Health is the wealth of wealth..

"To get rich never risk your health. For it is the truth that health is the wealth of wealth."

~Richard Baker

Drug Side Effects and Adverse Drug Reactions

Side Effects:

Side effects refer to reactions to a drug that are frequently experienced and expected. Some side effects may gradually subside. But some side effects may persist that may require the adjustment of drug dosage (dose reduction) or drug frequency. Consult your doctor or pharmacist first.

If the medicine makes you drowsy, do not drive or operate machinery or dangerous equipment.

Adverse Drug Reaction (ADR):

Adverse Drug Reaction refers to any unexpected or noxious reaction to a drug. An unwanted effect caused by the administration of a normal dose of drug. The onset of the adverse reaction may be sudden or develop over time.

There are few factors that may affect your body reactions towards certain drugs include:

• Age-eg. Elderly and pediatrics tends to experience more adverse drug reactions.
• Genetics-Genetic factors may cause abnormal pharmacokinetic. (eg drug metabolism).
• Medical conditions-Various diseases, especially those that cause kidney or liver insufficiency, may alter pharmacokinetic of a drug.
• Organ functions-Impaired organ functions may alter pharmacokinetic of a drug.
• Body weight.
• Synergistic effects either between a drug and a disease or two/more drugs (polypharmacy).

The adverse drug reaction can either be mild or even serious when the patient outcome is one of these:

• Hospitalization (initial or prolonged)
• Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
• Congenital Anomaly
• Requires Intervention to Prevent Permanent Impairment or Damage
• Life-Threatening
• Death

Many countries have official bodies that monitor drug safety and reactions. Internationally, 

• the WHO runs the Uppsala Monitoring Centre, 
• the European Union runs the European Medicines Agency (EMEA),
• the United States, the Food and Drug Administration (FDA) is responsible for monitoring post-marketing studies.

Tips on safety medication:

• Find out the name of your medication. Ask your doctor or pharmacist for further information about the medicine that you are taking. You must understand carefully on what your medication is for and how to administer your medication.
• Keep with you at all times a list of medicines  including health supplements and complementary medicines that you are taking. Share a copy of the medication list with a family member so that in an emergency, that person will be able to inform your doctors of your medications.
• Keep all your doctors and pharmacist informed about your medications and dietary supplements (including vitamins and herbals).
• Inform your doctor or pharmacist if you are allergic to any medicine.
• Read the medicine label carefully. Pay special attention to the warnings and precautions. 
• Take the medicine as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. 
• Do not share your medications with others.
• If adverse drug event occurs, see your doctor immediately. Bring the medication and medication list for adverse drug event verification and reporting.

Drug labels

It is vital to follow the doctor's or the pharmacist's instruction when taking medication. Refer to the instructions on the medicine label. When in doubt, consult your doctor or pharmacist.

Labels for the medicine's immediate containers, blisters, outer cartons (if any) or dispensing labels should follow each country's medicine labeling requirements or guidance. Refer to each country specific labeling requirements.

In Malaysia, normally, these should be present on the medicine's outer carton (if any):

• Product Name
• Dosage Form
• Name of active ingredient(s)
• Strength of active ingredient(s)
• Batch No
• Expiration Date
• Route of Administration
• Storage Condition
• Country's Registration No
• Name and Address of Marketing Authorization (Product Licence) Holder
• Name and Address of Manufacturer
• Warnings (if applicable)
• Pack Sizes
• Name and Content of Preservative(s) (if any)
• Name and Content of Alcohol (if any)
• Source of ingredient derived from animal origin , including gelatin (active, excipient and/or capsule shell)
• Recommended Daily Allowance (RDA) for vitamins, multivitamins and mineral preparations used as dietary supplements.
• The words `Keep medicine out of reach of children'
• Other country specific labeling requirements (if applicable). Examples are the word `Controlled Medicine' for controlled medicine only, the word `For External Use Only' for external use medicine and hologram tag.

 Meanwhile, the dispensing labels shall contain:

• Name and Address of the supplier/seller (clinic or pharmacy)
• The patient's name
• Date of medicine supplied/sold
• Reference no (especially for the prescription drugs entry)
• Full name of the medicine (Not just the drug's usage!!)
• Strength of the medicine
• Adequate directions for the use of the medicine.
• The word `Controlled Medicine' for the controlled medicine only.

Drug dosage, Frequency and Duration of Treatment

Drug Dosage

The maximum effect of the drug treatment is important. However practically the maximum effect is usually unattainable because at the maximum therapeutic doses, unwanted side effects from the drug could occur. Therefore, the dosage of the drug recommended is usually a compromise of what is the best level of therapeutic effect and free from any side effects. 

The dosage of drugs prescribed varies according to the individual it has been intended for (such as infants, children, adults and elderly). Additionally, different people may react differently to the same drug. Therefore, DO NOT give your drug to others or take other person's medication even if you experience similar symptoms. If you are pregnant, breast feeding, or suffering from any illness such as liver, kidney or heart failure, you must consult your doctor first before taking any medication.

Drug Frequencies

For some drugs, the timing of their doses depends on how long their effects last. The frequencies may differ as follows:

• Once daily (od)-The drug is best to be administered 24 hourly.
• Twice daily (bd)-The drug is best to be administered 12 hourly.
• Three times daily (tds)-The drug is best to be administered 8 hourly.
• Four times daily (qid)-The drug is best to be administered 6 hourly.
• Five times daily-The drug is best to be administered 4 hourly but omitting the night dose.

Drugs are also best taken at the same time each day. However, not all medications need to be taken at evenly spaced doses.

Q: What should I do if I miss a dose?

A: Missing a dose may cause a reduction of the drug amount in your body and hence reduce their effects. A pill reminder box or medication chart may be helpful in reminding you to consume the medication. If you miss a dose, consult your doctor or pharmacist. However, if you frequently miss the drug doses you should discuss it with your doctor.

Duration of the treatment

The duration of treatment that the doctor prescribes should be strictly followed unless you develop an allergic reaction to the medication, in which case you should consult your doctor first. If you are not sure or do not know about why you should continue taking the drug as prescribed, ask your doctor. 

Stopping the treatment unnecessarily without your doctor's advice may cause a recurrence or aggravation of the illness. For example, if the doctor prescribes a drug to be taken three times daily for 7 days, most people tend to stop taking the drug when they start to feel better or the symptoms disappear, for example after 3 days. In the case of antibiotics, stopping abruptly and prematurely will provide the opportunity for microorganisms to survive. Eventually, the microorganisms will develop resistance to the drug. 

You should visit your doctor for follow ups, periodic medical check-ups or drug monitoring if you are on long term drug treatments. 

Drug dosage adjustments or drug substitution may be required for some patients.

Dosage Forms and Drug Administration

Drugs are available in many different forms including tablets, capsules, soft gels, liquids (eg. solutions, drops, syrups, suspensions, lotions), sprays, inhalations (eg inhalers), powders, ointments, creams, suppositories, pessaries, transdermal patches, implants and injections.

There are also many ways the drug can be injected including intravenous injection, intravenous infusion, intramuscular injection, subcutaneous injection and others.

Additionally, not all the tablets are to be swallowed whole because they come in different forms.

 There are few types of tablets. Some are:

• Sublingual tablets. The tablets must be put under the tongue. They must not be swallowed. The drug will be dissolved and then absorbed into your blood stream via the blood vessels under the tongue.
• Buccal tablets. The tablets are put in between your cheek and teeth. They also must not be swallowed. The drug is absorbed into your blood stream via your blood vessels under your cheek.
• Effervescent tablets. The tablet must be dissolved into a glass of water before use. They are used to give a faster effects.
• Chewable tablets. The tablets need to be chewed to be effective and to give faster effects.
• Enteric coated tablets. The examples are sugar coated or film coated tablet. They must be swallowed whole with water and cannot be chewed. Active ingredients are released only after the drug has passed through the stomach. Usually they contain drugs that are easily destroyed by the stomach acid.
• Slow release tablets or controlled release tablets. The tablets are designed so that the active ingredients are released slowly over a prolonged period of time. They must be swallowed whole with water and cannot be chewed or crushed.

It is advisable to take your capsules or tablets in an upright position and take them with water.

Absorption of certain oral drugs may be affected by food therefore they need to be taken on an empty stomach (usually 1 hour before meal or 2 hours after meal).

However, some oral drugs should be taken after meal. If the drugs are taken on empty stomach or before meal, they can be rendered ineffective by gastric juices, or they may affect the lining of the stomach if taken before meal.


Alcohol and certain foods should not be taken simultaneously with certain drugs. Separate the intake at least 2 hours before or after taking the medication. If in doubt , consult your pharmacist.

Drugs or Medicines

Ever since the dawn of medical practice, drugs have been obtained from many natural sources including plants, animals and minerals. Now, however, tremendous advances in science and technology have resulted in the development of an immense range of new drugs and new formulation. These drugs are manufactured synthetically using a variety of chemicals or by newer techniques.

A drug is a chemical substance used to treat, cure, prevent, or diagnose disease, alleviate  symptoms or used to otherwise enhance physical or mental well-being.  A drug can also be used to correct deficiencies.

 There are 3 types of drug names:

1. Chemical name-technical, descriptive name
2. Generic name-a shorter, official medical name for the basic active ingredient.
3. Brand name-a name given by the drug's manufacturer.

Drug classification:

Drugs are classified according to:

• Chemical similarity-such as corticosteroids
• Their therapeutic use-such as antidiarrhoeals
• Their effects on the body-such as diuretics

Dispensing of medication is often regulated by governments into 3 categories:

1. Over-the-counter (OTC) medication-medications that you can buy without restrictions in pharmacies, shops or supermarkets/hypermarkets.
2. Behind-the-counter (BTC) or Pharmacy (P) medicines which can only be sold in registered pharmacies by pharmacist or under the supervision of a pharmacist. This medicine can be sold without needing a doctor's prescription. The range of medicines available without prescription varies from country to country.
3. Prescription only medicines (POM) must be prescribed by a registered medical professional.

BTC/P or POM medicines are categorized as Controlled Medicines.

Medications are typically produced by pharmaceutical companies and are often patented to give the developer exclusive rights to produce them. Generic drugs are the drugs that are not patented (or with expired patents) and they can be produced by other companies without restrictions or licenses from the patent holder.

Rights of medication administration

5 traditional rights of medication administration:

1. Right Patient

2. Right Drug

3. Right Dose

4. Right Route

5. Right Time

 

1. Right Patient

For health care providers:

Properly identify the patient. The medication should be prescribed and administered to the right patient.

• Verify the patient's full name (the first name and surname), ID, Registration No, Room No (Inpatient)
• Verify name with patient.
• Make sure the right patient's name written on the medication labels.

Before giving medication, patient should be assessed. (for eg. Blood Pressure? Pulse Rate? Fever? Difficulty in  swallowing food or liquid? Nausea? Pain? etc...)

For patients:

• Make sure the right patient's name stated on the medication labels.
• Medicine should not be shared with others.
  
• Medicine should be stored out of reach of children or pets.
  

2. Right Medication

 

For health care providers:

• Medication must be prescribed by the registered practitioner.
• Check whether right medication is given and administered to the right patient. 
• Prior to the drug administration: Diagnosis and investigation results should be referred to.  Contraindication and Precautions in certain patient group should be considered. Drug and Food interactions should also be looked into. Risk against benefit should be properly weighed.
• The medicine's name, strength and dosage form should be written on the prescription and medicine's container/label. 

For patients:

• Know the name (generic and/or brand) of all the medicines prescribed to you. Not identify the medicine by just its colour or shape or purpose! It's best to have and keep the patient medication record card  (if  any) with you.
• Know what medicine are used for and know the expected side effects after taking the medicine.
• If getting a new or unfamiliar medicine, verify with the doctor or pharmacist.
• When prescription is refilled, if the medicine does not look the same as previous, ask the pharmacist if it is a different brand.
• Check the medicine name, strength and dosage form on the medicine's label/container. Make sure the right medicine is dispensed to you.
• Read the instruction on the label and leaflet carefully before administering the medicine.  If necessary, put on your eyeglasses and turn on the lights to read the label. If you don't understand the instruction, consult with your doctor or pharmacist.
• Check the ingredient list of the medicine/supplements (if any) if you are allergy to any of the ingredient. Inform your doctor immediately if you have any allergy or adverse drug reaction to any of the medication.

3. Right Dose

For health care providers:

• Right dose should be prescribed and administered for the right patient.
• Check, calculate accurately and give a right dose to patient especially for pediatric, geriatric, patient with certain illness such as liver failure, renal failure etc.
• Double checking must be done before and after administering the medicine to patient.
• If the drug is withhold or the dose is adjusted, do the notification.
• Prescription must comply with the related rules and regulations.
• A clear drug name, dosage, strength, frequency and duration of the treatment must be written on prescription.
• Explain to patient on the how to administer the drug, drug dosage, frequency and duration of treatment.

For patients: 

• Read the direction on the medicine label and leaflet carefully. If in doubt, contact your doctor or pharmacist. 

• Always follow the direction on the medicine label as prescribed by your doctor.
• For liquid, use the syringe/measuring cup/spoon  rather than the household spoon.

4. Right Route 

For health care providers: 

• Confirm the route of administration especially for the new drug. Always refer to the reliable drug information.
• Confirm the route, the dosage and also assess ability and suitability before administering medicine to patient.
• Use aseptic technique when administering the medicine to patient.
• Explain to patient on proper way to administer the medicine.

For patients:

• Read the medicine label and leaflet properly. If in doubt, consult your doctor or pharmacist.
• Know the proper way to administer the medicine.

5. Right Time

 For health care providers: 

• Must order and administer the medicine to patient at the right time.
• Explain to patient on the right drug administration time and duration of treatment.
• For oral, explain to patient whether to take the medicine with or without food and tell patient what to avoid when taking the medication.
  

For patients: 

• Follow properly the instruction on the medicine label or leaflet as prescribed by your doctor.
• Administer the medicine at the right time, same time each day.
• Know what to do if a dose is missed.
• Know if the medicine will interact with food/beverage or other medicines.

Another additional rights of medication administration:

6. Right Assessment

For health care providers:

• Patient should be assessed properly and accurately before administering the medicine to patient.
• Before administering the medication to patient, patient should be assessed properly. (for eg Blood pressure? Pulse Rate? Blood Sugar? Fever? Difficulty in swallowing food or liquid? Nausea? Pain? Pregnant? Breast Feeding? etc...)
• Assess for any risks of taking the medication or risks of medication withdrawal.
• The possible benefits against the possible risks must be weighed.

For patients: 

• Consult your doctor or pharmacist before administering any medicine.
• For hypertension, for eg. regularly check your blood pressure.
• For diabetic, for eg. regularly check your blood sugar.
• Immediately inform your doctor or pharmacist if you experience any adverse effects after taking a medicine.
• Inform your doctor if you have any other illnesses.
• Inform your doctor if you have any allergy to medication etc.
• Inform your doctor if you are pregnant or breast feeding.

7. Right Documentation

For health care providers:

• Immediately record appropriate info for eg dose, route, time and date of administration, initial and signature, any notification, amendment, any drug refusal/withdrawal/with hold.
• Use correct abbreviation and symbols.
• Record patient's response to the medication.
• Record in the right document for the right patient.
• The record must be right and accurate.
  

For patients: 

• If required by physician, for patient self monitoring, the record of eg blood pressure/blood sugar level, the dose and timing of the medication, must be recorded/kept in the right document.
• The results/records must be recorded accurately.
• If the patient needs to sign the informed consent, he/she must understand the contents and sign the consent form first before the medicine is administered to the patient.
  

8. Right to Patient Education 

For health care providers:

• Inform patient on the medication's name, its therapeutic purpose, side effects and adverse drug reactions,  precautions, diet restrictions/requirements, skill of medicine administration, route, dosage, frequency, duration of treatment etc.
• Inform patient if they need to do laboratory monitoring or other monitoring/investigation.
• Explain on the principle of informed consent.
• Explain the risks that the patient might encounter when refuse to administer the medication or withdraw from the treatment.
• Provide counseling and give patient information leaflet to patient.

For patients: 

• Patients have the rights to know on the medications they are taking. 
• They have the rights to know the medication name not just the medication purpose!
• The have the rights to know why they are taking the medicine, what are the effects that they should expect after taking the medication, what they should do when they experience the effects.
• They have the rights to know the best treatment available to them.
• The have to know whether and when they need to do the laboratory monitoring and other monitoring.
  

9. Right of Patient to Refuse

For health care providers:

• Explain to patients that they have rights to refuse the medication and explain the withdrawal procedure.
• Explain to patients the risks or what they might encounter by not having taking the medication or by withdrawing from the treatment. 
• Determine when possible the reason for refusal.
• Reinforce the reason for medication. 
• If the patients still refuse to administer the medication, proper documentation should be done and physician should be notified immediately.
• Assess for possible risks/threats to patients when the treatment is omitted.

For patients: 

• Patients have the rights to refuse to administer the medication without giving the reason for refusal.
• However, they must know the risks that they might encounter when not taking the medication.
• Must know the reason for medication.

10. Right Evaluation 

For health care providers:

• Must regularly evaluate and review patient's condition/response after administering the medication to patient.
• Check whether the medication gives positive or negative effects to the patient.
• Evaluate the laboratory monitoring and other monitoring results.
• Review medication/treatment.
• Evaluate the effectiveness of the drug regimen.
• Report any adverse drug reactions immediately.

 For patients:

• Inform doctor or pharmacist immediately if experience any unexpected adverse drug reactions.
• Consult the doctor or pharmacist if have any doubts.

11. Right expiration date

For health care providers:

• Check the expiration date of the medicine before administer or dispense the medicine.
• Do not give the expired medicine to patient.
• Inform the patient on the storage condition of the medicine.
• The expiry date must have on the medicine's label/container.

For patients:

• Check the expiration date of the medication before administering it.
• Store the medicine as directed.
• Do not administer the expired or damaged medicine.

12. Right to Reason

For health care providers:

•  Explain the reason why the patient has to administer the medication.
• If medication fails to be administered for some reason or the medication is omitted/refused for some reason, document/record when possible.
  

For patients:

• Patients have the rights to know the reason they are taking the medication.
• If possible, inform the health care providers the reason the medication omitted/failed to be administered.