Pharmacy Practice (BP703T) Unit-1.pptx

This PPT covers the B. Pharm Pharmacy Practice Unit-I with topics 1. Hospital and it’s organization 2. Hospital pharmacy and its organization 3. Adverse drug reaction 4. Community Pharmacy

1. Unit-I

2. Unit I: Hospital and its Organization - Definition and classification of hospitals - Organization structure of a hospital - Medical staffs involved in the hospital and their functions Unit I: Hospital Pharmacy and its Organization - Definition and functions of hospital pharmacy - Organization structure and staff requirements - Responsibilities and functions of hospital pharmacists Unit I: Adverse drug reaction - Classification and types of adverse drug reactions - Drug interactions and methods for detecting them - Adverse drug reaction reporting and management Unit I: Community Pharmacy - Organization and structure of retail and wholesale drug stores - Legal requirements for establishment and maintenance - Dispensing of proprietary products and record keeping

3. Hospital and Its Organization Objectives Understand the concept of a hospital Explore different classifications of hospitals Discuss the importance of hospital organization

4. What is a Hospital? Definition: A hospital provides patient treatment with specialized medical and nursing staff and medical equipment. The main aim: To Provide healthcare services to patients to help them recover from illness or injury.

5. Characteristics of a Hospital

6. Classification of Hospitals Intro: Hospitals can be classified based on several criteria, such as ownership, type of services provided, length of stay, bed capacity, and clinical basis.

7. Classification by Ownership

8. Classification by Service

9. Classification by Length of Stay

10. Classification by Beds

11. Classification by c linical and non-clinical basis

12. Primary Hospitals Services like general medicine, preventive care, and minor surgeries are typically offered . Role in the healthcare system: Provide the first point of contact for patients.

13. Secondary Hospitals Services offered, including specialized medical services and minor and major surgical procedures. Role in the healthcare system: Provides care to patients referred from primary hospitals and stabilizes patients before moving to tertiary hospitals.

14. Tertiary Hospitals Services like highly specialized medical care, surgeries, and advanced diagnostic services are offered . Role in the healthcare system: Provides high-level care to patients referred from secondary hospitals and cares for complex and rare health conditions.

15. Clinical Aspects P atient care, diagnosis, treatment, nursing services, etc. Role in patient health outcomes and overall hospital performance.

16. Non-Clinical Aspects A dministration, finance, health information systems, facility management, etc. Importance in supporting clinical services and the overall functioning of the hospital.

17. Hospital Organization

18. Hierarchical Structure in Hospitals Illustrate the structure: Board of Directors -> CEO -> Administrative Staff -> Medical Staff -> Nursing Staff -> Allied Health Professionals -> Support Staff

19. Thought Each classification and organizational structure contribute significantly to the operation and function of hospitals, affecting patient care and overall efficiency.

20. Purpose of Hospital Organization The organization of a hospital is necessary to ensure the smooth running of hospital operations. This structure fosters collaboration and coordination among staff members and departments and helps efficiently deliver healthcare services.

21. Basic Structure of Hospital Organization A typical hospital's structure can be divided into several key components, including the board of directors, hospital administration, medical staff, nursing department, and other auxiliary departments.

22. The Board of Directors The board of directors is responsible for making high-level strategic decisions, setting policies, and overseeing the general direction of hospital operations.

23. Hospital Administration The hospital administration manages daily operations. They ensure the hospital functions smoothly, providing the necessary resources for medical staff to deliver quality patient care.

24. Medical Staff The medical staff includes physicians, surgeons, and specialists who directly provide patient care. They diagnose and treat patients, perform surgeries , and play a significant role in delivering healthcare services.

25. Nursing Department The nursing department comprises registered nurses, licensed practical nurses, and other support staff. They provide critical support in patient care, administering medications, monitoring patient health, and maintaining patient records.

26. Auxiliary Departments Auxiliary departments such as radiology, pathology, pharmacy, dietary services, and others provide crucial support services that help in the smooth functioning of the hospital.

27. Medical Staff in a Hospital and Their Functions A hospital's medical staff includes professionals with diverse roles and responsibilities. Let's explore these different roles and their contributions to patient care.

28. Physicians: The Core of Medical Staff Physicians are medical professionals who diagnose and treat illnesses. They might be general practitioners or specialize in cardiology, neurology, pediatrics, etc. They form the backbone of medical care in a hospital.

29. Surgeons: Masters of the Operating Room Surgeons are specialized physicians who perform operations as part of a patient's treatment plan. Their expertise lies in their understanding of human anatomy, surgical procedures, and patient care before, during, and after surgery.

30. Anesthesiologists: Guardians of Pain Management Anesthesiologists are specialists responsible for managing pain during and after surgical procedures. They administer anesthesia and monitor the patient's vital signs during surgery, ensuring patient comfort and safety.

31. Radiologists: The Imaging Experts Radiologists are doctors who specialize in diagnosing diseases and injuries using medical imaging techniques, such as X-rays, CT scans, and MRI scans. They provide crucial information for diagnosis and treatment planning.

32. Pathologists: The Disease Detectives Pathologists analyze laboratory samples, such as tissue biopsies or bodily fluids, to diagnose diseases. Their expertise aids in detecting diseases at the earliest stages, contributing to effective treatment.

33. Nurses: The Pillars of Patient Care Nurses provide direct care to patients, administer medication, monitor patient health, and maintain patient records. They work closely with doctors and other healthcare professionals to provide comprehensive care.

34. Pharmacists: Custodians of Medications Hospital pharmacists are responsible for medication management. They ensure the safe and effective use of pharmaceutical drugs and collaborate with physicians on medication selection, dosage, and potential side effects.

35. Conclusion for Medical Staff Role Each medical staff member plays a vital role in a hospital setting, contributing to the overall patient experience and care. Their combined expertise and collaboration ensure the hospital's successful operation and patients' health and well-being.

36. Hospital pharmacy

37. Hospital pharmacy and its organization A hospital pharmacy is a critical department within a healthcare facility responsible for safely and effectively managing medications and pharmaceutical supplies. It plays a vital role in patient care by ensuring that medicines are prescribed correctly, dispensed accurately, and administered safely. The organization of a hospital pharmacy varies based on the size of the hospital, patient population, and available resources.

38. Definition of Hospital Pharmacy Hospital pharmacy refers to the specialized pharmacy department within a healthcare facility, primarily a hospital, responsible for the procurement, storage, preparation, dispensing, and safe use of medications for patients under the care of the hospital's healthcare providers. It plays a crucial role in ensuring the appropriate and effective use of drugs and promoting patient safety and optimal health outcomes.

39. Functions of Hospital Pharmacy Medication Dispensing Function: Review and dispense medications based on prescriptions. Goal: Ensure accuracy, appropriateness, and patient safety.   Medication Review and Verification Function: Review medication orders for interactions, allergies, and dosages. Objective: Prevent medication-related errors.

40. Functions of Hospital Pharmacy Medication Counseling and Education Function: Counsel patients on proper medication use. Importance: Enhance patient understanding and adherence.   Medication Management Function: Manage medication inventory to avoid shortages and wastage. Goal: Ensure a steady supply of drugs.

41. Functions of Hospital Pharmacy Clinical Pharmacy Services Function: Participate in patient care rounds, and provide drug information. Purpose: Offer therapeutic recommendations and address medication-related issues. Pharmacy and Therapeutics (P&T) Committee Function: Evaluate and approve medications for the hospital formulary. Importance: Ensure appropriate drug selection and use.

42. Functions of Hospital Pharmacy Pharmacokinetic Dosing Services Function: Perform pharmacokinetic dosing for certain medications. Benefit: Ensure optimal dosing in patients with narrow therapeutic ranges. Parenteral Nutrition Compounding Function: Prepare parenteral nutrition solutions. Goal: Tailor solutions to individual patient needs.

43. Functions of Hospital Pharmacy Medication Reconciliation Function: Ensure the accuracy of a patient's medication regimen during care transitions. Importance: Maintain medication continuity. Adverse Drug Reaction Monitoring Function: Monitor and report adverse drug reactions. Role: Improve drug safety.

44. Functions of Hospital Pharmacy Pharmacy Quality Assurance Function: Implement programs to prevent medication errors. Purpose: Ensure compliance with standards. Infection Control and Sterile Compounding Function: Prepare sterile medications using aseptic techniques. Importance: Prevent infections.

45. Functions of Hospital Pharmacy Medication Safety Initiatives Function: Promote medication safety within the hospital. Strategies: Use of barcode scanning systems and other technologies. Pharmacy Information Systems Function: Manage medication orders, dispensing records, and drug data. Benefit: Streamline pharmacy operations.

46. Hospital Pharmacy Organization Structure The hospital pharmacy organization structure is a hierarchical framework that outlines the roles, responsibilities, and relationships of personnel within the pharmacy department of a hospital. It is designed to efficiently manage pharmacy services and ensure the safe and effective use of medications for patients.

47. Pharmacy Director / Chief Pharmacist Oversees the entire pharmacy department Sets strategic goals and objectives Ensures compliance with regulations Collaborates with hospital administration and healthcare departments

48. Pharmacy Managers / Supervisors Responsible for specific areas within the pharmacy department Manages daily operations and staff performance Roles may include Inpatient Pharmacy Manager, Outpatient Pharmacy Manager, Clinical Pharmacy Manager, etc.

49. Pharmacists Key players in the pharmacy organization Review medication orders and dispense medications Provide drug information and counseling to patients May specialize in areas such as Clinical Pharmacists, Oncology Pharmacists, etc.

50. Pharmacy Technicians Support pharmacists in various tasks Assist with medication preparation and dispensing Manage inventory and perform administrative duties

51. Pharmacy Interns / Residents Students completing practical training (Interns) Licensed pharmacists pursuing advanced training (Residents) Contribute to pharmacy department activities

52. Pharmacy Support Staff Additional support roles within the pharmacy department Assist with non-clinical tasks and administrative duties

53. Clinical Pharmacy Specialists Pharmacists with advanced training in specific clinical areas Participate in patient care rounds and collaborate with medical teams Provide specialized pharmaceutical care

54. Medication Safety Officer / Pharmacist Focuses on identifying and preventing medication errors Implements safety protocols and conducts training Ensures medication safety within the pharmacy

55. Pharmacy and Therapeutics (P&T) Committee Multidisciplinary committee including physicians, pharmacists, nurses, etc. Evaluates and approves hospital formularies Establishes medication use policies and reviews new drugs

56. Thought The hospital pharmacy organization structure is crucial for optimizing patient care and medication safety. Collaboration among pharmacists, technicians, and support staff ensures the smooth functioning of the pharmacy department. Specialized roles like Clinical Pharmacy Specialists and Medication Safety Officers contribute to enhanced patient outcomes.

57. Location of Hospital Pharmacy The location of the hospital pharmacy within a healthcare facility plays a vital role in ensuring efficient pharmaceutical services for patients and healthcare professionals.

58. Location of Hospital Pharmacy Ground Floor or Main Entrance Positioned on the ground floor or near the main entrance for easy access to inpatients and outpatients. Convenient location for patients as they enter or exit the hospital. 2. Adjacent to Outpatient Clinics Close proximity to outpatient clinics for swift prescription processing. Enables patients to obtain medications conveniently after appointments.

59. Location of Hospital Pharmacy 3 . Near Emergency Department (ED) Located near the emergency department for immediate access to critical medications. Supports efficient emergency care for patients in urgent need.

60. Location of Hospital Pharmacy 4 . Adjacent to Inpatient Units Satellite or decentralized pharmacies close to specific inpatient units (e.g., critical care, surgical ward). Ensures rapid medication delivery, reducing the time between prescription orders and administration. 5 . Central Pharmacy Department Central medication preparation and distribution hub in larger hospitals or medical centers. Streamlines medication inventory management and fosters coordination among different hospital departments.

61. Location of Hospital Pharmacy 6 . Pharmacy Inpatient Unit A dedicated pharmacy within specific inpatient units. Serves patients’ medication needs within that area, which is especially beneficial for patients with complex medical conditions. 7. Near Operating Rooms (ORs) Positioned close to hospital operating rooms with a focus on surgical services. Allows prompt access to medications required during surgeries and immediate post-operative care.

62. Location of Hospital Pharmacy The hospital layout, size, and patient volume influence the location of the hospital pharmacy. Primary objective: Ensure safe and efficient management of medications to support optimal patient care.

63. Layout and Staff Requirements of Hospital Pharmacy A hospital pharmacy's layout and staff requirements are crucial in providing efficient pharmaceutical services and ensuring patient safety.

64. Pharmacy Layout Considerations Optimal Workflow: Design the pharmacy layout to facilitate a smooth prescription processing and medication dispensing workflow. Storage Space: Sufficient storage for medications and medical supplies, ensuring proper organization and inventory management. Patient Privacy: Dedicated areas for patient counseling and consultation to respect patient privacy and confidentiality. Technology Integration: Incorporate technology for electronic prescription processing and medication tracking.

65. Staffing Positions in Hospital Pharmacy Pharmacy Director / Chief Pharmacist: Overseeing the entire pharmacy department and setting strategic goals. Pharmacy Managers / Supervisors: Responsible for specific pharmacy areas and daily operations. Pharmacists: Reviewing medication orders, counseling patients, and providing drug information. Pharmacy Technicians: Assisting pharmacists with medication preparation and administrative tasks.

66. Staffing Positions in Hospital Pharmacy Pharmacy Interns / Residents: Students completing practical training or licensed pharmacists pursuing advanced training. Clinical Pharmacy Specialists: Pharmacists with specialized expertise in specific clinical areas. Medication Safety Officer / Pharmacist: Focusing on identifying and preventing medication errors. Pharmacy Support Staff: Additional staff to assist with non-clinical tasks and administrative duties.

67. Staffing Ratios Staffing requirements depend on hospital size, patient volume, and pharmacy services. Ratios may vary for different shifts (day, evening, night) to meet fluctuating demands.

68. Role of Technology Pharmacy Management System: Facilitates prescription processing, medication tracking, and inventory management. Automated Dispensing Machines: Streamline medication dispensing and reduce errors. Electronic Health Records (EHR): Enhance communication and information sharing with other healthcare departments.

69. Ensuring Patient Safety Proper Staff Training: Regular training keeps staff updated on medication safety protocols and best practices. Medication Error Reporting: Encourage a culture of reporting and learning from errors to prevent future incidents. Quality Assurance: Implement processes for medication verification and double-checking.

70. A hospital pharmacy's layout and staff requirements significantly impact its efficiency and patient care. Proper staffing, technology integration, and patient safety measures are essential for successful pharmacy operations.

71. Responsibilities and Functions of H ospital Pharmacists Hospital pharmacists are crucial in patient care and medication management within a healthcare facility.

72. Medication Review and Verification Reviewing medication orders for accuracy, appropriateness, and potential drug interactions. Verifying dosages and ensuring medications are suitable for specific patient conditions.

73. Medication Dispensing and Compounding Accurate dispensing of medications to inpatients and outpatients. Compounding specialized medications for unique patient needs.

74. Patient Counseling and Education Providing patients with essential drug information and instructions for proper medication use. Addressing patient concerns and queries regarding medications.

75. Medication Monitoring and Assessment Monitoring patient responses to drug therapy and adjusting medications as needed. Assessing treatment outcomes and collaborating with healthcare teams for optimal patient care.

76. Clinical Pharmacy Services Participating in clinical rounds and interdisciplinary care meetings. Recommending evidence-based therapeutic interventions to healthcare providers.

77. Medication Safety and Adverse Event Prevention Identifying and preventing medication errors and adverse drug reactions. Implementing safety protocols and promoting a culture of safe medication use.

78. Medication Formulary Management Collaborating with the Pharmacy and Therapeutics (P&T) Committee to manage the hospital formulary. Assessing new medications for inclusion in the formulary based on safety, efficacy, and cost-effectiveness.

79. Drug Information and Consultation Serving as a drug information resource for healthcare professionals and patients. Providing evidence-based answers to medication-related inquiries.

80. Medication Supply Chain Management Ensuring an adequate inventory of medications and managing medication stock levels. Collaborating with supply chain and procurement teams to maintain a continuous supply.

81. Medication Policy and Protocol Development Developing and updating hospital medication use policies and protocols. Ensuring compliance with regulatory guidelines and best practices.

82. Research and Quality Improvement Initiatives Engaging in research projects to enhance medication-related knowledge and patient outcomes. Contributing to quality improvement initiatives to optimize pharmacy services.

83. Continuing Education and Professional Development Pursuing ongoing education to stay updated with the latest developments in pharmacy practice. Attending conferences and workshops to enhance skills and knowledge.

84. Adverse Drug Reactions Unintended and harmful effects caused by medications Occur due to individual differences, drug interactions, or drug properties

85. Classifications of ADRs Type A (Augmented) Reactions Common and dose-dependent Result from known pharmacological actions of the drug Examples: Nausea, vomiting, dizziness Type B (Bizarre) Reactions Less common and unpredictable Idiosyncratic or immune-related responses Examples: Severe allergic reactions, drug-induced liver injury

86. Classifications of ADRs (contd.) Type C (Chronic) Reactions Occur with prolonged drug use The result from cumulative effects Examples: Drug-induced osteoporosis, drug-induced diabetes   Type D (Delayed) Reactions Manifest after some time of drug administration Associated with long half-life drugs Examples: Certain drug-induced skin reactions, tardive dyskinesia

87. Classifications of ADRs (contd.) Type E (End-of-treatment) Reactions Occur upon drug discontinuation Related to withdrawal or rebound effects Example: Sudden withdrawal leading to withdrawal symptoms Type F (Failure of Therapy) Reactions Related to the drug's inability to achieve the therapeutic goal May be due to drug resistance or non-response

88. Excessive Pharmacological Effects ADRs due to excessive pharmacological effects occur when the drug’s usual therapeutic dose produces an exaggerated response. Examples include severe sedation from an overdose of sedative medications or hypotension from excessive antihypertensive drugs.

89. Secondary Pharmacological Effects ADRs resulting from secondary pharmacological effects occur when the drug produces unintended responses due to its influence on other body systems or receptors. Example: Antihistamines used to treat allergies may cause drowsiness due to their effects on the central nervous system.

90. Idiosyncrasy Idiosyncratic ADRs are unpredictable and occur in only a tiny percentage of individuals. They may be related to genetic factors, individual drug metabolism, or immune response differences. Example: Severe liver toxicity in some individuals after taking a specific medication.

91. Allergic Drug Reactions Allergic ADRs are immune-mediated responses to a drug. The body's immune system recognizes the drug as foreign and triggers an allergic reaction. Symptoms can range from mild skin rashes to life-threatening anaphylaxis.

92. Genetically Determined Toxicity Some individuals may have genetic variations that predispose them to drug toxicity. Genetic testing can help identify individuals at risk of adverse reactions to certain medications.

93. Toxicity Following Sudden Withdrawal Some drugs can lead to withdrawal reactions when abruptly discontinued. Examples include certain antidepressants, opioids, and benzodiazepines.

94. Drug Interactions: Beneficial, Adverse, and Pharmacokinetic Interactions Drug interactions occur when two or more drugs interact in the body, leading to changes in their effects or metabolism. Drug interactions can be beneficial or adverse and significantly impact patient outcomes.

95. Beneficial Drug Interactions Beneficial drug interactions occur when combining two or more drugs leads to enhanced therapeutic effects. Examples: - Combining two antibiotics to increase effectiveness against bacterial infections. - Synergistic effects of antihypertensive medications, leading to better blood pressure control.

96. Adverse Drug Interactions Adverse drug interactions result in harmful effects when drugs are taken together. Examples: -Increased risk of bleeding when combining anticoagulants and nonsteroidal anti-inflammatory drugs (NSAIDs). - Serotonin syndrome is caused by combining multiple drugs that increase serotonin levels.

97. Pharmacokinetic Drug Interactions Pharmacokinetic interactions involve drug absorption, distribution, metabolism, or elimination changes. Examples: - Drug A inhibits the metabolism of Drug B, leading to increased levels of Drug B and potential toxicity. - Drug C enhances the absorption of Drug D, resulting in higher drug concentrations and improved efficacy.

98. Mechanisms of Pharmacokinetic Interactions

99. Importance of Drug Interaction Management

100. Preventive Strategies Thorough medication reconciliation to identify potential drug interactions. Adjusting drug dosages or schedules to minimize interactions. Monitoring drug levels and patient response to detect interactions early.

101. Drug interactions can be beneficial or adverse, and pharmacokinetic interactions are critical considerations. Proper management and monitoring of drug interactions are crucial for safe and effective medication use. Collaborative efforts among healthcare providers can minimize the risks associated with drug interactions.

102. Methods for Detecting Drug Interactions, Spontaneous Case Reports, and Record Linkage Studies

103. Drug Interaction Detection

104. Spontaneous Case Reports

105. Record Linkage Studies

106. Adverse Drug Reaction Reporting and Management

107. Importance: ADRs contribute to patient morbidity and mortality, impacting healthcare systems and public safety.

108. ADR Reporting Spontaneous Reporting: Healthcare professionals and the public report ADRs to regulatory authorities (e.g., PvpI , FDA, EMA) through dedicated systems. MedWatch (US): The FDA's program for voluntary reporting of ADRs and medication errors. EudraVigilance (EU): European Medicines Agency's database for collecting ADR reports.

109. Pharmacovigilance Process

110. ADR Management

111. Preventive Measures Education: Healthcare professionals and patients should be educated about ADRs and their reporting. Monitoring: Regularly monitor patients during drug therapy to detect potential ADRs early. Risk Minimization: Implementing risk management plans for high-risk medications. Drug Interactions: Identify and manage drug interactions to reduce ADR risk. Labeling Updates: Timely update of drug labels with new safety information.

112. Community Pharmacy Organization and Structure A community pharmacy, or a retail pharmacy, is a healthcare facility where prescription medications and over-the-counter (OTC) drugs are dispensed to the public. The organization and structure of a community pharmacy typically include the following components:

113. Pharmacist-in-Charge (PIC): The pharmacist-in-charge is responsible for overseeing the pharmacy's operations, ensuring compliance with laws and regulations, supervising staff, and handling any issues that arise. Pharmacists: Licensed pharmacists are responsible for dispensing medications, counseling patients, conducting medication reviews, and offering healthcare advice. Pharmacy Technicians: Trained pharmacy technicians assist pharmacists in tasks such as prescription processing, medication preparation, inventory management, and customer service.

114. Support Staff: This may include cashiers, clerks, and other personnel who handle administrative and customer service functions. Prescription Area: This is where prescriptions are received, verified, and dispensed. It usually includes computer workstations, medication storage, and prescription counseling areas. OTC Section: Over-the-counter medications, health products, and personal care items are displayed for self-selection by customers. Counseling Area: A private area where pharmacists can offer medication counseling and answer patient questions confidentially.

115. Medication Storage: Secure storage areas for prescription and OTC medications, following proper storage conditions to maintain product integrity. Compounding Area (if applicable): Some community pharmacies offer compounding services to create customized medications as per physician orders. Records and Documentation: Pharmacies must maintain accurate and up-to-date records of prescriptions, sales, and other relevant information.

116. Legal Requirements for Establishment and Maintenance of Drug Store

117. Licensing: Pharmacies must obtain the necessary licenses and permits from the appropriate regulatory authorities, usually the state pharmacy board or equivalent agency. Pharmacist Requirements: A licensed pharmacist must be designated as the pharmacist-in-charge, and the pharmacy must employ a sufficient number of licensed pharmacists and pharmacy technicians per state regulations.

118. Physical Space: The pharmacy must have a suitable physical layout, including separate areas for prescription processing, counseling , and OTC sales. Security Measures: Pharmacies must implement security measures to prevent theft and ensure the safe storage of controlled substances.

119. Drug Inventory Management: Pharmacies must maintain accurate records of drug inventory, including purchases, sales, and disposition of medications. Patient Privacy: Pharmacies must comply with Health Insurance Portability and Accountability Act (HIPAA) regulations to protect patient privacy and confidentiality. Patient Counseling : Pharmacists must often counsel patients about proper medication use, potential side effects, and drug interactions.

120. Dispensing of Proprietary Products Community pharmacies may dispense proprietary products, including prescription and OTC medications. Pharmacists ensure that the correct medication and dosage are provided to patients and offer counseling on proper use.

121. Maintenance of Records of wholesale and retail Drug Stores Prescription Records: Patient information, prescriber details, medication dispensed, directions for use, and date filled. Inventory Records: Records of all medications purchased, received, and dispensed, including controlled substances. Patient Profiles: Pharmacists often maintain patient profiles containing medication history, allergies, and relevant health information.

122. Maintenance of Records of wholesale and retail Drug Stores Sales Records: Records of all sales, including OTC medications, along with details of purchasers. HIPAA Compliance: Pharmacies must maintain patient confidentiality and comply with HIPAA regulations regarding protecting patient information.

123. It's important to note that pharmacy regulations and requirements may vary by jurisdiction, so pharmacy owners and staff must stay informed about the specific laws and regulations that apply in their area.