The results show that medical treatment of all investigated diseases took place in German penal institutions. However, under the assumption that the number of adTP corresponds to the number of treated people per day, differences in quantity and extent of treatment were observed among the FS. To what extent requirements and directives of the MoJ affect the initiation of treatment and health care seems to differ not only among FS but also among prisons within the FS [
35,
42,
43]. The differences regarding treatment of diseases and OST in prisons might reflect the decentralized federal system in Germany, in which the states may pursue different approaches with respect to the management of medical care [
5,
6,
39].
TB treatment
Our data suggests intensive and continued tuberculosis treatments as well as chemoprevention in prisons of all participating FS except Saarland, where no TB medicine supply was observed. The treatment of resistant, complicated or severe TB was carried out in the FS Bavaria, Berlin and Thuringia. The federal city-states Berlin, Bremen and Hamburg showed high treatment prevalences for all TB substances, which implies largely initiated and continued TB treatment in those penal institutions. In Mecklenburg-Western Pomerania, Saarland and Schleswig-Holstein TB treatment was not initiated since these FS were not supplied with E and Z. However, Mecklenburg-Western Pomerania, Lower-Saxony, Saxony-Anhalt and Schleswig-Holstein showed high adTP of H and R which suggest mostly continued TB treatment and chemoprevention. In addition, Thuringia showed solely high H adTP, which might also indicate chemoprevention. A further indication of H is the treatment of R-resistant TB. However, since the proportion of corresponding E and Z is too low in the respective FS this may play only a marginal role [
26]. Further, we observed a ratio of the marker substances for the intensive and continuation phase that might indicate incomplete standard six-month regimen in most FS. However, since imprisonment can begin or end during the course of a treatment, our observation period did not necessarily capture the entire treatment time.
In all penal institutions in Berlin, each newly incarcerated person is screened for TB by chest x-ray [
24]. This active case-finding when entering prison can be equated with the prevalence of TB at the time of imprisonment [
24]. Bös and Hauer found a TB prevalence of 0.11% through active case-finding by chest x-ray examinations in 2007–2010 in Berlin’s penal institutions and 0.21% in 1996–1998 [
24,
44]. Our work found an adTP in Berlin of 0.08% and 0.10% for the marker substances E and Z, respectively. Comparing the most recent TB prevalence seen in Berlin’s penal institutions to the adTP from our analysis, treatment rates for TB were at least in Berlin consistent with the expected TB prevalence. The most important reason for not treating a prisoner in the study by Bös et al. was a too short duration of imprisonment [
24]. We found an almost equal distribution of the adTP for H and R possibly explained by the active case-finding in Berlin with no need for chemoprevention.
Treatment of Multidrug-Resistant-TB and of complicated or severe TB were each observed in only two FS, Berlin and Bavaria and Thuringia and Bavaria, respectively. This was possibly due to a transfer of patients to prison hospitals with necessary existing technical and logistical conditions.
The large range of the provision of drugs for TB treatment among the FS could be explained by co-operations between FS. Especially the co-operation of Saarland with Bavaria and North Rhine-Westphalia might be the reason why there was no TB treatments at all supplied to prisons in Saarland. According to this arrangement Saarland transferred TB infected male prisoners to Bavaria and TB infected female prisoners to North Rhine-Westphalia for treatment. Also Thuringia had a co-operation with Bavaria and transferred TB infected prisoners to Bavaria. However, TB treatments were still carried out in Thuringia with H, E and Rfb, and the latter is indicated for HIV-TB-coinfected patients. We speculate the reason why TB treatments were still carried out in Thuringia despite existing co-operations could be overcrowding or other factors that would need further investigation.
HIV treatment
HIV treatments were carried out in prisons of all participating FS, with highest treatment prevalences found in the federal city-states Bremen, Hamburg and Berlin. The higher HIV adTP compared to the HCV adTP is remarkable, especially considering that studies found a much lower HIV prevalence compared to the HCV prevalence among prisoners. Radun et al. found an HIV antibody prevalence of 0.7% [
3]. Schulte et al. came to an HIV prevalence of 1.2%. In this study, 147 prisoners were treated against HIV per year corresponding to 1.0% of all represented prisoners and to 89% of the infected prisoners [
5]. In a study by Reimer et al., 300 prisoners were treated corresponding to about 1.0% of the represented prisoners and to about 94% of the infected prisoners [
39]. Our results are in accordance with these previous studies, and the treatment prevalence of 0.39% for HIV matches more or less the expected prevalence of infection. HIV treatment seems to be the only of the four investigated treatments that is offered to an adequate proportion of estimated infected prisoners.
The combination of the agents and drug classes suggest treatment according to treatment guidelines which recommend a combination of two NRTI with either a NNRTI, PI or INI for first line therapy. The proportion of NRTI DDDcum to total NNRTI, PI and INI DDDcum suggests standard regimen distribution. Additionally, within the drug classes the DDDcum of the drugs correspond to a standard regimen. Substances differing from the standard therapy were rarely administered. This applies, for example, to the older NRTI substance didanosin and the nowadays less frequent PI substance fosamprenavir. On the other hand, newer substances were also prescribed rather infrequently, which could indicate a hesitation to apply them. This is clearly seen in rilpivirin in the substance group of the NNRTI. Furthermore, we found indication for continuation and switch of ART of previously treated prisoners. This can be seen through the delivery of etravirin in Bavaria, Hamburg and Saarland, which is indicated for the treatment in antiretroviral treatment-experienced patients.
HCV treatment
Our data suggest that HCV treatments were provided in prisons of all participating FS. Overall, during the observation period, only 0.12% of prisoners were treated per day with HCV antivirals. This HCV treatment prevalence appears to be too low considering that studies have shown HCV prevalences to be about 14% to 21% among prisoners [
3,
5,
39]. In the comparison of the FS, Bremen showed the highest HCV treatment prevalence, followed by Saarland and Schleswig-Holstein. In the two other federal city-states Berlin and Hamburg very low HCV treatment prevalences were observed, which is not consistent with the high HIV treatment prevalence in both cities. The one third lower adTP in Berlin compared to the overall adTP was therefore surprising considering Berlin has the highest incidence of newly diagnosed HCV of all FS [
45], and risk group populations are disproportionately present. We assume that the prevalence of HCV and the need of treatment among prisoners differ from prison to prison depending on the proportion of prisoners from FS with higher HCV prevalence, the proportion of PWID among prisoners, as well as the proportion of prisoners originating from countries with high HCV prevalence. Also, intra- and extramural co-operations among FS may at least partially explain the different treatment prevalences [
46]. Although studies found a much higher HCV prevalence than HIV prevalence among prisoners [
3,
5,
39] the amount of HCV treatment per prisoner is much lower than of HIV treatment.
Furthermore, the observed HCV treatment prevalence in view of the high HCV antibody prevalence of 20.6%, 14.3% and 15.0% found among prisoners in surveys is much too low [
3,
5,
39]. These studies in German prisons found low HCV treatment rates and support our findings, only 111 (0.8% of the represented prisoners) and 400 (1.4% of the represented prisoners) prisoners were treated per year [
5,
39]. According to Schulte et al., the main exclusion criteria for HCV treatment were short duration of imprisonment and drug abuse [
5]. Also in comparison to the prevalence of injecting drug use (IDU) by Radun et al. (29.7%) and Schulte et al. (21.9%), the HCV adTP of 0.12% appeared to be too low considering that studies have shown HCV antibody prevalences of 57.6% among PWID [
3,
5,
27]. Furthermore according to current guidelines, IDU is no contraindication for HCV therapy [
27].
At the time of the analysis, HCV was treated in particular with a dual combination of PEG-IFN and RBV according to the respective guidelines at that time. There was also the option of a triple therapy with one of the two protease inhibitors BOC or TVR in combination with PEG-IFN and RBV. However, this treatment was cost extensive and rich in side effects and assumedly therefore played virtually no role for the HCV treatment in prisons. Triple therapies containing BOC or TVR accounted for only 7.8% of all HCV treatments. Sligthly more triple therapies were observed in Berlin and about two times more in Bremen, Lower Saxony and Saxony. In 2013, new promising direct-acting antivirals (DAAs) against HCV had already been announced. It is possible that the low treatment numbers are partially related to the awaiting of upcoming treatment options as an analysis of drug prescription data of the general German population also suggests [
47]. Furthermore, due to the relative ineffectiveness and often serious side effects of interferon-based treatment, it seems plausible that prisoners are even less likely to wish to undergo debilitating treatment than non-prisoners. However, it is unknown to what extent costly DAA regimens have been prescribed since 2014 in the prison setting. An investigation of that would be a valuable follow-up assessment of the extent and quality of medical treatment in German prisons.
OST
We found a large range of the OST adTP between 0% in Saarland and 7.9% in Bremen. Thus, in some FS OST seems to be provided to a high proportion of prisoners, indicating a more liberal and harm-reduction-led politic. In the northern FS more prisoners had access to OST compared to Saarland and Bavaria and the eastern FS [
46]. None of the prisons in Saarland and only seven penal institutions in Bavaria were supplied with OST medicines. The amount of OST doses suggests therapy in the northern FS and an abstinence and denial approach in Saarland, Bavaria and the eastern FS. This imbalance and therapy slope among the FS was already described by Keppler et al. [
33,
46].
The low number of OST-supplied penal institutions in Bavaria is remarkable. Although OST needs no special medical tools or rooms and is simple to carry out only 7 of the 36 prisons were supplied with OST substances in Bavaria, corresponding to an OST adTP of 0.06%. Due to this low OST adTP, we assume a practice of denial or withdrawal rather than substitution treatments offered to prisoners in Bavaria [
48]. The number of 133 DDD
d OST we found in Berlin correlates well with the number of 154 and 120 OST reported for Berlin prisons by Keppler in Lehmann et al. [
46] and by Jakob et al. [
35]. According to this, 3.6% of the prisoners in Berlin received OST compared to 3.2% in our study [
46]. Schulte et al. accounted for 1,137 OST per year altogether, which corresponds to 8.0% of the represented prisoners and to 37% of the PWID in prison [
5]. In Reimer’s work, 320 long time opioid substitutions correspond to about 1.1% of the represented prisoners [
39]. The overall OST adTP of 2.18% we found in our study approximately matches the OST treatment prevalence of Schulte et al. and Reimer. However, given the IDU prevalence of 29.7% and 21.9% among prisoners found in other studies [
3,
5], even in the FS with a comparably high OST prevalence it can be concluded that only a minority of prisoners in need receive OST. Reporting on the prevalence of opioid dependence among people in prison was recently implemented in Germany, but the data is not yet published. It might be assumed that IDU mostly consists of opioid consumption. It is possible that some people coming into prison want to use the opportunity to be treated and to stop injecting but that others might prefer a cold withdrawal or do not want to reveal their addiction to avoid stigmatization or disadvantages concerning their prison conditions. Nonetheless our data show a need for scaling up OST, at least in some of the FS.
About 25% of the male and 50% of the female prisoners in Germany are PWID [
33]. OST provided during incarceration reduces the level of IDU in prison and thus the possibility of HIV and HCV transmission via unsafe use [
49]. OST as an approved effective therapy functions well in a prison setting, e.g. supervised application, regularity of intake and structured daily life [
33]. OST, particularly in combination with other harm-reduction strategies, is an evidence-based measure of HIV and HCV prevention [
16,
50,
51]. In addition, people who receive OST often show an increased compliance regarding antiviral and antiretroviral treatment [
52,
53]. For the above mentioned reasons and its protective effects, it is incomprehensible that OST is not offered in every prison. According to information provided by several prison doctors a certain proportion of PWID and thus, people in potential need of OST, are among every prison population, and no distribution of PWID to special prisons takes place. Further, this would not explain the high range of OST among the FS, suggesting an abstinence-oriented and denial approach in some FS.
IDU in prison is often unsafe due to the unavailability of sterile materials and is therefore one of the main transmission routes and major risks for HCV. Studies have shown an HCV antibody prevalence of 57.6% among PWID [
3] therefore, the HCV adTP of 0.12% appeared to be too low compared to the OST adTP of 2.18%. Studies revealed that OST access depended mainly on substitution treatment before imprisonment, short duration of imprisonment and co-morbidity such as infectious diseases [
5,
42].
Although OST guidelines exist for Germany [
54], this work shows that these guidelines are not consistently applied, and that intramural OST highly differs among the FS and prisons. This might be due to the lack of nationwide OST guidelines for prisons [
35]. However, in the absence of prison-specific guidelines the existing national OST guidelines should be applied to prisoners as well.
Limitations
The following limitations have to be considered in the interpretation of the data.
The evaluation of pharmacy delivery data allows no statement about which and how many medicines actually reached the individual patient. This can potentially lead to an overestimation of the calculated DDD for all evaluated drugs because they can be ordered in advance. On the other hand, emergency or ad hoc-orders are taken over by local pharmacies not included in our analysis, leading to a potential underestimation of the data and the corresponding treatments. However, according to a prison-supplying pharmacy, emergency orders amount to less than 2% [
55]. Furthermore, one drug package might be used for several patients. Usually, the pills are packaged according to the prescription per patient or per patient and day [
56]. We tried to avoid a bias by calculating the treatment prevalence per day. Tablets are divided only in particular cases. However, this procedure can differ from prison to prison. In addition, there are differences in the treatment management and the supply of medication in case of transfers of prisoners. In some cases, medicines are completely provided by the previously responsible prison. In other cases, after the transfer to another prison, the medicines are provided by the new prison [
56].
The treatment success and failure, including side effects and drug interactions, remain unknown. We had no knowledge of the treatment duration. Therefore we calculated the average treatment prevalence as point prevalence in percent at each single day of the whole study period. For OST we did not consider initial dosage or gradual reduction of OST, but assumed a steady dosage, so we might have underestimated the number of persons under OST medication.
Because of the missing pharmacy data of one sick ward in a prison in Mecklenburg-Western Pomerania with five beds and one correctional hospital in Lower Saxony with 52 beds, the data of Mecklenburg-Western Pomerania and Lower Saxony are not complete. Therefore the DDD and adTP in these FS might be underestimated.
Several co-operations exist among the FS limiting the representativeness of the data for the respective FS. For example, Saarland had a contract to transfer ill prisoners to Rhineland-Palatinate [
36]. Schleswig-Holstein had a transfer co-operation with Hamburg [
37]. Thuringia had co-operations with Saxony, Saxony-Anhalt and Hessen to transfer ill prisoners [
38]. Therefore the DDD and adTP of Saarland, Schleswig-Holstein and Thuringia are potentially underestimated and of Hamburg, Saxony and Saxony-Anhalt are potentially overestimated.
A further limitation is the different temporal units of the pharmacy delivery data on the one hand (per quarter of a year) and the number of the prisoners on the other hand (four calendar months). The actual duration of imprisonment as well as the information on releases such as the day of the release and the number of released prisoners cannot be derived from the available data and remain unknown. Therefore we chose to account the DDD for each day in the study period.
Moreover, this paper describes merely the proportion of treated persons among all prisoners and not among infected prisoners. To evaluate our treatment prevalence, we compared it with the prevalence seen in previous studies.