Management of Medication

By S K Bohra

Session Objectives
Define of the scope of Management of Medication Identify the Path of Workflow Discuss the components of a Management of Medication Discuss & establish the Management of Medication performance criteria for Continual Quality Indicators

ODNM

Objectives

Well-planned & implemented Medical Management System supports Patient Safety and Improve Quality of care following ways Monitoring MOM with regards to efficiency , quality & safety Reducing practice variation , errors & misuse Reporting potential & actual medication errors Improve MOM process
ODNM

Objectives
Edition 2 April 2009 Serial # Edition 3 November 2011 Objective Elements 3 4 8 7 Description of standards Pharmacy services &usage of medication Hospital Formulary Storage of Medication Prescription of Medication Objective Elements 4 5 7 12 Old 8 are clubbed in 7 Observation MOM 01 MOM 02 MOM 03 MOM 04

Description of standards Pharmacy services &usage of medication Hospital Formulary Storage of Medication Prescription of Medication

MOM 05
MOM 06 MOM 07 MOM 08 MOM 09

Dispensing of Medication
Medication Administration Education about safe medication & food drug interactions Monitoring after Medication Administration Narcotic Drugs and Psychotropic Substances

4
10 2 5 /43 4

Dispensing of Medication
Medication Management Monitoring after Medication Administration Near Misses ,Medication Errors and Adverse Drug Events Narcotic Drugs and Psychotropic Substances

6
10 4 /48 5 4 Changes in Objective Element -b No change No change

MOM 10 MOM 11 MOM 12 MOM 13

Chemotherapeutic Agents Radioactive Drugs Implantable Prosthesis Medical Gases

4 4 3 3 61

Chemotherapeutic Agents Radioactive Drugs Implantable Prosthesis and Medical Devices Medical Supplies & Consumables

4 4 4 4 73

ODNM

Pharmacy services and usage of medication. ( MOM 1)

Documented Policies & procedures guide the organization of Pharmacy services and usage of medication (There are 4 Objective Elements ) a) There is a documented policy and procedure for pharmacy services and medication usage b) These comply with the applicable laws and regulations. c) A multidisciplinary committee guides the formulation and implementation of these policies and procedures d) There is a procedure to obtain medication when Pharmacy is closed

ODNM

Hospital Formulary ( MOM 2)

There is a Hospital Formulary (There are 5 Objective Elements a) A list of medication appropriate for the patients and organizations resources is developed. b) The list is developed and up dated collaboratively by the multidisciplinary committee c) The formulary is available for clinicians to refer and adhere to. d) There is a defined process for acquisition of these medications. e) There is a procedure to obtain medication not listed in the formulary

ODNM

Storage of Medication( MOM 3)

Documented Policies & procedures guide the Storage of Medications (There are 7Objective Elements ) a) Documented policies and procedures exist for storage of medication b) Medications are stored in a clean, safe & secure environment ;and incorporating manufacturers recommendations c) Sound inventory control practices guide storage of the medications d) Sound-alike and look-alike medications are stored separately e) The list of emergency medications are defined and are stored in a uniform manner f) Emergency medications are available all the time g) Emergency medications are replenished in a timely manner when used
ODNM

Storage of Medication

Requirements Policy & Procedure exits for storage of medication such as

Medications are stored in the pharmacy/floor according to the manufacturer's or as per government recommendations.. ensure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security All medication storage areas to be inspected as per hospital policy ( once in six months) to ensure medications stored properly

ODNM

Storage of Medication

Temperature

Drugs required to be stored between temperature

ranges of -10 to - 30 degree C be stored in freezer Drug requiring cold chain to be stored in refrigerator within temperature range of 2 to 8 degree C and rest of the drug shall be stored at room temperature between 15 to 25 degree C. Monitoring of all refrigerated items done twice in a day with record maintained. When variation found repetitively, it will be notified to Engg deptt and all drugs to be removed & stored in other refrigerator All refrigerated medicine to be dispensed in ice box
ODNM

Storage of Medication

Light Sensitive Medicine

Medications that are considered light-sensitive, as labeled by their respective manufacturers, will be stored and dispensed in a manner as to protect them from light. If the medication is commercially available in a lightresistant package, the medication may be stored on the shelf as is. All refrigerated medicine to be dispensed in ice box

ODNM

Storage of Medication

Medications and chemicals used to prepare medications are accurately labeled with contents , expiry dates and Warnings Standardize and limit the number of drugs concentrations available Concentrated Electrolytes are removed from Care Unit areas ( unless patients safety at risk) and specific precautions are defined & taken to prevent inadvertent administrations

ODNM

Storage of Medication
Protected from Loss or Theft Floor Stock Nurse Supervisor responsible for control of floor stock & medications security within the hospital wards and patient care areas Controlled drugs ( Narcotics & Controlled, Investigational & Cytotoxic and Hazardous Drugs) will be double locked at all times prior to use All drugs stores to be accessible only to authorized pharmacists and pharmacy technicians. Others are admitted only when a pharmacist is present. Medications are stored either in lockable medication carts or the medication room & when unattended these are to be locked. ODNM

Storage of Medication

Look like and Sound Like Medications

Medications which have the potential for confusion due to look-alike or sound-alike drug names or packaging are identified and treated with extra precautions to

prevent error
o o o

Identify ( make list) Review the list annually and up date Take actions to prevent errors involving the interchange of these drugs
ODNM

Storage of Medication

Expiry Control of Medications

As per licensing regulation, expired items must not be found in shelves/ racks of the licensed pharmacy. These should be stored in locked cabinet exclusively for this purpose and must not be issued to patients Pharmacist has to issue batch wise so that HIS close to expiry list is effective Wards are required to return every month in advance ( during first week) expiry items close to three months using defined format F21/MTL(RED) , Return of Expiry Drugs . While checking in wards if no expiry medications found (with in 3 months) it is essential that ODNM NO Expiry RETURN needs to be sent in same format

Storage of Medication

o o o

Sound Inventory Control

Sound inventory control practices to be followed Ensure the drugs are available 24x7 in Pharmacy areas Ensure Emergency Medications ( as per defined list) a

available in STOCKS all the time and reorder levels are

defined and are replenished in defined time frame.
o

All medication storage areas to be inspected as per hospital policy ( once in six months) to ensure medications stocked as per Inventory Policy ODNM

Prescription of Medication ( MOM 4)

Documented Policies & procedures guide the Safe & rational Prescription of Medications (There are 12 Objective Elements ) a) Documented policies and procedures exist for prescription of medications b) These incorporate inclusion of good practices / guidelines for rational Prescription of Medications c) The organization determines the minimum requirements of a prescription d) Known drug allergies are ascertained before prescribing e) The organization determine who can write orders f) Orders are written in a uniform location in the medical records. g) Medication orders are clear, legible, dated, timed, named and signed.
ODNM

Prescription of Medication ( MOM 4)

h) Medication orders contain the name of the medicine , route of administration, dose of administration and frequency / time of administration i) Documented Policy and procedure on verbal orders is implemented j) The organization defines a list of high risk medication k) Audit of medication orders / prescription is carried out to check for safe and rational prescription of medications l) Corrective and preventive action(s) is taken based on the analysis , where appropriate

ODNM

Prescription of Medication
Authority for Prescribing medication orders Only Physicians authorized to prescribe medications orders & only those drugs listed in the Formulary except in specific instances. All medication orders to be written on HIS /Prescription Form/Letterhead or Case Sheets labeled with Patients name and Registration number at uniform location History for drug allergies to be documented in red ink. Use of HIS for reducing prescribing errors is desirable. Abbreviations for drug names are not be written. All medication orders to specify the drug name, dosage or dosage range, the route of administration , the frequency and duration of administration. High Risk medications need to be verified by treating Consultant prior to administration. ODNM Medication orders are to be clear, legible, dated, named and

Prescription of Medication

Ensure clinicians are trained / sensitized for rational( as per clinical needs in dose) prescription of medications Patients name, UHID, drug name, dose, route & frequency of administrationname , signature & registration number of prescribing doctor Drug allergies ascertained Uniform locations Authorization for prescribing orders Orders are clear , legible , dated , timed, named and signed Verbal orders to be counter signed with in 24 hrs Define High risk medications Audit & CAPA
ODNM

Prescription of Medication
All orders for a drug dose less than one shall have a zero

preceding the decimal amount. E.g. write 0.25mg instead of .25 mg. Do not use decimal points or trailing zeros. e.g. Write 2 mg instead of 2.0 mg. Microgram amounts shall be clearly written as microgram to clearly distinguish form milligrams (mg). All orders for units shall be clearly written in units. Orders calculated in either milligrams or micrograms doses shall be left in the units in which the calculation was made. If more than one physician is prescribing medications for one patient, each individual medication order must be written separately and each medication order must be signed

ODNM

Prescription of Medication
To change any of the medication orders, physician must cease the

original order and write a new order. To cease a medication order physician must draw a line across the area of the chart where administration is recorded (after the last entry) and sign and date adjacent to this line. The original order must not be obliterated. There shall be an automatic cancellation of drug orders when a patient changes service, when a patient is moved into or out of an intensive care unit, or when a patient is sent to the operating room or delivery room All the medications prescribed at the time of discharge should be included in the discharge summary, whether or not it is to be supplied by the hospital pharmacy

ODNM

Prescription of Medication
Orders for research drugs can only be written by the physician

involved in that research protocol Drops: specify which orifice (ear, eye, oral) and the number of drops to be given. Do not use Latin abbreviations such as AU for both ears, AS for left ear, AD for right ear. Skin creams: specify the area of skin on which application is required and the amount to be applied on a given occasion

Infusions: specify as subcutaneous, intravenous, epidural or

intrathecal. For intravenous infusions----specify via regular drip set, micro drip set or syringe pump; peripheral vs central access, mode of preparation of infusion , rate, duration, titrating orders for nursing staff (egas per BP level, as per HR, as per glucometer reading, etc)
ODNM

Prescription of Medication

Insulins and insulin syringes : specify 40 Unit/ml or 100 Units/ml Oxygen: specify as --- litre/min via nasal cannula/venturi mask/ventilator Vaccines: patient leaflet to accompany each vaccine. Batch number to be indicated on patents immunization card. Paediatrics: dose --- mg/kg/day in 3 divided doses is better written as --- mg thrice-a-day factoring in the patients weight. Avoid leaving that responsibility on the nurse/pharmacist. Narcotics: Requires narcotic prescribing license number Emergencies: write STAT next to the prescribed item Surgical / miscellaneous items: specify number of items needed and their size (eg: 16 gauge or small/medium/large/X large) . ODNM

Prescription of Medication

The Physician is to notify the nursing staff when Stat orders are written. Stat orders must be transcribed immediately and followed. Hold means discontinue the medication Emergencies: write STAT next to the prescribed item Surgical / miscellaneous items: specify number of items needed and their size (eg: 16 gauge or small/medium/large/X large) The Physician is to notify the nursing staff when Stat orders are written. Stat orders must be transcribed immediately and followed. Hold means discontinue the medication. Verbal Orders Procedure to be defined
ODNM

Dispensing of Medication( MOM 5)

Documented Policies & procedures guide the Safe & rational Prescription of Medications (There are 6 Objective Elements ) a) Documented policies and procedures guide the safe dispensing of medications b) The procedure addresses medication recall c) Expiry dates are checked prior to dispensing d) There is a procedure for near expiry medications e) Labeling requirements are documented and implemented by the organization f) High-risk medication orders are verified prior to dispensing

ODNM

Dispensing of Medication( MOM 5)

Dispense means the procedure which results in the receipt of a prescription Interpreting (Correctly identifying the drug prescribed; and Preparing a label which accurately reflects the instructions for use given on the prescription, such as form, dosage, route, and frequency of dosing ) an authorized prescribers prescription for a drug or device Selecting and labeling of the drug or device prescribed; and Measuring and packaging of the drug or device Dispensing of medicines from pharmacy will be done by the hospital pharmacist in hospital according to a written prescription. The pharmacist will check the validity and efficacy of the prescription, the appropriateness of the medicine for the individual patient, assembly of the product, labeling and information given for the patient.
ODNM

Dispensing of Medication( MOM 5)

The nurse shall strictly adhere to the following steps when dispensing a prescribed product. The nurse shall verify that drug is on the approved formulary of the hospital and verify that the prescription order includes at least the following information: Date of issue , Name of patient , Name, strength, dosage form, and quantity of drug prescribed , Route of administration, if applicable and Directions for use. Verify that prescription or prescription orders are signed by the physician Check the patient profile for pertinent information, including information on allergies, concurrent prescription drugs, and over the counter medications; and Determine that the prescription is not outdated
ODNM

Dispensing of Medication( MOM 5)

Selecting the appropriate drug or device Check the expiry date of the drug Recall : procedure applies when a defective drug or drug suspected for the same is found: Ward nurse Verbally informs Nursing Supervisor/ Immediate Manager Immediately. Nursing Supervisor/ Immediate Line Manager (Nursing ) Verbally Inform the Assistant Medical Superintendent immediately. Retain the remaining product/suspected product. If the product has been administered - STOP IMMEDIATELY. INFORM THE RESIDENT DOCTOR IMMEDIATELY. Nurse to document the notes of the incident in the Nursing notes with Date and time of discovery, Name of Product, Manufacturer's name and Batch No. and Expiry Date.
ODNM

Dispensing of Medication( MOM 5)

Resident Doctor to inspect the product immediately and discretely assess patient for any ADRs/Side Effects and document the incident in the Case Sheet Assistant Medical Superintendant to supervise withdrawal of Drug from the department and if same batch issued to others then withdrawal of Drug from all departments. Pharmacist to submit completed report to AMS. Assistant Medical Superintendent to submit completed Drug Recall Incident Form and Pharmacist Drug Recall Incident Form to V.P Medical Services. Report to be discussed between V.P Medical Services and Member D&T Committee. Action taken by committee to be documented at back of incident form and followed up. Punitive action/Rewards and Incentives to be given to respective staff.

ODNM

Medication Management (MOM 6)

a) b) c) d) e) f) g) h) i) j)

There are documented Policies & procedures for Medication Management (There are 10 Objective Elements ) Medication are administered by those who are permitted by law to do so Prepared Medication are labeled prior to preparation of a second drug Patient is identified prior to administration Medication is verified from the order prior to administration Dosage is verified from the order prior to administration Route is verified from the order prior to administration. Timing is verified from the order prior to administration. Medication administration is documented Documented Policies & procedures govern patients selfadministration of medication Documented Policies & procedures patients medication ODNM brought from out side the organization

Monitoring After Medication

Administration (MOM 7)

Patients are monitored after Medication Administration (There are 4 Objective Elements ) a) Documented policies and procedures guide for monitoring of patients after medication administration b) The organization defines those situations where close monitoring is required c) Monitoring is done in collaborative manner d) Medications are changed where appropriate based on the monitoring.

ODNM

Near Misses ,Medication Errors

and Adverse Drug Events (MOM 8)

Near Misses ,Medication Errors and Adverse Drug Events are

reported and analyzed (There are 5 Objective Elements ) a) Documented procedure exists to capture Near Misses ,Medication Errors and Adverse Drug Events b) Near Misses ,Medication Errors and Adverse Drug Events are defined c) These are reported with in a specified time frame d) They are collected and analyzed. e) Corrective and preventive action(s) is taken based on the analysis , where appropriate

ODNM

Near Misses ,Medication Errors and Adverse Drug Events (MOM 8)

Near Misses
A near miss is an unplanned event that did not result in injury, illness, or damage but had the potential to do so. Only a fortunate break in the chain of events prevented an injury, fatality or damage; in other words, a miss that was nonetheless very near. Although the label of 'human error' is commonly applied to an initiating event, a faulty process or system invariably permits or compounds the harm, and should be the focus of improvement. Other familiar terms for these events is a "close call", or in the case of moving objects, "near collision". Medication Errors A medical error may be defined as a preventable adverse effect of care, whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, ODNM behavior, infection, or other ailment.

Near Misses ,Medication Errors and Adverse Drug Events (MOM 8)

Medical Error As a general acceptance, a medical error occurs when a healthcare provider chose an inappropriate method of care or the health provider chose the right solution of care but executed it incorrectly. Medical errors are often described as human errors in healthcare.[ However, medical error definitions are subject to debate, as there are many types of medical error from minor to major, and causality is often poorly determined Adverse Drug Events Unintended, harmful reactions to medicines (known as adverse drug reactions) are among the leading causes of death in many countries. The majority of adverse drug reactions (ADR) are preventable.
ODNM

Narcotic Drugs and Psychotropic

Substances (MOM 9)

Documented procedure guide for use of Narcotic Drugs and Psychotropic Substances (There are 4 Objective
Elements ) Documented procedure guide for use of Narcotic Drugs and Psychotropic Substances which are in consonance with local and national regulations

a)

b)
c)

These drugs are stored in a secure manner

Proper record is kept of the usage , administration and disposal of these drugs d) These drugs are handled by appropriate personnel in accordance with the documented procedure

ODNM

Chemotherapeutic Agents(MOM10

Documented policies and procedure guide for use of use of Chemotherapeutic Agents (There are 4 Objective
Elements ) Documented policies and procedure guide for use of use of Chemotherapeutic Agents

a)

b)

Chemotherapy is prescribed by those who have the knowledge to monitor and treat the adverse effect Chemotherapy
Chemotherapy is prepared in a proper and safe manner and administered by qualified personnel Chemotherapy drugs are disposed of in accordance with legal requirements
ODNM

c) d)

Radioactive Drugs(MOM 11)

a)

Documented policies and procedure govern usage of Radioactive drugs(There are 4 Objective Elements )
Documented policies and procedure govern usage of Radioactive drugs

b)
c) d)

These policies and procedure are in consonance with laws and regulations
The policies and procedure include the safe storage , preparation, handling , distribution and disposal of Radioactive drugs Staff , patients and visitors are educated on safety precautions

ODNM

Implantable Prosthesis and Medical Devices (MOM 12)

Documented policies and procedure guide the use of Implantable Prosthesis and Medical Devices (There are 4
Objective Elements ) Usage of Implantable Prosthesis and Medical Devices id guided by scientific criteria for each individual item & national / international recognized guidelines / approval for each specific items

a)

b)

Documented policies and procedure govern procurement, storage/stocking, issuance & usage of Implantable Prosthesis and Medical Devices incorporating manufacturers recommendations
ODNM

Implantable Prosthesis and Medical Devices (MOM 12)

c) Patient and his/ her family are counseled for the usage of Implantable Prosthesis and Medical Devices including precautions if any
d) The batch and serial number of the Implantable Prosthesis and Medical Devices are recorded in the patients medical record and the master logbook

ODNM

Medical Supplies & Consumables

(MOM 13)

Documented policies and procedure guide the use of Medical Supplies & Consumables (There are 4 Objective
Elements ) There is a defined process for acquisition of Medical Supplies & Consumables

a)

Medical Supplies & Consumables are used in a safe manner , where appropriate c) Medical Supplies & Consumables are stored in a clean, safe & secure environment ;& incorporating manufacturers recommendations d) Sound inventory control practices guide storage of medical supplies and consumables.
b)
ODNM