Political and executive factors affecting program implementation include support for preventive programs in Iranian Development Plans laws, Patient request from Ministry of Health, relatively rapid changes in the Ministry of Health, job instability of team treatment at the hospitals and the shortage of manpower and equipment needed in the laboratories, working in parallel with the relevant scientific and executive organizations".The system should not change with the change of managers. It must be stable. After the management, specialized staff also changes. Then the problem happens "(P.19)."
The economic and financial factors affecting the implementation of the program included the effect of economic sanctions on drug and Phe-free milk imports for patients and the publication of scientific articles, inadequate allocation of funds and financial problems for families of patients.
"Iran's sanctions have made us constrained by drug access and low access to technology" (P.17). "Families pay most of the costs. This is not a disease that to treat it and say to the patient you can go and comeback next year. Intervals between following ups are short and this creates a financial burden for families "(P. 7).
Social and cultural factors affecting program implementation include positive attitudes towards the program and more reference in order to disease prevention, weak parenting skills of parents, poor self-care in adolescents, withdrawal from treatment in adulthood, and lack of internal control, the desire for family marriages in society and social stigma associated with the disease."With age, withdrawal from treatment increases and disease control becomes more difficult. Many patients develop seizures because they have not followed the diet and their blood phenylalanine levels have risen." (P.28). "Disease-related social stigma makes it difficult to care and follow up. The parents of one of the patients changed their home so that they would not be followed up so that they would not be found. A person who has a child with PKU doesn't even tell his sister and brother that his child has PKU" (P.36)
The purpose of phenylketonuria screening national program was to reduce physical disability, mental retardation and family damage. Phenylketonuria screening program was organized at the county, provincial, and national levels. The Genetics Department of the Ministry of Health was designated as responsible for implementing the program nationwide. In the health section, health deputy of medical universities and in the treatment section, children's specialized hospitals as PKU selected hospitals implemented the program in the provinces. In order to implement the program, guidelines of laboratory, care, clinical, nutritionist, genetic diagnosis and prevention, non-classic sampling guidelines and supplementary regulations of clinical psychologists were developed. In addition, a joint memorandum was signed between the Ministry of Health and the Post Office to transfer the laboratory samples. The infant's milk powder was subsidized by the Food and Drug Administration.
The problem stream can be attributed to physical and mental disabilities, IQ loss, and the costs of not being diagnosed early (First Stream). "There was a problem. Every year a number of patients were added to PKU patients. They suffer from severe physical and mental disabilities, reduced IQs and complications such as seizures and increased financial burden for the families and health system. On the other hand, the disease was able to be diagnosed early and be cared for.(P.1).
The above problems have led health policymakers to find a solution to these problems. Therefore, with the successful implementation of the hypothyroid screening program and the use of Infrastructure of this program for phenylketonuria screening, as well as executive and scientific efforts PKU screening program was developed (Second stream)."We had already experienced congenital hypothyroidism screening. Sampling time, sampling method and sending to the lab is the same as phenylketonuria screening".(P.14).
Despite opposition from the Network Development Office to integrate the program, insufficient support of insurance organizations and deputy of treatment of ministry of health, the Phenylketonuria national screening program was implemented due to the continuous persistence of parents and their demand to initiate screening and therapeutic interventions, interest, and perseverance of executives at the Genetics Bureau to convince policymakers. (Third stream (
We, patients' families, corresponded with the Vice- Chancellor of Health Minister. He met with us. We talked to him about our problems. He was very upset about our situation. He ordered all PKU patients to be served (P.22). One of the reasons for the success of this program was the presence of a capable, interested, and persistent responsible person. (P.16).
Formulation of phenylketonuria screening policies
The scientific proposal for the implementation of the screening program was formulated by two faculty members. A services package to patients with hereditary metabolic diseases was developed by faculty members from various universities. Program feasibility was performed by different health groups. The results of the health system evaluation for the implementation of the program showed that from the perspective of some officials, the PKU program was not a priority. Documentary statistics from PKU were not available at the start of the program. There was no complete information system to provide up-to-date information on the disease. There was a lack of HPLC to confirm the tests.
Implementation of PKU screening policies
The approach to implementing PKU screening policies was a top-down approach. The pilot program was conducted in 2007 at Universities of Medical Sciences Shiraz, Mazandaran and 3 Universities of Medical Sciences in Tehran. The screening program was nationwide after the pilot in early 2013. Organizing the laboratory tests, transferring the specimens and confirming the tests were done by the Health Reference Laboratory. In the center of each province, a children's specialized hospital was organized as PKU's selected hospital. A treatment team of pediatrician, nutritionist, psychologist, social worker, and secretary was formed in these hospitals. Patients' dietary milk was distributed by the selected hospital pharmacy. At the beginning of the program, a connector was selected from the parents of the patients, but after a while, this role was assigned to the hospital staff. The follow-up of the newborn baby is monitored by health center experts. Detailed statistics of treatment and absence of treatment from the selected hospital were provided to the Ministry of health. Malignant and non-classic diagnostic tests were conducted at the Pasteur Institute.
Evaluation of PKU screening policies
Provincial experts' performance is evaluated by the Genetic Department of the Ministry of Health. In this way, periodic monitoring and completing checklists and providing statistics and documentation is done.
Challenges of Implementing a PKU Screening Program
A national screening decision was made in 2011, but was delayed due to laboratory equipment problems in medical universities in 2012. Monitoring and follow-up of PKU patients have lower priority than other programs in some selected hospitals. Selected hospitals suffered from a shortage of milk powder. It was not appropriate to record hospital and non-hospital information. Qualitative evaluation of selected hospitals was not performed well due to inadequate co-operation of some hospital managers and the lack of a supervisory system for providing PKU services in hospitals.
From the year 2007 to 2011, when we wanted to start a national screening program, during these four years, the most problems were laboratory diagnostic problems "(P.3)."One of the problems is that hospital information is not recorded very well. (P.2).
Internal stakeholders involved in the PKU national screening program include Genetics department, Health Network Development Center, Office of Population & Family Health, Health Reference Laboratory, Children Health Department, Deputies of Health Universities of Medical Sciences, Deputies of treatment Services, Selected Hospitals of PKU, Pasteur Institute, Food and Drug Administration and related research centers were external stakeholders involved in the Welfare Organization, Health Insurance Organization, PKU Patient Support Association, the Post office and Registration Office.