Pharmacovigilance Definition, Introduction, and Quiz

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Questions and Answers

What is the main definition of pharmacovigilance?

The study of herbal medicine

The monitoring of drug-related problems (correct)

The administration of vaccines

The study of alternative medicine practices

Why is pharmacovigilance considered important in the medical field?

To reduce the availability of essential medicines

To promote the irrational use of drugs

To ensure patient safety and prevent adverse drug effects (correct)

To increase the cost of medications

What is the status of pharmacovigilance systems in low and middle income countries?

Some countries have no systems while others have systems comparable to industrialized countries (correct)

All countries have advanced systems

All countries have well-established systems

Only high-income countries have systems

Which organization has undertaken the initiative to produce a Pharmacovigilance Strategy for countries?

World Health Organisation (B) Signup and view all the answers

What is the purpose of identifying minimum requirements for pharmacovigilance?

To ensure a national PV system exists and provides medicine safety assurance (A) Signup and view all the answers

What does the minimum requirements document describe?

Minimum requirements for operating a national PV system (A) Signup and view all the answers

What is the main purpose of the USP/NF monographs mentioned in the text?

To ensure the quality of compounded preparations (B) Signup and view all the answers

The role of the national formulary does NOT include:

Providing drug information for veterinarians (D) Signup and view all the answers

What does the Essential Drug Programme emphasize in terms of drug management?

Ensuring quality drugs (A) Signup and view all the answers

Which category of medicines fall under Anti-Convulsants/Anti-Epileptics as mentioned in the text?

Carbamazepine and phenytoin (B) Signup and view all the answers

What is the purpose of Anti-allergic medicines as stated in the text?

To reduce allergies (B) Signup and view all the answers

What is the main objective of the WHO model formulary in national drug formulary as per the text?

To minimize therapeutic failure (A) Signup and view all the answers

What is the role of nurses in the implementation of the Essential Drug Programme?

Focusing on rationale drug selection (B) Signup and view all the answers

Which group of medicines is used to treat gout according to the text?

DMARDs (A) Signup and view all the answers

What is the important function of the Blood products and Plasma Substitutes mentioned in the text?

To treat anemia (B) Signup and view all the answers

What is the main focus of a national pharmacovigilance system?

To collect and manage adverse drug reaction reports (B) Signup and view all the answers

What is the purpose of a national pharmacovigilance system regarding medicine quality?

To identify quality problems in medicines resulting in adverse reactions (B) Signup and view all the answers

Which body contributed to the development of the minimum requirements document for national pharmacovigilance systems?

World Health Organization’s Advisory Committee on the Safety of Medicinal Products (A) Signup and view all the answers

What is one function of a national pharmacovigilance system?

Develop and maintain drug utilization information (A) Signup and view all the answers

What kind of committee should be present in a national pharmacovigilance system?

ADP or pharmacovigilance advisory committee (D) Signup and view all the answers

What is the purpose of a national spontaneous reporting system?

To provide a form for reporting adverse drug reactions (D) Signup and view all the answers

What is self-medication?

Medications selected and used by individuals to treat self-recognized conditions (B) Signup and view all the answers

Which entity should a national pharmacovigilance center collaborate with?

WHO Programme for International Drug Monitoring (A) Signup and view all the answers

What is a national pharmacovigilance center required to have?

At least one full-time designated staff member (A) Signup and view all the answers

Which function is NOT part of a national pharmacovigilance system?

Manufacturing all medicines in the country (B) Signup and view all the answers

What are the potential risks of self-medication practices?

Improper choice of therapy (B) Signup and view all the answers

Why is patient education important in the use of drugs?

To improve adherence and self-management of chronic diseases (A) Signup and view all the answers

What does non-compliance to medication in patients lead to?

Substantial worsening of diseases and death (B) Signup and view all the answers

What is the role of patient education according to the text?

Train patients in self-management of their chronic disease (D) Signup and view all the answers

What is a possible consequence of under-prescription in nursing homes?

Reduced immune response (D) Signup and view all the answers

Which type of adverse drug reaction is pharmacologically predicted and dose-related?

Type H (A) Signup and view all the answers

Why is counseling patients about the benefits and risks of a drug important?

To help inform decisions about starting or continuing treatment (D) Signup and view all the answers

What is the purpose of a national formulary?

To provide a list of approved medicines for prescription (C) Signup and view all the answers

What happens in over prescription of drugs?

Risk of coma or death (C) Signup and view all the answers

Why do some patients practice self-medication?

Lack of time or urge for self-care (B) Signup and view all the answers

Which type of adverse drug reaction depends on the interaction with microorganisms and is pharmacologically predictable?

Type B (C) Signup and view all the answers

What are the consequences of incorrect self-diagnosis in self-medication practices?

Substantial worsening of diseases (B) Signup and view all the answers

What can be a consequence of under-medicating a patient in terms of prescription?

Extreme pain (D) Signup and view all the answers

How does patient medication counseling help in drug use?

By helping patients understand their role in safe drug use (D) Signup and view all the answers

Which type of adverse drug reaction requires the activation of the immune system?

Type G (D) Signup and view all the answers

What is a possible consequence of multiple drug prescription (Poly pharmacy)?

Internal bleeding (D) Signup and view all the answers

What is a key aspect of compliance to medication according to the text?

Conformity to dosage and timing (A) Signup and view all the answers

Which classification of adverse effects is said to be the best according to the text?

Wills and Brown classification (B) Signup and view all the answers

What are withdrawal symptoms that can occur due to drug over prescription?

Nervous system hyperactivity and seizures (A) Signup and view all the answers

Which type of adverse drug reaction improves if the medicine is reintroduced?

Type E (C) Signup and view all the answers

What type of medicine is used for treating heart failure?

Medicines used in heart failure (A) Signup and view all the answers

Which medication is used as an anti-infective and anti-inflammatory agent for dermatological issues?

Crotamiton (C) Signup and view all the answers

Which medicine is used to treat psychotic disorders?

Prolinate (B) Signup and view all the answers

What is the purpose of disinfectants such as Sodium Hypochorite and Lysol?

Antiseptic use (B) Signup and view all the answers

Which category of medicines is used in the treatment of diarrhea?

Oral rehydration salts (ORS) (D) Signup and view all the answers

What are examples of anti-malarial medicines?

Mefloquine, Primaquine (B) Signup and view all the answers

What is the purpose of anti-leishmaniasis agents like Pentamidine isethionate?

Treatment of leishmaniasis (B) Signup and view all the answers

Which medicine would be useful in correcting water, electrolytes, and acid-base disturbances?

Parenteral Ringer lactate (C) Signup and view all the answers

In which category do medicines like Glucose, Glimipride, and Gliclazine fall?

Hormones (A) Signup and view all the answers

For what purpose are muscle relaxants like Atracurium besylate typically used?

Relaxing muscles during surgeries (D) Signup and view all the answers

Which type of adverse effect occurs unpredictably and often result in high morbidity and mortality?

Type B (D) Signup and view all the answers

What is an example of a Type C chronic adverse effect?

Bone marrow suppression from prednisolone (A) Signup and view all the answers

Which type of adverse effect arises from remote reactions and can occur years later?

Type D (A) Signup and view all the answers

What is an example of an end-of-reaction adverse effect that occurs upon stopping the drug?

Adrenocortical insufficiency after glucocorticoid cessation (D) Signup and view all the answers

Why are harmful drug interactions considered important?

They can cause adverse drug reactions requiring hospitalization (C) Signup and view all the answers

Which statement is true about drug-drug interactions?

They can lead to therapeutic failure (A) Signup and view all the answers

In pharmacokinetic interactions, how do drugs affect each other's effects?

They alter the magnitude and duration of the effects (A) Signup and view all the answers

What is an example of therapeutic duplication?

Combining two benzodiazepines for anxiety and insomnia (A) Signup and view all the answers

When clinicians use predictable drug-drug interactions to achieve a desired therapeutic result, what are they relying on?

Predictable changes in drug effects (A) Signup and view all the answers

In what way do Type E end-of-reaction effects typically occur?

When stopping a drug, especially suddenly (A) Signup and view all the answers

What is the main goal of pharmacovigilance?

Detecting, assessing, understanding, and preventing adverse effects (A) Signup and view all the answers

What does the text suggest about the practice of pharmacovigilance in low and middle income countries?

It varies, with some countries having no systems while some have systems comparable to industrialized countries (A) Signup and view all the answers

Who requested the World Health Organisation to develop a Pharmacovigilance Strategy?

Global Fund against AIDS, TB and Malaria (D) Signup and view all the answers

What is the purpose of establishing minimum requirements for pharmacovigilance systems?

To ensure that all countries have a basic level of pharmacovigilance (B) Signup and view all the answers

What is the role of the World Health Organization in advancing pharmacovigilance worldwide?

Embarking on a consultative process to create a Pharmacovigilance Strategy (C) Signup and view all the answers

Why is a national pharmacovigilance system described as important?

To provide some measure of assurance for medicine safety (A) Signup and view all the answers

What is a potential risk associated with self-medication practices?

Severe adverse reactions (C) Signup and view all the answers

What is a major problem related to self-medication as mentioned in the text?

Lack of time (D) Signup and view all the answers

What does medication non-adherence in patients lead to?

Worsening of diseases (B) Signup and view all the answers

What is the role of patient education in drug management?

To train patients in self-management of chronic diseases (C) Signup and view all the answers

Why is counseling patients about the benefits and risks of a drug important?

To enhance patient understanding for safe drug usage (C) Signup and view all the answers

What is the purpose of a national drug formulary?

To provide information on drug composition and administration (B) Signup and view all the answers

Compliance to medication refers to conformity with recommendations about:

Day-to-day treatment regimen (B) Signup and view all the answers

What can potential risks of self-medication practices arise from?

Incorrect self-diagnosis (B) Signup and view all the answers

What is an important aspect of patient education in drug management according to the text?

To educate patients on self-management of chronic diseases (C) Signup and view all the answers

What does non-compliance to medication in patients lead to?

Worsening of diseases (B) Signup and view all the answers

What is the purpose of prescribing excessive or unnecessary medication?

To increase the risk of antibiotic resistance (A) Signup and view all the answers

What is the risk associated with under-prescription or under-medication?

Increased risk of adverse effects (B) Signup and view all the answers

Which category of medicines is commonly used for urology purposes such as diuresis?

Hormones (D) Signup and view all the answers

What is the main purpose of anti-leishmaniasis agents like Pentamidine isethionate?

Management of parasitic infections (C) Signup and view all the answers

What is the primary function of anti-thrombotic medicines like Acetylsalicylic acid and Atorvastatin?

Preventing blood clot formation (C) Signup and view all the answers

Which category of medicines is used in the treatment of depression disorders?

Psychotherapeutic medicine (A) Signup and view all the answers

Which type of medicines are used in the management of respiratory conditions like asthma?

Muscle relaxants (C) Signup and view all the answers

What is the primary function of anti-malarial medicines like Mefloquine and Primaquine?

Preventing malaria (B) Signup and view all the answers

Which class of medicines is used for inducing ovulation?

Hormones (B) Signup and view all the answers

What role do anti-leishmaniasis agents like Pentamidine isethionate serve?

Treating parasitic infections (C) Signup and view all the answers

What could be a consequence of a nursing home intentionally under-medicating a patient?

Higher blood pressure (D) Signup and view all the answers

Which classification of adverse drug reactions involves adverse effects that are dose-related and improve upon drug withdrawal?

Type B (C) Signup and view all the answers

What is an example of an adverse reaction that is genetically predisposed and causes hemolytic anemia?

Hyperactivity due to stimulants (C) Signup and view all the answers

Which type of adverse drug reaction is relative to drug concentration and has irritant action?

Type C (B) Signup and view all the answers

What can multiple drug prescriptions (Poly pharmacy) lead to due to possible dangerous interactions between medications?

Internal bleeding (A) Signup and view all the answers

Which category of adverse drug reactions is dependent on the interaction with microorganisms and is pharmacologically predictable?

Type G (C) Signup and view all the answers

What is a possible consequence of under-prescribing medications to a patient?

Worsening of the patient's condition (D) Signup and view all the answers

Which type of adverse effect is characterized by genetic irreversible damages such as teratogenic effects?

Type G (D) Signup and view all the answers

How do stimulants, like those mentioned, potentially affect the body?

High body temperature (C) Signup and view all the answers

What is a possible effect of sudden stoppage of medication when given in an overdose?

Nervous system hyperactivity (C) Signup and view all the answers

What is one of the main objectives of a national drug formulary as established by the WHO model formulary?

Provide a single, convenient volume for drug information (A) Signup and view all the answers

Which group of medicines falls under Anti-Allergic and Medicines used in Anaphylaxis category?

Analgesics and Non-steroidal anti-inflammatory medicines (B) Signup and view all the answers

What is the role of nurses in the implementation of the Essential Drug Programme related to drug management?

Proper quantification of drug needs (A) Signup and view all the answers

Which category of medicine is used to treat Gout according to the text?

Disease Modifying Agents (A) Signup and view all the answers

What is one of the roles of the national formulary in the rationale prescribing process?

To prevent therapeutic failure (B) Signup and view all the answers

What is the main function of a national pharmacovigilance system?

Providing effective communication on medicine safety (C) Signup and view all the answers

Which category of medicine is considered part of the Anti-Infective Medicines as mentioned in the text?

Anti-helminthics and anti-protozoa medicines (B) Signup and view all the answers

What does a national ADR or pharmacovigilance advisory committee provide assistance on?

Crisis management and communication strategies (A) Signup and view all the answers

What type of adverse events does pharmacovigilance aim to identify?

Unknown or poorly characterized adverse events (D) Signup and view all the answers

What is the primary focus of the roles of the nurse in the implementation of the Essential Drug Programme?

Effective procurement practices (A) Signup and view all the answers

What is the primary goal of drug safety surveillance?

To monitor and manage adverse drug reactions (D) Signup and view all the answers

What is the purpose of the Essential Drug List Medicines mentioned in the text?

To promote rationale drug selection (C) Signup and view all the answers

What is the purpose of a national database for managing ADR reports?

Collating and managing adverse drug reaction reports (B) Signup and view all the answers

How do the USP/NF monographs ensure the quality of compounded preparations?

By containing specifications for tests, procedures, and acceptance criteria (A) Signup and view all the answers

What is the significance of having a clear communication strategy in pharmacovigilance?

Enhancing routine and crisis communication regarding medicine safety (D) Signup and view all the answers

What do essential drug lists primarily emphasize in terms of drug use management?

Promoting sensible drug use and dispensing (B) Signup and view all the answers

What is identified through pharmacovigilance for the benefit of public health programs?

Drug utilization information and quality issues (C) Signup and view all the answers

What is the role of global health organizations in promoting pharmacovigilance?

Supporting the development of national pharmacovigilance systems (D) Signup and view all the answers

Why is the identification of signals of medicine safety important in pharmacovigilance?

To understand adverse reactions for crisis management (B) Signup and view all the answers

How does a national pharmacovigilance system support national treatment guidelines?

By identifying issues with unregulated prescribing and dispensing (D) Signup and view all the answers

Which type of adverse effect occurs during prolonged exposure and not with single doses?

Type C (B) Signup and view all the answers

What is the term used for adverse effects that occur when a drug is suddenly stopped?

Type E (A) Signup and view all the answers

In drug interactions, what category may involve alterations in absorption, distribution, metabolism, or excretion of another drug?

Pharmacokinetic interactions (A) Signup and view all the answers

Which drug interaction may lead to either increased or decreased effects of the involved drugs?

Pharmacodynamic interactions (C) Signup and view all the answers

What term is used for interactions where two drugs with similar properties are taken together, resulting in additive effects?

Therapeutic duplication (A) Signup and view all the answers

Which type of adverse drug effect is uncommon, unpredictable, and often associated with high morbidity and mortality?

Type B (A) Signup and view all the answers

When do Type D adverse effects typically occur?

Years later (B) Signup and view all the answers

What happens in therapeutic duplication?

Two drugs with similar effects are taken together (B) Signup and view all the answers

Which type of adverse effect occurs when a drug is suddenly stopped?

Type E (C) Signup and view all the answers

In drug interactions, what category alters the effects of drugs at their target sites?

Pharmacodynamic interactions (A) Signup and view all the answers

What does the term 'Pharmacovigilance' refer to?

Preventing drug-related adverse effects and promoting rational drug use (A) Signup and view all the answers

What is the main focus of the World Health Organisation's Pharmacovigilance Strategy?

Ensuring the safety of medicines globally (D) Signup and view all the answers

What is the significance of the minimum requirements for any national Pharmacovigilance system?

To establish and maintain a basic level of Pharmacovigilance in every country (B) Signup and view all the answers

In the context of Pharmacovigilance, what does a national PV system provide assurance for and security of?

Medicines safety (D) Signup and view all the answers

Why is Pharmacovigilance considered an important medical discipline?

To ensure patient safety and prevent adverse events (C) Signup and view all the answers

What is the primary goal of the consultation process initiated by the World Health Organisation regarding Pharmacovigilance?

Producing a Pharmacovigilance Strategy for all countries seeking to advance PV systems (C) Signup and view all the answers

What is a key focus of a national pharmacovigilance system?

Promoting patient safety (C) Signup and view all the answers

What is one of the functions of a national pharmacovigilance system?

Identifying signals of medicine safety (C) Signup and view all the answers

What is the purpose of self-medication as defined in the text?

To treat self-recognized or self-diagnosed conditions (C) Signup and view all the answers

Which of the following is a minimum requirement for a national pharmacovigilance system?

Existence of a national spontaneous reporting system (C) Signup and view all the answers

Which type of pharmacovigilance involves identifying unknown or poorly characterized adverse events in relation to medicines?

Drug Safety Surveillance (A) Signup and view all the answers

What should a national pharmacovigilance system do to support public health programs and policies?

Apply information from pharmacovigilance for public health benefit (C) Signup and view all the answers

What is a requirement for effective communication in pharmacovigilance?

Having a clear communication strategy (D) Signup and view all the answers

What does a national pharmacovigilance system need to identify risks associated with in medicines?

Quality problems (B) Signup and view all the answers

What is the purpose of the national spontaneous reporting system?

To report adverse drug reactions (A) Signup and view all the answers

What is the main role of a national pharmacovigilance system in relation to pharmacovigilance advisory committees?

To provide assistance on risk assessment and crisis management (B) Signup and view all the answers

What are some potential risks associated with self-medication practices?

Incorrect dosage (D) Signup and view all the answers

What is medication non-adherence in patients associated with?

Worsening of diseases (A) Signup and view all the answers

Which of the following is a potential consequence of incorrect self-diagnosis during self-medication?

Delays in seeking medical advice when needed (B) Signup and view all the answers

What is the responsibility of healthcare members in relation to patient education?

To provide essential information to patients (B) Signup and view all the answers

What does counseling patients about the benefits and risks of a drug help with?

Informing decisions about a patient's treatment (D) Signup and view all the answers

What is a consequence of patients not adhering to medication?

Worsening of diseases (D) Signup and view all the answers

What is the main purpose of patient education in relation to chronic diseases?

To train patients in self-management of their chronic diseases (B) Signup and view all the answers

What does a national drug formulary provide information on?

Composition and administration of drugs (C) Signup and view all the answers

What can delays in seeking medical advice lead to?

Worsening of diseases (B) Signup and view all the answers

What is a potential danger associated with administering drugs incorrectly as part of self-medication?

Infrequent but severe adverse reactions (A) Signup and view all the answers

What can be a possible consequence of under-prescribing medications?

Chronic extreme fatigue (A) Signup and view all the answers

Which classification of adverse effects is pharmacologically predicted and dose-related, improving if the medicine is withdrawn?

Type D (C) Signup and view all the answers

What is the adverse response without treatment that occurs at normal doses of a drug for prophylaxis or diagnosis?

Adverse Drug Reaction (B) Signup and view all the answers

What is a possible implication of multiple drug prescriptions (Polypharmacy)?

Dangerous drug interactions (C) Signup and view all the answers

Which type of adverse effects occur due to the interaction with microorganisms and are pharmacologically predictable?

Type C (B) Signup and view all the answers

What can sudden stoppage of medication given in an overdose lead to?

Withdrawal symptoms (D) Signup and view all the answers

Which effect of under-prescription can worsen the patient's condition or cause a relapse?

Lack of immunity (D) Signup and view all the answers

What can be a consequence of an intentional under medicating in a nursing home violating its duty to patients?

Emotional volatility (A) Signup and view all the answers

What can over prescription of drugs cause?

Withdrawal symptoms (C) Signup and view all the answers

Which type of adverse effect is genetically predisposed and results in hemolytic anemia in specific individuals?

Type F (C) Signup and view all the answers

What is one of the main objectives of the national drug formulary as established?

To check the rising trend of therapeutic failure and adverse drug reactions (B) Signup and view all the answers

Which category of essential drug list medicines includes Sumitriptan?

Anti-Migraine medicines (A) Signup and view all the answers

What is a key role that the formulary plays in health care decision making?

Minimizing therapeutic failures and adverse drug reactions (C) Signup and view all the answers

Why are Anti-Parkinsonism Medicines like Trihexyphenidyl hydrochloride mentioned in the text?

For managing Parkinson's disease symptoms (D) Signup and view all the answers

What is the main purpose of presenting a single, convenient volume of the national drug formulary?

To provide an easy-to-use source of drug information for prescribing, dispensing, and administration (A) Signup and view all the answers

Which role does the Essential Drug Programme focus on in terms of effective drug management?

Proper quantification of drug needs (B) Signup and view all the answers

What is a notable characteristic of the USP/NF monographs in terms of compounded preparations?

Containment of specifications to assist in ensuring quality (C) Signup and view all the answers

Why are medicines like Fluconazole and Clotrimazole listed under the Anti-Fungal category in the text?

To address fungal infections (A) Signup and view all the answers

Which goal does the national formulary aim at achieving by promoting rational drug use?

Minimizing therapeutic failures and treatment complications (B) Signup and view all the answers

What is the primary function of the Essential Drug List Medicines mentioned?

To streamline and improve drug selection and use (A) Signup and view all the answers

What type of adverse drug reaction occurs unpredictably and often has a high rate of morbidity and mortality?

Type B (C) Signup and view all the answers

Which type of adverse effects occur during prolonged therapy and not with single doses?

Type C (C) Signup and view all the answers

What is the rare event that clinicians can sometimes utilize predictable drug interactions for?

Producing desired therapeutic effects (D) Signup and view all the answers

Which type of reaction occurs when a drug is stopped or suddenly discontinued?

Type E (A) Signup and view all the answers

What is the main characteristic of pharmacokinetic drug interactions?

Altering drug absorption and distribution (C) Signup and view all the answers

In therapeutic duplication, what effect can taking two drugs with similar properties simultaneously lead to?

Additive effects (C) Signup and view all the answers

What category of drug interactions refers to changes in drug effects resulting from ingestion of food or dietary supplements?

Drug-nutrient interactions (D) Signup and view all the answers

Which type of adverse drug reactions occur unpredictably and often have high mortality rates?

Type B (D) Signup and view all the answers

What is the primary impact of clinically significant drug interactions?

Potential adverse effects or therapeutic failure (A) Signup and view all the answers

Which type of drug reactions occur due to the interaction with microorganisms and are often pharmacologically predictable?

Type A (B) Signup and view all the answers

What is the primary function of anti-allergic medicines according to the text?

Reduce inflammation (B) Signup and view all the answers

Which category of medicine is used for the treatment of urology purposes like diuresis?

Anti-Hypertensive medicines (B) Signup and view all the answers

What category of medicines are Timolol, Acetazolamide, and Tropicamide examples of?

Ophthalmological preparations (B) Signup and view all the answers

What role do Anti-Thrombotic medicines like Acetylsalicylic acid and Atorvastatin play?

Prevent blood clot formation (C) Signup and view all the answers

Which medicines are likely used in the treatment of psychotic disorders according to the text?

Psychotherapeutic medicines (D) Signup and view all the answers

What is the purpose of Hormones like Insulin and Gliclazide?

Control blood sugar levels (A) Signup and view all the answers

What category do Dorzolamide, Streptokinase, and Sodium hylarunodise fall under?

Ophthalmological preparations (C) Signup and view all the answers

What effects do Muscle Relaxants like Atracurium besylate have?

Suppress nervous system activity (C) Signup and view all the answers

What is the primary function of Medicines considered part of the Anti-Infective category?

Treat infections (C) Signup and view all the answers

What role do Insulin and other anti-diabetic medicines play?

Control blood sugar levels (D) Signup and view all the answers

What is the primary focus of pharmacovigilance?

Preventing adverse drug reactions (D) Signup and view all the answers

Which organization has worked on developing a Pharmacovigilance Strategy for countries?

Global Fund for HIV/AIDS, Tuberculosis, and Malaria (D) Signup and view all the answers

What is the minimum goal of a national pharmacovigilance system according to the text?

Providing some measure of assurance for medicine safety (C) Signup and view all the answers

Which countries are generally reported to have a variable practice of pharmacovigilance?

Middle-income countries (A) Signup and view all the answers

What is one of the main outcomes of pharmacovigilance?

Ensuring patient safety (B) Signup and view all the answers

What has the World Health Organisation provided upon request to develop the Pharmacovigilance Strategy?

Extensive and wide-ranging consultative process (C) Signup and view all the answers

What is a major problem associated with self-medication according to the text?

Wastage of resources (C) Signup and view all the answers

What is the potential risk of incorrect self-diagnosis during self-medication?

Delays in seeking medical advice (B) Signup and view all the answers

What is the core objective of patient education in relation to chronic diseases?

Enhance patient understanding of self-management (C) Signup and view all the answers

What is the significance of introducing clear medication-related information to patients?

Improve patient adherence to medication (C) Signup and view all the answers

What is a consequence of non-compliance to medication as mentioned in the text?

Worsening of diseases (D) Signup and view all the answers

What is a documented potential danger associated with self-medication according to the text?

Infrequent but mild adverse reactions (B) Signup and view all the answers

Why is counseling patients about drug benefits and risks essential according to the FDA?

To inform patient decisions on treatment (C) Signup and view all the answers

What is the focus of patient education as mentioned in the text?

To train patients in self-management of chronic diseases (C) Signup and view all the answers

What is a consequence of medication non-adherence in patients?

Worsening of diseases (B) Signup and view all the answers

What is portrayed as a benefit of introducing a national drug formulary?

Regulating the use of interchangeable medicines (D) Signup and view all the answers

What is one of the key functions of a national pharmacovigilance system?

Collecting ADR reports and managing adverse drug reactions (C) Signup and view all the answers

What is the main purpose of a national pharmacovigilance center according to the text?

To collate and manage ADR reports with designated staff (A) Signup and view all the answers

What is the underlying focus of self-medication as defined in the text?

Using medicines without consultation or prescription (C) Signup and view all the answers

One of the functions of a national pharmacovigilance system is to provide effective communication on aspects related to medicine safety. What is NOT mentioned as part of this effective communication?

Promoting the sale of new pharmaceutical products (D) Signup and view all the answers

What is the expected stability requirement for funding a sustainable national pharmacovigilance system?

Stable basic funding (A) Signup and view all the answers

What is the primary purpose of identifying signals of medicine safety in a pharmacovigilance system?

To identify unknown or poorly characterized adverse events (B) Signup and view all the answers

What role does a national ADR or pharmacovigilance advisory committee fulfill in a pharmacovigilance system?

Assisting with causality assessment and case investigation (C) Signup and view all the answers

What is NOT a focus area for the functions of a national pharmacovigilance system as stated in the text?

Collecting and managing patient medical records (A) Signup and view all the answers

What is emphasized as the primary purpose of self-medication as defined in the text?

Treating conditions based on self-recognition or diagnosis (A) Signup and view all the answers

What is a key characteristic of a functional national pharmacovigilance system as described in the text?

Clear communication strategy for routine and crises communication (A) Signup and view all the answers

What is the primary function of Anti-Thrombotic medicines like Acetylsalicylic acid and Atorvastatin?

Prevent blood clots (D) Signup and view all the answers

What is the primary role of Dermatological medicines affecting skin differentiation and proliferation like coaltar + salicillic?

Affect skin cell growth (C) Signup and view all the answers

How do Nasal ENT medications like Saline nasal solution function?

Clear nasal passages (C) Signup and view all the answers

What is the main purpose of Muscle relaxants and Cholinesterase Inhibitor medicines like Atracurium besylate and Neostigmine?

Relax peripheral muscles (A) Signup and view all the answers

What is the primary function of Anti-leishmaniasis Agents like Pentamidine isethionate?

Treat parasitic infections (C) Signup and view all the answers

What is the main role of Vitamins and Minerals like Calcium carbonate and Vitamin A?

Enhance immune function (B) Signup and view all the answers

What is the primary purpose of Gastrointestinal medicines used for treating Diarrhea like Oral rehydration salts (ORS) and Zinc sulphate?

Combat dehydration (B) Signup and view all the answers

How do Anti-fibrinolytic and pressure agents function in the context of medications?

Prevent clot breakdown (B) Signup and view all the answers

What is the main purpose of Opthalmological Preparations like Anti-infective Agent: Ofloxacin and Neomycin?

Treat eye infections (C) Signup and view all the answers

How do Anti-arrhythmic medicines like Adenosine (phosphate) and Digoxin work?

Regulate heartbeat abnormalities (A) Signup and view all the answers

What is a possible harmful consequence of under-prescription in nursing homes?

Chronic extreme pain and cognitive decline (A) Signup and view all the answers

Which classification system divides adverse effects into Type A (pharmacological) and Type B (idiosyncratic)?

Rawlins and Thompson classification (C) Signup and view all the answers

What type of adverse effect is genetically predisposed in individuals and can cause hemolytic anemia?

Type H Hypersensitivity (C) Signup and view all the answers

What is a potential implication of multiple drug prescriptions (Polypharmacy)?

Internal bleeding and confusion (A) Signup and view all the answers

Which type of adverse effect is unpredictable and often has high mortality rates?

Type I Unclassified (D) Signup and view all the answers

What is the possible consequence of over-prescription or overdose of medication?

Withdrawal symptoms, coma, or death (A) Signup and view all the answers

What is the purpose of the classification system that includes Type A (Augmented) and Type B (Bugs) adverse effects?

To organize adverse effects based on pharmacological predictability (A) Signup and view all the answers

What is a potential consequence of under prescribing medication?

Relapse or worsening of patient condition (A) Signup and view all the answers

Which classification system for adverse drug reactions is considered the best according to the text?

Note: Wills and Browns classification is the best. (B) Signup and view all the answers

What is the concept related to concurrent use of multiple medications that can lead to dangerous interactions between drugs?

Polypharmacy (A) Signup and view all the answers

What is the classification of an adverse drug effect that occurs unpredictably and is often associated with high morbidity and mortality?

Type B Bizarre Adverse Effect (D) Signup and view all the answers

Which type of drug-drug interaction involves changes in absorption, distribution, protein binding, metabolism, or excretion of a drug?

Pharmacokinetic Interaction (A) Signup and view all the answers

What example of a Type D Delayed Effect is mentioned in the text as occurring years after exposure?

Adrenocortical insufficiency after drug cessation (A) Signup and view all the answers

Which outcome may occur due to a harmful drug-drug interaction?

Undesired therapeutic effects (C) Signup and view all the answers

What is a potential benefit of using predictable drug-drug interactions in a clinical setting?

Altered drug metabolism for effectiveness (C) Signup and view all the answers

Which classification of drug interactions may involve changes in dietary supplement-drug effects?

Drug-Nutrient Interactions (A) Signup and view all the answers

What example of a Type E End of Reaction Effect is mentioned as occurring after glucocorticoid cessation?

Adrenocortical insufficiency (A) Signup and view all the answers

In drug interactions, which category may involve alterations in excretion of another drug?

Pharmacokinetic Interactions (C) Signup and view all the answers

What is one possible result of therapeutic duplication in drug interactions?

Additive effects leading to toxicity (D) Signup and view all the answers

Which type of drug reactions occur during prolonged exposure and not with a single dose?

Type C Chronic Effects (C) Signup and view all the answers

What is one of the roles of the National Formulary in rationale prescribing as stated in the text?

To lead to timely decision making by providing correct drug information (C) Signup and view all the answers

Which category of medicines are Allopurinol, Azathioprine, and Chloroquine classified under?

Disease Modifying Agents used in Rheumatoid Disorders (A) Signup and view all the answers

What is the main goal of presenting a single, convenient volume of drug information, as per the WHO model formulary objectives?

To promote easy access to drug information for healthcare personnel (B) Signup and view all the answers

What is one of the essential functions of nurses in the implementation of the Essential Drug Programme according to the text?

Assuring the quality of drugs (A) Signup and view all the answers

Which category do Warfarin, Heparin sodium, and Iron Sucrose fall under in terms of medicines affecting the blood?

Medicines affecting coagulation (A) Signup and view all the answers

What is the category that includes Adrenaline, Methyl prednisolone, Cetirizine, and hydrocortisone as per the text?

Anti-Allergic and medicines used in Anaphylaxis (A) Signup and view all the answers

Which category of medicine includes drugs like Trihexyphenidyl hydrochloride as mentioned in the text?

Anti-Parkinsonism Medicines (B) Signup and view all the answers

What is the purpose of the Anti-Migraine medicines category that includes Sumitriptan in the text?

To provide pain relief during acute migraine attacks (A) Signup and view all the answers

Which category of medicines do Morphine sulphate and Tramadol hydrochloride belong to?

Opioids analgesics (D) Signup and view all the answers

What is the objective of having medicines like Propopanolol and Metoprolol as part of the Blood products and Plasma Substitutes?

To affect coagulation (C) Signup and view all the answers

What is one of the main objectives of the Essential Drug List Medicines presented in the text?

To promote rationale drug use across medical fields (C) Signup and view all the answers

Study Notes

Pharmacovigilance and Adverse Drug Reactions

Pharmacovigilance (PV) is defined as the detection, assessment, understanding, and prevention of adverse effects or other possible drug-related problems.
PV is essential to prevent drug-related adverse effects in humans, ensure patient safety, and promote the rational use of drugs.

Importance of Pharmacovigilance

PV is well established in most industrialized countries, but its practice in low and middle-income countries is variable.
The World Health Organisation has developed a Pharmacovigilance Strategy to advance PV systems globally.

Minimum Requirements for Pharmacovigilance

A national pharmacovigilance centre with designated staff, stable funding, clear mandates, and collaboration with the WHO Programme for International Drug Monitoring.
A national spontaneous reporting system with a national individual case safety report (ICSR) form.
A national database or system for collating and managing ADR reports.
A national ADR or pharmacovigilance advisory committee for technical assistance on causality assessment, risk assessment, and risk management.
A clear communication strategy for routine communication and crisis communication.

Types of Pharmacovigilance

Drug Safety Surveillance
Drug Abuse and Adverse Effects Monitoring
Safety Monitoring of New Products

Purposes of Pharmacovigilance

To improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.
To improve public health and safety in relation to the use of medicines.

Self-Medication

Self-medication is the selection and use of medicines by individuals to treat self-recognized or self-diagnosed conditions or symptoms.
Under-medication can lead to serious health problems, including chronic pain, high blood pressure, dementia, and cognitive decline.

Implications of Drug Over-Prescription

Over-prescription can cause withdrawal symptoms, coma, or death.
Sudden stoppage of medication can lead to withdrawal symptoms such as nervous system hyperactivity and seizures.

Implications of Drug Under-Prescription

Under-prescription can cause a relapse or worsen the patient's condition.

Implications of Multiple Prescription

Taking multiple medications can result in drug interactions, leading to internal bleeding, confusion, light-headedness, and other adverse effects.

Adverse Drug Reactions (ADR)

ADRs are unintended and harmful responses that occur at normal doses of the drug used for prophylaxis, diagnosis, or treatment.
Classification of ADRs includes:
- Type A: Augmented pharmacological effect
- Type B: Bizarre or idiosyncratic reactions
- Type C: Chemical reactions
- Type D: Delivery related reactions
- Type E: End-of-treatment reactions
- Type F: Familial or genetic reactions
- Type G: Genetic toxicity
- Type H: Hypersensitivity reactions
- Type I: Unclassified reactions### Pharmacovigilance
Defined as the "science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems"
Aims to prevent drug-related adverse effects in humans, ensure patient safety, and promote the rational use of drugs

Types of Adverse Reactions

Type A: Augmented pharmacological effects (e.g. hypoglycemia due to insulin injection)
Type B: Bizarre adverse effects (e.g. anaphylaxis due to penicillins, acute hepatic necrosis due to halothane)
Type C: Chronic effects (e.g. craniofacial malformation due to phenytoin)
Type D: Delayed effects (e.g. alkylating agent use in the treatment of Hodgkin's second cancer)
Type E: End of treatment effects (e.g. angina with beta-adrenergic receptor, adrenocortical insufficiency after glucocorticoid withdrawal)

Drug Interactions

Occur when a patient's response to a drug is modified by food, nutritional supplements, formulation excipients, environmental factors, other drugs, or disease
Can be beneficial or harmful
May increase or decrease the effects of one or both drugs
Examples: coadministration of lopinavir and ritonavir to patients with HIV infection, therapeutic duplication (e.g. taking a benzodiazepine for anxiety and another benzodiazepine at bedtime for insomnia)

Functions of a National Pharmacovigilance System

Promote pharmacovigilance in the country
Collect and manage adverse drug reaction reports, medication errors, and suspected counterfeit/substandard drugs
Identify signals of medicine safety and undertake assessment of risk and options for risk management
Provide effective communication on aspects related to medicine safety

Minimum Requirements for a Functional National Pharmacovigilance System

A national pharmacovigilance centre with designated staff, stable basic funding, clear mandates, well-defined structures and roles
A national spontaneous reporting system with a national individual case safety report (ICSR) form
A national database or system for collating and managing ADR reports
A national ADR or pharmacovigilance advisory committee able to provide technical assistance

National Drug Formulary

Contains a list of medicines approved for prescription throughout the country
Includes key information on the composition, description, selection, prescribing, dispensing, and administration of drugs/medicines
Examples: United States Pharmacopia and National Formulary (USP-NF), British National Formulary, Nigeria EMDS

Self-Medication

Defined as the selection and use of medicines by individuals to treat self-recognized or self-diagnosed conditions or symptoms
A global phenomenon and potential contributor to antimicrobial resistance
Risks include incorrect self-diagnosis, delayed seeking of medical advice, severe adverse reactions, and incorrect administration or dosage

Importance of Patient Education and Counseling on the Use of Drugs

Patient education aims to train patients in the self-management of their chronic disease
Includes providing clear medication-related information to improve adherence
Counseling enhances patient understanding of their role in safe drug use### Medicines and their Classification
Adenosine and Digoxin are anti-arrhythmic medicines
Methyldopa and Esmolol are anti-hypertensive medicines
Dobutamine and Noradrenaline are used in heart failure
Acetylsalicylic acid and Atorvastatin are anti-thrombotic medicines
Calamine, White petroleum, and Crotamiton are used for dermatological purposes
Disinfectants and Antiseptics include Providone iodine, Sodium hypochlorite, and Lysol (cresol with soap solution)
Mannitol and Frusemide are diuretics used in urology
Pantoprazole, Lactulose, and Oral rehydration salts (ORS) are used in gastrointestinal medicine
Insulin, Glucose, and Glimipride are used to treat diabetes
Clomiphene, Norethisterone, and Ethinyl estradiol are used to induce ovulation
Thyroxine sodium, Levothyroxine sodium, and Carbimazole are used to treat thyroid disorders
Sera and immunoglobulins, Anti-D, and Anti-Rabies immunoglobulins are used in immunological treatments
Atracurium besylate, Neostigmine, and Dexmedelomedine are used as muscle relaxants
Ofloxacin, Neomycin, and Timolol are used in opthalmological preparations
Nasal ENT medicines include Saline nasal solution, Glycerin, and Momentazoline
Oxytocin and Methyl Ergometrine are used as oxytocics
Isoxuprime and Ritodrine are used as anti-oxytocics
Prolinate, Haloperidol, Imipramine, and Escitalopram are used in psychotherapeutic medicine
Iopromide, Diathriazoate, and Barium Sulphate are used as radio contrast agents
Pentamidine isethionate and Sodium stibogluconate are used to treat leishmaniasis
Mefloquine, Primaquine, and Chloroquine are used to treat malaria
Vitamins and minerals include Calcium carbonate, Vitamin A, and B-Complex

Implications of Drug Over Prescription and Under Prescription

Over-prescription (poly-pharmacy) can lead to antibiotic resistance, disease severity, and adverse effects
Under-prescription can lead to chronic pain, high blood pressure, and cognitive decline
Over-prescription can cause withdrawal symptoms, coma, or death
Under-prescription can cause relapse or worsening of patient condition
Multiple drug prescription can result in drug interactions, leading to internal bleeding, confusion, and lightheadedness

Adverse Drug Reactions (Pharmaco-Therapeutic Complications)

Adverse drug reactions are unintended and harmful responses to medicines at normal doses
Classification of adverse drug reactions:
- Type A: Augmented pharmacological effect
- Type B: Bizarre
- Type C: Chronic effect
- Type D: Delay effect
- Type E: End of RXN effect
- Type F: Familiar
- Type G: Genetic toxicity
- Type H: Hypersensitivity
- Type I: Unclassified

Drug Interactions

Drug interactions occur when a patient's response to a drug is modified by food, nutritional supplements, formulation excipients, environmental factors, other drugs, or disease
Types of drug interactions:
- Drug-drug interactions
- Drug-nutrient interactions
- Dietary supplement-drug interactions
Harmful drug interactions can cause 10-20% of adverse drug reactions requiring hospitalization
Clinically significant interactions are often predictable and usually undesired