HOSPITAL PHARMACY COMPREHENSIVE EXAM REVIEWER

1. Hospital

Hospital organized structure w/e pools together all health professions, diagnostics & therapeutics facilities, equipment
& supplies & physical facilities into a coordinated system for delivering healthcare to the public.

Hospital Pharmacy - The practice of pharmacy in hospital. - department or division of hospital.

Types of HC 1. Long-term healthcare facility

Institutions - facility for inpatient other than a hosp.
- with medical staff, directors, nursing services.
2. Resident care facility
- facility providing safe, hygienic living arrangements for residents.
- with regular emergency services.
3. Clinic
- where ambulatory px are seen by appointment & treated.
- can also be outpatient diagnostie facility operated by hospital.
4. Health Maintenance Organization
- public/private organization that ptovides/manages comprehensive health services yo enrolled
individuals.

Requirements for • AT LEAST 6 IMPATIENT BEDS

Registration of - 6 separate patients who are unrelated to each other.
Hospital • Un-crowded, sanitary facilities
• Identifiable governing authority • Each patient shall be admitted on the
authority of a staff members
• Ceo to whom governing authority
delegates operation hospital • Current & complete medical record
• Organized medical staff & other licensed • Pharmacy service
hc professionals • Food service

Classification

Based on type of 1. General

Services • non-selective: all type of medical condition
2. Special
• specific medical condition.
3. Rehabilitation & Chronic Disease
• handicapped/disabled Individual requiring restorative and adjustive service.
4. Psychiatric
• psychiatric related illness.

Based on the Short Term- < 30 days Long term- > 30 days
length of stay

Based on • Governmental- federal or stale.

ownership • Non-Government- non-profit or profit.

Bed Capacity Under 50

50-99 200-299 400-499
100-199 300-399 500 UP

Service Capability • LEVEL 1 – emergency hospital

• LEVEL 2 – general care (nondepartmentalized)
• LEVEL 3 – specialty clinical care (specialty clinical care)
• LEVEL 4 – sub specialty clinical care (teaching and training care)
Pic table

Functions of • PATIENT CARE

Hospital • EDUCATION OF MEDICAL ALLIED PROFESSIONS OF THE PATIENT.
• RESEARCH- advancement of medical knowledge and for improvements of services.
• PUBLIC HEALTH/WELNES -community.

FOR SOBREVEGA | SOLIMAN | QUIJANO | RABANES | RAYMUNDO | TINA ONLY

SUPPORTING 1. Nursing Service 5. Blood Bank 8. Anesthesia
SERVICES 2. Dietary Service 9. Medical Social/Services
6. Pathology
3. Central Supply 10. Pharmacist
7. Radiology
4. Medical Record

MEDICAL STAFF MAIN TYPES

• Open Staff - certain physicians part of the active facilities & admitted patients to the Hospital.
• Closed Staff - all services are, controlled by the active staff.

SPECIFIC TYPES
• Honorary - retired, emeritus : highest designation the staff could achieved.
• Consulting - specialist.
• Active/Attending - regular patient care.
• Associate - considered for adjustment. - junior staff.
• Courtesy - given privilege to admit an occasional patients.
• Resident - receiving specialized

FUNCTIONS OF 1. To promote and evaluate service in support of medical care.

THE HOSPITAL 2. To implement the philosophy, objectives, policies, and standards of the hospital.
PHARMACY 3. To provide and implement a departmental plan of administrative authority.
4. To participate in the coordination of functions with all other departments.
5. To recommend and implement policies and procedures to maintain adequate and competent staff.
6. To provide means to interpret the objects of the hospital to community.
7. To develop and maintain an effective system of administrative records and reports.
8. To estimate needs for facilities, supplies and equipment
9. To participate in adhere to financial plan of the hospital.
10. To initiate, utilize, and/or participate in studies or research projects.
11. To provide and implement continuing education program for personnel.
12. To participate in/or facilitate educational programs.
13. To participate in adhere to the safety programs of hospital.

2. THE PHARMACY & THERAPEUTIC COMMITTEE

OBJECTIVE
To achieve optional patient care safety through rational and therapy.

PRIMARY PURPOSES:
1. Policy Development - policies regarding evaluation, selection, and use of the drugs.

2. Education - implementation of the programs to provide complete current knowledge to professional staff.

ORGANIZATION
Physicians, pharmacist, nurses, administrators, quality assurance coordinator and others as appropriate.
• Chairperson: Physician
• Secretary: Pharmacist

Function •Manages the formulary system

▪To prepare a hospital formulary
▪To publish pharmacy educational bulletin
•Evaluates the clinical use of the drug
▪To supervise the use of investigational drugs
•Develop policies for managing drug use and drug administration
•Develop and recommend to the medical staff and the administration on matters related to therapeutic use of
the drug and drug administration
▪To develop a program for reporting and investigation of ADR
▪To assist in the preparation of emergency kits
▪To initiate and direct drug use review programs
▪To make recommendation concerning drugs to be stocked in hospital patient care-areas
▪To advise the pharmacy in the implementation of effective drug distribution and control procedures.

THE PHARMACY & ▪MEETINGS:

THERAPEUTIC •at least 6 times a year •Large hospitals: 10-12 times a year

▪COMMITTEE AGENDA
1. Review of specified sections of the formulary for updating and deletion of drugs
2. Hospital non-formulary drugs and new drugs proposed for inclusion with the
3. approval of the DOH
 4. Evaluation of an investigational drug protocol
5. Review of the reports of ADR/DUR committees for appropriate plan and action.
6. Drug safety in the hospital

3. Formulary

Formulary A continually rescised compilation of pharmaceuticals that reflect the current clinical judgement of the
medical staff.

THE FORMULARY Method whereby the medical staff through the PTC, evaluates, appraises and selects from among the
SYSTEM numerous available drugs those considered useful in patient.

PARTS OF HOSPITAL FORMULARY

Part I. Information on hospital policies and procedures concerning drugs.
1. Categories of drugs
2. Description of the PTC
3. Hospital regulations regarding prescribing, dispensing, admin of drugs.
4. Pharmacy operating procedures. 5. Info on using the Formulary.

Part II. Drug Listing (Product)

- heart of the formulary
• Alphabetically by genetic name.
• Alphabetically within therapeutic class.
• Combination of the two.

Contents:
✓ Genetic name ✓ Active ing. (if comb. produces)
✓ Brand names/common synonyms ✓ Additional info. (warning, ci,
✓ Dosage form, strength, packaging, stoc size. precautions).

Part III. Special Information

1. Hospital-approved abbreviations.
2. Rules for calculating pediatric.
3. Dosing guides (for px with renal impairment.
4. Other list (eq. dialyzable poisons, etc..

PHILIPPINE government’s response to the problem of inadequate provision of good quality essential drugs to people.
NATIONAL DRUG
FORMULARY Criteria for INCLUSION of drugs in the PNDF
(PNDF) • Drug is needed for the preventive and treatment of condition not already covered in the existing list
• Drug is more effective and/or less toxic than listed for the same indication
• Drug is at least effective and safe and of lower cost
• Drug is deemed essential for a specific DOH health program/project

Criteria for DELETION of drugs in the PNDF

• A more effective equally effective but less toxic drug becomes available
• The therapeutic efficacy of the drug is unsatisfactory or questionable
• Risk outweighs the benefits
• Drug has fallen to disuse/ no longer use
• Drug is no longer deemed cost effective

▪CORE LIST
•A list of drugs for the health care needs of the majority of the population
•The listed drugs should therefore be made available at all times in adequate amounts and in appropriate
dosage forms at the lowest possible cost.

▪COMPLIMENTARY LIST
•A list of drugs for treating rare disorders or in exceptional circumstances
•Alternative drugs when drugs in the main list are known to be ineffective or inappropriate for a given
individual
•Alternative drugs when drugs in the main list cannot be made available

Stages of Drug First Stage-consists of discovery and introduction of new drugs, which have played an important role in the
usage in the treatment of illness
Hospitals
Second Stage-drug standardization necessitated by the influx of duplicate brands and similar type drugs,
which is achieved through a hospital drug formulary based on the PNDF
 Third Stage - involves an evaluation of the utilization of drugs which have been accepted into the formulary

DRUG •quantitatively & systematically reviewing prescription claims data to evaluate the appropriateness of drug
UTILIZATION therapy
REVIEW
TYPES OF DRUG UTILIZATION REVIEW
•Prospective – before dispensing •Concurrent – during use •Restrospetive – after dispensing

◦ helps to identify the physician’s prescribing & the patient’s drug utilization pattern
◦ improves the drug therapy process by eliminating previously occurring medication regimen problems

4. Drug Distributions Systems

Drug Distributions 5. Prescription order transmission

Systems 6. a pharmacy coordinated method of dispensing and controlling medication in organized health-care
settings

1.Floor-Stock 1. Nocharge floor-stock

System - ued at no specific charge to patients.
- inexpensive pharmaceutical with universal use.

2. Charge floor-stock

Advantages Disadavantage
✓ ready availability of drug. ✓ possible high in medication error.
✓ elimination of drug returns. ✓ increased drug inventory.
✓ reduction in no. of drug order ✓ greater risk for drug deterioration.
transcriptions. ✓ possible lack of proper storage facilities in
✓ reduction in no. of pharmacy the ward.
personnel needed. ✓ greater inroads upon nurses time.

2.INDIVIDUAL Advantages Disadvantages

PRESCRIPTION ✓ reduced manpower requirements. ✓ possible delay in obtaining required
ORDER ✓ individualized service. medication.
✓ all medications are reviewed by the pharmacist. ✓ increased cost to px.
✓ interaction of RPh, doctor, RN, Px.
✓ closer control of inventory..

3. COMBINA Most commonly employed drug distribution system but not so ideal.
TION OF FLOOR
STOCK &
INDIVIDUAL
PRESCRIPTION

4. UNIT 1. Centralized 3. Combination of 1&2

DOSE DISPENSING • Most common; most cost efficient. 4. Partial
2. Decentralized • Particularlly complete due to special circumstances of
• Satellite pharmacies. some hospitals.
• of some hospitals.
Advantage
✓ improved pharmaceutical service 24hrs a day more time for nurses for direct patient care allows checking
and interpreting of doctor's order.
✓ eliminates excessive duplication of orders and paper works at the pharmacy.
✓ eliminates credit.
✓ IV preparation and reconstitution done at the pharmacy
✓ more efficient utilization of personnel reduced revenue loss.
✓ conserves space in nursing units.
✓ eliminates polterage and drug waste.
✓ eliminate pharmacy control and coverage throughout the hospital.
✓ improved communication of medical orders and delivery system.
✓ provide the team effort needed for better patient care.

5. Pharmacy Management and Control

Pharmacy Hospitals are extremely complex organizations that depend on experienced, well-trained managers and
Management and clinicians with good management skills for the development and delivery of high-quality, efficient and patient-
Control centered services.

Leader • Ensure vision is developed and conveyed to the whole team

• Influence by setting direction for others.
• Excel at coping with change, and motivating and inspiring followers
• Seek commitment over compliance

Manager • Exert influence by providing order and consistency • Commitment is less

• Want people to do what they are told than compliance

Financial FOURMULA ONE PLAN (F1)

Management – financing reforms for healthcare institutions created by the DOH to be able to secure better and sustained
investments in health.

– involves strategic action plans that seek to provide equity and improve health outcomes

Other financial The following are the sources of funds that can be availed of:
Sources •Priority Development Assistance Fund (PDAF) •Insurance
•DOH Indigency Fund •NGOs
•PCSO •LGUs

Pharmacoeconomi • It was introduced to compare the value of one pharmaceutical or drug therapy to another.
cs • This involves weighing the total expected costs against the total expected benefits of one or more
actions in order to choose the best or most profitable option.

Four Economic Cost Minimization Analysis (CMA)

Techniques • simplest and is applied when comparing 2 drugs of equal efficacy and equal tolerability. It compares
the total costs of the therapies

Cost Effectiveness Analysis (CEA)

• compares the relative expenditures (costs) and outcomes (effects) of 2 or more courses of action.
This is often used where a full cost-benefit analysis is inappropriate.

Cost Utility Analysis (CUA)

• used to guide procurement decisions. Estimates the ration between the cost of health-related
intervention and the benefit it produces in terms of number of years lived in full health by the
beneficiaries.

Cost Benefit Analysis (CBA)

• refers to a formal discipline used to help appraise, or assess, the case for a project or proposal
(project appraisal). Also refers to an informal approach to making decisions of any kind

Drug Procurement Factors considered in effective medicines procurement:

•Right Quality Right Price •Right Time
•Right Quantity •Right Source
4.Choose procurement method 8.Receive and check drugs
Drug Procurement 1.Review drug selection
5.Locate and select 9.Make payment
Cycle 2.Determine quantities needed
6.Specify contract terms 10.Distribute drugs
3.Reconcile needs and funds
7.Monitor order status suppliers 11.Collect consumption information
Key Principle of 1.Procurement by generic name 8.Order quantities based on reliable estimate of actual
Good 2.Limitation of procurement to the essential need
Pharmaceutical drug list 9.Reliable payment and good financial management
Procurement 3.Procurement in bulk 10.Separation of key functions
4.Formal supplier qualification and 11. Product quality assurance program
monitoring 12. Annual audit with published reports
5.Competitive procurement 13. Regular reporting of procurement performance
6.Sole-source commitment indicators
7.Order quantities based on reliable estimate
of actual need
Other Means of Consignment System – agreement between the hospital and legitimate manufacturers or suppliers which
Acquiring Drugs have the capability to meet the demands of the hospital for essential medicines in a sustainable manner. It is
and Medicines where the goods are paid once they are sold.
 Drug Donations – often received to augment pharmaceutical requirements for the less fortunate members of
society.

Preparation of •Average consumption per day = Ave. monthly consumption / 30 days

Purchase Request
•Stock Level = Ave. consumption per day * (90 days + Lead time)

•Lead Time – time from the preparation of PR and the whole process of purchasing to the time of the delivery
of drugs to the hospital.

Drug • Methods of Proper Storage

Storage,Security • Special Storage Conditions
and Control
• Temperature monitoring

Methods of Proper 1. Keep the pharmacy and storeroom in good condition

Storage 2. Prevent damage and contamination
3. Protect Against Fire
4. Arrangement of Medicines

Storage Conditions • liquids, tablets, capsules and parenteral with temperature requirement below 30 ̊C are stored in a
normal storage area.
• dangerous drugs, attractive and expensive medicines, biological products, vaccines, flammable
liquids and corrosives, need storage in an access-controlled location.

Attractive/ Expensive Items

• Expensive drug products and antibiotics that are prone to theft, abuse or misuse should be stored in
a separate locked area.
• An update record keeping and more frequent inventory taking than other items are necessary

Flammables and Corrosives

• Bulk supplies of flammables such as alcohol and acetone should be stored in special building or
room.
• A separate building is best to reduce the risk of fire from spreading to the pharmacy or central
storeroom
• Storeroom must be well ventilated, fireproof and fitted with an “explosion hatch” as part of roof/wall
• Bulk supplies of flammables such as alcohol Small stock of flammables may be kept in a steel
cabinet, in well ventilated premises, away from open flames and electrical appliances
• Cabinet(s) should be marked “highly inflammable liquid” and must bear the international hazard
symbol
• Pharmacists must be aware of the Flash Point of flammable liquids that indicate susceptibility to
ignition.
• Acetone: -180C
• Undiluted alc: 18-230C
• Kerosene: 23-610C

Corrosives or oxidants should be stored away from flammables in a separate steel cabinet. In handling, the
pharmacist should wear appropriate industrial-type protective gloves and face masks

Glacial acetic acid, trichloroacetic acid, conc. ammonia solution, silver nitrate, sodium nitrate, and sodium
hydroxide pellets

Biological products, vaccines requiring refrigeration

• Vaccines should be arranged according to type, expiry date, duration of storage and number of
times they have been brought out to the field. Vaccines with the earliest expiration date should be
distributed or used first.
• Thermometers of the modified or pharmaceutical refrigerators should be properly calibrated twice in
a year to maintain the required storage temperature.
• There should be backup generators in case of electrical failures.

Cytotoxic Drugs
✓Kept in secure place and with access limited to specific authorized person
✓Properly labelled
✓Proper inventorY
 Temperature Monitoring

Inventory Purpose of Inventory

management Operational
•To ensure the adequate supply of drugs conform to the requirements of the hospital turn-over at a
reasonable rate without carrying excess quantities.
Financial
•To optimize the inventory investment at a given time, reduce the cost of handling, storage, issuance,
interest, and at the same time avoid losses from deterioration, expired drugs, pilferages, and fluctuating
prices

6.DANGEROUS DRUGS AND THEIR CONTROL

Dangerous drugs • refer to drugs included in the list of Schedules annexed to the 1961 Single Convention on Narcotic
Drugs, as amended by the 1972 protocol, and in the Schedules annexed to the 1971 Single
Convention on Psychotropic Substances as enumerated in the annexes which are an integral part of
the Comprehensive Dangerous Drugs Act of 2002.

Dangerous Drugs • policy-making and strategy-formulating body for the entire country with regard to dangerous drugs,
Board controlled precursor and essential chemical matters

Philippine Drug • implementing arm that is responsible for the efficient law enforcement of all provisions pertaining to
Enforcement Dangerous Drugs, and Controlled Precursor and Essential Chemicals
Agency (PDEA)

• The production, possession, importation, and distribution of these drugs is strictly regulated or outlawed,
and many may be dispensed by prescription only.

The basis for the regulation is to:

✓control the danger of addiction, abuse
✓physical and mental harm
✓the trafficking by illegal means
✓and the dangers from actions of those who have used these substances.

CONTROLLED The substances are listed in five categories, or schedules, according to their:
SUBSTANCE ✓Characteristics ✓Dangerousness ✓medical usage ✓addictive properties
SCHEDULES

• The Schedules are denoted as I – V, with

>>SCHEDULE I being the most dangerous and the highest potential for abuse

>> SCHEDULE V being the least dangerous and lowest potential for abuse.

Controlled Controlled Substances are segregated into DEA Schedules I, II, III, IV, or V based upon:
Substances DEA ✓Abuse potential,
Schedules ✓Medical value, and the
✓Danger of serious physical effects to the user.

Schedule 1 • A high potential for abuse.

• Have no currently accepted medical use in
• Lack of accepted safety for use of the drug or other substance under medical supervision.

• Three broad categories:

1. opiates
2. opium derivative
3. hallucinogens

Some examples of substances listed in schedule I are:

• heroin,
• lysergic acid diethylamide (LSD)
• marijuana (cannabis)
• peyote, methaqualone
• 3,4‐methylenedioxymethamphetamine (“ecstasy”)

• FDA has approved the marketing of the THC product, dronabinol (Marinol) snd synthetic cannabinoid,
nabilone (Cesamet) for the treatment of the nausea and vomiting associated with cancer chemotherapy.
Schedule 2 The drug or other substance has a high potential for abuse.
• The drug or other substance has a currently accepted medical use in treatment in the United States or a
currently accepted medical use with severe restrictions.
• Abuse of the drug or other substances may lead to severe psychological or physical dependence.

• Two broad categories:

1. Opiates and opium derivatives of coca leaves
2. Certain CNS stimulants and depressants
• Examples of Schedule II Drugs:
• Cocaine
• Amphetamines
• Pentobarbital
• Etorphine
• Fentanyl
• codeine, and many other opioids.

Schedule 3 “Class B Narcotics”

• The drug or other substance has a potential for abuse less than the drugs or other substances in schedules
I and II.
• The drug or other substance has a currently accepted medical use in treatment in the United States.
• Abuse of the drug or other substance may lead to moderate or low physical dependence or high
psychological dependence.
• Examples of Schedule III Drugs: barbiturates, hydrocodone, ketamine
▪ Empirin with codeine; ASA with codeine; Donnagesic #1; Paregoric; Hycodan; Tylenol with codeine, etc.

Schedule 4 • The drug or other substance has a low potential for abuse relative to the drugs or other substances in
schedule III.
• The drug or other substance has a currently accepted medical use in treatment in the United States.
• Abuse of the drug or other substance may lead to limited physical dependence or psychological
dependence relative to the drugs or other substances in schedule III.
• Schedule IV drugs are generally the long-acting barbiturates, certain hypnotics and the minor tranquilizers.
For all practical purposes there are no regulatory differences between Schedule III and IV.

Examples of Schedule IV drugs:

• Diazepam
• Phenobarbital • Butorphanol
• phenobarbital

Schedule 5 • Formerly known as “exempt narcotics”

• The drug or other substance has a low potential for abuse relative to the drugs or other substances in
schedule IV.
• The drug or other substance has a currently accepted medical use in treatment in the United States.
• consists of preparation containing limited quantities of certain narcotic drugs generally for antitussive and
antidiarrheal purposes.
• As a general rule, Schedule v are OTC preparations that might be sold without a prescription.
>>There are notable exceptions, and the pharmacist should always check the label to see if the FDA
has determined the item to be a prescriptions- only item.
>>For example, Lomotil is a Schedule V item, but it is prescription-only.
>>Paregoric now is restricted to prescription sales and included in Schedule III.

Examples of Schedule V drugs:

▪ Buprenorphine
▪ Diphenoxylate
▪ codeine cough syrup
▪Terpin hydrate with codeine

Handling • Only pharmacies with S-3 license secured from PDEA are allowed to sell, procure, acquire, deal in or with
specified
(a.) dangerous drug preparations or
(b.) drug preparations
in parenteral or tablet or capsule form, containing Table 1 controlled chemicals as the only active
medicinal ingredient or containing Table 1 controlled chemical and therapeutically insignificant
quantities of another active medicinal ingredient.
• The PTC shall develop policies pertaining to prescribing, proper administration, and control of dangerous
drugs in accordance with the DDB policies and regulations.
 Person Authorized ✓Pharmacist
to engage in ✓Licensed person
professional supply
✓ Practitioner
of dangerous drugs

Prescription A. No person shall prescribe a dangerous drug or drug preparations, unless that person is:
Requirements my • A medical practitioner, who prescribes the drug in the ordinary course of treatment of another
person’s physical or mental condition; OR
• A dentist, who prescribes the drug in the ordinary course of treatment of another person’s dental
condition; OR
• A veterinary surgeon, who prescribes the drug in the ordinary course of treatment of an animal; AND
• Granted an S-2 license to prescribe by the PDEA

B. A prescription for a dangerous drug shall:

• Be on a form as prescribed by the DOH •If issued by a veterinary surgeon:
✓ Be endorsed as being for the treatment of an animal
✓ Specify the name and address of the owner or caretaker of the animal
✓ Specify the species of animal; if possible, specify means of identifying the animal
• Be signed and dated by the prescribing practitioner
• Contain only one dangerous drug

C. The prescription required for drug preparation, in parenteral/tablet/capsule containing Table 1

controlled chemical as the only active medicinal ingredient or containing Table 1 controlled chemical
and therapeutically insignificant quantities of another active medicinal ingredient, shall be in an
ordinary form and shall contain:
•Name, address, tel. number, S-2 license number, and PTR of the prescribing physician
•Name and address of the patient •Date of prescription
•Prescription to be supplied, strength, and the total number of units to be supplied words
• Direction of use and the word “non-repetition” (“no refill”) •Signature of the doctor

D. No prescription once served by the drugstore or pharmacy shall be reused nor any prescription
once fully issued be refilled, provided however, that when a prescription is partially filled, the balance
may be fully filled by the drugstore or pharmacy.
D. No person shall supply any dangerous drug or drug preparation on presentation of a prescription,
if the person knows or has reason to believe that the prescription is:
•Forged, unlawfully altered, or cancelled; or
•Issued more than 1 month before presentation

E. The quantities of dangerous drugs that may be prescribed in a single applicable prescription by a
licensed practitioner should not exceed the specified quantities as follows:

E. The quantities of dangerous drugs that may be prescribed in a single applicable prescription by a
licensed practitioner should not exceed the specified quantities as follows:

Ordinary circumstances
• Benzodiazepines (anxiolytic or hypnotic or both) 30 tabs/caps
• Benzodiazepines (anxiolytic or hypnotic or both)
o 10 amps x 1mL
o 3 amps x 2mL
o 2 amps x 3mL
o 1 amp x 10mL
• Benzodiazepines (muscle spasm/dystonia/tetanus) 90 tabs (5mg)
• Phenobarbital preparations
2 weeks supply
2 bottles (100 tabs) each (for epilepsy patients)
•Sodium Pentothal
3 vials (in case of hospital use)

•Demerol 3 amps
•Other Dangerous Drugs (in vials)
1 vial (in case of hospital use

E. The quantities of drug preparations containing Table 1 controlled chemical as the only active medicinal
ingredient or containing Table 1 controlled chemical and therapeutically insignificant quantity of anotheractive
medicinal ingredient that may be prescribed in a single applicable prescription by a licensed practitioner
should not exceed the specified quantities as follows:
Ordinary circumstances
•Ephedrine (parenteral)
 1 amp (in case of hospital use)
•Ephedrine, pseudo-ephedrine, norephedrine 1.6g of base

F. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for
supplying the individual practitioner for the purpose of general dispensing to patients.

G. A practitioner may prescribe, administer, or dispense dangerous drugs or drug preparations for a
therapeutic purpose to a person diagnosed and treated by a practitioner for a condition resulting in intractable
pain, if this diagnosis and treatment has been documented in practitioner’s medical record. A Rx cannot be
written nor dispensed for more than 100 dosage units or a 31-day supply whatever is greater at on time.

H. A prescription may not be issued for the dispensing of dangerous drugs or drug preparations to a drug
dependent person for the purpose of continuing his dependence upon such drugs

I. A doctor with an S-2 license, whose area of residence/clinic/office is within a 5-km radius from a drugstore
which is not dispensing dangerous drugs or drug preparations for emergency use, may store or carry in his
medical carry bag a reasonable quantity of such drugs including paraphernalia for administering the drug.
He/she shall maintain record of receipts and disposal in a record book

Prescribing and When the need for treatment is urgent in an emergency case, an ordinary prescription not in DOH prescribed
filing of an order in official form may be given, and shall be acted upon by the licensed seller.
emergency
situation The prescriber shall inform the DOH, copy to PDEA unit responsible for the area where the emergency
occurred, in writing within 3 days after issuing such ordinary prescription.

The date and nature of emergency

condition should be stated at the back of that prescription.

The PO should be signed by the City/Municipal Health Officer or attending physician or senior medical officer
or military doctor or any available doctor supervising the medical team or unit rendering medical service in the
area where the emergency occurred.

The seller shall notify immediately the PDEA a written statement of the circumstances leading to the
purchase and how the medicine was dispensed or administered and to whom, within 7 days after the
particular emergency situation has ended.

The following are specified to be an emergency situation:

•As a result of man-made, natural and other disasters such as war, terrorist attack, rebellion, insurrection,
typhoons, earthquakes, volcaniceruptions,fire, deluge, grave accidents, epidemic, etc. to preclude prompt
access to the official prescription form or order form for dangerous drugs;
•Where, in the opinion of the prescribing physician, the immediate availability and administration of the
dangerous drugs would save the life and/or alleviate the pain of the patient.

Documentation A pharmacist dealing in drugs containing Table 1 controlled chemical, which requires and ordinary
prescription containing an S-2 license of prescribing doctor, shall maintain and keep an original record of
sales, purchases, acquisitions and deliveries of such drug preparations, indicating:
✓License number and address of the
pharmacist ✓ Name of the prescriber and telephone number
✓Name, address and license number of the ✓ Quantity and name of drugs sold or delivered
manufacturer, importer or wholesaler from ✓ Date of sale or delivery
whom the drugs have been purchased
✓ In the case of supply on requisition in an
✓Quantity and name of the drugs purchased or institution, details of the dispensary, ward or
acquired other place to which drug was supplied
✓ Date of acquisition or purchase ✓ In the case of return, the name of the person to
✓ Name, address and community tax certificate whom the drug was returned
number of the buyer

A certified true copy or computer print out of such record covering a period of 6 months, duly signed by the
pharmacist or the owner of the drugstore pharmacy shall be forwarded to the DDB through the PDEA, within
15 days following the last day of June and December of each year, with a copy thereof furnished the city
municipal health officer concerned.

Any person required to keep a register or other record under the Act and this regulation shall not:
✓ Make or cause or permit to be made, an entry in or on it that is, to the knowledge of that person, false or
misleading; or
 ✓ Cancel, obliterate or alter any entry, except to correct an error

Any person required to keep a register shall upon discovery, submit a written report immediately to PDEA:
➢ The loss or destruction of the register, or of whole or any part of the contents of the register; or
➢ Any discrepancy in the register, other than a mistaken entry.

Safekeeping of Any person authorized:

Dangerous Drugs •To import, export, manufacture, administer, supply or acquire a dangerous drug or controlled chemical or their
and Controlled respective preparations;
Chemicals •To engage in professional supply of dangerous drug or drug preparations
Shall while the drug or chemical is in the person’s custody or control, keep it or cause it to be kept in a vault,
safe or other prescribed secure storage or depot.
Authorized persons shall take such measures as the PDEA may direct in writing to ensure that no authorize
person has:
•Access to the combination, key or other means of access to any secure storage facilities or depot containing
a dangerous drug or controlled chemical; or
•The drug or chemical contained therein.

The licensed operator shall ensure that the safekeeping and handling of the chemicals is in accordance with
the requirements defined in the Material Safety Data Sheet of the chemical concerned.

Duties where there is Lost or Theft

Any authorized person, as previously stated shall immediately report to PDEA, in writing, the loss or theft of
any quantity of the dangerous drug or chemical in the person’s custody or control and record relevant
particulars of the loss or theft in the appropriate register.

Storage

Action Person/s Responsible

Post data of delivered dangerous drugs in the stock Pharmacist

card

• Arrange dangerous drugs systematically in Senior Pharmacist/ or designated pharmacist

a secured cabinet
• Keep keys in a secured drawer
• Monitor stocks daily

The security of the cabinet/ vault should conform to the regulatory standards of the Comprehensive Dangerous
Drugs Act of 2002:
•Double lock
•In isolated area
•Immovable/ Fixed Area Cabinet
•Exclusive storage for DD/DDP/PP containing Table 1 Substances/PECS

One senior pharmacist should be designated and shall be responsible for the keys of the controlled drugs
cabinet/s or rooms. Only the authorized staff is allowed at the restricted area.

An updated record of dangerous drugs in the DDB book in required.

7.Compounding Non-sterile & Sterile Preparations

Non-sterile ✘ Solid oral preparations ✘ Vaginal preparations

Preparations ✘ Liquid oral preparations ✘ Topical preparations
✘ Rectal preparations ✘Nasal and sinus preparations intended for local application
✘ Defined As Combining, admixing, ✘ Otic preparations
diluting, pooling, reconstituting other than
as provided in the manufacturer’s labeling,
or otherwise altering a drug or bulk drug substance to create a nonsterile medication.
✘ RequirementsfoundinChapter795 of the USP must be followed to minimize harm, including death, to patients
that could result from:
• Variability from the intended strength of correct ingredients,
 • Physical and chemical incompatibilities,
• Chemical and physical contaminants, and/or
• Use of ingredients of inappropriate quality.

Compounded Sterile ✘ A dose or doses of medication that are prescribed for a patient that must be prepared for administration and
Preparations (CSP is sterile.

INTRAVENOUS ✘Parenteralcomesfromagreekwords“para”and“enteron” =outside the intestine

ADMIXTURE ✘ Injection medication into veins and through subcutaneous tissue (performed at 45-600 angle)
SYSTEM
✘ When one or more sterile products are added to an IV fluid for administration, the resulting combination is
known as IV admixture

Manufactured LVPs ✘ Manufactured LVPs with additives stable in solution for longer periods of time
with additives ✘ available in many of sizes (250 mL, 500 mL, 1000
mL)
✘ dopamine
examples
✘ Human blood plasma has a pH of 7.4
✘ lidocaine
✘slightly alkaline
✘ potassium
✘parenteral IV solutions should have a pH that is
✘ nitroglycerin
neutral (near 7)

Type of IV Administration

INTRAVENOUS administration of a relatively small volume of solution directly from a syringe and is sometimes called an ‘IV
INJECTION push” when administered quickly.

INTRAVENOUS introduction of larger volume of solution directly into a vein in which the solution is permitted to drip into the
INFUSION vein.

PIGGY BACK intravenous administration by which solution from two (2) containers that flow in the patient’s vein through a
ADMINISTRATION common tubing and a common injection site (venipuncture)

Type of Solution

Hypertonic osmotic pressure is greater than that of blood or 0.9% NaCL

Hypotonic osmotic pressure is less than that of the blood or 0.9% NaCL

Isotonic osmotic pressure is equivalent to that of blood or 0.9% NaCl

Purpose of ✘ Centralizes responsibility for preparation of parenteral admixtures

Centralize Pharmacy ✘ Label admixtures with rate of infusion as prescribed by physician and provides a label standard format
IV Admixture
✘ Conforms to the standard
Service
recommended by Joint Commission on Accreditation of hospitals
✘ Conforms to the guidelines
established by the National Coordinating Committee on large volume parenterals
✘ Provides for the preparation of solution which is not commercially available
✘ Provides an aseptic environment for the preparation of admixtures

LAMINAR FLOW HOOD

◦ Provides aseptic conditions
- Observing a “NO TOUCH” technique
- Laminar flow hood – where sterile solutions are prepared
- Provides uniform flow of filtered air

IV FLUIDS ✘ Large Volume Injections intended to be administered by IV infusion

✘ LVP(100-1000mL)
✘ SVP (25-50 mL)

Components • which can be easily carried out by circulatory

system, and assimilated.
• Sugars
• prepared with water for injection - USP and
• amino acids or electrolytes
the solution is pyrogen free
Conditions where in iv fluids is commonly
used
 • Correction of disturbances in electrolyte balance
• Correction of disturbances in body fluids (fluid replacement)
• The means of providing basic nutrition
• The basis for the practice of providing Total Parenteral Nutrition
• Use as vehicle for other drug substances

IV THERAPY be sterilized before use by means of radiation or ethylene oxide

EQUIPMENTS
Infusion sets Administration Set
✗ IV injection or IV push or IV bolus ✗ Spike o Final Filters
✗ Drip Chamber o Needles
✗ Intermittent(irregular intervals)IV infusion
o Syringes
✗ IV PiggyBack ✗ VolumeControlchamber
✗ AdditiveSetInfusion ✗ Clamp
✗ Heparin Lock ✗ Catheter

FACTORS AFFECTING ✘ Complexation ✘ Time

✘ Temperature ✘ Order of Mixing ✘ Filter
COMPATIBILITY AND
✘ Light ✘ Diluent
STABILITY ✘ Buffer Capacity ✘ Container

COMPLICATIONS LOCAL ADMINISTRATION Systemic Administration

OF IV FLUIDS • Infiltration • Pyrogenic reaction • Speed Shock
• Hematoma • Air Embolism • Catheter embolism
• Phlebitis • Pulmonary Embolism
• Thrombophlebitis

Sites of ✘ Antecubital veins ✘ Hand veins ✘ Forearm veins ✘ Scalp veins ✘ Veins of the lower extremity
administration

TOTAL • termed as Hyperalimentation

PARENTERAL • provides all the patient’s daily nutritional requirements.
NUTRITION
• indicated for patients who are unable to ingest food due to carcinoma or extensive burns, patients
refuse to east, depressed patients, surgical patients
• infusion rates are begun at about 25 to 50 mL per hour and adjusted every 8 to 12 hours as dictated
by the patient’s condition and fluid and nutritional status.
• Clinically, TPN is indicated when adequate enteral intake is: Impossible (alimentary tract obstruction,
major burns, massive trauma)
• Improbable (anorexia, geriatric patients) Inadvisable (inflammatory bowel disease, or malabsorption
syndromes)

BASE COMPONENTS Additives

• dextrose (carbohydrates) • Electrolytes
• amino acids (protein) • Vitamins
• may also include fat & water • Trace elements (micronutrients)
• Drugs such as heparin, insulin, H2
antagonists
Container: silicone based bag superseded by
PVC and ethlyvinyl acetate
Packaging: polystyrene container
Storage and Packaging : stored at 2-60C, not allowed to be stored at room temperature for periods in excess
of 12-24 hours.
TPN preparation should be protected from light because of its vitamin contents

Intravenous Flow FLOW RATE - speed at which the fluid infuses into the patient
Rates - expressed in volume over time - gtts/minute; gtts/hour
- mL/minute; mL/hour
CALORIC for patients vary, depending on their physical state and medical condition.
REQUIREMENTS ✗ TheHarris-Benedict Equations,are commonly used to estimate the basal energy expenditure (BEE)
requirements for non-protein calories.
✗ The BEE is also referred to as the resting metabolic energy (RME) or the resting energy expenditure
(REE).

CARBOHYDRATE • formulas for parenteral nutrition, dextrose provides 3.4 kcal of energy per gram;
Requirements: • each 100 mL of a 25% dextrose injection provides 85 kcal of energy.
• :Parenteral nutrition, the factor used is 4 kcal/g.

8.Emergency Drug Therapy

⬢ The pharmacy shall participate in hospital decisions about the contents of code carts, emergency medication
kits and trays, and the role of pharmacists in medical emergencies.
⬢ Pharmacists should serve on cardiopulmonary resuscitation teams, and such pharmacists should receive
appropriate training and maintain appropriate certifications (Basic Life Support, Advanced Cardiopulmonary
Life Support, Pediatric Acute Life Support).

Hospital Codes Code BLUE

Code BLACK:
▪ Most universally recognized hospital code.
• Bomb threat
▪ Implies a patient experiencing a life threatening
medical emergency, such as cardiac arrest, a
Code ORANGE
dangerous arrhythmia, orrespiratoryarrest, usually
• Hazardous spill requiring medical
requiring cardiopulmonary resuscitation.
decontamination
Code WHITE
Code Violet:
• Code Blue for pediatric patients
• Hospital violence or a violent person is on the
• Mandatory evacuation
premises, and
• Situations requiring a quick/rapid response.
Code GREEN
These situations may escalate to Code Blue
• Patients arriving from a mass casualty event
Code RED:
• Emergency evacuation
• Fire or smoke
• Missing high-risk patient
• Total evacuation
• Information on the location would follow the code
Code YELLOW:
• Severe weather disaster that may initiate a
Code PURPLE/ PINK:
• Missing child or child abduction lockdown or evacuation.
 • PINK: Infant
• Code Pink 24
• Often times the hospital would be placed on lockdown.

Emergency carts or • mobile units that contain all the needed medications and supplies for emergencies.
crash carts • Emergency Drugs to be tackled in the Lab

High-Risk Medication High-alert Medication-

• WHO defined them as drugs that bear a heightened risk of significant patient harm when they are
used in error. Though mistakes may or may not be common with them, the consequences of those
errors are more devastating to patients. These HAMs also pose a major clinical challenge for
prescribers, with the most common type of prescribing error identified was dosage error.
• WHO defined them as drugs that bear a heightened risk of significant patient harm when they are
used in error.
• Though mistakes may or may not be common with them, the consequences of those errors are more
devastating to patients.
• These HAMs also pose a major clinical challenge for prescribers, with the most common type of
prescribing error identified was dosage error.
• Since HAMs are associated with the greatest risk of producing serious harm, it would be appropriate
to focus on them in every intervention plan.

Medications • Type A (Augmented) – dose- related “augmentation” of the known pharmacological effects of
associated with a the medication
high risk of Adverse • Type B (Bizarre) – Idiosyncratic; unpredictable effect and not related to the known
Drug Reactions pharmacological properties of the drug
(ADRs) are
traditionally
classified into

• Anti-infectives
> Vancomycin – rapid IV infusion increases the risk of anaphylactic- like reactions
•Potassium and other electrolytes
•NEVER administer KCl as IV Push
•Insulin
• Common errors: Use of non-insulin syringes, misreading of prescriptions due to
abbreviations (“U” or “IU”)
•Narcotics and Sedatives
• Type A reactions associated with opioids – respiratory depression
•NSAIDs
• Type A – GI effects and cardiotoxicity; may also precipitate renal failure
•Paracetamol
• Type A – dose-related liver failure especially in children
•Lithium – narrow therapeutic index

Strategies to Reduce • Standardization

Harm from HAM • Standardize and systematize processes and documentation, including naming, packaging,
and labeling.
• Use of tall man lettering
• Standardize use of terminology, abbreviations and symbols used in prescribing and
administering