Essential Drugs Concept and Rational Drug therapy

 

Essential Drugs Concept & Rational Drug Therapy –

1. Essential Drugs (Essential Medicines) Concept

Definition (WHO)

Essential medicines are medicines that satisfy the priority healthcare needs of the population.

Selection of Essential Medicines

Essential medicines are selected based on:

• Disease prevalence in the country/region
• Scientific evidence of efficacy
• Safety
• Cost-effectiveness
• Available healthcare facilities
• Skills and training of healthcare personnel
• Ease of administration
• Storage facilities
• Patient acceptability

Mnemonic: DESC HSP

• Disease prevalence
• Efficacy
• Safety
• Cost-effectiveness
• Healthcare facilities
• Skills of staff
• Patient acceptability

Importance of Essential Medicines

Essential medicines should be:

• Available at all times
• Available in adequate quantities
• In proper dosage forms
• Of assured quality
• Accompanied by proper information
• Affordable to individuals and the community

They are expected to cover 80–90% of the healthcare needs of the population.

2. Essential Medicines List (EML)

Definition

An Essential Medicines List (EML) is a limited list of carefully selected medicines that satisfies the priority healthcare needs of a population.

Selection is based on:

• Disease prevalence
• Safety
• Efficacy
• Cost-effectiveness

The EML is regularly updated considering:

• New scientific evidence
• Drug resistance patterns
• Emerging diseases
• New medicines
• Improved formulations

3. Advantages of Essential Medicines List

Public Health

• Prevents deaths from treatable diseases
• Ensures medicine availability
• Improves quality of healthcare

Drug Management

• Easier procurement
• Easier storage
• Prevents stock-outs
• Better inventory control
• Easier transportation

Cost

• Lower procurement cost
• Lower storage cost
• Easier quality testing

For Doctors & Pharmacists

• Better knowledge of fewer medicines
• Improved prescribing
• Better patient counseling
• Fewer medication errors

Standard Treatment

• Encourages treatment according to Standard Treatment Guidelines (STGs)

4. Rational Use of Drugs (RUD)

Definition

Rational use of drugs means:

Using the right drug for the right patient, in the right dose, by the right route, for the right duration, at the right time, after proper diagnosis.

Factors Leading to Irrational Drug Use

• Self-medication
• Medicines taken for minor illnesses
• Easy access to medicines
• Advice from friends or relatives
• Avoiding doctor consultation

5. Common Types of Irrational Drug Use

1. Polypharmacy

Use of too many medicines for one patient.

2. Irrational Antibiotic Use

• Wrong antibiotic
• Wrong dose
• Wrong duration
• Antibiotics for viral infections

3. Overuse of Injections

Using injections when oral medicines are sufficient.

4. Inappropriate Self-medication

Especially with prescription medicines.

5. Not Following STGs

Failure to prescribe according to Standard Treatment Guidelines.

6. Strategies to Improve Rational Drug Use

A. Managerial

• Supervise prescribing
• Use STGs
• Prescription audits
• Feedback to doctors

B. Economic

• Incentives for rational prescribing
• Insurance reimbursement only for EML medicines
• Competitive pricing

C. Regulatory

• Drug laws
• Licensing doctors and pharmacists
• Drug scheduling
• Ban unsafe medicines
• Regulation of pharmaceutical promotion

D. Educational

• Continuing education
• Training programs
• Formularies
• Clinical supervision
• Patient counseling
• Monitoring and feedback

7. National Strategies (WHO)

WHO recommends:

1. National medicine policy body
2. Evidence-based STGs
3. Essential Medicines List
4. Drug & Therapeutics Committee (DTC)
5. Problem-based pharmacotherapy training
6. Mandatory Continuing Medical Education (CME)
7. Independent drug information
8. Prescription audit and feedback
9. Public education
10. Remove financial incentives for irrational prescribing
11. Enforce drug regulations
12. Adequate government funding

8. Role of Pharmacist in Rational Drug Use

1. Drug & Therapeutics Committee (DTC)

• Helps select essential medicines
• Assists in EML preparation
• Develops medicine policies

2. Drug Procurement

• Purchase quality medicines
• Buy at reasonable prices
• Forecast medicine requirements
• Ensure EML medicines are procured

3. Drug Storage

• Follow Good Storage Practices (GSP)
• Prevent stock-outs
• Avoid expiry
• Proper handling of narcotics and costly medicines

4. Dispensing

• Accurate dispensing
• Reduce medication errors
• Prevent pilferage
• Maintain records

5. Patient Education

• Counsel patients
• Explain dosage
• Improve adherence
• Provide verbal and written instructions

6. Pharmacovigilance

• Detect adverse drug reactions (ADRs)
• Report ADRs
• Monitor medicine safety

7. Drug Information Service

Provide unbiased information to:

• Doctors
• Nurses
• Patients
• Public
• Other healthcare workers

8. Pharmaceutical Care

A patient-centered practice where the pharmacist:

• Takes responsibility for drug-related needs
• Collaborates with doctors
• Optimizes drug therapy
• Suggests dose adjustments
• Improves patient outcomes

Important Definitions for Exams

Essential Medicines

Medicines that satisfy the priority healthcare needs of the population.

Essential Medicines List (EML)

A limited list of carefully selected medicines based on efficacy, safety, disease prevalence, and cost-effectiveness.

Rational Drug Use

Use of the right medicine, for the right patient, in the right dose, by the right route, for the right duration, at the right cost.

Polypharmacy

Use of multiple medicines in a single patient unnecessarily.

High-Yield Mnemonics

Selection of Essential Medicines

DESC HSP

• Disease prevalence
• Efficacy
• Safety
• Cost-effectiveness
• Healthcare facilities
• Skills of healthcare personnel
• Patient acceptability

Strategies to Improve Rational Drug Use

MERE

• Managerial
• Economic
• Regulatory
• Educational

Pharmacist's Roles

PDSD PDPP

• Procurement
• DTC member
• Storage
• Dispensing
• Patient education
• Drug information
• Pharmacovigilance
• Pharmaceutical care

Frequently Asked Exam Questions

1. Define Essential Medicines.
2. Write the selection criteria for essential medicines.
3. Explain the advantages of the Essential Medicines List (EML).
4. Define Rational Use of Drugs.
5. Describe the types of irrational drug use.
6. Explain the strategies to improve rational drug use.
7. List the WHO national strategies for promoting rational drug use.
8. Discuss the role of pharmacists in promoting rational use of medicines.

 

Pharmaceutical Care

Introduction

Health is defined as a state of complete physical, mental, and social well-being and not merely the absence of disease.

Medicines are used to treat, prevent, and manage various diseases. When used appropriately, medicines provide therapeutic benefits and improve patients' health. However, inappropriate use of medicines can cause harm, lead to adverse drug reactions, treatment failure, and increase healthcare costs for both patients and governments.

Pharmacists worldwide provide professional services in community, hospital, and clinical settings. Owing to their expertise in therapeutics and clinical pharmacy, pharmacists can identify drug-related problems, provide appropriate solutions, counsel patients on the safe use of medicines, and educate them about diet and lifestyle modifications to maximize therapeutic outcomes.

Pharmaceutical Public Health is the application of pharmaceutical knowledge, skills, and resources to prevent disease, prolong life, and promote, protect, and improve the health of society in an organized manner.

• Pharmaceutical Public Health focuses on health issues at the community/societal level.
• Pharmaceutical Care focuses on health issues at the individual patient level.

Pharmaceutical Care

The term "Pharmaceutical Care" was first coined by Mikeal et al. (1975) and defined as:

"The care that a given patient requires and receives which assures safe and rational drug use."

In 1990, Douglas C. Hepler and Linda M. Strand proposed a new definition that gained worldwide acceptance:

"The responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life."

This definition is more patient-centered and outcome-oriented, particularly for chronic diseases such as diabetes, hypertension, and asthma, where maintaining quality of life is essential.

In 1998, the International Pharmaceutical Federation (FIP) adopted this definition.

Difference Between Traditional Pharmacy Practice and Pharmaceutical Care

Traditional Pharmacy Practice

• Dispensing medicines based on prescriptions.
• Limited involvement in patient follow-up.
• Focus on medication supply.

Pharmaceutical Care Practice

• Reviews and analyzes prescriptions.
• Identifies Drug-Related Problems (DRPs).
• Resolves DRPs in consultation with physicians and patients.
• Monitors therapeutic outcomes.
• Provides patient counseling and education.
• Focuses on improving quality of life and therapeutic outcomes.

Goal of Pharmaceutical Care

To ensure that patients receive:

• Appropriate drug therapy
• Effective drug therapy
• Safe drug therapy
• Convenient drug therapy

Resulting in:

• Desired therapeutic outcomes
• Improved health-related quality of life

Principles of Pharmaceutical Care Practice

Pharmaceutical Care is a patient-centered, outcome-oriented pharmacy practice that requires collaboration between the pharmacist, patient, and other healthcare professionals.

Main Goal

To optimize the patient's health-related quality of life and achieve positive clinical outcomes with reasonable healthcare expenditure.

1. Establish and Maintain a Professional Relationship

A strong relationship between the pharmacist and patient should be based on:

• Caring
• Trust
• Open communication
• Cooperation
• Mutual decision-making

Responsibilities of the Pharmacist

• Place the patient's welfare first.
• Demonstrate a caring attitude.
• Use professional knowledge and skills for the patient's benefit.
• Ensure continuous access to pharmaceutical care.

Responsibilities of the Patient

• Provide accurate personal and medical information.
• Share preferences and concerns.
• Participate actively in the therapeutic plan.

2. Collect, Organize, Record, and Maintain Patient-Specific Information

The pharmacist should collect comprehensive patient information, including:

Subjective and Objective Information

• General health status
• Activity status
• Past medical history
• Medication history
• Social history
• Diet history
• Exercise history
• History of present illness
• Financial and insurance status

Sources of Information

• Patient
• Medical records and reports
• Physical assessment
• Family members or caregivers
• Insurance providers
• Physicians
• Nurses
• Other healthcare professionals

Requirements of Patient Information

The information should be:

• Accurate
• Complete
• Timely
• Organized
• Easily retrievable
• Regularly updated
• Maintained confidentially

3. Evaluate Patient Information and Develop a Drug Therapy Plan

Based on the collected information, the pharmacist should:

• Understand the patient's disease and treatment needs.
• Collaborate with the patient and other healthcare providers.
• Develop an outcome-oriented drug therapy plan.
• Address all disease conditions and medication-related needs.

While Designing the Plan, Consider:

• Clinical condition of the patient
• Psychological factors
• Social factors
• Cost of therapy
• Complexity of treatment
• Patient adherence/compliance

Role of the Pharmacist

• Act as a patient advocate.
• Coordinate drug therapy with healthcare providers.
• Ensure safe, effective, and economical medication use.
• Monitor therapeutic outcomes and modify therapy when necessary.

4. Pharmacist Ensures Availability of Supplies, Information, and Knowledge

The pharmacist providing pharmaceutical care assumes responsibility for ensuring that the patient:

• Obtains all prescribed medications and related products.
• Has access to necessary medical equipment and supplies.
• Understands the disease condition.
• Understands the purpose, benefits, and risks of therapy.
• Knows how to use medications correctly.
• Is capable of following the prescribed treatment plan.

5. Pharmacist Reviews, Monitors, and Modifies the Therapeutic Plan

The pharmacist is responsible for:

• Monitoring the patient's progress toward desired therapeutic outcomes.
• Assessing the effectiveness and safety of therapy.
• Coordinating changes in therapy with physicians and other healthcare providers.
• Maintaining or improving treatment effectiveness.
• Reducing healthcare costs whenever possible.
• Documenting patient progress accurately.
• Communicating relevant information to patients and healthcare providers.
• Ensuring continuity of care when patients move between community, hospital, and long-term care settings.

Practice Principles of Pharmaceutical Care

A. Data Collection

1. Initial Patient Interview

The pharmacist:

• Establishes a professional relationship with the patient.
• Initiates the patient's pharmacy record.
• Collects essential patient information.

For patients who cannot communicate directly (e.g., pediatric, geriatric, critically ill patients), information may be collected from:

• Parents
• Guardians
• Caregivers

2. Collection of Patient Information

Information collected includes:

• General health status
• Activity status
• Past medical history
• Medication history
• Family history
• Social history
• Economic status
• Present illness
• Patient perceptions and concerns

3. Physical Assessment

The pharmacist may perform:

• Blood pressure monitoring
• Blood glucose monitoring
• Weight assessment
• Other appropriate health assessments

4. Use of Secondary Sources

Additional information may be obtained from:

• Medical records
• Laboratory reports
• Family members
• Physicians
• Nurses
• Other healthcare providers

5. Pharmacy Record Maintenance

The pharmacist should:

• Create and maintain patient records.
• Keep records accurate and up to date.
• Ensure confidentiality and security.
• Release information only with patient consent or as required by law.

B. Information Evaluation

1. Evaluation of Patient Information

The pharmacist evaluates collected data to identify:

• Opportunities to improve therapy.
• Drug-related problems.
• Potential health risks.
• Need for future pharmacist intervention.

2. Documentation

All conclusions and assessments should be documented in:

• Medical records
• Pharmacy records

3. Patient Discussion

The pharmacist explains:

• Disease condition
• Treatment expectations
• Possible outcomes
• Required monitoring

to ensure patient understanding.

C. Formulating a Plan

1. Selection of Appropriate Actions

The pharmacist collaborates with healthcare providers to:

• Improve safety of therapy.
• Improve effectiveness of therapy.
• Improve cost-effectiveness.
• Prevent future health problems.

2. Development of Patient-Specific Plan

The plan may include:

• Modifying drug therapy
• Drug therapy monitoring
• Dietary recommendations
• Lifestyle modifications
• Non-prescription medications
• Non-drug treatments
• Referral to specialists
• Implementation of treatment protocols

3. Establishing Desired Outcomes

For each identified problem:

• Desired outcomes are determined.
• Goals are agreed upon with the patient.
• Monitoring parameters are established.

4. Review with Patient

The pharmacist discusses:

• Treatment plan
• Expected outcomes
• Monitoring requirements

with the patient and healthcare team.

5. Documentation

The complete plan is documented in the patient's records.

D. Implementing the Plan

1. Carrying Out the Plan

Implementation may involve:

• Contacting physicians for clarification.
• Modifying prescriptions.
• Initiating therapy.
• Educating patients and caregivers.
• Arranging medication supply.
• Addressing financial or lifestyle barriers.
• Coordinating referrals.

2. Patient Education

The pharmacist ensures that the patient:

• Understands the treatment plan.
• Knows monitoring requirements.
• Understands medication administration.
• Uses equipment properly.

Examples of monitoring:

• Blood pressure monitoring
• Blood glucose monitoring
• Laboratory investigations

3. Ensuring Availability of Resources

The pharmacist ensures timely access to:

• Medicines
• Medical devices
• Monitoring equipment
• Other supplies

4. Documentation

The pharmacist records:

• Implementation steps
• Baseline monitoring values
• Potential barriers to treatment

5. Communication

The pharmacist communicates the plan to:

• The patient
• Caregivers
• Physicians
• Other healthcare providers

to ensure continuity of care.

E. Monitoring and Modifying the Plan (Ensuring Positive Outcomes)

1. Regular Monitoring

The pharmacist regularly reviews:

• Subjective parameters (symptoms, patient feedback)
• Objective parameters (lab values, BP, glucose levels)

to assess progress.

2. Modification of Plan

If desired outcomes are not achieved:

• The treatment plan is reassessed.
• Necessary changes are made.
• Revised plans are implemented.

3. Progress Reporting

The pharmacist:

• Discusses progress with the patient.
• Provides feedback to healthcare providers.
• Encourages patient adherence.

4. Follow-Up

A follow-up mechanism should be established to:

• Monitor adherence.
• Evaluate outcomes.
• Detect problems early.

5. Updating Records

Patient records should include:

• Current progress
• Monitoring results
• Pharmacist's assessment
• Patient's assessment
• Modifications made to therapy
• Communications with healthcare providers

Quick Exam Points

Pharmaceutical Care:
"The responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life." — Hepler & Strand (1990)

Definite Outcomes of Pharmaceutical Care

1. Cure of disease
2. Elimination or reduction of symptoms
3. Arresting or slowing disease progression
4. Prevention of disease or Symptoms

Steps of Pharmaceutical Care

1. Establish professional relationship.
2. Collect patient-specific information.
3. Evaluate information and develop care plan.
4. Ensure patient has medicines, supplies, and knowledge.
5. Monitor outcomes and modify therapy as needed.

Ultimate Goal of Pharmaceutical Care

To achieve definite therapeutic outcomes and improve the patient's quality of life through safe, effective, and economical drug therapy.

 

 

 

Code of ethics

 

 

Code of Ethics for Community Pharmacists –

Introduction

Ethics means moral principles and is the science of moral duty. A Code of Ethics is a carefully formulated set of principles and rules of professional conduct that guides members of a profession.

The development of a code of ethics reflects the growth of professional values and moral responsibility.

Difference Between Ethics and Law

Ethics	Law
Rules by which a profession regulates the conduct of its members	Rules of human conduct binding on all persons in a state or nation
Enforced by professional bodies	Enforced by government authorities
Violation may result in loss of professional privileges	Violation may result in fines, penalties, or imprisonment
Encourages moral responsibility and service	Prevents harmful actions and maintains order

Law may prevent a person from harming others, but ethics encourages individuals to help others and serve society.

Pharmaceutical Code of Ethics

The pharmacy profession is noble and service-oriented. Pharmacists are responsible for handling, compounding, dispensing, distributing, and selling medicines, including potent and poisonous drugs.

Pharmacists must:

• Safeguard public health.
• Maintain high standards of professional conduct.
• Understand that deviation from ethical standards lowers the status of the profession.
• Fulfil professional obligations honestly and responsibly.
• Uphold the laws of the state and nation.
• Serve society with dedication and integrity.

Ethics of Pharmacists in Relation to Their Job

1. Scope of Pharmaceutical Services

• Pharmaceutical services should be comprehensive and readily available.
• Emergency supplies should be provided whenever required.
• Pharmacy premises must be registered according to statutory requirements.

2. Conduct of the Pharmacy

The pharmacy should:

• Maintain cleanliness and proper conditions.
• Prevent contamination and dispensing errors.
• Reflect a professional appearance.
• Clearly indicate that professional pharmacy practice is being carried out.

Signboards and Notices

• Signs and notices should be modest in size and wording.
• Notices regarding government schemes such as Employees' State Insurance Scheme (ESIS) may be displayed.

Responsibility

• Every pharmacy should be under the personal control of a registered pharmacist.
• The pharmacist is primarily responsible for maintaining professional standards.
• Owners should not obstruct pharmacists in performing their duties.

3. Handling of Prescriptions

When receiving a prescription:

• Accept it without criticizing or commenting on the prescriber's treatment.
• Avoid expressions of surprise or alarm that may create anxiety in patients.
• Answer patient queries carefully and professionally.

Alteration of Prescription

A pharmacist should not:

• Add ingredients.
• Omit ingredients.
• Substitute ingredients.
• Alter the composition of a prescription.

without the consent of the prescriber, except in emergencies or when required purely for pharmaceutical technique without affecting therapeutic action.

Errors in Prescriptions

If there is:

• Omission
• Incompatibility
• Overdose
• Obvious error

The prescription should be referred back to the prescriber for clarification or correction.

Refilling Prescriptions

• Follow only the prescriber's instructions.
• Advise patients to use medicines exactly as directed.

4. Handling of Drugs

A pharmacist should:

• Dispense medicines accurately.
• Weigh and measure ingredients correctly using proper equipment.
• Avoid visual estimation.

Quality of Drugs

Only standard-quality medicines should be used.

A pharmacist must never dispense:

• Spurious drugs
• Substandard drugs
• Unethical preparations

Dangerous and Habit-Forming Drugs

A pharmacist should exercise caution while handling:

• Poisonous drugs
• Narcotic drugs
• Habit-forming substances

Such drugs should not be supplied if there is reason to believe they will be misused.

5. Apprentice Pharmacists

When supervising trainees:

• Provide adequate practical training.
• Ensure development of professional skills and competence.
• Issue certificates only when trainees have achieved the required standards.

Pharmacist in Relation to Trade

1. Price Structure

The price charged should be:

• Fair and reasonable.
• Consistent with the quality and quantity supplied.
• Sufficient to provide proper remuneration for professional knowledge, skill, time, and responsibility.
• Not excessive or exploitative.

2. Fair Trade Practices

A pharmacist should not:

• Engage in cut-throat competition.
• Offer gifts, prizes, or inducements to attract customers unfairly.
• Deliberately charge unreasonably lower prices to harm competitors.

Professional Courtesy

If a prescription or order intended for another pharmacy is received by mistake:

• Refuse to accept it.
• Direct the customer to the correct pharmacy.

Intellectual Property

A pharmacist should not imitate or copy:

• Labels
• Trademarks
• Trade names
• Symbols of other pharmacies

3. Purchase of Drugs

Drugs should always be purchased from:

• Genuine manufacturers
• Reputable wholesalers
• Authorized distributors

A pharmacist should never aid or support:

• Manufacture of spurious drugs
• Distribution of counterfeit drugs
• Sale of substituted drugs
• Illegal possession of medicines

Pharmacist in Relation to Trade

4. Hawking of Drugs

• Hawking (door-to-door selling) of drugs and medicinal products should not be encouraged.
• Pharmacists should not solicit orders for medicines by visiting homes or through unauthorized marketing methods.
• Self-service drug stores should be discouraged because:
• Medicines may be distributed without professional supervision.
• It promotes self-medication.
• It increases the risk of misuse of drugs.

5. Advertising and Displays

Advertisements should be ethical, dignified, and professional.

A pharmacist should not use advertisements that contain:

Prohibited Advertising Practices

a) Wording, designs, or illustrations that reflect unfavorably on pharmacists or the profession.

b) Direct or indirect criticism of competitors, products, remedies, or treatments.

c) Misleading, false, or exaggerated claims.

d) Use of the word "Cure" for any disease or illness.

e) Guarantees of therapeutic effectiveness.

f) Appeals to fear or anxiety.

g) Offers of money refunds for medicines.

h) Prize competitions, gifts, or lottery schemes.

i) References to doctors, hospitals, nurses, or use of terms such as "Doctor (Dr.)" or "Nurse" in relation to a medicine unless already established.

j) References to sexual weakness, premature ageing, or loss of virility.

k) Indecent or improper references to sexual disorders.

Display of Advertised Products

• A pharmacist should not display or promote products known to be advertised through unethical or misleading advertisements.

Pharmacist in Relation to the Medical Profession

1. Limitation of Professional Activity

Medical Practitioners

• Medical practitioners should generally avoid owning drug stores because it may encourage:
• Coded prescriptions
• Monopolistic practices
• Conflict of interest
• Harm to patients and the pharmacy profession

Pharmacists

A pharmacist must not:

• Diagnose diseases.
• Prescribe medicines independently.
• Practice medicine even if requested by patients.

Exception

• In accidents and emergencies, a pharmacist may provide First Aid until medical assistance becomes available.

Recommendation of Doctors

• A pharmacist should not recommend a particular doctor unless specifically asked by the patient.

2. Clandestine Arrangements

A pharmacist should never:

• Enter into secret agreements with physicians.
• Offer commissions, gifts, or financial benefits to doctors.
• Provide incentives in exchange for referrals or patronage.

Such practices are unethical and damage professional integrity.

3. Liaison with the Public

The pharmacist acts as a bridge between the medical profession and the public.

Professional Development

A pharmacist should:

• Keep up-to-date with advances in pharmacy and allied sciences.
• Regularly read:
• Books
• Journals
• Scientific magazines
• Professional publications

Public Education

A pharmacist should educate the public about:

• Health promotion
• Disease prevention
• Hygiene
• Sanitation
• Rational use of medicines

Contribution to Society

• Participate in nation-building activities.
• Promote public health awareness.
• Contribute to advancement of pharmaceutical knowledge.

4. Confidentiality

A pharmacist must:

• Maintain confidentiality of patient information.
• Never disclose information obtained during professional practice.

Disclosure Allowed Only When:

• Required by law.
• Ordered by a competent legal authority.

Maintaining patient trust is an essential ethical duty.

Pharmacist in Relation to His Profession

1. Professional Vigilance

A pharmacist should:

• Follow all pharmaceutical laws and regulations.
• Encourage others to comply with professional standards.
• Report unethical and illegal practices.

Professional Responsibility

• Support fellow pharmacists in legitimate scientific and professional matters.
• Help eliminate unethical individuals from the profession.
• Preserve the dignity and reputation of pharmacy.

2. Law-Abiding Citizen

A pharmacist should:

• Be a responsible citizen.
• Have adequate knowledge of relevant laws.

Important Areas of Law

• Drug laws
• Pharmacy laws
• Food laws
• Health laws
• Sanitation regulations

A pharmacist should comply with these laws in both professional and personal life.

3. Relationship with Professional Organizations

A pharmacist should:

• Join professional pharmacy organizations.
• Support activities that improve:
• Scientific knowledge
• Professional standards
• Moral values
• Cultural development of pharmacists

Such organizations should not conflict with the Code of Pharmaceutical Ethics.

4. Decorum and Propriety

A pharmacist should:

• Maintain dignity and professionalism.
• Avoid actions that bring disrepute to:
• Himself/Herself
• The pharmacy profession
• Professional colleagues

Pharmacist's Oath

A pharmacist solemnly pledges to:

1. Follow the Code of Ethics prescribed by the Pharmacy Council.
2. Act as an integral member of the healthcare team.
3. Uphold laws and professional standards.
4. Continuously improve knowledge and skills.
5. Provide the best pharmaceutical care and patient counseling.
6. Contribute to the advancement of pharmacy and public health.
7. Help discover, develop, and manufacture quality medicines.
8. Maintain confidentiality of patient information.
9. Support professional pharmacy organizations.
10. Serve humanity with honesty, dedication, and integrity.

 

Quick Exam Points

1. Ethics = Moral principles guiding professional conduct.
2. Law = Rules enforced by government.
3. Pharmacist should not alter a prescription without prescriber's consent.
4. Emergency pharmaceutical services should be available at all times.
5. Only standard-quality drugs should be dispensed.
6. Cut-throat competition is unethical.
7. Drugs should be purchased only from genuine and reputable sources.
8. Pharmacists must protect public health and uphold professional dignity.
9. Poisonous and habit-forming drugs require special caution.
10. The pharmacist in charge is responsible for maintaining ethical standards in the pharmacy.

 

OTC Medications

OTC (Over-the-Counter) Medications

Definition

OTC medicines are drugs that are considered safe and effective for the treatment of minor ailments and can be sold by a pharmacist without a valid prescription.

Self-Medication

• Selection and use of medicines by individuals to treat self-recognized minor illnesses.
• Promoted by World Health Organization for quick relief where healthcare access is limited.
• Also called responsible self-medication when used appropriately.

Classification of Medicines

1. Prescription Medicines

• Dispensed only with a valid prescription.

2. Pharmacist-Only Medicines

• Supplied by pharmacists based on professional judgment.

3. OTC Medicines

• Available without prescription.
• Used for minor ailments such as:
• Headache
• Fever
• Cold
• Indigestion

Advantages of OTC Medicines

Advantages

1. Safe and effective when used correctly.
2. Approved by regulatory authorities.
3. No consultation fee.
4. Saves waiting time.
5. Easily accessible.
6. Cost-effective.
7. Reduces burden on healthcare facilities.

OTC Drug Categories

1. H₂-Receptor Antagonists

Uses

• Heartburn
• Acid indigestion
• Sour stomach

Examples

Drug	Dose
Cimetidine	200 mg BD
Famotidine	10–20 mg daily
Nizatidine	75 mg BD
Ranitidine*	75 mg BD

Note: Do not use for more than 2 weeks without medical advice.

Mnemonic: CFNR = Cimetidine, Famotidine, Nizatidine, Ranitidine

2. Acne Preparations

Example

• Benzoyl Peroxide (2.5%, 5%, 10%)

Uses

• Mild to moderate acne

Directions

• Apply once or twice daily.
• Reduce frequency if irritation occurs.

3. Allergy and Cold Preparations

Antihistamines

Drug	Dose
Chlorpheniramine	4 mg every 4–6 h
Brompheniramine	4 mg every 4–6 h
Clemastine	1.34 mg every 12 h
Diphenhydramine	25–50 mg every 4–6 h

Key Point

• Relieve symptoms of allergic rhinitis and hay fever.
• Diphenhydramine causes significant drowsiness.

Mnemonic: "CBDC"

• Chlorpheniramine
• Brompheniramine
• Diphenhydramine
• Clemastine

4. Analgesics and Antipyretics

Uses

• Pain
• Fever

Drug	Dose
Aspirin	300–600 mg every 4–6 h
Acetaminophen (Paracetamol)	300–600 mg every 4–6 h
Ibuprofen	200–400 mg every 4–6 h
Naproxen	200 mg every 8–10 h
Ketoprofen	12.5 mg every 4–6 h

Important Points

• Acetaminophen has no anti-inflammatory action.
• Suitable liquid formulations available for children.

Mnemonic: AAINK

• Aspirin
• Acetaminophen
• Ibuprofen
• Naproxen
• Ketoprofen

5. Antacids

Example

• Magnesium hydroxide + Aluminum hydroxide

Uses

• Hyperacidity
• Gastric discomfort

Advantage

• Balanced combination reduces constipation and diarrhea.

6. Anthelmintics

Example

• Pyrantel Pamoate

Dose

• 11 mg/kg

Important Points

• Treat all household members.
• Maintain environmental hygiene to prevent reinfection.

7. Antidiarrheal Agents

A. Bismuth Subsalicylate

• 600 mg four times daily

B. Loperamide

• Initial: 4 mg
• Then: 2 mg after each loose stool
• Maximum: 16 mg/day

Important Points

• Loperamide is a synthetic opioid that does not cross the CNS.
• Avoid in febrile diarrhea.

Mnemonic: BL

• Bismuth
• Loperamide

8. Topical Antifungal Preparations

Drug	Formulation
Clotrimazole	1% cream, vaginal insert
Tolnaftate	1% cream/solution/powder
Miconazole	2% cream, vaginal tablet

Uses

• Tinea pedis
• Tinea cruris
• Tinea corporis
• Candidiasis

Mnemonic: CTM

• Clotrimazole
• Tolnaftate
• Miconazole

9. Topical Anti-inflammatory Preparations

Example

• Hydrocortisone 0.5–1%

Uses

• Insect bites
• Allergic dermatitis
• Contact dermatitis
• Hemorrhoids

Application

• Apply 3–4 times daily.

10. Anti-Seborrheal Agents

Examples

Drug	Strength
Selenium Sulfide	1–2%
Zinc Pyrithione	1–2%

Uses

• Dandruff
• Seborrheic dermatitis

Directions

• Apply to scalp for 5–10 minutes.
• Use 2–3 times weekly.

Mnemonic: SZ

• Selenium sulfide
• Zinc pyrithione

11. Antitussives

Examples

Drug	Dose
Codeine + Guaifenesin	10–20 mg every 4–6 h
Dextromethorphan + Guaifenesin	10–20 mg every 4 h or 30 mg every 6 h

Uses

• Dry cough

Mnemonic: CD

• Codeine
• Dextromethorphan

12. Decongestants

Topical

• Oxymetazoline
• Xylometazoline
• Phenylephrine

Oral

• Pseudoephedrine
• Phenylpropanolamine

Uses

• Nasal congestion
• Rhinorrhea

Key Point

• Pseudoephedrine has the least CNS stimulation.

Mnemonic: OXPP

• Oxymetazoline
• Xylometazoline
• Phenylephrine
• Pseudoephedrine

13. Expectorants

Example

• Guaifenesin

Use

• Facilitates mucus removal from respiratory tract.

Important Point

• Only expectorant with good evidence of efficacy.

14. Laxatives

Types

A. Bulk Forming

• Increase stool bulk.

B. Stool Softeners

• Docusate sodium.

C. Saline Laxatives

• Used for acute constipation.

Important Point

• Bulk-forming agents and stool softeners are safest for long-term use.

Quick Revision Table

Category	Example
H₂ Blocker	Famotidine
Acne Drug	Benzoyl peroxide
Antihistamine	Chlorpheniramine
Analgesic	Paracetamol
Antacid	Mg(OH)₂ + Al(OH)₃
Anthelmintic	Pyrantel pamoate
Antidiarrheal	Loperamide
Antifungal	Clotrimazole
Anti-inflammatory	Hydrocortisone
Anti-seborrheal	Selenium sulfide
Antitussive	Dextromethorphan
Decongestant	Pseudoephedrine
Expectorant	Guaifenesin
Laxative	Docusate sodium

Exam Mnemonic for OTC Categories

"Happy Acne Allergies And Antacids Avoid Diarrhea; Fungi Hate Seborrhea, Tough Colds Expect Laxatives."

(H₂ blockers → Acne → Allergy → Analgesics → Antacids → Anthelmintics → Diarrheals → Antifungals → Hydrocortisone → Seborrhea → Antitussives → Decongestants → Expectorants → Laxatives)

15. Pediculicides (Anti-Lice Agents)

Uses

Treatment of head lice (Pediculosis).

Examples

1. Permethrin 1%
2. Pyrethrins + Piperonyl Butoxide

Directions for Use

• Apply to dry hair and scalp.
• Wet entire scalp and hair thoroughly.
• Leave for 10 minutes.
• Add water, lather, and rinse.
• Avoid contact with eyes.
• Comb out nits (lice eggs).
• Repeat treatment if reinfestation occurs.

Counseling Points

• Wash combs, brushes, bedding, and clothing.
• Check family members for infestation.
• Avoid eye contact.

Mnemonic: PP = Permethrin + Pyrethrins

16. Sleep Aids

Example

Diphenhydramine

Dose

25–50 mg at bedtime

Mechanism

• First-generation antihistamine
• Produces CNS depression and sedation

Uses

• Temporary management of insomnia

Adverse Effects

• Drowsiness
• Dry mouth
• Dizziness

Counseling

• Avoid alcohol.
• Do not drive or operate machinery after use.

17. Smoking Cessation Aids

Examples

1. Nicotine
2. Nicotine Polacrilex (Nicotine Gum)

Uses

Helps reduce nicotine withdrawal symptoms during smoking cessation.

Important Points

• Requires gradual dose reduction (weaning).
• Follow instructions carefully.
• Quit rates are higher than placebo.

Counseling

• Do not smoke while using nicotine replacement therapy.
• Follow prescribed schedule for tapering.

Hidden Ingredients in OTC Products

Important Note

Many OTC medicines contain potent ingredients that patients may not recognize.

Problems

• Drug duplication
• Drug interactions
• Diagnostic confusion
• Increased adverse effects

Pharmacist's Role

• Review all prescription and OTC medicines.
• Identify duplicate ingredients.
• Prevent interactions.

OTC Counseling Questions

Purpose

To collect adequate information before recommending an OTC product.

Patient Assessment Questions

Medication History

• Which prescription medicines do you take regularly?
• Which OTC medicines are you currently using?
• Do you use herbal medicines?

Disease History

• What symptoms are you experiencing?
• How long have you had these symptoms?
• Have you consulted a doctor?

Previous Experience

• Have you used this medicine before?
• Did you experience any side effects?

Demographic Information

• Age
• Sex
• Pregnancy status
• Breastfeeding status
• Allergies
• Weight

Mnemonic: WWHAM

• W – Who is the patient?
• W – What are the symptoms?
• H – How long have symptoms been present?
• A – Action taken already?
• M – Medication being taken?

Patient Counseling Steps

Step 1: Introduction

The pharmacist should:

• Introduce himself/herself.
• Establish rapport.
• Explain available assistance.
• Discuss appropriate OTC product selection.

Step 2: Information Collection

Gather Information About

A. Patient Factors

• Age
• Sex
• Pregnancy
• Breastfeeding
• Weight
• Allergies
• Social history

B. Disease Factors

• Present illness
• Symptoms
• Duration of illness
• Past medical history
• Coexisting diseases

C. Drug Factors

• Current medications
• Previous medication history
• OTC drug history

Information to be Provided During Counseling

1. Drug Name

• Generic name
• Brand name

2. Dosage Information

• Dose
• Route
• Dosage form
• Frequency

3. Special Instructions

• Preparation
• Administration
• Precautions

4. Self-Monitoring

• How to monitor effectiveness
• Warning signs requiring medical attention

5. Storage Conditions

• Temperature
• Moisture protection
• Child safety

6. Drug Interactions

• Drug-drug interactions
• Drug-food interactions
• Contraindications

Counseling for Special Dosage Forms

The pharmacist should demonstrate proper use of:

• Inhalers
• Eye drops
• Ear drops
• Nasal sprays
• Ointments
• Patches
• Lozenges
• Gargles

Patients should repeat the demonstration to ensure understanding.

Counseling Points for NSAIDs

Common OTC NSAIDs

• Paracetamol*
• Ibuprofen
• Diclofenac

(*Paracetamol is technically an analgesic-antipyretic, not a true NSAID.)

Uses

• Fever
• Headache
• Musculoskeletal pain
• Joint pain

Important Adverse Effects

• Gastric irritation
• Peptic ulcer disease
• Renal impairment

Counseling Points

✓ Take after food.

✓ Drink plenty of water.

✓ Consult a doctor if symptoms persist.

✓ Asthmatic patients should use cautiously.

✓ Avoid combining aspirin with other NSAIDs without medical advice.

✓ Inform healthcare providers about NSAID use.

✓ Store safely away from children.

Warning Signs

Seek immediate medical care if:

• Facial swelling
• Leg swelling
• Reduced urine output
• Severe allergic reactions
• Confusion

Counseling Points for Antibiotics

Key Principle

Antibiotics should be used only under medical supervision.

Counseling Points

✓ Take at prescribed times.

✓ Complete the full course.

✓ Store properly.

✓ Keep away from children.

✓ Do not double doses after a missed dose.

✓ Report adverse effects promptly.

✓ Consult pharmacist regarding interactions.

Important Message

Incomplete antibiotic courses can contribute to antimicrobial resistance.

Counseling Points for Cold and Cough Medicines

Uses

Relief of:

• Sneezing
• Runny nose
• Nasal congestion
• Cough

Counseling Points

✓ May cause drowsiness.

✓ Avoid driving and operating machinery.

✓ Can cause dry mouth, nose, and throat.

✓ Sugar-free candies or ice chips may help relieve dryness.

✓ Decongestants may cause insomnia and restlessness.

✓ Take the last dose several hours before bedtime.

✓ Consult a healthcare professional before use with:

• CNS depressants
• MAO inhibitors

Special Populations

• Pregnant and breastfeeding women should seek medical advice before use.

Role of Community Pharmacist in OTC Dispensing

Responsibilities

1. Patient Education

• Promote safe medication use.
• Improve adherence.

2. Assessment of Minor Ailments

Common complaints:

• Headache
• Sore throat
• Common cold
• Cough
• Diarrhea
• Dysmenorrhea
• Body aches

3. Identification of Drug Interactions

Review all medications before recommending OTC products.

Clinical Example 1

Hypertensive Patient with Cold

Patient:

• Hypertension
• Taking antihypertensive drugs

Avoid:

• Phenylpropanolamine-containing cold preparations

Reason:

• May increase blood pressure.

Clinical Example 2

Ciprofloxacin + Antacid

Problem:

• Antacids reduce absorption of ciprofloxacin.

Counseling:

• Maintain at least 2-hour gap before or 4–6-hour gap after antacid administration.

Result:

• Better antibiotic effectiveness.

Exam-Oriented Quick Revision

Pediculicide

→ Permethrin 1%

Sleep Aid

→ Diphenhydramine

Smoking Cessation

→ Nicotine gum

OTC Assessment Tool

→ WWHAM

Common OTC Interaction

→ Ciprofloxacin + Antacid

NSAID Counseling

→ Take after food and with plenty of water

Cold Medicine Counseling

→ May cause drowsiness; avoid driving

Community Pharmacist Role

→ Assess, Counsel, Prevent Interactions, Monitor Outcomes

5-Mark Question: Role of Community Pharmacist in OTC Dispensing

1. Assess patient symptoms.
2. Obtain medication history.
3. Identify contraindications and interactions.
4. Recommend appropriate OTC medicine.
5. Counsel on dosage, administration, storage, and adverse effects.
6. Refer to a physician when necessary.
7. Promote rational and safe use of medicines.