Strengthening Sales Control of Codeine-containing Medicines Effective on January 26, 2024



News & Short Communications
HKPharm J Volume 31 (1), Jan-Apr-2024 (2024-04-29): P.4-6

Strengthening Sales Control of Codeine-containing Medicines Effective on January 26, 2024

Date: January 25, 2024

 

The Hong Kong government will publish the Pharmacy and Poisons (Amendment) Regulation 2024 on January 26th, 2024, to reinforce the sales control of codeine-containing medicines. The regulation will classify all medicines containing less than 0.2 percent of codeine as Part 1 Schedule 1 poisons under the Pharmacy and Poisons Regulations.

 

The Department of Health (DH) has expressed concern over the abuse of codeine-containing medicines in Hong Kong. Currently, medicines with 0.2 percent or more codeine are considered Part 1 Schedule 1 Schedule 3 poisons and can only be purchased at Authorized Sellers of Poisons (ASPs, commonly referred to as pharmacies) under the supervision of the registered pharmacist with a valid doctor's prescription. Medicines containing more than 0.1 percent codeine (but less than 0.2 percent) are classified as Part 1 Schedule 1 poisons, which can only be sold at ASPs under the supervision of the registered pharmacist, and require ASPs to register the purchaser's personal information (including the name, identity card number, address and signature) in the Poisons Book before sales completion.

 

Under the new regulation, to be effective on January 26th, 2024, medicines containing not more than 0.1 percent codeine will also be regarded as a Part 1 Schedule 1 poison, amending from the previous classification as a Part 1 poison. This strengthened control will require ASPs to comply with the additional requirement in the registration of the purchaser's personal information in the Poisons Book before finalizing the sale, while other current controls remain unchanged.

 

According to the Pharmacy and Poisons Ordinance, illegal sales of Part 1 poisons or prescription drugs is a criminal offense, with a maximum penalty of HKD100,000 and two years imprisonment for each offense. Pharmacies failing to comply with the requirement to make an entry in the Poisons Book before completing the sale of Part 1 Schedule 1 poison may face a maximum fine of HKD5,000.

 

Source: www.drugoffice.gov.hk

 

 

 

FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

Date: March 8, 2024

 

The U.S. Food and Drug Administration (FDA) has recently expanded the approved indication of Wegovy (semaglutide) injections. Now, in addition to aiding weight loss, Wegovy is approved for a new indication in reducing the risk of cardiovascular death, heart attack, and stroke in obese or overweight adults with cardiovascular disease. It is recommended that Wegovy is used alongside a calorie-reduced diet and increased physical activity.

 

The active ingredient of Wegovy, semaglutide, is a glucagon-like peptide-1 (GLP-1) receptor agonist, and hence should not be combined with other drugs containing semaglutide or other GLP-1 receptor agonists.

 

Wegovy’s efficacy and safety for the new indication were assessed in a multi-national, multi-center, placebo-controlled double-blind trial that involved more than 17,600 participants. Participants were randomly assigned to receive either Wegovy or a placebo, along with standard-of-care medical treatment (e.g. management of blood pressure and cholesterol) and healthy lifestyle counselling (including diet and physical activity). The result of the trial demonstrated that Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke), which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received the placebo.

 

It should be noted that Wegovy contains a boxed warning about the potential risk of thyroid C-cell tumors. As such, patients with a personal or family history of medullary thyroid carcinoma or those with Multiple Endocrine Neoplasia syndrome type 2 should avoid using this medication.

 

Further warnings on Wegovy encompass risks like pancreatitis, gallbladder problems (including gallstones), hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal thoughts or behaviors.

 

The most common side effects of Wegovy include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, belching, hypoglycemia in patients with diabetes, flatulence and gastroesophageal reflux disease (heartburn).

 

Source: www.fda.gov

 

 

FDA Approves Rezdiffra (Resmetirom) as First Treatment Option for Noncirrhotic Non-alcoholic Steatohepatitis with Liver Scarring

Date: March 14, 2024

 

Non-alcoholic Steatohepatitis (NASH) is commonly diagnosed during non-alcoholic fatty liver disease progression which may potentially lead to liver scarring and dysfunction over time. The disease is also found to have a strong association with chronic health problems including hypertension and type 2 diabetes. Currently, there is no specific medication indicated for NASH, and lifestyle modification is the suggested management method based on various guidelines.

 

Rezdiffra (Resmetirom) was approved by the U.S. Food and Drug Administration through the accelerated approval pathway on March 14th, 2024, for treating NASH with moderate to advanced liver fibrosis alongside diet and exercise in adults. Rezdiffra is a partial thyroid hormone receptor activation that exerts its pharmacological effect by reducing hepatic fat accumulation. It is also the first oral medication that demonstrates improvements in liver scarring among NASH patients.

 

Efficacy and safety evaluations of Rezdiffra were done based on the surrogate endpoints at month 12 in an ongoing 54-month, randomized, double-blind placebo-controlled trial involving 888 subjects with hepatic inflammation and moderate or advanced liver scarring due to NASH. Participants were randomly assigned to take 80 mg of Rezdiffra (n=298), 100 mg of Rezdiffra (n=296), or placebo (n=294) orally once daily in combination with lifestyle modification recommendations. A greater portion of participants receiving Rezdiffra treatment showed improvements in liver scarring or NASH resolution through liver biopsies 12 months after the first dose of Rezdiffra. Diarrhoea and nausea are the most common side effects observed during the trial. A post-approval study assessing Rezdiffra’s clinical benefit is expected upon the completion of the same 54-month study.

 

Drug-induced liver toxicity and gallbladder-related side effects were stated as warnings and precautions regarding Rezdiffra usage. Patients with severe hepatic impairments or decompensated cirrhosis should refrain from taking Rezdiffra. Dosage adjustments and monitoring of statin-related side effects are recommended for patients taking both Rezdiffra and statins due to potential drug interactions.

 

The recommended dose of Rezdiffra ranges from 80 – 100 mg daily based on the patient’s actual body weight and is to be taken once daily. The oral medication can be administered with or without food.

 

Source: www.fda.gov

 

 

Ribociclib plus Nonsteroidal Aromatase Inhibitor Prolongs Invasive Disease-free Survival in Patients with Early Stage Breast Cancer

Date: March 21, 2024

 

Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer is the most common subtype of breast cancer. The current treatment approach for early HR-positive, HER-2 negative breast cancer is surgical removal with or without radiotherapy or chemotherapy, followed by adjuvant endocrine therapy for 5 to 10 years. Ribociclib is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor indicated for patients with HR-positive, HER2-negative advanced breast cancer.

 

In the international and open-label phase 3 NATALEE trial, 5101 patients with HR-positive, HER2-negative early breast cancer were randomly assigned in 1:1 ratio to receive ribociclib (400 mg orally once daily for 21 days with 7 days off for 36 months) plus a nonsteroidal aromatase inhibitor (NSAI; either letrozole 2.5 mg or anastrozole 1 mg orally once daily) (n=2549) or NSAI monotherapy (n=2552) for 60 months. Men and premenopausal women in both groups also received subcutaneous goserelin 3.6 mg once every 28 days for gonadal suppression. The primary endpoint was invasive disease-free survival according to standardized definitions for efficacy endpoints (STEEP) criteria. Distant disease-free, recurrence-free, and overall survival were the secondary efficacy endpoints. Adverse events and serious adverse events were also monitored throughout the entire trial.

 

The second interim efficacy analysis for invasive disease-free survival at 3 years performed after 426 events of invasive disease, recurrence or death were higher in the ribociclib plus NSAI group (90.4%) compared with the NSAI monotherapy group (87.1%). The hazard ratio for invasive disease, recurrence, or death was 0.75 (95% confidence interval [CI], 0.62 – 0.91; P=0.003). Analysis on secondary efficacy endpoints in terms of distant disease-free and recurrence-free survival also demonstrated consistent results with primary findings. Reports of neutropenia (62.1% vs 4.5%) and liver-related events (25.4% vs 10.6%) were more prevalent in the ribociclib-NSAI group.

 

The prespecified interim analysis of the NATALEE trial showed a significantly lower risk of invasive disease, recurrence, or death in patients with early-stage HR-positive, HER2-negative breast cancer treated with adjuvant ribociclib-NSAI regimen.

 

Source: www.nejm.org

 


2024-04-29 於2024月04月25日

Strengthening Sales Control of Codeine-containing Medicines Effective on January 26, 2024

Date: January 25, 2024

 

The Hong Kong government will publish the Pharmacy and Poisons (Amendment) Regulation 2024 on January 26th, 2024, to reinforce the sales control of codeine-containing medicines. The regulation will classify all medicines containing less than 0.2 percent of codeine as Part 1 Schedule 1 poisons under the Pharmacy and Poisons Regulations.

 

The Department of Health (DH) has expressed concern over the abuse of codeine-containing medicines in Hong Kong. Currently, medicines with 0.2 percent or more codeine are considered Part 1 Schedule 1 Schedule 3 poisons and can only be purchased at Authorized Sellers of Poisons (ASPs, commonly referred to as pharmacies) under the supervision of the registered pharmacist with a valid doctor's prescription. Medicines containing more than 0.1 percent codeine (but less than 0.2 percent) are classified as Part 1 Schedule 1 poisons, which can only be sold at ASPs under the supervision of the registered pharmacist, and require ASPs to register the purchaser's personal information (including the name, identity card number, address and signature) in the Poisons Book before sales completion.

 

Under the new regulation, to be effective on January 26th, 2024, medicines containing not more than 0.1 percent codeine will also be regarded as a Part 1 Schedule 1 poison, amending from the previous classification as a Part 1 poison. This strengthened control will require ASPs to comply with the additional requirement in the registration of the purchaser's personal information in the Poisons Book before finalizing the sale, while other current controls remain unchanged.

 

According to the Pharmacy and Poisons Ordinance, illegal sales of Part 1 poisons or prescription drugs is a criminal offense, with a maximum penalty of HKD100,000 and two years imprisonment for each offense. Pharmacies failing to comply with the requirement to make an entry in the Poisons Book before completing the sale of Part 1 Schedule 1 poison may face a maximum fine of HKD5,000.

 

Source: www.drugoffice.gov.hk

 

 

 

FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

Date: March 8, 2024

 

The U.S. Food and Drug Administration (FDA) has recently expanded the approved indication of Wegovy (semaglutide) injections. Now, in addition to aiding weight loss, Wegovy is approved for a new indication in reducing the risk of cardiovascular death, heart attack, and stroke in obese or overweight adults with cardiovascular disease. It is recommended that Wegovy is used alongside a calorie-reduced diet and increased physical activity.

 

The active ingredient of Wegovy, semaglutide, is a glucagon-like peptide-1 (GLP-1) receptor agonist, and hence should not be combined with other drugs containing semaglutide or other GLP-1 receptor agonists.

 

Wegovy’s efficacy and safety for the new indication were assessed in a multi-national, multi-center, placebo-controlled double-blind trial that involved more than 17,600 participants. Participants were randomly assigned to receive either Wegovy or a placebo, along with standard-of-care medical treatment (e.g. management of blood pressure and cholesterol) and healthy lifestyle counselling (including diet and physical activity). The result of the trial demonstrated that Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke), which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received the placebo.

 

It should be noted that Wegovy contains a boxed warning about the potential risk of thyroid C-cell tumors. As such, patients with a personal or family history of medullary thyroid carcinoma or those with Multiple Endocrine Neoplasia syndrome type 2 should avoid using this medication.

 

Further warnings on Wegovy encompass risks like pancreatitis, gallbladder problems (including gallstones), hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal thoughts or behaviors.

 

The most common side effects of Wegovy include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, belching, hypoglycemia in patients with diabetes, flatulence and gastroesophageal reflux disease (heartburn).

 

Source: www.fda.gov

 

 

FDA Approves Rezdiffra (Resmetirom) as First Treatment Option for Noncirrhotic Non-alcoholic Steatohepatitis with Liver Scarring

Date: March 14, 2024

 

Non-alcoholic Steatohepatitis (NASH) is commonly diagnosed during non-alcoholic fatty liver disease progression which may potentially lead to liver scarring and dysfunction over time. The disease is also found to have a strong association with chronic health problems including hypertension and type 2 diabetes. Currently, there is no specific medication indicated for NASH, and lifestyle modification is the suggested management method based on various guidelines.

 

Rezdiffra (Resmetirom) was approved by the U.S. Food and Drug Administration through the accelerated approval pathway on March 14th, 2024, for treating NASH with moderate to advanced liver fibrosis alongside diet and exercise in adults. Rezdiffra is a partial thyroid hormone receptor activation that exerts its pharmacological effect by reducing hepatic fat accumulation. It is also the first oral medication that demonstrates improvements in liver scarring among NASH patients.

 

Efficacy and safety evaluations of Rezdiffra were done based on the surrogate endpoints at month 12 in an ongoing 54-month, randomized, double-blind placebo-controlled trial involving 888 subjects with hepatic inflammation and moderate or advanced liver scarring due to NASH. Participants were randomly assigned to take 80 mg of Rezdiffra (n=298), 100 mg of Rezdiffra (n=296), or placebo (n=294) orally once daily in combination with lifestyle modification recommendations. A greater portion of participants receiving Rezdiffra treatment showed improvements in liver scarring or NASH resolution through liver biopsies 12 months after the first dose of Rezdiffra. Diarrhoea and nausea are the most common side effects observed during the trial. A post-approval study assessing Rezdiffra’s clinical benefit is expected upon the completion of the same 54-month study.

 

Drug-induced liver toxicity and gallbladder-related side effects were stated as warnings and precautions regarding Rezdiffra usage. Patients with severe hepatic impairments or decompensated cirrhosis should refrain from taking Rezdiffra. Dosage adjustments and monitoring of statin-related side effects are recommended for patients taking both Rezdiffra and statins due to potential drug interactions.

 

The recommended dose of Rezdiffra ranges from 80 – 100 mg daily based on the patient’s actual body weight and is to be taken once daily. The oral medication can be administered with or without food.

 

Source: www.fda.gov

 

 

Ribociclib plus Nonsteroidal Aromatase Inhibitor Prolongs Invasive Disease-free Survival in Patients with Early Stage Breast Cancer

Date: March 21, 2024

 

Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer is the most common subtype of breast cancer. The current treatment approach for early HR-positive, HER-2 negative breast cancer is surgical removal with or without radiotherapy or chemotherapy, followed by adjuvant endocrine therapy for 5 to 10 years. Ribociclib is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor indicated for patients with HR-positive, HER2-negative advanced breast cancer.

 

In the international and open-label phase 3 NATALEE trial, 5101 patients with HR-positive, HER2-negative early breast cancer were randomly assigned in 1:1 ratio to receive ribociclib (400 mg orally once daily for 21 days with 7 days off for 36 months) plus a nonsteroidal aromatase inhibitor (NSAI; either letrozole 2.5 mg or anastrozole 1 mg orally once daily) (n=2549) or NSAI monotherapy (n=2552) for 60 months. Men and premenopausal women in both groups also received subcutaneous goserelin 3.6 mg once every 28 days for gonadal suppression. The primary endpoint was invasive disease-free survival according to standardized definitions for efficacy endpoints (STEEP) criteria. Distant disease-free, recurrence-free, and overall survival were the secondary efficacy endpoints. Adverse events and serious adverse events were also monitored throughout the entire trial.

 

The second interim efficacy analysis for invasive disease-free survival at 3 years performed after 426 events of invasive disease, recurrence or death were higher in the ribociclib plus NSAI group (90.4%) compared with the NSAI monotherapy group (87.1%). The hazard ratio for invasive disease, recurrence, or death was 0.75 (95% confidence interval [CI], 0.62 – 0.91; P=0.003). Analysis on secondary efficacy endpoints in terms of distant disease-free and recurrence-free survival also demonstrated consistent results with primary findings. Reports of neutropenia (62.1% vs 4.5%) and liver-related events (25.4% vs 10.6%) were more prevalent in the ribociclib-NSAI group.

 

The prespecified interim analysis of the NATALEE trial showed a significantly lower risk of invasive disease, recurrence, or death in patients with early-stage HR-positive, HER2-negative breast cancer treated with adjuvant ribociclib-NSAI regimen.

 

Source: www.nejm.org

 

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