Health Minister restricts the dispensing of ketamine, anesthetics, sedatives, and veterinary hormones to prescription only and tightens oversight of their trade

Abdul Karim Al-Abdullah: Health Minister Dr. Ahmed Al-Awadi issued a decision regarding the regulation of the trade of prescription veterinary medicines, a move aimed at tightening control over the dispensing and distribution of a group of veterinary drugs and preparations, primarily Ketamine, and establishing a clear regulatory framework for their prescription, dispensing, and documentation of incoming and outgoing quantities.

The decision comes as a continuation of efforts and cooperation between the Ministries of Health and Interior to strengthen oversight and control over the trade of narcotic drugs and psychotropic substances, and to reduce the likelihood of misuse, by tightening the regulations governing the dispensing and distribution of certain preparations used in the veterinary sector and enhancing tracking and monitoring mechanisms.

The decision, published by Al-Anbaa, stipulates that the licensed place for selling veterinary medicines shall be designated as a “veterinary pharmacy,” subject to the legal and executive controls and requirements. It also requires the appointment of a pharmacy manager, who must be either a pharmacist licensed to practice pharmacy or a veterinarian licensed to practice veterinary medicine.

**Ban on dispensing specific drugs without a veterinary prescription**

The decision emphasized that the drugs listed therein must not be dispensed from any veterinary medicine sales outlet, regardless of their pharmaceutical form, except upon presentation of a veterinary prescription issued by a veterinarian licensed to practice veterinary medicine in the State of Kuwait. This shifts the dispensing of these drug groups into a stricter framework based on the existence of a veterinary prescription that meets all data and regulatory requirements, with the ability to track incoming and outgoing quantities.

**Ketamine and sedatives under surveillance**

The decision placed anesthetic and sedative drugs (Anesthetics / Sedatives) on the list of medicines prohibited from being dispensed without a veterinary prescription. These include:

- Ketamine

- Dexmedetomidine

Subjecting these preparations to veterinary prescription is part of a system aimed at tightening control over their dispensing and distribution, reducing the likelihood of misuse, and documenting the movement of dispensed and available quantities at sales outlets.

**Regulating the dispensing of hormones**

The regulation extended to include a group of hormones (Hormones). The decision subjected the following to veterinary prescription:

- Hormones (general)

- Cyproterone Acetate

- Corticosteroids

- Oxytocin

Subjecting these substances to veterinary medical prescription enhances oversight of the dispensing of hormones and corticosteroids used in the veterinary field and limits the possibility of their distribution or use outside their designated medical and veterinary purposes.

**Preventing misuse of muscle-building drugs and stimulants**

The decision also included anabolic and androgenic steroids (Anabolic / Androgenic Steroids), a group associated with muscle-building processes, and subjected their dispensing to veterinary prescription. These include:

- Anabolic (general)

- Nandrolone Decanoate

- Finasteride

Tightening control over this category of veterinary medicines will help prevent their diversion to unauthorized uses and enhance the ability to track quantities entering veterinary facilities and those dispensed from them.

**Corticosteroids and stimulants...**

The decision establishes a stricter regulatory framework for the trade of corticosteroids, hormones, and anabolic stimulants used in veterinary practice by prohibiting their dispensing without a prescription and recording incoming and outgoing quantities as well as remaining balances. This regulation aims to reduce the opportunities for humans to misuse veterinary preparations for non-therapeutic purposes, including those related to muscle building and bodybuilding.

Antibiotics are prohibited without a veterinary prescription. The decision was not limited to narcotics, sedatives, hormones, and stimulants; it also subjected a wide range of antimicrobials to the requirement of a veterinary prescription. These include: Antibiotics, Antiprotozoals, Antifungals, Antivirals, and Anthelmintics. Consequently, the distribution of these categories covered by the decision is prohibited at veterinary pharmacy outlets without a prescription issued by a veterinarian licensed in Kuwait.

Central Nervous System Agents

The decision also covers drugs affecting the central nervous system (CNS Agents), specifically designating Atomoxetine, the dispensing of which at veterinary pharmacy outlets is now subject to a veterinary prescription in accordance with established regulations.

The decision includes an important dimension concerning the protection of human health and the safety of animal products. It mandates that prescriptions specify the purpose of animal rearing, indicating whether the animal is intended for food production or not. Additionally, it requires specifying the animal’s species, number, sex, age, weight, microchip number, and diagnosis. It also obligates the determination of the approved withdrawal period for the drug, if applicable, thereby regulating the interval that must be observed when using certain veterinary drugs in food-producing animals before their products are utilized for consumption. This enhances consumer health security and mitigates the risks of drug residues resulting from the unregulated use of medications in food-producing animals.

A Precise Prescription Specifying Dosage

The decision obligates the veterinarian to issue a prescription containing their complete details, including their full three-part name, professional license number, name of the hospital, center, clinic, or veterinary practice, address, phone number, email, signature, stamp, and the date of prescription issuance.

The prescription must also include the owner’s details, the animal’s details and diagnosis, as well as the drug’s trade or scientific name, pharmaceutical form, concentration, and prescribed quantity. The dosage and method of administration—whether intramuscular, intravenous, oral, or topical—must be specified, along with the frequency of administration and the duration of treatment. Furthermore, instructions regarding use, storage, and disposal of the medication must be provided.

An Official Register

To strengthen oversight, the decision obligates the manager of the veterinary pharmacy to maintain a dedicated register within the facility. The pages of this register must be sequentially numbered and stamped by the Ministry of Health. It must record, in a timely manner, all quantities of drugs covered by the decision received, dispensed, and remaining in stock, ensuring that the ledger’s data continuously matches the actual physical quantities on hand. The decision also mandates the retention of purchase invoices and dispensed prescriptions for at least six months from the date of purchase or dispensing.

Comprehensive Inventory and Monthly Reports

The decision requires agents of veterinary pharmaceutical companies to submit a detailed statement of their inventory of drugs covered by the decision, including types and quantities, within one month of the decision’s effective date, following approval by the Pharmaceutical Inspection and Licensing Administration. They are also obligated to submit monthly reports on the quantities received and dispensed of these drugs, in accordance with the controls and procedures approved by the Ministry of Health.

Pharmaceutical Inspection and Licensing Monitors Implementation

The Pharmaceutical Inspection and Licensing Department is tasked with reviewing records, ensuring compliance with the decision, and submitting a report to the Director General of the General Department of Veterinary Drug Control and Pharmaceutical Affairs to take the necessary action. Thus, the decision establishes a supervisory system that begins with companies’ stockpiles, extends through veterinary drug sales outlets, and concludes with the prescription, quantities dispensed, and remaining balance. The decision affirmed that the legally prescribed provisions, penalties, and administrative measures will be applied to any violator of its terms, and it shall enter into force from the date of its publication in the Official Gazette.