LEC8 05-05-2024 distribution of controlled drugsvf.pdf

Distribution of Controlled Substances PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content Controlled substances Laws applicable to controlled substances Distribution and dispensing...

Distribution of Controlled Substances PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content Controlled substances Laws applicable to controlled substances Distribution and dispensing of controlled substances  Controlled Substances A drug or other substance that is tightly controlled by the government because it may be abused or cause addiction. The control applies to the way the substance is made, used, handled, stored, and distributed. Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids. Controlled substances with known medical use, are available only by prescription from a licensed medical professional  Controlled Substances Division of controlled drugs, DRAP in consultation with the ministry of narcotics control is responsible for regulation and allocation of quota of narcotic drugs, psychotropic substances and precursor chemicals A number of psychoactive/chemical entities having important therapeutic uses are regulated internationally through UN Conventions There are three categories of controlled substances, namely: – Narcotic Drugs Psychotropic Substances Precursor Chemicals  Regulation of Controlled Substances Laws: Controlled substances (used as medicines) are regulated under:- DRAP Act, 2012. Drugs Act, 1976. Control of Narcotic Substances (CNS) Act, 1997 and rules framed thereunder  Distribution of Controlled Substances Fundamentals In the secure management of controlled substances, the following fundamental principles apply to all facilities and departments: Controlled substances are securely stored and handled throughout the medication management system, from the point of ordering to the time of administration or destruction Accurate and complete records of all transactions involving a controlled substance are maintained in a timely manner All manual documentation is made in indelible ink. There is a clear chain of signatures showing transfer of responsibility at each transition point. Records can be easily audited. All staff members check for completeness and accuracy of the records  Distribution of Controlled Substances Fundamentals Quantities of controlled substances are kept to the minimum needed, according to the patient population and degree of urgency. Only authorized staff handle, prescribe, or have access to controlled substances. Controlled substances are stored in restricted areas, such as locked rooms, carts, or fridges. All keys are accounted for at all times. Systems are set up to ensure that each user is uniquely identified and every transaction can be traced to a user.  Distribution of Controlled Substances Inventory Management Key principles of successful inventory management include keeping stock secure at all times, Maintaining accountability and sign-offs by authorized staff at all transition points, and Checking for completeness of an order and integrity of the product at all transition points Consideration should be given to maintaining the lowest amount of inventory possible while ensuring reasonable and timely access  Distribution of Controlled Substances Inventory Management The following factors are to be considered when determining the drug needs of a healthcare facility or a patient care area: medical conditions being treated; local protocols, pathways, and care maps; drug formulary and formulary policies utilization and prescribing patterns; range of dosing (e.g., pediatric vs adult care; acute vs chronic pain management) availability and capacity of secure storage; travel time between receiving department, pharmacy, care units, and other sites;  Distribution of Controlled Substances Inventory Management Once inventory levels are established, drug-use patterns should be periodically reviewed to assess the following:: Minimum and maximum stock levels; Changes in utilization trends; Changes in clinical practice or patient mix; Changes in regulatory requirements (e.g., schedules); Issues such as medication safety incidents that may shed light on potential for misuse or diversion of controlled substances;  Distribution of Controlled Substances Procurement A licensed dealer (e.g., manufacturer or distributor) shall supply a hospital with a controlled substance Manual Procurement Process Manual ordering should be minimized. When a manual procurement process is used, the forms used to purchase controlled substances should be sequentially prenumbered and closely controlled using a log Under no circumstances should blank purchase orders or requisitions for controlled substances be pre-signed or left unsecured. Electronic Procurement Process Only restricted to individual authorized Should have unique access code to order controlled substances  Distribution of Controlled Substances Storage Controlled substances maintained in the pharmacy department shall be stored a manner that Ensures their physical security, Adheres to the recommended storage conditions for the drug, and Meets relevant standards (e.g., from accreditation or regulatory authorities) Access to controlled substances or the areas where they are stored should be further limited to designated pharmacy staff. The issue of access and the list of individuals who may enter these areas should be specifically addressed in the facility’s policies and procedures  Distribution of Controlled Substances Storage In Patient Care Areas Should use a double or triple lock procedure The medication room door and the locked cupboard should never have the same lock, so this two-key system is desirable from both security and medication control standpoints. Alternatively, controlled substances may be stored in locked drawers in medication carts used to deliver the drugs to patients but it should never be left unattended  Distribution of Controlled Substances Dispensing Each formulation and container type should have a separate record within the perpetual inventory. As the drug is manipulated, each “new” type of repackaged or compounded drug requires a new inventory record. For each medication movement, the pharmacy record should include the following information: date; time of issue; patient care area; drug name, strength, and dosage form; quantity delivered or returned; and names and signatures of pharmacy and patient care area staff involved.  Distribution of Controlled Substances Dispensing For each medication movement, the record in the patient care area should include the following information: ▪ date; ▪ time of receipt; ▪ “Issued by Pharmacy” or “Returned to Pharmacy” (to indicate the direction of movement); ▪ Drug name, strength, and dosage form; ▪ Quantity added or subtracted from inventory in the patient care area; ▪ New Balance” (total after the addition or subtraction has been completed); ▪ Names and signatures of pharmacy and patient care area staff involved. Distribution of Controlled Substances  Distribution of Controlled Substances Model set of hospital control procedures Responsibility for controlled drug substances in hospital Administrator is responsible for the proper safeguarding and handling of controlled substances in the hospital Pharmacist in chief is responsible for purchase, storage, accountability and proper dispensing of controlled substances Registers must be maintained for dispensing of controlled substances Ward stock for controlled substances Stock is replaced by duly signed sheet and provision of empty vials Each request for new supply is therefore accompanied by controlled drug administration form For any drug that is lost or wasted, the nurse incharge must prepare incident form  Distribution of Controlled Substances Model set of hospital control procedures Doctor ’s order for administration of controlled drug Duly signed by physician in non edible ink Prescription can only be written by licensed and authorized physician or registered resident  Distribution of Controlled Substances Model set of hospital control procedures PRN or SOS orders Should be discouraged and non- entertained Telephone or Verbal orders Only during necessity, nurse can write the order which should be signed by physician within 24 hours  Distribution of Controlled Substances Miscellaneous Regulations Ward supplies of controlled medicines should only be used for patients on ward Narcotic prescriptions are not refilled Prescription is retained for records Physician may not prescribe narcotics for personal use  Distribution of Controlled Substances Control of Narcotics by Nurses Narcotics are audited for count and use in every shift change Every shift has designated nurse for narcotics control Both the nursing staff from new and old shift sign the records If discrepancy found, it should be reported to pharmacy  Distribution of Controlled Substances Research Use Personnel involved in research are to be registered under DRAP rules If there are more than one locations, each location has to be registered separately Each personnel has to keep records of research and controlled substance used Receipt records Dispensing records Administration records Thank you