lighter. Nature provides endless solace.

Nature is a strong force and a powerful source of healing. Have you ever been having, “one of those days” where everything is going wrong? Then you happened to step outside, and were dazzled by billowy clouds or the scent of flowers bursting all around you? These moments seem to create a momentary respite from what ails us.

People in Japan are encouraged to walk in the woods in forest therapy centers, participating in shinrin-yoku, or forest bathing. Japanese researchers studied the health benefits of spending time in nature, and found clear benefits to those who walked in the woods compared to urban walkers. Nature walkers had lower stress hormones, blood pressure and heart rates; they also had increased immune chemicals.

Today, instead of thinking about whatever weighs on you, immerse yourself in nature.  If you can’t go forest bathing, stroll in a place of natural beauty, such as a park, garden, or near water. Appreciate nature’s beauty and feel nature’s healing power.

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Nature is my go-to place when I am stressed.

All of us have stress. Life is an unpredictable string of events, and sometimes it feels like a circus juggling act. Lily Tomlin said, “Reality is the leading cause of stress for those in touch with it.”

Stress is any physical, chemical, or emotional factor that places tension on the body, mind or spirit.  This tension may disrupt the balance of health and the body’s ability to maintain wellness. Common stressors are work, family, illness, money and world events. Sometimes we are so overwhelmed that everything becomes a source of stress. From traffic to a dispute over a bill, everything can tip us over when there is too much of it.

Not all stress is harmful. Eustress is a positive form. Moderate exercise is a good example of eustress. Marriage, birth of a child or job promotions are other examples. However, these same factors may lead to harmful stress or distress.  For instance, the birth of a baby may bring joy, but it may also bring less sleep and the disruption of lives.  This type of stress is unlikely to cause health problems if coped with adequately.

The body is designed to respond to stress. If under pressure to finish a work-related project, then your body may help you by producing stress chemicals to keep you alert and active. If you have to take a test, your body will provide a little boost that may help you to do well on the exam. We want this stress response.

Stress becomes a potential problem when it is ongoing or intense. If you are constantly under deadlines or have too much to handle, your body is not going to be happy. If multiple stress factors visit you all at once, this may be distressful. It’s up to you to learn how to manage it.

Research shows that stress interacts with the immune system. Eustress may boost immunity while distress may reduce it. Chronic stress may cause immune cells to age prematurely.  In its early stages, stress may cause stomach problems, headaches, weight gain or loss, insomnia and other conditions. Chronic stress may contribute to more serious conditions, such as high blood pressure, heart disease or substance abuse.

For me, managing stress is an integral part of managing my health. I prefer to avoid stress whenever possible. I do not like the way stress feels. I like feeling calm. Realistically speaking, stress is a part of life. So in order to stay calm, I need stress management tools.

Recognizing the effects of stress is an important part of stress management.  In its early stages, it is common to feel irritable, anxious or angry. Muscles may feel tight, particularly the jaw, neck, and shoulders. It is easy to get upset at the slightest provocation and have sleeping problems. Headaches and stomach problems are more frequent. Heart rate and blood pressure may increase. Smoking, drinking or excessive eating may occur with stress. (Some people are unable to eat when they are stressed.  In short, one feels overwhelmed and tense.

If the effects of stress are severe, you may need professional help. If you have thoughts of suicide or hurting yourself or others, seek immediate professional help. If you have chest pain or any symptoms of a stroke or heart attack, call 911. Do not drive yourself to the emergency room.

Fortunately, most of us never have to face severe consequences of stress. Ours is more garden-variety. However, don’t let this fool you. Even mild stress may have long-term harmful effects if it is a constant companion. Imagine holding a one-pound rock at arm’s length. Then imagine holding the same rock at arm’s length for days, weeks or months. It would be very painful and damaging. This is much like the effects of chronic stress.

Learning how to manage stress is the best way to avoid these potentially harmful effects. My go to stress tool is self-care. When life is throwing too many things my way, I take time out for a nap, entertainment, distraction, or to putter.  I may not be able to take charge of the events in my life, but I am in charge of my response.

The following are some stress management tips. Note: If you do not think you can spare the time to try any of these activities, consider this – you may be more efficient if you manage stress. Learning stress management skills is time well spent.  Besides, can you risk getting a stress-related illness?

  • Do not aggravate stress by turning to smoking, overeating, skipping meals, drinking, or drug use that isn’t prescribed by your health care provider.
  • Find a physical outlet. Try walking, running, dancing, biking, golfing, swimming, gardening, playing with kids, or yoga. Do this for at least 15 minutes daily. Even better, do this twice a day or increase your activity to 30 or 45 minutes.
  • Maintain good nutrition. Try to eat a low fat, high fiber diet. If you are short on time, fast food restaurants now offer healthy alternatives to the usual fried fare.
  • Find ways to relax and turn your mind off. Spend time with friends and family. Go to the movies, play some music, watch a sporting event, play cards, read a magazine, take a hot bath, go to a favorite restaurant, get a massage, light a candle, do a crossword puzzle, read the comics.
  • Attend a stress-management class. Some employers, health care plans, health insurance and adult education services offer stress management classes.
  • Talk about it. Sometimes others can see ways to improve our situation.
  • Put a positive spin on things. Don’t turn little things into big things. Try saying to yourself, “This too shall pass.”
  • Help others. Sometimes the best way to get out of our head is to help someone else.
  • Let others help you. Perhaps you can off-load some of your responsibilities.
  • Set limits. Remember that the word “no” is a complete sentence.
  • Take issues one task at a time, one minute at a time. Don’t overwhelm yourself by thinking about everything you have to do. Make a list and focus on what you can accomplish. Be realistic. Prioritize. Put your health at the top of the list.
  • Prune your “to do” list. My favorite way to shrink my “to do” list is to cross something off without doing it. This is very liberating.
  • Waiting in long lines can be uncomfortable when we are stressed. Prepare for this by bringing along a puzzle or something to read. Try finding the longest line rather than the shortest one. This can be surprisingly therapeutic.
  • Avoid others who increase our stress.
  • Practice acceptance. Let go of what is unchangeable.
  • Find ways to laugh. When we laugh, the body produces helpful stress hormones. “He who laughs, lasts.”

More Information about Stress:

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