TRAINING OF SURVEYORS ON THE PHILHEALTH

BENCHBOOK II
MEDICATION MANAGEMENT
 GOVERNING LAWS ON THE REGULATIONS
ON THE USED OF DRUGS
 RA 5921, THE PHARMACY LAW (1969)
 RA 6425, DANGEROUS DRUG ACT
 RA 9165, COMPREHENSIVE DANGEROUS DRUG ACT
 RA 8203, SPECIAL LAW ON COUNTERFEIT DRUGS
 RA 7394, CONSUMER ACT OF THE PHILIPPINES
 RA 2382, THE MEDICAL ACT OF 1959
 RA 3720, FOOD, DRUGS, DEVICES & COSMETIC ACT (FDA)
 E.O 49 – DIRECTING MANDATORY USE OF PNDF AS BASIS FOR
PROCUREMENT OF DRUG PRODUCTS BY GOV’T.
 6. MEDICATION MANAGEMENT (NEW)
STANDARDS CRITERIA EVIDENCES
1. Drugs are selected and procured based on the 38 •Document Review
organization's usual case mix
2. Drugs are stored safely and securely •Chart review
3. Drugs are dispensed in a standardized manner CORE = 6
4. Drugs are prepared according to technical standards •Management
5. Drug prescribing complies with professional standards Interview
6. Drugs are administered in a timely, safe, and
appropriate manner •Staff Interview
7. Drug effects are monitored
8. Resources are allocated •Patient Interview
9. Drugs are administered in a standardized manner
10.Drugs are disposed in a standardized manner •Direct Observation

GOAL: MEDICATIONS ARE MANAGED AND PROVIDED

EFFECTIVELY, SAFELY AND IN CONTROLLED MANNER
6. STANDARDS NO.1
 DRUGS ARE SELECTED AND PROCURED BASED ON THE ORGANIZATION'S USUAL
CASE MIX AND ACCORDING TO POLICIES AND PROCEDURES THAT ARE
CONSISTENT WITH SCIENTIFIC EVIDENCE AND GOVERNMENT POLICIES.
CODE CRITERIA EVIDENCE
6.1.a a. Policies and procedures that define the •Document review
collaborative selection of drugs, consistent with
scientific evidence and government policies are
present.

6.1.b b. The formulary list contains all the drugs to be •Document review
used by the organization.

6.1.c c. The formulary list contains alternative cost •Document review

effective treatment drugs. e.g. generics
6. STANDARDS NO.2
 DRUGS ARE SELECTED AND PROCURED BASED ON THE ORGANIZATION'S USUAL
CASE MIX AND ACCORDING TO POLICIES AND PROCEDURES THAT ARE
CONSISTENT WITH SCIENTIFIC EVIDENCE AND GOVERNMENT POLICIES.
CODE CRITERIA EVIDENCE
6.1.d d. The formulary list is reviewed and, if needed, •Document review
updated annually.

6.1.e e. Drugs are procured based on the •Staff interview

organization's formulary list. •Direct observation

6.1.f f. Drug procurement ensures a reliable and •Staff interview

constant drug supply for the organization. •Patient interview
6. STANDARDS NO.2
 DRUGS ARE SAFELY AND SECURELY ACCORDING TO TECHNICAL AND
REGULATORY STANDARDS.

CODE CRITERIA EVIDENCE

6.2.a a. Medications are stored throughout the •Staff interview
organization to ensure authorized access. •Direct observation

6.2.b b. Medications are labeled and stored to •Document review

minimize medication errors. •Staff interview
•Direct observation
6.2.c c. High risk medications are stored to ensure •Staff interview
controlled use. •Direct observation
 DRUG
Drug storage
STORAGE IN
AinPATIENT
a patient
ward
WARD
6. STANDARDS NO.2
 DRUGS ARE SAFELY AND SECURELY ACCORDING TO TECHNICAL AND
REGULATORY STANDARDS.

CODE CRITERIA EVIDENCE

6.2.d d. Required drug storage conditions are •Document review
monitored and maintained. •Staff interview
•Direct observation

6.2.e e. Regulated drugs are stored separately and •Staff interview (pharmacist)
under controlled conditions. •Direct observation
EXERCISE

What categories
of drugs need
special handling?
SPECIAL CATEGORIES OF DRUGS

• Usually vaccines, these drugs need a system of

Drugs requiring keeping, transporting and storing within a
Cold chain recommended temperature range of +2 to +8
degrees Celsius (°C).

•Drugs requiring special handling such as

High risk drugs temperature control, cytotoxic drugs, corrosives, highly
reactive to water or shock, flammable, poisons.
EXPLOSION HATCH

also called a relief flap or explosion

vent, it seals an opening in the roof
or façade of a building; must open
immediately if pressure in a room
increase.
 DISPENSING

The act of a valid registered pharmacist

of filling of a doctor’s prescription or
order in a patient’s chart (DOH
Hospital Pharmacy Management
Manual).

A prescription is a written or electronic

order and instruction of a valid
registered physician, or dentist for the
use of a specific drug product for a
specific patient. A doctor’s order on
the patient’s chart for the use of
specific drugs is considered a
prescription.
6. STANDARDS NO.3
 DRUGS ARE DISPENSED IN A STANDARDIZED AND SYSTEMATIC MANNER IN
THE PROVIDER ORGANIZATION.
CODE CRITERIA EVIDENCE
6.3.a a. Dispensing follows professional and legal •Document review
standards. •Staff interview
6.3.b b. Qualified staff reviews new prescriptions or •Staff interview
orders prior to dispensing or administration, based
on the formulary.
6.3.c c. Review of new orders or prescriptions cover: •Staff interview
•Correctness of dosage, route and frequency
•Possible therapeutic duplication.

6.3.d d. A process to contact the prescriber for any •Staff interview

questions is in place.
6. STANDARDS NO.4
 DRUGS ARE PREPARED ACCORDING TO TECHNICAL AND PROFESSIONAL
STANDARDS OF PRACTICE.

CODE CRITERIA EVIDENCE

6.4.a a. Drug preparation complies with drug-specific •Staff interview
pharmacologic requirements.

6.4.b b. Drugs are prepared in clean and controlled •Document review

environment. •Direct observation
 DRUG
PREPARATION
 Must adhere to a Quality
Control Protocol
 Protocols for handling
cytotoxic and regulated
drugs
 Authorized individuals
only
 Routine monitoring for
compliance
Prescription
A written or electronic order and
instruction of a valid registered
physician for the use of a specific drug
product for a specific patient.

A doctor’s order on the patient’s chart

for the use of specific drugs is
considered a prescription.

A common, but crucial, concern in

hospitals is illegible prescriptions.
Policies should include processes for
double checking and verification.
6. STANDARDS NO.5
 DRUGDS PRESCRIBING COMPLIES WITH PROFESSIONAL, PHARMACOLOGIC
AND REGULATORY STANDARDS

CODE CRITERIA EVIDENCE

6.5.a a. Policies and procedures define the elements •Document review
of a complete prescription or order, consistent
with laws.

6.5.b b. All orders or prescriptions are documented in •Chart review

the patient’s chart.

6.5.c c. The organization supports formulary-based •Staff interview

prescription and sets criteria for allowing •Document review
prescribers to order non-formulary drugs.
6. STANDARDS NO.5
 DRUGDS PRESCRIBING COMPLIES WITH PROFESSIONAL, PHARMACOLOGIC
AND REGULATORY STANDARDS

CODE CRITERIA EVIDENCE

6.5.d d. Written, verbal and phone orders are •Document review
immediately read back to prescribers for •Staff interview
confirmation.

6.5.e e. Policies and procedures define that telephone •Document review

orders are signed by the prescriber within 24
hours and the critical situations when telephone
orders are acceptable.
6. STANDARDS NO.6
 DRUGS ARE ADMINISTERED IN A TIMELY, SAFE AND APPROPRIATE AND
CONTROLLED MANNER
CODE CRITERIA EVIDENCE
6.6.a a. Drugs are administered only after •Nursing Manual – P/P and SOP on verification of
the order or prescription was prescription and orders
verified. CORE • Interview how prescriptions are verified against
doctor’s order
• Counter check/ countersign
6.6.b b. Drugs are administered after •Observation on how the nurse verifies the identity of
verifying medication order against patient prior to drug administration
patient’s identity. CORE • Patient will be interview how he was identified
6.6.c c. Drug administration is properly •Medication sheet/ Patient chart should show time of
documented in the patient chart. administration
CORE •Interview
Patient Care Core Indicator 6.6.a
Evidence:
– Patient chart from the medical
records
• For the timeliness of drug administration,
check the hospital policy. If hospital
does not have policy, frequency of drug
administration in the chart should be
checked and validate it thru patient
interview
6. STANDARDS NO.6
 DRUGS ARE ADMINISTERED IN A TIMELY, SAFE AND APPROPRIATE AND
CONTROLLED MANNER

CODE CRITERIA EVIDENCE

6.6.d d. Drug administration follows time frames set • P/P on missed dose
by pharmacologic and therapeutic • Medication sheet – reasons for missed
specifications. CORE dose
• Staff interview

6.6.e e. A process to oversee self-administration of • Patient interview

drugs brought in by patients is in place. •Staff interview
CORE
6. STANDARDS NO.7
 DRUGS EFFECTS ARE MONITORED IN A STANDARDIZED AND SYSTEMATIC
MANNER IN THE PROVIDER ORGANIZATION

CODE CRITERIA EVIDENCE

6.7.a a. Adverse drug events are documented, •Document review

monitored and reported as required by •Management and staff interview
regulations.

6.7.b b. First dose effects are monitored. •Patient chart review

SIX (6) CLASSIFICATIONS OF ADRS

Type A (Augmented) - Related to the pharmacologic effect of the drug

Type B (Bizarre) - Genetically determined abnormal response to a drug; little or no

relation to usual pharmacologic effects of the drug

Type C (Continuous) - Long term effects of drugs related to dose and duration of
treatment; dependence; habituation; tolerance; addiction

Type D (Delayed) - Reactions manifest long after drug exposure

Type E (Ending of Use – withdrawal syndrome) - Disorientation; confusion;

hallucination

Type F (Failure of efficacy) – due to lack of efficacy of drug, microbial resistance,

counterfeit drug, under-dosing, inappropriate administration, or poor patient
compliance
 FDA
SUSPECTED
ADR FORM
  All suspected adverse drug reactions for
medicines and vaccines, including established
medicines, traditional medicines, household and
herbal remedies & suspected counterfeit
 All serious expected and/or unexpected adverse
drug reactions
 All suspected adverse drug reaction for new
GUIDELINES FOR medicines
ADR REPORTING TO  All suspected adverse drug reaction occurred in
FDA special populations including children, pregnant
women and elderly
 All medication errors that result in an adverse
reaction

 Report even if you are not sure that the drug

caused the event
6. STANDARDS NO.8
 RESOURCES ARE ALLOCATED FOR THE TRAINING, SUPERVISION AND
EVALUATION OF PROFESSIONALS WHO PRESCRIBE AND ADMINISTER
DRUGS, ACCORDING TO POLICIES AND PROCEDURES
CODE CRITERIA EVIDENCE
6.8.a a. There are policies and procedures for the •Document review
training, supervision, and evaluation of •Staff interview
professionals who prescribe and administer drugs.
6.8.b b. Clinical staff are oriented to the organization’s •Staff interview
medication policies prior to deployment. •Document review

6.8.c c. Resources support managers who train, •Document review

supervise and evaluate drug prescription and •Staff interview
administration practices. •Direct observation
6.8.d d. Physicians are trained and evaluated in rational •Staff interview
drug use/prescribing. •Document review
6. STANDARDS NO.9
 DRUGS ARE ADMINISTERED IN A STANDARDIZED AND SYSTEMATIC
MANNER IN THE PROVIDER ORGANIZATION

CODE CRITERIA EVIDENCE

6.9.a a. Only qualified staff order, prescribe, prepare, •P/P

dispense and administer drugs. • PRC
CORE •Chart review

6.9.b b. All doctors, nurses and pharmacists who •Document review

handle high risk drugs have additional education Chart review
and training as appropriate
PROPER DISPOSAL OF WASTES
6. STANDARDS NO.10
 DRUGS ARE DISPOSED IN A STANDARDIZED AND CONTROLLED MANNER
CONSISTENT WITH REGULATORY AND SAFETY REQUIREMENTS
CODE CRITERIA EVIDENCE

6.10.a a. Policies and procedures indicate how expired, •Document review

discontinued or recalled drugs are retrieved and/or
safely disposed.

6.10.b b. Drugs, drug containers and medication •Document review

equipment are disposed of following statutory •Staff interview
requirements •Direct observation

6.10.c c. These policies are implemented. •Document review

•Staff interview
•Direct observation
UNIVERSALLY ACCEPTED
HAZARD SYMBOLS
“We are we repeatedly do.
Excellence, then, is not an act
but a habit.”
- Aristotle