Management and set up of pharmacy

Sum-yi Wu 胡琛怡, Wan-shu Huang 黃婉舒, Wilson Chu 朱偉舜, Gary Chong 章宗康

HK Pract 2025;47:8-15

Summary

Keywords: Physicians, Family, Primary care, Ambulatory Care Facilities, Pharmacy

摘要

關鍵詞：家庭醫生，基層醫療，門診醫療，藥劑部

Introduction

It is important for medical clinics in Hong Kong to have access to a well-stocked pharmacy that can provide necessary medications as a part of quality care to patients. However, setting up and maintaining a pharmacy is no easy task. In this article, we will discuss the many essential details that are involved in the set up and management of a pharmacy in a clinic.

Setting up of the premises

A proper environment with necessary equipment is the foundation for a quality dispensing service. The Good Dispensing Practice Manual issued by the Hong Kong Medical Association has the following recommendations:¹

• The premises should be designed and maintained to provide a safe and hygienic environment for both the staff and the public.
• Regular cleaning and disposal of waste is important to avoid infestation and potential risk of contamination. It is especially recommended for the walls to have a smooth impervious surface to facilitate easy cleaning.
• Food and drinks should not be allowed in the dispensing areas. The level of light, temperature, noise, humidity and ventilation of the premises should be carefully controlled so as to provide a suitable environment for both the personnel and the pharmaceutical products.
• All the drugs should be properly stored and clearly labelled. Dangerous drugs must be stored separately, locked, and handled in accordance with the Dangerous Drug Ordinance (Cap. 134), which will be further discussed later in this article. The working surface, storage cabinets and shelves should again be kept clean and tidy and to be made of smooth, impervious and non-absorbent materials.
• Ergonomics and occupational health should be kept in mind in the design. Ideally, work surfaces and shelves should have appropriate heights to promote good posture and minimise reaching. More commonly used products could be stored in places within reach. Heavy things should be stored at a lower level. Appropriate tools such as carts and trolleys should be provided for the handling of heavy items.
• Dispensing equipment should be kept clean and in a good state. Common equipment includes tablets and capsules counting devices, measures, dispensing containers etc. Attention should be made to avoid cross contamination of the products.
• Medications that are temperature-sensitive need to be stored in the refrigerator. It is especially important for vaccines, which should be kept within the optimal temperature range of +2°C to +8°C from the time they are manufactured, during distribution and storage, and until they are administered, in order to maintain their safety and efficacy. Therefore, refrigerators in pharmacies should be specially designed to ensure there is no breach in the cold chain. There should be at least a maximum/minimum thermometer and it should be regularly checked and recorded. Ideally, audible and visual alarms could alert the staff when the temperatures are outside the optimal range. Domestic refrigerators are not ideal for vaccine storage as the temperature setting tends to be crude and inaccurate, and the cabinet temperature is easily affected by ambient temperature.

Proper dispensing

In a private General Practitioner (GP) clinic, very often the doctor is responsible for supervising drug dispensing. One should ensure the dispensed medication would not expire within the treatment period. The dispensed medicines should be properly labelled. The label should clearly state the prescribing doctor’s name, the patient’s name, the date of dispensing, the trade name or pharmacological name of the drug, the dosage, the route of administration, and if there are any instructions and precautions that the patient needs to be aware of. There should only be one medication per bag.¹

Dispensing is a multi-steps process and errors could be made in any of the steps. The principle of “Three Checks and Seven Rights” would help to minimise mishaps in a very busy clinic. It includes: Checking 1. Before and 2. After taking the medication out from the container, and 3. Checking the medication against the container before dispensing. And to check if it is the Right 1. Date, 2. Patient, 3. Drug, 4. Dose, 5. Route, 6. Frequency, 7. Container.¹

Stores procurement and stock management

In order to dispense drugs safely and effectively, proper drug stock management is essential. Stock should be purchased through writing, and the orders be kept for future reference. Upon receiving new drug stock, drug labels including the expiry date should be checked, and unlabelled items are rejected and the supplier is informed, so that the correct medicine delivery is ensured.¹ The principle of stock management lies in the fact that all medications should be stored under their specified conditions, including keeping them in their original manufacturer boxes or containers for easy differentiation.² Temperature of the pharmaceutical fridge should be monitored regularly in the ways described in the previous section. We would like to pay special attention to the organisation of Look-Alike, Sound-Alike (LASA) drugs, as well as documentation and management of Dangerous Drugs which should be locked in their designated cupboard or cabinets.¹

Look-Alike or Sound-Alike (LASA)

Look-Alike or Sound-Alike (LASA) drugs often bring confusion which may subsequently result in error during drug dispensing. A few common examples of LASA may include carbamazePINE and carbimaZOLE, GliCLAzide and GliMEPiride, TraMADOL and TraZODONE.

Prescription or dispensing error of LASA may be further complicated by the following common scenarios which one should be alert of during storage:³

1. Drugs with similar names may also have similar clinical dosage e.g. AmiloRIDE 5mg and AmloDIPINE 5mg.
2. Drugs with similar clinical use, may in fact have similar strength e.g. Diazepam 5mg and Nitrazepam 5mg.
3. Drugs with similar names also have similar dosage schedules and usage e.g. ZolpiDEM and zopiCLONE.
4. The same drug, especially combination drug, have different combination dosage available e.g. Sinemet® 25/100 tab, 25/250 tab, 50/200 CR tablets.
5. Drugs with immediate release and controlled release forms available such as OXYNORM® and OXYCONTIN®.
6. Deficient knowledge in drug names.
7. Newly available products that clinicians and pharmacists may not be familiar with.

As demonstrated, “tall man” lettering is an easy way to highlight these LASA drugs to raise our awareness before dispensing them. Other similar strategies such as colour-coding and LASA warning labels also further emphasise the LASA natures of these drugs to alert pharmacists when they are dispensed. It is not recommended to organise drugs in alphabetical order, instead deliberately separating LASA drugs far away from each other is preferred. Different preparations or potencies of the same drug should also be stored separately for the same reason. In addition, staff education, such as “LASA and medication safety notice board” may serve as a constant reminder in the pharmacy for raising awareness to constantly keep an attentive eye against mixing up these drugs in storage and dispensing.³

“For External Use Only” medicines

Other than ways to minimise confusion in storage, we may also broadly categorise medications according to their external and internal use first. It is good practice to distinctively mark external products with a clear “For External Use Only” label.¹

Drug replenishment

Similar to storage, the original containers should be used for drug replenishment as well. One should be aware not to mix different batches of the same product in the container, hence, replacing the whole pre-pack tray is recommended over topping up when refilling containers for pre-packs, and that clearly documenting the date of replenishment and corresponding batch number is expected. Each container should also have properly labelled drug name, strength, batch number and expiry date, so that they can be checked upon stock receipt, as well as before putting the drugs on the shelf, and that expiry dates can be regularly monitored.¹

Dangerous Drugs

Dangerous Drugs require more effort to be documented. Its management is guided by The Dangerous Drug Ordinance (Chapter 134) , The Dangerous Drugs Regulations (Chapter 134A), which recommend the use of a Dangerous Drug Register for recording its transaction in a pharmacy.⁴ A Daily Dangerous Drug Register Report is filled in chronological order, typically written one item per page and cross-checked daily against prescriptions, while an Accumulated Dangerous Drug Report is expected to be printed on the first working day of each month. In general, the register is kept for 2 years from the date on which the last entry therein was made.

Dangerous Drugs are kept in designated locked cupboards. Unserviceable Dangerous Drugs e.g., expired items should be removed timely as chemical wastes, and witnessed and recorded by a pharmacist with the clinic’s own recording system when disposed.⁴

Inspection

Random and regular inspections of licenced premises will be conducted by Department of Health. Such inspections will take place without previous notification. Additionally, if there is any change of particulars with respect to your licence, the related premises may also be inspected. During inspections, the labelling of pharmaceutical products, the facilities' storage conditions, and transaction records with the pertinent supporting documents are audited. If noncompliance with the law is found, prosecution action may be initiated. The Department of Health may issue a warning letter, revoke or suspend the licence for a period if the licensee has been convicted of an offence.⁵

For details , please refer to :
https://www.healthbureau.gov.hk/download/press_and_publications/otherinfo/100105_pharm_review/en_chapter5.pdf

Unserviceable drugs

Unserviceable drugs are defined as expired drugs, or drugs that have been improperly stocked according to the manufacturer’s recommendations, or recalled products. In order to employ the “first expired, first out” principle, and to reduce waste. We may identify short -expiry items early and label them “short expiry – use first”, or we may exchange them with suppliers, or compile a list of slow-using items to intentionally increase their usage.² The disposal of pharmaceutical chemical waste including unserviceable drugs are regulated by the Waste Disposal Ordinance (Chapter 354), the Waste Disposal (Chemical Waste) (General) Regulation (Chapter 354C). Chemical waste other than Dangerous Drugs that also require special disposal action include antibiotics, poisons and other pharmaceutical products and medicine, not elsewhere specified.⁴

A pharmacy, which acts as a chemical waste producer, is required to register with the Environmental Protection Department (EPD). When the EPD is notified of waste disposal through Form EPD 132 by the pharmacy, a licensed Chemical Waste Collector whom has signed a contract with the EPD will be sent to collect the waste, transport the waste with a standard container provided by the Collector itself, and dispose of any pharmaceutical chemical wastes at the Chemical Waste Treatment Center (CWTC). A fee applies. Appropriate labelling, again, is needed, to alert the surrounding that the content is chemicals with potential hazards. A Trip Ticket should be filed and retained for at least 12 months.⁶ For details, please refer to the “Guidance on Disposal of Unserviceable/Expired Medicines for Licensed Pharmaceutical Traders” which is available at the webpage of our office:
http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/drugdisposalguidance_eng.pdf

Figure 1. A Pharmacy layout in a medical clinic.

Expired dangerous drugs

It is similar to the procedures as stated above, the only exception is that we need to contact Licensing & Compliance Division of our office for arrangement of an inspector to oversee the disposal for dangerous drugs.

Pharmacy Automation

Automation could help to reduce the workloads of pharmacists’ and pharmacy staff, lower medication errors and shorten patient wait times. Robotic pharmacy dispensing machines could automate the clinic pharmacy’s daily prescriptions and dispense, label, count, and present medications within a few seconds. A scan-verification process could facilitate checks and balances, alert any drug mismatches and record every fill in seconds. Software programmes, automatic dispensers, and counting equipment could track output quantities and automatically update inventory, reduce reordering and stock redundancy. Additionally, electronic logs could replace manual records and integrate with the clinic pharmacy software, making reconciliations easier to manage and tightening control over sensitive or costly medications like opioids. When pharmacists can take up more patient care and clinical work like consultations, patient education, or immunisations, this may help to lower the operation costs and improve the revenue and profit margins. These systems could be explored in the near future.

Reviews the laws related to manage a pharmacy within a Medical Clinic in Hong Kong

In this section, the major laws related to medical clinic and its pharmacy are summarised.

Table 1: Laws related to medical clinic and pharmacy in Hong Kong.⁴

Conclusions

To run a well-functioning and safe pharmacy in a clinic requires a lot of effort. From design and set up, ordering and stock management, to dispensing, there are a lot of rules and regulations to be followed. The authors hope this article is able to provide some brief reminders on the important points in management of a pharmacy in clinics in Hong Kong.

References

1. The Hong Kong Medical Association. The Good Dispensing Practice Manual. Available from: https://www.thkma.org/members/guidelines/upload/guidelines/8/self/62d7a1a54b870.pdf
2. Food and Health Bureau. Report of the Review Committee on Regulation of Pharmaceutical Products in Hong Kong 2009 p. 37–43.
3. Hospital Authority, Medication safety bulletin, 2011 July; Volume 2.
4. Hong Kong e-Legislation. https://www.elegislation.gov.hk/ Accessed 19 July 2023.
5. Pharmacy and Poisons Ordinance. https://www.ppbhk.org.hk/eng/ordinance/138.html Accessed 09 May 2024.
6. Pharmacy and Poisons Regulations. https://www.ppbhk.org.hk/eng/ordinance/138a.html Accessed 10 May 2024.