Yemens drug system: Need for change [Archives:2002/07/Health]
By Ali Mohammed Saeed
M. Sc. (Pharmacy)
The time has come for Yemen to adopt the same type of system for regulating drugs as developed countries. Among the greatest needs is to separate the administration of common over-the-counter drugs from those which are prescribed by doctors.
This will take commitment from the organizations that govern drug administration.
Without a new system, however, consumers will continue to be frustrated by unnecessary regulations when needing to buy the most basic of medicines. And doctors will continue to spend time on administrative duties, when they could spend more time on patient care.
The good news is that there is a good foundation on which to make the changes possible.
Following is an overview of the present system, its history, and how the necessary changes can be made. This review looks at:
The current situation of import regulations of medicines.
The pricing system of medicines (from supplier to the public.)
The supply of medicines to the public through government hospitals, through an evaluation of the performance of Drug Fund for Medical Supply.
The supply of medicines from abroad to the private market must pass through the Supreme Board for Drugs and Medical Appliances’. Before we analyze the registration system for medicines which is adopted by SBDMA, let’s look at the OTC (over-the-counter) drugs and the need to separately classify and regulate them.
In all government documents dealing with primary healthcare, the emphasis is on those services provided by health professionals: GPs (General Practitioners i.e. doctors), dentists, community pharmacists and opticians.
Granted, the public needs to have these qualified professionals in many situations.
But we know that nearly 90% of people with minor health problems, handle it themselves, and only 10% seek the advice of a professional such as GP. There are at least 80 specified common ailments that can be treated without a doctor’s prescription.
A person can approach the pharmacy and purchase them from Over The Counter. This is why they are called OTC medicines.
The Supreme Board for Drugs and Medical Appliances (SBDMA), however has not yet classified this group of medicines separately, nor a clear policy for how to regulate them: which documents are required for their registration and what registration fees should be paid.
The SBDMA’s role
SBDMA main role is to organize and control the import of medicines and medical appliances into the country. This process is aimed to fix a fair retail drug prices for the public, by demanding the lowest possible export prices from foreign manufacturers.
This is an essential procedure for the sale of patents and is in line with government policy in this field. In order to achieve such a goal, the SBDMA has adopted a Registration System or the imported drugs.
They advise foreign manufacturers that, if they intend to export medicines into Yemen, these drugs must be first registered with them. They request a Registration File containing certificates, scientific documents and some other materials, and they require manufacturers to print the price by non-erasable ink on the outer carton/packet of the medicine.
The SBDMA, however, has also applied the registration system for over-the-counter drugs. Almost full registration system is being applied for this group of medicines, unnecessarily.
Surely, it is essential now for this board to deregulate this group of medicine, similar to what is applied in other countries. It is time to differentiate between these OTC medicines that could be dispensed without prescriptions, and the prescribed only medicines (PoM), medicines that can only dispersed with doctor’s prescription.
The third group: Controlled drugs
There is another group of medicines called Controlled Drugs (CD). These are medicines which can only be dispersed with doctor’s prescription. The dispensed quantity is controlled by health authority from wholesalers to pharmacies and from pharmacies to patents.
It is worth to mention that some 10 years ago, SBDMA already separated the Controlled Drugs and arranged separate import permits for each quantity intended to be imported into Yemen. In June 2001, SBDMA advised importers, that is agents of drugs manufactures, that SBDMA is in the process of implementing a ‘Control System for Holding and Dispensing Narcotic and Psychtropic Drugs’, that is these controlled drugs.
The board instructed the importers to start recording quantities they receive from the supplier and quantities sold to pharmacies, either directly or through wholesalers.
The next step need now is to control the dispensing of these medicines to the patient. It is not known yet which health authority will follow up this mission.
The key for change: The Yemen Drug Index
In 1994, SBDMA has already edited the Yemen Drugs Index, which is an advanced step and an important guide for doctors and other health professionals. This index has adopted the Anatomo Therapeutico Chemical classification (ATC classification system). In the index, there is a chapter for the Registered Drugs (medicines) and a chapter for the Registered Medical Appliances.
The index includes 15 main groups based on ATC classification, subgroups and five levels. Such unique classification led to the creation of a special code for each generic name.
For example, the generic name Paracetamol now has a scientific code: N02BE01. All trade names containing peracetamol comes under this code, so that each trade name has its own number according to the pharmaceutical for (tablet, syrup, suppository etc.)
This number was adopted by SBDMA as the Registration Number for that particular commercial product, and the board requested manufactures to print it on each pack, to enable SBDMA to differentiate the officially registered drugs from those smuggled ones.
Therefore, this index will ease for us to separate the registered OTC products. It is, in fact, the key to simplify the OTC drug system.
From my experience, I suggest that we categorize the OTC products into three main groups:
1. Products of internal use of human body.
2. Products of external use for human body.
3. Products for hospitals use (medical appliances).
The first group of products are those preparations that are administered for internal use of human body. These are preparations such as:
(a) Antacids, laxatives, antidiarrhoeals, worm treatments, analgesics, cough preparations, as well as travel sickness preparations, tonic and charcoal preparations.
(b) Multi-vitamins with or without minerals, mineral supplements, herbal medicaments.
(c) Sweetening agents for diabetics and Topical (oral) contraceptives etc..
The second group of products are those preparations that are administered for external use. These are preparations such as:
(a) Cream / ointments for the treatment of nappy rash, skin and scalp, hemorrhoids, circulatory disorders, antiseptic creams.
(b) Oral hygiene products such as mouthwashes, mouth gargles and throat lozenges. Dental pastes, which prevent or treat gingivitis, stomatitis, and other mouth problems.
c) Eardrops without antibiotics for the removal of earwax, pain in acute otities media and externa.
(d) Eye care solutions/drops without antibiotics for the treatment of minor eye and eyelid infections.
(e) Foot care products for the removal of hard corns and athlete’s foot.
The third groups includes:
(a) Cotton wool, different kinds of bandages, tulles, medicated dressings and plasters.
(b) Disposable syringes, water for injection and IV solutions for various purposes.
(c) Enemas, topical anesthetics, intravaginal contraceptive, condoms, vaginal dush and preparations for diagnostic purpose.
Suggested registration and fee:
As the first group consists of medicaments of internal use, then the registration file should be arranged similar to those registration files required for registering medicines for internal use with prescription (PoM). The registration fee could be 50% of the current stipulated fee fop PoM.
As the second group consists of preparations for external use, then the registration file may confine to two documents, Certificate of Good Manufacturing Practice and Certificate of a Pharmaceutical Product, which conforms to the format recommended by the World Health Organization (WHO).
The registration fee could be 25% of the current stipulated fee for PoM.
As the third group consists of products for hospital use, then the registration file may confine to two documents, a Certificate of Good Manufacturing Practice and a Certificate of Sterilization.
The registration fee could be a lump sum of USD 50/- for each product.
The need for a guide directory for OTC products
As a completion step to the separation of OTC products, it is essential for SBDMA to arrange an OTC Directory for OTC products. This directory could provide a readily accessible reference to products available without prescription.
GPs and pharmacists will benefit from the directory in the management of common ailments.
It is ideal if the products would be arranged in this directory into therapeutic categories according to their indications, to help locate and compare products that may be used for the same conditions.
The directory should contain a table of Drug Interactions of OTC preparation with other drugs taken by the patent in the same time (Pharmaco-dynamic or Pharmaco-kinetic). Where interactions are possible, the OTC label should give sufficient warning.
Our hope: More time for patients
It is hour hope that the SBDMA takes this issue seriously, and takes the necessary steps to separate the OTC products, to issue a regulatory decree for the required registration files and registration fees, and to also arrange a special directory for them.
By implementing such, doctors will certainly devote more time to patent care and education, especially in the primary healthcare sector. The Yemeni public will be less frustrated and receive better care.
It would be a step to bring Yemen’s health care system up to par with others in the international community.