PYQ\\\\\\\'s (Previous Year Questions)

5 Marks Questions

• What is inventory control? Enlist different techniques of inventory control. Explain the “Economic Order Quantity\\\\\\\" method. Marking scheme: 1 M for Inventory control definition, 2 M for enlisting any eight inventory techniques, 2 M for EOQ explanation (SUMMER 2023)
• What is inventory control? Enlist different techniques of inventory control. Explain economic order quantity method. (SUMMER 2024)
• Define Supply Chain. Explain drug purchase procedure. (SUMMER 2025)
• Define Inventory control. Enlist their methods and describe in detail “Economic Order Quantity\\\\\\\" Method. Marking scheme: 1 M for Inventory control definition, 2 M for enlisting any eight inventory techniques, 2 M for EOQ explanation (Winter 2023)
• Define inventory control and enlist method to control it and describe EOQ. (Winter 2024)

3 Marks Questions

• Explain in detail the FIFO and FEFO method with its advantages and disadvantages. Marking scheme: 0.5 marks each for explanation, advantages and Disadvantages of FIFO and FEFO Method. (SUMMER 2023)
• Explain FEFO and FIFO methods with its advantages and disadvantages. (SUMMER 2024)
• Enlist different inventory control techniques and explain any one. (SUMMER 2025)
• Write various storage conditions with temperature as per IP. Marking scheme: 3 M for any 3 storage conditions (Winter 2023)
• Explain any 3 cold storage devices. (Winter 2024)

1 Marks Questions

• Number of copies of purchase order are prepared. (SUMMER 2023)
  • Ans : 7
• Define High Risk drugs. (SUMMER 2023)
  • Definition: High risk medications are drugs that have a heightened risk of causing significant patient harm when they are used in error. OR High risk drugs are the drugs that have a high risk of causing harm to patient when Misused
• Which method is not suitable for Cytotoxic drug disposal. (SUMMER 2023)
  • Ans: iii) Medium temperature incineration
• Numbers of copies of purchase order prepared. (SUMMER 2024)
  • i) 5, ii) 7, iii) 3, iv) 4
• Define reorder level. (SUMMER 2025)
• Which disposal method is used for cytotoxic drugs. (Winter 2023)
  • i) Incineration Method
  • ii) Disposal to Sewers
  • iii) Directly to land fill
  • iv) All the above
  • Ans. i) Incineration method
• List the warning given for schedule H1 drugs. (Any two) (Winter 2024)
• What does FEFO stands for?(Winter 2024)

INTRODUCTION

Definition: A supply chain is the network of all parties involved in fulfilling a customer\\\\\\\'s request, from the initial procurement of raw materials to the final delivery of the finished product.

A supply chain includes supplier, transporters, warehouses, retailer and customer.

PREPARATION OF DRUG LIST

• The list of drugs guides to detect medications that require special precautions to reduce the risk of errors.
• Precautions may include limiting access to certain drugs. The list of drugs categorized into High risk drugs, Emergency drugs, Schedule H1 drugs, NDPS drugs, reserved antibiotics.

HIGH RISK MEDICINE OR HIGH ALERT MEDICATION

Definition: High-risk drugs are medications that have a higher potential for causing significant harm to patients if used incorrectly.

1. Insulin

• Purpose: Insulin is a hormone used to control blood glucose levels in patients with diabetes.
• Why It\\\\\\\'s High-Risk:
  • Narrow Therapeutic Range: Insulin has a very narrow therapeutic range, meaning the difference between a therapeutic dose and a harmful dose is small.
  • Risk of Hypoglycemia: Incorrect dosing, timing, or administration can cause severe hypoglycemia (dangerously low blood sugar), which can lead to confusion, seizures, loss of consciousness, or even death.
  • Complex Administration: Insulin requires precise dosing based on the patient\\\\\\\'s blood glucose levels, diet, activity, and other medications. Errors in calculation or administration (e.g., giving the wrong type of insulin or dose) can have serious consequences.

2. Opioids

• Purpose: Opioids are pain-relieving medications that are often used to manage moderate to severe pain.
• Why They\\\\\\\'re High-Risk:
  • Respiratory Depression: Opioids can depress the central nervous system, leading to respiratory depression (slowed or stopped breathing), which can be fatal.
  • High Potential for Overdose: Due to their potency, even small dosing errors can result in an overdose. This is particularly dangerous when combined with other depressants like alcohol or benzodiazepines.
  • Addiction and Abuse: Opioids have a high potential for addiction and misuse. Incorrect dosing, extended use, or use without proper medical supervision can lead to physical dependence and addiction.
  • Tolerance and Variability: Patients may develop a tolerance to opioids, requiring higher doses to achieve the same effect, which increases the risk of overdose.

3. Anticoagulants

• Purpose: Anticoagulants, such as warfarin or heparin, are used to prevent blood clots in conditions like atrial fibrillation, deep vein thrombosis (DVT), or after certain surgeries.
• Why They\\\\\\\'re High-Risk:
  • Bleeding Risk: Anticoagulants thin the blood to prevent clotting, but this also increases the risk of excessive bleeding. Minor injuries can lead to significant blood loss, and internal bleeding may go unnoticed until it becomes critical.
  • Complex Dosing and Monitoring: Anticoagulants require careful monitoring of blood coagulation levels (e.g., INR for warfarin) to maintain a balance between preventing clots and causing excessive bleeding. Variability in patient response due to diet, other medications, or medical conditions makes dosing challenging.
  • Drug and Dietary Interactions: Anticoagulants have numerous interactions with other medications and foods (e.g., vitamin K-rich foods affect warfarin levels), which can alter their effectiveness and safety, requiring frequent dose adjustments.

Emergency Drugs

Definition: These drugs are used in critical, life-threatening situations where immediate intervention is necessary.

1. Adrenaline (Epinephrine):

Why:
Adrenaline rapidly reverses life-threatening symptoms of severe allergic reactions.
It boosts heart and brain blood flow during cardiac arrest resuscitation.
Adrenaline treats severe asthma, shock, and supports urgent surgical procedures.

2. Atropine:

Why:
Atropine blocks muscarinic effects in deadly organophosphate or nerve agent poisoning.
It rapidly increases dangerously slow heart rate in severe bradycardia cases.
Atropine reduces airway secretions and supports emergency cardiac arrest protocols.

Schedule H1 Drugs

Definition: These drugs are regulated in India due to their potential for abuse or misuse and require a prescription.

1. Cefixime:

Why:
Cefixime\\\'s broad use risks antibiotic resistance, so strict regulation is essential.
Schedule H1 mandates prescription-only sale with detailed pharmacy record keeping.
Boxed warnings and legal controls help prevent misuse and safeguard public health.

2. Levofloxacin:

Why:
Levofloxacin misuse increases bacterial resistance, so Schedule H1 restricts access.
Law requires prescriptions and detailed records to prevent unauthorized self-medication.
Mandatory boxed warnings alert about risks and controlled antibiotic status.

NDPS Drugs (Narcotic Drugs and Psychotropic Substances)

Definition: These drugs have a high potential for abuse, addiction, or dependence and are strictly regulated under the Narcotic Drugs and Psychotropic Substances Act.

1. Morphine:

Why:
Morphine is globally controlled under UN conventions for high abuse potential.
NDPS Act ensures morphine\\\'s medical use while preventing misuse and diversion.
Only licensed institutions can dispense morphine under strict documented procedures.

3. Fentanyl:

Why:
Fentanyl is a synthetic opioid that is 50-100 times more potent than morphine.
Fentanyl is an Essential Narcotic Drug with strict NDPS Act controls.
Law regulates its manufacture, sale, and use to prevent medical misuse.
Class-wide control stops illicit production and trafficking of dangerous analogs.

Reserved Antibiotics

Definition: These antibiotics are reserved for use only when other treatments have failed, to prevent the development of antibiotic resistance.

1. Colistin:

Why:
Colistin is a last-line antibiotic for multidrug-resistant Gram-negative infections.
Restricted use slows resistance spread, preserving its effectiveness for critical cases.
WHO recognizes colistin as critically important, demanding strict global stewardship.

2. Carbapenems:

Why:
Carbapenems are last-resort drugs for severe multidrug-resistant bacterial infections.
Misuse promotes dangerous carbapenem-resistant strains with high mortality rates.
Reserved status ensures strict use, preserving effectiveness for critical global health.

Procedures of Drug Purchases

The procurement process ensures the continuous availability of quality medications at optimal costs while maintaining therapeutic effectiveness and patient safety.

1. Drug Selection Process

1.1 Formulary-Based Selection

The Pharmacy and Therapeutics Committee (PTC) establishes adequate standards for drug purchase and maintains the hospital formulary. Key principles include:

• Limiting formulary scope to conserve resources - stocking all medicines on the national formulary is usually not necessary
• Eliminating generic duplication - only one brand or label of each generic medicine should be routinely stocked
• Minimizing multiple strengths for the same medication; multiples of lower strengths can be used for infrequently needed higher strengths
• Selecting medications based on diseases and conditions treated at the facility

1.2 Selection Criteria

Drug selection involves evaluating medicines based on multiple parameters:

• Efficacy and safety profiles
• Cost-effectiveness and availability
• Pharmacokinetic properties and bioequivalence
• Pharmaceutical and therapeutic equivalence
• Toxicity considerations

2. Types of Drug Purchase Processes

2.1 Short-Term Purchase Process

Short-term purchasing involves immediate or urgent procurement for:

• Emergency situations where stocks are depleted
• New medication requirements not in regular inventory
• Seasonal demand fluctuations

Emergency purchases from local market are conducted when items are not available through regular channels or when emergency drugs are out of stock. For this, a purchase form is prepared in duplicate - one copy sent to the department and another retained in the pharmacy.

2.2 Long-Term Purchase Process

Long-term purchasing involves systematic procurement planning including:

• Annual rate contracts with suppliers to prevent delays in supply
• Bulk purchasing agreements for cost optimization
• Contract purchase arrangements with manufacturers
• Strategic supplier partnerships for continuous supply

The process requires lead time information for all products, considering factors like floods, strikes, accidents, and other emergency situations.

3. Sources of Supply

3.1 Primary Sources

Procurement of drugs is generally done through the following sources:

1. By inviting tenders from wholesalers and manufacturers
2. By direct purchase from wholesalers and manufacturers
3. Emergency purchase from a local retail drug store
4. By a contract purchase arrangement with the manufacturer
5. The list of items to be purchased is sent to various suppliers or tender is invited
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4. Tender and E-Tender Process

4.1 Formal Tender Process

• Tender is the process whereby hospital invites bids for drugs that must be submitted within given time limit.
• Tenders are broadly advertised to offer opportunities to a different supplier, encourage competition and make available greater pool of offer to select from.

A comprehensive tender process includes:

• Preparation: Define requirements, terms, and conditions for goods/services needed.
• Publication: Invitation to Tender (ITT) or Notice Inviting Tender (NIT) is published (often in newspapers or organizational bulletins).
• Submission: Potential suppliers submit their bids (proposals) in sealed documents, typically as physical paperwork.
• Evaluation: All received bids are opened, assessed for compliance and evaluated on predetermined criteria (price, quality, capability).
• Negotiation: May involve clarification or negotiation with shortlisted suppliers.
• Award: The contract is awarded to the selected supplier, and unsuccessful vendors are notified.
• Contract Signing: Both parties sign and execute the contract, formalizing the agreement.

4.2 E-Tender Implementation

It is the process for sending and getting tenders by electronic means, instead of old paper-based technique.

Modern procurement utilizes electronic tendering systems with the following features:

• Define Requirements and Publish Online: Requirements are clearly specified and published digitally on an e-tendering portal.
• Connecting with Suppliers: Interested suppliers access tender documents online and submit bids electronically, often needing registration and digital signatures.
• Bid Submission: Bids, supporting documents, and inquiries are submitted electronically by the deadline.
• Evaluation: The organization evaluates all bids based on compliance, price, quality, and other criteria. Negotiations or clarifications can take place online if needed.
• Awarding the Contract: The winning bidder is notified through the platform, and a legally binding contract follows.

4.3 Tender Evaluation Criteria

Technical evaluation considers:

• Supplier credentials and licensing requirements
• Quality certifications and compliance documentation
• Supply capacity and delivery capabilities

Financial evaluation focuses on:

• Discount percentages on Maximum Retail Price (MRP)
• Inclusive pricing covering excise duty, surcharges, GST, packing, and delivery charges
• L1 supplier selection based on highest discount offered

5. Quotation Process

• The pharmacy identifies which medicines and quantities are needed, often based on doctor requests and patient needs.
• A Request for Quotation (RFQ) is prepared and sent to multiple potential suppliers, specifying exact medicine requirements.
• Suppliers submit quotations with prices, delivery time, and required legal documents.
• The pharmacy team compares all quotes based on price, product quality, supplier reputation, and compliance with regulations.
• Negotiations may be held to secure better terms or discounts.
• The preferred supplier is recommended for approval by hospital authorities.
• A formal purchase order is issued to the selected supplier.
• On receiving the medicines, the pharmacy checks quantities, expiry/batch numbers, and ensures products match the order.
• Medicines are then stored securely and distributed to hospital departments.
• The process ensures transparency, cost control, quality, and legal compliance at every step.

Steps in Purchase Procedure:

Purchase procedure involve various steps for procurement of product:

1. Purchase requisition: whenever the existing stock of an article approaches minimum limit or the reorder level. Departmental head prepare requisition slip according to specification of products required and send it to administrative head of concern department. The purchase requisition form includes type of material to be purchased, time of requirement, available and required quantity. Once requisition slip approved then send to purchasing officer & one copy retained by pharmacist.
2. Selection of supplier/ Sources of suppliers: Based on the selection criteria, the supplier quoting the lowest rate is selected.
3. Purchase order: After selecting the supplier, Purchase officer or chief pharmacist prepare purchase order. The purchase order is in written form evidence of agreement between the buyer and supplier. The purchase order gives detailed description, specifications, quantity required and terms conditions of contract.

Distribution of Purchase Order Copies (7 Copies):

The seven copies of purchase order are prepared & to whom these are sent is given below:

1. First Copy → Supplier: Sent to the supplier (the one selling the goods) by post or hand, so they know what to supply.
2. Second Copy → Accounts Department: Kept in the accounts office for making payment records and bills.
3. Third Copy → Purchase Department: Kept by the purchase officer in his own file, to track the order.
4. Fourth Copy → Requisition Department: Sent back to the department that asked for the items (so they know the order has been placed).
5. Fifth Copy → Receiving Department (Completed Copy): Filled once the goods arrive, then sent to accounts to confirm receipt.
6. Sixth Copy → Receiving Department (Back Order Copy): Used if some items are not delivered and are still pending (back order).
7. Seventh Copy → History File: Kept by the purchase officer for record/reference in the future.

4. Receipt of goods: When the ordered goods received in department, the quantities and prices are checked. Invoice of supplier is compared to the purchase order. Received goods bill sent to the account section where bill is entered in purchase record form. If part of order is returned to supplier, a Good Returned Note (one copy to supplier and another to the department) must be prepared.
5. Release of payment to the supplier.

Inventory control technique (Model Answer)

Definition: Inventory Control is the balance between not ordering too much and avoiding stock out situations of material.

Different techniques of Inventory control:

• Economic Order Quantity (EOQ)
• Reorder quantity level
• Inventory turnover
• ABC analysis
• VED analysis
• ABC-VED matrix analysis
• FEFO, FIFO analysis
• Lead time
• Buffer stock

Economic Order Quantity (EOQ):

Economic Order Quantity is the purchasing of item in bulk amount at which ordering cost and inventory carrying cost will be minimum. EOQ is a profitable quantity for those materials which are used regularly & in bulk quantities are purchased in economic lot size. This technique is used to decide how much quantity of material is to be ordered.

Hence it is determined by following formula: EOQ = √((2 x AC x OC) / (UC x ICC)) OrEOQ = √((2 x AC x OC)) / HC

Where: AC = Annual Consumption, OC = Ordering cost, UC = Unit cost, ICC = Inventory carrying cost, HC = Holding cost

REORDER QUANTITY METHOD

• The quantity of items is to be ordered so as to continue production without any interruption in future.
• Reorder Quantity = Average Daily Usage x Average Lead Time
• For example, if the average daily usage is 10 units and the average lead time is 29 days, the reorder quantity is 290.
• Determine Average Daily Usage: Average daily use refers to the number of your product\\\\\\\'s units that are sold each day. Usually, thirty days is a common timeframe but it changes during different seasons or festivals. For instance, if you need to place an order for a product before a festival, your ADU should be determined using that festival\\\\\\\'s ADU from the previous year.
• Calculate Average Lead Time: Average lead time refers to the time span between when a supplier receives a purchase order and when they deliver it to the seller\\\\\\\'s warehouse. The average lead time is calculated in days. If you reordered inventory on 1st January, your average lead time is 30 days if it is available to be used to fulfill customer orders by 30th January.

Why is the Reorder Quantity Formula Important?

• Helps to Avoid Stockouts
• Helps in Managing Inventory
• Assists in Minimizing Expenses

INVENTORY TURNOVER

• Inventory turnover is a measure of the number of times inventory is sold or used in a time period such as a year.
• It is calculated to see if a business has an excessive inventory in comparison to its sales level.
• The equation for inventory turnover equals the cost of goods sold divided by the average inventory. Inventory Turnover = Cost of Goods Sold / Average Inventory at Cost
• High turnover rate = stock shortages.
• A low turnover rate = overstocking.

Calculating the inventory turnover ratio can help businesses make better decisions on pricing, manufacturing, marketing, and purchasing new inventory.

INVENTORY MANAGEMENT OF CENTRAL DRUG STORE

Various storage conditions with temperature as per IP 1996 (Model Answer)

• Cold: Any temperature not exceeding 8°C and usually between 2°C to 8°C.
• Cool: Any temperature between 8°C to 25°C
• Room temperature: The temperature prevailing in a working area. This temperature falls between 15°C to 30°C
• Warm: Any temperature between 30°C to 40°C
• Excessive heat: Any temperature above 40°C
• Light resistant container
• Well closed container

METHOD OF STORAGE

1. Proper drug storage
2. Storage environment
3. The storeroom Techniques
4. The dispensary

1. PROPER DRUG STORAGE

Drugs are stored in a specially designed secure area or space of a building in order to:

• Avoid contamination or deterioration
• Avoid disfiguration of labels
• Maintain integrity of packaging and so guarantee quality and potency of drugs during shelf life,
• Prevent or reduce pilferage, theft or losses,
• Prevent infestation of pests and vermin.

The storage should not hinder the cleaning and should have sufficient space for movement of stocks and handling. Basis products are to be stored in a manner that prevents damage due to excessive vertical stocking heights and not to exceed eight stocks.

2. THE STORE ROOM Techniques

• A well arranged store enables easy identification of drugs and save time when picking a drug from the shelves.
• This helps remove drugs quickly and makes for easy inventory control.
• FIFO should be applied always
• FEFO should apply.
• To have access to drugs with oldest/shorter expiration dates first, put these in front of the shelves.

3. THE DISPENSARY

• Clean after each use tablet counters and place within easy reach on the table.
• Avoid dispensing wrong drugs by arranging drugs on the table in alphabetical order so that the drug being dispensed is not confused with another

COLD CHAIN

• A system of storing and transporting the vaccine at a low temperature from the place of manufacture to the actual Vaccination site is called cold chain.
• Cold chain is also referred to as both vaccine supply chain and immunization.

IMPORTANCE OF COLD CHAIN

• Obtaining the vaccines from the manufacturers
• Storing and transporting the vaccines
• Maintaining the supply of vaccines
• Having information about essential equipment, supply of electricity etc.
• Keeping the vaccine at low temperature
• Protecting the vaccine from sunlight exposure
• Maintaining the potency of vaccines

Devices used in COLD CHAIN (Model Answer)

Equipment used for maintaining cold storage conditions.

Refrigerator:

• The medicines are kept safely in narrow temperature range and their efficiency is maintained.
• It comprises of thermally protected compartments.
• Temperature range is between 2°C to 8°C.
• Medicines stored in the refrigerator include vaccines, insulin, chemotherapy drugs, topical preparations, eye drops, insulin, glucagon etc.

ILR (Ice lined refrigerator):

• This device has a lining of ice packs hence the name is ice lined refrigerator.
• Internal lining contains ice, ice packs or cold water filled compartments.
• If electricity fails, the ice lining keeps the inside temperature at a safe level.
• 2°C to 8°C temperature can be maintained with just 8 hours of power supply in 24 hours.
• Additionally, top opening lid prevents loss of cold air during door opening hence temperature can be maintained for a longer span in deep freezer.
• They are mostly used in the vaccine cold chain.

Walk in cold room:

• Walk in cold rooms ensure the temperature is constant and within range in all over the room.
• It is designed for exact observing of temperature conditions required for cold storage.
• It works between 0°C to 25°C.
• It maintains precise temperature for long term cold storage.

Methods of Controlling Cold Chain and Other Components

1. SUPPLIES: Supplies are the vaccines and solvents. They should kept at low temperature.
2. MANUAL EFFORTS: People working with the manufacturer, health officers, health workers and those storing and transporting the vaccines, work together to maintain cold chain.
3. TRANSPORTATION: To maintain the potency of vaccine rapid means transport should be used in specific temperature. Refrigerators should be arranged in the trucks with a heat resistant equipment\\\\\\\'s. Aeroplanes are used to save time.
4. COMMUNICATION: All information and orders associated with cold chain should be immediately and clearly sent and received.

Key Practices:

• Keep the vaccine in appropriate conditions as suggested by manufacturer.
• Follow up the precautions while transporting vaccines.
• Record the temperature of storage place twice a day and preparing the temperature chart.
• Maintain the equipment of cold chain and the appropriate functioning of its components, conducting potency tests from time to time.
• Communication system effective and latest.
• Train all the people associated with vaccination about the maintenance and control of cold chain.

Stock Management Methods (FIFO & FEFO)

FIFO Method: (Model Answer)

First in First out is one of the methods of stock management. It is based on the assumption that materials which are purchased first are issued/used/distributed/dispensed first.

Advantages (any 1)

1. It is easy to implement/Apply.
2. The condition of dead stock never arises.
3. It assumes flow of costs corresponds with normal physical flow of goods.
4. It produces higher income during the inflation period.

Disadvantages (any 1)

1. If the longer the product stays in the warehouse, the higher the possibilities for decomposition of the product, that affect on economy.
2. It does not accurately reflect the actual cost of production or operations.
3. It increases the tax liability in periods of rising prices.
4. It shows a lower net income and a higher cost of goods sold in periods of falling prices.

FEFO Method: (Model Answer)

First Expired First Out is one of the methods of stock management. In this method the shelf-life of the product is considered. The product having short shelf-life is issued/distributed/dispensed first.

Advantages (any 1)

1. It ensures that the product with the shortest expiry date is issued/sold first.
2. It reduces business overheads from wastage.
3. It ensures that products reaching end-users have sufficient remaining shelf-life.
4. It avoids excess or dead inventory at warehouse level.
5. It give assurance to consumer about guarantee product quality and their by consumer satisfaction.
6. The condition of dead stock never arises.

Disadvantages (any 1)

1. It requires an accurate product tracking system.
2. It requires good management of warehouse space for stocking and it should be well maintained.
3. Higher taxes on products.

EXPIRY DRUG REMOVAL AND HANDLING

Reason Behind Expiry Drug Removal:

• Loss of Efficacy: Expired drugs may lose potency, reducing effectiveness.
• Safety Concerns: Chemical changes in expired drugs can make them unsafe.
• Toxicity Risk: Some drugs become toxic after expiration.
• Regulatory Compliance: Laws require the removal of expired drugs.
• Preventing Misuse: Expired drugs can lead to accidental or intentional misuse.
• Environmental Protection: Improper disposal can harm water and soil.

Drug disposal regulations are set and governed by:

• Central Drugs Standard Control Organization (CDSCO): Regulates pharmaceuticals and ensures compliance with proper disposal practices for drugs.
• Ministry of Environment, Forest and Climate Change (MoEFCC): Governs hazardous waste management, including pharmaceutical waste.

The manufacturer of a pharmaceutical product can only be held responsible for any harmful effects of the product within its shelf life and only if the product was transported and stored under the conditions recommended by the manufacturer.

Methods of disposal of pharmaceutical waste: (Model Answer)

1. Return to donor or manufacturer: Returning unusable drugs for safe disposal by the manufacturer. For unwanted, unrequested donations, especially those that arrive past or unreasonably near their expiry date, it may be possible to return them to the donor for disposal.
2. Landfill: Place the waste directly into a land disposal site without prior treatment or preparation. It is the oldest and the most widely practiced method of disposing of solid waste.
3. Encapsulation (Waste immobilization): Encapsulation involves immobilizing the pharmaceuticals in a solid block within a plastic or steel drum. They are filled to 75% capacity with solid and semi-solid waste of pharmaceuticals, and the remaining 25% space is filled by pouring in a medium such as cement or cement/lime mixture, plastic foam or bituminous sand. Lastly sealed drums are placed at the base of landfill and covered with fresh municipal solid waste.
4. Sewer: Liquid pharmaceuticals, e.g. syrups and intravenous fluids, can be diluted with water. Then, flushed into the sewers in small quantities over a period of time without serious public health or environmental affect.
5. Inertization: Inertization involves removing the packaging materials, paper, cardboard and plastic, from the pharmaceuticals. Pills are removed from their blister packs. The pharmaceuticals are then ground and a mix of water, cement and lime added to form a homogenous paste. The paste is then transported in the liquid state by concrete mixer truck to a landfill and decanted into the normal urban waste.
6. Medium temperature Incineration: The expired solid form pharmaceuticals using a two- chamber incinerator that operates at the minimum temperature of 850°C, with a combustion retention time of at least two seconds in the second chamber. Before incineration the pharmaceutical waste is diluted with large quantities of municipal waste.
7. High Temperature Incineration: Expired pharmaceuticals, chemical waste, used oil wastes are burnt at very high temperatures more than 850°C in cement kiln.
8. Chemical Decomposition: If an appropriate incinerator is not available, the option of chemical decomposition can be used in accordance with the manufacturer\\\\\\\'s recommendations, followed by landfill.

Disposal of Special Categories of Drugs

DISPOSAL OF NARCOTICS DRUGS

Disposal of narcotic drugs is highly regulated by national authorities to prevent diversion, misuse, or illegal distribution. In many countries, disposal is governed by laws such as the Narcotic Drugs and Psychotropic Substances Act (NDPS) in India or the Controlled Substances Act (CSA) in the USA.

Regulatory agency in India: Narcotics Control Bureau (NCB)

• Incineration: Disposed of by burning
• Chemical Neutralization: Treated chemically to neutralize their active ingredients
• Deep Burial: Buried in deep, secure landfill sites, especially in remote or designated areas.
• Return to Manufacturer: they typically have the necessary facilities for safe destruction.
• Dissolution (Limited Use): flushed into wastewater. The FDA also offers a list of medicines that are safe to flush down the toilet. Ex. fentanyl patch
• Supervised Destruction: The drugs are destroyed in the presence of officials, and detailed records are maintained to ensure transparency and accountability.
• Court-Ordered Disposal: Disposal of seized narcotics is often carried out after obtaining court orders. The drugs are sealed and stored securely until they can be destroyed following legal procedures.

DISPOSAL OF CYTOTOXIC DRUGS

• Cytotoxic waste is highly hazardous and should never be landfilled or discharged into the sewerage system.
• The disposal options include: Return to the original supplier or take back program, incineration at high temperatures, and chemical degradation in accordance with manufacturer\\\\\\\'s instructions.

Drug Purchase and Inventory Documentation

Drug Purchase Documentation:

• Formal Procurement Procedures: Develop formal procedures for drug procurement. Procedures reviewed regularly for regulatory updates.
  • Doc: Procurement Policy Document (Outlines standardized procedures for purchasing), Approval Documentation (formal approval of drug purchases), Tender/Quotation (Competitive bidding records), Drug Purchase Orders (PO) (Official records of orders placed)
• Formulary Process: Define the drug list (formulary) to guide purchases. Competitive bidding to secure optimal pricing.
  • Doc: Formulary List, Pharmacy and Therapeutics (P&T) Committee Meeting Minutes, Formulary Approval Documents, Criteria for Drug Inclusion
• Vendor Management: Regular monitoring of vendor invoices and ensuring correct product delivery. Use of analytics to compare vendor pricing with negotiated contracts.
  • Doc: Vendor Contracts, Vendor Qualification Documentation, Vendor Invoices, Payment Records

Drug Inventory Documentation:

• Receipt and Reconciliation: Drugs are reconciled with purchase orders before entering inventory.
  • Doc: Purchase Orders, Delivery Receipts, Reconciliation Records (comparison between drugs received and drugs ordered)
• Automated Tracking Systems: Use pharmacy management systems for real-time inventory management, including tracking expiration dates and quantities to monitor inventory levels.
  • Doc: Inventory Management System Logs
• Storage Documentation: Maintain records for temperature-controlled storage and security of controlled substances.
  • Doc: Access Control Logs, Controlled Substances Vault Logs, Stock Rotation Records (rotated to use those closest to expiration first.), Daily Inventory Count Sheets (checks of stored drugs against system records)
• Inventory Audits: Regularly audit inventory records to prevent discrepancies, theft, and drug diversion
  • Docs: Compliance and Regulatory Audit Reports, Physical Inventory Audit Reports, Controlled Substance Audit Records, Discrepancy Reports