A draft law on the regulation of Cayman’s pharmacy practice – set to replace 44-year-old legislation – has been published online and public consultation has begun.
Residents have two months to offer their thoughts on the long-awaited Pharmacy Bill, 2023 which provides comprehensive new rules for the control, quality and safety of medicines.
According to the Ministry of Health and Wellness on its online ‘Citizens guide’ to the bill, it will “close gaps” that exist because the current Pharmacy Law, 1979 is so outdated.
The bill provides rules for clear categorisation, as well as proper handling and storage of medicines, including their importation and distribution.
It ensures the proper regulation of anyone holding a manufacturing, wholesale or dispensing licence.
The bill assigns further responsibilities to the Pharmacy Council in addition to their duties attributed in the Health Practice Act (2021 Revision).
And it ensures that the law will be successfully implemented due to the appointment of inspectors for enforcement purposes.
“The legislation is needed in order to respond to the current needs of the community by ensuring that medicines imported are of the highest quality,” the ministry said.
Key changes
There are several changes in the draft bill from current legislation – namely the Pharmacy Act, 1979 and the Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations (2017 Revision).
In the case of national health emergencies, the bill empowers Cabinet to issue an emergency-use authorisation for a non-approved medicine.
The Pharmacy Council will have the power to issue an exceptional-use authorisation for a non-approved medicine.
Medicines that are already approved in a country prescribed by regulations will not require further approval for importation to the Cayman Islands.
The bill allows the Pharmacy Council to issue, suspend or revoke licences depending on the conditions associated with each application.
It establishes clear rules on the types of medicines and who is allowed to import, manufacturer, wholesale, dispense or distribute.
Pharmacies will not be allowed to stock medicines with leaflets not written in English.
Pharmacists will also be given authority to dispense an emergency supply of a prescription-only medicine without a prescription.
That can happen only if the medicine is not a narcotic and is essential in maintaining the patient’s life or continuing therapy for a chronic condition.
Currently, those under the bill who can prescribe medicines include a medical doctor, dentist and veterinary surgeon.
“It is hoped that, once the regulations are completed, other registered practitioners, such as pharmacists and nurse practitioners, will have prescribing rights,” the health ministry said.
And the bill allows for the appointment of inspectors and empowers them to enforce certain stipulations.
Bill benefits
Among the benefits of the bill, if enacted, are that it will creates minimum standards for import, storage, wholesale, manufacturing, prescribing and dispensing of medicines.
It will ensure quality and safety of medicines imported into the Cayman Islands by meeting international standards, according to the health ministry.
Additional safeguards will be put in place to reduce importation of substandard and unregistered medicine.
The bill gives the Pharmacy Council the ability to issue various licences to address the safety and reliability of medicines manufactured, imported, supplied and distributed through a wholesaler.
It strengthens the relationship with the Customs and Border Control Service, helping to identify counterfeit or illegal importation of medicines.
The bill addresses threats posed by the illicit abuse or use of narcotic drugs and it balances the demand for and supply of narcotic drugs and psychotropic substances for legitimate purposes.
Public impact
There are three ways that the Pharmacy Bill, 2023 will directly affect the average resident if enacted, according to the health ministry.
It will grant approval for a person to import an approved medicine for self-administration purposes under certain conditions.
The law will also allow the average person to participate in the business aspects of the pharmacy practice, and it will ensure better quality, safety and efficacy of medicines.
The public-consultation period for the bill runs from 29 Sept. to 30 Nov.
Health Minister Sabrina Turner said the bill is long overdue, adding: “I encourage the community to engage with my ministerial team, as our aim is to bring it to Parliament as soon as possible.”
The Ministry of Health and Wellness will monitor and compile all the feedback that is received.
This will then be used to improve and clarify concepts, procedures or provisions within the bill.
Once approved by Cabinet, the bill will then be debated in Parliament.
For details on the draft bill and how to submit feedback visit www.gov.ky/pharmacybill.
Outdated law
Efforts have been made since at least the early 1990s to update the Pharmacy Law, 1979, but none have yet resulted in new legislation.
In 1991, a new law was drafted following a review on the pharmacy sector. That law was passed by legislators, but was never enacted.
In 2011, a Pharmacy Council subcommittee submitted suggestions for revisions to the law, but those suggestions were not incorporated into the legislation.
In 2017, then Health Minister Dwayne Seymour said in the Legislative Assembly that efforts were being made to update the legislation to “provide for prescription drugs monitoring”.
This is “a matter of particular importance, as there is evidence that suggests the misuse and abuse of prescribed drugs”, he said at the time.
According to an Office of the Auditor General report in 2017 on the healthcare system, there are no legislated regulations for pharmaceuticals in Cayman.
It said, among other things, that patients could receive multiple prescriptions from different physicians and obtain drugs from multiple pharmacies.
“We were not able to identify any other policies or guidelines in place to help ensure appropriate quality and safety protocols for prescribing pharmaceuticals,” the report added.
In January 2019, an updated Pharmacy Law was drafted and expected to be submitted to Cabinet within two months to be approved for public consultations, but no further information has been made publicly available.
Related Videos
