For Discussion
on 28 September 1999

Purpose

Drugs are sold or supplied by dispensaries, medicine companies and registered medical practitioners. This paper provides information on the monitoring of the sale and supply of drugs.

Licensing of Dispensaries and Medicine Companies

2. Dispensaries and medicine companies are required to obtain a licence prior to commencement of business. The licensing authority is the Pharmacy and Poisons Board, a statutory body established under the Pharmacy and Poisons Ordinance. The Board will only issue a licence to applicants who have adequate experience, knowledge and a good track record related to the sale of medicines.

3. Dispensaries are premises which are allowed to sell controlled medicines. They can be identified by the R-x logo. They are required to employ a full time registered pharmacist who is responsible for personally supervising the dispensing of prescriptions and the sale of medicines classified as Part I poisons. The certificate of registration of the pharmacist and a notice of his duty hours must be displayed in the pharmacy. The premises must have adequate facilities for the dispensing and sale of medicines. The Pharmacy and Poisons Board has also promulgated a Code of Practice for dispensaries. The Code sets out the standard required of matters including: professional independence of the registered pharmacist, publicity for services provided, and the working conditions of the premises.

4. The above requirements do not apply to medicine companies. These companies are allowed to possess and sell only a limited range of medicines which can be used safely without medical supervision or pharmacist's advice.

5. As at the end of August 1999, there are 317 dispensaries and 2,501 medicine companies.

Monitoring of Dispensaries and Medicine Companies

6. With the executive support of the Department of Health, the Board monitors dispensaries and medicine companies to ensure their compliance with the law. For dispensaries, their compliance with the Code of Practice is also monitored. Requirements of the law applicable to dispensaries include:

1. All medicines must be registered before they can be sold.

2. Some medicines can only be sold upon a doctor's prescription and under the supervision of a registered pharmacist.

3. Some other medicines (Part I poisons) can only be sold under the supervision of the registered pharmacist but without a doctor's prescription.

4. Dangerous drugs, prescription medicines and some cough medicines must be stored in locked facilities, the key of which must be kept by the registered pharmacist.

5. Records must be kept of the sale of dangerous drugs, prescription medicines and some cough medicines.

7. Both dispensaries and medicine companies are monitored by pharmacist inspectors of the Department of Health who conduct surprise inspections at their premises. The purpose of the inspections is to ensure that the law regulating the possession, sale, storage and record-keeping of the various types of medicines are complied with, and to provide professional advice on the standard of practice as per the Code of Practice of dispensaries.

8. On average, each dispensary and medicine company is inspected twice a year. More frequent visits are conducted at those with a poor record of compliance or are being complained against. A total of 6,408 inspections were conducted in 1998.

9. Besides inspections, test purchases are also conducted to detect any illegal sale of medicines. In 1998, the Department of Health conducted 9,399 test purchases. Prosecution will be initiated, upon legal advice, for offences detected during inspections or test purchases. In 1998, there were 51 prosecutions. Most of these related to the sale of prescription medicines without a prescription, the sale of some cough medicines without the supervision of a registered pharmacist, or the possession of unregistered pharmaceutical products.

10. For dispensaries, disciplinary actions are also taken by the Pharmacy and Poisons Board after a court conviction. These may result in suspension of the licence for a period of time, or the issue of a warning letter. In 1998, 15 dispensaries had their licences suspended, and 7 received a warning letter. If the conviction relates to the registered pharmacist, the latter will also be subject to disciplinary action. Since January 1999, two pharmacists have been censored, and one disqualified for a period as a result of convictions.

11. Likewise, a medicine company convicted of offences may have its licence cancelled or receive a warning letter. In 1998, 3 licences were cancelled, and 18 medicine companies received a warning letter.

Monitoring of Registered Medical Practitioners

12. All registered medical practitioners have to comply with the provisions of the Medical Registration Ordinance and the Professional Code and Conduct promulgated by the Medical Council. Registered medical practitioners are authorised to supply drugs in the course of their professional practice. However, they are required to comply with the law related to medicines including the use of registered medicines, proper record keeping of supplies of certain designated medicines, and the proper storage of dangerous drugs.

13. In 1998, the Department of Health investigated 6 complaints related to the illegal supply of medicines by registered medical practitioners. One of the registered medical practitioners was convicted of failing to keep proper record of dangerous drugs. The conviction was further referred to the Medical Council for disciplinary action.

Department of Health
September 1999

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