[6] Dispensing - Philippine National Drug Policy

Philippine National Drug Policy (PNDP) — Definition

The government's response to the problem of inadequate provision of good quality essential drugs to the people.

Philippine National Drug Policy (PNDP) — Problem addressed

High-cost drugs, which render them inaccessible to the majority of the population.

Philippine National Drug Policy (PNDP) — Main objective

To bring about the availability and affordability of safe, effective, and good quality drugs for all sectors of the country, especially for the poor who need them most, but who can least afford them.

Philippine National Drug Policy (PNDP) — Number of pillars

Five pillars.

Philippine National Drug Policy (PNDP) — Relationship among the five pillars

They form an integral unit, mutually complementary and supportive of each other.

PNDP — First pillar: Quality Control

The assurance of the safety, efficacy, and usefulness of pharmaceutical products.

PNDP — Quality Control: Scope

Regulation of the importation, manufacture, marketing, and consumer utilization of all drugs and their intermediates.

PNDP — Second pillar: Rational Use of Drugs

The promotion of the rational use of drugs by both health professionals and the general public.

PNDP — Rational Use of Drugs: Definition

A carefully considered pattern of behavior on the part of the prescriber and the consumer.

PNDP — Rational Use of Drugs: Limiting medicine use

Limit the use of medicines to situations where there are clear valid indications for them.

PNDP — Rational Use of Drugs: Drug selection

Only the most necessary and scientifically proven efficacious drugs should be used.

PNDP — Rational Use of Drugs: Key strategy

Development and implementation of a Philippine National Drug Formulary (PNDF).

PNDP — PNDF: Purpose

List those drugs which are most essential for the diseases and conditions encountered in the Philippines, and describe the appropriate use of these essential drugs.

PNDP — Rational Use of Drugs: Advertising regulations

Rules and regulations governing the promotion and advertising of pharmaceutical products shall be reviewed and amended in order to contribute towards the promotion of rational use of drugs.

PNDP — Rational Use of Drugs: Expected outcome

Consumers will be properly guided as to which drugs to use for their particular needs and conditions.

PNDP — Third pillar: Self-Reliance

Development of self-reliance in the local pharmaceutical industry.

PNDP — Self-Reliance: Purpose

Strengthen Filipino capabilities for the manufacture of basic and intermediate ingredients for drugs and medicines.

PNDP — Self-Reliance: Reducing imports

By developing a capability to produce strategic essential drugs locally, the country's dependence on imported drugs can be greatly reduced.

PNDP — Self-Reliance: Competitiveness

Enable local drug manufacturers to be competitive with the transnational drug firms.

PNDP — Fourth pillar: Tailored or Targeted Procurement of Drugs

Tailored or targeted procurement of drugs by government.

PNDP — Targeted Procurement: Objective

Make available to its own clientele, particularly the lower-income sectors of society, the best drugs at the lowest possible cost.

PNDP — Targeted Procurement: Government role

The government is widely acknowledged as the single largest purchaser of drugs in the country, allocating a major part of its health budget for drugs and medicines.

PNDP — Fifth pillar: People Empowerment

People empowerment.

PNDP — People Empowerment: Scope

Cuts across all the four pillars.

PNDP — People Empowerment: Objective

Assist people in exercising an informed choice in the purchase of cost-effective medicines.

List A — Dangerous Drug Preparations (A1): Prescription requirements

Drugs requiring S-2 License and DDB Prescription Form.

List A — Dangerous Drug Preparations (A1): Total

19.

List A — Dangerous Drug Preparations (A1): Drug 1

Alprazolam.

List A — Dangerous Drug Preparations (A1): Drug 2

Bromazepam.

List A — Dangerous Drug Preparations (A1): Drug 3

Butorphanol (as tartrate).

List A — Dangerous Drug Preparations (A1): Drug 4

Clonazepam.

List A — Dangerous Drug Preparations (A1): Drug 5

Codeine (as phosphate).

List A — Dangerous Drug Preparations (A1): Drug 6

Diazepam.

List A — Dangerous Drug Preparations (A1): Drug 7

Fentanyl (as citrate).

List A — Dangerous Drug Preparations (A1): Drug 8

Flurazepam.

List A — Dangerous Drug Preparations (A1): Drug 9

Ketamine.

List A — Dangerous Drug Preparations (A1): Drug 10

Lorazepam.

List A — Dangerous Drug Preparations (A1): Drug 11

Methylphenidate.

List A — Dangerous Drug Preparations (A1): Drug 12

Midazolam.

List A — Dangerous Drug Preparations (A1): Drug 13

Morphine (as sulfate).

List A — Dangerous Drug Preparations (A1): Drug 14

Nalbuphine.

List A — Dangerous Drug Preparations (A1): Drug 15

Oxycodone.

List A — Dangerous Drug Preparations (A1): Drug 16

Phenobarbital.

List A — Dangerous Drug Preparations (A1): Drug 17

Pethidine (meperidine).

List A — Dangerous Drug Preparations (A1): Drug 18

Thiopental sodium.

List A — Dangerous Drug Preparations (A1): Drug 19

Zolpidem.

List A — Controlled Chemicals (A2): Prescription requirements

Drugs requiring S-2 License using Ordinary Prescription Form.

List A — Controlled Chemicals (A2): Total

3.

List A — Controlled Chemicals (A2): Drug 1

Ephedrine (as sulfate).

List A — Controlled Chemicals (A2): Drug 2

Ergotamine (as tartrate).

List A — Controlled Chemicals (A2): Drug 3

Methylergometrine (methylergonovine).

List B Medicines — Definition

Immediate-release, solid oral dosage forms of multisource (generic) pharmaceutical products that require in-vivo bioequivalence studies as proposed by the World Health Organization (WHO).

Biopharmaceutics Classification System (BCS) — Classification basis

Active pharmaceutical ingredients (APIs) are classified according to solubility and permeability.

BCS — Class I

High solubility — high permeability.

BCS — Class II

Low solubility — high permeability.

BCS — Class III

High solubility — low permeability.

BCS — Class IV

Low solubility — low permeability.

BCS — Class II API: Oral bioavailability

Heavily dependent on the formulation and manufacturing method (poorly soluble yet highly permeable).

BCS — Class III API: Oral bioavailability

Mostly dependent on the API's permeability properties (highly soluble yet poorly permeable).

Biowaiver — Eligible formulation: API

Should contain a Class I API.

Biowaiver — Eligible formulation: Dissolution

Should be rapidly dissolving, releasing at least 85% of its content in 30 minutes in media with pH 1.2, pH 4.5, and pH 6.8 at 37°C.

Biowaiver — Eligible formulation: Excipients

Should not contain excipients which could influence the absorption of the API.

Biowaiver — Eligible formulation: Therapeutic index

Should not contain an API with a narrow therapeutic index.

Biowaiver — Eligible formulation: Absorption site

Should not be designed to be absorbed from the oral cavity.

High permeability — Significance

Ensures complete uptake of 85% or more of the API during its passage in the small intestines.

BCS-based biowaiver — Consideration 1

Solubility and permeability characteristics.

BCS-based biowaiver — Consideration 2

Therapeutic use and therapeutic index of the API.

BCS-based biowaiver — Consideration 3

Pharmacokinetic properties of the API.

BCS-based biowaiver — Consideration 4

Similarity of the dissolution profiles of the multisource and comparator products in standard buffers with a pH of 1.2, pH 4.5, and pH 6.8 at 37°C.

BCS-based biowaiver — Consideration 5

Data related to the excipients composition in the multisource product are also required.

WHO biowaiver tables — Products exceeding the highest WHO EML dose

In some countries, products may be available at doses exceeding the highest dose on the WHO Essential Medicines List (EML). In such cases, the WHO tables on biowaivers may no longer be appropriate.

WHO biowaiver — Reassessment for doses exceeding the highest EML dose

The dose solubility ratio and permeability will have to be reassessed at the product dose.

PNDF Volume 1, 7th Edition — List B Medicine 1

Acetazolamide 250 mg.

PNDF Volume 1, 7th Edition — List B Medicine 2

Albendazole 400 mg.

PNDF Volume 1, 7th Edition — List B Medicine 3

Artemether 20 mg + lumefantrine 120 mg.

PNDF Volume 1, 7th Edition — List B Medicine 4

Artesunate 50 mg.

PNDF Volume 1, 7th Edition — List B Medicine 5

Azathioprine sodium 50 mg.

PNDF Volume 1, 7th Edition — List B Medicine 6

Azithromycin 500 mg.

PNDF Volume 1, 7th Edition — List B Medicine 7

Carbamazepine 200 mg.

PNDF Volume 1, 7th Edition — List B Medicine 8

Cefixime 400 mg.

PNDF Volume 1, 7th Edition — List B Medicine 9

Ciclosporin 25 mg.

PNDF Volume 1, 7th Edition — List B Medicine 10

Clofazimine 100 mg.

PNDF Volume 1, 7th Edition — List B Medicine 11

Dapsone 100 mg.

PNDF Volume 1, 7th Edition — List B Medicine 12

Diloxanide furoate 500 mg.

PNDF Volume 1, 7th Edition — List B Medicine 13

Efavirenz 200 mg.

PNDF Volume 1, 7th Edition — List B Medicine 14

Erythromycin stearate and ethylsuccinate 250 mg.

PNDF Volume 1, 7th Edition — List B Medicine 15

Etoposide 100 mg.

PNDF Volume 1, 7th Edition — List B Medicine 16

Furosemide 40 mg.

PNDF Volume 1, 7th Edition — List B Medicine 17

Glibenclamide 5 mg.

PNDF Volume 1, 7th Edition — List B Medicine 18

Griseofulvin 250 mg.

PNDF Volume 1, 7th Edition — List B Medicine 19

Haloperidol 2 mg.

PNDF Volume 1, 7th Edition — List B Medicine 20

Indinavir sulfate 400 mg.

PNDF Volume 1, 7th Edition — List B Medicine 21

Ivermectin 6 mg.

PNDF Volume 1, 7th Edition — List B Medicine 22

Lopinavir 133.3 mg + ritonavir 33.3 mg.

PNDF Volume 1, 7th Edition — List B Medicine 23

Mefloquine hydrochloride 250 mg.

PNDF Volume 1, 7th Edition — List B Medicine 24

Mercaptopurine 50 mg.

PNDF Volume 1, 7th Edition — List B Medicine 25

Nelfinavir mesylate 250 mg.

PNDF Volume 1, 7th Edition — List B Medicine 26

Nevirapine 200 mg.

PNDF Volume 1, 7th Edition — List B Medicine 27

Nifedipine 10 mg.

PNDF Volume 1, 7th Edition — List B Medicine 28

Nitrofurantoin 100 mg.