Have I Lost My Abilities? My Pharmacist Votes Yes.

I read a story in the Toronto Star last week about the parents of a teenage girl who died after taking a drug called Diane-35 for acne. They are suing the drugstore that dispensed the prescription for failing to warn her and them about the dangerous side effects of taking it and for not mentioning that use should be limited to 3 to 4 months maximum.

The story in The Star, by Diana Zomislic, quotes a senior pharmacist for the company that supplies the HealthWatch information given out with each new prescription to Shoppers Drug Mart customers. He said that they restrict the number of side effects they mention on the newer info sheets to six because they don't want to frighten the customers. 

They made this change for the worse in 2004 and I complained to the pharmacist about the drug information sheet at the time. As a demonstration of how big the change is I will show you what the cautions and side effects were for the rheumatology drug called Arava (leflunomide) in April 2004 compared to the new style warning that I received in June of 2004. 

Here's the original old style information sheet. Note all of the words (620) and the caps to let you know what is crucial.

BRAND NAME: ARAVA 20MG
GENERIC NAME: LEFLUNOMIDE (le-FLUN-o-mide)

DATE: 04/04/14                                                            DIN: 02241889 

                    

COMMON USES: This medicine is a pyrimidine synthesis inhibitor used to treat rheumatoid arthritis.

BEFORE USING THIS MEDICINE: WARNING: Pregnancy must be excluded before the start of treatment with leflunomide. This drug must not be used during pregnancy, nor by women of childbearing age who are not using reliable birth control (contraception). Unless female leflunomide users go through a certain process to eliminate this drug from their body, pregnancy must be avoided for 2 years after this drug has been stopped. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of blood, bone marrow, or immune system disorders. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. STORE THIS MEDICINE at room temperature below 77 degrees F (25 degrees C) in a tightly-closed container, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.

CAUTIONS: DO NOT STOP USING THIS MEDICINE without first checking with your doctor. It may take 4 weeks or more to notice any improvement while taking this medicine. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. THIS MEDICINE MAY LOWER YOUR RESISTANCE TO INFECTION. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. CHECK WITH YOUR DOCTOR BEFORE HAVING IMMUNIZATIONS (VACCINATIONS) for up to 2 years after stopping this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. 

FOR WOMEN:THIS MEDICINE CAN CAUSE SEVERE BIRTH DEFECTS. DO NOT USE THIS MEDICINE if you are pregnant. You must have a negative pregnancy test before starting this medicine. Use a reliable form of birth control while taking this medicine and for 2 years after stopping this medicine. IF YOU SUSPECT THAT YOU COULD BE PREGNANT or if your period is late, contact your doctor immediately. If you plan to become pregnant within 2 years of stopping this medicine, you may need to follow drug elimination procedures. Ask your doctor, nurse, or pharmacist for more information about these procedures. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include diarrhea or hair loss. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience a skin rash, headache, flushing, blurred vision, sudden onset of sweating, pale skin, yellowing of skin or eyes, dark urine or pale stools, unusual fatigue, or loss of consciousness. If signs of infection, anemia, or easy bruising or bleeding develop, this medicine may need to be stopped. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. KEEP THIS PRODUCT out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

And here is the new one in the current style. Half the words and half the side-effects.

ARAVA   LEFLUNOMIDE 20MG    HealthWATCH-
Date: 2004-06-05 Tx: 10479202 DIN: 02241889

Common uses

This medication is typically used to control rheumatoid arthritis. It requires a few weeks to take effect.

How to use this medication

This medication is typically used only once a dav, However, your doctor or pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects.

This medication may be taken with or without food. It is recommended to drink plenty of water while using this medication.

Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up.

As with most medications, this product should be stored at room temperature. Store it in a secure location where it will not be exposed to excessive heat, moisture or direct sunlight. Keep it out

of reach of young children.

Possible side effects

In addition to its desired action, this medication may cause some side effects, 

 notably: - it may cause hair loss;

--         - - it may cause headaches;

- it may cause diarrhea;

- it may cause spots or redness of the skin;

- it may cause dizziness -- use caution when getting up from a lying or sitting position;

- it may cause nausea or, rarely, vomiting.

Each person may react differently to a treatment. If you think this medication may be causing side effects (including those described here, or others), talk to your doctor or pharmacist.

Additional information

A treatment with this medication requires regular monitoring by a doctor. Be sure to see your doctor for all regularly scheduled appointments.

It sounds a lot better in the second version, doesn't it? It also looks better. I appreciate that health literacy is a problem but the original version, though longer, is quite easy to follow.  The new style is so lacking that I questioned whether this was actually the drug info form when it was given to me.

When I compared these two back when the change was made I was indignant that the pharmacy had decided for me that 'dumbing it down' was necessary and I complained about the missing side effects which could occur to anyone. I'd rather be alive and afraid than happy and dead.

Now that I see a case where better information might have helped a particular patient I wonder if Shoppers Drug Mart will make a change.  It sounds unlikely.

There was an another occasion where I went to my doctor and I got a new prescription that changed one of my long time medications for a similar one at my request and for health reasons. The pharmacy thought the doctor must have made an error and phoned and got it changed. When I picked it up I was dismayed thinking that they had filled the wrong prescription. It upset me that they had interfered between me and my doctor without my consent or knowledge.

Another thing that is distressing to me as a patient is the continual change from one brand of generic drug to another generic based on what is good for the company. 

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