Who Are Ambulatory Patients?

Methods of Dispensing

1. Individual Prescription Dispensing (Most Common)

2. Automated Dispensing Devices

3. Blister/Unit-of-Use Packaging

4. Telepharmacy / E-prescribing

The Dispensing Pathway (Step-by-Step)

Patient Arrives at Outpatient Pharmacy
              ↓
1. PRESCRIPTION RECEIPT
   - Written, faxed, electronic, or (limited) spoken order
   - Spoken orders only for emergencies; must be immediately documented
              ↓
2. PRESCRIPTION VERIFICATION
   - Confirm prescriber identity, license, and authorization
   - Check patient identity (name, age, allergies)
   - Validate drug name, dose, route, frequency, and duration
              ↓
3. CLINICAL SCREENING (DUR - Drug Utilization Review)
   - Screen for drug-drug interactions
   - Check for contraindications, allergies, duplications
   - Verify appropriateness of dose for patient's age/weight/renal/hepatic status
              ↓
4. PREPARATION / RETRIEVAL
   - Retrieve correct drug from stock
   - Count, measure, or compound as needed
   - Automated dispensing systems may handle this step
              ↓
5. PACKAGING & LABELING
   - Comply with federal/state law and USP standards
   - Label must include: patient name, drug name, dose, directions, prescriber, dispensing date, pharmacy info, expiry
   - Hazardous drugs require special precautions and packaging
              ↓
6. PHARMACIST FINAL CHECK
   - Independent double-check of drug, dose, label, and quantity before dispensing
              ↓
7. PATIENT COUNSELING & EDUCATION
   - Explain drug name, purpose, dose, timing, side effects
   - Provide written information/leaflet if needed
   - Address adherence, storage instructions
              ↓
8. MEDICATION RECONCILIATION
   - Compare current prescription against the patient's existing medication list
   - Resolve discrepancies and communicate the updated medication list
              ↓
9. DISPENSING & DOCUMENTATION
   - Hand medication to patient after proper identification
   - Record dispensing in the pharmacy system
              ↓
10. FOLLOW-UP
    - Arrange refill schedule if applicable
    - Flag patients needing monitoring (e.g., warfarin, lithium)

Key Standards (ASHP Minimum Standards for Ambulatory Care)

• Medications dispensed only after a valid prescription from an authorized prescriber
• All dispensed medications must be packaged and labeled per federal/state law and USP standards
• Hazardous drugs (e.g., chemotherapy) require special handling, spill kits, personnel monitoring, and disposal protocols
• Patient counseling is mandatory before the patient leaves
• Privacy of patient must be maintained throughout the dispensing encounter

Goals of the Ambulatory Dispensing System

1. Reduce patient waiting time
2. Minimize dispensing/medication errors
3. Ensure effective patient counseling
4. Improve medication adherence/compliance
5. Maintain patient privacy
6. Perform medication reconciliation at every encounter
7. Strengthen pharmacist-patient rapport

Dispensing of Controlled Substances in the Hospital

Definition

Regulatory Framework

• Governed by the Drug Enforcement Administration (DEA) (USA) under the Controlled Substances Act (CSA) and 21 CFR Part 1317
• Internationally, governed by the International Narcotics Control Board (INCB) and national equivalents
• Hospitals must be DEA-registered to handle, store, and dispense controlled substances
• All controlled substances must be accounted for from receipt to destruction - no discrepancy is permitted

Key Requirements for Dispensing

Dispensing Pathway in the Hospital

Physician writes a valid order/prescription
              ↓
Pharmacist receives and verifies order
(check prescriber authorization, dose, drug name, patient identity)
              ↓
Pharmacist performs Drug Utilization Review (DUR)
(interactions, appropriateness, allergy check)
              ↓
Drug retrieved from double-locked narcotic cabinet
(pharmacist or authorized technician; count verified before & after)
              ↓
Dispensed to ward/nurse via Automated Dispensing Cabinet (ADC)
OR directly to patient at outpatient pharmacy window
              ↓
Nurse administers exact prescribed dose to patient
              ↓
Any unused/partial dose is immediately WASTED
(witnessed and documented by a second staff member)
              ↓
Perpetual inventory updated; records retained

Procedure for Waste, Destruction, and Contamination of Narcotics

A. Wastage

1. The nurse/clinician administers the required dose to the patient
2. The remaining amount is wasted in the presence of a second authorized witness (another nurse, pharmacist, or anesthesia provider)
3. Both parties document and co-sign the wastage record, noting:
   • Drug name, strength, and amount wasted
   • Date, time, and patient name
   • Names/signatures of both staff members
4. The waste is placed into a sequestration/solidification device (e.g., DisposeRx, Rx Destroyer) or a sealed collection receptacle
5. No DEA Form 41 is required for wastage - but internal documentation is mandatory
6. The perpetual inventory is updated immediately

Failure to witness and document wastage is a serious violation and can indicate drug diversion.

B. Destruction of Narcotics (Pharmacy Inventory)

Methods of Destruction:

Steps for Formal Destruction (Inventory):

1. Inventory all drugs to be destroyed (separate lists for controlled vs. non-controlled substances)
2. Each list must include: facility name/address, pharmacist name/license number, date of destruction, prescription date, drug name, quantity
3. Two authorized employees witness the destruction and sign the record
4. DEA Form 41 completed and retained for at least 2 years
5. Destruction method used is documented - must meet the non-retrievable standard
6. Records submitted/retained as required by state and federal regulations

C. Contamination of Narcotics

How Contamination Occurs:

• A staff member diverts (steals) narcotic content and replaces it with another substance (e.g., tap water, saline, or another drug)
• The contaminated syringe or vial is then administered to the patient, who receives no therapeutic drug effect
• Use of unsterile tap water as a substitute places the patient at risk of blood-borne infection (e.g., hepatitis, sepsis)
• The staff member may introduce blood-borne pathogens via needle tampering

Consequences of Narcotic Contamination:

• Patient harm: inadequate pain control, risk of infection (hepatitis B/C, HIV)
• Staff: criminal prosecution, loss of license, imprisonment
• Institution: regulatory action, loss of DEA registration, liability

Prevention Measures:

1. Tamper-evident seals on all narcotic vials and syringes
2. Witnessed administration and immediate witnessed wastage
3. Chain of custody documentation for every narcotic dose
4. Closed-circuit video (CCTV) monitoring at narcotic storage areas
5. Routine reconciliation - any unexplained discrepancy triggers investigation
6. Random drug testing of staff with access to controlled substances
7. Prompt reporting to DEA and law enforcement when diversion is confirmed

Summary Table

The Pharmacy and Therapeutics Committee (P&TC)

What is the P&TC?

The P&TC's authority is formally defined in the hospital's medical staff bylaws and institutional policy documents.

Composition of the P&TC

• A formal charter with defined scope
• Quorum rules (typically at least 5 members, including 3 physicians, needed to pass formulary changes)
• Defined term limits
• A conflict of interest (COI) disclosure process
• A process for appealing committee decisions
• Attendance tracking and delegation rules

Operation of the P&TC

How It Works:

1. Meets regularly (typically monthly or quarterly) with a structured agenda
2. All drug-related policies, regardless of their origin, must flow through the P&TC before final approval by the Medical Executive Committee
3. Subcommittees (permanent or ad hoc) may be created for specific issues (e.g., antimicrobial stewardship, oncology, pain management)
4. The committee communicates with related hospital committees - order set review, patient safety, infection control, etc.
5. A permanent record of all activities, decisions, and minutes is maintained
6. Periodic reports and recommendations are submitted to the Medical Executive Committee / hospital administration

Core Functions:

Hospital Formulary Policy

What is a Hospital Formulary?

Key Policies Governing the Hospital Formulary

1. Drug Selection Criteria

• Clinical efficacy - evidence from clinical trials, systematic reviews
• Safety profile - adverse effect burden, interactions, contraindications
• Cost-effectiveness - therapeutic value relative to cost
• Need - fills a therapeutic gap not covered by existing formulary drugs
• Availability - reliable supply from approved vendors

2. Formulary Addition / Removal Process

• Any physician, pharmacist, or clinical staff can request addition or removal of a drug
• The P&TC evaluates the request using the above criteria
• A minimum quorum of members must vote to approve changes
• New drugs are added with therapeutic use guidelines and monitoring parameters
• Drugs may be removed if safer/more effective alternatives exist, or if they are discontinued

3. Therapeutic Substitution Policy

• When a non-formulary drug is prescribed, the pharmacist - under P&TC-approved protocols - may substitute it with a therapeutically equivalent formulary drug
• The prescribing physician is informed; patient consent may be required
• This is distinct from generic substitution (same drug, different brand)

4. Non-Formulary Drug Requests

• A physician may request a non-formulary drug for a specific patient if no formulary alternative exists
• Requires completion of a non-formulary request form and justification
• May require P&TC or pharmacy director approval
• Use is monitored; if requests are frequent for the same drug, it triggers a formulary addition review

5. Formulary Review and Update

• The formulary must be reviewed at least annually by the P&TC
• Drug class reviews are conducted on a rolling basis
• New drug approvals (FDA/national regulatory body) trigger an automatic review for potential addition
• The LASA (Look-Alike/Sound-Alike) medication list is updated concurrently

6. Scope of the Formulary

• Prescription drugs (brand and generic)
• Nutritional supplements and nutraceuticals
• Non-prescription (OTC) drugs used in the hospital
• Blood derivatives and contrast media
• Herbal/alternative remedies used in patient care
• Investigational drugs (under separate IRB oversight)

7. Communication and Compliance

• Updated formulary is made available to all prescribers via printed book, intranet/EHR, or app
• Prescribers are not compelled to use only formulary drugs, but are strongly encouraged to do so
• Non-compliance or excessive non-formulary requests are reviewed by the P&TC

Summary

Classification of Hospitals Based on Ownership

1. Government (Public) Hospitals

• Services provided free or at heavily subsidized rates
• Obligated to serve all citizens regardless of economic status
• Funded and regulated by Ministry of Health / health departments
• Governed by a Board of Governors or government-appointed administration
• Subject to government policies, public accountability, and audit
• Staff employed as government servants (civil service rules apply)
• May be affiliated with medical colleges for teaching purposes

2. Private (For-Profit) Hospitals

• Run by owners or a C-suite executive team accountable to shareholders/investors
• Budget determined by management; profit-driven
• Tend to offer a wider range of amenities, better doctor-to-patient ratios, and more comfortable facilities
• Costs are borne directly by patients or their health insurance
• Governed by a Board of Directors or owner-appointed management committee
• Employ medical staff on contract, salary, or fee-for-service basis
• Examples: large corporate hospital chains, nursing homes, specialty clinics

3. Teaching (Medical College / Academic) Hospitals

• Dual function: patient care + training of healthcare professionals
• Usually affiliated with a medical/pharmacy/nursing school
• Staffed by faculty physicians who hold academic appointments
• Higher level of specialization and subspecialty services
• Often serve as referral centers for complex cases
• Funded by tuition, government grants, research funds, and patient fees
• Governed by both the hospital administration and university authorities

4. Charity / Voluntary / Non-Profit Hospitals

• Funded by donations, endowments, philanthropic grants, and patient fees (often subsidized)
• Aim to provide care to underserved or indigent populations
• Governed by a Board of Trustees or a charitable trust committee
• Tax-exempt status in most jurisdictions
• Examples: hospitals run by Aga Khan Foundation, Edhi Foundation, religious missions, Red Cross
• Subject to regulations of charitable trusts and nonprofit laws

Comparison Table

Organizational Pattern of a Hospital

A. Administrative Structure

1. Board of Governors / Board of Directors

• Setting hospital policy
• Approval of the annual budget
• Appointment of the Hospital Director / CEO
• Ensuring compliance with government/regulatory policies
• Fiduciary responsibility (financial oversight)
• Strategic planning and institutional goals

2. Hospital Director / Chief Executive Officer (CEO)

• Overall management of all non-clinical and clinical departments
• Implementation of Board decisions
• Supervision of all hospital directors and department heads
• Resource allocation and financial management
• Liaison between the Board and the medical/clinical staff
• Personnel management and compliance

3. Medical Superintendent (MS) / Chief Medical Officer (CMO)

• Supervision of all clinical departments
• Quality of medical care
• Medical staff credentialing and appointments
• Clinical policy development
• Patient safety and outcomes monitoring

4. Middle Management Layer

• Implement policies set by the top administration
• Manage day-to-day operations of their respective departments
• Report upward to the Director/MS and downward to staff

5. Medical Staff Categories

B. Clinical Departments

Department of Medicine (Non-Surgical):

• General Medicine
• Dermatology & Venereology
• Psychiatry & Mental Health
• Pulmonology / Chest Medicine
• Neurology
• Pediatrics
• Endocrinology & Diabetology
• Rheumatology
• Gastroenterology & Hepatology
• Nephrology
• Cardiology
• Oncology/Hematology

Department of Surgery:

• General Surgery
• Neurosurgery
• Ophthalmology
• Orthopedic Surgery
• Obstetrics & Gynecology
• Dental & Oral Surgery
• Urology
• Cardiothoracic Surgery
• Plastic & Reconstructive Surgery
• ENT (Ear, Nose & Throat)
• Vascular Surgery

Emergency & Critical Care:

• Accident & Emergency (A&E) Department
• Intensive Care Unit (ICU)
• Neonatal ICU (NICU)
• Pediatric ICU (PICU)
• Coronary Care Unit (CCU)

Diagnostic (Para-clinical) Services:

• Pathology / Clinical Laboratory
• Radiology & Imaging (X-ray, CT, MRI, Ultrasound)
• Nuclear Medicine
• Radiotherapy / Oncology

C. Support Services Departments

Organizational Design Types

Simplified Organizational Chart

Board of Governors / Board of Directors
              |
     Hospital Director / CEO
         /           \
Medical Superintendent    Hospital Administrator
(Clinical Wing)           (Administrative Wing)
       |                        |
  Department Heads          Finance / HR / Stores
  (Medicine, Surgery,       Medical Records
   Pediatrics, OB/GYN,      Housekeeping
   Emergency, etc.)         Biomedical Engineering
       |                    Material Management
  Associate / Courtesy
  Medical Staff
       |
  Nursing Staff / Paramedics
       |
  Support Services
  (Pharmacy, Lab, Radiology,
   Blood Bank, CSSD, etc.)

Staffing in the Pharmacy

Definition

• Every pharmacy function (dispensing, clinical review, counseling, procurement, compounding) is covered
• Workload is distributed without overburdening or underutilizing staff
• Patient safety is maintained at all times
• Legal and regulatory requirements (e.g., pharmacist supervision ratios) are met
• Services are available across all shifts (24-hour coverage in hospitals)

Why Staffing Matters in Hospital Pharmacy

Categories of Pharmacy Staff

1. Professional / Clinical Staff

2. Para-professional / Technical Staff

3. Support / Non-professional Staff

Algorithm of Professional Staffing for a Public Hospital Pharmacy

Step-by-Step Algorithm

STEP 1 - Define the Scope of Pharmacy Services

• OPD (Outpatient) Dispensary
• In-patient / Ward Pharmacy
• Emergency Pharmacy
• Chronic Disease / Specialist Pharmacy
• Central Pharmacy Store (procurement & stores)
• IV Admixture / Compounding Unit
• Clinical Pharmacy (ward rounds)

Each unit has a different workload and requires a different staffing calculation.

STEP 2 - Measure the Workload of Each Unit

STEP 3 - Apply Standard Workload Benchmarks

STEP 4 - Calculate Number of Staff Required

Number of Staff Required =  Total Monthly Workload
                           ─────────────────────────
                            Benchmark per Staff/Month

• OPD monthly prescriptions = 8,000
• Benchmark = 1,000 prescriptions/pharmacist/month
• Pharmacists needed = 8,000 ÷ 1,000 = 8 pharmacists

• Total beds = 300
• Benchmark = 25 beds/pharmacist/day
• Pharmacists needed = 300 ÷ 25 = 12 pharmacists

• Daily prescriptions = 150
• Benchmark = 30 prescriptions/pharmacist/day
• Pharmacists needed = 150 ÷ 30 = 5 pharmacists

STEP 5 - Factor in Shift Coverage and Leave

• Number of working shifts (1, 2, or 3 shifts per day)
• Days per week of operation (5-day vs. 7-day)
• Leave allowance - add ~20-25% to calculated FTE to cover annual leave, sick leave, and public holidays

Adjusted Staff = Calculated Staff × Shift Factor × (1 + Leave Factor)

STEP 6 - Determine the Professional Mix

• Prescription verification and clinical review
• Patient counseling
• Clinical ward rounds
• Supervision of all dispensing

• Counting, measuring, labeling
• Stock replenishment
• IV preparation support
• Record-keeping

STEP 7 - Assess Efficiency and Adjust

Staffing Efficiency (%) = Current Workload
                         ─────────────────────────── × 100
                          (Current FTE × Benchmark)

Summary: The Staffing Algorithm at a Glance

STEP 1 → Define all pharmacy service units
         ↓
STEP 2 → Measure workload per unit (prescriptions, beds, episodes)
         ↓
STEP 3 → Apply standard benchmarks (WHO/national guidelines)
         ↓
STEP 4 → Calculate raw staff numbers = Workload ÷ Benchmark
         ↓
STEP 5 → Adjust for shifts, hours of operation, and leave
         ↓
STEP 6 → Determine professional mix (Pharmacist : Technician ratio)
         ↓
STEP 7 → Monitor efficiency monthly; adjust as workload changes