Homepage[Homepage] - [Newsletter]
Search
or
orAdvanced search  Contact
Volume 1
 Warehouse and Administration
 Relief and Logistics Kits, ERU, RDU
 Personnel security equipment
 Radio and Telecommunication
 Power supply and electrical equipment
 Tools and Hardware
 Food
 Household
 Shelter and construction materials
 Livelihood
 Vehicles and consumables
 Water and Sanitation

Volume 2
 Drug products
 Medical disposable supplies
 Medical equipment
 Cold chain
 Laboratory
 Physical Rehabilitation

Volume 3
 Basic health care ERU
 Emergency care and triage
 Rapid Deployment Emergency Hospital
 Referral hospital ERU
 Surgical hospital, weapon wounded
 Medical kits
 Feeding and nutrition Kits
 Medical sets
 Surgical instruments and sets

 Introduction-Acknowledgements
 Quality-Standards-Inspection
 Item database, codes and description
 Units conversion
 Medical weight and volume
 Symbols
   Drug products > Introduction

This chapter is a reference list of Drugs recommended for use in the Red Cross/Red Crescent medical activities.

The selected drugs fill as much as possible the criteria: essential, effective and generally available at a low price. The list reflects the experience of various users in the field and also refers to the WHO Model List of Essential medicines 2007.

It will be up to each organisation to select from this list the drugs adapted to the level of users and to the specific medical programmes. The drugs selected for the Catalogue are listed according to therapeutic group according to the classification utilised in the WHO Model List of Essential Medicines.

Details concerning dosage, contra-indications, adverse effects, precautions, storage conditions and specific remarks may be found in the MSF "Essential Drugs practical guidelines", WHO Formulary, or any official compendium.

Quality assurance in medical procurement

Counterfeits and substandards are an increasing problem from year to year. Medical products are highly affected in all countries.

  1. -      According to WHO , most industrialized countries with effective regulatory systems and market control (e.g. USA, most of EU, Australia, Canada, Japan, New Zealand) have a low proportion, i.e. less than 1% of market value of counterfeit drugs on the market
  2. -      Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit, while other developing markets have less than 10%; overall, a reasonable range is between 10% and 30%
  3. -      Many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value — this falls into the developing country range
  4. -      Medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases.

Considering the above, it is recommended that qualified persons are employed to secure procurement of medical products. Qualified person should be able to control different topics such as :

Specification of the products against Pharmacopoeias: These establish official quality specifications for most commonly used pharmaceutical substances, excipients, dosage forms and packaging materials.

GMP (Good Manufacturing Practices): GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate with their intended use and as required by the marketing authorization. GMP establish official requirements in respect of premises, equipment, personnel, documentation, quality control etc. for drug manufacturers and recently for manufacturers of medical devices.

GDP (Good Distribution Practices): GDP is that part of quality assurance which ensures that the quality levels are maintained throughout the distribution network so that authorized medical products are distributed without any alterations of their properties.

Licensing of manufacturers, wholesalers, importers and retail outlets

Product licences (marketing authorizations). Product licences are official documents issued by a competent drug regulatory authority, within a country, for the purpose of marketing or free distribution of a product. It establishes, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula, specifications of its ingredients, its packaging, storage characteristics and shelf life.

ISO standards issued by the International Organization of Standardization (ISO), exist for certain items of medical equipment.

Quality certificates or Export certificates issued under various national and regional standards.

Also the qualified person should be able to deal with independent quality control laboratories, in case an analysis of the product needs to be performed.

Narcotic and psychotropic drugs

Medications subject to particular international and national controls

The import, export, transport, storage and distribution of some medications are problematic because they are subject to particular controls by virtue of their nature.

The United Nations has adopted conventions providing for international controls on narcotics and certain psychotropic substances, i.e. substances that can be used for non-medical purposes (leading to drug addiction).

The International Narcotic Control Board in Vienna is responsible for administering these controls on the production, consumption and movement of these substances.

All items in the catalogue that are or contain narcotic or psychotropic drugs are indicated with C1 in their respective sheet (see list of restricted medicines below).

Those on the list are:

Morphine, Pethidine, Fentanyl

(Narcotics, schedule I)

Pentazocine

(Psychotropic drugs, schedule III)

Phenobarbital, Diazepam

(Psychotropic drugs, schedule IV)

The governments that have signed the conventions are required to take steps at national level to enable them to control these substances.

The domestic legislation, however, differs considerably from on country to another, since not all the signatories have yet implemented the Vienna requirements. Some countries are still rather tolerant, but more and more countries are following INCB recommendations regulating schedule III and IV psychotropic substances (like Diazepam and Phenobarbital) as severely as narcotics substances. Some have introduced even more stringent regulations and control substances not on the lists of the international conventions.

Import permits are sometimes required for Chlorpromazine, Ketamine, Thiopental and Tramadol (e.g. in Russia) although they are not regulated internationally.

Import permits are sometimes required for Ergometrine and Ephedrine (e.g. in Russia), even if Vienna Conventions only apply for those substances as raw materials (those could be used for illicit traffics in psychotropics and narcotics substances) and not as finished products. Substances that sometimes need an import permit are indicated with C2 in their respective sheet (see list of restricted medicines below).

Please note that the import/export authorisation system makes the quick international transportation of controlled drugs to site of emergencies virtually impossible. Consequently, simplified regulation procedures have been agreed upon during emergencies. They are described in "Model Guidelines for the International Provision of Controlled Medicines for Emergency Medical Care, WHO/PSA/96.17".

Practical recommendation :

Any organisation can be accused by national authorities of illicit traffic of narcotics or psychotropics if  international and national regulation are not followed.

This is why it is recommended to always meet Narcotics Department of the Ministry of Health to enquire about :

  1. -      The national list of controlled drugs
  2. -      Purchase rules (import allowed ?)
  3. -      Import license
  4. -      Storage condition of these drugs (lock cupboard, seal cupboard, cage, need of a pharmacist or not)
  5. -      Registration of movements
  6. -      Dispensing rule (only Medical Doctors ? empty ampoules back to ministry ?)
  7. -      Destruction of these medicines (sometimes an official from Ministry of Health is required)
  8. -      Archiving of Document (import/export licence, bin cards, register…)

Expired drugs

General point

The conventional expiry date is based on the average rate of deterioration under standard conditions of light, temperature and humidity. The date is set such that under those conditions, the therapeutic effectiveness remains unchanged (at least 90% of the active ingredients must be present and there must be no substantial increase in toxicity).

In tropical countries, storage conditions, temperature, humidity and light are very often different from those under which the stability of the drugs was tested. It therefore needs to be asked whether the drugs are still safe and effective.

The first point is that drugs do not suddenly become ineffective when they reach their expiry date. They deteriorate slowly and in different ways as time goes by.

Deterioration varies from one product to another, in the case of each product depending on the form, and in the case of each form depending on the manufacturing technique, the quality of the raw materials, additives and so on.

Expiry

In most countries the regulations require manufacturers to establish the stability of their products under standard conditions and to guarantee a minimum shelf life. Common periods are 3 and 5 years. Some fragile products are guaranteed for only one or two years.

The expiry date must appear on the packaging together with any storage requirements.

Remember that procurement should aim at insuring 2/3 remaining shelf life on delivery to end user.

Deterioration

It is important to ascertain the normal characteristics of every drug (colour, odour, solubility, consistency) in order to be able to detect any changes which might indicate impairment. It is worth noting, however, that some forms of deterioration are not always apparent.

The main consequence of any deterioration is a decrease in therapeutic activity, which may have more or less serious consequences for the individual or the community. Using expired -i.e. less active- antibiotics, for example, encourages the development of resistant strains.

As time goes by, some drugs undergo changes which lead to the formation of far more hazardous substances and therefore to an increase in toxicity. Tetracycline is the prime example: the pale yellow powder becomes brownish and viscous; it is then dangerous to use it even if it has not reached its expiry date.

An increase in the allergenic properties of some drugs has been observed. This is the case, for example, with penicillins and cephalosporins.

Suppositories, ovules, creams and ointments which have melted in the heat must not be used. The active constituent will no longer be homogeneously distributed throughout the base.

Some fragile compounds should be rejected even before their expiry date if they have been stored at excessively high temperatures.

 

Disposal of unwanted products (medicines)

Drug products which are not needed or have expired must be disposed of safely in order to prevent posing any risks to public health (diversion for use or sale) or the environment (contamination of water sources or air pollution).

Any disposal must comply with national legislation and regulations in the respective country and special procedures are often required for disposal of drug products subject to international control [controlled drugs]. The "Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies" (WH0 1999, WHO/EDM/PAR/99.2) should be followed with disposal in purpose built incinerators as the preferred method.

Heat sensitive item

Classification and shipment

Heat sensitive drugs and diagnostics require that temperature conditions are respected both in transport and storage.

Very sensitive items, such as vaccines or insulin lose their potency quickly when exposed to temperatures above 10°C.. There are also other items which, even though not as sensitive to heat as the vaccines, require that cold chain is respected.

All heat sensitive items must be dispatched respecting the following precautions:

-      They are transported by air, the field is informed about the date and time of arrival.

-      They are transported in insulated vaccine packaging boxes coated with ice packs. These boxes maintain the correct temperature for 72 hours after leaving the supplier.

-      In order not to interrupt the cold chain, it is recommended to transport the cold boxes to the place of destination and to put the vaccines in the refrigerator upon arrival.

-      They must be accompanied by a cold chain monitor card

 

In addition, you may find the following indication for some items in relation to their sensitiveness to freezing: NF: "Do not freeze".

This concerns mainly adsorbed vaccines in Liquid formulations like diphtheria, pertussis, tetanus, hepatitis B, Haemophilus influenzae, type b, IPV and their combinations .

 

Practical recommendation :

In case of a breakdown in the cold chain, products have to be quarantined and the supplier contacted for further instruction.

List of medicines

The list here presented corresponds to the standard list for ICRC and IFRC, classified under the WHO EML classification (EML: Essential Medicines List).

Legend:

WHO n°

Included in WHO EML

No WHO n°

Not included in WHO EML

*

Transport and storage in cold chain

C1 and C2

See introductory remarks "Narcotic and psychotropic drugs - Medications subject to particular international and national controls"

J

To justify - request for this item must be justified by Health Coordinator and submitted to health department for approval, it applies to both ICRC & IFRC

 

Applies to IFRC:  

C1 and C2

Use restricted to hospital settings, for use in primary health care settings request needs to be justified by Health Coordinator and submitted to IFRC Health Department for approval, import permit required

H

Request for use outside hospital settings needs to be justified by Health Coordinator and submitted to IFRC Health Department for approval.

 

List of restricted medicines

 

Notes

Code

Description

C1

DINJDIAZ1A

DIAZEPAM, 5mg/ml, 2ml, amp.

C1

DINJFENT1A

FENTANYL, 0.05mg/ml, 2ml, amp.

C1

DINJMORP1A

MORPHINE HYDROCHLORIDE, 10mg/ml, 1ml, amp.

C1

DINJPENA3A

PENTAZOCINE, 30mg/ml, 1ml, amp.

C1

DINJPETH1A

PETHIDINE, 50mg/ml, 2ml, amp.

C1

DORADIAZ5T

DIAZEPAM, 5mg. tab.

C1

DORAPENA2T

PENTAZOCINE, 25mg, tab.

C1

DORAPHEN5T

PHENOBARBITAL, 50mg, tab.

C1

KMEDKIAE01SN

IEHK, NARCO/PSYCHO MODULE

C2

DINJCHLM5A

CHLORPROMAZINE, 25mg/ml, 2ml, amp.

C2

DINJEPHE3A

EPHEDRINE, 30mg/ml, 1ml, amp.

C2

DINJERGM2A

METHYLERGOMETRINE, 0.2mg/ml, 1ml, amp.

C2

DINJERGM5A

ERGOMETRINE, 0.5mg/ml, 1ml, amp.

C2

DINJKETA5V

KETAMINE, 50mg/ml, 10ml, vial

C2

DINJNALO4A

NALOXONE, 0.4mg/ml, 1ml, amp.

C2

DINJTHIO5V

THIOPENTAL SODIUM, 500mg, powder, vial

C2

DINJTRAM1A

TRAMADOL HYDROCHLORIDE, 50mg/ml, 2ml, amp.

C2

DORAERGM5T

ERGOMETRINE MALEATE, 0.5mg, tab.

C2

DORATRAM5C

TRAMADOL, 50mg, caps.

C2

KMEDKIAE01S

(iehk, suppl.,10.000 pers./3m) NO NARCO/PSYCHO/MALARIA/PEP  

C2

KMEDKREP01

KIT, REPRODUCTIVE HEALTH

C2

KMEDKWWF05

KIT, 50 WAR WOUNDED, FIRST AID & TRIAGE, MEDICAL- single use

C2

KMEDKWWH05   

KIT, 50 WAR WOUNDED, HOSPITALIZED, SINGLE USE        

C2

KMEDMAEC01B    

MODULE, ADVANCED EMERGENCY CARE, for health prof., back pack

C2

KMEDMFAT50A  

MODULE, FIRST AID-TRI. A: SINGLE USE, 50 war wou./casualties

C2

KMEDSDRU05F

SET, DRUGS, for 50 First aid-triage war wounded/casualties  

C2

KMEDSDRU05SB

SET, DRUGS FOR SURG. AND ANAEST., BASIC for 50 patients     

C2

KMEDSDRU05SS

SET, DRUGS FOR SURG. AND ANAEST., SUPLEMENTARY, 50 patients

C2

KMEDZGVA098

(k rep.h.) KIT, SURGICAL, drugs & med. mat. s.u, B 11/UNFPA

 

About this site and copyright
powered by SolidPepper