Saturday, February 28, 2009

Whom to Report Adverse Drug Reactions?

Adverse Drug Reaction (ADR) is defined as any unintended and undesired effect of a duly prescribed drug which occurs at a dose used in humans for prophylactic, therapeutic or diagnostic purposes. All drugs taken externally or internally produce some undesirable effects along with their beneficial effects. Adverse events that occur as a result of drug use may range from local reaction, respiratory distress, renal lesions/damage or liver function impairment to serious life threatening condition. The liver and kidney are the organs which bear the brunt of majority of adverse drug reactions (ADRs) as these are associated with the drug metabolism and clearing from the body. The nature of the beneficial effects of a drug is predictable, but the nature of adverse reaction could be predictable to some extent otherwise unpredictable. The term drug here means any substance or product used to modify or explore physiological system and pathological states for the benefit of the patient/recipient. The health products considered to be drugs include vaccines, food supplements, blood and blood products, herbals, traditional or complementary medicines, pace maker devices and implants. Mismatched blood would cause transfusion reaction with life threatening implications. Blood products like platelet rich plasma (PRP) which is normally infused in patients suffering from Dengue virus infection may lead to the development of antibodies against human leukocyte antigens (HLAs) as platelets carry Major Histocompatibilty Complex, class-I (MHC class-I) antigens i.e. HLA-A, HLA-B, & HLA-C antigens at their surface and these antibodies may lead to lyses of platelets and thrombocytopenia (decreased platelet count) at a later stage.

How and Whom to Report ADR?

Independent reporting can be undertaken by any one who is prescribing a drug, administering a drug or consuming a duly prescribed drug. This type of reporting is called Reporting or Spontaneous Reporting. One should be ready with the following information while reporting ADR: Patient"s short name, age, sex, height, weight, trade name of drug, manufacturer, date of manufacture, date of expiry, mode of administration, type of reaction, duration of administration, route of use, date of reaction, date of recovery and associated medication etc. Adverse Drug Reaction should be reported to the Pharmacovigilance Center. There are National, Zonal, Regional and Peripheral Pharmacovigilance Centers in all the countries. The matter can also be reported to the Drug Controller General of the Country or reported directly to the United States FDA. For reporting the ADR or adverse events to the International Regulatory Authority like US FDA one can use online reporting facility at the website http://www.fda.gov/medwatch/ . Go to the FDA-Medwatch website and visit the link-Medical Product Reporting for reporting adverse drug reaction or adverse events.

Important: Regulatory approval to market drug is usually based on the results of controlled clinical trials, as such, these short term studies in a specific population may not be sufficient to explore the ill effects of a particular drug. The ADR monitoring begins with the earliest administration of a drug to man and continues throughout, as long as a drug is on prescription list of clinicians. Long term surveillance studies are also being undertaken to evaluate effectiveness and safety of a drug in various subpopulations such as, children, elderly patients and patients with associated ailments like impaired liver function, kidney disease and diabetes. In order to highlight the ADR events, the pharmacovigilance is important. The ADR events include the events due to non-compliance, drug interactions with co-administered drugs and drug over dosages and adverse effect of the drug per se. As per the data available to-date, about 6% of Emergency visits are related to ADRs and about 0.1% of these could be life threatening.

Can we prevent Adverse Drug Reactions?

Yes, a lot of these ADRs are preventable, most probably those resulting from mere ignorance of route of administration or non-compliance. There are ADR cases wherein patients have swallowed the tablets prescribed for intra vaginal infection.

Thursday, February 26, 2009

Neurostimulators or Fashion drugs: Worrisome Scenario

The neurostimulator materials have been known to mankind in the one form or the other, from the time immemorial. The alcohol in the form of wine has been known for ages. Now, synthetic chemicals are the core source of majority of drugs for various ailments. The stimulatory action of most of the drugs is being exploited by many to earn a quick buck. The scenario is worrisome the world over. The diversion of pharmaceutical products like ephedrine, pseudoephedrine and morphine for the production of amphetamine type stimulants (ATS)is a matter of grave concern and should be checked effectively by the governments of various countries. Pharmaceutical preparations like pethidine, codeine-based cough syrups, ephedrine and pseudoephedrine should be sold on the production of valid prescription only to avoid misuse as neurostimulators or fashion drugs. The Internet Pharmacies should be issued strict guidelines on narcotics. The manufacture of synthetic drugs like methamphetamine should be done in the government owned drug houses only. It is our duty to educate our siblings, children, students and friends, about the health hazards of narcotics. Effective policing and administrative measures at the National and International Level are the needs of the hour to check the smuggling of traditional narcotics like heroin. Avoid experimentation with fashion drugs for health and longevity.

Hazards of Over Compliance of Drugs

There are substantial health benefits to the patients if the drug compliance by them is 100 percent. The good communication skills of the attending physician could be helpful to overcome the chances of over compliance by a considerable number of patients. Patients need to be briefed about the side effects of over doses as well as the extra doses of the drugs prescribed to them. The intake of over doses or extra doses of any prescribed drug is called over compliance. Inspite of best efforts by the prescribing doctors, about 20% patients may even take more drugs than the prescribed dose to get cured quickly and earlier, but this can be harmful and lead to serious toxicity or a variety of side effects.


Just remember, all drugs are poisonous chemicals and if taken in excess these may affect our health in many wrong ways. Even an indicative dose of an anti-allergic causes drowsiness and if taken in excess it may lead to impairment of judgment while driving. Take an example of common salt, excessive intake of it may induce vomiting and raise the blood pressure. Over use of antibiotics may disturb the normal flora of our intestine and suppress the blood formation in the bone marrow. Over compliance of steroids is known for suppressing the immune system of our body. An over dose of insulin may lead to serious hypoglycemia (low level of glucose in blood) in a diabetic patient. Overuse of some drugs may lead to serious health hazards including organ failure. Be wise and never take over dose of any drug.

Tuesday, February 24, 2009

Steps to Improve the Drug Compliance

The doctor prescribing the treatment could play a vital role to instill confidence in the patient for proper drug compliance as well as improving it. Sharing of knowledge about the disease and drugs could motivate the patient for timely intake of drugs. The patient and his /her family members should be explained the schedule of the treatment regimen. The following tips could be beneficial for improving the drug compliance:


  1. Educate the patient about the dosage, timings and mode of administration of a drug.

  2. Un-necessary investigations should be avoided during the course of treatment.

  3. Written material or audiovisual aids about the drug information should be made available to the patient for proper compliance.

  4. The physician/surgeon should be extra generous to the elderly patients.

  5. The treatment related cost-benefit issues should be discussed with the patient or his/her family members.

  6. The patient should be encouraged to maintain a periodic record of his/her weight, diet, blood pressure and blood sugar level if so required.

  7. The doctor should write prescriptions legibly to avoid any mistaken dispensing.

  8. The doctor should prescribe rationally and accurately to win the faith of his/her patient.

  9. The importance and consequences of a missed dose should be explained to the patient.

Ten Causes of Poor Drug Compliance

There could be following reasons for the poor drug compliance:


  1. Deliberate intention with a sense of suspicion about the side effects of the drugs.

  2. Lack of understanding about the disease and associated complications if treatment is disrupted.

  3. Over busy schedule of daily engagements at the place of work.

  4. High and unaffordable cost of medicines.

  5. Forgetfulness leading to unintentional missed doses.

  6. High cost of investigations required for monitoring of the effects and side effects of a treatment regimen.

  7. Longer schedule or life time medication may become boring for the patient, leading to poor drug compliance.

  8. Lack of motivation in case of patients suffering from chronic diseases and psychological disorders.

  9. Lack of cooperation from the family members.

  10. Cumbersome drug intake schedule when multiple drugs are prescribed to the patients with multiple health ailments.

Sunday, February 22, 2009

Drug Compliance

The health ailments are as old as mankind. The food articles, herbs and roots of some plants had been used as drugs for thousands of years and there existed a schedule for patients' compliance. The drug compliance refers to the willingness of a patient to follow the health related advice to take drugs/medicines as advised prescribed and to attend the follow up appointments. The drug compliance is must for the assessment of the effect of a treatment. The failure of a treatment may depend on the failure of a drug/medicine itself or due to poor compliance.

The problem is more prevalent in well educated people as compared to least educated class. Patients' commitment to drug compliance is a major health issue with outcomes restricted to the status of drug resistance, failure of a treatment, morbidity and mortality. The patients' adherence to treatment schedule or drug compliance is must for better health outcomes.