Pain management is an important and sensible problem for those who work in the public healthcare system. In the access of opioids, prices, lack of information and non-rational use of drugs, among others, are some impediments to reach them. Public production opioids might be a strategic solution.
Some impediments to access opioids
In Latin America, the consumption of opioids is below the world average and Argentina is not different to this data.
When we investigated this situation we found these impediments to access them:
1 - The lack of different presentations of medicines.
2 - The resistance for the physicians to prescribe opioids.
3 - Regulatory controls: the purchase of opioides demands meeting the international requirements.
4 - High cost to produce complex medicines with extended release.
5 - The lack of knowledge in the population about the use of opioids.
6 - Low quality information.
The development of opioids: a custom-made suit
In 2013, I received the invitation to participate, as LIF’s Director, in different meetings organized by the National Institute of Cancer (NIC).
Physicians and pharmacists from different hospitals specialised in oncology therapy attended in these activities. They formed an advisory committee to suggest a proposal about opioid supply around the country.
The development of one program to provide drugs for pain treatment in patients with active, progressive and advanced diseases was the summary and main objective of this committee.
Methadone and morphine were the drugs selected and LIF would be responsible for developing and producing the medicines.
In particular, I like explaining this project such as a custom-made suit for the NIC because the two drugs were developed under express requirements of physicians and pharmacists specialised in oncology therapy, as well as ANMAT’s regulations and technical advice of the National Program of Public Production of Medicines.
Subsequently, LIF started developing morphine 10 mg and methadone 5 and 10 mg. Both were formulated for immediate release (IR).
In the case of morphine 10 mg (IR), this was a new medication in Argentina.
LIF received a contribution to develop this project by the Health National Ministry.
Pilot Program to provide drugs for pain treatment in patients with active, progressive and advanced diseases.
Since 2014, LIF has delivered more than one million tablets of morphine and methadone through Pilot Program for pain treatment in patients with active, progressive and advanced diseases as a result of a Collaboration and Mutual Assistance agreement between LIF and NIC.
At the same time, LIF’s Technical Direction developed a strict and specific pharmacovigilance system for opioids.
At the beginning, NIC only included those hospitals which had trained staff members in palliative care.
Hospitals such as: Gabriel Carrasco, Roque Sáenz Peña, Juan B. Alberdi, de Niños Víctor J. Vilela and CEMAR (from Rosario city); General de Agudos Dr. Tornu (CABA); el Instituto de Investigaciones Médicas Alfredo Lanari (CABA) and Dr. Baldomero Sommer (General Rodríguez, Buenos Aires province) were the first institutions under Pilot Program.
Then, in 2016, NIC added other places such as: Farmacia Central del Ministerio de Salud de la Provincia de Catamarca; USAD de Ensenada (Buenos Aires province); Coronel Suárez (Buenos Aires province); Benito Juárez (Buenos Aires province), Viedma, San Luis, Cipolletti and Formosa.
Agreement between LIF and the Health Ministry of Buenos Aires province
From Novembre 2016, LIF has started delivering morphine and methadone to the Health Ministry of Buenos Aires province through a similar agreement as NIC. Due to this, LIF provided 850.000 tablets of both opioids.
Hospital Cestino de Ensenada (La plata); Hospital de las Flores; Hospital Gonnet (La Plata); Hospital Luciano y Mariano de la Vega (Moreno); Hospital Magdalena V. de Martínez (Pacheco); Hospital Mercante (José C.Paz); Hospital Oncológico Fortabat (Olavarría); Hospital Rossi (La Plata); Hospital Juan C Sanguinetti (Pilar); Hospital Municipal de Avellaneda Dr. Wilde (Avellaneda); Hospital Oncológico (Lanús); Hospital Gandulfo (Lomas de Zamora); Hospital San Juan (La Plata); Hospital Larcade (San Miguel); Hospital Eva Perón (Merlo); Hospital de Morón; Melchor Romero (La Plata) and Hospital Penna (Bahía Blanca) were the places where Health Ministry of Buenos Aires province delivered the LIF’s opioids.
Summary
Some important aspects to highlight about this successful project:
- Low production cost of opioids through public production of medicines;
- Opioids’ development according to users’ specifications (custom-made suit);
- Improvement in the access of opioids to patients with active, progressive and advanced diseases.
- Opioids’ use under an estrict pharmacovigilance system;
- Palliative care training of staff members in hospitals by NIC to include more institutions under the program.
Some impediments to access opioids
In Latin America, the consumption of opioids is below the world average and Argentina is not different to this data.
When we investigated this situation we found these impediments to access them:
1 - The lack of different presentations of medicines.
2 - The resistance for the physicians to prescribe opioids.
3 - Regulatory controls: the purchase of opioides demands meeting the international requirements.
4 - High cost to produce complex medicines with extended release.
5 - The lack of knowledge in the population about the use of opioids.
6 - Low quality information.
The development of opioids: a custom-made suit
In 2013, I received the invitation to participate, as LIF’s Director, in different meetings organized by the National Institute of Cancer (NIC).
Physicians and pharmacists from different hospitals specialised in oncology therapy attended in these activities. They formed an advisory committee to suggest a proposal about opioid supply around the country.
The development of one program to provide drugs for pain treatment in patients with active, progressive and advanced diseases was the summary and main objective of this committee.
Methadone and morphine were the drugs selected and LIF would be responsible for developing and producing the medicines.
In particular, I like explaining this project such as a custom-made suit for the NIC because the two drugs were developed under express requirements of physicians and pharmacists specialised in oncology therapy, as well as ANMAT’s regulations and technical advice of the National Program of Public Production of Medicines.
Subsequently, LIF started developing morphine 10 mg and methadone 5 and 10 mg. Both were formulated for immediate release (IR).
In the case of morphine 10 mg (IR), this was a new medication in Argentina.
LIF received a contribution to develop this project by the Health National Ministry.
Pilot Program to provide drugs for pain treatment in patients with active, progressive and advanced diseases.
Since 2014, LIF has delivered more than one million tablets of morphine and methadone through Pilot Program for pain treatment in patients with active, progressive and advanced diseases as a result of a Collaboration and Mutual Assistance agreement between LIF and NIC.
At the same time, LIF’s Technical Direction developed a strict and specific pharmacovigilance system for opioids.
At the beginning, NIC only included those hospitals which had trained staff members in palliative care.
Hospitals such as: Gabriel Carrasco, Roque Sáenz Peña, Juan B. Alberdi, de Niños Víctor J. Vilela and CEMAR (from Rosario city); General de Agudos Dr. Tornu (CABA); el Instituto de Investigaciones Médicas Alfredo Lanari (CABA) and Dr. Baldomero Sommer (General Rodríguez, Buenos Aires province) were the first institutions under Pilot Program.
Then, in 2016, NIC added other places such as: Farmacia Central del Ministerio de Salud de la Provincia de Catamarca; USAD de Ensenada (Buenos Aires province); Coronel Suárez (Buenos Aires province); Benito Juárez (Buenos Aires province), Viedma, San Luis, Cipolletti and Formosa.
Agreement between LIF and the Health Ministry of Buenos Aires province
From Novembre 2016, LIF has started delivering morphine and methadone to the Health Ministry of Buenos Aires province through a similar agreement as NIC. Due to this, LIF provided 850.000 tablets of both opioids.
Hospital Cestino de Ensenada (La plata); Hospital de las Flores; Hospital Gonnet (La Plata); Hospital Luciano y Mariano de la Vega (Moreno); Hospital Magdalena V. de Martínez (Pacheco); Hospital Mercante (José C.Paz); Hospital Oncológico Fortabat (Olavarría); Hospital Rossi (La Plata); Hospital Juan C Sanguinetti (Pilar); Hospital Municipal de Avellaneda Dr. Wilde (Avellaneda); Hospital Oncológico (Lanús); Hospital Gandulfo (Lomas de Zamora); Hospital San Juan (La Plata); Hospital Larcade (San Miguel); Hospital Eva Perón (Merlo); Hospital de Morón; Melchor Romero (La Plata) and Hospital Penna (Bahía Blanca) were the places where Health Ministry of Buenos Aires province delivered the LIF’s opioids.
Summary
Some important aspects to highlight about this successful project:
- Low production cost of opioids through public production of medicines;
- Opioids’ development according to users’ specifications (custom-made suit);
- Improvement in the access of opioids to patients with active, progressive and advanced diseases.
- Opioids’ use under an estrict pharmacovigilance system;
- Palliative care training of staff members in hospitals by NIC to include more institutions under the program.
