Essential Principles of Hospital Pharmacy and Patient Safety

Key Terminology in Pharmacy and Healthcare

NICU (Neonatal Intensive Care Unit)

NICU stands for “Neonatal Intensive Care Unit.” It is a specialized unit in a hospital that provides intensive care for newborn infants with complex health problems.

Pharmacovigilance

Pharmacovigilance is the science and activity of detecting, assessing, understanding, and preventing adverse effects or any other problem related to medicine or vaccines.

LASA (Look-Alike, Sound-Alike) Drugs

LASA drugs are medications that have similar names or packaging but differ in their active ingredients or dosages, which can lead to medication errors.

Medication Error

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient.

Antenatal and Prenatal Care

Antenatal care, also known as prenatal care, is the medical and lifestyle support provided to a pregnant woman and her baby throughout pregnancy.

Drug Interaction

A drug interaction is a change in how a drug acts in the body when taken with another substance, such as another drug, food, or supplement.

Tests for Cardiac Disorders

Common tests associated with cardiac disorders include electrocardiograms (ECGs), echocardiograms, blood tests, and imaging techniques like CT scans and MRIs.

FIFO (First In, First Out)

The full form of FIFO is “First In, First Out,” an inventory management principle.

DPIC (Drug and Poison Information Center)

The Drug and Poison Information Center (DPIC) is a primary resource for poison education, prevention, and treatment advisories, aimed at providing a complete range of drug and poison decontamination treatment services.

Inventory Management

Inventory management refers to the process of ordering, storing, using, and selling a company’s inventory, which includes raw materials, components, and finished goods.

Examples of Antidotes

Common antidotes include activated charcoal, acetylcysteine, naloxone, and sodium bicarbonate.

Hospital and Clinical Pharmacy

Hospital pharmacy is a specialized field of pharmacy integrated into the care of a medical center. Clinical pharmacy is a specialty within pharmacy practice focused on patient care and optimizing medication therapy to improve health outcomes.

Understanding Hematological Tests

Significance and Interpretation

Hematological tests evaluate numerous conditions involving blood and its components. They can be used to diagnose inflammation, anemia, infection, hemophilia, blood-clotting disorders, leukemia, and the response to chemotherapy, among many other things. A hematology test is any test that requires blood or its components to provide a doctor with information about what is happening in the blood. The most common hematology tests include:

  • Complete Blood Count (CBC): This test counts the number of white blood cells, red blood cells, platelets, and more. It helps diagnose anemia, some blood cancers, inflammatory diseases, infections, and other health concerns. A CBC measures several components and features of your blood and is tested on whole blood.
  • Platelet Count: This test is included in a CBC but can also be done on its own to monitor clotting or bleeding disorders.

Fluid and Electrolyte Balance

Electrolytes are minerals in your body that have an electric charge. They are found in your blood, urine, tissues, and other body fluids. Electrolytes like sodium, calcium, potassium, chloride, phosphate, and magnesium are important because they help:

  • Balance the amount of water in your body.
  • Balance your body’s acid/base (pH) level.
  • Move nutrients into your cells.
  • Move waste out of your cells.
  • Ensure that your nerves, muscles, heart, and brain work as they should.

You get electrolytes from the foods you eat and the fluids you drink. The levels of electrolytes in your body can become too low or too high when the amount of water in your body changes. The amount of water you take in should equal the amount you lose. If something upsets this balance, you may have too little water (dehydration) or too much water (overhydration). Some medicines, vomiting, diarrhea, sweating, and liver or kidney problems can all upset your water balance. Treatment helps manage the imbalance and involves identifying and treating its cause.

Drug and Poison Information Center (DPIC) Services

A Drug and Poison Information Center (DPIC) is a specialized facility that provides information about drugs and poisons to healthcare professionals, patients, and the general public. These centers serve as a valuable resource for the education, prevention, and treatment of drug-related problems.

Objectives

  • To provide independent, unbiased, authentic, accurate, and objective drug information to assist health professionals in rational prescribing to optimize patient care.
  • To advise the general public regarding the safe, effective, and economic use of medicines.

Requirements

Requirements for a DPIC may vary by country, but generally, it should have a team of experts, including pharmacists, toxicologists, and healthcare professionals with expertise in drug-related issues. The center must also have access to a comprehensive database of information on drugs and poisons, as well as the ability to perform research on drug-related issues.

Information Resources

  • Databases: DPICs often maintain their own databases with information on pharmacology, toxicology, interactions, side effects, and dosing guidelines.
  • Online Resources: DPICs may offer online resources, such as websites, apps, or chatbots, where people can access information.
  • Phone Helplines: Many DPICs offer phone helplines for people to speak with a healthcare professional or pharmacist.

Services Offered

Services offered by the DPIC at the Department of Pharmacy, University of Peshawar, include guidance on:

  • Choice of Therapy
  • Medicine Dose
  • Duration of Therapy
  • Drug Identification
  • Therapeutic Alternatives
  • Drug Interactions & Their Management
  • Drugs Contraindicated in Pregnancy and During Lactation

Pharmacovigilance: Ensuring Drug Safety

Pharmacovigilance is defined as ‘the activities involved in the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.’

Aim of Pharmacovigilance

  • The primary aim is to detect Adverse Drug Reactions (ADRs), which are any harmful or unintended effects associated with the use of medicines. Timely detection can help prevent serious harm.
  • It aims to minimize the risks associated with medicine use, which can involve changing how a medicine is used or updating product labeling or packaging.
  • It aims to promote public health by ensuring that medicines are used safely and effectively.

Scope of Pharmacovigilance

  • It involves activities related to understanding, assessing, detecting, and preventing adverse effects or any other drug-related problems. It is a continuous process for safety evaluation.
  • It is a science important for reversing most adverse effects by modifying the dose or omitting the offending drug.
  • Knowledge on the safety of drugs is obtained from daily clinical usage involving patients, health professionals, regulatory authorities, and pharmaceutical companies.
  • In pharmaceutical companies, it involves monitoring the safety of a drug post-launch.
  • The implementation of pharmacovigilance is growing steadily in the Indian healthcare system with increasing awareness among patients and health professionals.

Managing LASA (Look-Alike, Sound-Alike) Drugs

“LASA” stands for “Look-Alike, Sound-Alike” drugs, which are medications that have similar names or packaging but differ in their active ingredients or dosages. This can lead to medication errors if healthcare providers or patients mistake one drug for another. To prevent these errors, healthcare providers should always double-check the medication name and dosage before administering or prescribing it. Patients should always confirm with their healthcare provider or pharmacist that they have received the correct medication. It is also important to store medications in their original packaging and keep a current list of all medications, including their names, dosages, and purposes.

Common Risk Factors

  • Illegible handwriting
  • Incomplete knowledge of drug names
  • Newly available products
  • Similar packaging or labeling

Strategies to Avoid Errors

  • Procurement and Storage
  • Prescribing
  • Dispensing and Supply
  • Administration

Clinical Significance of Drug Interactions

  1. Decreased Effectiveness: When two drugs interact, the effectiveness of one or both may be reduced. This can result in a decreased therapeutic effect, leading to inadequate treatment.
  2. Increased Toxicity: Drug interactions can increase the risk of adverse effects or toxicity. For example, when two drugs metabolized by the same enzyme are taken together, they may compete, leading to an accumulation of one or both drugs.
  3. Altered Pharmacokinetics: Interactions can alter the pharmacokinetics (how the drug is absorbed, distributed, metabolized, and eliminated) of one or both medications, affecting their blood levels, effectiveness, and toxicity.

Understanding Poisoning

A poison is any substance that is harmful to your body. You might swallow, inhale, inject, or absorb it through your skin. Any substance can be poisonous if too much is taken. Poisons can include:

  • Prescription or over-the-counter medicines taken in doses that are too high
  • Overdoses of illegal drugs
  • Carbon monoxide from gas appliances

Types of Poisoning

  1. Ingestion Poisoning: Occurs when someone swallows a toxic substance. Examples include household cleaners, medications, and poisonous plants.
  2. Inhalation Poisoning: Occurs when someone breathes in toxic fumes or gases, such as carbon monoxide or chlorine gas.
  3. Injection Poisoning: Occurs when a toxic substance is injected into the body, such as through contaminated needles. This is commonly associated with drug abuse.
  4. Absorption Poisoning: Occurs when a toxic substance is absorbed through the skin. Examples include pesticides, lead, and mercury.
  5. Radiation Poisoning: Occurs when the body is exposed to high levels of ionizing radiation, which can cause radiation sickness, cancer, and organ damage.

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Types of Drug Interactions

Hospital Pharmacy: Definition and Scope

Hospital pharmacy is a specialized field of pharmacy that is integrated into the care of a medical center, such as a hospital, outpatient clinic, drug-dependency facility, poison control center, drug information center, or residential care facility.

Scope of Hospital Pharmacy

  1. To ensure the availability of the right medication at the right time in the right dose at the minimum possible cost.
  2. To professionalize the functioning of pharmaceutical services in a hospital.
  3. To act as a data bank on drug utilization.
  4. To participate in research projects.
  5. To coordinate and cooperate with other departments of the hospital.

Pharmacy and Therapeutics (P&T) Committee

Composition

The committee typically includes:

  • The Medical Superintendent (Chairman)
  • Chief of Pharmacy Services (Secretary)
  • One representative each from the departments of:
    • Internal Medicine
    • Surgery
    • Clinical Pharmacology
    • Microbiology
    • Nursing
    • Nutrition

Functions

  • Maintain the Drug Formularies to promote safety, effectiveness, and affordability.
  • Oversee Commercial Drug Formularies, the Medicare Formulary, and State Program Formularies.
  • Maintain pharmacy-related medical policies that promote the safety, effectiveness, and affordability of medications used in clinic settings.

Hospital Formulary

The hospital formulary is a continuously revised compilation of pharmaceutical dosage agents and their forms which reflects the current clinical judgment of the medical staff. The hospital formulary system is a method whereby the medical staff of a hospital, with the help of the P&T committee, selects and evaluates medical agents and their dosage forms which are considered to be most useful in patient care.

Healthcare Quality and Accreditation Standards

NQAS (National Quality Assurance Standards)

The NQAS program was initiated by the Ministry of Health and Family Welfare to highlight top-performing facilities and enhance the reliability of public hospitals in the community.

Organizational Structure

  1. State Quality Assurance Committee (SQAC): A state-level organization responsible for policy decisions, guidance, and QA initiatives. Its main responsibility is to regulate, guide, and monitor the districts’ QA initiatives.
  2. District Quality Assurance Committee (DQAC): A district-level organization with a District Quality Assurance Unit (DQAU) as a functional body that performs various duties.

Areas of Focus

  • Service Provision
  • Patient Rights
  • Infection Control
  • Quality Management
  • Hand Washing Facilities
  • Postpartum Care (ensuring hormonal levels and uterus size return to a non-pregnant state after 6 weeks of childbirth)
  • Oxytocin administration within 60 seconds of childbirth
  • Availability of curtains for privacy

NABH (National Accreditation Board for Hospitals)

The National Accreditation Board for Hospitals and Healthcare Providers (NABH) is a constituent board of the Quality Council of India (QCI) established to create and operate a Hospital Accreditation Program for healthcare organizations.

Aim

To operate accreditation and allied programs with stakeholders, focusing on patient safety and quality of healthcare based on national/international standards, through a process of self and external evaluation.

Benefits of Accreditation

  • High-quality medical care and patient safety are the results of accreditation.
  • Patients receive services from licensed medical personnel.
  • Patients’ rights are valued and protected.
  • Patient satisfaction can be assessed.

High-Risk and Emergency Medications

High-Risk Drugs

High-risk drugs are medicines that can cause significant harm to the patient; they may cause serious side effects, especially when administered incorrectly or when a dose is calculated incorrectly.

Examples of High-Risk Drugs

  1. Adrenergic Agonists IV: Epinephrine, Norepinephrine
  2. Adrenergic Antagonists IV: Propranolol, Prazosin, Atenolol
  3. Anesthetic Agents (General, Inhaled, and IV): Ketamine, Propofol
  4. Antiarrhythmic Agents: Lidocaine, Procainamide
  5. Antithrombotic Agents (Anticoagulants): Heparin, Argatroban
  6. Hypoglycemic Agents: Metformin
  7. Sedative Agents: Alprazolam, Diazepam
  8. Narcotic Drugs: Codeine, Morphine
  9. Neuromuscular Blocking Agents: Succinylcholine
  10. Insulin (IV and Subcutaneous)

Emergency Drugs and Schedule H1 Drugs

Emergency drugs are essential to meet the immediate therapeutic needs of patients and are not available from any other approved source in the required time to prevent risk or harm.

List of Emergency Drugs

  1. Life-saving drugs: Atropine, Adrenaline
  2. Painkillers (Analgesics): Paracetamol
  3. Cardiac drugs: Dopamine
  4. Respiratory drugs: Dexamethasone
  5. Gastrointestinal drugs: Drotaverine
  6. Central nervous system drugs: Phenytoin, Magnesium Sulphate
  7. Obstetrics: Drotaverine
  8. Allergy: Dexamethasone
  9. Antibiotics: Monocef

Schedule H1 drugs comprise sensitive antibiotics, habit-forming medications, and drugs with severe side effects if used without the supervision and prescription of a registered medical practitioner.

  • List of Schedule H1 Drugs: Ethambutol hydrochloride, Ethionamide, Isoniazid, Levofloxacin, Moxifloxacin, Pyrazinamide, Rifabutin, Rifampicin.

Cold Chain Management

Maintaining a cold chain means providing a 2-8°C temperature for any product, like vaccines, during manufacturing, storing, transporting, and distribution to maintain its potency.

Devices Used for Cold Storage

  1. Refrigerator
  2. Thermometer to indicate the temperature level.
  3. Cold boxes for storage and transportation.
  4. Ice packs

Specialized Equipment

  • Ice-Lined Refrigerators (ILRs): These have an extra function where cold ice water or ice packs are filled. They maintain the inside temperature at a safe level in case of electricity failure.
  • Walk-In Cold Rooms (WIC): This is a cold storage solution on a large scale that provides a constant and comfortable temperature throughout the space.

Inventory Management: FEFO and FIFO Methods

  • FIFO (First In, First Out): A method in which the product that came first into the warehouse is taken out first to avoid expiration.
  • FEFO (First Expire, First Out): In this method, the products whose expiry date is closest are taken out first to avoid expiration.

Advantages

  • Reduction of obsolete stock
  • Spending cuts for warehouse logistics
  • Increase in customer satisfaction rate
  • Reducing the impact of inflation on business

Disadvantages

  • An accurate product tracking system is required.
  • Warehouse space has to be well-organized.
  • Difficult to scale up a business.
  • Higher taxes

Role of Pharmacists in Preventing Antimicrobial Resistance

Pharmacists’ responsibilities for antimicrobial stewardship and infection prevention include promoting the optimal use of antimicrobial agents, reducing the transmission of infections, and educating health professionals, patients, and the public.

  • Pharmacists have a significant impact on antimicrobial stewardship teams in a community setting.
  • Pharmacists improve patient outcomes after emergency department discharge.
  • Pharmacists play a key role in educational interventions.
  • Pharmacist-led antimicrobial therapy significantly decreases the duration of IV treatment.

Technology and Patient Care in Pharmacy

Software Used in Hospital Pharmacy

Common software includes Cerner Pharmacy, McKesson Pharmacy Systems, Epic Willow, and Allscripts Pharmacy.

Patient Populations

  • Geriatrics: The medical specialty dedicated exclusively to providing high-quality, patient-centered care for older adults.
  • Pediatrics: The branch of medicine dealing with the health and medical care of infants, children, and adolescents from birth up to the age of 18.
  • In-patient: Someone who stays in the hospital while they receive their treatment.
  • Out-patient: A patient who visits a hospital for diagnosis or treatment without staying overnight.

Good Pharmacy Practice (GPP)

Good Pharmacy Practice (GPP) is an international standard for pharmacy services focused on providing patients with quality, evidence-based care. It is at the very heart of the profession, expressing a covenant with the patient not only to “do no harm” but also to facilitate good therapeutic outcomes with medicines. GPP responds to the needs of the people who use pharmacists’ services to provide optimal care. To support this practice, it is essential that there be an established national framework of quality standards and guidelines.

Organizational Structure of a Hospital Pharmacy

Location and Layout

  • The pharmacy should be situated on the ground or first floor to ease accessibility and provide adequate service to various departments and nursing stations.
  • If the hospital has an out-patient department, the pharmacy or its branch should be near it.
  • The layout should be such that a continuous flow of personnel and materials is maintained.
  • The design and construction should consider functionality, supporting personnel and inventory movement, work processes, and activities.
  • It should include built-in storage for documents, bulk supplies, and portable medical gas cylinders.

Role of Pharmacists in Hospital Pharmacy

  1. Review Prescriptions
  2. Dispense Prescription / Non-Prescription Medicines
  3. Provide Patient Counseling / Education
  4. Manage Hospital and Community Pharmacy Operations
  5. Serve as Experts on Medications
  6. Maintain Proficiency on Drugs / Pharmaceuticals
  7. Demonstrate Entrepreneurship and Leadership
  8. Deliver Primary and Preventive Healthcare
  9. Adhere to Professional, Ethical, and Legal Practices
  10. Engage in Continuing Professional Development

Inventory Control Techniques

Inventory refers to a company’s goods and products that are ready to sell, along with the raw materials used to produce them. It can be categorized as raw materials, work-in-progress, and finished goods.

ABC Analysis

An inventory management technique that determines the value of inventory items based on their importance to the business.

VED Analysis

An inventory management strategy that classifies materials according to their importance (Vital, Essential, Desirable).

Economic Order Quantity (EOQ)

A method to purchase the appropriate quantity of raw material for manufacturing at one time to minimize ordering and carrying costs.

  • Ordering Cost: Includes all expenses related to ordering, like travel costs.
  • Carrying Cost: Includes all expenses related to goods, like transportation charges, insurance, and storage expenses.

Compounding in Hospitals

Compounding in hospitals refers to the process of preparing and mixing medications in a controlled environment, such as a pharmacy. This can include creating new formulations, adjusting the strength of medications, or combining multiple medications into a single dose.

Reasons for Compounding

  • Limited number of available dosage forms.
  • Limited number of available drug strengths.
  • Shortages or stability issues of drug products.
  • New therapeutic approaches.
  • Changes in environmental or patient conditions.

Ideal Requirements for Compounding

For compounding medicine, an aseptic area, controlled room temperature, and necessary equipment are required, such as:

  • Compounding platform
  • Lab coat and gloves
  • Sterile equipment like a mortar and pestle
  • Sterile containers and closures
  • Packing material

Bulk Compounding

This involves the preparation of large quantities of a medication for use in the hospital, such as creating new formulations, adjusting strengths, or combining multiple medications.

Adverse Drug Reaction (ADR) Monitoring

The World Health Organization (WHO) defines Adverse Drug Reactions (ADRs) as noxious and unwanted effects produced by a drug when it is applied for the ailment of a disease or diagnosis.

Classification of ADRs

  • Type A (Augmented)
  • Type B (Bizarre)
  • Type C (Chemical)
  • Type D (Delayed)
  • Type E (Exit/End of treatment)
  • Type F (Familial)
  • Type G (Genotoxicity)
  • Type H (Hypersensitivity)
  • Type U (Unclassified)

Methods for Identifying ADRs

  1. Case Record Review
  2. Drug Chart Review
  3. Laboratory Data
  4. Computerized ADR Reporting System
  5. Attendance at Ward Rounds
  6. Interviewing Patients

Patient Counseling

Patient counseling is the process of providing information, advice, and assistance to help patients use their medications correctly. Counseling patients is an important responsibility for pharmacists. Pharmacists are often the only healthcare providers focusing patient education on medication: how to take it, what to expect, and potential side effects and drug interactions.

Dispensing and Disposal of Radiopharmaceuticals

Dispensing

  • Verify the patient’s identity to ensure the correct drug and dosage is given to the correct patient.
  • Handle and administer radiopharmaceuticals using appropriate protective equipment (gloves, gowns, shields) to minimize radiation exposure.
  • Follow the manufacturer’s instructions and applicable regulations for storage, handling, and administration.

Disposal

  • Disposal should be done in accordance with local, state, and federal regulations, as well as guidelines from professional organizations.
  • Any remaining radiopharmaceuticals should be properly disposed of, which may involve returning the unused portion to the supplier or disposing of it in a licensed radioactive waste disposal facility.
  • The patient’s urine, feces, and other bodily fluids that may contain traces of radiopharmaceuticals should also be handled and disposed of properly.

Application of Computers in Hospital Pharmacy Practice

  1. Medication Management: Computerized systems are used to manage medication administration, prescription orders, and inventory control. These systems can track medication usage, monitor errors, and streamline distribution.
  2. Clinical Decision Support: Pharmacists use computer-based tools to help make clinical decisions regarding drug therapy. These tools provide access to patient records, drug interactions, and patient-specific information.
  3. Electronic Medical Records (EMRs): EMRs allow pharmacists to access patient records, including medical history, medications, allergies, and laboratory results.

Drug Distribution Methods

Individual Prescription Order Method

Advantages

  1. Reduces Medication Errors: The chances of medication errors are significantly reduced since the medication is packaged and labeled specifically for the individual patient.
  2. Convenient for Patients: This method is convenient as patients do not have to worry about remembering to take multiple pills at different times.

Disadvantages

  1. Cost: This method can be more expensive than other methods like ward stock or unit-dose dispensing due to the packaging and labeling process.
  2. Time-consuming: The process of packaging and labeling each individual dose can be time-consuming for healthcare professionals.

Automated Drug Dispensing Systems and Devices

These are computerized systems that can accurately dispense medications to patients in hospitals, pharmacies, and other healthcare facilities. Types include:

  1. Robotic Dispensing Systems: These systems use robots to dispense medications and can handle multiple medications at once.
  2. Barcode Scanning Systems: These systems use barcode technology to ensure the correct medication is dispensed to the right patient by scanning the patient’s wristband and the medication.

Drug Basket Method

The drug basket method is a type of clinical trial design in which a group of patients receives a combination of different drugs (a “drug basket”) for the treatment of a specific disease. The goal is to evaluate the safety and effectiveness of the combination.

Advantage

  1. Efficiency: Allows for the simultaneous testing of multiple drugs in combination, which can speed up the drug development process and reduce costs.
  2. Enhanced Efficacy: Combination therapies can be more effective than single drugs alone.

Disadvantage

  1. Complexity: This method can be more complex than testing single drugs, increasing the risk of drug interactions and side effects.
  2. Cost: Testing multiple drugs in combination can be more expensive.

Unit Dose Drug Distribution Method

This is a method of dispensing medications in individual, pre-measured doses, typically packaged in single-use containers like blister packs. This system aims to ensure the safe and accurate delivery of medication and reduce errors.

Advantages

  • Accuracy: Each dose is individually measured and labeled, reducing the risk of errors.
  • Convenience: The system can be designed for easy administration of medications, particularly in busy settings.
  • Cost-effectiveness: By reducing medication errors and minimizing waste, the system can result in cost savings.