Challenges in the management of high-priced drugs in the SUS: evaluation of Pharmaceutical Policy in São Paulo, Brazil

Fatel, Karina de Oliveira; Rover, Marina Raijche Mattozo; Mendes, Samara Jamile; Leite, Silvana Nair; Storpirtis, Silvia

doi:10.1590/1413-812320212611.00842021

Acessibilidade / Reportar erro

Brasil

Español English

sumário « anterior atual seguinte »

Sumário

ARTICLE • Ciênc. saúde coletiva 26 (11) • Nov 2021 • https://doi.org/10.1590/1413-812320212611.00842021 copy

Challenges in the management of high-priced drugs in the SUS: evaluation of Pharmaceutical Policy in São Paulo, Brazil

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

The aim of this study is to evaluate the management capacity of the Specialized Component of Pharmaceutical Services (CEAF, in Portuguese) in the state of São Paulo (SP), according to the organizational, operational and sustainability aspects. The study was designed as an evaluative investigation, with the adoption of a theoretical model and protocol of indicators developed for application at the national level and validated (Nominal Group and Traditional Committee) for application in the reality of the SP. The data collection in the 35 CEAF units was carried out in 2017 and 2018, and covered all technical areas that participate in the management/execution of CEAF, in both its central and regional scopes. The assessment of management capacity was based on a critical analysis of the obtained results, analyzing their strengths and weaknesses. After collecting data from 35 CEAF units, it was found that the management capacity was positive in the operational dimension with challenges concentrated in the other dimensions. The results showed greater investments and development in the technical aspects of pharmaceutical services, but deficiencies in such areas as the monitoring of clinical results, infrastructure, regulation, and communication with the actors involved.

Key words:
Health Services Research; Population Health Management; Pharmaceutical Services; High-cost drugs

Indicators	Meaning of indicators	Maximum score	Results of evaluation	Points achieved	Color of indicator
Organizational Dimension				Points achieved	Color of indicator
1. Participation	Managers participate in social participation departments and there are instances which allow participation of all parts involved	10	Participated in 3 or more instances: CES, CIB, meetings for creation/monitoring of PES, technical meetings at CONASS	7.5	Green
1. Participation		10	State management developed strategies or created instances for the participation of all parts involved with CEAF: a strategy with association of patients	7.5	Green
2. Transparency	Information is published about medication out of stock and the prices paid for medication	10	State-level management developed strategies or created instances for the participation of all those involved with CEAF: a strategy with association of patients	5.0	Yellow
2. Transparency		10	The prices paid by the State for CEAF medication (group 1B and 2), are disclosed and made available for the population through the Farmanet digital system (online)	5.0	Yellow
3. Planning	Inclusion of CEAF actions in PES. Existence of planning meetings specific for CEAF	10	In PES, there are specific actions related to pharmaceutical care that involve matters related to CEAF	5.0	Yellow
3. Planning		10	CEAF managers do not hold strategic planning meetings	5.0	Yellow
4.Monitoring and evaluation of actions	There are indicators and their monitoring is used for planning actions	10	Indicators for monitoring actions related to CEAF are not used for planning actions or there are no indications of monitoring	0.0	Red
5.Partnerships	Partnerships with other institutions for the development of CEAF activities	10	There are partnerships with other institutions to decentralize care for the patients, and some partnerships are not formalized	5.0	Yellow
6. Regulamentation	There are regulated flows for the evaluation of requests and guidelines on the processes of work in the units	10	In the state, there is no established flow (documented) for the evaluation of CEAF medication requests	0.0	Red
6. Regulamentation		10	There are established guidelines (documented) for work processes only for one execution phase, at the units which develop CEAF activities	0.0	Red
7. Institutionalization	There is an institutionalized instance responsible for all the CEAF activities	10	In the administrative structure of the SES, there is an institutionalized instance (and formalized by means of publication) related to pharmaceutical care, and its competence involves only technical issues related to CEAF management. Administrative issues are handled by another coordination department.	5.0	Yellow
8.Decentralized access	Users receive care in the town where they reside	10	CEAF activities related to care for the users (requests, renewals, delivery) are decentralized for 95% of the State’s municipalities, so users can receive care in the town where they reside (state units or municipal units)	10.0	Green
Results of the dimension		-	37.5	Orange	Laranja
Operational Dimension
1. Communication	Communication between units	10	53% of the units - FME and Central Warehouse consider the communication with the central team good or very good. (score of 4 or 5)	5.0	Yellow
2. Complementarity	Concern with addressing the lines of care	10	There is no agreement on key medication (minimum list of CEAF Group 3) for the first line of care	5.0	Yellow
2. Complementarity	Concern with addressing the lines of care	10	Formalization in APAC is done for the delivery of Group 2 medication	5.0	Yellow
3.Normative conditions	Units have legal and sanitary conditions to perform their activities	10	50% of the units (FME and Central Warehouse) have a current sanitary permit	1.8	Red
			State management does not monitor updating of sanitary permits for the units which handle CEAF medication
			44% of the units (FME and Central Warehouse) have a current PGRSS
			State management does not monitor the updating of the PGRSS of the units that handle CEAF medication
			68% of the units (FME and Central Warehouse) have a current technical regularity certification issued by the CRF
			State management does not monitor the updating of the technical regularity certification issued by the CRF for the units which handle CEAF medication
4. Infrastructure	There is investment in the units, and they have the minimum infrastructure conditions	10	The current PPA does not include investment in infrastructure of the pharmacies (which includes those which deliver CEAF medication	1.3	Red
4. Infrastructure		10	35% of the units (FME and Central Warehouse) declare having 75% or more of the necessary infrastructure items	1.3	Red
5. Centers for application of medication/SR	There are SR in several places in the State	10	64% of the units declare having 75% or more of the SR of centers for application of medication researched	5.0	Yellow
6.Information systems	There are information systems for the development of activities	10	The informatized system(s) cover every activity: logistics, patient requests and management archives, except for clinical activities.	5.0	Yellow
			The system(s) used for registering CEAF activities feeds the national databank
			The system(s) does/do not interface with other systems at municipal level (ex., prescription, case files, CBAF distribution
7. Human Resources	There are Human Resources, and there is interest in continuous capacitation	10	Has capacitation training twice a year or more for pharmacists and once a year for professionals other than pharmacists who work with CEAF	5.0	Yellow
8. Financing	Capacity to apply strategies for financial balance and availability of resources	10	The state has budget planning and financial availability to cover CEAF’s acquisition needs	10.0	Green
			CEAF’s state management has a rate of 0.21% of failed purchases of APAC, in relation to the totality of APAC generated by the state management of CEAF
			The state management monitors the transfer of federal funds, referring to Group 1B, in relation to the accountability generated
9. Programing/Acquisition of Medicines	There are systems which qualify programming and acquisition of medicines	10	There is an established tool/method for the process of programing CEAF medication (of purchases centralized by the Ministry of Health and of purchases by state management)	10.0	Green
			The State always succeeds in creating tax exemptions (ICMS) for the acquisition of CEAF medication
			The State always succeeds in applying the CAP for the acquisition of CEAF medication
			There are systems of penalization, established in official publications and/or contracts for the providers who do not fulfill the established criteria, and they are always applied.
			State management develops formal and informal strategies to deal with problems in the process of acquisition of CEAF medication.
10. Best Practices in Logistics	There are systems which qualify the distribution and control of the supply of medication	10	State management provides guidelines for the Central Warehouse, aimed at achieving best practices in transportation of medication to the units which develop CEAF activities	9.0	Green
			There is an established chronogram for supplying medication for the units and extra flow chronogram
			Central Warehouse does periodic physical inventories
			94% of the FME do periodic physical inventories
11. Availability of Medication	There is interest in providing opportune care for the users	10	37.4% of the medication from Group 1B and 2 were missing for more than a month out of the year	6.5	Yellow
			The State has strategic stock in the units which develop execution activities for CEAF of the Central Warehouse
			There is no evaluation by a Pharmacy Council to select CEAF medication by line of care, aimed at producing/updating the state’s list
			76% of the FME do not detect delays in medication distribution due to HR fault and/or infrastructure deficiencies in caring for the users (in case there is medication available)
Results of the dimension		110	-	63.5	Yellow
Sustainability dimension
1.Social Control	Inclusion of CEAF in CES discussions	10	During the last year, CEAF matters were not brought to CES for discussion. The team attended the CES only to clarify information	0.0	Red
2. Manager’s profile	There is a manager of pharmaceutical assistance position, formally instituted, responsible for the management of CEAF, who receives qualification	10	There is the position of coordinator/director/manager of pharmaceutical care, who is formally appointed; however, he/she is not responsible for full CEAF management (in technical and administrative terms)	7.5	Green
2. Manager’s profile		10	The coordinator/director/manager of pharmaceutical care is educated in the area of management and has experience in pharmaceutical care	7.5	Green
3 Accessibility	Time required to provide the needs of the users, existence of litigation, and systems for avoiding litigations	10	Only 13.5% of the patients who sought the “Acessa SUS” program in the last year were eligible for the CEAF	9.0	Green
			The average time lapse between registering the process and the first delivery (of medication) for the 10 most frequent diseases in the State is 6 to 20 days
			91% of the patients registered in the last year received care
4.Relationship between services	Actions of follow-up at the units, periodical provision of orientation, and relationship between management and other areas of the healthcare network	10	Manager (central level): considers that he/she provides orientation, regarding CEAF execution, and does follow-up actions at the units. FME: 91% reported having received orientation from the central CEAF manager on execution and only 9% reported having received an in-house, technical, follow-up visit	3.5	Orange
4.Relationship between services		10	State management does not discuss CEAF demands (consultations, exams, absences, basic care) with other services of the healthcare network	3.5	Orange
5. Clinical Aspects	There is treatment follow-up and provision of first care by pharmacist	10	In only 21% of the units, the first distribution (of every medication or for Hepatitis C and other specific pathologies) to the patient is done by a pharmacist	0.0	Red
5. Clinical Aspects		10	0.7% of the clinical aspects dealt with by the PCDT are registered in an information system	0.0	Red
6. Relationship with the users	Management shows concern with the users’ satisfaction, through evaluations and Ombudsman services	10	30% of the FME did surveys of customer satisfaction in the last year	3.8	Orange
			27% of the FME used data obtained from customer satisfaction surveys to improve their services
			There are Ombudsman services, which receive patient opinions concerning the services provided by CEAF state-level management; however, the management does not use the information obtained for planning purposes
Results of the dimension		60	-	23.8	Orange
Total score for the protocol		250	-	125	-

Judgement Criteria	Color	Scoring	Meaning
Indicators	Green	75% to 100% of the points	Maintain/Improve - represents the indicators which meet the parameters considered acceptable by experts
	Yellow	50% to 74% of the points	Needs Care - represents the indicators which had improvements but still need to be perfected
	Orange	25% to 49% of the points	Warning - represents indicators that must be improved
	Red	0% to 24% of the points dos pontos	Urgent - represents indicators which must be prioritized
Dimensões	Green	75% to 100% of the points	The situation found in the dimension is in accordance with what is expected of the management capacity of CEAF
	Yellow	50% to 74% of the points	There have been improvements in the situation found, but there is need for improvement in management capability
	Orange	25% to 49% of the points	Management capability must be improved
	Red	0% to 24% of the points	The situation found is critical and compromises management capability of CEAF, indicating a priority for management

ABRASCO - Associação Brasileira de Saúde Coletiva Av. Brasil, 4036 - sala 700 Manguinhos, 21040-361 Rio de Janeiro RJ - Brazil, Tel.: +55 21 3882-9153 / 3882-9151 - Rio de Janeiro - RJ - Brazil
E-mail: cienciasaudecoletiva@fiocruz.br

Acompanhe os números deste periódico no seu leitor de RSS

[1] Collaborations

The authors participated equally in every phase of the production of this article.