PHARMACY, PHARMACY AND/OR PHARMACIES OF THE POE-…..No.

USA. OF HEALTH
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DISPENSATION OF PHARMACEUTICAL PRODUCTS
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(SUGGESTED MODEL)
1. GOALS:

GENERAL:

Provide the patient with the necessary information that helps them optimize the use of
medications during their treatment and is willing to assume it; Likewise, deliver the
Pharmaceutical Product in optimal conditions and in accordance with current legal regulations.

SPECIFICS:

o Deliver the pharmaceutical product in optimal conditions for use and in accordance with
current legal regulations.
o Guide patients to the proper use of pharmaceutical products.
o Identify and contribute to solving and/or minimizing Drug Related Problems (DRP) detected
during dispensing.
o Detect other needs on the part of the patient to be able to offer, where appropriate, other
pharmaceutical care services (Pharmacotherapeutic Monitoring, pharmacovigilance, health
education).
o Record and document pharmaceutical interventions carried out in the dispensing process,
including physician referral reports and patient information, preferably in writing, if deemed
necessary.

2. SCOPE

Professional Chemical Pharmaceutical and Pharmacy Technician Staff of the

Pharmaceutical Offices (Pharmacies and Pharmacies) and Pharmacy of the Health
Establishment.

3. LEGAL BASE

• Law No. 26842 – General Health Law.

• Law No. 29459 Law on Pharmaceutical Products, Medical Devices and Health Products.
• Law No. 28173. Labor Law of the Pharmaceutical Chemist of Peru.
• Supreme Decree No. 016-2001-SA – Establishes that pharmacies of Public Sector
entities are authorized to sell essential medications and medical supplies directly to the
public.
• Supreme Decree No. 015-2009-SA Establish modifications to DS No. 019-2001 that
establishes provisions for access to information on prices and ICD
• Supreme Decree No. 023-2001-SA. Regulation of Psychotropic Narcotics and other
substances subject to Health Control.
• Supreme Decree No. 014-2011-SA Approves Regulations for Pharmaceutical
Establishments.
• Supreme Decree No. 016-2011-SA - Approval of Regulations for the Registration, Control
and Health Surveillance of Pharmaceutical Products, Medical Devices and Health
Products, and its amendments.
• Ministerial Resolution No. 1240-2004/MINSA. “The National Medicines Policy” is
approved.
• Ministerial Resolution No. 585-99-SA/DM Approves the Manual of Good Storage
Practices for Pharmaceutical and Related Products

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DISPENSATION OF PHARMACEUTICAL PRODUCTS
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• Ministerial Resolution No. 013-2009/MINSA Approves Manual of Good Dispensing

Practices.
4. RESPONSIBILITY
From the Pharmaceutical Chemist:
Adequate professional practice in dispensing requires continuous training of the
Pharmaceutical Chemist. Furthermore, to achieve maximum efficiency in the service, the
Pharmaceutical Chemist will promote and facilitate the continuous training of technical
personnel.

From the Pharmacy Technician :

Support the Pharmaceutical Chemist in administrative and logistical tasks.

5. DEFINITIONS

Pharmaceutical Care : Act of the Pharmaceutical Chemist professional for the improvement
and maintenance of the patient's health and quality of life, which are carried out through
correct dispensing practices and pharmacotherapeutic monitoring.

Dispensing: Professional act of the Pharmaceutical Chemist of providing one or more

pharmaceutical products, medical devices and health products to a patient or user, generally
in response to the presentation of a prescription prepared by an authorized professional. In
this act, the Pharmaceutical Chemist professional informs and guides the patient or user
about the proper use of the pharmaceutical product, adverse reactions, drug interactions and
the storage conditions of the product or device.

Dispensing: Retail sale of pharmaceutical products, medical devices or health products,

directly to the end user, without the act of dispensing.

Incidence : Action aimed at modifying some characteristic of the treatment, the patient using
it or the conditions of use, and which aims to resolve a Problem Related to the Medication.

Personalized Medication Information: It is the information that the pharmacist provides to

the patient about their treatment, in the Dispensing process, with the aim of achieving
effective and safe use of the same.

Health Problem : Any complaint, observation or fact that the patient and/or the doctor
perceives as a deviation from normality that has affected, may affect or affects the patient's
functional capacity (WONCA).

Minor Disorder : Health Problem perceived as mild by the patient, self-limited and of short
duration, susceptible to symptomatic treatment, with over-the-counter medications and/or
non-pharmacological measures.

Warning Signs : Symptoms, signs or complementary findings that increase the probability of
an unfavorable evolution and, consequently, require medical intervention.

Drug-related problem (DRP): Health problem experienced by the patient, as a negative

clinical result derived from pharmacotherapy and which, due to its real or potential
interference, does not allow the expected therapeutic objective to be achieved or generates
undesirable effects.

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Intervention Sheet: Document designed to record the actions of the pharmaceutical

chemist both in the pharmaceutical consultation process and in the process of dispensing
prescription and non-prescription medications.

6. STAGES OF THE PROCEDURE:

6.1 The dispensing of medicines can originate:

• For medication demand when the user presents a prescription (official or from a
private doctor).
• Due to demand for medications without presenting the prescription (self-
medication).
• As a result of a pharmaceutical query raised by the client.

6.2 The dispensing process includes all the activities carried out by the Pharmaceutical
Chemist professional from receiving the prescription to delivering the pharmaceutical
product to the patient. Correct dispensing is a procedure that guarantees the detection and
correction of errors in all its stages.

6.3 Reception and validation of the prescription

6.3.1 Receives the user, very courteously, and makes a consultation about their request.
Evaluates the request to determine if it corresponds to an order for over-the-counter (OTC)
products or, if the sale of the pharmaceutical product It is conditional on the delivery of
a Medical Prescription. From this evaluation you can choose one of these two procedures:

a) When it comes to the Dispensing of Free Sale pharmaceutical products or

OTC.

1. The Pharmaceutical Chemist will carry out a quick analysis of the user's and/or patient's
request , and as determined, will provide care or not.
2. In the event that the following circumstances occur, the request will not be processed:
 When the user and/or patient is a minor or does not have full capacity for
discernment.
 When there is suspicion that the user and/or patient intends to misuse these
pharmaceutical products, in accordance with what is stated in section 4 of this
document.

b) When it comes to the Dispensing of pharmaceutical products, the sale of which is

conditioned on the delivery of a Medical Prescription.

3. The Pharmaceutical Chemist requests that the patient give him his Medical Prescription,
if he does not have the Medical Prescription, it will not be Dispensed.
4. If you present your Medical Prescription, proceed to validate it, for which you must take
into account the following:
 It must be current, that is, the issue date must not be older than 15 days.
 It should not present corrections, erasures and/or amendments.
 It must contain all the minimum required information: Patient information (name,
age, sex); Prescriber data (name, tuition, address, seal and signature); diagnosis ;
Dosage of the pharmacological treatment (name of pharmaceutical product in

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International Common Denomination (INN) and/or medical devices in International

Technical Denomination (ITD), concentration, pharmaceutical form, indicated daily
dose, frequency of use, treatment period and route of administration; place and date
of issuance and expiration of the prescription .
5. In the event that, as a result of the validation of the recipe, it meets the requirements of
section 4, the dispensing act is carried out.
6. The NON-validation of the Recipe may be conditioned by the following:
 Amended prescription, for no reason does Dispensation apply.
 In the event that data is missing in the prescription and/or its indication is not
understood, the professional who prescribed it must be consulted. This may occur
through the user, who must return to the office, so that the prescription can be raise
observations on the prescription or, if feasible and if the prescription had the
prescriber's telephone number; The Pharmaceutical Chemist may be contacted by
this means, in order to complete the information and/or answer any questions; Only
in the supposed case that, with the consultation made to the prescriber, the
observations initially found in the prescription are lifted, can the act of dispensing the
requested pharmaceutical products be continued.

6.3.2 Pharmaceutical Chemist will verify the basic principles of dispensing:

a. Absence of pharmacotherapeutic or clinical criteria that indicate that dispensing
should not be carried out :
 Allergies.
 intolerances
 Pregnancy.
 Lactation.
 Teratogenicity
 Duplications.
 Other health problems (Contraindications with diseases or health problems PS)
 If you have previously used the requested medication.
 Some interactions of clinical relevance.
This evaluation is essential in the first dispensation and the identification of any of these
criteria suggests the need to refer the patient to the prescriber.

6.3.3 In the case of prescriptions for psychotropic medications and narcotics, these will
comply with the particular conditions of current legal regulations.

6.4 Analysis and interpretation of the prescription

6.4.1 Read the prescription, interpret the abbreviations, adjust the dose according to the
patient's condition, calculate the dose and quantity of the medication to be delivered,
identify interactions, therapeutic duplication, etc.
6.4.2 When appropriate and/or the requested medication is not available in the
Pharmaceutical Office, the Pharmaceutical Chemist may offer the user alternatives
to the medication with another that contains the same principle, the same
concentration and the same pharmaceutical form. In this case, the fact must be
recorded on the back of the recipe.

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6.5 Preparation and selection of products for delivery

6.5.1 Identify the products on the shelf, ensuring that the name, concentration,
pharmaceutical form and presentation correspond to what is prescribed
6.5.2 The products must be packaged in safe packaging for conservation and
transportation, respecting the cold chain, when appropriate.
6.5.3 If these are masterful or official preparations, the amount of the product must be
calculated for a complete treatment and following strict hygiene standards.

6.6 Delivery and information by the dispenser

6.6.1 The Pharmaceutical Chemist must provide information and guidance on the
administration, use and dosage of the pharmaceutical product, its interactions,
adverse reactions and storage conditions.
6.6.2 Ensure that the patient understands the instructions, evaluating the patient's
Knowledge and acceptance of the medication use process:
It is necessary to check, or where appropriate instruct the patient, that he knows
how the prescribed medications should be used. This basic principle includes three
major components:

 Knowledge of the pharmacotherapeutic characteristics of the medication:

Ask the user the following question: what is it and what is it for?
Provide the patient with all useful and accessible information on the technical
characteristics of the medication: indication, possible precautions (compatibility of
use with foods or medications), possible contraindications and any aspect of health
education or warning that is necessary depending on the specific medication.
(coloration of urine or feces, discomfort at the beginning of treatment, staggered
completion of treatment, etc.)

 Knowledge related to the process of using the medicine :

Provide the patient with all the necessary information regarding: handling of the
medication (preparation of extemporaneous solutions, use of inhalation devices,
handling of eye drops, injectables that must be self-administered, etc.), dosage,
administration schedule, duration of treatment and storage conditions.

 Knowledge of indicators and controls of the evolution of treatment :

To verify that adequate monitoring of the treatment is carried out in terms of
effectiveness.
In chronic use medications, it must be ensured that the patient performs or will
perform the necessary controls to establish compliance with the expected
therapeutic objectives. Thus, as examples, the following can be noted: periodic blood
pressure measurements, cholesterol, glucose, glycosylated hemoglobin
determinations, hematological controls, periodic check-ups, etc.

All this knowledge is part of the Personalized Medication Information (PMI) that the
pharmacist must provide to the patient during the first dispensing.

Patient perception of the effectiveness and safety of the medication and presence
of indicators of control of the effectiveness and safety of the treatment .
Establish the patient's subjective and objective perception of the effectiveness and safety
of the medication, which allows for a general idea related to the fulfillment of the desired
therapeutic objectives, that is, the effectiveness of the treatment (control or remission of

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signs and symptoms of pathologies) as well as their safety. To this we can add the
indicators for controlling the effectiveness and safety of the medication (objective
parameters), such as laboratory values, blood pressure figures, etc.

This principle is important in repeated dispensing, and if there is a perception of

ineffectiveness or insecurity, it is necessary to verify, again, the knowledge of the process
of using the medication.

If this is correct, the Pharmaceutical Chemist must consider the possibility of offering
other services, especially Pharmacotherapeutic Monitoring or referring to the prescriber.
In the case of suspected adverse reactions or adverse incidents related to the
pharmaceutical products taken by the patient, notification will be made to the Peruvian
Pharmacovigilance System.

The final result of dispensing must be the delivery or not of the pharmaceutical product,
meeting the established objectives. In both cases the Pharmaceutical Chemist can
decide:

• Provide information (IPM).

• Offer Health Education.
• Refer to Pharmacotherapeutic Follow-up.
• Refer to the doctor communicating the DRP.
• Refer to the doctor proposing changes in treatment.
• Propose other modifications.
• Notify Pharmacovigilance in accordance with current legislation.

The Pharmaceutical Chemist must record all incidents observed in the dispensing activity.

To complete the professional act, the Pharmaceutical Chemist must deliver to the user
and/or patient the Pharmaceutical Product, Medical Device and/or Health Product in
optimal conditions; In addition, they must provide all the necessary information regarding:
the handling of the medication, dosage, administration, duration of treatment and the
conditions of conservation and storage of these at home. In case of partial delivery of the
prescribed products, the units dispensed by the establishment, the establishment's seal
and the signature of the Pharmaceutical Chemist professional will be noted on the back of
the prescription. If the patient requires another service, they are referred to where
appropriate.

6.7 Documents and records generated by the procedure

6.7.1 Pharmaceutical benefits must be documented to obtain statistical data that

contributes to achieving improvements in care; must have the following as applicable:

 Recipe book
 Book of occurrences.
 Narcotics control book.
 Psychotropic control book.
 Dispensing Record (when applicable) (ANNEX 1).
 Intervention Record (when applicable) (ANNEX 2).
 Recipe review record (ANNEX 3).
 Record of “Dispensing Errors” (when applicable) (ANNEX 4).

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7. REVIEW OF RECIPES AND DETECTION OF DISPENSING ERRORS

On a daily basis, the Pharmaceutical Chemist assigned to this activity will review the
dispensed prescriptions and record this activity in the “Prescription Review” format
(ANNEX 3). If during the review you detect any error, you will document it in the
“Dispensing Error” form (ANNEX 4), notifying this circumstance to the dispenser who
made the error and to the Technical Director.

8. PERFOMANCE INDEX

Indicator: Percentage of prescriptions dispensed

Source: Recipe
Formula = No. of prescriptions dispensed X 100/ No. of prescriptions served
Responsible: Technical Director.

9. Flowchart

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