Ships Controlled Drugs Register

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"Controlled Drugs" or "Scheduled Drugs", are medicines that require safe custody by the majority of governments worldwide. The definition of "safe custody" differs from country to country, however, a common definition is that they need to be locked up in a safe or cabinet or other locked receptacle.

List of controlled drugs on ships

The most common medicine found in a ship's inventory that fits into the Controlled Drug (CD) legal category is Morphine sulfate, 10mg/ml, 1-ml disposable cartridges for injections. This medicine is classified as an opioid analgesic and is often required in First Aid Kits for life boats¹.

Legislative requirements

In addition to storage requirements, international medical legislation mandates that receipt and supply of Controlled Drugs need to be logged in a Ship's Controlled Drugs Register. The format of which is determined by the Medicines Legislation of the country the ship is registered in. Failure to do so in some countries is considered is a penal provision which is ultimately the ship operators responsibility².

Voyager Medical has performed an analysis of pharmaceutical legal requirements set out in international law of the following jurisdictions:

• UK inc Gibraltar - Human Medicines Regulations 2012.
• Australia - The Medicines and Poisons Act 2014
• US - Controlled Substances Act 1971
• Bahamas - Bahamas Medical Act 2014
• Panama - Ministry of Health Legislation 2010
• The Marshall Islands - Narcotics Drugs Act 1987 (updated 2014)
• Liberia - Liberia Medicines and Health Products Regulatory Act 2010
• Singapore - Medicines Act 1987
• Hong Kong - Pharmacy and Poisons Ordinance

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Common Legal Requirements

The common legal particulars that must be recorded in a ship's Controlled Drug Register are:

• the full name of the person to whom the specified drug is administered;
• the reason for administering the specified drug;
• the date and time at which the specified drug was administered;
• the name and quantity of the specified drug administered;
• the name and designation of the person who administered the specified drug.

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Nuanced Legal Requirements

The individualised legal particulars of the different medical jurisdictions include:

• Person collecting - an additional requirement is someone is collecting on behalf of the patient.
• Was ID requested? / Was ID shown? - a requirement if the person collecting is unknown to the dispenser.
• Running balance - a requirement to ensure that inventory levels meet theoretical levels.

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Maritime Best Practice Requirements

In addition to the required fields set out above, the following maritime best practice was analysed:

• MLC, 2006, Maritime Labour Convention, 2006.
• IHR, 2005, International Health Regulations, 2005, as amended
• RMI Maritime Regulations (MI-108), §7.42
• IMO Circular MSC/Circ. 1042, List of contents of the “Emergency Medical Kit/Bag” consideration for its use on Ro-Ro Passenger Ships not normally carrying a medical doctor, issued 28 May 2002 (IMDG Code Supplement, Medical First Aid Guide for Use in Accidents Involving Dangerous Goods (MFAG), 2014 Edition
• World Health Organization, International Medical Guide for Ships (IMGS), 3rd Edition 2007
• World Health Organization, Quantification Addendum, International Medical Guide for Ships, 3rd Edition 2010
• International Maritime Health 60 1-2, 2009, Guidance to the International Medical Guide for Ships 3rd edition: Interim advice regarding the best use of the medical chest for ocean-going merchant vessels without a doctor onboard

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In, conclusion, a Ship's Controlled Drugs register should meet the required fields as listed above. Modern pharmacy Best Practice stipulates this should be maintained electronically or hardcopy in a bound book (see example here). To meet all of these requirements, why not try our easy to use, no-obligation, free trial of our Ship Controlled Drugs register here of for more bespoke requirements please contact us.

HubNet.io Free Trial

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References

¹Guidance to the International Medical Guides for Ships 3rd edition, Interim advice on the best use of the medical chest. Accessed on 10^th June 2020 via: https://lagaay.com/assets-frontend/flags/IMGS1_2009.pdf

²Australian Government - Federal Register of Legislation Marine Orders - Part 10: Medical first aid on ships, Issue 4 (Order No. 13 of 2001). Accessed on 10^th June 2020 via https://www.legislation.gov.au/Details/F2006B00669